Next-Generation Antibody Therapies:
World Industry and Market
2014-2024

©notice
This material is copyright by visiongain....
Contents
1. Executive Summary
1.1 Next-Generation Therapies: World Market Review 2014
1.2 Report Contents
1.2.1 Benefits o...
Contents
2.3 Leading National Markets for Next-Generation Antibody Therapies 2014-2024
2.3.1 The US Leads the Market in 20...
Contents
3.5.4.2 Synthon Biopharmaceuticals
3.5.5 ADCs Are Attracting High Value Deals
3.6 ADC Pipeline: Outlook 2014-2024...
Contents
4. The Engineered Antibodies Submarket 2014-2024
4.1 The Engineered Antibodies Submarket 2012-2013
4.1.1 Two Engi...
Contents
4.6.10 Ublituximab (TG Therapeutics/LFB)
4.6.11 XmAb5871 (Xencor/Amgen)
4.6.12 RG7116: A Future Addition to Roche...
Contents
5.5.5 BAY2010112 (Bayer)
5.5.6 MEDI-565: A Third BiTE Candidate
5.5.7 AFM13 (Affimed Therapeutics)
5.5.8 TF2: Uti...
Contents
6.3.5 Which Platform Will Lead the Market 2014-2024?
6.4 Clinical Development of Next-Generation Antibody Fragmen...
Contents
7.4.3.1 Two Companies Halted Development 2012-2013
7.4.3.2 Celltrion: Development Delayed 2013
7.4.3.3 GP2013: Sa...
Contents
8. Next-Generation Antibodies: Industry Trends 2014-2024
8.1 Next-Generation Antibodies: Strengths and Weaknesses...
Contents
9. Research Interviews 2013-2014
9.1 Dr Edwin Moses, CEO, Ablynx
9.1.1 The Benefits of Nanobodies over Traditiona...
Contents
10.2 Outlook for the Next-Generation Antibody Therapies Market 2014-2024
10.2.1 Growth in the Market 2014-2024
10...
Contents
List of Tables
Table 1.1 Currency Exchange Rates, 2013
Table 1.2 Monoclonal Antibody Types and Sources, 2014
Tabl...
Contents
Table 3.4 Adcetris: Revenue Forecast ($m), 2012-2024
Table 3.5 Kadcyla: Revenue ($m) by Region, Q1-Q4 2013
Table ...
Contents
Table 5.5 Selected MacroGenics Deals, 2010-2013
Table 5.6 Bispecific Antibodies Clinical Pipeline, 2014
Table 6.1...
Contents
Table 7.13 Biosimilar Adalimumab Pipeline, 2014
Table 7.14 Biosimilar Adalimumab: Revenue Forecast ($m), 2012-202...
Contents
List of Figures
Figure 2.1 Next-Generation Antibody Therapies Market: Revenues ($m), 2008-2013
Figure 2.2 Next-Ge...
Contents
Figure 3.6 Kadcyla: Revenue ($m) by Quarter, 2013
Figure 3.7 Kadcyla: Revenue Forecast ($m), 2012-2024
Figure 3.8...
Contents
Figure 7.1 Biosimilar Antibodies Submarket by Sector, 2012
Figure 7.2 Biosimilar Antibodies Submarket: Revenue Fo...
Contents
Companies and Other Organisations Mentioned
AbbVie
Abgenix (part of Amgen)
Ablynx
Actavis
ADC Therapeutics
Adnexu...
Contents
Biotest
BioWa (part of Kyowa Hakko Kirin)
BioXpress Therapeutics
Boehringer Ingelheim
Bristol-Myers Squibb
BZL Bi...
Contents
Egis Pharmaceuticals
Elan Pharmaceuticals
Eli Lilly
Epirus Biopharmaceuticals
ESBATech (part of Novartis)
ETH Zur...
Contents
ImmunoGen
Immunomedics
Intas Biopharmaceuticals
Isu Abxis
J&J
Janssen Biotech (part of J&J)
Janssen-Cilag (part o...
Contents
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma
Molecular Partners
MorphoSys
Mylan
...
Contents
Roche
Roche Glycart (part of Roche)
Royal Institute of Technology (KTH) [Sweden]
SAFC
Samsung Bioepis
Samsung Bio...
Contents
TG Therapeutics
TRION Pharma
UCB
US Patent and Trademark Office
World Health Organization (WHO)
Wyeth (part of Pf...
Next-Generation Antibody Therapies:
World Industry and Market 2014-2024
4.4.2 Gazyva: Revenue Forecast 2014-2024
Uptake of...
Next-Generation Antibody Therapies:
World Industry and Market 2014-2024
4.5 Leading Technology Platforms for Engineered An...
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Next Generation Antibody Therapies World Industry 2014-2024

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For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1210/Next-Generation-Antibody-Therapies-World-Industry-and-Market-2014-2024

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Next Generation Antibody Therapies World Industry 2014-2024

  1. 1. Next-Generation Antibody Therapies: World Industry and Market 2014-2024 ©notice This material is copyright 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.
  2. 2. Contents 1. Executive Summary 1.1 Next-Generation Therapies: World Market Review 2014 1.2 Report Contents 1.2.1 Benefits of this Report 1.3 Study Methods 1.3.1 Financial Information in this Report 1.3.2 Who is this Report for? 1.4 Introduction to Next-Generation Antibodies 1.4.1 Defining Next-Generation Antibodies 1.4.2 A Brief History of Antibody Drug Development 1.4.3 The Need for Next-Generation Technologies 1.4.4 Development Trends for Next-Generation Antibodies 2. The World Next-Generation Antibody Therapies Market: Outlook and Forecast 2014-2024 2.1 The Next-Generation Antibody Therapies Market 2012-2023 2.1.1 Leading Sectors of the Next-Generation Antibody Therapies Market 2012-2013 2.1.1.1 There Are Products Approved in All Market Sectors 2.1.2 Next-Generation Antibodies in the Overall Antibody Market 2.2 The Next-Generation Antibody Therapies Market 2014-2024 2.2.1 Growth in the Antibody Therapies Market 2014-2024 2.2.2 Next-Generation Antibody Therapies: Market Forecast 2014-2024 2.2.3 Approvals in All Market Sectors Will Drive Growth to 2024 2.2.4 High Levels of Competition Will Restrain Growth in this Decade 2.2.5 ADCs Lead the Market in 2014 2.2.5.1 ADCs Will Account for 40% in 2018 2.2.5.2 What Will Be the Leading Market Sector in 2024? www.visiongain.com
  3. 3. Contents 2.3 Leading National Markets for Next-Generation Antibody Therapies 2014-2024 2.3.1 The US Leads the Market in 2014 2.3.1.1 US Submarket Forecast 2014-2024 2.3.2 Next Generation Antibodies in the EU 2014-2024 2.3.3 The Japanese Submarket 2014-2024 2.3.4 Demand for Next-Generation Antibody Therapies in Emerging National Markets 3. Antibody-Drug Conjugates (ADCs): Pipeline and Commercial Outlook 2014-2024 3.1 ADC Submarket 2012-2013 3.1.1 Two Products Launched Since 2011 3.1.2 Mylotarg: The First ADC Is No Longer Marketed 3.2 ADC Submarket 2014-2024 3.2.1 ADC Submarket Forecast 2014-2024 3.2.2 ADC Submarket Drivers: A Long and Growing R&D Pipeline 3.2.3 Competition for Leading Drugs Will Restrain Growth 2014-2024 3.2.3.1 Manufacturing ADCs Forms a Challenge 3.3 Adcetris (Brentuximab Vedotin, Seattle Genetics/Takeda) 3.3.1 Expanding the Label for Future Revenue Growth 3.3.2 Adcetris: Revenue Forecast 2014-2024 3.4 Kadcyla (Trastuzumab Emtansine, Roche) 3.4.1 Part of Roche’s HER2 Portfolio 3.4.2 Kadcyla: Revenue Forecast 2014-2024 3.5 Two Platforms Dominate the Pipeline in 2014 3.5.1 Seattle Genetics’ Platform Accounts for 60% of the Clinical Pipeline 3.5.2 ImmunoGen: TAP Technology 3.5.3 Leading Biotechs Are Assessing Both Platforms 3.5.4 Other Platforms for ADC Development 3.5.4.1 Immunomedics: Lower Potency Cytotoxics for Extended Use www.visiongain.com
  4. 4. Contents 3.5.4.2 Synthon Biopharmaceuticals 3.5.5 ADCs Are Attracting High Value Deals 3.6 ADC Pipeline: Outlook 2014-2024 3.6.1 The Longest Pipeline in the Next-Generation Antibodies Market 3.6.2 Cancer Is the Only Target for Current Clinical-Stage ADCs 3.6.3 Pfizer’s CMC544 Is the Only Phase III Candidate 3.6.4 Roche Has Eight Clinical-Stage Candidates 3.6.4.1 RG7593 and RG7596: ADCs for NHL 3.6.4.2 Three Candidates for Ovarian Cancer 3.6.4.3 RG7450 for Prostate Cancer 3.6.5 CDX-011: Another ADC for Breast Cancer Patient Subsets 3.6.6 SAR3419 (Sanofi): Targeting CD19 in Lymphoma 3.6.7 BT-062 (Biotest) 3.6.8 Immunomedics: Two Phase II ADCs from its Proprietary Platform 3.6.9 PSMA ADC (Progenics Pharmaceuticals): A Second Candidate for Prostate Cancer 3.6.10 ABT-414 (AbbVie) 3.6.11 Seattle Genetics: Three Phase I Candidates 3.6.11.1 SGN-CD33A: Using a New Cytotoxin and Linker Technology 3.6.12 Astellas Pharma: Partnered with Seattle Genetics for Phase I ADCs 3.6.13 ImmunoGen: Three Phase I Candidates 3.6.14 SAR566658 (Sanofi) 3.6.15 MLN0264 (Millennium Pharmaceuticals) 3.6.16 AMG 595 (Amgen) 3.6.17 BAY 94-9343 (Bayer) 3.6.18 AMG 172 (Amgen) 3.6.19 PF-06263507 (Pfizer) 3.6.20 HuMax-TF-ADC (Genmab) 3.7 Future Developments in ADC Technology 3.7.1 Site-Specific Linkage for Improved Safety Profiles www.visiongain.com
  5. 5. Contents 4. The Engineered Antibodies Submarket 2014-2024 4.1 The Engineered Antibodies Submarket 2012-2013 4.1.1 Two Engineered Antibodies Approved 2012-2013 4.2 The Engineered Antibodies Submarket Forecast 2014-2024 4.2.1 What Will Drive Submarket Growth to 2024? 4.2.2 Engineered Antibodies: Submarket Restraints 2014-2024 4.3 Poteligeo: The First Engineered Antibody Is Only Available in Japan 4.3.1 Poteligeo: Revenue Forecast 2014-2024 4.4 Gazyva: A Follow-On to Roche’s Marketing-Leading Rituxan 4.4.1 Gazyva as a Challenger in the anti-CD20 Market 4.4.1.1 Competition beyond Rituxan and Biosimilars 4.4.2 Gazyva: Revenue Forecast 2014-2024 4.5 Leading Technology Platforms for Engineered Antibodies 2014-2024 4.5.1 Enhancing ADCC: The Potelligent Platform 4.5.2 Roche Glycart: Glycosylation for Improved ADCC 4.5.3 XmAb (Xencor): Modifying Amino Acids in the Fc Domain 4.5.4 Other Platforms for Increased Potency 4.5.4.1 GlycoExpress (Glycotope) 4.6 Engineered Antibodies Pipeline 2014 4.6.1 Pipeline Changes 2011-2013 4.6.2 Benralizumab (MedImmune/Kyowa Hakko Kirin) 4.6.3 Margetuximab (MacroGenics) 4.6.4 MEDI-551: MedImmune and Kyowa’s Second Collaboration 4.6.5 MOR-208 (Xencor/MorphoSys) 4.6.6 PankoMab-GEX: Glycotope’s Lead Candidate 4.6.7 Teplizumab: Failed in Phase III but Undergoing Phase II Investigator-Led Studies 4.6.8 Kyowa Hakko Kirin Has Four Early-Stage Candidates 4.6.9 Ocaratuzumab (Mentrik Biotech): Phase I for NHL www.visiongain.com
  6. 6. Contents 4.6.10 Ublituximab (TG Therapeutics/LFB) 4.6.11 XmAb5871 (Xencor/Amgen) 4.6.12 RG7116: A Future Addition to Roche’s Breast Cancer Portfolio 4.6.13 CetuGEX and TrasGEX: Two Early-Stage Glycotope Biosuperiors 4.6.14 MGA271 (MacroGenics/Servier) 5. The Bispecific Antibodies Submarket: Commercial Potential 20142024 5.1 The Bispecific Antibodies Submarket 2012-2013 5.2 The Bispecific Antibodies Submarket 2014-2024 5.2.1 Commercial Outlook for Bispecific Antibodies: Revenue Forecast 2014-2024 5.2.2 Bispecific Antibodies: Submarket Drivers 2014-2024 5.2.3 Bispecific Antibodies: Submarket Restraints 2014-2024 5.2.3.1 Manufacturing Bispecific Antibodies: Maintaining Stability and Purification 5.3 Removab: The First Bispecific Antibody 5.3.1 Removab: Revenue Forecast 2014-2024 5.4 Many Platforms Are Under Investigation to Develop Bispecific Antibodies 5.4.1 BiTE Platform: The Current Market Leader 5.4.2 MacroGenics’ DART Platform Holds Promise 5.4.3 TriomAbs (TRION Pharma): Limited Market Impact 2014-2024 5.4.4 ImmTAC (Immunocore) 5.4.5 DuoBodies (Genmab) 5.5 A Growing Pipeline for Bispecific Antibodies 5.5.1 Blinatumomab (Amgen): The Only Phase III Bispecific Antibody 5.5.1.1 The Outlook for Blinatumomab in ALL 5.5.2 Symphogen Has Two Phase II Candidates 5.5.2.1 Symphogen’s Recombinant Antibody Mixtures 5.5.3 MM-111 (Merrimack Pharmaceuticals) 5.5.4 IMCgp100 (Immunocore) www.visiongain.com
  7. 7. Contents 5.5.5 BAY2010112 (Bayer) 5.5.6 MEDI-565: A Third BiTE Candidate 5.5.7 AFM13 (Affimed Therapeutics) 5.5.8 TF2: Utilising Immunomedics’ Dock-and-Lock Platform 5.5.9 MM-141 (Merrimack Pharmaceuticals) 5.5.10 SAR156597 (Sanofi) 6. The Next-Generation Antibody Fragments and Antibody-Like Proteins (ALPs) Submarket 2014-2024 6.1 There Is One Marketed Product in 2014 6.1.1 Kalbitor (Ecallantide, Dyax) 6.1.1.1 Kalbitor: Revenue Forecast 2014-2024 6.2 Outlook for the Antibody Fragments and ALPs Submarket 2014-2024 6.2.1 Antibody Fragments and ALPs Submarket Forecast 2014-2024 6.2.2 Investment from Big Pharma Will Drive Growth 2014-2024 6.2.3 No Late-Stage Candidates to Restrain Growth to 2024 6.3 There Are Many Development Platforms in this Sector 6.3.1 Single-chain Variable Fragment Platforms 6.3.1.1 ESBATech and Delenex Therapeutics: Two Approaches Using the Same Platform 6.3.2 Nanobodies: The Smallest Antibody Fragment 6.3.2.1 Ablynx’ Nanobody Platform Has Created Many Clinical Candidates 6.3.3 Domain Antibodies: GSK and Crescendo Biologics 6.3.4 Non-Antibody Protein Scaffolds: Antibody-Like Proteins 6.3.4.1 DARPins: One Tenth the Size of Antibodies 6.3.4.2 Anticalins (Pieris): Tested in Clinical Trials 6.3.4.3 Affibodies 6.3.4.4 Fynomers (Covagen) 6.3.4.5 Affilins (Scil Proteins): Three Products in Pre-Clinical Development 6.3.4.6 Adnectins (Bristol-Myers Squibb) www.visiongain.com
  8. 8. Contents 6.3.5 Which Platform Will Lead the Market 2014-2024? 6.4 Clinical Development of Next-Generation Antibody Fragments and ALPs 6.4.1 Limited Activity for Five Clinical Candidates 2013-2014 6.4.2 Ablynx Leads the Pipeline with Seven Clinical Projects 6.4.2.1 ALX-0061: AbbVie Partners for RA Development 6.4.2.2 ALX-0141: A Next-Generation Osteoporosis Therapy 6.4.2.3 ALX-0761: A Third RA Candidate 6.4.3 AGN-150998: Development Delayed for Allergan’s AMD Product 6.4.4 ESBA1008: An Ophthalmology Competitor in Phase II 6.4.5 DLX105 (Delenex Therapeutics) 6.4.6 GSK Has Two Early-Stage Candidates: GSK1995057 and GSK2374697 6.4.7 PRS-050 (Pieris): Targeting VEGF in Solid Tumours 7. The Biosimilar Antibodies Submarket 2014-2024 7.1 Biosimilar Antibodies Are the Target for Many Follow-On Biologics Developers 7.2 More Than Five Biosimilars Approved Worldwide in 2014 7.2.1 Biosimilar Antibodies Submarket 2013: Revenues from Emerging Markets Only 7.3 The Biosimilar Antibodies Submarket 2014-2024 7.3.1 Rapid Growth in Revenues Forecast from 2015 Onwards 7.3.2 Launches in the US and EU to Drive Growth to 2024 7.3.3 How Can Developers Ensure Uptake Among Physicians? 7.3.3.1 Automatic Substitution of Biosimilar Antibodies 7.3.4 Patent Expiries Will Hit Many Leading Antibodies in this Decade 7.3.5 Will Biosimilars Challenge Next-Generation Antibodies in this Decade? 7.4 Biosimilar Rituximab 2014-2024 7.4.1 Reditux: The First Rituximab Biosimilar in the World 7.4.1.1 Mabtas: Biosimilar Competition in India 7.4.2 Kikuzubam: Biosimilar Competition for Roche in Latin America 7.4.3 Biosimilar Rituximab Pipeline 2014 www.visiongain.com
  9. 9. Contents 7.4.3.1 Two Companies Halted Development 2012-2013 7.4.3.2 Celltrion: Development Delayed 2013 7.4.3.3 GP2013: Sandoz Is the Pipeline Leader 7.4.3.4 BI 695500 (Boehringer Ingelheim) 7.4.3.5 MabionCD20: Mabion Prepares Phase III for Developed Markets 7.4.3.6 BCD-020 (Biocad) 7.4.3.7 PF-05280586 (Pfizer) 7.4.4 Biosimilar Rituximab: Revenue Forecast 2014-2024 7.5 Biosimilar Infliximab: The First Target for Developed Markets 7.5.1 Inflectra/Remsima: Approved in South Korea and the EU 7.5.1.1 Flammegis: Egis Pharmaceuticals Markets the Biosimilar in Eastern Europe 7.5.2 Biosimilar Infliximab Pipeline 2014 7.5.2.1 BOW-015: Epirus Targets Emerging Markets First 7.5.2.2 Reliance Life Sciences: Biosimilar Infliximab in India 7.5.3 Biosimilar Infliximab: Revenue Forecast 2014-2024 7.6 Biosimilar Trastuzumab 2014-2024 7.6.1 CANMAb: The First Biosimilar Trastuzumab Approved in India 7.6.2 Herzuma: Approved in South Korea 2014 7.6.3 Fewer Clinical Candidates than for Biosimilar Rituximab 2014 7.6.3.1 Amgen and Actavis Advance to Phase III 7.6.3.2 Pfizer: A Third Candidate Set for Phase III 7.6.4 Biosimilar Trastuzumab: Revenue Forecast 2014-2024 7.7 Biosimilar Adalimumab 2014-2024 7.7.1 Humira Is the World’s Leading Antibody Therapy 7.7.1.1 AbbVie Seeks to Protect its Lead Asset 7.7.2 Biosimilar Adalimumab Pipeline 2014 7.7.2.1 Amgen Advances to Phase III 7.7.2.2 Sandoz: A Second Phase III Candidate 7.7.2.3 Pfizer and Boehringer Ingelheim: Two Biosimilars in Phase I 7.7.3 Biosimilar Adalimumab: Revenue Forecast 2014-2024 www.visiongain.com
  10. 10. Contents 8. Next-Generation Antibodies: Industry Trends 2014-2024 8.1 Next-Generation Antibodies: Strengths and Weaknesses 2014 8.1.1 Approved Products Indicate a Path to Market Acceptance 8.1.2 Challenges Exist With Current Monoclonal Antibody Therapies 8.2 Next-Generation Antibodies: Opportunities and Threats 2014-2024 8.2.1 Big Pharma Is Investing Heavily in Next-Generation Pipelines 8.2.2 Will Biosimilars Slow Growth in the Next-Generation Antibody Market? 8.3 Next-Generation Antibodies: STEP Analysis 2014-2024 8.3.1 Social Factors: Rising Demand for Cancer Therapies 8.3.1.1 Cancer Incidence Is Rising Rapidly 8.3.1.2 Next-Generation Antibodies for Personalised Medicine 8.3.2 Technological Developments Will Drive Pipeline Growth 8.3.2.1 There Are Many Competing Platforms 8.3.2.2 Manufacturing Challenges Exist for Most Sectors 8.3.2.3 New Analytical Tools for Target Identification and Protein Characterisation 8.3.3 Economic Pressures 8.3.3.1 Next-Generation Antibodies Are High-Cost 8.3.3.2 Outsourced Manufacturing: CMOs Are Expanding Capabilities 8.3.3.3 Next-Generation Launches for Product Lifecycle Management 8.3.4 Political and Regulatory Issues 8.3.4.1 Regulatory Challenges for Biosimilar Antibodies 8.4 Key Targets for Next-Generation Antibody Development 2014-2024 8.4.1 Oncology Is the Lead Indication in All Sectors 8.4.1.1 HER2 and HER3 for Breast Cancer 8.4.1.2 CD19 and CD20 for Lymphoma and Leukaemia www.visiongain.com
  11. 11. Contents 9. Research Interviews 2013-2014 9.1 Dr Edwin Moses, CEO, Ablynx 9.1.1 The Benefits of Nanobodies over Traditional Antibody Therapies 9.1.1.1 Manufacturing Nanobodies 9.1.2 Turning Challenges to Advantages 9.1.3 Nanobodies Are Further Developed than Other Antibody Scaffolds 9.1.4 The Commercial Potential for Nanobodies 9.1.5 Next-Generation Antibodies in China and Other Emerging Markets 9.2 Dr Marco Timmers, CSO, Synthon 9.2.1 Synthon 9.2.2.1 Second-Generation ADC Development 9.2.2 Key Benefits to Synthon’s ADC Technology 9.2.2.1 Broader Use in HER2-Positive Disease 9.2.3 Clinical Development of Synthon’s ADCs 9.2.4 Challenges in Developing ADCs 9.2.4.1 High Manufacturing Costs for Advanced Technologies 9.2.4.2 Regulatory Risks in ADC Development 9.2.5 Data Reporting for ADC Development 9.3 Dr Ivan Horak, CSO and CMO, Symphogen 9.3.1 Advantages of Antibody Mixtures 9.3.2 Activating the Immune System 9.3.3 Symphogen’s Pipeline Outlook 9.3.4 The Next Ten Years 10. Conclusions to Our Study 10.1 The Next-Generation Antibody Therapies Market 2012-2013 10.1.1 ADCs Lead the Next-Generation Antibodies Market in 2014 www.visiongain.com
  12. 12. Contents 10.2 Outlook for the Next-Generation Antibody Therapies Market 2014-2024 10.2.1 Growth in the Market 2014-2024 10.2.2 Commercial Drivers for Growth to 2024 10.2.3 Threats and Opportunities Exist in the Market 2014-2024 www.visiongain.com
  13. 13. Contents List of Tables Table 1.1 Currency Exchange Rates, 2013 Table 1.2 Monoclonal Antibody Types and Sources, 2014 Table 2.1 Next-Generation Antibody Therapies Market: Revenues ($m), 2008-2013 Table 2.2 Next-Generation Antibody Therapies Market: Revenues ($m) and Market Shares (%) by Sector, 2012 Table 2.3 Next-Generation Antibody Therapies Approved, 2014 Table 2.4 Antibody Therapies Market: Revenues ($m) and Market Shares (%), 2012 Table 2.5 Antibody Therapies Market Forecast ($m), 2012-2024 Table 2.6 Next-Generation Antibodies Market: Overall Market and Revenue Forecasts ($m) by Sector, 2012-2024 Table 2.7 Next-Generation Antibody Therapies Market: Submarket Shares (%), 2012-2024 Table 2.8 Next-Generation Antibody Therapies Market: Revenues ($m) and Market Shares (%) by Country/Region, 2012 Table 2.9 Next-Generation Antibodies Market: Overall Market and Revenue Forecasts ($m) by Country/Region, 2012-2024 Table 2.10 US Next-Generation Antibody Therapies Submarket Forecast ($m), 2012-2024 Table 2.11 EU Next-Generation Antibody Therapies Submarket Forecast ($m), 2012-2024 Table 2.12 Next-Generation Antibody Therapies Market: Regional Submarket Shares (%), 20122024 Table 2.13 Japanese Next-Generation Antibody Therapies Submarket Forecast ($m), 2012-2024 Table 3.1 ADC Submarket: Revenues ($m) and Market Shares (%) by Drug, 2011-2013 Table 3.2 ADC Submarket: Overall Submarket and Revenue Forecasts ($m) by Drug, 2012-2024 Table 3.3 Adcetris: Revenue ($m) by Company, 2011-2013 www.visiongain.com
  14. 14. Contents Table 3.4 Adcetris: Revenue Forecast ($m), 2012-2024 Table 3.5 Kadcyla: Revenue ($m) by Region, Q1-Q4 2013 Table 3.6 Kadcyla: Revenue Forecast ($m), 2012-2024 Table 3.7 ADC Pipeline by Platform, 2014 Table 3.8 ImmunoGen: Collaboration Revenue ($m), 2012-2013 Table 3.9 Selected Pre-Clinical ADC Development Platforms, 2014 Table 3.10 Selected High-Value Deals for ADC Development, 2013-2014 Table 3.11 ADC Clinical Pipeline, 2014 Table 3.12 Selected Clinical Projects Discontinued, 2010-2013 Table 3.13 ADC Pipeline by Indication, 2014 Table 3.14 Ongoing Clinical Trials for CMC544, 2014 Table 4.1 Engineered Antibodies Submarket: Overall Submarket and Revenue Forecasts ($m) by Drug, 2012-2024 Table 4.2 Poteligeo: Revenue ($m), 2012-2013 Table 4.3 Poteligeo: Revenue Forecast ($m), 2012-2024 Table 4.4 Gazyva: Revenue Forecast ($m), 2012-2024 Table 4.5 Engineered Antibodies Pipeline by Technology Platform, 2014 Table 4.6 Selected Licensing Agreements for the Potelligent Platform and Cell Lines, 2008-2013 Table 4.7 Engineered Antibodies Pipeline, 2014 Table 4.8 Selected Clinical-Stage Engineered Antibody Projects Discontinued, 2010-2013 Table 5.1 Bispecific Antibodies Submarket: Overall Submarket and Revenue Forecasts ($m) by Drug, 2012-2024 Table 5.2 Removab: Revenue ($m), 2010-2013 Table 5.3 Removab: Revenue Forecast ($m), 2012-2024 Table 5.4 Selected Pre-Clinical Bispecific Antibody Platforms, 2014 www.visiongain.com
  15. 15. Contents Table 5.5 Selected MacroGenics Deals, 2010-2013 Table 5.6 Bispecific Antibodies Clinical Pipeline, 2014 Table 6.1 Kalbitor: Revenue ($m), 2011-2013 Table 6.2 Kalbitor: Revenue Forecast ($m), 2012-2024 Table 6.3 Antibody Fragments and ALPs Submarket: Overall Submarket and Revenue Forecasts ($m) by Drug, 2012-2024 Table 6.4 Ablynx: Selected Big Pharma Development Agreements, 2012-2014 Table 6.5 Antibody Fragments and ALPs Pipeline by Indication, 2014 Table 6.6 Antibody Fragments and ALPs Pipeline, 2014 Table 6.7 Pipeline Programmes with Limited Development, 2013-2014 Table 6.8 Antibody Fragments and ALPs Pipeline by Platform, 2014 Table 7.1 Top Ten Bestselling Biologics: Revenues ($m), 2012 Table 7.2 Biosimilar Antibodies Approved Worldwide, 2014 Table 7.3 Biosimilar Antibodies Submarket: Revenues ($m) and Submarket Shares (%) by Sector, 2012 Table 7.4 Biosimilar Antibodies Submarket: Overall Submarket and Revenue Forecasts ($m) by Drug, 2012-2024 Table 7.5 Patents Expiries for Leading Antibody Therapies in the US, EU and Japan, 2013-2022 Table 7.6 Reditux: Revenue ($m), 2008-2013 Table 7.7 Biosimilar Rituximab Pipeline, 2014 Table 7.8 Biosimilar Rituximab: Revenue Forecast ($m), 2012-2024 Table 7.9 Biosimilar Infliximab Pipeline, 2014 Table 7.10 Biosimilar Infliximab: Revenue Forecast ($m), 2012-2024 Table 7.11 Biosimilar Trastuzumab Pipeline, 2014 Table 7.12 Biosimilar Trastuzumab: Revenue Forecast ($m), 2012-2024 www.visiongain.com
  16. 16. Contents Table 7.13 Biosimilar Adalimumab Pipeline, 2014 Table 7.14 Biosimilar Adalimumab: Revenue Forecast ($m), 2012-2024 Table 8.1 World Next-Generation Antibody Therapies Market: Strengths and Weaknesses, 2014 Table 8.2 World Next-Generation Antibody Therapies Market: Opportunities and Threats, 20142024 Table 8.3 Big Pharma Acquisitions in the Next-Generation Antibodies Sector, 2005-2012 Table 8.4 World Next-Generation Antibody Therapies Market: STEP Analysis, 2014-2024 Table 8.5 Selected CMOs Investing in Next-Generation Antibody Technologies, 2005-2013 Table 8.6 Next-Generation Antibody Pipeline by Indication, 2014 Table 8.7 HER-Targeting Next-Generation Antibodies: Pipeline, 2014 Table 8.8 CD19- and CD20-Targeting Next-Generation Antibodies: Pipeline, 2014 Table 10.1 World Next-Generation Antibodies Market: Submarket Forecasts ($m) and Market Shares (%), 2012-2024 Table 10.2 Next-Generation Antibodies Pipeline by Phase, 2014 www.visiongain.com
  17. 17. Contents List of Figures Figure 2.1 Next-Generation Antibody Therapies Market: Revenues ($m), 2008-2013 Figure 2.2 Next-Generation Antibody Therapies Market: Market Shares (%) by Sector, 2012 Figure 2.3 Antibody Therapies Market: Market Shares (%), 2012 Figure 2.4 Antibody Therapies Market Forecast ($m), 2012-2024 Figure 2.5 Next-Generation Antibodies Market: Revenue Forecast ($m), 2012-2024 Figure 2.6 Next-Generation Antibody Therapies: Market Drivers, 2014-2024 Figure 2.7 Next-Generation Antibody Therapies: Market Restraints, 2014-2024 Figure 2.8 Next-Generation Antibody Therapies: Market Shares (%) by Sector, 2018 Figure 2.9 Next-Generation Antibody Therapies: Market Shares (%) by Sector, 2024 Figure 2.10 Next-Generation Antibody Therapies: Market Shares (%) by Country/Region, 2012 Figure 2.11 US Next-Generation Antibody Therapies Submarket: Revenue Forecast ($m), 20122024 Figure 2.12 EU Next-Generation Antibody Therapies Submarket: Revenue Forecast ($m), 20122024 Figure 2.13 Next-Generation Antibody Therapies: Market Shares (%) by Country/Region, 2018 Figure 2.14 Next-Generation Antibody Therapies: Market Shares (%) by Country/Region, 2024 Figure 2.15 Japanese Next-Generation Antibody Therapies Submarket: Revenue Forecast ($m), 2012-2024 Figure 3.1 ADC Submarket: Revenues ($m) by Drug, 2011-2013 Figure 3.2 ADC Submarket: Revenue Forecast ($m), 2012-2024 Figure 3.3 ADC Submarket: Drivers and Restraints, 2014-2024 Figure 3.4 Adcetris: Revenue ($m) by Company, 2011-2013 Figure 3.5 Adcetris: Revenue Forecast ($m), 2012-2024 www.visiongain.com
  18. 18. Contents Figure 3.6 Kadcyla: Revenue ($m) by Quarter, 2013 Figure 3.7 Kadcyla: Revenue Forecast ($m), 2012-2024 Figure 3.8 ADC Pipeline by Platform, 2014 Figure 3.9 ADC Pipeline by Phase, 2014 Figure 3.10 ADC Pipeline by Indication, 2014 Figure 4.1 Engineered Antibodies Submarket: Revenue Forecast ($m), 2012-2024 Figure 4.2 Engineered Antibodies Submarket: Drivers and Restraints, 2014-2024 Figure 4.3 Poteligeo: Revenue ($m), 2012-2013 Figure 4.4 Poteligeo: Revenue Forecast ($m), 2012-2024 Figure 4.5 Gazyva: Revenue Forecast ($m), 2012-2024 Figure 4.6 Engineered Antibodies Pipeline by Technology Platform, 2014 Figure 4.7 Engineered Antibodies Pipeline by Indication, 2014 Figure 4.8 Engineered Antibodies Pipeline by Phase, 2014 Figure 5.1 Bispecific Antibodies Submarket: Revenue Forecast ($m), 2012-2024 Figure 5.2 Bispecific Antibodies Submarket: Drivers and Restraints, 2014-2024 Figure 5.3 Removab: Revenue ($m), 2010-2013 Figure 5.4 Removab: Revenue Forecast ($m), 2012-2024 Figure 5.5 Bispecific Antibodies Pipeline by Technology Platform, 2014 Figure 5.6 Bispecific Antibodies Pipeline by Phase, 2014 Figure 6.1 Kalbitor: Revenue ($m), 2011-2013 Figure 6.2 Kalbitor: Revenue Forecast ($m), 2012-2024 Figure 6.3 Antibody Fragments and ALPs Submarket: Revenue Forecast ($m), 2012-2024 Figure 6.4 Antibody Fragments and ALPS Submarket: Drivers and Restraints, 2014-2024 Figure 6.5 Antibody Fragments and ALPs Pipeline by Indication, 2014 Figure 6.6 Antibody Fragments and ALPs Pipeline by Platform, 2014 www.visiongain.com
  19. 19. Contents Figure 7.1 Biosimilar Antibodies Submarket by Sector, 2012 Figure 7.2 Biosimilar Antibodies Submarket: Revenue Forecast ($m), 2012-2024 Figure 7.3 Biosimilar Antibodies Submarket: Drivers and Restraints, 2014-2024 Figure 7.4 Reditux: Revenue ($m), 2008-2013 Figure 7.5 Biosimilar Rituximab: Revenue Forecast ($m), 2012-2024 Figure 7.6 Biosimilar Infliximab: Revenue Forecast ($m), 2012-2024 Figure 7.7 Biosimilar Trastuzumab: Revenue Forecast ($m), 2012-2024 Figure 7.8 Biosimilar Adalimumab: Revenue Forecast ($m), 2012-2024 Figure 8.1 Platforms Used for Clinical Development of Next-Generation Antibodies by Sector, 2014 Figure 8.2 Next-Generation Antibody Pipeline by Indication, 2014 Figure 10.1 Next-Generation Antibody Approvals, 2007-2014 Figure 10.2 Next-Generation Antibodies: Market Forecast ($m) by Sector, 2012-2024 Figure 10.3 Next-Generation Antibodies Pipeline by Phase, 2014 www.visiongain.com
  20. 20. Contents Companies and Other Organisations Mentioned AbbVie Abgenix (part of Amgen) Ablynx Actavis ADC Therapeutics Adnexus (part of Bristol-Myers Squibb) AET BioTech Affibody Affimed Therapeutics Agensys (part of Astellas Pharma) Alcon (part of Novartis) Alexion Pharmaceuticals Allergan Allozyne Ambrx Amgen AMRI Aprogen Arana Therapeutics (part of Cephalon) Astellas Pharma AstraZeneca Auven Therapeutics Bayer Healthcare Biocad Bioceros Biocon Biogen Idec www.visiongain.com
  21. 21. Contents Biotest BioWa (part of Kyowa Hakko Kirin) BioXpress Therapeutics Boehringer Ingelheim Bristol-Myers Squibb BZL Biologics Catalent Pharma Solutions Celgene Celldex Therapeutics Celltech (part of UCB) Celltrion Cephalon (part of Teva) CinnaGen Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) [Mexico] Concortis Biosystems (part of Sorrento Therapeutics) Corixa Covagen Crescendo Biologics CVie Therapeutics CytomX Therapeutics Daiichi Sankyo Defiante Farmaceutica (part of Sigma-Tau) Delenex Therapeutics Dendreon Domantis (part of GSK) Dong-A Pharmaceutical Dr. Reddy's Laboratories Drug Controller General of India (DCGI) Dyax Eddingpharm www.visiongain.com
  22. 22. Contents Egis Pharmaceuticals Elan Pharmaceuticals Eli Lilly Epirus Biopharmaceuticals ESBATech (part of Novartis) ETH Zurich European Medicines Agency (EMA) EvaluatePharma (now Evaluate) F-star Five Prime Therapeutics Food and Drug Administration (FDA) [US] Fresenius Biotech (now named Neovii Biotech, part of Neopharm) Fresenius Group Fujifilm Fujifilm Diosynth Biotechnologies Fujifilm Kyowa Kirin Biologics GE Healthcare Gedeon Richter Genentech (part of Roche) Genmab Gilead Sciences GlycoExpress Glycotope GSK Hanwha Chemical Helmholtz Zentrum München Hospira IBC Pharmaceuticals (part of Immunomedics) Igenica Immunocore www.visiongain.com
  23. 23. Contents ImmunoGen Immunomedics Intas Biopharmaceuticals Isu Abxis J&J Janssen Biotech (part of J&J) Janssen-Cilag (part of J&J) KaloBios Karolinska Institute Kyowa Hakko Kirin Kyowa Medex (part of Kyowa Hakko Kirin) Laboratoires Français de Fractionnement et des Biotechnologies (LFB) LFB Biomanufacturing (part of LFB) Life Science Pharmaceuticals LINDIS Biotech LMC Lonza Mabion MacroGenics MedImmune (part of AstraZeneca) Mentrik Biotech Merck & Co. Merck Serono Merrimack Pharmaceuticals Mersana Therapeutics Merus Biopharmaceuticals Micromet (part of Amgen) Millennium Pharmaceuticals (part of Takeda) Ministry of Food and Drug Safety (MFDS) [South Korea] Ministry of Health [Brazil] www.visiongain.com
  24. 24. Contents Ministry of Health, Labor and Welfare (MHLW) [Japan] Mitsubishi Tanabe Pharma Molecular Partners MorphoSys Mylan National Health Service (NHS) [UK] National Institute for Health and Care Excellence (NICE) [UK] National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Nektar Therapeutics Neopharm Group Nichi-Iko Pharmaceutical Novartis Novellus Biopharma Orygen Biotecnologia Oxford BioMedica Oxford BioTherapeutics Pfizer Pharmacyclics PharmaPraxis Pieris Piramal Group PlantForm Probiomed Progenics Pharmaceuticals ProStrakan Group (part of Kyowa Hakko Kirin) Ranbaxy Laboratories (part of Daiichi Sankyo) Redwood Bioscience Regeneron Pharmaceuticals Reliance GeneMedix (part of Reliance Life Sciences) Reliance Life Sciences www.visiongain.com
  25. 25. Contents Roche Roche Glycart (part of Roche) Royal Institute of Technology (KTH) [Sweden] SAFC Samsung Bioepis Samsung BioLogics Sandoz (part of Novartis) Sanofi Scil Proteins Seattle Genetics Servier Shanghai CP Guojian Sigma-Tau Pharmaceuticals Sorrento Therapeutics Sothema Laboratories Spectrum Pharmaceuticals Spirogen (part of AstraZeneca) Stada Stelis Biopharmaceuticals (part of Strides Arcolab) Strides Arcolab Sutro Biopharma Swedish Orphan Biovitrum (Sobi) Swiss Federal Institute of Technology Symphogen Synthon Synthon Biopharmaceuticals (part of Synthon) Takeda Pharmaceutical Company Talon Therapeutics (part of Spectrum Pharmaceuticals) Targa Therapeutics Teva Pharmaceutical Industries www.visiongain.com
  26. 26. Contents TG Therapeutics TRION Pharma UCB US Patent and Trademark Office World Health Organization (WHO) Wyeth (part of Pfizer) Xencor Zydus Cadila www.visiongain.com
  27. 27. Next-Generation Antibody Therapies: World Industry and Market 2014-2024 4.4.2 Gazyva: Revenue Forecast 2014-2024 Uptake of Gazyva in its first year on the market, in direct competition with Rituxan, will provide a good indication of the revenue potential for the drug. If it gains rapid uptake, visiongain believes that Roche will be able to switch patients from the older therapy before biosimilars enter the US and EU markets - these will be priced well below the cost of Gazyva, which is expected to be close to $80,000 annually in the US. We predict that by 2018, revenue for Gazyva will have reached $919m, up from $200m in 2014. Approvals in additional indications in this period will drive growth, as will the launch in the EU and Japan. Biosimilar competition and competition from other antiCD20 antibody therapies will restrain growth throughout the period. However, we predict that Gazyva will achieve blockbuster revenue - by 2024, revenue for the drug will have reached $1,773m (Table 4.4 and Figure 4.5). Figure 4.5 Gazyva: Revenue Forecast ($m), 2012-2024 1,800 1,600 1,400 Revenue ($m) 1,200 1,000 800 600 400 200 0 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Year Source: visiongain 2014 Table 4.4 Gazyva: Revenue Forecast ($m), 2012-2024 2012 Revenue ($m) 2013 2014 2015 2016 2017 2018 0 0 200 344 533 741 919 72 55 39 24 Annual Growth (%) CAGR (%, 2014-2018) 46.4 2019 2020 2021 2022 2023 2024 Revenue ($m) 1,094 1,269 1,421 1,549 1,657 1,773 Annual Growth (%) 19 16 12 9 7 7 CAGR (%) 11.6 Source: visiongain 2014 www.visiongain.com Page 98
  28. 28. Next-Generation Antibody Therapies: World Industry and Market 2014-2024 4.5 Leading Technology Platforms for Engineered Antibodies 2014-2024 Two antibody engineering platforms have produced commercial products in 2014 - Kyowa Hakko Kirin’s Potelligent and Roche Glycart’s GlycoMAbs. The Potelligent platform has also produced five further clinical-stage drugs, accounting for almost a third of the pipeline in this sector (Table 4.5 and Figure 4.6). MacroGenics and Glycotope have produced three clinical trial drugs from their engineered antibody platforms. By contrast, Roche only has one drug in clinical trials, following the approval of Gazyva in 2013, as well as the discontinuation of one project in that year. Thus far, antibody engineering platforms have focused on enhancing two of the characteristics discussed at the beginning of this chapter - ADCC and half-life. Extending half-life is beneficial as it provides a more convenient dosing regimen, as well as greater efficacy for the drug. The two leading platforms achieve enhanced ADCC by defucolsylating the antibody - removing the fucose sugar units from the Fc domain. Fucose on an antibody’s Fc domain has been linked to lower ADCC activity against tumour cells. Visiongain believes that only one company has tested an amino acid-modifying platform in clinical trials so far - Xencor reports that modifying as few as two amino acids in the Fc domain can have a significant impact on ADCC activity. Unlike the glycoengineering platforms, Xencor’s platform can also be used to extend antibody half-lives, we note. Figure 4.6 Engineered Antibodies Pipeline by Technology Platform, 2014 Roche 6.3% Other 12.5% Kyowa Hakko Kirin 31.3% Xencor 12.5% Glycotope 18.8% MacroGenics 18.8% Source: visiongain 2014 www.visiongain.com Page 99

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