Table of Content

CONTENTS
METHODOLOGY............................................................................................XXVI
CHAPTER 0: DEMOGRAPHICS............................................................................1
Introduction..........................................................................................................................1
0-1 Respondents’ Area of Involvement ..........................................................................2
0-2 Respondents’ Qualifications.....................................................................................4
0-3 Facility Locations.......................................................................................................6
0-4 Areas of Biopharmaceutical Manufacturing Operations........................................8
0-5 Production Operations, Phase of Development.................................................... 11
0-6 Employees at Facility ..............................................................................................14
0-7 Batches Run at Facility per Year ............................................................................15
0-8 Single-Use Bioreactor Capacity in Use at Site......................................................17
0-9 Stainless Steel Bioreactor Capacity in Use at Site ...............................................19
CHAPTER 1: INTRODUCTION AND DISCUSSION .............................................21
1-1 Sector and Market Overview...................................................................................21
The Biopharma(ceutical) Industry is Losing its Core Identity.....................................22
M&A Activities ............................................................................................................23
Contract Manufacturing Trends..................................................................................24
1-2 Biopharmaceutical Industry Status and Market Trends.......................................25
U.S. Healthcare is Changing .....................................................................................25
1-3 Pharma Industry is Shifting to Biopharmaceuticals.............................................28
Pharmaceutical Industry Dependence on Biopharmaceuticals..................................28
1-4 Global Biopharmaceutical Market Trends ............................................................29
Growth in Biopharmaceutical Product Sales is Increasing the Demand
for Bioprocessing .......................................................................................................30
Overall Health of the Biopharmaceutical Sector ........................................................34
U.S. Industry Leadership Continues ..........................................................................36
Biopharmaceuticals in the Rest-of-the-World.............................................................36

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1-5 Biopharmaceutical Markets by Product Class......................................................38
Monoclonal Antibodies (mAbs) are the Leading Product Class .................................39
Monoclonals are a Costly Treatment .........................................................................39
Animal Derived Products and Biopharmaceuticals ....................................................41
Plant-based Biopharmaceutical Manufacturing ........................................................41
1-6 Future Trends in the Biopharmaceutical Industry ................................................42
Future Trends in Biopharma ......................................................................................42
Conclusion .................................................................................................................46
CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE ..............47
2-1 2023 FDA Biopharmaceutical Approvals: Promising Year for Novel
Biologics Driven by Innovation and Targeted Therapies.....................................48
2-2 China’s Position in Global BioManufacturing: A Comparison of
China’s Emerging Position vs Established Regions’ Manufacturing
Capacity and Production.........................................................................................54
2-3 Gene-modified Cell Therapies: A Brief Overview of the Field’s
Most Advanced Modality.........................................................................................63
2-4 Design Principles and Solutions to Purification Challenges of
Asymmetric Fc-Containing Bispecific Antibodies................................................67
2-5 CRISPR-based Treatment: Capabilities and Challenges......................................78
CHAPTER 3: TRENDS AND EMERGING TECHNOLOGIES ..................................81
3-1 Industry Trends in 2024...........................................................................................81
Introduction ................................................................................................................81
3-2 Bioprocessing Improvements Needed
in 2024.......................................................................................................................82
Bioprocessing Improvements Most Needed ..............................................................82
Novel Bioprocessing Systems/Innovations ................................................................85
Novel Bioprocessing Systems/Innovations, Biomanufacturers vs. CMOs .................89
3-3 Operational Changes in 2024..................................................................................91
Operational Changes (2010 – 2012, 2022-2024) ......................................................93
Operational Changes: Biomanufacturers vs. CMOs ..................................................96
Operational Changes: U.S. vs. Western Europe........................................................98
3-4 Budget Issues in 2024 ...........................................................................................100
Budget Change Comparisons (2009-2024) .............................................................103
3-5 Top Bioprocessing Budget Expenditures............................................................108
Top New Bioprocessing Budget Expenditures (2020-2024) .................................... 110
3-6 New Bioprocessing Products Development Opportunities (2024).................... 112
Upstream New Product Areas of Interest................................................................. 112
Trends: Upstream New Product Areas of Interest (2010-2024)............................... 114
Downstream New Product Areas of Interest ............................................................ 116
Trends: Downstream New Product Areas of Interest (2010-2024) .......................... 118
Other General New Product Areas of Interest .........................................................120
Trends: Other General New Product Areas of Interest (2010-2024)........................122

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New Product Development Areas: Biomanufacturers vs. CMOs .............................124
New Product Development Areas: U.S. vs. Western Europe and ROW.................126
3-7 Cost-Cutting Actions & Development Timelines ................................................128
Cost-Cutting Changes: Specific to Outsourcing ......................................................130
Factors Impacting Reduction in Cost of Goods (2020-2024)...................................132
3-8 Average Cost per Gram Recombinant Protein....................................................133
Distribution, Average Cost per Gram for PRIMARY Recombinant Protein
(2017-2024) ............................................................................................................134
3-9 Assay Development...............................................................................................136
Biomanufacturing Assay Areas Required; Biomanufacturers vs. CMOs ................138
Biomanufacturing Assay Areas Required, U.S. vs Western Europe .......................140
3-10 Selecting and Purchasing Commercial-Scale Bioreactors ...............................142
Largest Commercial-Scale Bioreactor Expected in Next Two Years (2022 data)....142
Top Options for Bioreactor Platforms at Commercial Scale.....................................143
Largest Stainless Steel Bioreactor Capacity Purchase in Next Two Years
(2024) (2022 data) ...................................................................................................146
Largest Single-Use Bioreactor Capacity Purchase in Next Two Years
(2024) (2022 data) ...................................................................................................147
3-11 Discussion: Industry Trends and Issues ............................................................148
Cost Cutting Trends ................................................................................................148
Discussion of Needed Single-use Innovations.........................................................149
Trends in Bioprocessing Industry Desires for Improved Products and Services .....150
CHAPTER 4: CAPACITY UTILIZATION .............................................................151
4-1 Capacity Utilization Trends ...................................................................................151
Capacity Utilization Definitions.................................................................................151
Relevance of Capacity Utilization ............................................................................151
Capacity Utilization in Other Industries, 2024: US Federal Reserve Board
Comparisons...........................................................................................................152
Capacity Utilization in Biomanufacturing, 2024........................................................153
Capacity Utilization in Biomanufacturing, By System, 2024 ....................................153
Capacity Utilization Changes (2006-2024) ..............................................................154
Average Growth Rate in Capacity Utilization (2006-2024).......................................157
4-2 Capacity Utilization: Biomanufacturers vs. CMOs .............................................157
4-3 Capacity Utilization: U.S. vs. Western European Manufacturers ......................160
Historical 12-year US vs EU Trends in Capacity Utilization .....................................161
Availability of CMO/CDMO Capacity........................................................................163
4-4 Respondents’ Current Total Production Capacity ..............................................164
Mammalian Cell Culture Capacity............................................................................164
Microbial Fermentation Capacity .............................................................................169
Cell Therapy Capacity..............................................................................................173
Gene Therapy Capacity ...........................................................................................176
4-5 Global Bioreactor Capacity ..................................................................................179
The Largest Capacity Facilities................................................................................181

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Biopharmaceutical Capacity Expansions Continue .................................................182
Biopharmaceutical Developers/Manufacturers as CMOs ........................................183
Major CMOs in Terms of Facilities and Capacity .....................................................184
4-6 Range of Titers with mAb Production..................................................................185
Annual mAb Titer Changes (2008-2024) .................................................................187
4-7 DISCUSSION: CAPACITY AND INDUSTRY TRENDS...........................................189
The Risks of Biomanufacturers Seeking to become a CMO....................................189
Future Capacity Trends............................................................................................190

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS AND
QUALITY FACTORS..........................................................................................191
5-1 Current Capacity Constraints ...............................................................................191
Introduction .............................................................................................................191
Current Capacity Constraints...................................................................................191
Respondents Experiencing No Capacity Constraints (2004-2024)..........................195
Respondents’ Perception of Capacity Constraints (2004-2024) ..............................195
Differences in Capacity Constraints: Biomanufacturers vs. CMOs .........................197
Capacity Constraints: U.S. vs. Western European Biomanufacturers & CMOs ....199
5-2 Expected Capacity Constraints ............................................................................200
Respondents’ Expectations of Capacity Constraints in Five Years (2029) ..............200
Expected Capacity Constraints Five-year Projections (2004-2024) ........................202
Expected Capacity Constraints in Five Years: Biomanufacturers vs. CMOs
(2029).......................................................................................................................204
Expected Capacity Constraints in Five Years: U.S. vs. Western Europe (2029) ....206
5-3 Factors Impacting Future Production Capacity..................................................207
Factors Creating Future Capacity Constraints in Five Years (2029)........................207
Factors Creating Future Capacity Constraints (2008-2024) ....................................209
CMO Capacity Bottleneck Projections, in Retrospect..............................................215
Biomanufacturers’ Capacity Bottleneck Projections, in Retrospect .........................215
Factors Creating Capacity Constraints: U.S. vs. Western Europe Respondents.....215
5-4 Key Areas to Address to Avoid Future Capacity Constraints............................218
Areas to Avoid Capacity Constraints: Changing Perspectives (2006-2024) ............220
Key areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs 223
Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe .....225
5-5 Batch Failures in Biopharmaceutical Manufacturing .........................................227
Average Time Between Batch Failures (2009-2024) ...............................................227
Batch Failure Frequency Distribution (2009-2024) ..................................................229
Improving Failure Rates...........................................................................................229
Primary Cause of Batch Failures, Percentages of Failures .....................................231
5-6 Automation Implementation..................................................................................238
Demand for Automation ..........................................................................................238
Automation Implementation ....................................................................................238
Comparison of Implementation Plans (2009-2013, 2022-2024) ..............................240

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5-7 Quality Problems in Biomanufacturing Attributed to Vendors..........................242
Global Quality Supply Management (2023).............................................................242
Global Quality Supply Management (2011-2013, 2022-2023).................................243
Global Quality Supply Management Biomanufacturers vs. CMOs (2023)...............245
U.S. vs. W. Europe Global Quality Supply Management (2023)..............................246
Addressing Supply Chain Security...........................................................................247
5-8 Discussion: Industry Trends.................................................................................249
Automation...............................................................................................................249
Single-use Systems .................................................................................................249
Skilled Staff .............................................................................................................249
CHAPTER 6: PLANNED FUTURE CAPACITY EXPANSIONS .............................251
6-1 Planned Future Capacity Expansions..................................................................251
Industry Average Planned Production Increases, Five Years Estimates (2029)......251
Planned Future Capacity Expansions: Five Year Estimates (2009-2029)...............253
6-2 Planned Future Capacity Expansions for Biomanufacturers vs CMOs,
by System ...............................................................................................................255
Planned Future Capacity Expansions for Biomanufacturers vs. CMOs,
Five Year Estimates (2029)......................................................................................255
6-3 Planned Future Capacity Expansions for U.S. vs. Western Europe,
by System ...............................................................................................................256
Planned Future Capacity Expansions for U.S. vs. Western European
Manufacturers, Five Year Estimates (2029).............................................................256
6-4 Planned Future Capacity Expansions of >100%, by Systems...........................258
Planned Future Capacity Expansions of >100%, by Systems.................................258
6-5 Planned Future Global Capacity Expansions ....................................................260
CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL
MANUFACTURING ..........................................................................................263
Introduction ..............................................................................................................263
Why Outsource? ......................................................................................................264
Strategic Manufacturing Planning ............................................................................264
Future Projections....................................................................................................265
7-1 Current Outsourcing by Production System.......................................................266
Facilities Currently Outsourcing No Production (All Production “In-house”)
(2006-2024) .............................................................................................................268
Historical Trends in Outsourcing Production............................................................270
7-2 Future Outsourcing................................................................................................271
Biotherapeutic Developers’ Outsourcing, 5-Year Projections, by System (2029) ....271
Five Year Projections for Biomanufacturers Outsourcing Some Production............273
7-3 Outsourced Activities in Biopharmaceutical Manufacturing.............................275
Comparison of Biomanufacturers’ Outsourcing, (2010-2024)..................................277
Increased Outsourced Activities, 24-Month Projections ..........................................280
Outsourcing Activities Projected at ‘Significantly Higher Levels’ (2010-2024) ........282

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Average Percentage of Activities Outsourced Today, 2024 .....................................285
Comparison of Outsourcing Activities (2010-2024)..................................................287
Change in Average Spending on Outsourcing Activities..........................................290
Average Change in Outsourcing Spending by Facilities (2013-2024) .....................292
7-4 CMOs’ Problems with Their Clients .....................................................................293
CMOs Problems with Their Clients (2018 data).......................................................293
7-5 Country Selections for International Outsourcing (Offshoring)
of Biomanufacturing..............................................................................................294
Country Selections for International Outsourcing (Offshoring) of
Biomanufacturing, Over Five Years (2016-2024).....................................................297
U.S.-based Companies Capacity Expansion Destinations ......................................301
U.S.-based Companies Outsourcing Destinations...................................................304
W. European – based Companies Capacity Expansion Destinations......................306
W. European – based Companies Outsourcing Destinations ..................................309
7-6 Offshoring Trends to Lower-Cost Regions..........................................................312
5-Year Projection for Biomanufacturing International Outsourcing /Offshoring
to Lower-Cost Regions ............................................................................................312
Five Year Projection for Biomanufacturing International Outsourcing/Offshoring
to Lower-Cost Regions (2011-2024) ........................................................................314
Five Year Projection for Average Percentages of Biomanufacturing
International Outsourcing/Offshoring to Lower-Cost Regions (2011-2024) .............316
Outsourcing to New Regions (2020 data)................................................................318
7-7 Discussion of Outsourcing and Offshoring ........................................................319
Strategic Shifts in Outsourcing.................................................................................319
Future Projections....................................................................................................319

CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN
BIOPHARMACEUTICAL MANUFACTURING....................................................321
8-1 Use of Disposables and Single-Use Systems .....................................................321
Disposables Applications in Biopharmaceutical Manufacturing ...............................322
Trends in Disposable Applications (2006-2024).......................................................324
Average Annual Growth Rate for Disposables: Market Penetration/Usage.............327
18-Year Average Growth in Disposable Applications, Percentage-Point Gains.......330
Disposable Use by Stage of Production/Application ...............................................332
Use of Disposables: Biomanufacturers vs. CMOs ...................................................334
8-2 Leachables and Extractables ...............................................................................336
Issues Related to Leachables and Extractables (2018 data)...................................336
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems ................336
Single Most Critical Reason for Increasing the Use of Disposables (2018 data).....336
8-4 Factors That May Restrict Use of Disposables ..................................................337
Most Critical Reasons for Restricting Use of Disposables (2019 data) ...................337
Most Important Reasons for Not Increasing Use of Disposables (2008-2019)........337
Cell-Culture Problems due to Single-Use Devices (2022 vs. 2021) ........................337
Recycling of Disposables (2020) .............................................................................338

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8-5 Single-Use Adoption Issues..................................................................................340
Evolution of SUS Adoption.......................................................................................340
Single-use Failures by Timeframe and SUS Type ...................................................340
Average Weeks Before Failures of Single-use Devices, 2023 vs 2024...................342
8-6 Need for Single-use Sensors, and Bioreactor Attributes...................................343
Single-Use Sensor Technologies (2012-2017, 2019)...............................................343
8-7 Satisfaction with Single-Use Device Vendors (2008-2024) ................................346
Single-Use Attribute Importance Analysis ................................................................348
Single-Use Suppliers’ Issues (2013-2024)...............................................................350
8-8 Single-Use Operations and Trends ......................................................................353
Percentage of Unit Operations that are Single-Use (2014-2024) ............................353
Percentage of Single-Use Device Usage in Biomanufacturing................................355
8-9 Discussion: Single-use Bioprocessing ...............................................................357
Single-use Advantages ............................................................................................357
Growth in the Use of Single-use Systems ...............................................................357
Downstream Single-use Systems Usage.................................................................358
CMOs’ Use of Single-use Equipment.......................................................................359
Modular: The Next Trend after Single-Use?............................................................359
Single-use Equipment Sourcing, Quality Issues, and L&E Testing..........................360
CHAPTER 9: DOWNSTREAM PURIFICATION..................................................363
9-1 Impact of Downstream Processing on Capacity.................................................363
Impact of Downstream Processing on Overall Capacity..........................................364
Impact of Downstream Processing on Capacity, Biomanufacturers vs. CMOs .......366
Impact of Downstream Processing on Capacity, U.S. vs. Western European
Biomanufacturers.....................................................................................................369
9-2 Specific Purification Step Constraints.................................................................371
Changes in Impact on Capacity of Purification Steps (2008-2024) .........................373
Specific Purification Step Constraints, U.S. vs. Western European
Biomanufacturers.....................................................................................................374
9-3 Downstream Purification Issues ..........................................................................377
Protein A and Alternatives (2022 data).....................................................................377
Changes in Perception of Protein A and Alternatives (2009-2017, 2020-2022).......378
Protein A Downstream Purification Issues, U.S. vs. Western Europe (2022 data) ..380
9-4 mAb Purification Capacity Estimates .................................................................381
Upstream Production Titer vs. Max Capacity...........................................................381
9-5 New Downstream Processing Technologies.......................................................385
New Downstream Processing Solutions (2010-2024) .............................................387
New Downstream Processing Technologies; Biomanufacturers vs. CMOs.............390
New Downstream Processing Technologies: U.S. vs. Western Europe ..................392
9-6 Improvements to Downstream Operations .........................................................394
Improving Downstream Operations (2019)..............................................................394
9-7 Discussion: Industry Trends.................................................................................396
Upstream Expression Titer Trends and Impact on Downstream Operations ...........396
Downstream Processing Solutions ..........................................................................396

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CHAPTER 10: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN
BIOPHARMACEUTICAL MANUFACTURING....................................................401
Industry Overview ....................................................................................................401
10-1 Hiring Trends..........................................................................................................402
Trends in New Hires, by Area (2008-2024)..............................................................402
10-2 Five Year Trends in Hiring (2029)..........................................................................405
10-3 Hiring Challenges Today .......................................................................................406
Hiring Difficulties (2010-2024)..................................................................................408
U.S. and Western Europe Hiring Difficulties ............................................................412
10-4 Training in Biopharmaceutical Manufacturing....................................................414
Skills or Hands-On Training Required in New Hires in GMP Bioprocessing............414
10-5 Discussion: Strategies For Successful Employment Growth ...........................416
Educational Programs..............................................................................................416
Strategic Trainings ...................................................................................................416
Attractive Career Paths............................................................................................417

CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS
INTENSIFICATION, CELL AND GENE THERAPIES............................................419
Introduction to Innovative Bioprocessing...........................................................419
Advanced Therapies ................................................................................................419
Improved, Continuous Bioprocessing ......................................................................419
11-1 Future Adoption of Continuous Bioprocessing and Process Intensification..421
Future of Continuous Bioprocessing (2021-2024) ...................................................423
11-2 Perfusion Operations and Continuous Bioprocessing Operational Issues.....425
Perfusion Operation Issues (2010-2016, 2020, 2023-2024)....................................425
Perfusion vs. Batch Fed Bioprocessing – Areas of Much Bigger Concern ..............427
Evaluating or Considering CBP technologies (Upstream)
Over the Next 12 Months (2016-2024) ....................................................................429
Evaluating or Considering CBP technologies (Downstream)
Over the Next 12 Months (2016-2024) ....................................................................431
11-3 Cell and Gene Therapy Platforms ........................................................................433
Cell Therapy Manufacturing Improvements, Systems, Platforms,
and Infrastructure (2019-2024) ................................................................................433
Gene Therapy Manufacturing Improvements, Systems, Platforms,
and Infrastructure (2019-2024) ................................................................................436
Advanced Therapy (Cell or Gene Therapy) GMP and Commercial
Manufacturing (2020-2024)......................................................................................437
Cell Therapy Capacity Plans for In-House Bioprocessing Facilities:
Five Year Estimates (2023-2024).............................................................................440
Cellular Therapies Commercial Manufacturing Scales (2021).................................441
Gene Therapy Vectors and Products Commercial Manufacturing Scales (2021)....442
11-4 Discussion..............................................................................................................443
Continuous Bioprocessing and Perfusion Trends ....................................................443
Cell & Gene Therapy Manufacturing........................................................................444

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TABLE OF CONTENTS / FIGURES AND TABLES

CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING
AND LIFE SCIENCES ........................................................................................449
Introduction ..............................................................................................................449
12-1 Demographics ........................................................................................................449
Areas of Involvement ...............................................................................................449
Location of Vendor Sales ........................................................................................453
Vendor / Supplier Respondents’ Primary Job ..........................................................456
12-2 Growth Rate of Sales by Suppliers .....................................................................457
Average Industry Growth Rate, By Segment ...........................................................459
Supplier Annual Sales, Distribution..........................................................................462
12-3 Budget Issues and Problems Faced by Industry Suppliers ..............................464
Budget Challenges in 2024......................................................................................464
Vendor Average Pricing Changes ............................................................................468
12-4 Problems Clients Have with Their Vendors.........................................................472
Quality of Business Relationships with Suppliers ....................................................472
Quality of Business Relationships with Clients ........................................................474
Quality Problems Traced to Vendors (2018 data)....................................................476
12-5 Impacts of COVID-19 on Suppliers’ Activities....................................................476
Biopharma Industry’s Response to COVID on Bioprocessing-Related
Business (2023 data)...............................................................................................476
Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in
COVID-Related Factors (2021-2023) ......................................................................477
Post COVID Impact on Suppliers: Permanent Changes on Business Operations ..478
Biopharma Vendor Business Trends .......................................................................479
Biopharma Vendor Business Trends (2010-2024)...................................................483
12-6 Vendors’ Products and Services .........................................................................485
New Technology Areas in Development by Vendors................................................485
Suppliers’ R&D Spending/Budgets for New Products/Services ..............................489
Average Annual Suppliers’ R&D Spending/Budgets for New Products/Services
(2017-2022) .............................................................................................................490
12-7 Sales Staff Training................................................................................................492
Days of Training Provided by Suppliers (2021 data)................................................492
Areas where Training May Help Sales Staff Perform, Trends (2010-2024) .............492
Clients’ Demands on Vendors..................................................................................495
12-8 Biopharma Vendors’ Financial Outlook for 2024 ................................................497
12-9 CMO Pricing Changes for Biopharmaceutical Services ....................................499
12-10 Discussion: Biopharma Suppliers.......................................................................503
Vendor and Industry Growth ...................................................................................503
Trends Favor Increased Vendor Sales.....................................................................503
Vendors are Offering More Services........................................................................504
Biopharma Suppliers in Emerging Regions .............................................................505

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Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing (2010-2024).........3
Fig 0.2: Respondents’ Job Responsibilities (2011-2024)..........................................................5
Fig 0.3: Facility Location, 2024 .................................................................................................7
Fig 0.4: Facility Location, by Region, 2024 ...............................................................................8
Fig 0.5: Biopharmaceutical Manufacturing Systems, Trends (2007-2024) .............................10
Fig 0.6: Phase of Development of Surveyed Respondents (2006-2024)................................12
Fig 0.7: Phase of Development of Surveyed Respondents, U.S. vs. Western Europe (2024)13
Fig 0.8: Distribution of Employees at Facility, and Organization, 2024...................................14
Fig 0.9: Distribution of Total Batches Run at Facility in Past 12 Months,

by Scale of Production (2024)....................................................................................16
Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity, 2024 ...............................18
Fig 0.11: L Average SINGLE-USE Bioreactor Volume (2017-2024) .........................................19
Fig 0.12: Distribution of Largest STAINLESS Bioreactor Capacity, 2024 .................................20
Fig 1.1: Top 50 Biopharmaceutical Products, Percentage of Total Market Revenue ..............33
Fig 2.1: Numbers of Recombinant and Non-Recombinant Biopharmaceuticals Approved
by FDA Since 1981 ....................................................................................................48
Fig 2.2: Selected Areas--Single Most Important Biomanufacturing Trend or Operational
Area Industry Must Focus Efforts (China, US, W. Europe, and ROW), 2024 ............56

Fig 2.3: Average Cost per Gram for PRIMARY Recombinant Protein

(by region, 2022 – 2024)............................................................................................57
Fig 2.4: Capacity Utilization, By System (China), 2022-2024 .................................................58
Fig 2.5: Selected Areas: Percent Expecting “Some” Increase in Budgets for 2024 (Global)..59
Fig 2.6: Selected Cost-Cutting Changes: Actions in “Past 12 Months” (Global), 2024 ...........60
Fig 2.7: Estimated Percentage of Facilities’ Unit Operations that are “Single-Use”

(Global), 2024 ............................................................................................................61
Fig 2.8: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 Months
(Global) ......................................................................................................................62
Fig 2.9: EMA and FDA Approved Gene-Modified Cell Therapies - aka Ex-Vivo Gene
Therapies- by Year of Approval And DP (Manufacturer) ............................................65
Fig 2.10: Overview of Common bsAb MoA (5)..........................................................................68
Fig 2.11: Designs of asymmetric Fc based bsAbs....................................................................69
Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area (2014-2024) 84
Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months

(2018-2024) ...............................................................................................................86

Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months

(Biomanufacturers vs. CMOs), 2024..........................................................................90
Fig 3.4: Operational Changes Due to Recent Global Economics, 2024 .................................92
Fig 3.5: Operational Changes Due to Recent Global Economics (2010 - 2012, 2022-2024) .94
Fig 3.6: Operational Changes Due to Recent Global Economics; Biomanufacturers vs.
CMOs, 2024...............................................................................................................97

Fig 3.7: Operational Changes Due to Recent Global Economics; U.S. vs.

Western Europe, 2024 ...............................................................................................99
Fig 3.8: Biomanufacturers’ Budget Shifts, 2024....................................................................101
Fig 3.9: Approximate Average Change in Biomanufacturers’ Budgets, 2024 .......................102
Fig 3.10: Average Biomanufacturers’ Budget Changes (2009-2024) .....................................104
FIGURES

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Fig 3.11: New Expenditures Focus Areas, 2024.....................................................................109
Fig 3.12: New Expenditures Focus Areas (2020-2024) .......................................................... 111
Fig 3.13: New Product Development-Upstream Focus Areas, 2024 ......................................113
Fig 3.14: Upstream New Product Development Areas Cited Where Suppliers Should Focus
Development Efforts (2010-2024)............................................................................115
Fig 3.15: Downstream New Product Development Areas Cited Where Suppliers Should
Focus Development Efforts, 2024............................................................................117
Fig 3.16: New Product Development – Downstream Focus Areas (2010-2024) ....................119
Fig 3.17: New Product Development – General Focus Areas, Biomanufacturers

& CMOs, 2024 .........................................................................................................121
Fig 3.18: New Product Development – General Focus Areas (2010-2024)............................123
Fig 3.19: Top 10 New Product Development Areas of Interest:

Biomanufacturers vs. CMOs, 2024 ..........................................................................125
Fig 3.20: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe
vs. ROW, 2024........................................................................................................127

Fig 3.21: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months”

Comparing (2011-2016, 2019-2024)........................................................................129
Fig 3.22: Cost-Cutting Changes, Outsourced Jobs, by Segment, (2011-2016, 2019-2024)...131
Fig 3.23: Factors That Will Have the Greatest Impact on REDUCING YOUR

COST OF GOODS for Biotherapeutic Products (2020-2024)..................................132
Fig 3.24: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2024 ....134
Fig 3.25: Distribution, Average Cost per Gram for PRIMARY Recombinant

Protein (2017-2024).................................................................................................135

Fig 3.26: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved

Testing Methods (2011-2015, 2018-2019, 2024) .....................................................137

Fig 3.27: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved

Testing Methods; Biomanufacturers vs. CMOs, 2024..............................................139

Fig 3.28: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved

Testing Methods; US vs. Western Europe, 2024 .....................................................141

Fig 3.29: Largest Commercial-Scale Bioreactor Expected in the Next Two Years

(2024) (2022 data) ...................................................................................................142
Fig 3.30: Top Options for Bioreactor Platforms at Commercial Scale, 2024...........................144
Fig 3.31: Top Options for Bioreactor Platforms at Commercial Scale (2021-2024) ................145
Fig 3.32: Distribution of Largest Stainless Steel Bioreactor Capacity Next Two Years
(2024) (2022 data) ...................................................................................................146
Fig 3.33: Distribution of Largest SINGLE-USE Bioreactor Capacity Next Two Years (2024)..147
Fig 4.1: Capacity Utilization, By System, 2024 .....................................................................154
Fig 4.2: Capacity Utilization, By System (2006-2024)...........................................................156
Fig 4.3: Change in Capacity Utilization, CAGR (2006-2024)................................................157
Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs, 2024 ......................159
Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2024............................160
Fig 4.6: Western European vs US Biomanufacturers’ Average Capacity

Utilization (2012-2024) ............................................................................................162
Fig 4.7: Availability of CMO/CDMO Capacity, 2024..............................................................164
Fig 4.8: Current Production Capacity Distribution, Mammalian Cell Culture, 2024 ..............165
Fig 4.9: Production Capacity Distribution, Mammalian Cell Culture (2010-2024).................168
Fig 4.10: Current Production Capacity Distribution, Microbial Fermentation, 2024 ................170
Fig 4.11 Current Production Capacity Distribution, Microbial Fermentation (2010-2024)......172

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Fig 4.12: Current Production Capacity Distribution, Cell Therapy, 2024.................................173
Fig 4.13: Production Capacity Distribution, Cell Therapy (2020-2024)...................................175
Fig 4.14: Current Production Capacity Distribution, Gene Therapy, 2024 ..............................176
Fig 4.15: Production Capacity Distribution, Gene Therapy (2010-2024) ................................178
Fig 4.16: Bioprocessing Concentration, Capacity Data, 2024 ................................................180
Fig 4.17: Range of Titers for mAbs Obtained at Various Production Scales,

Distribution, 2024 .....................................................................................................186
Fig 4.18: Average mAb Titer Trend (2008-2024).....................................................................188
Fig 5.1: Capacity Constraints, by Stage of Production, 2024 ...............................................194
Fig 5.2: Capacity Constraints ‘Today’ (2004-2024) ...............................................................196
Fig 5.3: Capacity Constraints Trends (2004-2024) ...............................................................197
Fig 5.4: Capacity Constraints, Biomanufacturers vs. CMOs, 2024.......................................198
Fig 5.5: Capacity Constraints, U.S. vs. Western Europe, 2024 ............................................200
Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year

Projections (by 2029)...............................................................................................201
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections (2004-2024)..............203
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections (Trend Line)

(2004-2024) .............................................................................................................204

Fig 5.9: Five-year Projections for Capacity Constraints:

Biomanufacturers vs. CMOs (2029).........................................................................205

Fig 5.10: Five-year Projections for Capacity Constraints:

U.S. vs. Western Europe (2029) ..............................................................................206
Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (2029)........................208
Fig 5.12A: Factors Creating Future Capacity Constraints in Five Years (2008-2024)...............210
Fig 5.12B: Factors Creating Future Capacity Constraints in Five Years (2008-2024)...............211
Fig 5.13: Factors Creating Future Capacity Constraints:

Biomanufacturers vs. CMOs, 2024 ..........................................................................214

Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western Europe

Biomanufacturers, 2024...........................................................................................217
Fig 5.15: Key Areas to Address to Avoid Capacity Constraints, 2024.....................................219
Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints (2006-2024)..........................221
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints (2006-2024) ..........................222
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints;

Biomanufacturers vs. CMOs, 2024 ..........................................................................224

Fig 5.18: Key Areas to Address to Avoid Capacity Constraints;

U.S. vs. Western Europe, 2024................................................................................226
Fig 5.19: Average Time (weeks) Between Batch Failures (2009-2024)..................................227
Fig 5.20: Batch Failure Frequency Distribution (2009-2024) ..................................................230
Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2024.....233
Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing
(Commercial Manufacture) (2009-2024)..................................................................236
Fig 5.23: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing
(“Clinical” Scale) (2009-2024)..................................................................................237
Fig 5.24: Automation Technologies Implemented/to be Implemented in 2024........................239
Fig 5.25: Automation Technologies to be Implemented; Comparing

(2009 - 2013, 2022-2024) ........................................................................................241
Fig 5.26: Global Quality Supply Management (2011-2013, 2022-2023).................................244

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TABLE OF CONTENTS / FIGURES AND TABLES

Fig 5.27: Global Quality Supply Management, Biomanufacturers vs. CMOs, 2023 ...............245
Fig 5.28: Global Quality Supply Management (U.S. vs. W. Europe), 2023.............................246
Fig 5.29: Addressing Supply Chain Security (2023-2024)......................................................248
Fig 6.1: Industry Average Planned Production Increase: Five Year Estimates (2029)..........252
Fig 6.2: Planned Future Capacity Expansion: Five Year Estimates (2009–2029) ................254
Fig 6.3: Planned Future Capacity Expansions: Five Year Estimates,

Biomanufacturers vs. CMOs, by 2029 .....................................................................255

Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates,

U.S. vs. Western Europe, by 2029...........................................................................257

Fig 6.5: Percentage of Respondents Projecting Production Increases over 100%:

Five Year Trend (2029) ............................................................................................259
Fig 7.1: Current Percent Production Outsourced; by System, 2024 .....................................267
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production

(2006-2024) .............................................................................................................269

Fig 7.3: Current Percent Respondents Outsourcing up to 50% of Production,

by System, 2009-2024 .............................................................................................270
Fig 7.4: Biomanufacturers’ Outsourcing, Five Year Projections, by System (2029)..............272
Fig 7.5: Five Year Projections: % Biotherapeutic Developers Planning to Outsource
at Least Some Production; Projections made 2007-2024........................................274
Fig 7.6: Biomanufacturers Outsourcing Some Activity Today, 2024......................................276
Fig 7.7A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today

(2010-2024) .............................................................................................................278

Fig 7.7B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today

(2010-2024) .............................................................................................................279
Fig 7.8: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’
in 2 Years (2024)......................................................................................................281
Fig 7.9A: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’
in 2 Years, Trends (2010-2024)................................................................................283
Fig 7.9B: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’
in 2 Years, Trends (2010-2024)................................................................................284
Fig 7.10: Estimated Average Percentage of Activity Outsourced, by Facilities Today, 2024...286
Fig 7.11A: Estimated Average Percent of Activity Outsourced, by Facilities (2010-2024) ........288
Fig 7.11B: Estimated Average Percent of Activity Outsourced, by Facilities (2010-2024) ........289
Fig 7.12: Change in Spending on Outsourcing for R&D or Manufacturing,

Next 12 months (2012-2024) ...................................................................................291
Fig 7.13: Average Change in Outsourcing Spending by Facilities (2013-2024) .....................292
Fig 7.14: Percent Indicating USA as Likely or Strong Likely Selection for
INTERNATIONAL (non-US respondents) Outsourcing Over
Next Five Years, 2009-2024 (targeting 2029) ..........................................................294

Fig 7.15: Country Selections for International Outsourcing/Capacity Expansion

Over Next Five Years, 2029 ....................................................................................296
Fig 7.16A: Country Selections for “Possible” International Outsourcing/Capacity Expansion
Over Next Five Years (2016-2024) ..........................................................................298
Fig 7.16B: Country Selections for “Possible” International Outsourcing/Capacity Expansion
Over Next Five Years (2016-2024) ..........................................................................299

Fig 7.17A: U.S. Respondents Considering International Country as “Possible”

International Outsourcing Destination, over Next Five Years (2009-2024)..............302

Fig 7.17B: U.S. Respondents Considering International Country as “Possible”

International Outsourcing Destination, over Next Five Years (2009-2024)..............303

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Fig 7.18: U.S. Respondents Considering Country as “Strong likelihood” or “Likelihood”
as Outsourced Capacity Destination, Next Five Years (2029).................................305

Fig 7.19A: Western European Respondents Considering Country as “Possible”

Outsourcing Destination, Next Five Years, (2009-2024)..........................................307

Fig 7.19B: Western European Respondents Considering Country as “Possible”

Outsourcing Destination, Next Five Years, (2009-2024 ...........................................308
Fig 7.20: Western European Respondents Considering Country as ‘Strong likelihood’ or
‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years (2029) ......310
Fig 7.21: Percent of Biomanufacturing Operations Offshored (International Outsourcing)
to Lower-Cost Regions Within Five Years (2029) ....................................................313
Fig 7.22: Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring
Over Next Five Years (2011-2024)...........................................................................315

Fig 7.23: Estimated Average Percentage of Operations to be Done as International

Outsourcing/Offshoring to Lower-Cost Regions During
Next Five Years (2011-2024)....................................................................................317
Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D
or Manufacture, 2024..............................................................................................323
Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D
or Manufacture (2006-2024) ....................................................................................325
Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D
or Manufacture (2006-2024) ....................................................................................326
Fig 8.3: Average Annual Growth Rate, Disposables (2006-2024) ........................................329
Fig 8.4: 18-Year Percentage-Point Increase in First Usage of Disposables (2006-2024).....331
Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture

(R&D–Commercial), 2024........................................................................................333

Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing:

Biomanufacturers vs. CMOs, 2024 ..........................................................................335
Fig 8.7: Cell Culture Problems Due to Single-Use Devices (2022 vs. 2021)........................338
Fig 8.8: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal
Process (2020 data).................................................................................................339
Fig 8.9: Time Since Facility’s Last Failure of Single-use Devices and Equipment, 2024......341
Fig 8.10: Average Weeks Before Failures of Single-use Devices and Equipment

(2023-2024) .............................................................................................................343
Fig 8.11: Need for Improved Single-Use Sensors (2012-2017, 2019) (2019 data) ................345
Fig 8.12: Single-Use Product Vendor Satisfaction Factors (2008-2024) ................................347
Fig 8.13: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction, 2024349
Fig 8.14: Percentage Point Gap between Importance of SUS Product Attributes

and Level of Satisfaction (2013-2024) .....................................................................352

Fig 8.15: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use”

(2014-2024) .............................................................................................................354
Fig 8.16: Distribution of Responses, % Single-Use Devices in Biomanufacturing, 2024........356
Fig 9.1: Impact of Downstream Processing on Overall Capacity (2008-2024) .....................366
Fig 9.2: Impact of Downstream Processing on Overall Capacity;

Biomanufacturers vs. CMOs, 2024 ..........................................................................368

Fig 9.3: Impact of Downstream Processing on Overall Capacity;

U.S. vs. Western Europe, 2024................................................................................370
Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps, 2024 ...372
Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’
Constraints (2008-2024) ..........................................................................................374

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TABLE OF CONTENTS / FIGURES AND TABLES

Fig 7.18: U.S. Respondents Considering Country as “Strong likelihood” or “Likelihood”
as Outsourced Capacity Destination, Next Five Years (2029).................................305

Fig 7.19A: Western European Respondents Considering Country as “Possible”

Outsourcing Destination, Next Five Years, (2009-2024)..........................................307

Fig 7.19B: Western European Respondents Considering Country as “Possible”

Outsourcing Destination, Next Five Years, (2009-2024 ...........................................308
Fig 7.20: Western European Respondents Considering Country as ‘Strong likelihood’ or
‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years (2029) ......310
Fig 7.21: Percent of Biomanufacturing Operations Offshored (International Outsourcing)
to Lower-Cost Regions Within Five Years (2029) ....................................................313
Fig 7.22: Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring
Over Next Five Years (2011-2024)...........................................................................315

Fig 7.23: Estimated Average Percentage of Operations to be Done as International

Outsourcing/Offshoring to Lower-Cost Regions During
Next Five Years (2011-2024)....................................................................................317
Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D
or Manufacture, 2024..............................................................................................323
Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D
or Manufacture (2006-2024) ....................................................................................325
Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D
or Manufacture (2006-2024) ....................................................................................326
Fig 8.3: Average Annual Growth Rate, Disposables (2006-2024) ........................................329
Fig 8.4: 18-Year Percentage-Point Increase in First Usage of Disposables (2006-2024).....331
Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture

(R&D–Commercial), 2024........................................................................................333

Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing:

Biomanufacturers vs. CMOs, 2024 ..........................................................................335
Fig 8.7: Cell Culture Problems Due to Single-Use Devices (2022 vs. 2021)........................338
Fig 8.8: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal
Process (2020 data).................................................................................................339
Fig 8.9: Time Since Facility’s Last Failure of Single-use Devices and Equipment, 2024......341
Fig 8.10: Average Weeks Before Failures of Single-use Devices and Equipment

(2023-2024) .............................................................................................................343
Fig 8.11: Need for Improved Single-Use Sensors (2012-2017, 2019) (2019 data) ................345
Fig 8.12: Single-Use Product Vendor Satisfaction Factors (2008-2024) ................................347
Fig 8.13: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction, 2024349
Fig 8.14: Percentage Point Gap between Importance of SUS Product Attributes

and Level of Satisfaction (2013-2024) .....................................................................352

Fig 8.15: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use”

(2014-2024) .............................................................................................................354
Fig 8.16: Distribution of Responses, % Single-Use Devices in Biomanufacturing, 2024........356
Fig 9.1: Impact of Downstream Processing on Overall Capacity (2008-2024) .....................366
Fig 9.2: Impact of Downstream Processing on Overall Capacity;

Biomanufacturers vs. CMOs, 2024 ..........................................................................368

Fig 9.3: Impact of Downstream Processing on Overall Capacity;

U.S. vs. Western Europe, 2024................................................................................370
Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps, 2024 ...372
Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’
Constraints (2008-2024) ..........................................................................................374

Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe, 2024..............376
Fig 9.7: Issues Regarding Protein A Usage (2022)...............................................................377
Fig 9.8: Issues Regarding Protein A Usage (2009-2017, 2020-2022) ..................................379
Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe (2022) .....................380
Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses

(2014 -2016, 2018-2024) .........................................................................................382

Fig 9.11: Bioreactor Output at which DOWNSTREAM Purification Train Becomes

Bottlenecked (2014-2016, 2018-2024) ....................................................................384
Fig 9.12: New Downstream Processing Solutions, 2024 ........................................................386
Fig 9.13A: New Downstream Processing Solutions Comparison (2010-2024).........................388
Fig 9.13B: New Downstream Processing Solutions Comparison (2010-2024).........................389
Fig 9.14: New Downstream Processing Solutions: Biomanufacturers vs. CMOs, 2024 .........391
Fig 9.15: New Downstream Processing Solutions: U.S. vs. Western Europe, 2024...............393
Fig 9.16: Improving Downstream Operations, 2011-2019 (2019 data) ...................................395
Fig 10.1: New Hires in Biopharmaceutical Manufacturing, 2024 ............................................402
Fig 10.2: Estimated Hiring, by Area (2008-2024)....................................................................404
Fig 10.3: New Hires in Biopharmaceutical Manufacturing in Five Years (2029) .....................405
Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2024 ........407
Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2024)410
Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2024)411
Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations,

U.S. vs. Western Europe, 2024................................................................................413
Fig 10.7: Skills or Hands-On Training Required in NEW HIRES in GMP Bioprocessing
(2023 vs. 2024)........................................................................................................415
Fig 11.1: Future of Continuous Bioprocessing and Process Intensification, 2024..................422
Fig 11.2: Future of Continuous Bioprocessing and Process Intensification (2021-2024) .......424
Fig 11.3: Perfusion Operations Issues (2010 – 2016, 2020, 2023-2024) ...............................426
Fig 11.4: Concerns Over Perfusion Processes vs. Batch-fed Processes in

Bioprocessing, 2024 ................................................................................................428
Fig 11.5: Facilities Evaluating CBP Technologies Over the Next 12 Months (Upstream)
(2016-2024) .............................................................................................................430
Fig 11.6: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream)
(2016-2024) .............................................................................................................432
Fig 11.7: Most Needed Cell Therapy Manufacturing Improvements, Systems, Platforms,
and Infrastructure (2019-2024) ................................................................................435
Fig 11.8: Most Needed Gene Therapy Manufacturing Improvements, Systems, Platforms
and Infrastructure (2019-2024) ................................................................................437
Fig 11.9: Cell or Gene Therapy Plans for GMP and Commercial Manufacturing (2020-2024)439
Fig 11.10: Cell Therapy Capacity Plans for In-House Bioprocessing Facilities

Next Five Years (2029) ............................................................................................441
Fig 11.11: Commercial Manufacturing of Cell Therapies (2021)...............................................442
Fig 11.12: Commercial Manufacturing of Gene Therapy Vectors and Products (2021)............443
Fig 12.1: Area of Biopharmaceutical Involvement, Vendor, 2024 ...........................................450
Fig 12.2: Area of Biopharmaceutical Involvement, Vendor (2010-2024) ................................452
Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently

Actively Sell (2008-2024).........................................................................................454

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xxiv WWW.BIOPLANASSOCIATES.COM
TABLES
Table 0.1: Areas of Biopharmaceutical Manufacturing Operations (2018-2024)..........................9
Table 1.1 Worldwide Revenue of Biopharmaceuticals ($USD billions)......................................25
Table 1.2 Number of Biopharmaceutical Products in U.S. and European Markets,

2023/2024 ..................................................................................................................30
Table 1.3 Global Market for Top 50 Biopharma Products in (2022-2023, $USD Million)...........31
Table 1.4 Top 50 Biopharmaceutical Products Vs. Total Market Size (%) $mm ........................33
Table 1.5 Bioprocess Related Industry Expenditures on Manufacture of Biotherapeutics
(estimated $USD, billions) .........................................................................................34
Table 1.6 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class,
2007 and 2024 ...........................................................................................................38
Table 2.1: Biopharmaceuticals Approved by FDA, 2023 ............................................................49
Table 2.2: Biopharmaceuticals Approved by FDA in 2024 (till 10 June’24) ................................50
Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently

Actively Sell (2008-2024).........................................................................................455
Fig 12.4: Vendor Respondents’ Primary Job Function, 2024..................................................456
Fig 12.5: Average Annual Vendor Sales Growth Rate (2007-2024)........................................457
Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution, 2024 ........458
Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2024.................................460
Fig 12.8: Average Annual Vendor Sales Growth Rate, by Segment (2007-2024) ..................461
Fig 12.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment % (2012-2024) .....463
Fig 12.10: Vendors’ Average Budget Change, 2024 .................................................................465
Fig 12.11: Vendors’ Average Budget Change, Summary (2009-2024).....................................467
Fig 12.12: Vendors’ Average Pricing Changes, Last Year (2024 data) .....................................468
Fig 12.13: Vendors’ Average Pricing Changes (2009-2023 Actual and 2024 projected) ..........471
Fig 12.14: ‘Most Important’ Factors to Measure The ‘Quality’ of Business Relationships
with Suppliers, 2022-2024 .......................................................................................473

Fig 12.15: Factors Important in Measuring the ‘Quality’ of Business Relationships,

Suppliers Perspective vs. Facility Perspective, 2024...............................................475
Fig 12.16: Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in
COVID-Related Factors (2023-2021) ......................................................................477
Fig 12.17: Post COVID Impact on Suppliers: Permanent Changes caused by Pandemic on
Your Business Operations, 2024..............................................................................479
Fig 12.18: Biopharma Business and Marketing Plans, 2024 ....................................................482
Fig 12.19: Biopharma Business and Marketing Plans (2010-2024)..........................................484
Fig 12.20A: Top New Technologies or New Product Development Areas (2011-2024)...............486
Fig 12.20B: Top New Technologies or New Product Development Areas (2011-2024)...............487
Fig 12.21: R&D Spending/Budgets for New Products/Services, 2024......................................490
Fig 12.22: Approximate Average Annual R&D Spending/Budget for New Products/Services
(2017-2024) .............................................................................................................491
Fig 12.23: Areas Where Training is Considered as Needed, All Vendor Respondents

(2010-2024) .............................................................................................................494
Fig 12.24: Client Demands of Vendors, Service and Support (2012-2024)..............................496
Fig 12.25: Vendors Views of Financial (Sales) Outlook for Next Year (2011-2024)..................498
Fig 12.26: Average CMOs Service Price Shifts over the Past 12 Months, 2024 ......................500
Fig 12.27: CMOs Service Price Shifts Over Past 12 Months, Distribution, 2024......................502

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TABLE OF CONTENTS / FIGURES AND TABLES

Table 2.3: All FDA/ EMA Approved or Pre-Registered In-Vivo Gene Therapies and

Their Manufacturers...................................................................................................63
Table 2.4: All FDA/ EMA Approved or Pre-Registered Gene-Modified Cell Therapies and
Their Manufacturers..................................................................................................64
Table 2.5: Approved bsAb (1).....................................................................................................67
Table 2.6: Approaches Enforcing HC Heterodimer Formation ...................................................71
Table 2.7: Approaches Minimizing HC-LC Mispairing ................................................................72
Table 2.8: Purification Strategies To Eliminate Product Related Impurities (40).........................72
Table 3.1 Areas of Significant Projected Budget Percentage Increases for Biomanufacturing
(2011-2024)..............................................................................................................106
Table 4.1 Leading Biopharma Company Capacity Estimates, 2024........................................180
Table 4.2: Regional Distribution of Total Worldwide Average Capacity*...................................182
Table 4.3: Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated
Total Capacity*.........................................................................................................184
Table 4.4 Compound Annual Change in mAb Titers (2008-2024) ...........................................187
Table 5.1 Severe or Significant Capacity Constraints, by Stage of Production (2009-2024)...193
Table 5.2: Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe

(2010-2024) .............................................................................................................199

Table 5.3: Average Rates of Failure, by Primary Cause, and Phase of Manufacture

(2017-2024) .............................................................................................................234
Table 6.1: U.S. Biomanufacturers’ Five-Year Projected Capacity Increases, by System
(2008-2024) .............................................................................................................256
Table 6.2: Western European Biomanufacturers’ Five-Year Projected Capacity Increases,
by System (2008-2024)............................................................................................257
Table 6.3: Future Capacity Expansions Coming Online in the Next 24 Months .......................260
Table 7.1: Percentage of U.S.-based Respondents Indicating Country as a ‘Strong likelihood’
or ‘Likelihood’ as Outsourcing Destination (2009-2024) ..........................................306
Table 7.2 Percent of Western European-based Respondents Indicating International
Countries as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing
Destination (2011-2024)...........................................................................................311
Table 9.1 Percent of Biomanufacturers vs. CMO Facilities experiencing “Serious” or “Some”
Capacity Problems due to Downstream Processing (2008-2024) ...........................368
Table 9.2 Percent of U.S. vs. Western Europe Facilities Experiencing ‘Serious’ Capacity
Problems due to Downstream Processing (2009-2024) ..........................................369
Table 9.3 Percent U.S. vs. Western Europe Facilities Not Expecting to see Bottlenecks
due to Downstream Processing (2008-2024) ..........................................................369
Table 9.4 Upstream Production Titer vs. Max Capacity (2018-2024) ......................................381
Table 12.1 Average Vendor Sales and Technical Training Days (2011-2013, 2019-2021)..........492