バイオシミラーのグローバル市場動向...市場調査レポートについてご紹介

1. Executive Summary

2. What are Biosimilars?

3. Emergence of Biosimilars
3.1 Role of the Biologics Price Competition and Innovation (BPCI) ACT
3.2 Issue of Data Exclusivity

4. Industry Definition
4.1 Defining Biosimilars
4.2 Specificity of Biosimilars
4.3 Categories of Biologics
4.4 Importance of Biosimilars
4.5 Comparing Biosimilars with Generics
4.6 Branded Product Business Model

5. Overview of the Biopharmaceutical Industry
5.1 Market Profile
5.2 Biopharmaceutical Manufacturing Process

6. Global Biosimilars Market Statistics
6.1 Market Profile
6.2 Market Size
6.3 Market Value of Branded Biologics Facing Patent Expiry
6.4 Operating Margin for Biosimilar Manufacturers
6.5 Investor Concerns regarding Biosimilars
6.6 Commercial Impact of the European Biosimilars Industry

7. Key Success Factors for Biosimilars
7.1 Long Term Strategy
7.2 Developing Competitive Intelligence
7.3 Proper Financial Structure
7.4 Developing Key Biomanufacturing Competencies
7.5 Developing Clinical Capabilities and Regulatory Expertise
7.6 Well Developed Sales and Distribution Channels

8. Factors Impacting the Global Biosimilars Industry
8.1 Growth of the Industry in Developed Countries
8.2 Growth of the Industry in BRIC Countries
8.3 High Cost of Biologics
8.4 Use of Branded Biologics to Increase
8.5 Introduction of Approval Pathways in the US and Japan
8.6 EU’s Draft on Biosimilar Monoclonal Antibody Guidance
8.7 Unfavorable Tendering Procedures
8.8 Problem of Reference Pricing
8.9 Strategy of Biosimilar Companies with Regards to Hospital and Retail Setting
8.10 Issue of Biosimilar Comparability
8.11 Lack of Incentives, Service Agreements and Marketing Costs
8.12 Availability of Second Generation Branded Biologics
8.13 No Automatic Substitution of Branded Biologics
8.14 Cost-containment to Boost Uptake of Biosimilars
8.15 Lack of Proper IP Protection in Emerging Countries
8.16 Ease of Market Entry in BRIC Countries
8.17 Strong Biologic Capabilities in BRIC Countries
8.18 Restricted Market Access for Domestic Players in Emerging Countries
8.19 Problem of Low Purchasing Power in Emerging Markets

9. Biosimilar Market Drivers & Challenges
9.1 Factors Driving Growth of Biosimilars
9.1.1 Need to Lower Healthcare Costs
9.1.2 Lower Development Costs of Biosimilars as compared to New Biologic Drug
9.1.3 Lower Cost of Treatment with Biosimilars
9.1.4 Upcoming Patent Expiries for Blockbuster Biologics
9.1.5 Large Sales of Biologic Drugs
9.1.6 Greater Profitability of Biosimilars as compared to Generic Drugs
9.2 Factors Restraining the Growth of Biosimilars
9.2.1 Lack of Automatic Substitution
9.2.2 High Cost of Development and Manufacturing as compared to Generics
9.2.3 High Entry Barriers to the Biosimilar Industry
9.2.4 Emergence of Second Generation Biologic Drugs
9.2.5 Patent Protection for Biologic Drugs

10. Regulatory Framework
10.1 Regulatory Framework in Europe
10.1.1 EMEA’s Current Position
10.1.2 Bolar Type Provision
10.1.3 Comparability Exercises
10.1.4 Approval Process for Biosimilars
10.2 Regulatory Framework in Japan
10.2.1 Current Position on Biosimilars
10.3 Regulatory Framework in the USA
10.3.1 BPCIA and the Approval Pathway for Biosimilars
10.3.1.1 Role of Biosimilarity and Interchangeability
10.3.1.2 FDA Regulations Biosimilars Approval and Regulation
10.3.1.3 Demonstration on Basis of Data
10.3.1.4 12 Years of Market and Data Exclusivity
10.3.1.5 Resolution to Patent Dispute
10.3.1.6 Notice of Commercial Marketing to Reference Product Sponsor
10.3.1.7 Substitution of Small Molecular Products
10.4 Differences between FDA & the EMEA
10.5 Issues with Momenta

11. Factors Determining Market Entry in the Global Biosimilar Industry
11.1 Long Drawn-out Biosimilar Clinical Development Timeline
11.2 Approval Pathways for Biosimilars
11.3 High Development Costs of Biosimilars
11.3.1 Costs in Developed Markets
11.4 Biosimilars Manufacturing in Developing Countries – Pros & Cons
11.4.1 Issues with Regulatory Approval
11.4.2 Clinical Trials
11.4.3 Cost of Research & Development
11.4.4 Manufacturing Barriers
11.5 Proving of ‘Biosimilarity’
11.6 Issues with EMA Draft Guidelines for Biosimilar MAb Approval
11.7 Challenges with Patents
11.8 Role of Market Exclusivity for Branded Biologics
11.9 Strategic Partnerships Driving the Industry
11.9.1 Role of M&A Deals
11.9.1.1 Merck & Co.
11.9.1.2 Pfizer
11.10 Lack of Proper Safety Regulations

12. Biosimilar Approval Pathways in the US and Europe

13. Competitive Landscape
13.1 Key Industry Players
13.2 Key Industry Suppliers
13.3 Generic Drug Producers
13.4 Key Investors in the Industry
13.5 Major Stakeholders in the Industry
13.6 Developed versus Emerging Markets
13.7 Biosimilar Launches
13.8 Analysis by Markets
13.8.1 Biosimilars in Australia
13.8.2 Biosimilars in BRIC Countries
13.8.3 Biosimilars in the European Union (France, Germany, Italy, Spain, the UK)
13.8.4 Biosimilars in Japan
13.8.5 Biosimilars in United States

14. Analysis of Major Biosimilars
14.1 Epoetin
14.2 Filgrastim
14.3 Somatropin

15. Upcoming Patent Expiries and Opportunities for Biosimilars

16. Strategies of Big Pharma to Combat Biosimilars

17. Country-wise Biosimilar Market Analysis
17.1 France
17.1.1 Overview of the Healthcare System
17.1.2 Pricing and Reimbursement
17.1.3 Drivers & Challenges for Biosimilars in France
17.2 Germany
17.2.1 Overview of the Healthcare System
17.2.2 Pricing and Reimbursement
17.2.3 Drivers & Challenges for Biosimilars in Germany
17.3 India
17.4 Italy
17.4.1 Overview of the Healthcare System
17.4.2 Pricing and Reimbursement
17.4.3 Drivers & Challenges for Biosimilars in Italy
17.5 Japan
17.6 Spain
17.6.1 Overview of the Healthcare System
17.6.2 Pricing and Reimbursement
17.6.3 Drivers & Challenges for Biosimilars in Spain
17.7 United Kingdom
17.7.1 Overview of the Healthcare System
17.7.2 Pricing and Reimbursement
17.7.3 Drivers & Challenges for Biosimilars in the UK
17.8 United States

18. Major Industry Players
18.1 Dr. Reddy’s Laboratories Limited
18.1.1 Company Overview
18.1.2 Business Segments
18.1.3 Presence in Biosimilars Market
18.1.4 SWOT Analysis
18.2 Hospira Inc
18.2.1 Company Overview
18.2.2 Business Segments
18.2.3 Presence in Biosimilars Market
18.2.4 SWOT Analysis (Brief Analysis)
18.3 Sandoz International
18.3.1 Company Overview
18.3.2 Business Segments
18.3.3 Presence in Biosimilars Market
18.3.4 SWOT Analysis
18.4 STADA Arzneimittel AG
18.4.1 Company Overview
18.4.2 Business Segments
18.4.3 Presence in Biosimilars Market
18.4.4 SWOT Analysis
18.5 Teva Pharmaceutical Industries
18.5.1 Company Overview
18.5.2 Business Segments
18.5.3 Presence in Biosimilars Market
18.5.4 SWOT Analysis
18.6 Watson Pharmaceuticals
18.6.1 Company Overview
18.6.2 Business Segments
18.6.3 Presence in Biosimilars Market
18.6.4 SWOT Analysis
18.7 3SBio Inc.
18.8 Biocon Limited
18.9 Biopartners Gmbh
18.10 Celltrion Inc
18.11 Intas Biopharmaceuticals
18.12 Kyowa Hakko Kirin Co., Ltd.
18.13 Reliance Life Sciences
18.14 Shanghai Fosun Pharmaceutical (Group) Co., Ltd
18.15 Wockhardt

19. Global Biosimilars Market Outlook
19.1 Market Outlook
19.2 Forecast for Biosimilar Sales
19.3 Forecast for US Biosimilars Market
19.4 Forecast for European Biosimilars Market
19.5 Forecast for Japanese Biosimilars Market
19.6 Forecast for Biosimilars
19.6.1 Biosimilars for Monoclonal Antibodies against Cancer
19.6.2 Erythropoietin (EPO) Biosimilars Markets
19.6.3 Human Growth Hormone (hGH) Biosimilars Markets
19.6.4 Granulocyte – Colony Stimulating Factor (G-CSF) Biosimilars Markets
19.6.5 Insulin and Insulin Analogs Biosimilars
19.6.6 Interferon alfa Biosimilars
19.6.7 Interferon beta Biosimilars
19.6.8 TNF alfa Inhibitor Biosimilars

20. Appendix

21. Glossary