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【英文タイトル】Biosimilar Monoclonal Antibodies Market Forecast 2016-2026 : Biosimilar Versions of Infliximab, Rituximab, Trastuzumab, Adalimumab, Bevacizumab and Abciximab

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【レポートの概要(一部)】

1. Report Overview
1.1 Overview of Biosimilar Monoclonal Antibodies: R&D, Industry and Market
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 Method of Research and Analysis
1.7 Frequently Asked Questions (FAQs)
1.8 Associate visiongain 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
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 of a Concern is Immunogenicity?
2.7 Biosimilar Monoclonal Antibodies Currently on the Market

3. The Global Market for Biosimilar Monoclonal Antibodies, 2016-2026
3.1 The Present Global Market for Biosimilar Monoclonal Antibodies
3.2 The Global Market for Biosimilar mAbs: A Revenue Forecast, 2016-2026
3.3 The Global Market for Biosimilar mAbs by Compound: Predictions for Revenue and Market Share in 2020 and 2026
3.4 The World Market for Biosimilar mAbs by Compound: Revenue Forecasts, 2016-2026
3.4.1 Will Biosimilar Versions of Monoclonal Antibodies Capture a Large Proportion of the Market?
3.4.2 Biosimilar Infliximab: Currently the Second Largest Submarket
3.4.2.1 Biosimilar Infliximab Revenue Forecast 2016-2026
3.4.3 Biosimilar Rituximab: The current Leading Submarket Driven by Sales in Russia
3.4.3.1 Biosimilar Rituximab: Revenue Forecast 2016-2026
3.4.4 Biosimilar Abciximab: Revenue Forecast 2016-2026
3.4.4.1 Biosimilar Abciximab: Revenue Forecast, 2016-2026
3.4.5 Biosimilar Trastuzumab: Pipeline Rich in Phase III Candidates
3.4.5.1 Biosimilar Trastuzumab: Revenue Forecast, 2016-2026
3.4.6 Biosimilar Adalimumab: Patents Hold Back Revenue on a Large Pipeline
3.4.6.1 Biosimilar Adalimumab: Revenue Forecast 2016-2026
3.4.7 Biosimilar Bevacizumab: Will Late Entry to the Biosimilar mAb Market Restrict Revenue?
3.4.7.1 Biosimilar Bevacizumab: Revenue Forecast, 2016-2026
3.5 Drivers and Restraints for the Biosimilar mAb market 2016-2026
3.5.1 Driving Factors of the Biosimilar mAb Market 2016-2026
3.6 Restraining Factors of the Biosimilar mAb Market 2016-2026

4. Individual Biosimilar mAb Products: Marketed and Pipeline Drugs, 2016-2026
4.1 Biosimilar mAbs on the Market in 2015
4.1.1 Celltrion’s Remsima/ Hospira’s Inflectra. Egis’ Flammegis (Infliximab): The First Official Biosimilar Monoclonal Antibody
4.1.1.1 Remsima/Inflectra/Flammegis Revenue Forecast, 2016-2026
4.1.2 Infimab (Infliximab): Launched a Quarter Ahead of Schedule
4.1.2.1 Infimab Revenue Forecast ($m) 2016-2026
4.1.2.2 Dr Reddy’s Reditux (Rituximab): No Application for EU or US Approval
4.1.2.3 Reditux Revenue Forecast, 2016-2026
4.1.3 Intas Pharmaceuticals’ Mabtas (Rituximab)
4.1.3.1 Mabtas (Rituximab) Revenue Forecast 2016-2026
4.1.4 AcellBia (Rituximab): Sales in Russia Generating Large Revenue Figures
4.1.4.1 AcellBia Revenue Forecast 2016-2026
4.1.5 MABALL: Faces Competition from other Biosimilar Rituximabs in India
4.1.5.1 MABALL Revenue Forecast, 2016-2026
4.1.6 Isu Abxis’ Clotinab (abciximab):
4.1.6.1 Clotinab Revenue Forecast, 2016-2026
4.1.7 AbcixiRel: The First Indian Abciximab Biosimilar
4.1.7.1 AbcixiRel Revenue Forecast 2016-2026
4.1.8 Herzuma (Trastuzumab): Approved in South Korea
4.1.8.1 Herzuma Revenue Forecast 2016-2026
4.1.9 CANMAb/Hertraz (Trastuzumab)
4.1.9.1 CANMAb/Hertraz Revenue Forecast, 2016-2026
4.2 Pipeline Biosimilars
4.2.1 BI695500 (Rituximab): An EU Launch Anticipated in 2017
4.2.1.1 BI695500 Revenue Forecast, 2016-2026
4.2.2 CT-P10 (Rituximab): Celltrion’s Reputation for Biosimilars will Assist Sales
4.2.2.1 Celltrion’s CT-P10 (Rituximab) Revenue Forecast, 2016-2026
4.2.3 Boehringer Ingelheim’s BI695501 (Adalimumab)
4.2.3.1 BI695501 Revenue Forecast, 2016-2026
4.2.4 BCD-022 (Trastuzumab): Currently under Development in Russia Only
4.2.4.1 BCD-022 Revenue Forecast, 2016-2026
4.2.5 Fujifilm Kyowa Kirin Biologics’ FKB327 (Adalimumab)
4.2.5.1 FKB327 Revenue Forecast, 2016-2026
4.2.6 Fujifilm Kyowa Kirin Biologics’ FKB238 (Bevacizumab)
4.2.6.1 Fujifilm Kyowa Kirin Biologics’ FKB238 Revenue Forecast 2016-2026
4.2.7 BCD-021 (Bevacizumab): Russia Will Contribute the Most Revenue
4.2.7.1 BCD-021 Revenue Forecast 2016-2026

5. Leading National Markets for Biosimilar Monoclonal Antibodies
5.1 What Were the Leading National Markets for Biosimilar mAbs in 2015?
5.2 How Will National Market Shares Change Over the Forecast Period?
5.3 India: The Current Leading Nation for Biosimilar mAbs but Growth will Slow
5.3.1 India Releases New Biosimilar Development Guidelines
5.3.2 Indian Biosimilar Submarket Forecast 2016-2026
5.4 Russia: Lack of Regulatory Framework Works Well in the Short Term
5.4.1 Russian Government Backed ‘Pharma 2020’ Initiative
5.4.2 Russian Biosimilar mAb Revenue Forecast, 2016-2026
5.4 South Korean Market has Benefitted from Early Biosimilar Guidelines
5.4.1 Significant Investment in Biosimilars in South Korea
5.4.2 South Korean Biosimilar mAb Revenue Forecast, 2016-2026
5.5 China: A Fragmented Biosimilar mAb Market
5.5.1 Chinese FDA Publishes Finalised Biosimilar Guidelines in 2015
5.5.2 China Biosimilar mAb Revenue Forecast, 2016-2026
5.6 Brazil: ANVISA’s Biosimilar Regulations Are Similar the EMA’s
5.6.1 Brazil Biosimilar mAb Revenue Forecast 2016-2026
5.7 The Outlook for Biosimilar mAbs in the EU 2016-2026
5.7.1 Updating Biosimilar Regulation: Guidelines for the Specific Approval of Biosimilar mAbs
5.7.2 Biosimilar mAbs in the EU5: Revenue Forecasts, 2016-2026
5.7.3 Germany: the Current EU Leader
5.7.4 France: Will the Uptake of Biosimilar mAbs be Restricted?
5.7.5 UK: NICE Recommends Use of Remsima for Certain Indications
5.7.6 Italy: Healthcare Spending Cuts Will Drive Growth
5.7.7 Spain: High Biosimilar mAb Discounts Expected
5.8 The Outlook for Biosimilar mAbs in Japan
5.8.1 Regulations for Naming Biosimilars
5.8.2 Biosimilar mAb Market Activity in Japan
5.8.3 Japanese Biosimilar Submarket Forecast 2016-2026
5.9 US Biosimilar mAb Outlook: None Currently on the Market
5.9.1 US FDA Biosimilar Guidelines were Released in 2015
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, 2016-2026

6. Leading Companies in Biosimilar Monoclonal Antibodies
6.1 Collaboration in Biosimilar mAb Development
6.2 BioXpress: Targeting Patent Expiry Dates in 2019-2023
6.3 Celltrion: Company’s Market Value Surges to Exceed $10.7bn
6.4 Harvest Moon: Six Compounds Under Development
6.5 Genor Biopharma: A Biosimilar mAb Market Leader in China
6.6 Samsung Bioepsis
6.7 Mabion: Poland’s Leading Biosimilar mAb Developer
6.8 Gene Techno Science: Substantial Revenue Increases Since 2014
6.9 India’s Biocon:
6.10 Coherus Biosciences
6.11 BIOCAD: World Leader Biosimilar Rituximab Sales
6.12 Big Pharma and the Biosimilar mAb Market
6.13 Significant Acquisitions in the Biosimilar mAb Market
6.13.1 Pfizer Acquires Hospira
6.13.2 Epirus Acquires Bioceros

7. Qualitative Analysis of Biosimilar Monoclonal Antibodies
7.1 Strengths and Weaknesses of the Biosimilar Monoclonal Antibody Market, 2016-2026
7.1.1 Global Demand for Affordable Biopharmaceuticals has Never Been Greater
7.1.2 Adoption of Biosimilar mAbs will be Proportional to the Rate of Discount
7.1.3 Approval Pathways are Now Established in Developed Markets
7.1.4 Complexity of Protein Molecules Leads to Technical Challenges
7.1.5 Doctor and Patient Confidence May Take Time
7.2 Opportunities and Threat Facing the Biosimilar Monoclonal Antibody Market, 2016-2026
7.2.1 Market Opportunities from Patent Expiries and a Well-stocked Pipeline
7.2.2 Substitution may Not Occur Automatically
7.2.3 Biobetters Offer a Serious Threat to the Production and Uptake of Biosimilars
7.3 Social and Technological Forces Influencing the Biosimilar Monoclonal Antibodies Market 2016-2026
7.3.1 Social Factors: Driving or Restraining the Market?
7.3.2 Technological Factors Concentrate on Reducing Costs and Increasing Ease of Production
7.3.3 Economic Pressures Raise Demand for Biosimilar mAbs
7.3.3.1 Fragmentation of the Market Could Limit Individual Drug Revenues
7.3.4 Political Issues: Stringent Regulations Hurdles to Market Entry

8. Research Interviews
8.1 Interview with Professor Steve Morgan, UBC
8.1.1 On the Benefits of mAbs
8.1.2 On the FDA Biosimilar Regulatory Pathway
8.1.3 On the Challenges in Bringing Biosimilar mAbs to Market
8.1.4 On the Rate of Uptake of Biosimilar mAbs
8.1.5 On What Can be Learnt From Previous Case Studies
8.2 Interview with Dr. Seoyoung C. Kim, Harvard
8.2.1 On the use of Remsima in Korea
8.2.2 On Adoption Rates of Biosimilar Infliximab in the US
8.2.3 On the Indications for Biosimilar Infliximab

9. Conclusions From our Study
9.1 Biosimilar Monoclonal Antibodies: World Market, 2016-2026
9.2 Future of Compounds on the Market and in the Pipeline
9.3 Leading National Markets for Biosimilar Monoclonal Antibodies 2016-2026
9.4 Leading Companies in the Biosimilar mAb Market
9.5 Current and Expected Industry Trends 2016-2026
9.5.1 Cost Control of Healthcare Will Work in Favour mAbs
9.5.2 Upcoming Patent Expiries in Developed Markets Offer Large Market Potential
9.5.3 Complex Production Processes are a Restraining Factor
9.5.4 Clinician and Patient Confidence Must be Maximised to Ensure Uptake
9.5.5 Biobetters Pose a Threat

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Appendix A
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Appendix B
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【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の世界市場:インフリキシマブ、リツキシマブ、トラスツズマブ、アダリムマブ、ベバシズマブ、アブシキシマブ
■ 英文:Biosimilar Monoclonal Antibodies Market Forecast 2016-2026 : Biosimilar Versions of Infliximab, Rituximab, Trastuzumab, Adalimumab, Bevacizumab and Abciximab
■ 発行日:2016年2月
■ 調査会社:visiongain
■ 商品コード:VGAIN6041527
■ 調査対象地域:グローバル
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