Table of Content


Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst’s Credentials
BCC Custom Research
Related BCC Research Reports
Chapter 2 Summary
ROI and R&D Outlays
Using Technology to Weed Out Losers, Focus on Potential Winners
Identifying Biomarkers
Revolutionizing Clinical Research with AI, ML and Patient Centricity
Global Oncology Markets by Region and Selected Types
Global Chronic Disease Drugs Market by Region
Global Cardiovascular Drugs Market by Region
Global Neurology Therapies Market by Region
Global Market for Infectious Disease Treatments by Region
Global Market for Orphan Drugs by Region
Wanted: Digitally Literate Employees Open to Continuous Learning
Chapter 3 Challenges Facing Pharma and Biotech Companies
Strong Revenues, but Decreasing ROI
Tracking the Decline in ROI
Reasons that IRR Has Been Exceptionally Low
The Competitive, Expensive Search for Novel Drugs
Eroom’s Law
Emerging Global Players from India, China, Russia
Expiring Patents
Complying with Changing Regulatory Environments
Pricing Pressures in the US and Elsewhere
Traditional Structure is Blurring
Increasing Complexity of Clinical Trials
Oncology Clinical Trials Remain Complex
Is Oncology Research Showing the Way?
Patient Recruitment Consumes a Major Part of Trial Duration
Is the Pool of Viable New Drug Targets Diminishing?
The Malfunctioning Clinical Trial System
Solutions are Out There, and Already Working
The 21st Century Cures Act of 2016
The US FDA’s New Population Pharmacokinetics Guidance Document
Pharma Market Update
M&A Activity
Biotech Market Update
Next-Generation Biotherapeutics Pipelines Have More than Doubled
Biotech Pricing Pressure
What’s Ahead
Chapter 4 Regulatory Overview and New Drug Approvals
Improving Regulatory Compliance
Drug Development Continues to be Slow Process
Record New Drug Approvals in 2018
US FDA Selected Drug Approvals
Drug Approval Processes in the US, EMA, China, Japan
US FDA and the EU’s EMA
China’s Drug Regulatory Process
Japan’s Drug Regulatory Process
Chapter 5 Key Financial Ratios for Pharma and Biotech Companies
Return on Investment and Project-wise ROI
Ensuring Financial Accountability for R&D Outlays
Return on Research Capital (RORC)
Profitability Ratios
Liquidity and Debt Coverage Ratios
Return on Equity (ROE)
Chapter 6 Maximizing Clinical Development Success Rates
Driving Change in Clinical Development
Utilizing Mobile Health Technologies
Ramping Up Real-World Data and Real-World Evidence: the FDA’s New RWE Framework
Maximizing Immuno-Oncology Clinical Trial Success with Immune-Related Response Criteria (irRC)
irRC More Useful Than RECIST for immune-oncology drugs
Case Study: Ipilimumab
Identifying Biomarkers
Challenges and Hurdles to Biomarker Detection and Usage
Use of Patient-Reported Outcomes and Pools of Prescreened Patients
Predictive Analytics
Revolutionizing Clinical Research with AI, ML and Patient Centricity
One Example: Patient Centricity Enabled by the Medidata Patient Cloud
23andMe Wants to Solve the Patient Recruitment Problem
Chapter 7 The Advantages of Being?or Acting?Small
Breaking Down the Silo Mentality
Just Say No
Turn on a Dime
Small Companies with Big Visions
Virgo Surgical Video Solutions
Ovid Therapeutics
Melinta Therapeutics
Applied Genetic Technologies
BioCryst Pharmaceuticals
Chapter 8 The Digital Transformation of Biopharma Companies
Robotic Process Automation (RPA)
Machine Learning (ML)
MELLODDY (Machine Learning Ledger Orchestration for Drug Discovery) project
AI Lighthouse Projects: Digital Transformation Continues Apace
Evidation, Apple, Eli Lilly and Digital Alzheimer’s Biomarkers
Accelerating Therapeutics for Opportunities in Medicine (ATOM) Consortium
DeepMind Technologies, AI and Protein Folding
AI For Drug Discovery and Accelerating Clinical Trials
Alliance for Artificial Intelligence in Healthcare (AAIH)
MIT’s Machine Learning for Pharmaceutical Discovery and Synthesis Consortium
The Challenges Found in Deploying AI
Healx Uses AI to Discover Rare Disease Treatments
Business Strategy Should Include Technology Investment
Empower a Cultural Change: From “Doing Digital” to “Being Digital”
The Implementation of Digital Trials
The Tortoise and the Hare
The Time is Now
Chapter 9 Leveraging Open Innovation to Solve Development Challenges
Collaboration/Partnering
Centers of Innovation
J&J and Pfizer: Global Centers of Innovation
Germany Fosters Biopharma Innovation
Co-location
Crowdsourcing Technical and Scientific Ideas
Other Examples of Open Innovation in Pharma
Otsuka’s Collaboration with the Riken Center for Developmental Biology
AstraZeneca and its Center for Innovation
How Takeda Chose to Move Forward
Internal Crowd Sourcing Through Entrepreneurship Venture Program
External Crowd Sourcing: COCKPI-T
Hybrid model: Innovation Park “Shonan iPark”
Chapter 10 The Global Pharma and Biotech Market for Oncology
Challenges in Treating Cancer
Clinically Significant Types of Cancers
Lung Cancer
Breast Cancer
Ovarian Cancer
Smarter R&D Leads to More Oncology Drug Approvals
Global Oncology Market by Region and Selected Types
Global Market for Lung Cancer Chemotherapy by Region
Global Market for Breast Cancer Therapy by Region
Global Market for Ovarian Cancer Therapy by Region
Chapter 11 The Global Pharma and Biotech Market for Chronic Diseases
Chronic Kidney Disease (CKD)
Background to CKD
Renal Disease
Causes of Chronic Kidney Disease
Incidence of End Stage Renal Disease by Country
Prevalence of End Stage Renal Disease by Country
Pharmaceutical Drugs
Global Market for Chronic Kidney Disease Stage 1-5 Drugs
Chronic Respiratory Disease Market
Global Diabetes Therapy Market
Global Chronic Gastrointestinal Market
Chapter 12 The Global Pharma and Biotech Market for Cardiovascular Disease
Global Cardiovascular Drug Market by Region
Chapter 13 The Global Pharma and Biotech Market for Neurological Diseases
Parkinson’s Disease
Overview
Prevalence
Alzheimer’s Disease
Overview
Prevalence
Schizophrenia
Overview
Prevalence
Bipolar Disorders
Overview
Prevalence
Depression
Overview
Prevalence
Epileptic Disorders
Overview
Prevalence
Autism Spectrum Disorders
Overview
Prevalence
Global Market for Neurology Therapies by Region
Chapter 14 The Global Pharma and Biotech Market for Infectious Diseases
Infectious Diseases
Classification of Infectious Agents
Management of Infectious Diseases
Bacterial Infectious Diseases
Viral Infectious Diseases
HIV/AIDS
Influenza A and Influenza B
Risk Factors
Etiology and Symptoms
Socioeconomic Burden
Global Markets for Infectious Disease Treatments
Global Market for Infectious Disease Treatments by Region
Chapter 15 The Global Pharma and Biotech Market for Rare Diseases
Legal Definitions of Orphan Diseases
Playing Games with Orphan Drug Approvals?
Genetically Based Tools for Rare Disease R&D
Chapter 16 The Changing Future of Biopharma Work
Wanted: Digitally Literate Employees Open to Continuous Learning
Acquiring AI Capabilities Through Cloud-Based Enterprise Software with Integrated AI
Chapter 17 Company Profiles
23ANDME
ABBVIE
ALLERGAN PLC
AMGEN INC.
ASTELLAS PHARMA INC.
ASTRAZENECA PLC
BAYER AG
BIOGEN IDEC
BOEHRINGER INGELHEIM GMBH
BRISTOL-MYERS SQUIBB CO.
CELGENE CORP.
CSL BEHRING
ELI LILLY AND CO.
EXSCIENTIA
GILEAD SCIENCES INC.
GLAXOSMITHKLINE PLC
JOHNSON & JOHNSON INC.
MERCK & CO., INC.
NOVARTIS AG
NOVO NORDISK A/S
NUMERATE INC.
PFIZER INC.
ROCHE (F. HOFFMAN-LA ROCHE AG)
SANOFI
VERTEX PHARMACEUTICALS
Chapter 18 Appendix: Acronyms



List of Figures


Summary Figure : Global Market for Lung, Breast and Ovarian Cancer Therapies, by Region, 2016-2024
Summary Figure A : Global Chronic Disease Drugs Market, by Region, 2016-2024
Summary Figure B : Global Chronic Disease Drugs Market, by Region, 2016-2024
Summary Figure C : Global Chronic Disease Drugs Market, by Region, 2016-2024
Summary Figure D : Global Chronic Disease Drugs Market, by Region, 2016-2024
Summary Figure E : Global Chronic Disease Drugs Market, by Region, 2016-2024
Figure 1 : Selected Challenges
Figure 2 : Annual Revenues of Leading Pharmaceutical Companies, 2010-2018
Figure 3 : Annual Revenues of Leading Biotech Companies, 2010-2018
Figure 4 : Selected Pharma Companies’ Return on R&D Spend, 2010-2018
Figure 5 : Selected Pharma Companies’ R&D Spend, 2010-2018
Figure 6 : Selected Biotech Companies’ R&D Spend, 2010-2018
Figure 7 : Pharma/Biotech Drug Development Cycle
Figure 8 : Likelihood of Approval from Phase I, by Disease Area
Figure 9 : Complexity of Oncology Clinical Trials, 2010-2018
Figure 10 : Number of Next-Generation Biotherapeutic Pipeline Products in Late-Stage Pipeline, 2009-2018
Figure 11 : Drugs Approval Process, US FDA and EU
Figure 12 : China CFDA Drug Regulatory Approval Process
Figure 13 : Japan PMDA Drug Regulatory Approval Process
Figure 14 : AI for Clinical Trial Design from Methodology to Improved Outcomes
Figure 15 : Percentage of US and EU5 Patients Tested for Biomarker, by Cancer Type
Figure 16 : Build Digital Capabilities Now
Figure 17 : Annual Incidence and Mortality Data for Lung Cancer in the U.S., 1975-2015
Figure 18 : Annual Incidence and Mortality Data for Lung Cancer in Five EU Countries, 1975-2012
Figure 19 : Annual Incidence and Mortality Data for Breast Cancer in the U.S., 1975-2015
Figure 20 : Annual Incidence and Mortality Data for Breast Cancer in Five E.U. Countries, 1975-2012
Figure 21 : Annual Incidence and Mortality Data for Ovarian Cancer in the U.S., 1975-2015
Figure 22 : Annual Incidence and Mortality Data for Ovarian Cancer in Five EU Countries, 1975-2012
Figure 23 : Number of New Active Substance Approvals in Oncology, by Indication, 2019
Figure 24 : Global Market for Lung Cancer Chemotherapy, by Region, 2016-2024
Figure 25 : Global Market for Breast Cancer Therapy, by Region, 2016-2024
Figure 26 : Global Market for Ovarian Cancer Therapy, by Region, 2016-2024
Figure 27 : Global Cardiovascular Deaths, by Region, 2015 and 2030 (Forecast)
Figure 28 : Global Health Estimates, Leading Causes of Death, Infectious Diseases, by WHO Region, 2015
Figure 29 : Global Market Share of New HIV Infections, by WHO Region, 2015
Figure 30 : Number of Deaths due to 2009 Pandemic Influenza A H1N1, by WHO Region, August 2009-August 2010
Figure 31 : Global Market for Infectious Diseases, by Product Type, 2016-2024
Figure 32 : Top 10 Pharmaceutical Companies, by Global Orphan Drug Projected Revenues, 2024
Figure 33 : Global Market for Orphan Drugs, by Region, 2016-2024
Figure 34 : AbbVie’s Pipeline, at the Time of Proposed Merger with Allergan, June 2019
Figure 35 : Allergan Developments, 2018
Figure 36 : Astellas Pharma Inc.: Revenue Share, by Region, 2018
Figure 37 : Astellas Pharma Inc.: R&D Expenditure, 2017-2019 (forecast)
Figure 38 : AstraZeneca PLC: Revenue Share, by Region, 2018
Figure 39 : AstraZeneca PLC: Revenue Share, by Business Segment, 2018
Figure 40 : AstraZeneca PLC: R&D Expenditure, 2016-2018
Figure 41 : Bayer AG: Regional Sales Share, 2018
Figure 42 : Boehringer Ingelheim GmbH: Revenue Share, by Region, 2018
Figure 43 : Boehringer Ingelheim GmbH: Revenue Share, by Business Segment, 2018
Figure 44 : Boehringer Ingelheim GmbH: R&D Expenditure, 2016-2018
Figure 45 : Bristol-Myers Squibb Co.: Revenue Share, by Region, 2018
Figure 46 : CSL Behring: Sales Share, by Region, FY2018 and FY2019
Figure 47 : Eli Lilly and Co.: Revenue Share, by Business Segment, 2018
Figure 48 : Eli Lilly and Co.: Revenue Share, by Region, 2018
Figure 49 : Gilead Sciences Inc.: Revenue Share, by Region, 2018
Figure 50 : GlaxoSmithKline PLC: Revenue Share, by Business Segment, 2018
Figure 51 : GlaxoSmithKline PLC: Revenue Share, by Region, 2018
Figure 52 : Johnson & Johnson Inc.: Revenue Share, by Business Segment, 2018
Figure 53 : Johnson & Johnson Inc.: Revenue Share, by Region, 2018
Figure 54 : Merck & Co., Inc.: Revenue Share, by Business Segment, 2018
Figure 55 : Merck & Co., Inc.: Revenue Share, by Region, 2018
Figure 56 : Novartis AG: Revenue Share, by Region, 2018
Figure 57 : Novartis AG: Revenue Share, by Business Segment, 2018
Figure 58 : Novo Nordisk A/S: Revenue Share, by Region, 2018
Figure 59 : Novo Nordisk A/S: Revenue Share, by Business Segment, 2018
Figure 60 : Pfizer Inc.: Revenue Share, by Region, 2016
Figure 61 : Pfizer Inc.: Revenue Share, by Business Segment, 2018
Figure 62 : Roche: Revenue Share, by Business Segment, 2018
Figure 63 : Roche Pharmaceuticals: Revenue Share, by Region, 2018
Figure 64 : Sanofi: Revenue Share, by Country/Region, 2018
Figure 65 : Sanofi: Revenue Share, by Business Segment, 2018


List of Tables


Summary Table : Global Market for Lung, Breast and Ovarian Cancer Therapies, by Region, Through 2024
Summary Table A : Global Chronic Disease Drugs Market, by Region, Through 2024
Summary Table B : Global Cardiovascular Drugs Market, by Region, Through 2024
Summary Table C : Global Market for Neurology Therapies, by Region, Through 2024
Summary Table D : Global Market for Infectious Disease Treatments, by Region, Through 2024
Summary Table E : Global Market for Orphan Drugs, by Region, Through 2024
Table 1 : Likely Applications of AI in Pharma and Biotech Companies
Table 2 : Selected M&A Deals, 2018-August 2019
Table 3 : Selected US Highest-Priced Drugs
Table 4 : US FDA Expedited Pathways and Other Attributes, 2017 and 2018
Table 5 : US FDA Selected Drug Approvals, 2017 and 2018
Table 6 : Selected FDA Orphan Drug Approvals, 2017 and 2018
Table 7 : Clinical Trial Challenges and the Role of AI
Table 8 : Selected Pharma Companies Utilizing AI
Table 9 : Global Cancer Incidence (Both Sexes)
Table 10 : Global Markets for Lung, Breast & Ovarian Cancer Therapies, by Region, Through 2024
Table 11 : Global Market for Lung Cancer Chemotherapy, by Region, Through 2024
Table 12 : Global Market for Breast Cancer Therapy, by Region, Through 2024
Table 13 : Global Market for Ovarian Cancer Therapy, by Region, Through 2024
Table 14 : Incidence of ESRD, by Country, 2015
Table 15 : Prevalence of ESRD, by Country, 2015
Table 16 : Global CKD 1-5 Stage Drugs Market, by Region, Through 2024
Table 17 : Global Chronic Respiratory Disease Therapies Market, by Region, Through 2024
Table 18 : Global Diabetes Therapy Market, by Region, Through 2024
Table 19 : Global Chronic Gastrointestinal Therapy Market, by Region, Through 2024
Table 20 : Global Cardiovascular Drug Market, by Region, Through 2024
Table 21 : AstraZeneca PLC: Cardiovascular Pipeline
Table 22 : Amgen Inc.: Cardiovascular Pipeline
Table 23 : Sanofi: Cardiovascular Pipeline
Table 24 : Novartis AG: Cardiovascular Pipeline
Table 25 : Merck and Co., Inc.: Cardiovascular Pipeline
Table 26 : Bristol-Myers Squibb Company: Cardiovascular Pipeline
Table 27 : Global Market for Neurology Therapies, by Region, Through 2024
Table 28 : Global Health Estimates, Leading Causes of Death, Infectious Diseases, by WHO Region, 2015
Table 29 : Prevalence and Incidence of Hepatitis B, 2015
Table 30 : Prevalence and Incidence of Hepatitis C, 2015
Table 31 : Global Prevalence and Incidence of Genital Herpes, 2005-2015
Table 32 : Prevalence of HIV, Adults (15-49 years old), by WHO Region, 2015
Table 33 : New HIV Infections (per 1,000 uninfected population), Adults (15-49 years old), by WHO Region, 2015
Table 34 : New HIV Infections, 2000-2030
Table 35 : Years of Life Lost (YLLs), Pandemic Influenza A H1N1, by WHO Region, 2009
Table 36 : Global Market for Infectious Diseases, by Product Type, Through 2024
Table 37 : Global Market for Infectious Diseases, by Region, Through 2024
Table 38 : Selected Country/Regional Definitions of Orphan Disease
Table 39 : Description of Selected Orphan Diseases
Table 40 : Global Market for Orphan Drugs, by Region, Through 2024
Table 41 : Applications of AI in Pharma and Biotech Companies
Table 42 : Details of Allergan’s Late-Stage Pipeline, 2019
Table 43 : Astellas Pharma Inc.: Selected Financials, 2016-2018
Table 44 : Astellas Pharma Inc.: Marketed Products, 2018
Table 45 : AstraZeneca PLC: Selected Financials, 2016-2018
Table 46 : AstraZeneca PLC: Selected Marketed Products, 2018
Table 47 : AstraZeneca PLC: Selected Global Product Sales, 2017 and 2018
Table 48 : Bayer AG: Selected Financials, 2017 and 2018
Table 49 : Biogen: Selected Financials, 2017 and 2018
Table 50 : Boehringer Ingelheim GmbH: Selected Financials, 2017 and 2018
Table 51 : Boehringer Ingelheim GmbH: Top 4 Human Pharmaceutical Product Sales, 2018
Table 52 : Bristol-Myers Squibb Co.: Selected Financials, 2017 and 2018
Table 53 : Bristol-Myers Squibb Co.: Selected Marketed Products, 2018
Table 54 : Celgene Corp.: Selected Financials, 2017 and 2018
Table 55 : Celgene Corp.: Selected Marketed Products, 2018
Table 56 : CSL Behring: Selected Financials, 2017 and 2018
Table 57 : Eli Lilly and Co.: Selected Financials, 2017 and 2018
Table 58 : Eli Lilly and Co.: Selected Products
Table 59 : Gilead Sciences Inc.: Selected Financials, 2017 and 2018
Table 60 : Gilead Science: Selected Products and Indications
Table 61 : GlaxoSmithKline PLC: Selected Financials, 2017 and 2018
Table 62 : GlaxoSmithKline PLC: Selected Marketed Products
Table 63 : Johnson & Johnson Inc.: Selected Financials, 2017 and 2018
Table 64 : Johnson & Johnson Inc.: Selected Marketed Products, 2018
Table 65 : Merck & Co., Inc.: Selected Financials, 2016-2018
Table 66 : Merck & Co., Inc.: Selected Marketed Products, 2018
Table 67 : Novartis AG: Net Revenue, 2017 and 2018
Table 68 : Novartis AG: Selected Marketed Products, by Indication, 2018
Table 69 : Novo Nordisk A/S: Net Revenue, 2017 and 2018
Table 70 : Novo Nordisk A/S: Selected Products and Indications, 2018
Table 71 : Pfizer Inc.: Net Revenue, 2017 and 2018
Table 72 : Pfizer Inc.: Selected Products and Indications, 2018
Table 73 : Roche: Net Revenue, 2017 and 2018
Table 74 : Roche: Revenues from Top 10 Pharma Products, 2018
Table 75 : Sanofi: Net Revenue, 2017 and 2018
Table 76 : Sanofi: Selected Products and Indication, 2018
Table 77 : Vertex Pharmaceuticals: Net Revenue, 2017 and 2018
Table 78 : Acronyms Used in This Report