Biosimilars and Follow-On Biologics:
World Industry and Market Prospects
2014-2024
©notice
This material is copyright by v...
www.visiongain.com
Contents
1.1 Biosimilars: World Market Review 2014
1.2 Report Contents
1.2.1 Benefits of this Report
1....
www.visiongain.com
Contents
3.1 Which Were the Leading National Submarkets for Biosimilar Sales in 2013?
3.1.1 Growth in L...
www.visiongain.com
Contents
3.4.3 Biosimilar MAbs Could be Launched in 2014
3.4.4 Japanese Biosimilars Submarket Forecast ...
www.visiongain.com
Contents
5.1 Monoclonal Antibodies (MAbs): The Largest Biologics Market Sector in 2013
5.1.1 High Deman...
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Contents
5.5 Biosimilar Infliximab 2014-2024
5.5.1 Hospira and Celltrion: Biosimilars for Developed Mar...
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Contents
5.8.5 Biosimilar Etanercept Pipeline 2014
5.8.5.1 GP2015 (Sandoz)
5.8.5.2 CHS-0214 (Coherus Bi...
www.visiongain.com
Contents
6.4.3 Biosimilar Insulin Analogue Revenue Forecast 2014-2024
6.4.4 Insulin Market Leaders Are ...
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Contents
7.3.2 Companies Preparing for US Launch in 2015
7.3.2.1 The US Is an Appealing Submarket for D...
www.visiongain.com
Contents
9.1 Steady Growth in the Interferon Alpha and Beta Submarkets 2011-2013
9.1.1 Many Challengers...
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Contents
10.1.3 Biosimilar Growth Hormone Submarket 2013
10.1.3.1 Omnitrope: The World’s Bestselling Bi...
www.visiongain.com
Contents
11.3.1 The Pipeline for New Biosimilars Is Long
11.3.2 Blockbuster Biologics Face Patent Expir...
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Contents
12.2.1 Current Biosimilars Business and Product Portfolio
12.2.2 Regional Competition Facing B...
Page 53www.visiongain.com
Biosimilars and Follow-On Biologics: World
Industry and Market Prospects 2014-2024
2.2.5 Biosimi...
Page 119www.visiongain.com
Biosimilars and Follow-On Biologics: World
Industry and Market Prospects 2014-2024
5.5.2 Biosim...
Page 186www.visiongain.com
Biosimilars and Follow-On Biologics: World
Industry and Market Prospects 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 https://www.visiongain.com/Report/1253/Biosimilars-and-Follow-On-Biologics-World-Industry-and-Market-Prospects-2014-2024


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Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024

  1. 1. Biosimilars and Follow-On Biologics: World Industry and Market Prospects 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. www.visiongain.com Contents 1.1 Biosimilars: World Market Review 2014 1.2 Report Contents 1.2.1 Benefits of this Report 1.3 Report Methods 1.3.1 Financial Information in this Report 1.3.2 Who is this Report for? 1.4 An Introduction to Biosimilars and Biosimilar Drug Development 1.4.1 A Brief History of Biological Drug Development 1.4.2 The Advent of Biosimilars 1.4.2.1 What Is a Biosimilar? 1.4.3 What Is Driving Demand for Biosimilar Development? 1.4.4 What Has Slowed Biosimilar Drug Development? 1.4.5 Important Sectors of the Biosimilar Market 2.1 The World Biosimilars Market 2013 2.1.1 Biosimilars as a Share of the Biologics Market, 2013 2.1.2 Eleven Drugs Account for More than 50% of Biological Drug Revenues 2.1.3 Leading Biologics Sectors Represent Leading Targets for Biosimilars 2.2 Outlook for the World Biosimilars Market 2014-2024 2.2.1 Revenue Growth in the Biologics Market 2014-2024 2.2.2 Biosimilars Market Forecast 2014-2024 2.2.3 Changing Market Shares for Leading Segments 2014-2024 2.2.4 What Will Drive Growth in the Biosimilars Market to 2024? 2.2.5 Biosimilars Market Restraints, 2014-2024 1. Executive Summary 2. The World Biosimilars Market: Outlook and Forecast 2014-2024
  3. 3. www.visiongain.com Contents 3.1 Which Were the Leading National Submarkets for Biosimilar Sales in 2013? 3.1.1 Growth in Leading Developed Markets to 2024 3.2 The Outlook for Biosimilars in the US 2014-2024 3.2.1 When Will Finalised FDA Development Guidelines be Released? 3.2.1.1 A Fourth Draft Guideline Released in 2013 3.2.2 US States Introduce their Own Biosimilar Rules 3.2.3 US Biosimilars Submarket Forecast, 2014-2024 3.2.3.1 What Rates of Uptake Can We Expect for Biosimilars in the US? 3.3 Biosimilars in the EU: Outlook 2014-2024 3.3.1 The EU Led the World in Biosimilar Regulation 3.3.2 The EMA Updates its Overarching Guidelines 2012-2014 3.3.3 Biosimilar Uptake in the EU 2008-2013 3.3.4 The EU Biosimilars Submarket Forecast 2014-2024 3.3.4.1 Biosimilar MAbs in the EU from 2014 3.3.5 Biosimilars in Germany: High Uptake for Current Biosimilars 3.3.5.1 German Biosimilars Submarket: Revenue Forecast 2014-2024 3.3.6 The French Biosimilars Submarket 2014-2024 3.3.6.1 New Rules Introduce the Possibility of Biosimilar Substitution 3.3.6.2 French Biosimilars Submarket Forecast 2014-2024 3.3.7 Biosimilars in the UK: High Uptake for Filgrastim 3.3.7.1 UK Biosimilars Submarket Forecast 2014-2024 3.3.8 The Italian Biosimilars Submarket Forecast 2014-2024 3.3.9 Outlook for Biosimilars in Spain: Submarket Forecast 2014-2024 3.4 The Japanese Biosimilars Submarket 2014-2024 3.4.1 Biosimilar Regulation in Japan 2014 3.4.1.1 Differences Exist Between EU and Japanese Guidelines 3.4.2 Collaboration Agreements Drive Biosimilar Development in Japan 3. Biosimilars in Leading Developed Markets, 2014-2024
  4. 4. www.visiongain.com Contents 3.4.3 Biosimilar MAbs Could be Launched in 2014 3.4.4 Japanese Biosimilars Submarket Forecast 2014-2024 4.1 China and India Lead in Biosimilar Range and Revenues 2014 4.1.1 Biosimilar Growth in Emerging National Markets 2014-2024 4.2 Outlook for the Chinese Biosimilars Submarket 2014-2024 4.2.1 Biosimilar Development Guidelines Set for Release 4.2.2 Biosimilars Account for Less than Half of Biotech Revenues in China 4.2.3 Chinese Biosimilars Submarket Forecast 2014-2024 4.3 Biosimilars in India: Regulatory and Commercial Outlook 2014-2024 4.3.1 CDSCO Guidelines Released in 2012: How will they Affect Developers? 4.3.2 Biosimilar Uptake in India 2014 4.3.3 Strong Growth Forecast for the Indian Biosimilars Submarket 2014-2024 4.4 The Brazilian Biosimilars Submarket 2014-2024 4.4.1 Biosimilar Regulations Are Similar to those in the EU 4.4.2 Promoting Domestic Biosimilar and Biologic Development 4.4.3 Brazilian Biosimilar Submarket Forecast 2014-2024 4.5 What Potential is there for Biosimilars in Russia to 2024? 4.5.1 No Specific Guidelines for Biosimilar Development 4.5.2 Russian Biosimilars Submarket Forecast 2014-2024 4.6 South Korea: A Leading Country for Biosimilar Development 4.6.1 Established Biologic and Biosimilar Guidelines 4.6.2 Local Players Are Keen on Biosimilar MAb Development 4.6.3 South Korean Biosimilars Submarket Forecast 2014-2024 4. Outlook for Biosimilars in Emerging Markets 2014-2024
  5. 5. www.visiongain.com Contents 5.1 Monoclonal Antibodies (MAbs): The Largest Biologics Market Sector in 2013 5.1.1 High Demand in Cancer and Autoimmune Disease 5.2 The MAbs Submarket Forecast 2014-2024 5.2.1 Rising Disease Incidence to Stimulate Sales Growth 5.2.2 MAbs: Product and Portfolio Lifecycle Management 5.3 Biosimilar MAbs Outlook 2014-2024 5.3.1 There Are Challenges in Antibody Development and Manufacturing 5.3.2 Partnering to Launch Biosimilar MAbs 5.3.3 Biosimilars MAbs Submarket Forecast 2014-2024 5.3.4 Multiple Product Launches Will Drive Submarket Growth 5.3.5 Biosimilar MAbs and FPs: Submarket Restraints 2014-2024 5.3.6 Leading Targets for Biosimilar Development 2014-2024 5.4 Biosimilar Rituximab 2014-2024 5.4.1 Three Biosimilars Available in 2014 5.4.1.1 Reditux (Dr. Reddy’s Laboratories) 5.4.1.2 Mabtas: A Second Indian Biosimilar 5.4.1.3 Kikuzubam: Removed from the Market, 2014 5.4.2 Biosimilar Rituximab: Revenue Forecast 2014-2024 5.4.3 Biosimilar Rituximab Pipeline 2014 5.4.3.1 A Reduced Late-Stage Pipeline 2012-2014 5.4.3.2 GP2013 (Sandoz): The Most Advanced Developed-Market Candidate 5.4.3.3 BI 695500 (Boehringer Ingelheim) 5.4.3.4 MabionCD20 (Mabion) 5.4.3.5 BCD020 (Biocad) 5.4.3.6 CT-P10 (Celltrion): Development Delayed 5.4.3.7 PF-05280586 (Pfizer) 5. Biosimilar Monoclonal Antibodies and Fusion Proteins: Submarket Forecast and Pipeline 2014-2024
  6. 6. www.visiongain.com Contents 5.5 Biosimilar Infliximab 2014-2024 5.5.1 Hospira and Celltrion: Biosimilars for Developed Markets 5.5.1.1 Egis Pharmaceuticals Launches Flammegis in Eastern Europe 5.5.2 Biosimilar Infliximab: Revenue Forecast 2014-2024 5.5.3 Biosimilar Infliximab Pipeline 2014 5.5.3.1 BOW-015 (Epirus Biopharmaceuticals) 5.5.3.2 R-TPR-015 (Reliance Life Sciences) 5.5.3.3 Nichi-Iko: A Second Biosimilar for Japan 5.6 Biosimilar Trastuzumab 2014-2024 5.6.1 Biocon/Mylan: Biosimilar Approval in India 5.6.1.1 Roche Sues Biocon and Mylan over Hertraz Launch 5.6.2 Herzuma: Approved in South Korea 2014 5.6.3 Biosimilar Trastuzumab: Revenue Forecast 2014-2024 5.6.4 Biosimilar Trastuzumab Pipeline: Four Clinical-Stage Candidates in 2014 5.6.4.1 Amgen and Actavis Advance to Phase III 5.6.4.2 PF-05280014 (Pfizer): Phase III Launched 2014 5.6.4.3 BCD-022 (Biocad): A Third Phase III Biosimilar 5.7 Biosimilar Adalimumab 2014-2024 5.7.1 Humira is the World’s Leading Antibody Therapy 5.7.2 AbbVie Seeks to Protect its Lead Asset 5.7.3 Biosimilar Adalimumab: Revenue Forecast 5.7.4 First Biosimilar to Launch in India 5.7.4.1 Amgen Advances to Phase III 5.7.4.2 GP2017 (Sandoz) 5.7.4.3 Phase I Biosimilar Adalimumab Candidates 5.8 Biosimilar Etanercept 2014-2024 5.8.1 Enbrel Is the Leading Fusion Protein 5.8.2 Extended Patent Protection in the US 5.8.3 Biosimilars Are Available in Emerging National Markets 5.8.4 Biosimilar Etanercept: Revenue Forecast 2014-2024
  7. 7. www.visiongain.com Contents 5.8.5 Biosimilar Etanercept Pipeline 2014 5.8.5.1 GP2015 (Sandoz) 5.8.5.2 CHS-0214 (Coherus BioSciences) 5.8.5.3 Hanwha Chemical: Submitted in South Korea 5.8.5.4 TuNEX (Mycenax Biotech) 5.9 Other Leading Antibody Targets 2014-2024 5.9.1 Avastin Loses Patent Protection in 2018 6.1 Insulin: The Second-Largest Biological Drug Sector 2014 6.1.1 Insulin Submarket Forecast 2014-2024 6.1.2 Diabetes Prevalence Is Rising Worldwide 6.2 Biosimilar Insulin Submarket 2014-2024 6.2.1 There Are No Biosimilars in Developed Markets in 2014 6.2.2 Biosimilar Insulin Submarket Forecast 2014-2024 6.2.3 Launch of Biosimilar Insulin Analogues to Stimulate Growth from 2014-2024 6.2.4 Biosimilar Insulin Submarket Restraints 2014-2024 6.3 Biosimilar Human Insulin Submarket 2014-2024 6.3.1 A Submarket Restricted to Emerging Markets? 6.3.2 Biosimilar Human Insulin in China 6.3.2.1 Biosimilar Insulin Uptake in China 2014 6.3.3 Biosimilar Human Insulin in India 6.3.3.1 What Share Do Biosimilars Hold of the Indian Insulin Submarket? 6.3.3.2 Indian Developers Target the US and EU? 6.3.4 Biosimilar Human Insulin in Other Emerging Markets 6.3.5 Biosimilar Human Insulin Submarket Forecast 2014-2024 6.4 Biosimilar Insulin Analogues 2014-2024 6.4.1 Insulin Analogues Account for Three Quarters of Global Insulin Revenues 6.4.2 Insulin Glargine Is the Main Biosimilar Target 6. Biosimilar Insulin Submarket Outlook 2014-2024
  8. 8. www.visiongain.com Contents 6.4.3 Biosimilar Insulin Analogue Revenue Forecast 2014-2024 6.4.4 Insulin Market Leaders Are Developing Ultra-Acting Insulin Analogues 6.5 Biosimilar Insulin Glargine 2014-2024 6.5.1 Two Biosimilars Are Available in India 6.5.1.1 Mylan Partners with Biocon for Insulin Analogues 6.5.2 Biosimilar Insulin Glargine: Revenue Forecast 2014-2024 6.5.3 Ultra-Long Acting Insulin Analogues in Development 6.5.4 Biosimilar Insulin Glargine Pipeline 2014 6.5.4.1 Eli Lilly and Boehringer Ingelheim Submit Approval Applications in the EU and US 6.5.4.2 Merck & Co. Partners with Samsung Bioepis 6.6 Biosimilar Insulin Lispro 2014-2024 6.6.1 One Biosimilar Available in 2014 6.6.2 Biosimilar Insulin Lispro Revenue Forecast 2014-2024 6.6.3 Ultra-Rapid Acting Insulin: New Options from 2014 6.6.4 Biosimilar Insulin Lispro Pipeline 2014 6.6.4.1 Insulin Lispro Biosimilars in India 7.1 Three Products Lead the EPO Therapy Submarket in 2014 7.1.1 Aranesp and Procrit: Falling Revenue 2011-2013 7.1.2 Safety Concerns for Erythropoietin-Stimulating Agents 7.2 EPO Submarket Forecast 2014-2024 7.2.1 The Challenge from Oral Therapies Is Coming 7.2.2 Prevalence of Chronic Kidney Disease Will Rise 2014-2024 7.3 The Biosimilar EPO Submarket 2014-2024 7.3.1 Biosimilar Epoetin in the EU 2006-2013 7.3.1.1 Pipeline Epoetin Alpha for the EU Submarket 2014 7.3.1.2 Trends in Uptake for Biosimilar Epoetins in the EU 7. Biosimilar Erythropoietins: Future Directions 2014-2024
  9. 9. www.visiongain.com Contents 7.3.2 Companies Preparing for US Launch in 2015 7.3.2.1 The US Is an Appealing Submarket for Developers 7.3.3 Biosimilar Epoetin: Japanese Submarket Overview 2010-2013 7.3.4 Biosimilar Epoetins in Emerging Markets: Multiple Players in a Fragmented Market 7.3.5 Second-Generation EPO Biosimilars 7.3.5.1 Biosimilar Darbepoetin Alpha Pipeline 2014 7.3.6 Biosimilar EPO Submarket Forecast 2014-2024 8.1 Amgen Leads the G-CSF Submarket in 2014 8.1.1 G-CSF Submarket Outlook and Forecast 2014-2024 8.1.2 Teva Launches Long-Acting Pegfilgrastim 8.1.2.1 Other Long-Acting Therapies in Development 8.2 The Biosimilar G-CSF Submarket 2014 8.2.1 One of the First Biosimilars in the EU and US 8.2.1.1 Zarzio Is the Most Prescribed Filgrastim Therapy in Europe 8.2.1.2 Tevagrastim: The First EU Biosimilar 8.2.1.3 Nivestim (Hospira) 8.2.2 Multiple Launches in Japan 2013-2014 8.2.3 Biosimilar Pegfilgrastim and Filgrastim in Emerging Markets 8.2.3.1 A Competitive Biosimilar Submarket in Russia 8.3 Biosimilar G-CSF Submarket 2014-2024 8.3.1 Biosimilar G-CSF Submarket Forecast 2014-2024 8.3.2 Biosimilar G-CSF Submarket: US Launches to Drive Growth 2014-2024 8.3.3 Trends in Biosimilar Uptake in the EU 2008-2013 8.3.4 Biosimilars Targeting the US Submarket 8.4 Biosimilar Pegfilgrastim: Pipeline 2014 8.4.1 Sandoz Leads the Way for Developed Markets 8.4.2 Hospira Gains Funding for Parallel Filgrastim and Pegfilgrastim Development 8. Biosimilar G-CSF: Outlook and Forecast 2014-2024
  10. 10. www.visiongain.com Contents 9.1 Steady Growth in the Interferon Alpha and Beta Submarkets 2011-2013 9.1.1 Many Challengers Exist in the Multiple Sclerosis Market 9.1.2 All-Oral Regimens Will Challenge Interferon Alpha Therapy 9.1.2.1 Oral Therapies Will be High Cost 9.2 Interferon Submarket Forecast: Falling Revenue to 2024 9.3 Biosimilar Interferon Submarket 2013 9.3.1 There Are No Biosimilars Approved in Developed Markets 9.3.2 Biosimilar Interferon Submarket Forecast 2014-2024 9.4 Biosimilar Interferon Alpha 2014-2024 9.4.1 Biosimilar Interferon Alpha Is a Common Target in BRIC Nations 9.4.2 Biosimilar Peginterferon Alpha Pipeline 2014 9.4.3 Hepatitis Is a Growing Problem in Emerging Markets 9.4.4 Biosimilar Interferon Alpha Submarket Forecast 2014-2024 9.5 Biosimilar Interferon Beta 2014-2024 9.5.1 Biosimilars Are Well-Established in Emerging Markets 9.5.1.1 Biosimilar Interferon Beta Pipeline 2014 9.5.2 Will EMA Guidance Drive Development in the EU? 9.5.3 Long-Acting Interferon Beta to Launch in 2014 9.5.4 Biosimilar Interferon Beta Submarket Forecast 2014-2024 10.1 Biosimilar Growth Hormones Submarket 2014-2024 10.1.1 Novo Nordisk and Pfizer Dominate the Growth Hormones Submarket 10.1.2 Product Lifecycle Management Will Maintain Revenues for Submarket Leaders 2014- 2024 9. Biosimilar Interferons Submarket 2014-2024 10. Recombinant Hormones: Biosimilar Submarket Outlook 2014- 2024
  11. 11. www.visiongain.com Contents 10.1.3 Biosimilar Growth Hormone Submarket 2013 10.1.3.1 Omnitrope: The World’s Bestselling Biosimilar 10.1.4 Many Biosimilars Are Available Worldwide 10.1.4.1 Biosimilar Growth Hormones in Japan and China 10.1.5 Biosimilar Uptake Varies by Region 10.1.6 Biosimilar Growth Hormone Submarket Forecast 2014-2024 10.2 Biosimilar Fertility Hormones Submarket 2014-2024 10.2.1 Two Products Lead the Fertility Hormone Submarket 2014 10.2.2 Long-Acting Follicle-Stimulating Hormone (FSH) 10.2.3 Fertility Hormone Submarket Forecast 2014-2024 10.2.4 Biosimilar Fertility Hormones 2014-2024 10.2.4.1 Two Biosimilars Approved in the EU 2013-2014 10.2.4.2 Biosimilars Beyond FSH 2014 10.2.5 Biosimilar Fertility Hormone Submarket Forecast 2014-2024 10.2.6 Rising Infertility to Drive Demand to 2024 11.1 Biosimilars Market: Strengths 2014 11.1.1 Biosimilars Are Available and Well-Established in Many National Markets 11.1.2 Leading Classes of Biological Drug Face Biosimilar Competition 11.1.3 Biosimilars Offer Cost Savings 11.1.4 Outsourcing Offers the Chance for Further Cost Savings 11.2 Biosimilars Market: Weaknesses 2014 11.2.1 Uptake for Most Biosimilars Remains Low in 2014 11.2.2 Biosimilars Are High Cost to Develop and Manufacture 11.2.3 Development Timelines for Biosimilars Are Long 11.2.4 Few Companies Dominate the Late-Stage Pipeline 11.2.5 Awareness of Biosimilars Remains Low 11.3 Biosimilars Market: Opportunities 2014-2024 11. Biosimilars and Follow-On Biologics: Industry Trends 2014-2024
  12. 12. www.visiongain.com Contents 11.3.1 The Pipeline for New Biosimilars Is Long 11.3.2 Blockbuster Biologics Face Patent Expiry 11.3.3 Rising Disease Chronic Disease Prevalence 11.3.4 Licensing Agreements for Biosimilars 11.3.5 The Opportunity for Biosimilar Substitution? 11.4 Biosimilars Market: Threats 2014-2024 11.4.1 The Threat of Biobetters and Next-Generation Biologics 11.4.2 Product Lifecycle Management to Extend Branded Revenues 11.4.3 Many Companies Are Chasing the Same Targets 11.4.4 Long Market and Data Exclusivity Periods Will Slow Biosimilar Development 11.4.5 Biosimilars Require Marketing 11.5 Porter’s Five Forces Analysis for the Biosimilars Market 2014-2024 11.5.1 Rivalry Among Competitors 11.5.2 Threat of New Entrants 11.5.3 Bargaining Power of Suppliers 11.5.4 Bargaining Power of Buyers 11.5.5 Threat of Substitutes 12.1 Dr Don Stewart, CEO, PlantForm 12.1.1 Benefits in Plant-Based Systems 12.1.1.1 PlantForm Uses Tobacco Plants 12.1.2 Technological Challenges in Plant-Based Systems 12.1.3 Developing Biosimilars for North America and Europe 12.1.4 Differentiating Biosimilar Antibodies 12.1.5 The Threat of Biobetters 12.1.6 PlantForm’s Biosimilar Development 12.1.7 Biosimilar Development for Emerging Markets 12.2 Biosidus 12. Research Interviews
  13. 13. www.visiongain.com Contents 12.2.1 Current Biosimilars Business and Product Portfolio 12.2.2 Regional Competition Facing Biosidus 12.2.3 Future Strategies for Growth and Company Threats 13.1 The Biosimilars Market Will Grow Strongly to 2024 13.2 Biosimilar MAb Development Will Lead the Market 13.3 Rising Costs Will Drive Demand for Biosimilars 13.4 Challenges Remain in Developing and Successfully Launching Biosimilars About Visiongain’s Bespoke Research Service Appendix A: About Visiongain Appendix B: Visiongain Report Evaluation Form 13. Conclusions of the Research and Analysis Appendices
  14. 14. Page 53www.visiongain.com Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 2.2.5 Biosimilars Market Restraints, 2014-2024 The main restraints for growth in the global biosimilars market for the period 2014-2024 are identified in Figure 2.9. Although there are many new biosimilars in development, most companies are chasing the same targets, notably high-revenue mAbs. Not all biosimilars currently in development are likely to be approved but the more that are, the more fragmented biosimilar markets will become. Thus far, where multiple biosimilars have been launched for one target, one biosimilar tends to dominate, with other achieving steadier uptake and revenue growth. Emerging markets will continue to be the most fragmented for biosimilar revenues, we believe, given the lower barriers to market entry and higher rates of approval. The launch of novel biologics targeting similar indications and patient populations will act as a slight restraint on the biosimilars market. Although novel therapies, including biologics offering advantages in convenience, safety and efficacy over current biopharmaceutical therapies, will be priced significantly higher than biosimilars, in less cost-conscious markets payers will be willing to reimburse these treatments in place of biosimilars. Biosimilars must also compete with novel small molecule therapies that offer oral administration and improved efficacy over standard biological therapies. In the interferons market, for example, development of biosimilars for developed There are many stakeholders that must be convinced of the value of biosimilars, their safety and efficacy. Doctors, patients and payers all need to be persuaded to use the still high-cost follow-on therapies Companies will protect lead assets through lifecycle management, patent litigation and next-generation therapy development Opportunities for automatic biosimilar substitution are limited in most markets in 2014 and will be for the foreseeable future Revenue for individual biosimilars remains low. Few products achieve revenue over $0.10bn Figure 2.9 Biosimilars Market Restraints, 2014-2024 Source: visiongain 2014
  15. 15. Page 119www.visiongain.com Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 5.5.2 Biosimilar Infliximab: Revenue Forecast 2014-2024 In 2014, biosimilar infliximab revenues will be low, stemming from sales in South Korea, Canada and small European submarkets. In that year, Hospira and Celltrion’s biosimilars - and their partners’ brands - will achieve combined revenue of $0.03bn. This will rise rapidly from 2015 onwards, following launches in further international markets, including across the EU and in Japan. Remicade achieved revenue of a little over $2bn in the EU during 2013. However, the largest national submarket by far for the drug is the US. Visiongain forecasts that biosimilars will launch there from 2018 onwards, driving revenue growth for biosimilar infliximab in the second half of the forecast period. By 2018, revenue for infliximab biosimilars will total $0.69bn, having grown with a CAGR of 133.2% since 2013. Celltrion and its various commercialisation partners will experience limited biosimilar competition for infliximab in the first half of the forecast period. We believe that only Epirus Biopharmaceuticals and Pfizer have clinical programmes targeting the US and EU markets in 2014. These biosimilars will not launch there until after 2016 though, meaning that Inflectra and Remsima will be the only biosimilars available in most markets in the first half of the period 2014-2024. Biosimilar competition in the second half of the period will result in falling prices, we predict, although the launch of biosimilars has thus far not had a significant impact on Remicade’s price. By 2024, revenue for infliximab biosimilars will total $1.71bn (Table 5.12 and Figure 5.8). 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Revenue($bn) Year Figure 5.8 Biosimilar Infliximab: Revenue Forecast ($bn), 2013-2024 Source: visiongain 2014
  16. 16. Page 186www.visiongain.com Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 showed comparability to Neupogen in 120 breast cancer patients in the pivotal phase III trial, Stada announced that it would launch the drug in 2014. In 2013, visiongain predicts that EU revenues accounted for 74.1% of the global biosimilar G-CSF submarket, driven by high uptake in leading Western European countries, including the UK and Germany. In 2013, there were no revenues for biosimilar filgrastim in the US, we believe, as patents protecting Neupogen there did not expire until November of that year. Then, under agreement with Amgen, Teva launched its biosimilar - approved through the standard BLA pathway - under the name Granix. Product Company Market Zarzio/Filgrastim Hexal Sandoz/Hexal Developed Nivestim Hospira Developed Grastofil Stada/Apotex Developed Tevagrastim/ratiograstim/Biograstim Teva Developed Li Sheng Su Beijing SL Pharmaceutical China - Xiamen Amoytop Biotech China - Beijing Four Rings China - Qilu Pharmaceutical China - Shandong Kexing Pharma China - Hangzhou Jiuyuan Gene Eng. China Baojilin - China Scimax GenSci China Itact Emcure Pharmaceuticals India Nufil Biocon India Grafeel Dr. Reddy's Laboratories India Neukine Intas Biopharmaceuticals India ReliGrast Reliance Life Sciences India Nugraf Zenotech/Ranbaxy India Neutromax Biosidus Latin America - Amega Biotech Latin America - Aché Latin America SciLocyte SciGen/Bioton Emerging Neupomax Pharmstandard Russia Leucostim Dong-A Pharmaceutical South Korea Grastin CCL Pharmaceuticals Pakistan Source: visiongain 2014 Table 8.3 Selected Filgrastim Biosimilars Approved Worldwide, 2014

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