1. Report Overview
1.1 Biologics Overview
1.2 Why you Should Read this Report
1.3 How this Report Delivers
1.4 Main Questions Answered by this Report
1.5 Who is this Report for?
1.6 Research and Analysis Methods
1.7 Frequently Asked Questions (FAQ)

2. Market Dynamics
2.1 Drivers
2.1.1 Increasing Biologics Approvals
2.1.2 Rise in the Prevalence of Chronic Diseases
2.2 Restraints
2.2.1 Complex in Nature
2.2.2 High Cost
2.3 Opportunities
2.3.1 Strong Pipeline of biologics drugs
2.3.2 Emerging technology
2.4 Trends
2.4.1 Growing strategic partnerships in China
2.4.2 Outsourcing strategies

3. Introduction to the Biologics Market and Key Concepts
3.1 Biologics: Large and Complex Products
3.2 A Brief History of Biological Drug Development
3.3 Why are Biologics the Most Lucrative Products in the Global Pharmaceutical Market?
3.4 What are Biosimilars?
3.4.1 Brief History of Biosimilars
3.4.2 What are Interchangeable Biological Products and how do They Differ from Biosimilars?
3.4.3 Why Many Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars
3.5 Marginal Cases
3.6 Vaccines Market

4. The Global Biologics Market 2019 - 2029
4.1 The Global Biologics Market 2019 - 2029
4.2 What Factors Will Drive Growth in the Biologics Market?
4.2.1 Ageing Population and the Rise of Chronic Disease
4.2.2 Biologics Constitute 19% of the Global Pharmaceutical Market - Further Launches Will Drive Market
4.3 Biosimilars - Both an Opportunity and a Threat
4.4 What Factors Will Restrain Growth in the Biologics Market?
4.4.1 High Costs in the Face of Declining National Healthcare Budgets
4.4.2 In Some Areas, Clinical Efficacy is not Superior Enough to Justify the Price Gap
4.4.3 Over $100bn worth of Biologic Patents due to Expire by 2020
4.4.4 Administration is Often not as Convenient
4.5 Biologics Market: Submarket Forecasts 2019 - 2029

5. Protein Therapeutics Submarket 2019 - 2029
5.1 Largest and Most Diverse Submarket
5.2 Proteins have been used Medicinally since the 19th Century
5.2.1 Recombinant DNA Technology - The Major Breakthrough in the use of Protein Drugs
5.3 Protein Therapeutics Submarket Forecast 2019 - 2029
5.4 Insulin Submarket 2019 - 2029
5.4.1 The First Protein Therapeutic
5.4.2 Around 430 Million People Expected to be Diagnosed with Diabetes by 2030
5.4.3 Insulin Submarket Forecast 2019 - 2029
5.4.4 Lantus: The Market Leading Drug by Far
5.4.4.1 Lantus Revenue Forecast 2019 - 2029
5.4.5 NovoLog/NovoRapid Revenue Forecast to 2029
5.4.6 Humalog Revenue Forecast to 2029
5.4.7 New Approvals and Pipeline
5.4.7.1 Tresiba (Novo Nordisk)
5.4.7.2 BIOD-123 (Biodel)
5.5 Biosimilar Insulin
5.5.1 Approved Insulin Biosimilars
5.5.2 Abasaglar/Basaglar/Insulin Glargine BS - The First Insulin Biosimilars to be Approved in Developed Markets. Delayed in the US
5.6 Other Recombinant Hormones: Erythropoietins, G-CSF and Human Growth Hormone
5.6.1 Erythropoietin
5.6.1.1 First-Generation Therapies Launched in the 1980s
5.6.1.2 Aranesp: Slowly Growing
5.6.1.3 Epogen: Increases in Selling Price Are No Longer Enough to Ward off Decline
5.6.1.4 Procrit/Eprex: In Decline Since 2013
5.6.1.5 NeoRecormon and Mircera (Roche) Provides Competition for Market Leader Amgen
5.6.1.6 Safety Concerns for Erythropoietin-Stimulating Agents is Leading to Decreased Demand
5.6.1.7 The Challenge from Oral Therapies is Coming
5.6.1.8 Treating Anaemia in Patients with CKD - The Leading Use of EPO Therapies
5.6.1.9 Many Biosimilar Epoetins Approved Around the World
5.6.2 G-CSF
5.6.2.1 G-CSF: Discovered 1983. Recombinant Forms Available Since 1991
5.6.2.2 Amgen Leads the Market
5.6.2.3 Neupogen and Neulasta Revenues
5.6.2.4 Teva Aiming to Challenge Amgen’s Dominance
5.6.2.5 Facing Much Biosimilar Competition Around the World
5.6.3 Human Growth Hormone
5.6.3.1 Human Growth Hormone: First Extracted in 1958
5.6.3.2 Novo Nordisk Dominates Market
5.6.3.3 Novo Nordisk Aiming to Retain Dominance Through FlexPro Device and NN8640 Somatropin Candidate
5.6.3.4 Multiple Biosimilars Available - Omnitrope is Market Leader
5.6.3.5 Biosimilar Growth Hormones in Asia
5.6.4 Other Recombinant Hormones Submarket Forecast 2019 to 2029
5.7 Plasma and Recombinant Coagulating Factors
5.7.1 Types of Recombinant Factor
5.7.2 Clotting Factor Deficiency Diseases
5.7.3 Baxter/Baxalta: Entered the Bleeding Disorders Market in 1992, Markets Various Leading Products
5.7.3.1 Baxter: New Product Launches Include Rixubis and Obizur
5.7.4 Novo Nordisk: Committed to Remaining a Leading Company in the Bleeding Disorders Market
5.7.4.1 Novo Nordisk: Has filed for Approval for N9-GP and NovoEight is Doing Well
5.7.5 Bayer: Markets Kogenate, Kogenate FS, and has Received FDA Approval for Kovaltry
5.7.6 Limited Opportunities for Biosimilar Challenge
5.7.7 Plasma and Recombinant Coagulating Factors Submarket Forecast 2019 - 2029
5.8 Interferons
5.8.1 Interferons: Key Antiviral and MS Therapies Since the 1990s
5.8.2 Interferons for Treating Hepatitis: Its Influence is Decreasing
5.8.3 Competition from Oral Protease and Polymerase Inhibitors
5.8.3.1 Oral Therapies are Expensive
5.8.4 Avonex: The Leading Interferon Therapy
5.8.4.1 Avonex Revenue Forecast 2019 - 2029
5.8.5 Rebif: Merck Attempting to Differentiate Rebif from Other Interferon Therapies
5.8.5.1 Rebif Revenue Forecast 2019 - 2029
5.8.6 Betaseron
5.8.7 Plegridy: New Therapy with High Potential
5.8.8 Biosimilar Interferons: None Approved in Developed Markets, but Many Available in Emerging Nations
5.8.9 Interferon Submarket Forecast 2019 - 2029
5.9 Enzyme Replacement and Other Protein Therapies Submarket
5.9.1 Cerezyme: Genzyme’s Leading Enzyme Replacement Therapy
5.9.2 Myozyme and Lumizyme
5.9.3 Fabrazyme and Aldurazyme
5.9.4 Botulinum Toxin Brands Include Botox, Dysport and Xeomin
5.9.5 Other Protein Therapeutics Pipeline
5.9.5.1 Anthera Buys Sollpura from Eli Lilly, Phase 3 Results Expected Q4 2016
5.9.5.2 Multikine (CEL-SCI)
5.9.5.3 Vonapantiase (Proteon Therapeutics)
5.9.6 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast 2019 - 2029

6. Monoclonal Antibodies Submarket 2019 - 2029
6.1 Monoclonal Antibodies Submarket: Scientific and Historical Background
6.1.1 Natural Antibodies: Key to the Immune System
6.1.2 From Serum Therapy to Monoclonal Antibodies
6.1.3 Humanising the mAb
6.1.4 MAbs have found Success in Treating Autoimmune Disorders, Cancers and Others Diseases - Great Potential for the Future
6.1.5 MAbs for All? Technologies Come Off Patent
6.2 Autoimmune mAbs
6.2.1 Past Approvals
6.2.2 Humira - The World’s Best-Selling Prescription Drug
6.2.2.1 AbbVie Plans to Drive Growth Through New Indications
6.2.2.2 Positive Opinion from CHMP for Treatment of Non-Infectious Uveitis
6.2.2.3 Recently Approved for Hidradenitis Suppurativa in the US, Europe, and Japan
6.2.2.4 Biosimilar Adalimumab: Patents Protect Humira in Developed Markets for Now
6.2.2.5 Humira Revenue Forecast 2019 - 2029
6.2.3 Remicade: Second Only to Humira
6.2.3.1 Has Defended Revenues Well but Now Has to Deal with Biosimilar Competition
6.2.3.2 Patent Dance in US
6.2.3.3 Biosimilar Infliximab: Multiple Launches
6.2.3.4 Remicade Revenue Forecast 2019 - 2029
6.2.4 Stelara: Blockbuster Status Well Established
6.2.4.1 Stelara Revenues 2016-2018
6.2.4.2 Orphan Drug Designation for paediatric Crohn’s Disease
6.2.5 Tysabri: Blockbuster Drug’s High Efficacy Offsets its Risks
6.2.5.1 Tysabri Revenue Forecast 2019 - 2029
6.2.6 Xolair: New Indication, and Revenue Breakdown
6.2.7 Actemra/RoActemra: Strong Growth in All Regions
6.2.8 Cimzia: Blockbuster Which has been Used by Over 90,000 Patients
6.2.9 Autoimmune mAbs Pipeline: RA is the Main Target
6.2.9.1 Sarilumab (REGN88/SAR153191) by Regeneron and Sanofi: BLA Accepted for Review and Decision Expected by November 2016
6.2.9.2 Sirukumab (CNTO-136) by J&J and GSK: Multiple Phase 3 Studies Around the World
6.2.9.3 Clazakizumab: Developed by Alder Biopharmaceuticals and BMS but now Licensed to Vitaeris
6.2.9.4 Tregalizumab (BT-061) by Biotest: AbbVie Backs out After Poor Results
6.2.9.5 Mavrilimumab by AstraZeneca: Approaching Phase 3
6.2.9.6 Zinbryta (daclizumab high-yield process) by Biogen and AbbVie: Positive Opinion from CHMP
6.2.9.7 Lebrikizumab by Roche: Undergoing Phase 3 After Positive Phase 2b Results
6.2.9.8 Sifalimumab (MEDI-545) by AstraZeneca: Hasn’t Made the Cut for Phase 3
6.2.9.9 Anifrolumab by AstraZeneca
6.3 Oncology mAbs
6.3.1 Past Approvals
6.3.2 Rising Incidence of Cancer Will Drive Demand
6.3.3 Rituxan: The World’s Leading Anti-Cancer mAb
6.3.4 Biosimilar Rituximab: Two Candidates Await Approval in Europe
6.3.5 Gazyva: Roche’s Successor to Rituxan, Will Help to Retain Revenues in Face of Biosimilar Competition
6.3.5.1 Approval for Follicular Lymphoma and Being Investigated for Other Indications
6.3.6 Avastin: Growing under CER, Through New Indications
6.3.6.1 Controversy over Off-Label Avastin use: Roche is Backed up by Incidents in India, and Opinion of EFPIA
6.3.6.2 Biosimilar Bevacizumab: Late Patent Expiry is a Blessing for Roche, Although Various Biosimilars in Development
6.3.7 Herceptin: Breast Cancer Blockbuster
6.3.7.1 Pricing Challenges in Emerging Markets, and 2016 Revenues
6.3.7.2 Roche Builds Franchise of Anti-HER2 mAbs Around Herceptin
6.3.7.3 Herceptin Revenue Forecast 2019 - 2029
6.3.7.4 Biosimilar Trastuzumab
6.3.8 Kadcyla
6.3.8.1 Mixed Results from Different Clinical Trials
6.3.8.2 Kadcyla Sales Forecast 2019 -2029
6.3.9 Perjeta
6.3.9.1 Positive Results from Different Clinical Trials
6.3.9.2 Perjeta Revenue Forecast 2019 - 2029
6.3.10 Yervoy: Bristol-Myers Squibb’s Leading Anti-Cancer mAb, KeepsHigh Revenues, but with Decline over 2015
6.3.11 Opdivo: Big Potential for Bristol-Myer Squibb’s PD-1 Inhibitor
6.3.11.1 Good News and Bad News for NSCLC from CheckMate Trials
6.3.11.2 Cyramza (Eli Lilly): Approved in Three Additional Indications Since its First Approval in April 2014
6.3.12 Oncology mAbs: New Approvals and Pipeline
6.3.12.1 Empliciti (Elotuzumab) by Bristol-Myers Squibb and AbbVie): Recently Approved
6.3.12.2 Avelumab: Pfizer and Merck KGaA Team Up to Develop Their Own Anti-PD mAb
6.3.12.3 Unituxin (United Therapeutics) Receives FDA Approval March 2015
6.3.12.4 SAR3419 (coltuximab ravtansine) (anti-CD19, Sanofi)
6.4 Monoclonal Antibodies Submarket Forecast 2019 - 2029

7. Fusion Proteins SubMarket 2019 - 2029
7.1 Scientific and Historical Background
7.2 Differentiating Fusion Proteins
7.3 Enbrel: The First FP to be Approved, in 1998
7.3.1 Gradually Approved for Additional Indications
7.3.2 Enbrel Granted Extended Patent Protection in the US, Patent has Expired in EU
7.3.3 Multiple Biosimilars Available in Emerging Markets
7.3.4 Enbrel Revenue Forecast 2019 - 2029
7.4 Eylea: Blockbuster FP Treatment for Wet AMD
7.4.1 Eylea Revenue Forecast 2019 - 2029
7.5 Orencia: Grows Blockbuster Revenues for Second Year in a Row
7.6 Nplate: Generates Half a Billion in Revenues for Amgen
7.7 Eloctate: Approved June 2014, Fulfils Unmet Need in the Haemophilia Community
7.8 Nulojix: Bristol-Myers Squibb’s Therapy for Preventing Organ Rejection
7.9 Arcalyst by Regeneron Pharmaceuticals: For Very Rare Conditions
7.10 Fusion Proteins Pipeline
7.10.1 Trebananib (Amgen)
7.10.2 Sotatercept by Acceleron Pharma and Celgene Corporation - Currently Undergoing Eight Clinical Trials
7.10.3 Blisibimod (Anthera Pharmaceuticals) for the Treatment of Various Autoimmune Diseases, in Late Stage Development
7.11 Fusion Protein Submarket Forecast to 2019 - 2029

8. Regenerative Medicines Submarket 2019 - 2029
8.1 Regenerative Medicines Market Breakdown
8.2 Regenerative Medicines Submarket Forecast, 2019 - 2029
8.3 Stem Cell Therapies Submarket, 2019 - 2029
8.3.1 Stem Cells: Scientific Breakdown
8.3.2 Stem Cell Therapies Submarket Breakdown
8.3.3 Haematopoietic Stem Cell Transplantation: Over 95,000 Carried out in 2016
8.3.3.1 From Procedures to Products: Cord Blood Stem Cell Approvals
8.3.4 Osteocel Plus: The Leading Stem Cell Orthobiologic
8.3.4.1 Osteocel Plus Revenue Forecast 2019 - 2029
8.3.5 Trinity Evolution and Trinity Elite
8.3.5.1 Trinity Evolution and Trinity Elite Revenue Forecast to 2029
8.3.6 MSC-100-IV (Previously Known as Prochymal): World’s First Approved Stem Cell Drug Outside of South Korea
8.3.6.1 An Important Role to Play in the Future of HSCT, and also Wins Approval in Japan through Partner
8.3.7 CARTISTEM (MEDIPOST): The World’s First Allogeneic Stem Cell Drug
8.3.8 Hearticellgram-AMI (PharmaCell B.V.): One of the First Approved Cardiovascular Stem Cell Treatments in the World
8.3.9 Stem Cell Therapies Pipeline
8.3.9.1 Cx601 by TiGenix: Marketing Authorisation Application has been Submitted to EMA
8.3.9.2 CardiAMP (BioCardia) for Heart Failure: Undergoing Phase 3 Trial and has Received Grant from MSCRF
8.3.9.3 NurOwn (BrainStorm Cell Therapeutics): Neurotrophic Factor -Releasing Stem Cells for ALS in Phase 2 and Due to end Soon
8.3.9.4 Agenmestencel-T (Apceth): Phase 1/2 Due to end Soon
8.3.10 Stem Cell Therapies Submarket Forecast 2019 - 2029
8.4 Tissue Engineering Therapies SubMarket 2019 - 2029
8.4.1 Tissue Engineering – In Vitro Manipulation for Therapeutic Purposes
8.4.2 Current Status of the Market
8.4.3 Apligraf: The Leading Product
8.4.3.1 Apligraf Revenue Forecast 2019 - 2029
8.4.4 Dermagraft: Organogenesis Further Strengthens Position Through this 2014 Acquisition
8.4.4.1 Dermagraft Revenue Forecast 2019 - 2029
8.4.5 ReCell
8.4.6 MySkin and CyroSkin
8.4.7 Tissue Engineering Therapies Pipeline
8.4.7.1 NeoCart by Histogenics: Undergoing Phase 3 Trial for Knee Cartilage Repair
8.4.7.2 Extracorporeal Bio-Artificial Liver Therapy by Vital Therapies
8.4.7.3 StrataGraft by Stratatech Corporation Demonstrates Positive Top-Line Results
8.5 Gene Therapies SubMarket 2019 - 2029
8.5.1 Gene Therapy: Historical and Scientific Background
8.5.2 Harnessing Infectivity: Viral Vectors in Gene Therapy
8.5.3 Approved Gene Therapy Products
8.5.3.1 Gendicine: The World’s First Commercial Gene Therapy Product
8.5.3.2 Oncorine: First Oncolytic Viral Therapy
8.5.3.3 Neovasculgen: Russia’s First Gene Therapy
8.5.3.4 Neovasculgen: Drop in Revenues in 2015, but HSCI Predicts Notable Increases as Product is Added to VED List
8.5.3.5 Glybera: The First Gene Therapy for Western Markets, Although Has Abandoned Hope of Receiving FDA-Approval
8.5.4 IMLYGIC
8.5.4.1 IMLYGIC: Clinical Trials and Development Efforts
8.5.4.2 IMLYGIC: Revenue Forecast 2019 - 2029
8.5.5 Gene Therapies Pipeline
8.5.5.1 AAV2-hRPE65v2 (Spark Therapeutics): Undergoing Phase 3 Trial
8.5.5.2 AdV-tk/ProstAtak (Advantagene): Phase 3
8.5.5.3 Collategene (beperminogene perplasmid, AMG0001) - (AnGes MG/Vical)

9. Leading National Markets for Biologics 2019 - 2029
9.1 Regional Forecasts for the Global Biologics Market to 2029
9.2 US Biologics Market 2019 - 2029
9.2.1 The Major National Market
9.2.2 Value-Based Pricing in the US
9.2.3 Regulation of Biologics in the US
9.2.4 US Biosimilars Market
9.2.4.1 FDA Finalises Biosimilar Guidelines and Biosimilar Naming
9.2.5 US Biologics Market Forecast 2019 - 2029
9.3 EU5 Biologics Market 2019 - 2029
9.3.1 Current Composition and Future Outlook
9.3.2 European Biosimilar Market
9.3.2.1 History of EMA Guidelines and Updates
9.3.3 EU5 Market Forecast by Nation 2019 - 2029
9.4 Japanese Biologics Market 2019 - 2029
9.4.1 Current Status of the Japanese Biologics Market
9.4.2 Japanese Biosimilar Market
9.4.3 Japanese Biologics Market Forecast 2019 - 2029
9.5 BRIC National Biologic Markets 2019 - 2029
9.5.1 BRIC Markets Overview
9.5.2 BRIC Biologic Market Forecast 2019 - 2029
9.5.2.1 Unique Challenges Faced by the Biologics Industry have led to Current Composition of the BRIC Biologic Market
9.5.2.2 Future Outlook
9.5.2.3 BRIC Nation Market Shares in the Global Biologics Market Will Nearly Double During the Forecast Period
9.5.3 Brazil: Disproportionately High Government Spending on Biologics
9.5.3.1 Brazilian Government Eager to Promote Domestic Biologic and Biosimilar Development
9.5.4 Russia: Another Government Which is Eager to Increase Domestic Biological Drug Development
9.5.5 India: Biologics Market Behind that of Other BRIC Nations, but Biosimilars Submarket Thriving
9.5.5.1 CDSCO Guidelines Released in 2012
9.5.6 China: Expected to be the Largest BRIC Market for Biologics by 2020
9.5.6.1 The Largest National Biosimilar Market in the World

10. Qualitative Analysis of the Biologics Market and Industry
10.1 SWOT Analysis of the Global Biologics Market and Industry
10.1.1 Strengths
10.1.2 Opportunities
10.1.3 Weaknesses
10.1.4 Threats
10.2 STEP Analysis of the Global Biologics Market and Industry
10.2.1 Social Factors
10.2.2 Technological Developments
10.2.3 Economic Pressures
10.2.4 Political Issues

11. Company Profiles
11.1 AbbVie Inc.: Profile
11.1.1 AbbVie Inc.: Company Overview
11.2 Amgen: Profile
11.2.1 Amgen: Company Overview
11.3 AstraZeneca PLC: Profile
11.3.1 AstraZeneca PLC: Company Profile
11.4 Bayer AG: Profile
11.4.1 Bayer AG: Profile
11.5 Eli Lilly: Profile
11.5.1 Eli Lilly: Company Overview
11.6 F. Hoffmann-La Roche Ltd.: Profile
11.6.1 F. Hoffmann-La Roche Ltd.: Company Overview
11.7 GlaxoSmithKline Plc.: Profile
11.7.1 GlaxoSmithKline Plc.: Company Overview
11.8 Johnson & Johnson Services, Inc.: Profile
11.8.1 Johnson & Johnson Services, Inc.: Company Overview
11.9 Merck & Co., Inc.: Profile
11.9.1 Merck & Co., Inc.: Company Overview
11.10 Novartis AG: Profile
11.10.1 Novartis AG: Profile
11.11 Pfizer Inc.: Profile
11.11.1 Pfizer Inc.: Company Overview
11.12 Sanofi S.A.: Profile
11.12.1 Sanofi S.A.: Company Overview
11.13 Novo Nordisk A/S: Profile
11.13.1 Novo Nordisk A/S: Company Overview
11.14 Takeda Pharmaceutical Company Limited: Profile
11.14.1 Takeda Pharmaceutical Company Limited: Company Overview
11.14.2 Subsidiary of Takeda Pharmaceutical
11.14.2.1 Shire PLC: Company Overview
11.15 Gilead Sciences Inc.,: Profile
11.15.1 Gilead Sciences Inc.: Company Overview
11.16 Alexion Pharmaceuticals, Inc.,: Profile
11.16.1 Alexion Pharmaceuticals, Inc.,: Company Overview
11.17 Samsung Biologics Co., Ltd: Profile
11.17.1 Samsung Biologics Co., Ltd.: Company Overview
11.18 UCB SA: Profile
11.18.1 UCB SA: Company Overview
11.19 Celgene Corporation: Profile
11.19.1 Celgene Corporation: Company Overview
11.20 Precision Biologics, Inc.: Profile
11.20.1 Precision Biologics, Inc.: Company Overview

12. Conclusions
12.1 Biologics Market to Achieve Steady Growth Throughout the Forecast Period
12.2 Changes in Market Composition: mAbs to Become Leading Submarket
12.3 The Emergence of Biosimilars
12.4 Challenges for the Market

Appendices