【レポートの概要（一部）】
1. Report Overview
1.1 Overview of the World Market for Biosimilar Monoclonal Antibodies
1.2 Why You Should Read This Report
1.3 How This Study Delivers
1.4 Main Questions Answered by the Analysis
1.5 Who Is This Investigation For?
1.6 Methods of Research and Analysis
1.7 Frequently Asked Questions (FAQs)
1.8 Some Associated Reports
1.9 About Visiongain
2. Introduction to Biosimilar Monoclonal Antibodies
2.1 Natural Antibodies: Key to the Immune System
2.2 From Serum Therapy to Monoclonal Antibodies (MAbs)
2.3 Humanising the MAb
2.4 Biologics (Biological Drugs) and Biosimilars
2.5 Why are Biosimilars in High Demand?
2.6 Considerations for the Development of Biosimilars
2.6.1 Biologics and Biosimilars Are Large, Complex Molecules
2.6.2 How Much a Concern is Immunogenicity?
2.7 Biosimilar Monoclonal Antibodies on the Market
3. World Market Prospects for Biosimilar Monoclonal Antibodies, 2015-2025
3.1 The World Market for Biosimilar Monoclonal Antibodies, 2013- 2014: Three Biosimilar MAbs on Sale
3.2 The World Market for Biosimilar MAbs: An Overarching Revenue Forecast, 2014-2025
3.3 The World Market for Biosimilar MAbs by Compound: Revenue and Market Share Predictions, 2019 and 2025
3.4 The World Market for Biosimilar MAbs by Compound: Revenue Forecasts, 2014-2025
3.4.1 Will Biosimilar Versions of Monoclonal Antibodies Capture a Large Proportion of the Market?
3.4.2 Biosimilar Infliximab: High Growth Expected
3.4.2.1 Biosimilar Infliximab: Revenue Forecast, 2015-2025
3.4.3 Biosimilar Rituximab: With Many Compounds Under Development, Will Sales Growth be Driven or Restrained?
3.4.3.1 Biosimilar Rituximab: Revenue Forecast, 2015-2025
3.4.4 Biosimilar Abciximab: Low Market Incentive Means Few Compounds in Development
3.4.4.1 Biosimilar Abciximab: Revenue Forecast, 2015-2025
3.4.5 Biosimilar Trastuzumab: The 4th Biosimilar MAb to Enter the Market
3.4.5.1 Biosimilar Trastuzumab: Revenue Forecast, 2015-2025
3.4.6 Biosimilar Adalimumab: Great Incentive to Develop Biosimilar Versions of the Leading Drug of 2013 & 2014
3.4.6.1 Biosimilar Adalimumab: Revenue Forecast, 2015-2025
3.4.7 Biosimilar Bevacizumab: Will Late Entry to the Market Restrict Revenue Generation?
3.4.7.1 Biosimilar Bevacizumab: Revenue Forecast, 2015-2025
3.5 Large Market Potential to Drive Growth to 2025
3.6 What Will Restrain Expansion of the Biosimilar MAbs Market Between 2013 and 2025?
4. Promising Biosimilar MAb Products and Their Predicted Future Successes, 2015-2025
4.1 Biosimilar Versions on the Market: Remsima Dominated in 2013
4.1.1 Celltrion’s Remsima / Hospira’s Inflectra / Egis’ Flammegis (infliximab): The First Official Biosimilar Monoclonal Antibody
4.1.2 Dr. Reddy’s Reditux (rituximab): Are US and EU Approval Expected?
4.1.3 Isu Abxis’ Clotinab (abciximab): The First Biosimilar Monoclonal Antibody?
4.1.4 Instas Pharmaceuticals’ Mabtas (Rituximab)
4.1.5 Reliance Life Sciences’ AbcixiRel (abciximab)
4.1.6 Probiomed’s Kikuzubam (rituximab): Registration Revoked, Reports Suggest
4.2 Biosimilar Versions on the Market and Promising Compounds in the R&D Pipeline: Revenue Forecasts, 2015-2025
4.2.1 Celltrion’s Remsima / Hospira’s Inflectra / Egis’ Flammegis (infliximab): Revenue Forecast, 2015-2025
4.2.2 Epirus Biopharmaceuticals’ Infimab (infliximab): Revenue Forecast, 2014-2025
4.2.3 Dr. Reddy’s Reditux (rituximab): Revenue Forecast, 2015-2025
4.2.4 Intas Pharmaceuticals’ Mabtas (rituximab): Revenue Forecast, 2015-2025
4.2.5 BIOCAD’s AcellBia (rituximab): Revenue Forecast, 2015-2025
4.2.6 Boehringer Ingelheim’s BI695500 (rituximab): Revenue Forecast, 2015-2025
4.2.7 Celltrion’s CT-P10 (rituximab): Revenue Forecast, 2015-2025
4.2.8 Isu Abxis’ Clotinab (abciximab): Revenue Forecast, 2015-2025
4.2.9 Reliance Life Sciences’ AbcixiRel (abciximab): Revenue Forecast, 2015-2025
4.2.10 Biocon and Mylan’s CANMAb/Hertraz (trastuzumab): Revenue Forecast, 2015-2025
4.2.11 Celltrion’s Herzuma (trastuzumab): Revenue Forecast, 2015-2025
4.2.12 BIOCAD’s BCD-022 (trastuzumab): Revenue Forecast, 2015-2025
4.2.13 Boehringer Ingelheim’s BI695501 (adalimumab): Revenue Forecast, 2015-2025
4.2.14 Fujifilm Kyowa Kirin Biologics’ FKB327 (adalimumab): Revenue Forecast, 2015-2025
4.2.15 BIOCAD’s BCD-021 (bevacizumab): Revenue Forecast, 2015-2025
4.2.16 Fujifilm Kyowa Kirin Biologics’ FKB238: Revenue Forecast, 2015-2025
5. Leading National Markets for Biosimilar Monoclonal Antibodies, 2015-2025
5.1 What Were the Leading National Markets for Biosimilar Monoclonal Antibody Development in 2013?
5.2 What Were the Leading National Markets for Sales of Biosimilar Monoclonal Antibodies in 2013?
5.3 Which Markets Will Grow Fastest to 2025?
5.4 Market Shares of the Leading National Markets: All Set to Change, 2015-2025
5.5 South Korea: The World’s Leading Nation for Biosimilar MAbs
5.5.1 KFDA Introduced Biosimilar Guidelines in 2009
5.5.2 Significant Investment in Biosimilars in South Korea
5.5.3 Outlook for the South Korean Biosimilar MAb Market, 2014-2025
5.6 The Outlook for Monoclonal Antibody Biosimilars in China, 2015-2025
5.6.1 China to Release Formal Biosimilar Development Guidelines
5.6.2 China: Becoming the World’s Leading Market for Biosimilar MAbs
5.7 Brazil: The Third Leading Country in the 2013 Biosimilar MAb Market, But What Does The Future Hold?
5.7.1 ANVISA’s Biosimilar Regulations Are Similar to the EMA’s
5.7.2 Outlook for Monoclonal Antibody Biosimilars in Brazil, 2015-2025
5.8 Outlook for Monoclonal Antibody Biosimilars in India, 2015-2025
5.8.1 India Releases New Biosimilar Development Guidelines
5.8.2 Indian Biosimilars Submarket Forecast 2015-2025
5.9 The Outlook for Biosimilar MAbs in the US, 2015-2025
5.9.1 When Are the Final FDA Biosimilar Guidelines Expected?
5.9.2 Legal Challenges for Biosimilars in the US
5.9.3 State Regulation of Biosimilar Substitution
5.9.4 The US Biosimilar MAb Market: Revenue Forecast, 2015-2025
5.10 The Outlook for Monoclonal Antibody Biosimilars in Japan 2015-2025
5.10.1 Regulatory Processes for Biosimilars in Japan
5.10.2 Regulations for Naming Biosimilars
5.10.3 Biosimilar MAbs to be Launched in Japan in 2016
5.10.4 Japanese Biosimilar Submarket Forecast 2015-2025
5.11 The Outlook for Monoclonal Antibody Biosimilars in the EU, 2015-2025
5.11.1 The EU Led the World in Biosimilar Regulation
5.11.2 Updating Biosimilar Regulation: Guidelines for the Specific Approval of Biosimilar MAbs
5.11.3 EMA Simplifies Biosimilar Development in the EU
5.11.4 Biosimilar MAbs in the EU5 Countries: Revenue Forecasts, 2015-2025
5.11.5 Germany: Set to Become the Largest National Market for Biosimilar MAbs in the EU
5.11.6 France: Will the Uptake of Biosimilar MAbs Be Restricted?
5.11.7 UK: Drug Uptake Will Be High
5.11.8 Italy: Healthcare Spending Cuts Will Drive Growth
5.11.9 Spain: High Biosimilar MAb Discounts Expected
5.12 The Outlook for Monoclonal Antibody Biosimilars in Russia, 2015-2025
5.12.1 No Specific Biosimilar Legislation Exists in Russia, 2014
5.12.2 Russian Government Investing in Development of Biosimilars
5.12.3 Russian Biosimilar MAb Revenue Forecast 2015-2025
6. Leading Companies for Developing and Producing Biosimilar MAbs
6.1 Prominent Companies in the Biosimilar Monoclonal Antibodies Industry, 2014
6.2 Collaboration in Biosimilar MAb Development
6.3 BioXpress: 16 Compounds in the R&D Pipeline
6.4 Celltrion: One Compound on the Market and Two in Phase III of Development, and Others Wait In The Wings
6.5 Harvest Moon: Six Compounds Under Development
6.6 Genor Biopharma: Five Compounds in Development
6.7 Mabion: Poland’s Leading Biosimilar MAb Developer
6.8 Gene Techno Science: Three Compounds Under Development
6.9 India’s Biocon: A Quiet Competitor
6.10 Pfizer: Entering the Biosimilar MAbs Industry and Market
6.11 BIOCAD: Company Based in Russia
6.12 Big Pharma and the Biosimilar MAbs Market
7. Qualitative Analyses of the Biosimilar MAbs Market, 2015-2025
7.1 Strengths and Weaknesses of the Biosimilar Monoclonal Antibody Market, 2014
7.1.1 Worldwide Demand for More-Affordable Therapies Underpins that Market
7.1.2 Complexity of Protein Molecules Gives Technical Challenges
7.2 Opportunities and Threats Facing the Biosimilar Monoclonal Antibody Market, 2015-2025
7.2.1 A Well-Stocked Pipeline in the Face of Approaching Patent Expiries: Opportunities for Market Expansion
7.2.2 Competition and Lack of Confidence: Threats to Market Penetration?
7.2.2.1 Biobetters as a Threat to Biosimilars
7.3 Social, Technological, Economic and Political Forces Influencing the Biosimilar Monoclonal Antibodies Market (STEP Analysis) 2015-2025
7.3.1 Social Factors: Driving or Restraining the Market?
7.3.2 Advances in Technology: Producing Biosimilar MAbs Cheaply and Easily
7.3.3 Economic Pressures Raise Demand for Biosimilar MAbs
7.3.4 Political Issues: Stringent Regulations Hurdles to Market Entry
8. Research Interviews from Our Survey
8.1 Interview with Bruce Burnett
8.1.1 On Regulations for and Testing of Biosimilars
8.1.2 On Drivers and Restraints for Biosimilar MAbs
8.1.3 Biosimilars and Immunogenicity
8.1.4 On Biosimilars and Research
8.2 Interview with Dr Corrine SinQuee-Brown, The Cancer Center Bahamas
8.2.1 On Biosimilar MAbs in The Bahamas
8.2.2 On Drivers and Restraints for Biosimilar MAbs
8.3 Interview with Dr Xing Wang, President of Array Bridge
8.3.1 On Challenges Surrounding the Development of Biosimilar MAbs
8.3.2 On the Services Offered by Array Bridge
8.3.3 On the Demand for Biosimilar MAbs
8.3.4 On Factors Determining the Success of Biosimilar MAbs
8.3.5 On Regulatory Approval of Biosimilar MAbs: The US vs. the EU
8.4 Interview With Dr Terence Ryan, SVP, iBio
8.4.1 iBio and its Biosimilar Pipeline, 2013
8.4.2 The iBioLaunch Platform
8.4.3 Differences Between Developing Biosimilar and Biologics
8.4.4 Product Differentiation in the Biosimilar Market
8.4.5 Biosimilars and Immunogenicity
8.4.6 Challenges in Developing Biosimilars for the US Market
9. Conclusions from the Research and Analysis
9.1 Biosimilar Monoclonal Antibodies: World Market, 2015-2025
9.2 The Future of Top Compounds in Development and Testing
9.3 Leading National Markets for Biosimilar Monoclonal Antibodies, 2015-2025
9.4 Leading Companies in the Industry
9.5 Trends in the Industry and Market
9.5.1 Economic Pressures Stimulate Demand for Therapeutic MAbs
9.5.2 Patent Expiries of Several Blockbuster MAbs Are Approaching, Creating Large Opportunities for Biosimilars
9.5.3 Complexity of the Molecules Make Production Challenging
9.5.4 Doctor and Patient Doubt Regarding Interchangeability Will Restrict Uptake
9.5.5 Do Biobetters Pose a Threat?
【レポート販売概要】
■ タイトル：バイオシミラー・モノクローナル抗体（MAb）の世界市場■ 英文：Biosimilar Monoclonal Antibodies: World Industry and Market Outlook 2015-2025
■ 発行日：2015年1月
■ 調査会社：visiongain
■ 商品コード：VGAIN5020406
■ 調査対象地域：世界
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