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Global Biosimilars Market 2015 - 2025

1. Preface
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. Executive Summary
3. Introduction
3.1. Context and Background
3.2. Biologics: An Overview
3.3. Biosimilars and Biobetters: Definition
3.4. Difference between Biosimilar and Innovator Product
3.5. Difference between Biosimilar and Generic
3.6. The Need for Biosimilars
3.7. Biosimilars: Cost Saving Potential
3.8. Manufacturing of Biosimilars
3.8.1. Expression Systems
3.8.1.1. Bacterial Protein Expression System
3.8.1.2. Yeast Protein Expression System
3.8.1.3. Mammalian Protein Expression System
3.8.1.4. Insect Protein Expression System
3.8.1.5. Plant Protein Expression System
3.9. Time and Cost of Biosimilars
3.10. Quality Considerations for Development of Biosimilars
3.11. Clinical Trial Design
3.12. Pharmacovigilance and Risk Management
3.13. Marketing of Biosimilars
3.14. Safety and Immunogenicity
3.15. Naming of Biosimilars
3.16. Prescription of Biosimilars
4. Biosimilars: Developed Markets
4.1. Chapter Overview
4.2. Biosimilars in the US
4.2.1. Regulatory Landscape in the US
4.2.2. Approval Pathway for Biosimilars in the US
4.2.3. Approaches to Gain Regulatory Authorisations in the US
4.2.4. Purple Book
4.2.5. Biosimilar Pricing in the US
4.3. The US Biosimilar Market Overview
4.3.1. The US Biosimilar Market: Distribution by Status of Development
4.3.2. The US Biosimilar Market: Distribution by Product Category
4.3.3. The US Biosimilar Market: Distribution by Indication
4.4. The US: Leading Biosimilar Developers
4.4.1. Hospira
4.4.1.1. Company Overview
4.4.1.2. Financial Performance
4.4.1.3. Biosimilars Drug Portfolio
4.4.1.4. Partnerships
4.4.2. Amgen
4.4.2.1. Company Overview
4.4.2.2. Financial Performance
4.4.2.3. Development and Manufacturing of biosimilars
4.4.2.4. Biosimilar Drug Portfolio
4.4.2.5. Partnerships
4.4.2.6. Developments
4.4.3. Eli Lilly
4.4.3.1. Company Overview
4.4.3.2. Financial Performance
4.4.3.3. Biosimilars Drug Portfolio
4.4.3.4. Partnerships
4.4.4. Harvest Moon Pharmaceuticals
4.4.4.1. Company Overview
4.4.4.2. Biosimilars Drug Portfolio
4.4.5. Pfizer
4.4.5.1. Company Overview
4.4.5.2. Financial Performance
4.4.5.3. Development and Manufacturing of Biosimilars
4.4.5.4. Biosimilars Drug Portfolio
4.4.5.5. Partnerships
4.5. Biosimilars in Europe
4.5.1. Approval Pathways in Europe
4.5.2. Regulatory Guidelines in Europe
4.5.3. Evolution of Biosimilars in EU
4.6. Europe Biosimilar Market Overview
4.6.1. Europe Biosimilar Market: Distribution by Status of Development
4.6.2. Europe Biosimilar Market: Distribution by Product Category
4.6.3. Europe Biosimilar Market: Distribution by Indication
4.7. Europe: Leading Biosimilar Developers
4.7.1. Sandoz
4.7.1.1. Company Overview
4.7.1.2. Financial Performance
4.7.1.3. Development and Manufacturing of biosimilars
4.7.1.4. Biosimilars Drug Portfolio
4.7.1.5. Partnerships
4.7.2. Stada Arzneimittel
4.7.2.1. Company Overview
4.7.2.2. Financial Performance
4.7.2.3. Biosimilars Drug Portfolio
4.7.2.4. Partnerships
4.7.3. BioXpress Therapeutics
4.7.3.1. Company Overview
4.7.3.2. Biosimilars Drug Portfolio
4.7.3.3. Partnerships
4.8. Japan Biosimilar Market Overview
4.8.1. Japan Biosimilar Market: Distribution by Status of Development
4.8.2. Japan Biosimilar Market: Distribution by Product Category
4.8.3. Japan Biosimilar Market: Distribution by Indication
4.9. Japan: Leading Biosimilar Developers
4.9.1. Nippon Kayaku
4.9.1.1. Company Overview
4.9.1.2. Financial Performance
4.9.1.3. Biosimilars Drug Portfolio
4.9.1.4. Partnerships
4.9.2. Gene Techno Science
4.9.2.1. Company Overview
4.9.2.2. Financial Performance
4.9.2.3. Development and Manufacturing
4.9.2.4. Biosimilars Drug Portfolio
4.9.2.5. Partnerships
4.9.3. JCR Pharmaceuticals
4.9.3.1. Company Overview
4.9.3.2. Financial Performance
4.9.3.3. Biosimilars drug portfolio
4.9.3.4. Partnerships
4.10. Other Markets
5. Biosimilars: Emerging Markets
5.1. Chapter Overview
5.2. Opportunities in Emerging Markets
5.3. Regulatory Considerations in Emerging Markets
5.4. China Biosimilar Market Overview
5.4.1. Chinese Biosimilar Market: Distribution by Status of Development
5.4.2. Chinese Biosimilar Market: Distribution by Product Category
5.4.3. Chinese Biosimilar Market: Distribution by Indication
5.5. China: Leading Biosimilar Developers
5.5.1. Fosun Pharma
5.5.1.1. Company Overview
5.5.1.2. Financial Performance
5.5.1.3. Development and Manufacturing
5.5.1.4 Biosimilars Product Portfolio
5.5.2. CP Guojian Pharmaceutical
5.5.2.1. Company Overview
5.5.2.2. Biosimilars Product Portfolio
5.6. India Biosimilar Market Overview
5.6.1. Regulatory Guidelines for Approval of biosimilars
5.6.2. Indian Biosimilar Market: Distribution by Status of Development
5.6.3. Indian Biosimilar Market: Distribution by Product Category
5.6.4. Indian Biosimilar Market: Distribution by Indication
5.7. India: Leading Biosimilar Developers
5.7.1. Dr. Reddy’s Laboratories
5.7.1.1. Company Overview
5.7.1.2. Financial Performance
5.7.1.3. Biosimilars Product Portfolio
5.7.1.4. Partnerships
5.7.2. Inbiopro
5.7.2.1. Company Overview
5.7.2.2. Biosimilars Product Portfolio
5.7.3. Wockhardt
5.7.3.1. Company Overview
5.7.3.2. Financial Performance
5.7.3.3. Biosimilars Product Portfolio
5.7.4. Biocon
5.7.4.1. Company Overview
5.7.4.2. Financial Performance
5.7.4.3. Biosimilars Product Portfolio
5.7.5. Zydus Cadila
5.7.5.1. Company Overview
5.7.5.2. Biosimilars Product Portfolio
5.7.5.3. Partnerships
5.7.6. Reliance Life Sciences
5.7.6.1. Company Overview
5.7.6.2. Biosimilars Product Portfolio
5.7.6.3. Partnerships
5.8. Brazil
5.8.1. Approval Pathway in Brazil
5.8.2. Brazil Biosimilar Market Overview
5.8.2.1. Brazil Biosimilar Market: Distribution by Status of Development
5.8.2.2. Brazil Biosimilar Market: Distribution by Product Category
5.8.2.3. Brazil Biosimilar Market: Distribution by Indication
5.9. Korea
5.9.1. Korea Biosimilar Market Overview
5.9.1.1. Korean Biosimilar Market: Distribution by Status of Development
5.9.1.2. Korean Biosimilar Market: Distribution by Product Category
5.9.1.3. Korean Biosimilar Market: Distribution by Indication
5.10. Mexico
5.10.1. Mexico Biosimilar Market Overview
5.10.1.1. Mexican Biosimilar Market: Distribution by Status of Development
5.10.1.2. Mexican Biosimilar Market: Distribution by Product Category
5.10.1.3. Mexican Biosimilar Market: Distribution by Indication
5.11. Argentina
5.11.1. Argentina Biosimilar Market Overview
5.11.1.1. Argentina Biosimilar Market: Distribution by Status of Development
5.11.1.2. Argentina Biosimilar Market: Distribution by Product Category
5.11.1.3. Argentina Biosimilar Market: Distribution by Indication
6. Global Market Overview
6.1. Chapter Overview
6.2. Biosimilars: Database
6.3. Biosimilars: Distribution by Geography
6.4. Biosimilars: Distribution by Status of Development
6.5. Biosimilars: Distribution by Product Category
6.6. Biosimilars: Distribution by Indication
6.7. Leading Biosimilar Targets
6.8. Leading Biosimilar Developers
7. Market Dynamics
7.1. Chapter Overview
7.2. Drivers
7.2.1. Impending Patent Expiry
7.2.2. Shift in Disease Patterns and Increasing demand for biologics
7.2.3. Soaring Healthcare Costs
7.3. Challenges
7.3.1. Efficacy and Safety Concerns
7.3.2. Lack of Automatic Substitution
7.3.3. Cost and Complexity Involved in Manufacturing
7.3.4. Bioanalytical Challenges
7.3.5. Difficulties in Clinical Studies
8. Monoclonal Antibody Biosimilars
8.1. Chapter Overview
8.2. Challenges in mAb Biosimilar Development
8.3. Regulatory Guidelines
8.4. Immunogenicity of Biosimilar mAbs
8.5. Opportunities in Emerging Markets
8.6. Approval of Infliximab: An Important Milestone
8.7. Leading mAb Biosimilar Targets
8.7.1. Rituximab
8.7.1.1. Drug Overview
8.7.1.2. Background and History of Development
8.7.1.3. Indications and Dosage Forms
8.7.1.4. Target Population
8.7.1.5. Sales, 1999 - 2014
8.7.1.6. Patent Status
8.7.1.7. Marketed Biosimilars
8.7.1.8. Pipeline Biosimilars
8.7.1.9. Discontinued Efforts
8.7.1.10. Challenges
8.7.2. Infliximab
8.7.2.1. Drug Overview
8.7.2.2. Background and History of Development
8.7.2.3. Indications and Dosage Forms
8.7.2.4. Sales
8.7.2.5. Patent Status
8.7.2.6. Marketed Biosimilars
8.7.2.7. Pipeline Biosimilars
8.7.3. Trastuzumab
8.7.3.1. Drug Overview
8.7.3.2. Background and History of Development
8.7.3.3. Indications and Dosage Forms
8.7.3.4. Target Population
8.7.3.5. Sales, 1999 - 2014
8.7.3.6. Patent Status
8.7.3.7. Marketed Biosimilars
8.7.3.8. Pipeline Biosimilars
8.7.4. Adalimumab
8.7.4.1. Drug Overview
8.7.4.2. Indications and Dosage Forms
8.7.4.3. Sales, 2003 - 2014
8.7.4.4. Patent Status
8.7.4.5. Marketed Biosimilars
8.7.4.6. Pipeline Biosimilars
8.7.5. Etanercept
8.7.5.1. Drug Overview
8.7.5.2. Background and History of Development
8.7.5.3. Indications and Dosage Forms
8.7.5.4. Sales, 2002 - 2014
8.7.5.5. Patent Status
8.7.5.6. Marketed Biosimilars
8.7.5.7. Pipeline Biosimilars
8.8. Other mAb Biosimilars
9. Insulin Biosimilars
9.1. Chapter Overview
9.2. Insulin: Definition and Classification
9.3. Target Patient Population
9.3.1. Diabetes
9.3.2. Basal Insulin Users
9.4. Insulin Biosimilars: Potential Market
9.4.1. Global Insulin Market
9.5. Mechanism of Action
9.6. High Cost of Insulin Therapy: The Key Driver in Biosimilar Uptake
9.7. Regulatory Guidelines for Insulin Biosimilars
9.7.1. Non Clinical Studies
9.7.1.1. Pharmacodynamic Studies
9.7.1.2. Toxicological Studies
9.7.2. Clinical Studies
9.7.2.1. Pharmacology Studies
9.7.2.2. Clinical Efficacy
9.7.2.3. Clinical Safety
9.8. Insulin Biosimilars: Authorisation Application Withdrawals
9.9. Human Insulin
9.9.1. Actrapid
9.9.1.1. Drug Overview
9.9.1.2. Background and History of Development
9.9.1.3. Indications and Dosage Forms
9.9.2. Insulatard
9.9.2.1. Drug Overview
9.9.2.2. Background and History of Development
9.9.2.3. Indications and Dosage Forms
9.9.3. Marketed Biosimilars
9.9.4. Wosulin
9.9.4.1 History of Development
9.9.5. Insugen
9.9.5.1 History of Development
9.9.5.2 Pipeline Biosimilars
9.10. Insulin Analogues
9.10.1. Insulin Glargine
9.10.1.1. Drug Overview
9.10.1.2. Background and History of Development
9.10.1.3. Indications and Dosage Forms
9.10.1.4. Patent Status
9.10.1.5. Marketed Biosimilars
9.10.1.6. Abasaglar
9.10.1.7. Basalog
9.10.1.8. Glaritus
9.10.1.9. Pipeline Biosimilars
9.10.2. Insulin Lispro
9.10.2.1. Drug Overview
9.10.2.2. Background and History of Development
9.10.2.3. Indications and Dosage Forms
9.10.2.4. Patent Status
9.10.2.5. Insulin Lispro: Biosimilars
9.10.3. Insulin Aspart
9.10.3.1. Drug Overview
9.10.3.2. Background and History of Development
9.10.3.3. Indications and Dosage Forms
9.10.3.4. Insulin Aspart: Biosimilars
10. Biosimilar Interferons
10.1. Chapter Overview
10.2. Biosimilar Interferons: A Challenging Road Ahead
10.3. Regulations
10.3.1. Interferon Alpha
10.3.1.1. Non-Clinical Studies
10.3.1.2. Clinical Studies
10.3.2. Interferon Beta
10.3.2.1. Non Clinical Studies
10.3.2.2. Clinical Studies
10.4. Interferons
10.4.1. Interferon alfa-2a
10.4.1.1. Drug Overview
10.4.1.2. Background and History of Development
10.4.1.3. Indications and Dosage Forms
10.4.1.4. Patent Status
10.4.1.5. Marketed Biosimilars
10.4.2. Interferon alfa-2b
10.4.2.1. Drug Overview
10.4.2.2. Background and History of Development
10.4.2.3. Indications and Dosage Forms
10.4.2.4. Patent Status
10.4.2.5. Marketed Biosimilars
10.4.2.6. Pipeline Biosimilars
10.4.3. Interferon beta-1a
10.4.3.1. Drug Overview
10.4.3.2. Background and History of Development
10.4.3.3. Indications and Dosage Forms
10.4.3.4. Sales
10.4.3.5. Patent Status
10.4.3.6. Marketed Biosimilars
10.4.3.7. Pipeline Biosimilars
10.4.4. Interferon beta-1b
10.4.4.1. Drug Overview
10.4.4.2. Background and History of Development
10.4.4.3. Indications and Dosage Forms
10.4.4.4. Sales
10.4.4.5. Patent Status
10.4.4.6. Marketed Biosimilars
10.4.4.7. Pipeline Biosimilars
10.4.5. Peginterferon beta-1a
10.4.5.1. Drug Overview
10.4.5.2. Background and History of Development
10.4.5.3. Indications and Dosage Forms
10.4.5.4. Sales
10.4.5.5. Patent Status
10.4.5.6. Pipeline Biosimilars
10.4.6. Peginterferon alfa-2a
10.4.6.1. Drug Overview
10.4.6.2. Background and History of Development
10.4.6.3. Indications and Dosage Forms
10.4.6.4. Sales
10.4.6.5. Patent Status
10.4.6.6. Marketed Biosimilars
10.4.6.7. Pipeline Biosimilars
10.4.7. Peginterferon alfa-2b
10.4.7.1. Drug Overview
10.4.7.2. Background and History of Development
10.4.7.3. Indications and Dosage Forms
10.4.7.4. Sales
10.4.7.5. Patent Status
10.4.7.6. Marketed Biosimilars
10.4.7.7. Pipeline Biosimilars
11. Other Leading Biosimilar Markets
11.1. Chapter Overview
11.2. Filgrastim
11.2.1. Drug Overview
11.2.2. Background and History of Development
11.2.3. Indications
11.2.4. Dosage and Administration
11.2.5. Sales
11.2.6. Patent Status
11.2.7. Marketed Biosimilars
11.2.8. Pipeline Biosimilars
11.3. Pegfilgrastim
11.3.1. Drug Overview
11.3.2. Background and History of Development
11.3.3. Indications and Dosage Forms
11.3.4. Sales, 2003-2013
11.3.5. Patent Status
11.3.6. Marketed Biosimilars
11.3.7. Pipeline Biosimilars
11.4. Erythropoietins
11.4.1. Epoetin alfa
11.4.1.1. Drug Overview
11.4.1.2. Background and History of Development
11.4.1.3. Indications and Dosage Forms
11.4.1.4. Sales
11.4.1.5. Patent Status
11.4.1.6. Marketed Biosimilars
11.4.1.7. Pipeline Biosimilars
11.4.2. Other Erythropoietins: Biosimilars
11.4.3. Darbepoetin Alfa
11.4.3.1. Drug Overview
11.4.3.2. Background and History of Development
11.4.3.3. Indications and Dosage Forms
11.4.3.4. Sales
11.4.3.5. Patent Status
11.4.3.6. Marketed Biosimilars
11.4.3.7. Pipeline Biosimilars
11.5. Somatropin
11.5.1. Drug Overview
11.5.2. Indications and Dosage Forms
11.5.3. Marketed Biosimilars
11.5.5. Pipeline Biosimilars
12. Recent Developments
12.1. Partnerships in the Biosimilars Industry
12.1.1. Growing Trend of Partnerships
12.1.2. Celltrion Leads the Partnership Activity
12.2. Investments in Biosimilars
13. Outsourcing of Biosimilars
13.1. Chapter Overview
13.2. Need for Outsourcing Biosimilars
13.3. Impact of Biosimilars on the CMOs
13.4. Biosimilars to Drive Cost Effectiveness
13.5. Presence of CMOs and CROs in the Biosimilars Market
13.6. Technology Trends
14. Market Forecast
14.1. Chapter Overview
14.2. Forecast Methodology
14.3. Global Biosimilars Market, 2020 and 2025
14.4. mAb Biosimilars Market, 2020 and 2025
14.5. Insulin Biosimilars Market Forecast, 2020 and 2025
14.6. Interferon Biosimilars Market Forecast, 2020 and 2025
14.7. G-CSF/ GM-CSF Biosimilars Market Forecast, 2020 and 2025
14.8. Erythropoietin Biosimilars Market Forecast, 2020 and 2025
15. Conclusion
15.1. Biosimilars: A Mammoth Opportunity
15.2. Key Market Drivers and Restraints
15.3. mAb Biosimilars to Rise Substantially
15.4. A Diversified Landscape on the Cusp of Significant Growth
16. Interview Transcripts
17. Appendix 1: Tabulated Data
18. Appendix 2: List of Companies and Organisations
LIST OF FIGURES
Figure 3.1 Numbers of Biologics Approved by the USFDA, 2009-2015
Figure 3.2 Biosimilars: Definition
Figure 3.3 Need for Biosimilars
Figure 3.4 Types of Expression Systems
Figure 3.5 Biosimilar Development: Sequential Steps
Figure 3.6 Innovator Biologic and Biosimilar Development Timeline
Figure 3.7 Clinical Trial Design for Biosimilars
Figure 4.1 Evolution of Biosimilars in the US
Figure 4.2 Biosimilar Development and Approval Pathway
Figure 4.3 The US Biosimilar Market: Distribution by Status of Development
Figure 4.4 The US Biosimilar Market: Distribution by Product Category
Figure 4.5 The US Biosimilar Market: Distribution by Indication
Figure 4.6 Hospira: Revenues, 2010-2014 (USD Billion)
Figure 4.7 Hospira Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
Figure 4.8 Amgen: Revenues, 2010-2014 (USD Billion)
Figure 4.9 Eli Lilly: Revenues, 2010-2014 (USD Billion)
Figure 4.10 Eli Lilly Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
Figure 4.11 Pfizer: Revenues, 2010-2014 (USD Billion)
Figure 4.12 Pfizer Revenues: Distribution by Business Segments, 2014 (USD Billion %)
Figure 4.13 Summary of the European Biosimilar Guidelines
Figure 4.14 EMA Guidelines for Biosimilars
Figure 4.15 Evolution of Biosimilars in Europe
Figure 4.15 The EU Biosimilar Market: Distribution by Status of Development
Figure 4.16 The EU Biosimilar Market: Distribution by Product Category
Figure 4.17 The EU Biosimilar Market: Distribution by Indication
Figure 4.18 Sandoz: Revenues, 2010-2014 (USD Billion)
Figure 4.19 Sandoz Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
Figure 4.20 Sandoz: Revenues Generated by Biosimilars, 2010-2014 (USD Million)
Figure 4.21 Stada: Revenues, 2010 –2014 (EUR Billion)
Figure 4.22 Stada Revenues: Distribution by Business Segments, 2014 (EUR Billion, %)
Figure 4.23 Japan Biosimilar Market: Distribution by Status of Development
Figure 4.24 Japan Biosimilar Market: Distribution by Product Category
Figure 4.25 Japan Biosimilar Market: Distribution by Indication
Figure 4.26 Nippon Kayaku: Revenues, FY 2010/11 – FY 2014/15 (JPY Billion)
Figure 4.27 Gene Techno Science: Revenues, FY 2010/11 – FY 2014/15 (JPY Million)
Figure 4.28 JCR Pharmaceuticals: Revenues, 2009-2014 (JPY Billion)
Figure 4.29 JCR Pharmaceuticals Revenues: Distribution by Business Segments, FY 2013/14 (JPY Billion)
Figure 5.1 China Biosimilar Market: Distribution by Status of Development
Figure 5.2 China Biosimilar Market: Distribution by Product Category
Figure 5.3 China Biosimilar Market: Distribution by Indication
Figure 5.4 Fosun Pharma Revenues: Distribution by Business Segments, 2014 (RMB Billion)
Figure 5.5 Indian Biosimilar Market: Distribution by Status of Development
Figure 5.6 Indian Biosimilar Market: Distribution by Product Category
Figure 5.7 Indian Biosimilar Market: Distribution by Indication
Figure 5.8 Dr. Reddy’s Laboratories Revenues: Distribution by Business Divisions, FY 2013/14 (INR Billion)
Figure 5.9 Wockhardt: Revenues, FY2010/11- FY2014/15 (INR Billion)
Figure 5.10 Biocon Revenues: Distribution by Business Segments, FY 2014/15 (INR Billion)
Figure 5.11 Brazil Biosimilar Market: Distribution by Status of Development
Figure 5.12 Brazil Biosimilar Market: Distribution by Product Category
Figure 5.13 Brazil Biosimilar Market: Distribution by Indication
Figure 5.14 Korean Biosimilar Market: Distribution by Status of Development
Figure 5.15 Korean Biosimilar Market: Distribution by Product Category
Figure 5.16 Korean Biosimilar Market: Distribution by Indication
Figure 5.17 Mexican Biosimilar Market: Distribution by Status of Development
Figure 5.18 Mexican Biosimilar Market: Distribution by Product Category
Figure 5.19 Mexican Biosimilar Market: Distribution by Indication
Figure 5.20 Argentina Biosimilar Market: Distribution by Status of Development
Figure 5.21 Argentina Biosimilar Market: Distribution by Product Category
Figure 5.22 Argentina Biosimilar Market: Distribution by Indication
Figure 6.1 Global Biosimilars Market: Distribution By Geography
Figure 6.2 Global Biosimilars Market: Distribution by Status of Development
Figure 6.3 Global Biosimilars Market: Distribution by Product Category
Figure 6.4 Global Biosimilars Market: Distribution by Indication
Figure 6.5 Leading Biosimilar Targets
Figure 6.6 Leading Biosimilar Developers
Figure 7.1 Top Selling Biologics: Estimated Patent Expiry
Figure 8.1 Rituxan/MabThera: Target Population for Follicular NHL
Figure 8.2 Rituxan/MabThera: Target Population for Diffuse Large B-cell NHL
Figure 8.3 Rituxan/MabThera: Target Population for CLL
Figure 8.4 Rituximab Sales, 1999 - 2014 (CHF Billion)
Figure 8.5 Rituximab: Regional Sales, 2012-2014 (USD Billion)
Figure 8.6 Infliximab: Sales, 2006-2014 (USD Billion)
Figure 8.7 Inflectra: Overview of Clinical Studies
Figure 8.8 HER2 Expression in Breast Cancer Patients (%)
Figure 8.9 Herceptin Sales, 1999 - 2014 (CHF Billion)
Figure 8.10 Herzuma: Clinical Trials Overview
Figure 8.11 Humira Global Sales, 2003-2014 (USD Billion)
Figure 8.12 Enbrel US Sales, 2002-2014 (USD Million)
Figure 9.1 Classification of Human Insulin and Analogs
Figure 9.2 Diabetes: Worldwide Prevalence and Diagnosis (Million)
Figure 9.3 Diabetes: Prevalence and Diagnosed Cases by Region/Countries (2014), Million
Figure 9.4 Worldwide, 2013: Distribution by Type (USD Billion, %)
Figure 9.5 US Insulin Market: Distribution by Type (%)
Figure 9.6 Western Europe Insulin Market: Distribution by Type (%)
Figure 9.7 Wosulin: Clinical Trials Overview
Figure 10.1 Avonex and Rebif: Sales, 2007-2014 (USD Billion)
Figure 10.2 Betaferon/Betaseron and Extavia: Sales, 2007-2014 (USD Billion)
Figure 10.3 Pegasys: Sales, 2005-2014 (CHF Billion)
Figure 10.4 PegIntron: Sales, 2009-2014 (USD Billion)
Figure 11.1 Neupogen: Sales, 1997-2014 (USD Billion)
Figure 11.2 Neulasta Sales, 2003 - 2014 (USD Billion)
Figure 11.3 Epogen and Procrit/ Eprex: Sales, 2005-2014 (USD Billion)
Figure 11.4 Aranesp: Sales, 2004-2014 (USD Billion)
Figure 12.1 Biosimilars: Cumulative Partnerships by Year, Pre 2010 - 2015
Figure 12.2 Biosimilars: Leading Players by Partnerships
Figure 14.1 Global Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Figure 14.2 Global Biosimilars Market Forecast: Distribution by Product Category, 2020 and 2025 (USD Billion)
Figure 14.3 Global mAb Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Figure 14.4 Global Insulin Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Figure 14.5 Global Interferon Biosimilars Market: Distribution by Region, 2020 and 2025 (USD Billion)
Figure 14.6 Global G-CSF/GM-CSF Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Figure 14.7 Global Erythropoietin Biosimilars Market: Distribution by Region, 2020 and 2025 (USD Billion)
Figure 15.1 Biosimilars: Key Market Drivers and Restraints 
LIST OF TABLES
Table 3.1 Marketed Biologics, 2014 and 2015
Table 3.2 Difference Between Generic, Biosimilar and Reference Biologic Products
Table 3.3 Assays for Product Characterisation
Table 4.1 FDA Draft Guidelines on Biosimilars
Table 4.2 Biologics Price Competition and Innovation Act (BPCIA) Requirements
Table 4.3 Hospira: Late-Stage Development Pipeline
Table 4.4 Inflectra/Remsima: Clinical Trials in the US
Table 4.5 Retacrit: Clinical Trials in the US
Table 4.6 Credima/Herzuma: Clinical Trials in the EU and RoW
Table 4.7 Amgen: Late-Stage Development Pipeline
Table 4.8 ABP 501: Clinical Trials in the US, EU and RoW
Table 4.9 ABP 980: Clinical Trials in the EU and RoW
Table 4.10 ABP 215: Clinical Trials in the US, EU and RoW
Table 4.11 ABP 798: Clinical Trials in the US, EU and RoW
Table 4.12 Amgen: Early-Stage Development Pipeline
Table 4.13 Pfizer: Late-Stage Development Pipeline
Table 4.14 PF-05280014: Clinical Trials in the US, EU, Japan and RoW
Table 4.15 PF-05280586: Clinical Trials in the US, EU, Japan and RoW
Table 4.16 PF-06438179: Clinical Trials in the US, EU and RoW
Table 4.17 PF-06439535: Clinical Trials in the US, EU and RoW
Table 4.18 Guidelines issued by EMA and International Partners
Table 4.19 Sandoz: Late-Stage Development Pipeline
Table 4.20 GP 2017: Clinical Trials in the US and EU
Table 4.21 GP 2015: Clinical Trials in the EU and RoW
Table 4.22 LA-EP 2006: Clinical Trials in the US, EU and RoW
Table 4.23 GP 2013: Clinical Trials in the US, EU, Japan and RoW
Table 4.24 HX 575 (SC): Clinical Trials in the US and EU
Table 4.25 BioXpress Therapeutics: Biosimilars Pipeline
Table 4.26 Gene Techno Science: Biosimilars Pipeline
Table 4.27 JR-013: Available Forms and their Prices
Table 4.28 Countries with Regulatory Guidelines for Biosimilars
Table 5.1 Difference between Chinese Final Regulatory Guidelines on Biosimilars and its Previous Draft
Table 5.2 Fosun Pharma: Late-Stage Development Pipeline
Table 5.3 Fosun Pharma: Early-Stage Development Pipeline
Table 5.4 Dr. Reddy’s Laboratories: Marketed Biosimilars
Table 5.5 Inbiopro: Marketed Biosimilars
Table 5.6 Inbiopro: Pipeline Biosimilars
Table 5.7 Wockhardt: Marketed Biosimilars
Table 5.8 Biocon: Marketed Biosimilars
Table 5.9 Biocon: Late-Stage Development Pipeline
Table 5.10 Biocon: Early-Stage Development Pipeline
Table 5.11 Zydus Cadila: Marketed Biosimilars
Table 5.12 Zydus Cadila: Biosimilar Pipeline
Table 5.13 Reliance Life Sciences: Marketed Biosimilars
Table 6.1 Global List of Marketed and Pipeline Biosimilars
Table 7.1 Best Selling Biologics: Revenues
Table 8.1 Rituximab: Marketed Biosimilars
Table 8.2 Rituximab: Pipeline Biosimilars
Table 8.3 Infliximab: Dosage Regimen
Table 8.4 Infliximab: Marketed Biosimilars
Table 8.5 Inflectra: Product Specifications
Table 8.6 Infliximab: Pipeline Biosimilars
Table 8.7 Trastuzumab: Marketed Biosimilars
Table 8.8 Biosimilars Pipeline: Trastuzumab
Table 8.9 Adalimumab: Pipeline Biosimilars
Table 8.10 Etanercept: Marketed Biosimilars
Table 8.11 Etanercept: Pipeline Biosimilars
Table 8.12 Other mAb Biosimilars
Table 9.1 Biosimilar Insulins: Withdrawn Applications
Table 9.2 Human Insulin: Marketed Biosimilars
Table 9.3 Human Insulin: Pipeline Biosimilars
Table 9.4 Insulin Glargine: Marketed Biosimilars
Table 9.5 Insulin Glargine: Pipeline Biosimilars
Table 9.6 Insulin Lispro: Biosimilars
Table 9.7 Insulin Aspart: Biosimilars
Table 10.1 Types of Interferons
Table 10.2 Interferon alfa-2a: Marketed Biosimilars
Table 10.3 Intron A: Dosage Forms for Various Indications
Table 10.4 Interferon alfa-2b: Marketed Biosimilars
Table 10.5 Interferon alfa-2b: Pipeline Biosimilars
Table 10.6 Interferon beta-1a: Marketed Biosimilars
Table 10.7 Interferon beta-1a: Pipeline Biosimilars
Table 10.8 Interferon beta-1b: Marketed Biosimilars
Table 10.9 Interferon beta-1b: Pipeline Biosimilars
Table 10.10 Peginterferon alfa-2a: Marketed Biosimilars
Table 10.11 Peginterferon alfa-2a: Pipeline Biosimilars
Table 10.12 Peginterferon alfa-2b: Marketed Biosimilars
Table 10.13 Peginterferon alfa-2b: Pipeline Biosimilars
Table 11.1 Neupogen: Recommended Dosage
Table 11.2 Filgrastim: Marketed Biosimilars
Table 11.3 Filgrastim: Pipeline Biosimilars
Table 11.4 Pegfilgrastim: Marketed Biosimilars
Table 11.5 Pegfilgrastim: Pipeline Biosimilars
Table 11.6 Epoetin Alfa: Marketed Biosimilars
Table 11.7 Epoetin Alfa: Pipeline Biosimilars
Table 11.8 Other Erythropoietins: Biosimilars
Table 11.9 Darbepoetin Alfa: Marketed Biosimilars
Table 11.10 Darbepoetin Alfa: Pipeline Biosimilars
Table 11.11 Somatropin: Marketed Biosimilars
Table 11.12 Somatropin: Pipeline Biosimilars
Table 12.1 Instances of Partnerships in the Biosimilars Industry
Table 13.1 Contract Service Providers in Biosimilars
Table 17.1 Numbers of Biologics Approved by the USFDA, 2009-2015
Table 17.2 The US Biosimilar Market: Distribution by Status of Development
Table 17.3 The US Biosimilar Market: Distribution by Product Category
Table 17.4 The US Biosimilar Market: Distribution by Indication
Table 17.5 Hospira: Revenues, 2010-2014 (USD Billion)
Table 17.6 Hospira Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
Table 17.7 Amgen: Revenues, 2010 –2014 (USD Billion)
Table 17.8 Eli Lilly: Revenues, 2010-2014 (USD Billion)
Table 17.9 Eli Lilly Revenues: Distribution by Business Segments(USD Billion)
Table 17.10 Pfizer: Revenues, 2010-2014 (USD Billion)
Table 17.11 Pfizer Revenues: Distribution by Business Segments, 2014 (USD Billion)
Table 17.12 The EU Biosimilar Market: Distribution by Status of Development
Table 17.13 The EU Biosimilar Market: Distribution by Product Category
Table 17.14 The EU Biosimilar Market: Distribution by Indication
Table 17.15 Sandoz: Revenues, 2010-2014 (USD Billion)
Table 17.16 Sandoz: Revenues by Business Segments, 2014 (USD Billion, %)
Table 17.17 Sandoz: Revenues Generated by Biosimilars, 2010-2014 (USD Million)
Table 17.18 Stada: Revenues, 2010 –2014 (EUR Billion)
Table 17.19 Stada Revenues: Distribution by Business Segments, 2014 (EUR Billion)
Table 17.20 Japan Biosimilar Market: Distribution by Status of Development
Table 17.21 Japan Biosimilar Market: Distribution by Product Category
Table 17.22 Japan Biosimilar Market: Distribution by Indication
Table 17.23 Nippon Kayaku: Revenues, FY 2010/11 – FY 2014/15 (JPY Billion)
Table 17.24 Gene Techno Science: Revenues, FY 2010/11 – FY 2014/15 (JPY Million)
Table 17.25 JCR Pharmaceuticals: Revenues, 2009- 2014 (JPY Billion)
Table 17.26 JCR Pharmaceuticals Revenues: Distribution by Business Segments, FY 2013/14 (JPY Billion)
Table 17.27 Chinese Biosimilar Market: Distribution by Status of Development
Table 17.28 Chinese Biosimilar Market: Distribution by Product Category
Table 17.29 Chinese Biosimilar Market: Distribution by Indication
Table 17.30 Fosun Pharma Revenues: Distribution by Business Segments, 2014 (RMB Billion)
Table 17.31 Indian Biosimilar Market: Distribution by Status of Development
Table 17.32 Indian Biosimilar Market: Distribution by Product Category
Table 17.33 Indian Biosimilar Market: Distribution by Indication
Table 17.34 Dr. Reddy’s Laboratories Revenues: Distribution by Business Segments, FY 2013/14 (INR Billion)
Table 17.35 Wockhardt: Revenues, FY2010/11- FY2014/15 (INR Billion)
Table 17.36 Biocon Revenues: Distribution by Business Segments, FY2014/15 (INR Billion)
Table 17.37 Brazil Biosimilar Market: Distribution by Status of Development
Table 17.38 Brazil Biosimilar Market: Distribution by Product Category
Table 17.39 Brazil Biosimilar Market: Distribution by Indication
Table 17.40 Korean Biosimilar Market: Distribution by Status of Development
Table 17.41 Korean Biosimilar Market: Distribution by Product Category
Table 17.42 Korean Biosimilar Market: Distribution by Indication
Table 17.43 Mexican Biosimilar Market: Distribution by Status of Development
Table 17.44 Mexican Biosimilar Market: Distribution by Product Category
Table 17.45 Mexican Biosimilar Market: Distribution by Indication
Table 17.46 Argentina Biosimilar Market: Distribution by Status of Development
Table 17.47 Argentina Biosimilar Market: Distribution by Product Category
Table 17.48 Argentina Biosimilar Market: Distribution by Indication
Table 17.49 Global Biosimilars Market: Distribution By Geography
Table 17.50 Global Biosimilars Market: Biosimilars: Distribution by Status of Development
Table 17.51 Global Biosimilars Market: Distribution by Product category
Table 17.52 Global Biosimilars Market: Distribution by Indication
Table 17.53 Leading Biosimilar Targets
Table 17.54 Leading Biosimilar Developers
Table 17.55 Rituxan/MabThera: Target Population for Follicular NHL
Table 17.56 Rituxan/MabThera: Target Population for Diffuse Large B-cell NHL
Table 17.57 Rituxan/MabThera: Target Population for CLL
Table 17.58 Rituximab Sales, 1999 - 2014 (CHF Billion)
Table 17.59 Rituximab: Regional Sales, 2012-2014 (USD Billion)
Table 17.60 Infliximab: Sales, 2006-2014(USD Billion)
Table 17.61 HER2 Expression in Breast Cancer Patients (%)
Table 17.62 Herceptin Sales, 1999 - 2014 (CHF Billion)
Table 17.63 Humira Global Sales, 2003-2014 (USD Billion)
Table 17.64 Enbrel US Sales, 2002-2014 (USD Million)
Table 17.65 Diabetes: Worldwide Prevalence and Diagnosis
Table 17.66 Diabetes: Prevalence by Region/Countries (2014), Million
Table 17.67 Diabetes: Diagnosed Cases by Region/Countries (2014), Million
Table 17.68 Worldwide Insulin Market, 2013: Distribution by Type (USD Billion, %)
Table 17.69 US Insulin Market: Distribution by Type (%)
Table 17.70 Western Europe Insulin Market: Distribution by Type (%)
Table 17.71 Avonex and Rebif: Sales, 2007-2014 (USD Billion)
Table 17.72 Betaferon/ Betaseron and Extavia: Sales, 2007-2014 (USD Billion)
Table 17.73 PegIntron: Sales, 2009-2014 (USD Billion)
Table 17.74 Pegasys: Sales, 2005-2014 (CHF Billion)
Table 17.75 PegIntron: Sales, 2009-2014 (USD Billion)
Table 17.76 Neupogen: Sales, 1997-2014
Table 17.77 Neulasta Sales, 2003 - 2013 (USD Billion)
Table 17.78 Epogen and Procrit/ Eprex: Sales, 2005-2014 (USD Billion)
Table 17.79 Aranesp: Sales, 2004-2014 (USD billion)
Table 17.80 Biosimilars: Cumulative Partnerships by Year, Pre 2010 – 2015
Table 17.81 Biosimilars: Leading Players by Partnerships
Table 17.82 Global Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Table 17.83 Global Biosimilars Market Forecast: Distribution by Product Category, 2020 and 2025 (USD Billion)
Table 17.84 Global mAb Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Table 17.85 Global Insulin Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Table 17.86 Global Interferon Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Table 17.87 Global G-CSF/ GM-CSF Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
Table 17.88 Global Erythropoietin Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)

Global Biosimilars Market 2015 - 2025

INTRODUCTION

Characterised by increased utility in chronic diseases and capital intensive manufacturing, the global biopharmaceutical market is expanding robustly. As the demand for biologics is increasing continuously, manufacturers are on the lookout for novel strategies that will help them attain maximum returns on investment. Derived from biological elements, biologic medications have transformed the treatment paradigm of life threatening, debilitating diseases. However, such drugs come at staggering prices in the market. Hence, cheaper biological products have become an economic and healthcare requisite.

Amongst the impending patent cliffs, shrinking drug pipelines and increasing pressure to reduce treatment costs, biosimilars are poised to capture an unprecedented position in the biopharmaceutical industry. Supported by numerous factors including the recent progression in the regulatory landscape, the biosimilars market is witnessing an increased extent of adoption and heightened investment and deal making activity.

Biosimilars have currently attained a small portion of their anticipated future potential. The real commercial prospects lie in the two leading innovator biologics markets, the US and Europe, which account for a major proportion of the global spending on biologics. Europe, with the introduction of regulatory guidance in 2005 and the first biosimilar authorisation in 2006, is well ahead of the US. Till date, there are 16 marketed biosimilar products in Europe. However, in the recent years, the US has witnessed tremendous progression in terms of the advances in the regulatory landscape.

The involvement of generic manufacturers and R&D based pharmaceutical and biotechnology companies has led to the emergence of a diversified competitive marketplace. Realizing the huge commercial prospects, several innovator biotech companies are actively engaged in the development of biosimilars. In addition, this segment has become lucrative for other companies such as Fujifilm and Samsung. The contribution by such players does ensure a fresh inflow of money to fund development programs.

Overall, with the learning curve for biosimilars still evolving, the market offers huge growth opportunities along with demanding requirements in terms of clinical development, manufacturing and marketing authorisation. Driven by an extensive pipeline, contribution of numerous pharmaceutical players and the huge market opportunity likely to unfold in the US and EU, the biosimilars industry is poised to witness an unrivalled market uptake.

SCOPE OF THE REPORT

The ‘Global Biosimilars Market, 2015 - 2025’ report provides an extensive study of the rapidly growing biosimilars market. With the blockbuster biologics losing patent protection and biotechnology industry striving to minimize costs, biosimilars are being viewed as viable substitutes to the highly expensive biological medications. The study presents an in-depth review of the developments in established markets and emerging regions, with respect to the market landscape, global and local players, regulatory scenario and emerging opportunities. It provides a detailed analysis of the worldwide pipeline of biosimilars on key parameters such as product categories, indications, biosimilar targets and status of development.

The study presents a comprehensive view of key product classes into which biosimilars can be categorized; these include monoclonal antibodies (mAbs), insulin, interferons, G-CSF/ GM-CSF, erythropoietins and others. We have highlighted some of the important aspects specific to these product categories including regulatory guidelines, development challenges, marketed / pipeline biosimilars, sales data (where available) and information on patent expiry of the reference products.

The report assesses some of the key drivers that have governed the evolution of biosimilars market over the past several years along with an elaborate discussion on the future trends that will shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity in the biosimilars market over the next decade, segmented on the basis of geographical clusters and product categories.

The study also provides information on some of the most recent activities in this market; amongst others, these include growing collaborations, investment activity and technological advancements. In addition to some of the well-known benefits and a promising outlook, the study also highlights considerable challenges currently prevalent in the market. Examples of such challenges include manufacturing complexities, heterogeneous regulatory framework, and associated safety and efficacy issues. Nevertheless, these challenges are paving the way for new strategies and technological improvements, which will indeed be advantageous in the long run.

The report provides market forecasts for the time period 2020 and 2025. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.

EXAMPLE HIGHLIGHTS

1. The market is driven by the presence of a growing pipeline; during our research, we identified over 600 biosimilar products across various product categories covering mAbs, insulin, interferons amongst others.
2. Specifically, mAb biosimilars being developed for multiple diseases form a sizeable proportion of the preclinical/clinical development pipeline. In our pipeline, we reviewed around 200 mAb biosimilars. Neupogen, Enbrel and Humira, owing to their staggering revenues, are examples of some of the most popular target reference products.
3. The emerging pharmaceutical markets of Asia, Latin America and Eastern Europe, with benefits such as lower labour costs, access to regional / domestic markets and, most importantly, relaxed regulatory requirements serve as attractive destinations for biosimilars research and commercialisation. This geographical cluster currently dominates the market with respect to the number of approved products.
4. In order to exploit the advantages of combined resources and use licensed assets, stakeholders have announced numerous collaborations in the recent past. During our research, we identified around 70 partnerships which have taken place in the biosimilar market over the last few years.
5. Looking at the ongoing focus, the market is well positioned to achieve a robust growth in the coming decade as the number of patent expiries grows and the legal and regulatory squabbles are sorted out; based on a very comprehensive analysis, we have projected the market to be worth USD 32 billion worldwide by 2025.
6. Although emerging markets have been on a fast track in the recent past, the desired market uptake in the US and Europe will drive the market to attain its peak potential.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming nine years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.


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