Next Generation Antibody Therapies World Industry 2014-2024

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Next-Generation Antibody Therapies: World Industry and Market

2014-2024

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Contents

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

2.1 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


2.2.1 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?

1. Executive Summary

2. The World Next-Generation Antibody Therapies Market: Outlook and Forecast 2014-2024

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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

3.1 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

3. Antibody-Drug Conjugates (ADCs): Pipeline and Commercial Outlook 2014-2024

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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

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Contents

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

4. The Engineered Antibodies Submarket 2014-2024

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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)

5.1 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)

5. The Bispecific Antibodies Submarket: Commercial Potential 2014-2024

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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)

6.1 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)

6. The Next-Generation Antibody Fragments and Antibody-Like Proteins (ALPs) Submarket 2014-2024

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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

7.1 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

7. The Biosimilar Antibodies Submarket 2014-2024

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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

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Contents

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

8. Next-Generation Antibodies: Industry Trends 2014-2024

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Contents

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


10.1.1 ADCs Lead the Next-Generation Antibodies Market in 2014

9. Research Interviews 2013-2014

10. Conclusions to Our Study

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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

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Contents

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 (%), 2012-

2024

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

List of Tables

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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

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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

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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, 2014-

2024

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

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Contents

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), 2012-

2024

Figure 2.12 EU Next-Generation Antibody Therapies Submarket: Revenue Forecast ($m), 2012-

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

List of Figures

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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

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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

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Contents

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

Companies and Other Organisations Mentioned

www.visiongain.com

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

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

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

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

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

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

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 anti-

CD20 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).

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Rev

enue

($m

)

Year

2012 2013 2014 2015 2016 2017 2018

Revenue ($m) 0 0 200 344 533 741 919

Annual Growth (%) 72 55 39 24

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

Table 4.4 Gazyva: Revenue Forecast ($m), 2012-2024

Figure 4.5 Gazyva: Revenue Forecast ($m), 2012-2024


www.visiongain.com

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.

Kyowa Hakko Kirin 31.3%

MacroGenics 18.8%

Glycotope 18.8%

Xencor 12.5%

Roche 6.3%

Other 12.5%

Figure 4.6 Engineered Antibodies Pipeline by Technology Platform, 2014


Next Generation Antibody Therapies World Industry 2014-2024

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