World Biological Drugs Market 2013-2023

notice This material is copyright 2010 by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.

Contents
1. Executive Summary
1.1 World Biological Drugs Market Review 1.2 Summary of Report Contents 1.3 Research and Analysis Methods

2. Biological Drugs Market: Clinical and Commercial Overview, 20132023

2.1 Biologics Market Projections for 2013-2023 2.2 The Importance of Biological Drugs to the Global Pharmaceutical Market 2.2.1 Defining Biological 2.2.2 Biological Drugs Constituted 15% of the Global Pharmaceutical Market in 2012 2.2.2.1 The Leading Biological Products and How they Rank Overall 2.2.2.2 Why are Biologics the Most Lucrative Pharmaceutical Products in the Global Market Overall? 2.2.3 The Biosimilars Revolution: Coming Soon? 2.2.3.1 Biosimilars Represented Just Over 1% of the Biologics Market in 2012 2.2.3.2 An Important Decade for Biosimilars 2.2.4 Autoimmune Diseases, Cancer and Diabetes Treatments Make Up 73% of the Biologics Market 2.2.4.1 Other Therapeutic Areas within the Biologics Market 2.2.4.2 How the Biologics Markets Therapeutic Focus Differs from the Broader Pharmaceutical Market 2.2.5 Roche Still Leads the Biologics Market 2.3 Overview of the Four Submarkets, 2013-2023 2.3.1 Superior Pipeline Will Drive Increased Market Share for MAbs Submarket 2.4 Protein Therapeutics Submarket: Scientific and Historical Background 2.4.1 Proteins Have Been Used Medicinally Since the 19th Century

www.visiongain.com

Contents
2.4.2 Recombinant DNA Technology 2.4.3 Biotechs and Biotechnology 2.4.4 Insulin: The First Protein Therapeutic 2.4.5 Approval of Recombinant Hormones 2.4.6 Discovery of Plasma and Clotting Proteins 2.4.7 Interferons Approved in 1990s 2.4.8 Other Protein Therapeutics 2.5 MAbs Submarket: Scientific and Historical Background 2.5.1 Natural Antibodies: Key to the Immune System 2.5.2 From Serum Therapy to Monoclonal Antibodies (MAbs) 2.5.3 Humanising the MAb 2.5.4 MAbs for Autoimmune Indications 2.5.5 MAbs for Cancer Indications 2.5.6 MAbs for Other Therapeutic Area Indications 2.5.7 MAbs for All? The Technology Comes Off Patent 2.5.8 Next-Generation Technologies 2.6 Fusion Proteins Submarket: Scientific and Historical Background 2.6.1 Differentiating Fusion Proteins 2.7 Cellular and Regenerative Medicines Submarket: Scientific and Historical Background 2.7.1 Tissue Engineering 2.7.2 Cellular Therapies 2.7.3 Gene Therapy 2.8 Marginal Cases 2.8.1 The Vaccines Market 2.8.1 The Vaccines Market

3. Protein Therapeutics Submarket 2013-2023

3.1 Protein Therapeutics Submarket Projections for 2013-2023 3.2 Protein Therapeutics Submarket: Breakdown by Segment, 2013-2023 3.2.1 Insulins Segment: Set to Grow Rapidly to 2023 3.2.1.1 Novo Nordisk, Sanofi and Eli Lilly Dominate the Insulins Segment

www.visiongain.com

Contents
3.2.1.2 Duration of Action the Major Differentiator for Insulins 3.2.1.3 Tresiba: A Game-Changer for the Segment? 3.2.1.4 Pegylated Insulins, Ultra-Concentrated Insulins, and Insulin Tablets: Insulin Pipeline for the Big Three 3.2.1.5 Biosimilars and Other Insulins in Development 3.2.1.6 Diabetes Prevalence the Major Driver for Insulins 3.2.1.7 Market Forecast for Insulins Segment, 2013-2023 3.2.2 Other Recombinant Hormones: Set for Biosimilar Competition 3.2.2.1 Revenues for Erythropoietins Continue to Fall in 2012 3.2.2.2 Biosimilars, Safety Concerns and Other Restraints for Erythropoietins 3.2.2.3 G-CSF: How Long Can Amgen and Kyowa Continue to Dominate? 3.2.2.4 Biosimilar Filgrastim and Pegfilgrastim to Reach All the Major Regional Markets 3.2.2.5 Somatropin: Another Well-Established Recombinant Hormone 3.2.2.6 Biosimilar and Safety Challenges to Growth Hormones 3.2.2.7 Pipeline for Other Recombinant Hormones 3.2.2.8 Drivers and Restraints for Other Recombinant Hormones 3.2.2.9 Market Forecast for Other Recombinant Hormones Segment, 2013-2023 3.2.3 Plasma and Recombinant Coagulating Factors: A Growth Opportunity 3.2.3.1 Types of Recombinant Factor 3.2.3.2 Key Clotting Factor Deficiency Diseases 3.2.3.3 Six Companies Dominate the Segment 3.2.3.4 Other Companies Targeting this Segment: Biogen Idec Leads the Pack 3.2.3.5 Extended Duration of Action to be a Differentiator 3.2.3.6 Limited Opportunities for Biosimilar Challenges 3.2.3.7 Other Pipeline Developments 3.2.3.8 Drivers and Restraints for Plasma and Recombinant Coagulating Factors, 2013 3.2.3.9 Market Forecast for Plasma and Recombinant Coagulating Factors Segment, 2013-2023 3.2.4 Interferons: Two Decades as Key Antiviral and MS Therapeutics 3.2.4.1 Leading Interferon Brands in 2012 3.2.4.2 Interferons Remain Part of Hepatitis Standard of Care Despite Severe Limitations

www.visiongain.com

Contents
3.2.4.3 How Will Interferons Compete Against the Pipeline Protease and Polymerase Inhibitors? 3.2.4.4 Aubagio, Tecfidera and Lemtrada to Reduce Interferons Hold on the MS Therapeutic Area 3.2.4.5 Biosimilar First-Generation Interferons Widely Available in Emerging Markets 3.2.4.6 Can the Pipeline Rejuvenate the Interferons Segment? 3.2.4.7 Drivers and Restraints for the Interferons Segment, 2013 3.2.4.8 Market Forecast for Interferons Segment, 2013-2023 3.2.5 Other Protein Therapeutics: Enzyme Replacement A Key Area 3.2.5.1 Pipeline for Other Protein Therapeutics 3.2.5.2 Market Forecast for Other Protein Therapeutics Segment, 2013-2023 3.3 Leading Products in the Protein Therapeutics Submarket, 2013-2023 3.3.1 Changing Market Shares, 2013-2023 3.3.2 Lantus (Sanofi), 2013-2023 3.3.2.1 Tresibas Cardiovascular Concerns Mean Lantus Will Stay In Front 3.3.2.2 Market Forecast for Lantus, 2013-2023 3.3.3 Neulasta/Neupogen (Amgen), 2013-2023 3.3.3.1 Biosimilars the Main Concern for Amgen 3.3.3.2 Market Forecast for Neulasta/Neupogen, 2013-2023 3.3.4 Epogen (Amgen), 2013-2023 3.3.4.1 Amgens Defence of Epogens Market Share 3.3.4.2 Market Forecast for Epogen, 2013-2023 3.3.5 Avonex (Biogen Idec), 2013-2023 3.3.5.1 How Will Avonex Fare in the Changing MS Therapeutic Area? 3.3.5.2 Market Forecast for Avonex, 2013-2023 3.3.6 NovoRapid (Novo Nordisk), 2013-2023 3.3.6.1 Competition in the Short-Acting Insulin Analogues Market 3.3.6.2 Market Forecast for NovoRapid, 2013-2023 3.3.7 Other Products, 2013-2023 3.3.7.1 Major Future Approvals in this Submarket 3.3.7.2 Market Forecast for Other Products, 2013-2023

www.visiongain.com

Contents
3.4 Leading Products in Development in the Protein Therapeutics Submarket, 2013 3.4.1 Recombinant Factor XIII (Novo Nordisk) 3.4.2 NN7008 (Novo Nordisk) 3.4.3 Liprotamase (Eli Lilly) 3.4.4 IDegLira (Novo Nordisk) 3.4.5 LY2605541(Eli Lilly / Boehringer Ingelheim) 3.4.6 LY2963016 (Eli Lilly / Boehringer Ingelheim) 3.4.7 FIAsp (Novo Nordisk) 3.4.8 Somatropin (LG Life Sciences) 3.4.9 Natpara (NPS Pharmaceuticals) 3.4.10 Recombinant von Willebrand Factor (Baxter) 3.4.11 IB1001 (Inspiration Biopharmaceuticals) 3.4.12 NN7088 (Novo Nordisk) 3.4.13 NN7999 (Novo Nordisk) 3.4.14 Recombinant Factor VIII Fc (Biogen Idec) 3.4.15 Recombinant Factor IX Fc (Biogen Idec) 3.4.16 BAY 94-9027 (Bayer) 3.4.17 Human Recombinant Factor VIII (Octapharma) 3.4.18 OBI-1 (Inspiration Biopharmaceuticals) 3.4.19 BIIB017 (Biogen Idec) 3.4.20 Alferon N Injection (HemispherX Biopharma) 3.4.21 PEG-interferon Lambda (Bristol-Myers Squibb) 3.4.22 NU-100 (Nuron Biotech) 3.4.23 Multikine (CEL-SCI) 3.4.24 Talactoferrin Alpha (Agennix) 3.4.25 Desmoteplase (Lundbeck) 3.4.26 Mycobacterium Cell Wall-DNA complex (Bioniche Therapeutics)

4. Monoclonal Antibodies Submarket 2013-2023

4.1 Monoclonal Antibodies Submarket Projections for 2013-2023

www.visiongain.com

Contents
4.2 Monoclonal Antibodies Submarket: Breakdown by Segment, 2013-2023 4.2.1 Autoimmune MAbs: Leading Segment of Biologics Market in 2012 4.2.1.1 Humira and Remicade Dominate Autoimmune MAbs Segment 4.2.1.2 TNF Blockers Represent 79% of All Revenues in the Autoimmune Segment 4.2.1.3Johnson & Johnson Leads the Autoimmune Segment with 41% Market Share 4.2.1.4 The Autoimmune MAbs Pipeline 4.2.1.5 Asthma and Lupus Next Behind RA as R&D Focus for Autoimmune MAbs 4.2.1.6 Competition for the Autoimmune MAbs 4.2.1.7 Drivers and Restraints for Autoimmune MAbs, 2013 4.2.1.8 Market Forecast for Autoimmune MAbs Segment, 2013-2023 4.2.2 Oncology MAbs: Focus for Next-Generation Antibody Innovation 4.2.2.1 Roches Three Major Products Dominate the Segment 4.2.2.2 Perjeta and Kadcyla Will Cement the Importance of HER2 as Key Molecular Target 4.2.2.3 Eight Approved MAbs Target Haematological Cancers 4.2.2.4 Bristol-Myers Squibb Rank Second in Oncology Segment 4.2.2.5 Next-Generation Formats Bolster Extensive Oncology Pipeline 4.2.2.6 Solid Tumours are the Major Challenge for Oncology MAbs 4.2.2.7 Drivers and Restraints for Oncology MAbs, 2013 4.2.2.8 Market Forecast for Oncology MAbs Segment, 2013-2023 4.2.3 Other Therapeutic Areas MAbs: New Breakthroughs to Come? 4.2.3.1 Lucentis Continues to Dominate this Segment 4.2.3.2 Pipeline Targets Several New Therapeutic Areas 4.2.3.3 Anti-PCSK9 MAbs to Combine with Statins? 4.2.3.4 After Bapineuzumab: New Hope for Alzheimers MAbs 4.2.3.5 Building on Lucentis: MAbs for Ophthalmic Indications 4.2.3.6 Anti-Infective MAbs: The New Antibiotics? 4.2.3.7 Drivers and Restraints for Other Therapeutic Areas MAbs, 2013 4.2.3.8 Market Forecast for Other Therapeutic Areas MAbs Segment, 2013-2023 4.3 Leading Products in the MAbs Submarket, 2013-2023 4.3.1 Changing Market Shares, 2013-2023

www.visiongain.com

Contents
4.3.2 Humira (AbbVie), 2013-2023 4.3.2.1 Approved for Ulcerative Colitis, but will Oral RA Treatments Threaten Humira? 4.3.2.2 Market Forecast for Humira, 2013-2023 4.3.3 Remicade (Johnson & Johnson), 2013-2023 4.3.3.1 Can Remicade Survive the Biosimilar Challenge from Korea? 4.3.3.2 Market Forecast for Remicade, 2013-2023 4.3.4 Rituxan (Roche), 2013-2023 4.3.4.1 Battle for the CD20 Market: Rituxan vs The Rest 4.3.4.2 Market Forecast for Rituxan, 2013-2023 4.3.5 Herceptin (Roche), 2013-2023 4.3.5.1 The First Major PLM Strategy in the MAb Submarket: Herceptin, Perjeta and Kadcyla 4.3.5.2 Market Forecast for Herceptin, 2013-2023 4.3.6 Avastin (Roche), 2013-2023 4.3.6.1 Is Avastin Reaching its Limits? 4.3.6.2 Market Forecast for Avastin, 2013-2023 4.3.7 Other MAb Products, 2013-2023 4.3.7.1 Forecast for Other MAb Products, 2013-2023 4.4 Leading Products in Development in the MAbs Submarket, 2013 4.4.1 CNTO-136 (Johnson & Johnson) 4.4.2 Daclizumab (AbbVie/Biogen Idec) 4.4.3 Epratuzumab (UCB/ Immunomedics) 4.4.4 Ocrelizumab (Biogen Idec/ Roche) 4.4.5 Sarilumab (Sanofi) 4.4.6 Secukinumab (Novartis) 4.4.7 Tabalumab (Eli Lilly) 4.4.8 Ixekizumab (Eli Lilly) 4.4.9 Tanezumab (Pfizer) 4.4.10 Mepolizumab (GlaxoSmithKline) 4.4.11 Reslizumab (Cephalon) 4.4.12 Lebrikiuzmab (Genentech)

www.visiongain.com

Contents
4.4.13 Tildrakizumab (Merck) 4.4.14 ch14.18 (United Therapeutics) 4.4.15 Inotuzumab Ozogamicin (Pfizer) 4.4.16 Elotuzumab (Bristol-Myers Squibb) 4.4.17 Farletuzumab (Eisai) 4.4.18 Ganitumab (Amgen) 4.4.19 MABp1 (Xbiotech) 4.4.20 GA101 (Roche) 4.4.21 Mogamalizumab (Kyowa Hakko Kirin) 4.4.22 Necitumumab (Eli Lilly) 4.4.23 Nivolumab (Bristol-Myers Squibb) 4.4.24 Onartuzumab (Roche) 4.4.25 Ramucirumab (Eli Lilly) 4.4.26 Girentuximab (Wilex) 4.4.27 AMG145 (Amgen) 4.4.28 SAR 236553 (Sanofi/ Regeneron) 4.4.29 Gevokizumab (XOMA) 4.4.30 Teplizumab (MacroGenics) 4.4.31 Anthraximmune Globulin (Cangene) 4.4.32 Actoxumab (Merck) 4.4.33 Romosozumab (Amgen) 4.4.34 Solanezumab (Eli Lilly)

5. Fusion Proteins Submarket 2013-2023

5.1 Fusion Proteins Submarket Projections for 2013-2023 5.2 Leading Products in the Fusion Proteins Submarket, 2013-2023 5.2.1 New Approvals to Drive Submarket Growth to 2023 5.2.2 Enbrel (Amgen): Leading Fusion Protein, 2013 5.2.2.1 Biosimilar Enbrel Competitors on Hold?

www.visiongain.com

Contents
5.2.2.2 Market Forecast for Enbrel, 2013-2023 5.2.2.3 Can Orencia Differentiate Itself in the RA Market? 5.2.3 Eylea (Regeneron): Breaking Into the AMD Market in 2012 5.2.3.1 Scope for Expansion with Eylea 5.2.3.2 Market Forecast for Eylea, 2013-2023 5.2.4 Other Fusion Proteins, 2013-2023 5.3 Leading Products in Development in the Fusion Proteins Submarket, 2013 5.3.1 Albiglutide (GlaxoSmithKline) 5.3.2 Dulaglutide (Eli Lilly) 5.3.2.1 Could the Fifth in Class Become the Best in Class? 5.3.3 Atacicept (Merck KGaA/ZymoGenetics) 5.3.4 AMG 386 (Amgen)

6. Cellular and Regenerative Medicines Submarket, 2013-2023

6.1 Cellular and Regenerative Medicines Submarket Projections for 2013-2023 6.2 Cellular and Regenerative Medicines Submarket: Breakdown by Segment, 2013-2023 6.2.1 Tissue Engineered Products: Prospects Beyond Wound Repair? 6.2.1.1 Apligraf Leads the Tissue Engineered Products Segment in 2013 6.2.1.2 Apligraf Competes with Dermagraft in Diabetic Foot Ulcers Therapeutic Area 6.2.1.3 Other Potential Applications for Tissue Engineering 6.2.1.4 Drivers and Restraints for the Tissue Engineered Products Segment, 2013 6.2.1.5 Market Forecast for Tissue Engineered Products Segment, 2013 6.2.2 Cellular Therapies Segment, 2013-2023 6.2.2.1 Approvals in Canada and South Korea Bolster Stem Cell Field 6.2.2.2 The Big Stem Cell Breakthrough I: The New Wave of MSC Treatments 6.2.2.3 The Big Stem Cell Breakthrough 2: Regenerating Organs 6.2.2.4 Chondrocytes for Cartilage Repair 6.2.2.5 Drivers and Restraints for Cellular Therapies, 2013 6.2.2.6 Market Forecast for Cellular Therapies, 2013-2023

www.visiongain.com

Contents
6.2.3 Gene Therapy: Has the Time Come at Last for This Technology? 6.2.3.1 Existing Gene Therapy Products: Asian Approvals 6.2.3.2 Glybera Brings Gene Therapy to Europe 6.2.3.3 Significant Pipeline for Gene Therapies 6.2.3.4 Drivers and Restraints for Gene Therapy, 2013 6.2.3.5 Market Forecast for Gene Therapy, 2013-2023 6.3 Leading Products in Development in the Cellular and Regenerative Medicines Submarket, 2013 6.3.1 CAIS (Depuy Mitek) 6.3.2 Neocart (Histogenics Corporation) 6.3.3 Ixmyelocel-T (Aastrom Biosciences) 6.3.4 "Off-the-shelf" Mesenchymal Precursors (Mesoblast) 6.3.4.1 Gamida Cell Competing for this Market Opportunity 6.3.5 Prochymal (Osiris Therapeutics) 6.3.6 Auto-CD34+ Cells (Baxter) 6.3.6.1 NeoStem vs Baxter 6.3.7 Cx601 (Tigenix) 6.3.8 Talminogene Laherparepvec (Amgen) 6.3.9 Generx (Cardium Therapeutics)

7. Leading National Markets for Biological Drugs 2013-2023

7.1 The US Remained the Largest Market in 2012 7.2 Overview of Market Change, 2013-2023 7.3 Breakdown by Region, 2013-2023 7.3.1 US, 2013-2023 7.3.1.1 US Health Spending Nears $3 Trillion 7.3.1.2 Value-Based Pricing in the US 7.3.1.3 US Regulation of Biologics 7.3.1.4 Biologics Price Competition and Innovation Act 7.3.1.5 Market Forecast for the US, 2013-2023

www.visiongain.com

Contents
7.3.2 EU5, 2013-2023 7.3.2.1 European Leadership on Biosimilars 7.3.2.2 Other Biosimilar Regulations 7.3.2.3 Market Forecast for EU5, 2013-2023 7.3.2.4 Breakdown of the EU5, 2013-2023 7.3.3 Japan, 2013-2023 7.3.3.1 Sandoz and JCR Pioneering Japanese Biosimilars 7.3.3.2 Market Forecast for Japan, 2013-2023 7.3.4 BRIC Nations, 2013-2023 7.3.4.1 Market Forecast for the BRIC Nations, 2013-2023 7.3.4.2 Brazil: Government to Take the Lead in Biologics Manufacture? 7.3.4.3 Russia: Targeting Domestic Biomanufacturing Capacity 7.3.4.4 India: Will the Generics Hub Become the Biosimilars Leader? 7.3.4.5 China: The Major Market Opportunity 7.3.4.6 Breakdown of the BRIC Nations, 2013-2023

8. Qualitative Industry Analysis: Drivers and Restraints, 2013

8.1 Strengths: An Established and Successful Market 8.2 Weaknesses: Has the Advance of Biopharmaceuticals Reached its Limits? 8.3 Opportunities: Time for a New Phase in the Biologics Revolution 8.4 Threats: Where Will the Innovations Needed to Keep the Market Moving Come From? 8.5 Social Factors: How Much do Physicians and Patients Want the New Biologics? 8.6 Technological Developments: Crucial to the Market 8.7 Economic Pressures: A Constant Theme in the Biologics Market 8.8 Political Issues: Governments Shaping the Regulatory Future of the Market

9. Research Interviews
9.1 Overview of the Biotech Industry in 2013: Interview with Ronald A. Rader, President of Biotechnology Information Institute 9.1.1 Steady Growth, but a Dearth of New Blockbusters

www.visiongain.com

Contents
9.1.2 The Price of Biological Drugs 9.1.3 Biosimilars to Outnumber Innovator Products 9.1.4 Differentiated Biologics: Biosimilars vs Bio-Betters 9.1.5 Changing of the Guard: Can New Classes of Biopharmaceuticals Transform the Market? 9.1.6 Big Pharma and the Biotechs 9.1.7 Bundled Payments and Bulked-up Portfolios, and Other Reasons Why Every Major Player Will Get Involved in Biosimilars 9.1.8 Modular Bioprocessing: The Next Revolution? 9.2 Next-Generation MAbs: Interview with Dr Janice Reichert 9.2.1 On Antibody-Drug Conjugates 9.2.2 On Engineered Improvements to Antibodies 9.2.3 On the Current Scientific Understanding of Antibody Functions 9.2.4 On Bispecific Antibodies 9.2.5 On Antibody Fragments and Market Pricing 9.2.6 On the Overall Prospects for Next-Generation Antibodies 9.3 MAb vs. Fusion Protein in the AMD Market: Interview with Dr Michael Stewart, Mayo Clinic 9.3.1 The Impact of Eylea, 2011-2012 9.3.2 The Comparative Dosing Schedules of Eylea and Lucentis 9.3.3 Patient Transitioning to Eylea: Salvage Switching 9.3.4 Avastin After the CATT Study 9.3.5 Prospects for Eylea in Other Indications and Combinations 9.3.6 Future Possibilities in Wet AMD Treatment 9.4 A Revolution in Regenerative Medicine? Interview with Dr Alan Trounson, President, California Institute for Regenerative Medicine (CIRM) 9.4.1 Current Stem Cell Clinical Trials 9.4.2 Big Pharma Investment in Stem Cells 9.4.3 Mesenchymal Cells in Clinical Trials 9.4.4 On Definitions of Cell Types and Regulatory Pathways 9.4.5 The Prospects for Stem Cell Cures

www.visiongain.com

Contents
10. Conclusions
10.1 The Biologics Market Will Grow in Importance for the Pharmaceuticals Industry 10.2 MAbs and Protein Therapeutics Will Continue to Be the Dominant Submarkets 10.3 Biosimilars Will Transform the Market 10.4 Cost will Remain the Main Challenge

www.visiongain.com

Contents
List of Tables
Table 2.1 World Biological Drugs Market: Total Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 2.2 World Biological Drugs Market: Total Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 2.3 Comparative Biological Molecule Sizes Table 2.4 Top 10 Biological Drugs: Revenues ($m), Market Share (%), 2012 Table 2.5 Top 10 Drugs in the Global Pharmaceutical Market: Revenues ($m), 2012 Table 2.6 Key Therapeutic Areas in the Biologics Market: Revenues ($m), Market Share (%), 2012 Table 2.7 Leading Companies in the Biologics Market: Revenues ($m), Market Share (%), 2012 Table 2.8 Breakdown by Submarket: Revenues ($m), Market Share (%), 2012 Table 2.9 Breakdown by Submarket: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 2.10 Breakdown by Submarket: Revenues ($m), Market Share (%), 2017 Table 2.11 Breakdown by Submarket: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 2.12 Breakdown by Submarket: Revenues ($m), Market Share (%), 2023 Table 2.13 Regions of an Antibody Table 2.14 Natural Antibody Mechanisms of Action Table 2.15 Potency and Source of Stem Cells Table 3.1 Protein Therapeutics Submarket: Total Revenues ($m), AGR (%), CAGR (%), 20122017 Table 3.2 Protein Therapeutics Submarket: Total Revenues ($m), AGR (%), CAGR (%), 20182023 Table 3.3 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket Share (%), 2012 Table 3.4 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%) Submarket Share (%), 2012-2017 Table 3.5 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket Share (%), 2017

www.visiongain.com

Contents
Table 3.6 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 3.7 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket Share (%), 2023 Table 3.8 EU and US Patent Expiry Dates for Leading Insulins Table 3.9 Types of Insulin Product, 2013 Table 3.10 Insulins Pipeline: Selected Products, 2013 Table 3.11 Classes of Diabetes Treatments, 2013 Table 3.12 Insulins Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.13 Insulins Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.14 EU and US Patent Expiry Dates for Leading Erythropoietins Table 3.15 Other Recombinant Hormones Pipeline: Selected Products, 2013 Table 3.16 Other Recombinant Hormones Segment: Revenues ($m), AGR (%), CAGR (%), 20122017 Table 3.17 Other Recombinant Hormones Segment: Revenues ($m), AGR (%), CAGR (%), 20182023 Table 3.18 Selected Coagulating Factors Significant in Segment R&D, 2013 Table 3.19 Plasma and Recombinant Coagulating Factors Pipeline: Selected Products, 2013 Table 3.20 Plasma and Recombinant Coagulating Factors Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.21 Plasma and Recombinant Coagulating Factors Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.22 Leading Interferon Products: Revenues ($m), Market Share (%), 2012 Table 3.23 EU and US Patent Expiry Dates for Leading Interferons Table 3.24 Interferons Pipeline: Selected Products, 2013 Table 3.25 Interferons Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.26 Interferons Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.27 Other Protein Therapeutics Pipeline: Selected Products, 2013 Table 3.28 Other Protein Therapeutics Segment: Revenues ($m), AGR (%), CAGR (%), 20122017

www.visiongain.com

Contents
Table 3.29 Other Protein Therapeutics Segment: Revenues ($m), AGR (%), CAGR (%), 20182023 Table 3.30 Leading Protein Therapeutic Products: Revenues ($m), Submarket Share (%), 2012 Table 3.31 Leading Protein Therapeutic Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 3.32 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2017 Table 3.33 Leading Protein Therapeutic Products: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 3.34 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2023 Table 3.35 Lantus: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.36 Lantus: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.37 Neulasta/Neupogen: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.38 Neulasta/Neupogen: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.39 Epogen: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.40 Epogen: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.41 Avonex: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.42 Avonex: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.43 NovoRapid: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.44 NovoRapid: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.45 Other Products: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.46 Other Products: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.47 Protein Therapeutics Late-Stage Pipeline, Selected Products, 2013 Table 4.1 Monoclonal Antibodies Submarket: Total Revenues ($m), AGR (%), CAGR (%), 20122017 Table 4.2 Monoclonal Antibodies Submarket: Total Revenues ($m), AGR (%), CAGR (%), 20182023 Table 4.3 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2012 Table 4.4 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%) Market Share (%), 2012-2017

www.visiongain.com

Contents
Table 4.5 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2017 Table 4.6 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%) Market Share (%), 2018-2023 Table 4.7 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2023 Table 4.8 Leading Products in Autoimmune MAbs Segment, Revenues ($m), Share of Segment (%), 2012 Table 4.9 Main Molecular Targets in Autoimmune Segment: Revenues ($m), Market Share (%), 2012 Table 4.10 Level of Antibody Humanisation in Autoimmune Segment: Revenues ($m), Market Share (%), 2012 Table 4.11 Leading Companies in Autoimmune Segment: Revenues ($m), Market Share (%), 2012 Table 4.12 Autoimmune MAbs Pipeline: Selected Products, 2013 Table 4.13 RA MAbs Pipeline: Selected Products, 2013 Table 4.14 Asthma MAbs Pipeline: Selected Products, 2013 Table 4.15 Lupus MAbs Pipeline: Selected Products, 2013 Table 4.16 MS MAbs Pipeline: Selected Products, 2013 Table 4.17 Psoriasis MAbs Pipeline: Selected Products, 2013 Table 4.18 Other Autoimmune MAbs Pipeline: Selected Products, 2013 Table 4.19 Autoimmune MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.20 Autoimmune MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 4.21 Leading Products in Oncology MAbs Segment, Revenues ($m), Share of Segment (%), 2012 Table 4.22 Main Molecular Targets in Oncology Segment: Revenues ($m), Market Share (%), 2012 Table 4.23 Leading Companies in Oncology Segment: Revenues ($m), Market Share (%), 2012 Table 4.24 Oncology MAbs Pipeline: Selected Products, 2013 Table 4.25 Oncology MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

www.visiongain.com

Contents
Table 4.26 Oncology MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 4.27 Leading Products in Other Therapeutic Areas MAbs Segment, Revenues ($m), Share of Segment (%), 2012 Table 4.28 Other Therapeutic Areas MAbs Pipeline: Selected Products, 2013 Table 4.29 Cardiovascular MAbs Pipeline: Selected Products, 2013 Table 4.30 Alzheimers Disease MAbs Pipeline: Selected Products, 2013 Table 4.31 Ophthalmic MAbs Pipeline: Selected Products, 2013 Table 4.32 Anti-Infectives MAbs Pipeline: Selected Products, 2013 Table 4.33 Other Therapeutic Areas MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 20122017 Table 4.34 Other Therapeutic Areas MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 20182023 Table 4.35 Leading MAbs: Revenues ($m), Market Share (%), 2012 Table 4.36 Leading MAbs: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 4.37 Leading MAbs: Revenues ($m), Market Share (%), 2017 Table 4.38 Leading MAbs: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 4.39 Leading MAbs: Revenues ($m), Market Share (%), 2023 Table 4.40 Humira: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 4.41 Humira: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 4.42 Remicade: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 4.43 Remicade: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 4.44 Rituxan: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 4.45 Rituxan: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 4.46 Herceptin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 4.47 Herceptin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 4.48 Avastin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 4.49 Avastin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 4.50 Other MAb Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

www.visiongain.com

Contents
Table 4.51 Other MAb Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 4.52 Selected Late-Stage MAbs Pipeline, 2013 Table 5.1 Fusion Proteins Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 5.2 Fusion Proteins Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 5.3 Approved Fusion Proteins, 2013 Table 5.4 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2012 Table 5.5 Fusion Proteins Submarket Leading Products: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 5.6 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2017 Table 5.7 Fusion Proteins Submarket Leading Products: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 5.8 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2023 Table 5.9 Enbrel: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 5.10 Enbrel: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 5.11 Orencia: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 5.12 Orencia: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 5.13 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 5.14 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 5.15 Other Fusion Protein Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017 Table 5.16 Other Fusion Protein Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023 Table 5.17 Fusion Proteins Pipeline: Selected Products, 2013 Table 6.1 Cellular and Regenerative Medicines Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 6.2 Cellular and Regenerative Medicines Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 6.3 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2012

www.visiongain.com

Contents
Table 6.4 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%) Market Share (%), 2012-2017 Table 6.5 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2017 Table 6.6 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), AGR (%), CAGR (%) Market Share (%), 2018-2023 Table 6.7 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2023 Table 6.8 Tissue Engineered Products Pipeline: Selected Products, 2013 Table 6.9 Tissue Engineered Products Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 6.10 Tissue Engineered Products Segment: Revenues ($m), AGR (%), CAGR (%), 20182023 Table 6.11 Cellular Therapies Pipeline: Selected Products, 2013 Table 6.12 Cellular Therapies Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 6.13 Cellular Therapies Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 6.14 Gene Therapy Pipeline: Selected Products, 2013 Table 6.15 Gene Therapy Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 6.16 Gene Therapy Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 6.17 Cellular and Other Regenerative Medicines Submarket: Selected Late-Stage Pipeline, 2013 Table 7.1 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares (%), 2012 Table 7.2 Regional Breakdown of the Biological Drugs Market: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 2012-2017 Table 7.3 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares (%) 2017 Table 7.4 Regional Breakdown of the Biological Drugs Market: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 2018-2023 Table 7.5 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares (%), 2023

www.visiongain.com

Contents
Table 7.6 US: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 7.7 US: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 7.8 EU5: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 7.9 EU5: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 7.10 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2012 Table 7.11 National Breakdown of the EU5, Revenues ($m), AGR (%), CAGR (%), Share of Market (%), 2012-2017 Table 7.12 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2017 Table 7.13 National Breakdown of the EU5, Revenues ($m), AGR (%), CAGR (%), Share of Market (%), 2018-2023 Table 7.14 National Breakdown of the EU5, Revenues ($m), Share of Market (%) 2023 Table 7.15 Japan: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 7.16 Japan: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 7.17 BRIC Nations: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017 Table 7.18 BRIC Nations: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023 Table 7.19 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%) 2012 Table 7.20 National Breakdown of the BRIC Nations, Revenues ($m), AGR (%), CAGR (%), Share of Market (%), 2012-2017 Table 7.21 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2017 Table 7.22 National Breakdown of the BRIC Nations, Revenues ($m), AGR (%), CAGR (%), Share of Market (%), 2018-2023 Table 7.23 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2023 Table 8.1 World Biologics Market: Strengths and Weaknesses, 2013 Table 8.2 World Biologics Market: Opportunities and Threats, 2013 Table 8.3 World Biologics Market: STEP Analysis, 2013-2023

www.visiongain.com

Contents
Figure 2.1 World Biological Drugs Market: Total Revenues ($m), 2012-2023 Figure 2.1 World Biological Drugs Market: Total Revenues ($m), 2012-2023 Figure 2.2 Comparative Biological Molecule Sizes Figure 2.3 Biologics Market as Sector Within the Global Pharmaceuticals Market: Revenues ($bn), Market Share (%), 2012 Figure 2.4 Top 10 Biological Drugs: Revenues ($m), Market Share (%), 2012 Figure 2.5 Top 10 Drugs in the Global Pharmaceutical Market: Revenues ($m), 2012 Figure 2.6 Biosimilars as Segment of the Overall Biologics Market: Revenues ($m), Market Share (%), 2012, 2017, 2023 Figure 2.7 Key Therapeutic Areas in the Biologics Market: Revenues ($m), Market Share (%), 2012 Figure 2.8 Key Therapeutic Areas in the Biologics Market, Compared to Overall Pharmaceutical Market: Market Share (%), 2012 Figure 2.9 Breakdown by Submarket: Revenues ($m), Market Share (%), 2012 Figure 2.10 Breakdown by Submarket: Revenues ($m), Market Share (%), 2017 Figure 2.11 Breakdown by Submarket: Revenues ($m), Market Share (%), 2023 Figure 2.12 Breakdown by Submarket: Revenues ($m), 2012-2023 Figure 2.13 Breakdown by Submarket: Revenues ($m), 2012, 2017, 2023 Figure 3.1 Protein Therapeutics Submarket: Total Revenues ($m), 2012-2023 Figure 3.2 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket Share (%), 2012 Figure 3.3 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket Share (%), 2017 Figure 3.4 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket Share (%), 2023 Figure 3.5 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), 2012-2023 Figure 3.6 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), 2012, 2017, 2023 Figure 3.7 Drivers and Restraints in the Insulins Segment, 2013

List of Figures

www.visiongain.com

Contents
Figure 3.8 Insulins Segment: Revenues ($m), 2012-2023 Figure 3.9 Drivers and Restraints in the Other Recombinant Hormones Segment, 2013 Figure 3.10 Other Recombinant Hormones Segment: Revenues ($m), 2012-2023 Figure 3.11 Drivers and Restraints in the Plasma and Recombinant Coagulating Factors Segment, 2013 Figure 3.12 Plasma and Recombinant Coagulating Factors Segment: Revenues ($m), 2012-2023 Figure 3.13 Leading Interferon Products: Revenues ($m), Market Share (%), 2012 Figure 3.14 Drivers and Restraints for the Interferons Segment, 2013 Figure 3.15 Interferons Segment: Revenues ($m), 2012-2023 Figure 3.16 Other Protein Therapeutics Segment: Revenues ($m), 2012-2023 Figure 3.17 Leading Protein Therapeutic Products: Revenues ($m), Submarket Share (%), 2012 Figure 3.18 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2017 Figure 3.19 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2023 Figure 3.20 Leading Protein Therapeutic Products: Revenues ($m), 2012-2023 Figure 3.21 Leading Protein Therapeutic Products: Revenues ($m), 2012, 2017, 2023 Figure 3.22 Drivers and Restraints for Lantus, 2013 Figure 3.23 Lantus: Revenues ($m), 2012-2023 Figure 3.24 Drivers and Restraints for Neulasta/Neupogen, 2013 Figure 3.25 Neulasta/Neupogen: Revenues ($m), 2012-2023 Figure 3.26 Drivers and Restraints for Epogen, 2013 Figure 3.27 Epogen: Revenues ($m), 2012-2023 Figure 3.28 Drivers and Restraints for Avonex, 2013 Figure 3.29 Avonex: Revenues ($m), 2012-2023 Figure 3.30 Drivers and Restraints for NovoRapid, 2013 Figure 3.31 NovoRapid: Revenues ($m), 2012-2023 Figure 3.32 Other Products: Revenues ($m), 2012-2023 Figure 4.1 Monoclonal Antibodies Submarket: Total Revenues ($m), 2012-2023 Figure 4.2 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2012

www.visiongain.com

Contents
Figure 4.3 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2017 Figure 4.4 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2023 Figure 4.5 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), 20122023 Figure 4.6 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), 2012, 2017, 2023 Figure 4.7 Leading Products in Autoimmune MAbs Segment, Revenues ($m), Share of Segment (%), 2012 Figure 4.8 Main Molecular Targets in Autoimmune Segment: Revenues ($m), Market Share (%), 2012 Figure 4.9 Level of Antibody Humanisation in Autoimmune Segment: Revenues ($m), Market Share (%), 2012 Figure 4.10 Leading Companies in Autoimmune Segment: Revenues ($m), Market Share (%), 2012 Figure 4.11 Drivers and Restraints for Autoimmune MAbs Segment, 2013 Figure 4.12 Autoimmune MAbs Segment: Revenues ($m), 2012-2023 Figure 4.13 Leading Products in Oncology MAbs Segment, Revenues ($m), Share of Segment (%), 2012 Figure 4.14 Main Molecular Targets in Oncology Segment: Revenues ($m), Market Share (%), 2012 Figure 4.15 Leading Companies in Oncology Segment: Revenues ($m), Market Share (%), 2012 Figure 4.16 Drivers and Restraints for Oncology MAbs Segment, 2013 Figure 4.17 Oncology MAbs Segment: Revenues ($m), 2012-2023 Figure 4.18 Leading Products in Other Therapeutic Areas MAbs Segment, Revenues ($m), Share of Segment (%), 2012 Figure 4.19 Drivers and Restraints for Other Therapeutic Areas MAbs Segment, 2013 Figure 4.20 Other Therapeutic Areas MAbs Segment: Revenues ($m), 2012-2023 Figure 4.21 Leading MAbs: Revenues ($m), Market Share (%), 2012

www.visiongain.com

Contents
Figure 4.22 Leading MAbs: Revenues ($m), Market Share (%), 2017 Figure 4.23 Leading MAbs: Revenues ($m), Market Share (%), 2023 Figure 4.24 Leading MAbs: Revenues ($m), 2012-2023 Figure 4.25 Leading MAbs: Revenues ($m), 2012, 2017, 2023 Figure 4.26 Drivers and Restraints for Humira, 2013 Figure 4.27 Humira: Revenues ($m), 2012-2023 Figure 4.28 Drivers and Restraints for Remicade, 2013 Figure 4.29 Remicade: Revenues ($m), 2012-2023 Figure 4.30 Drivers and Restraints for Rituxan, 2013 Figure 4.31 Rituxan: Revenues ($m), 2012-2023 Figure 4.32 Drivers and Restraints for Herceptin, 2013 Figure 4.33 Herceptin: Revenues ($m), 2012-2023 Figure 4.34 Drivers and Restraints for Avastin, 2013 Figure 4.35 Avastin: Revenues ($m), 2012-2023 Figure 4.36 Other MAb Products: Revenues ($m), 2012-2023 Figure 5.1 Fusion Proteins Submarket: Total Revenues ($m), 2012-2023 Figure 5.2 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2012 Figure 5.3 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2017 Figure 5.4 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2023 Figure 5.5 Leading Products in Fusion Proteins Segment: Revenues ($m), 2012-2023 Figure 5.6 Leading Products in Fusion Proteins Segment: Revenues ($m), 2012, 2017, 2023 Figure 5.7 Drivers and Restraints for Enbrel, 2013 Figure 5.8 Enbrel: Revenues ($m), 2012-2023 Figure 5.9 Orencia: Revenues ($m), 2012-2023 Figure 5.10 Drivers and Restraints for Eylea, 2013 Figure 5.11 Eylea: Revenues ($m), 2012-2023 Figure 5.12 Other Fusion Protein Products: Revenues ($m), 2012-2023

www.visiongain.com

Contents
Figure 6.1 Cellular and Regenerative Medicines Submarket: Total Revenues ($m), 2012-2023 Figure 6.2 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2012 Figure 6.3 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2017 Figure 6.4 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), Market Share (%), 2023 Figure 6.5 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), 2012-2023 Figure 6.6 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues ($m), 2012, 2017, 2023 Figure 6.7 Tissue Engineered Products: Drivers and Restraints, 2013 Figure 6.8 Tissue Engineered Products Segment: Revenues ($m), 2012-2023 Figure 6.9 Cellular Therapies: Drivers and Restraints, 2013 Figure 6.10 Cellular Therapies Segment: Revenues ($m), 2012-2023 Figure 6.11 Gene Therapy: Drivers and Restraints, 2013 Figure 6.12 Gene Therapy Segment: Revenues ($m), 2012-2023 Figure 7.1 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares (%), 2012 Figure 7.2 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares (%), 2017 Figure 7.3 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares (%), 2023 Figure 7.4 Regional Breakdown of the Biological Drugs Market: Revenues ($m), 2012-2023 Figure 7.5 Regional Breakdown of the Biological Drugs Market: Revenues ($m), 2012, 2017, 2023 Figure 7.6 Healthcare Spending as Share of GDP (%) for the US, France, Germany, the UK, Spain and Italy, 2010 Figure 7.7 US: Revenues ($m), 2012-2023 Figure 7.8 EU5: Revenues ($m), 2012-2023

www.visiongain.com

Contents
Figure 7.9 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2012 Figure 7.10 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2017 Figure 7.11 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2023 Figure 7.12 National Breakdown of the EU5, Revenues ($m), 2012-2023 Figure 7.13 National Breakdown of the EU5, Revenues ($m), 2012, 2017, 2023 Figure 7.14 Japan: Revenues ($m), 2012-2023 Figure 7.15 BRIC Nations: Revenues ($m), 2012-2023 Figure 7.16 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2012 Figure 7.17 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2017 Figure 7.18 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2023 Figure 7.19 National Breakdown of the BRIC Nations, Revenues, 2012-2023 Figure 7.20 National Breakdown of the BRIC Nations, Revenues, 2012, 2017, 2023 Figure 10.1 World Biologics Market: Revenues ($m), 2012-2017 Figure 10.2 World Biologics Market: Revenues ($m), 2018-2023 Figure 10.3 Breakdown by Submarket: Revenues ($m), 2012-2023 Figure 10.4 Breakdown by Segment: Revenues ($m), 2012-2023

www.visiongain.com

Contents
Abbott Laboratories 3SBio AbbVie AbGenomics International Ablynx Actavis Actinium Pharmaceuticals Advanced Technologies and Regenerative Medicine Aerovance AET BioTech Affimed Therapeutics Agennix Agensys AgonOx Alcon Labs (subsidiary of Novartis) Alder Biopharmaceuticals Alexion Allergan Allozyme Altor BioScience Altrika Ambrx Amgen Apeiron Biologics AREVA Med Argos Therapeutics Artaeus Therapeutics Artisan Pharma AryoGen

Organisations Mentioned in the Report

www.visiongain.com

Contents
Asahi Kasei Pharma Astellas AstraZeneca AVEO Oncology Avesthagen Avita Medicals Baxter Bayer Beijing Shuanglu Medicine BioArctic Neuroscience BioCancell Therapeutics Biocon Biogen Idec BioInvent International Biolex Bioniche Therapeutics Biopartners BioSante Pharmaceuticals Biotest Bioton Biotechnology Information Institute BioXpress Therapeutics Boehringer Ingelheim Bristol-Myers Squibb BZL Biologics California Institute for Regenerative Medicine (CIRM) Cambridge Antibody Technology Cangene Catalyst Biosciences CCL Pharmaceuticals

www.visiongain.com

Contents
Cell Control CellCoTec Celldex Cell Therapeutics Celltrion CEL-SCI Celtic Pharma Centocor (subsidiary of Johnson & Johnson) Cephalon (part of Teva Pharmaceutical Industries) Chiron Chugai (subsidiary of Roche) CinnaGen Circadian Technologies Clinimmune Labs Co-Genesys Compass Biotechnologies Crucell CSL Behring CT Arzneimittel CureTech Cytheris Cytimmune Sciences CytoDyn Cytograft Tissue Engineering Cytovance Biologics Daiichi Sankyo Dekkun Dendreon Depuy Mitek Domp

www.visiongain.com

Contents
Dong-A Dr. Reddys Laboratories Duke University School of Medicine Eisai Elan Eli Lilly Elusys Therapeutics EMA (European Medicines Agency) Emergent BioSolutions Endo Pharmaceuticals Esteve Exsulin Facet FDA (Food and Drug Administration, US) Feron Fibrocell Science Fibrogen Fresenius Fujifilm Kyowa Kirin Biologics Fuji Pharma Functional Genetics Galaxy Biotech Gedeon Richter Genentech Genesis GenMab Genzyme Getz Pharma Gilead Sciences GlaxoSmithKline

www.visiongain.com

Contents
Glycotope Grifols Halozyme Therapeutics HanAll Biopharma Hanmi Pharmaceutical Helix BioPharma HemispherX Biopharma Hexal Histogenics Hoechst Marion Roussel Hospira Hualida Biotech Human Genome Sciences ImClone Systems Immunocore ImmunoGen Immunomedics InnoMab PTE Inspiration Biopharmaceuticals ISTO Technologies Intarcia Therapeutics Intas Biopharmaceuticals InterMune InterveXion Therapeutics Ipsen Janssen Alzheimer Immunotherapy (subsidiary of Johnson & Johnson) Janssen Biotech (subsidiary of Johnson & Johnson) Johnson & Johnson KaloBios Pharmaceuticals Kaketsuken

www.visiongain.com

Contents
Korean Food and Drug Administration Kyowa Hakko Kirin Labrys Biologics LFB LG Life Sciences LifeCell Life Science Pharmaceuticals Lipoxen Lpath Lundbeck Mabgene MabVax Therapeutics MassBiologics Maxygen Mayo Clinic Medarex (subsidiary of Bristol-Myers Squibb) Medice MedImmune (subsidiary of AstraZeneca) Medixion Medtronic Menarini MENTRIK Biotech Merck & Co. Merck KGaA Merrimack Pharmaceuticals Merz Pharma Michigan University Micromet (subsidiary of Amgen) Millennium Minapharm Pharmaceuticals

www.visiongain.com

Contents
Ministry of Health, Labour and Welfare (MHLW, Japan) Mitsubishi Tanabe Mochida Pharmaceutical Morphosys Myriad The National Hemophilia Foundation (US) National Institute of Allergy and Infectious Diseases (US) National Institute for Health and Clinical Excellence (NICE, UK) Neogenix Oncology Neurochem New York Blood Center Nippon Kayaku NovaQuest Novo Nordisk Novartis NPS Pharmaceuticals Nuron Biotech NuVasive Octapharma OncoMed Pharmaceuticals Organogenesis Ortho Pharmaceutical Corporation (subsidiary of Johnson & Johnson) Otsuka Pacira Pharmaceuticals Parexel PDL BioPharma Peptech Peregrine Pharmaceuticals Pfizer Pharmstandard

www.visiongain.com

Contents
PlantForm Prana Biotechnology ProChon Biotech Progenics Pharmaceuticals Prolor Biotech Promedior Prometheus Laboratories Proteon Therapeutics Quest Pharmatech Quintiles Transnational Qilu ratiopharm Regeneron Reliance Life Sciences Repligen Rentschler Biotechnologie rEVO Biologics (subsidiary of LFB) Roche Sandoz (subsidiary of Novartis) Sanofi Santarus Schering-Plough (subsidiary of Merck & Co.) SciGen (subsidiary of Bioton) Seattle Genetics Selexys Pharmaceuticals Shantha Biotechnics Shire Regenerative Medicine Singapore Eye Research Institute (SERI) Spectrum Stada

www.visiongain.com

Contents
Stanford University Stratatech Stem Cell Therapeutics Swedish Orphan Biovitrum Symphogen Syntonix TaiMed Biologics Takeda Targacept Targa Therapeutics TauRx Tengion Teva Pharmaceutical Industries TG Therapeutics Theraclone Sciences TiGenix Tolera Therapeutics Toronto University TPG-Axon Capital TRACON Pharmaceuticals Transkaryotic Therapies TransTech Tufts Center for the Study of Drug Development UCB UCSF United Therapeutics University of Colorado Cord Blood Bank University Hospital of Tubingen University of Tokyo Vaccinex

www.visiongain.com

Contents
Versartis Vertex Pharmaceuticals Vidara Therapeutics International Viropharma Viventia Biotechnologies Wake Forest University Baptist Medical Center Walter and Eliza Hall Institute Wilex Wockhardt Wyeth (subsidiary of Pfizer) Xbiotech Xencor XOMA Zilip-Pharma Zimmer Zydus Cadila ZymoGenetics

www.visiongain.com

World Biological Drugs Market 2013-2023

5.2.3.1 Scope for Expansion with Eylea
Regeneron have a range of additional indications planned for Eylea. These include oncology, with aflibercept approved (under the brand name Zaltrap) as a treatment for various cancers in early 2013. Within the retinal diseases market, Regeneron has won approval for Eylea in Central Retinal Vein Occlusion in the US, and has commenced trials in choroidal neovascularisation of the retina as a result of pathologic myopia in early 2011, in collaboration with the Singapore Eye Research Institute (SERI). In all of these new retinal indications, Eylea will have to compete with the moreestablished Lucentis, yet the evidence from its sales to date is that it is strongly-placed in this particular struggle. To date, Eylea has been one of the most successful biopharmaceutical launches in history. Regeneron apparently fixed an initial price of $1,850 per dose for Eylea, undercutting Lucentis by about 5%. Market penetration has been more extensive than expected, with physicians switching patients from Lucentis and off-label Avastin to the newer drug. Regeneron reported that 90% of the prescribing physicians it monitors had switched patients to Eylea at one point in 2012. The key areas in which Eylea is differentiated, visiongain believes, are these: i) it has a slightly better dosing schedule than Lucentis; ii) it is slightly cheaper; iii) it benefits from reported ill-will towards Lucentis on the part of some ophthalmologists, apparently due to Roche and Novartis reported attempts to protect Lucentis from competition from off-label Avastin. In section 9.3, visiongain discusses with Dr Michael Stewart some of the factors driving the uptake of Eylea since its launch. Eyleas chances in the longer term may depend on its success in penetrating additional markets and in gaining additional on-label indications. Bayer is a significant international player, with a dominant position in China particularly.

Figure 5.10 Drivers and Restraints for Eylea, 2013

Restraints Lucentis is established in wet AMD and other indications Relative to Lucentis, Eylea is reportedly slightly cheaper, shows slightly superior VEGF-binding, and has a preferable dosing schedule Strong initial take-up shows physicians are willing to switch patients to Eylea, which may also profit from ill-will to Lucentis Expansion opportunities in new markets and indications, including oncology Drivers Avastin represents a far cheaper alternative to Eylea Data thus far does not indicate much difference between Eylea and Lucentis in terms of dosing schedule in practice

Source: visiongain 2013

www.visiongain.com

Page 238

World Biological Drugs Market 2013-2023

5.2.3.2 Market Forecast for Eylea, 2013-2023
Visiongain anticipates that Eylea will reach sales of over $1.1bn 2013, reaching blockbuster status with 34% growth from 2012. Its share of the fusion protein submarket will grow from 8% to 12% by 2017, as Eylea reaches double-blockbuster status with a five-year CAGR of 23%. Visiongain anticipates that widening indications and successful competition against Lucentis will see Eylea record an 11-year CAGR of 14%, with 2023 revenues of $3.5bn, representing 13% of the fusion proteins submarket overall. See Table 5.13, Table 5.14 and Figure 5.11.

Table 5.13 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 20122017
2012 Revenues ($m ) AGR (%) CAGR (%, 2012-2017) Share of subm arket (%) 838 2013 1125 34 2014 1545 37 2015 1870 21 2016 2055 10 2017 2340 14 23 8 9 11 11 11 12

Source: visiongain 2013

Table 5.14 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 20182023
2018 Revenues ($m ) AGR (%) CAGR (%, 2018-2023) CAGR (%, 2012-2023) Share of subm arket (%) 2410 3 2019 2525 5 2020 2790 10 2021 2975 7 2022 3230 9 2023 3460 7 8 14 13 12 13 13 13 13

Source: visiongain 2013

5.2.4 Other Fusion Proteins, 2013-2023

Amgens 2008-approved Nplate (romiplostim), a thrombopoietin receptor agonist indicated for chronic idiopathic (immune) thrombocytopenic purpura, is the only other product in the submarket with substantial revenues to date. It recorded sales of $368m in 2012. Other fusion proteins on the market have low revenues relative to the submarket-leading products; for example, Regenerons first product Arcalyst (rilonacept; approved in cryopyrin-associated periodic syndromes since 2008,

www.visiongain.com

Page 239