【レポートの概要（一部）】
1. Report Overview
1.1 Biosimilars Overview
1.2 Biosimilars Market Segmentation
1.3 Why You Should Read this Report
1.4 How this Report Delivers
1.5 Main Questions Answered by this Report
1.6 Who is this Report for?
1.7 Research and Analysis Methods
1.8 Frequently Asked Questions (FAQ)
1.9 Some Associated Reports
1.10 About Visiongain
2. An Introduction to Biosimilars and Biosimilar Drug Development
2.1 What are Biologics?
2.1.1 Biologics can be Very Effective but also Very Expensive
2.1.2 Brief History of Biological Drug Development
2.1.3 Why are Biologics the Most Lucrative Products in the Global Pharmaceutical Market?
2.2 What are Biosimilars?
2.3 Brief History of Biosimilars
2.4 What are Interchangeable Biological Products and how do They Differ from Biosimilars?
2.4.1 FDA Guidelines on Prescription of Interchangeables vs Biosimilars
2.4.2 Where does the EMA Stand with Regard to Interchangeables?
2.4.3 Where do the EU5 and other European Countries Stand with Regard to Automatic Substitution?
2.4.4 Why Would Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars?
2.5 Main Segments of the Overall Biosimilars Market
3. The Global Biosimilars Market 2016-2026
3.1 The Global Biosimilars Market
3.2 Biosimilars as a Share of the Biologics Market, 2014
3.2.1 Seven of the Top Ten Best-Selling Drugs are Biologics
3.2.2 Outlook for the Overall Biologics Market
3.3 Global Biosimilars Market Forecast, 2016-2026
3.4 What will Drive Growth in the Biosimilars Market?
3.4.1 Biosimilars Can Bring about Savings of Billions – $44bn for the US by 2024 and $33bn for Europe by 2020
3.4.2 Over $67bn Worth of Biologic Patents due to Expire by 2020
3.4.3 US Approves First Biosimilar – Zarxio. Will this Open the Floodgates? Interchangeability Can also Drive Growth
3.4.4 Other Developed and Emerging Markets Will also Provide Opportunities for Growth
3.4.5 Competitive Landscape Emerging for Biosimilars
3.5 What Factors can Restrain Sales Growth in the Biosimilars Market?
3.5.1 Complexity of Biologics Means that Biosimilar Development Faces Many Challenges
3.5.2 Opposition from Originator Companies and Patent Issues
3.5.3 Fragmentation in the Market as Many Companies Chase the Same Targets
3.5.4 The Threat of Biobetters and Next-Generation Biologics
3.6 Summary of the Drivers and Restraints for the Global Biosimilars Market
3.7 Global Biosimilars Market Forecast by Submarket, 2016-2026
3.7.1 Leading Segments in the Biosimilars Market
3.7.2 How Will the Composition of the Market Change Over the Next Ten Years?
4. Outlook for Biosimilars in Leading Developed Markets, 2016-2026
4.1 The Leading National Biosimilar Submarkets
4.2 National Submarket Forecasts 2016-2026
4.3 How will the Regional Composition of the Global Market Change from 2016-2026?
4.4 US Biosimilars Market Outlook 2016-2026
4.4.1 Status of the US Market in 2014 and 2015
4.4.2 FDA Finalises Three New Guidelines on 351(k) Applications in April 2015
4.4.2.1 The History of the US’ Biosimilar Guidelines
4.4.3 FDA Finally Releases Guidance on Biosimilar Naming in August 2015
4.4.4 Individual States Can Pass their Own Biosimilar Substitution Laws
4.4.5 US Biosimilars Market Forecast 2016-2026
4.5 The EU Biosimilar Market: History and Current Status
4.5.1 History of EMA Guidelines and Updates
4.5.2 Biosimilar Uptake in the Europe Varies between Nations
4.5.3 European Biosimilars Market Forecast, 2016-2026
4.5.4 Inflectra and Remsima in Europe – Demonstrates a Path for Other Biosimilar mAbs
4.5.5 German Biosimilar Market Outlook, 2016
4.5.5.1 German Biosimilar Market Forecast, 2016-2026
4.5.6 French Biosimilars Market Outlook, 2016
4.5.6.1 Biosimilar Substitution Passed but Requires Decrees to Come into Effect, Expected Sometime This Year
4.5.6.2 French Biosimilar Market Forecast, 2016-2026
4.5.7 UK Biosimilar Market Outlook, 2016
4.5.7.1 UK Biosimilar Market Forecast, 2016-2026
4.5.8 Italian Biosimilars Market Outlook, 2016
4.5.8.1 Italian Biosimilars Market Forecast, 2016-2026
4.5.9 Spanish Biosimilars Market Outlook, 2016
4.5.9.1 Spanish Biosimilar Market Forecast, 2016-2026
4.5.10 Biosimilar Regulation in Japan and Currently Approved Biosimilars
4.5.10.1 Differences between the European and Japanese Guidelines
4.5.10.2 Currently Approved Biosimilars in Japan
4.5.10.3 Japanese Biosimilar Market Forecast, 2016-2026
5. Outlook for Biosimilars in Emerging Markets, 2016-2026
5.1 China and India Lead Biosimilar Revenues
5.2 Leading Emerging Biosimilar Markets Forecast, 2016-2026
5.3 Chinese Biosimilars Market Outlook, 2016
5.3.1 China Publishes Final Guidelines for Biosimilars
5.3.2 Biosimilars Account for less than Half of Biotech Revenues in China
5.3.3 Chinese Biosimilars Market Forecast, 2016-2026
5.4 Indian Biosimilars Market Outlook, 2016
5.4.1 CDSCO Guidelines Released in 2012
5.4.2 Indian Biosimilars Market Forecast, 2016-2026
5.5 South Korea’s Established Biosimilar Guidelines
5.5.1 Currently Approved Biosimilars in South Korea, 2016
5.5.2 South Korean Biosimilars Market Forecast, 2016-2026
5.6 Russian Biosimilars Market Outlook and Forecast, 2016-2026
5.7 Brazilian Biosimilar Regulation
5.7.1 Government Eager to Promote Biosimilar Development, and Two Major Conglomerates, Bionovis and Orygen, are Racing to Produce Biosimilars
5.7.2 Brazilian Biosimilars Market Forecast, 2016-2026
6. Biosimilar Monoclonal Antibodies: Submarket Forecast and Pipeline, 2016-2026
6.1 MAbs as Part of the Overall Biologics Market in 2014
6.2 Monoclonal Antibodies (mAbs): Largest Biologic Submarket, with Individual Drugs Accumulating Multi-Billion Dollar Revenues
6.3 Biosimilar Monoclonal Antibodies Market and Submarkets Forecast, 2016-2026
6.4 Drivers for the Biosimilar Monoclonal Antibodies Market
6.4.1 New Launches of Biosimilar mAbs in Developed and Emerging Markets
6.4.2 Rising Incidence of Cancer will Drive Demand
6.4.3 The Need for Lower Cost Therapies
6.4.4 Partnering to Launch Biosimilar mAbs
6.5 Restraints for the Monoclonal Antibodies Market
6.5.1 Novel mAb Developers Choosing to Develop Biobetters and Next-Generation Therapies in Face of Biosimilar Competition
6.5.1.1 Hope for Biosimilars when Competing Against Next-Generation Therapies
6.5.2 Challenges in Antibody Development and Manufacturing
6.5.3 Patent Issues, Market Fragmentation and Perception of Biosimilars
6.6 Leading Targets for Biosimilar Development, 2016-2026
6.7 Biosimilar Rituximab
6.7.1 Rituxan: The First Anti-Cancer mAb
6.7.2 Approved Biosimilars and Rituxan Patent Expiry
6.7.2.1 Reditux (Dr. Reddy’s Laboratories): First Biosimilar Rituximab
6.7.2.2 MabTas (Intas Pharmaceutical): Another Indian Biosimilar
6.7.2.3 AcellBia (Biocad): The Leading Biosimilar Rituximab
6.7.2.4 Kikuzubam (PROBIOMED) – Faced Challenges
6.7.3 Biosimilar Rituximab Pipeline, 2016-2026
6.7.3.1 Terminated Developments
6.7.3.2 GP2013 (Sandoz): One of the Biggest Names in the Biosimilar Industry Throws its Hat into the Ring with Advanced Stage Candidate
6.7.3.3 BI 695500 (Boehringer Ingelheim)
6.7.3.4 MabionCD20 (Mabion): Focusing on Markets with High Demand
6.7.3.5 CT-P10 (Celltrion)
6.7.3.6 PF-05280586 (Pfizer)
6.7.4 Biosimilar Rituximab: Revenue Forecast 2016-2026
6.8 Biosimilar Infliximab
6.8.1 Remicade: Second Only to Humira
6.8.2 Approved Biosimilars and Remicade Patent Expiry: Uncertainty in the US after FDA Rejection
6.8.2.1 Inflectra and Remsima (Hospira and Celltrion)
6.8.2.2 Celltrion Speeds Ahead with US FDA Filing, and Inflectra Approved in Australia and Canada
6.8.2.3 Inflimab and BOW015 (Epirus Biopharmaceuticals and Ranbaxy Laboratories)
6.8.3 Biosimilar Infliximab Pipeline, 2015-2026
6.8.3.1 SB2 (Samsung Bioepis): Has been Filed for EU Approval and Shows Positive Phase 3 Results
6.8.3.2 NI-071 (Nichi-Iko): Advanced Stages
6.8.3.3 ABP 710 (Amgen) and BX2922 (BioXpress Therapeutics)
6.8.4 Biosimilar Infliximab: Revenue Forecast 2016-2026
6.9 Biosimilar Trastuzumab
6.9.1 Herceptin: Another Jewel in Roche’s Cancer mAb Portfolio
6.9.2 Approved Biosimilars and Herceptin Patent Expiry
6.9.2.1 Hertraz and CanMab (Mylan and Biocon): The First to Win Approval
6.9.2.2 Herzuma (Celltrion)
6.9.3 Biosimilar Trastuzumab Pipeline, 2015-2026
6.9.3.1 BCD-022 (Biocad): Leading Biosimilar Rituximab Developer Tries its Hand at Trastuzumab
6.9.3.2 ABP 980 (Amgen and Allergan): Phase 3
6.9.3.3 PF-05280014 (Pfizer): Phase 3
6.9.3.4 SB3 (Samsung Bioepis) and BX2318 (BioXpress Therapeutics)
6.9.4 Biosimilar Trastuzumab: Revenue Forecast 2016-2026
6.10 Biosimilar Adalimumab
6.10.1 Humira – The World’s Best-Selling Prescription Drug
6.10.2 Approved Biosimilars and Humira Patent Expiry
6.10.2.1 Exemptia (Zydus Cadila): The First Biosimilar Adalimumab
6.10.3 Biosimilar Adalimumab Pipeline, 2015-2026
6.10.3.1 ABP 501 (Amgen and Allergan): Positive Phase 3 Results Released
6.10.3.2 GP2017 (Sandoz): Phase 3
6.10.3.3 BI 695501 (Boehringer Ingelheim)
6.10.3.4 SB5 (Samsung Bioepis): Phase 3 Results
6.10.4 Biosimilar Adalimumab: Revenue Forecast 2016-2026
6.11 Biosimilar Bevacizumab
6.11.1 Avastin: High Revenues and Late Patent Expiry
6.11.2 Biosimilar Bevacizumab Pipeline, 2016-2026
6.11.2.1 BCD-021 (Biocad)
6.11.2.2 ABP 215 (Amgen and Allergan): Positive Phase 3 Results
6.11.2.3 BI 695502 (Boehringer Ingelheim): Phase 3
6.11.2.4 PF-06439535 (Pfizer): Phase 3
6.11.3 Biosimilar Bevacizumab: Revenue Forecast, 2016-2026
7. Biosimilar Fusion Proteins: Submarket Forecast and Pipeline, 2016-2026
7.1 Scientific Background
7.2 Differentiating Fusion Proteins
7.3 Fusion Proteins as Part of the Overall Biologics Market
7.4 Biosimilar Fusion Proteins Market Forecast, 2016-2026
7.5 Biosimilar Etanercept, 2016-2026
7.5.1 Enbrel is the Leading Fusion Protein
7.5.2 Enbrel Granted Extended Patent Protection in the US, Patent has Expired in EU
7.5.3 Multiple Biosimilars Available in Emerging Markets
7.5.3.1 Brenzys / SB4 (Merck and Samsung Bioepis): First Product Approval to Result from Biosimilar Collaboration
7.5.3.2 Yi Sai Pu (Shanghai CP Guojian Pharmaceutical) and Qiangke (Shanghai Celgen Biopharmaceutical)
7.5.3.3 Etacept (Cipla) and Intacept (Intas Pharmaceuticals)
7.5.3.4 Davictrel / HD-203 (Hanwha Chemical and Merck KGaA)
7.5.4 Biosimilar Etanercept Pipeline
7.5.5 GP2015 (Sandoz)
7.5.5.1 Sandoz Goes in Early: FDA Accepts Application for GP2015, Despite the Fact that Enbrel Patents are not due to Expire any time Soon
7.5.6 SB4 (Samsung Bioepis): EMA Accepts Application
7.5.6.1 Samsung Bioepis Releases Positive Phase 3 Data for SB4
7.5.7 CHS-0214 (Coherus Biosciences and Baxter)
7.5.8 TuNEX / ENIA11 (Mycenax Biotech / TSH Biopharm Corp): Phase 3 in Taiwan
7.5.9 LBEC0101 (LG Life Sciences): Phase 3
7.5.10 Biosimilar Etanercept: Revenue Forecast 2016-2026
7.6 Eylea and Biosimilar Aflibercept
7.7 Orencia and Biosimilar Abatacept
8. Biosimilar Insulin Submarket Outlook, 2016-2026
8.1 Insulin as Part of the Biological Drug Sector
8.2 30 Million People Expected to be Diagnosed with Diabetes by 2030
8.3 Approved Insulin Biosimilars
8.4 Abasaglar / Basaglar / Insulin Glargine BS – The First Insulin Biosimilars to be Approved in Developed Markets
8.5 EMA Releases Finalised Insulin Biosimilars Guideline
8.6 Basaglar Delayed in the US until End of 2016
8.7 Biosimilar Insulin Market and Submarkets Forecast, 2016-2026
8.8 Biosimilar Human Insulin Submarket, 2016-2026
8.8.1 A Submarket Mostly Restricted to Emerging Markets?
8.8.2 Biosimilar Human Insulin in China
8.8.3 Biosimilar Human Insulin in India
8.8.3.1 Wockhardt and Biocon – Given up on their Desire to Target the US and Europe?
8.8.4 Biosimilar Human Insulin in Russia
8.8.5 Biosimilar Human Insulin Submarket Forecast, 2016-2026
8.9 Biosimilar Insulin Analogues Submarket, 2016-2026
8.9.1 Available Biologic Insulin Analogues – Sanofi’s Lantus Tops Revenues
8.9.2 Insulin Glargine in the Main Biosimilar Target
8.9.2.1 Limited Development for the Other Targets
8.9.3 Insulin Market Leaders are Developing Ultra-Rapid Acting Insulin Analogues
8.9.3.1 Ultra-Long Acting Insulin also in Development
8.9.4 Mylan Partners with Biocon for Insulin Analogues
8.9.5 Biosimilar Insulin Analogue Revenue Forecast, 2016-2026
8.10 Biosimilar Insulin Glargine
8.10.1 Biosimilars in India and China
8.10.2 Biosimilar Insulin Glargine Pipeline
8.10.2.1 MK-1293 (Merck / Samsung Bioepis)
8.10.2.2 Mylan’s Insulin Glargine (Mylan and Biocon)
8.10.3 Biosimilar Insulin Glargine: Revenue Forecast, 2016-2026
8.11 Biosimilar Insulin Lispro
8.11.1 One Biosimilar is Currently Available – Prandlin
8.11.2 Much Smaller Pipeline than for Insulin Glargine
8.11.3 Biosimilar Insulin Lispro: Revenue Forecast, 2016-2026
9. Biosimilar Erythropoietins Submarket Outlook, 2016-2026
9.1 Three Products Lead the Biologic EPO Therapy Market
9.2 Safety Concerns for Erythropoietin-Stimulating Agents
9.3 The Challenge from Oral Therapies is Coming
9.4 Treating Anaemia in Patients with CKD – the Leading Use of EPO Therapies
9.5 Biosimilar Epoetin Approvals in Europe
9.6 Epoetin Alfa Pipeline for the European Market
9.7 Trends in Uptake for Biosimilar Epoetins in Europe
9.8 Epoetin Alfa Pipeline for the US – Companies Preparing for Launch
9.8.1 Pfizer’s Retacrit Delayed after Response Letter from FDA
9.8.2 Binocrit / HX575 has Completed Trials
9.9 Biosimilar Epoetin in Japan
9.10 Biosimilar Epoetin in South Korea
9.11 Biosimilar Epoetin in India and China
9.12 Second-Generation EPO Biosimilars
9.13 No Mircera Biosimilars in Clinical Development
9.14 Biosimilar EPO Market Forecast, 2016-2026
10. Biosimilar G-CSF Submarket Outlook, 2016-2026
10.1 Amgen Leads the Branded Biologic G-CSF Market
10.2 Teva Launches Long-Acting Pegfilgrastim
10.3 Selected Filgrastim Biosimilars Approved Worldwide
10.3.1 The European G-CSF Biosimilars Market
10.3.1.1 Trends in Biosimilar Uptake Across Europe
10.3.2 Tevagrastim (Teva): The First Biosimilar in Europe, Launched as Granix in the US
10.3.3 Nivestim (Hospira – Pfizer)
10.3.4 Zarzio (Sandoz): The Most Prescribed Biosimilar Therapy in Europe
10.3.5 Zarxio Becomes the First Biosimilar to be Approved in the US, Launched in September
10.3.6 Apotex: FDA has Accepted Applications for both its Biosimilar Filgrastim, and its Biosimilar Pegfilgrastim
10.3.7 Multiple Launches in Japan in Recent Years
10.3.8 Biosimilar Filgrastim and Pegfilgrastim in India
10.3.9 Biosimilars in Russia, China and Other Emerging Markets
10.4 Biosimilar G-CSF Market Forecast, 2016-2026
11. Biosimilar Interferons Submarket Outlook, 2016-2026
11.1 Interferons: Key Antiviral and MS Therapies Since the 1990s
11.2 Leading Interferon Brands
11.3 Competition for the Multiple Sclerosis Market – Challenges for Interferon Beta Therapies
11.4 All-Oral Regimens will Challenge Interferon Alfa Therapy
11.4.1 However Oral Therapies will be Expensive
11.5 There are no Approved Biosimilars in Developed Markets
11.6 Biosimilar Interferon Market Forecast, 2016-2026
11.7 Biosimilar Interferon Alfa
11.7.1 Biosimilar Interferon Alfa – a Common Target in Developing Countries, Leading to Fragmented Markets
11.7.2 Biosimilar Peginterferon Alfa
11.7.3 Hepatitis Treatment Rates are Low
11.7.4 Biosimilar Interferon Alfa Submarket Forecast, 2016-2026
11.8 Biosimilar Interferon Beta
11.8.1 Biosimilars are Well-Established in Emerging Markets
11.8.2 Biosimilar Interferon Beta Pipeline
11.8.3 EMA Guidance
11.8.4 Long-Acting Interferon Beta
11.8.5 Biosimilar Interferon Beta Submarket Forecast, 2016-2026
12. Biosimilar Recombinant Hormones Submarket Outlook, 2016-2026
12.1 Human Growth Hormone: First Extracted in 1958
12.2 Biologic Growth Hormone Market in 2014 – Novo Nordisk and Pfizer Dominate
12.2.1 Novo Nordisk Aiming to Retain Dominance Through FlexPro Device and NN8640 Somatropin Candidate
12.3 Biosimilar Growth Hormones
12.3.1 Omnitrope – Well Established in Developed Markets
12.4 Multiple Biosimilars Available Worldwide
12.4.1 Biosimilars Growth Hormones Outside of Asia
12.4.2 Biosimilar Growth Hormones in Asia
12.4.3 Biosimilar Uptake Varies by Region
12.5 Biosimilar Growth Hormones Market Forecast, 2016-2026
12.6 Fertility Hormones
12.6.1 Two Products Lead the Branded Fertility Hormone Market
12.6.2 Long-Acting Follicle Stimulating Hormone (FSH)
12.6.3 Branded Fertility Hormones Market Outlook
12.6.4 Available Biosimilar Fertility Hormones
12.6.5 Biosimilars Approved in Europe
12.6.5.1 Ovaleap (Teva)
12.6.5.2 Befomla (Finox Biotech) Approved in Europe, Undergoing Phase 3 for US
12.6.6 Rising Infertility to Drive Demand to 2026
12.6.7 Biosimilar Fertility Hormones Market Forecast, 2016-2026
13. Biosimilars: Qualitative Analysis and Industry Trends
13.1 SWOT Analysis of the Biosimilars Market
13.2 Biosimilars Market: Strengths
13.2.1 Biosimilars Can Offer Huge Cost Savings
13.2.2 The US has Finally Joined the Global Biosimilars Market
13.2.3 Biosimilars are Already Well-Established in Many National Markets
13.2.4 Outsourcing Offers the Chance for Further Cost Savings
13.3 Biosimilars Market: Weaknesses
13.3.1 Biosimilars are High Cost to Develop and Manufacture
13.3.2 Complexity Means that Development Timelines are Long
13.3.3 Uptake for Biosimilars Varies and is Low in Some Regions
13.4 Biosimilars Market: Opportunities
13.4.1 Blockbuster Biologics Face Patent Expiry
13.4.2 Rising Disease Prevalence
13.4.3 Licensing Agreements for Biosimilars
13.5 Threats
13.5.1 Biobetters and Next-Generation Biologics
13.5.2 Patent Issues and Product Life Cycle Management from Originator Companies
13.5.3 Fragmentation in the Market
13.5.4 Long Market and Data Exclusivity Periods
13.5.5 Biosimilars Require Marketing and Education
14. Research Interviews from Our Survey
14.1 Interview with PROBIOMED
14.1.1 Introduction to PROBIOMED
14.1.2 PROBIOMED’s Most Prominent Biosimilars and its Future Pipeline
14.1.3 Withdrawal of Kikuzubam and Changes in Mexican Biosimilar Regulation
14.1.4 On Standing out from the Competition
14.1.5 On How the Biosimilars Market will Develop over the Next Ten Years and its Main Strengths
14.2 Interview with Dr Ralph Warsinsky, Executive Director of Product Communications at Boehringer Ingelheim
14.2.1 On Boehringer Ingelheim’s Current Biosimilar Pipeline and its Reasons for Entering the Biosimilars Space
14.2.2 On Boehringer Ingelheim’s Track Record with Biopharmaceuticals and the Factors Needed to Become Successful in the Biosimilars Industry
14.2.3 Advantages over Competitors and Thoughts on the US Market
15. Conclusions from Visiongain’s Research and Analysis
15.1 Rapid Growth Expected for this High-Potential Market
15.2 Biosimilar Monoclonal Antibodies to be the Fastest Growing Segment
15.3 A Range of Factors Will Stimulate Demand
15.4 Challenges Remain in Developing and Successfully Launching Biosimilars
【レポート販売概要】
■ タイトル：バイオシミラーおよび後発生物製剤の世界市場動向・研究開発・売上予測：MAbs、融合蛋白質、インスリン、G-CSF、エリトロポエチン、インターフェロン、成長ホルモン、生殖ホルモン■ 英文：Biosimilars and Follow-On Biologics’ Trends, R&D and Revenue Forecasts 2016-2026 : Assess Prospects for MAbs, Fusion Proteins, Insulin, G-CSF, Erythropoietin, Interferons, Growth and Fertility Hormones
■ 発行日：2016年2月
■ 調査会社：visiongain
■ 商品コード：VGAIN6022514
■ 調査対象地域：グローバル
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- 世界のオキサリプラチン市場2015The Global Oxaliplatin Industry Report 2015 is a professional and in-depth study on the current state of the Oxaliplatin industry. The report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Oxaliplatin market analyses are provided for the international markets including development trends, competitive landscape analys …
- アルファ-マンノシドーシス（Alpha-Mannosidosis）：グローバル臨床試験レビュー（2014年上半期）Alpha-Mannosidosis Global Clinical Trials Review, H1, 2014 Summary GlobalData's clinical trial report, “Alpha-Mannosidosis Global Clinical Trials Review, H1, 2014" provides data on the Alpha-Mannosidosis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Alpha-Mannosidosis. It includes an overview of the trial numbers and their recruitme …
