バイオシミラーおよび後発生物製剤の世界市場:モノクローナル抗体、融合タンパク質、インスリン、エリスロポエチン、G-CSF、インターフェロン、ヒト成長ホルモン、生殖ホルモン...市場調査レポートについてご紹介

【英文タイトル】Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2015-2025

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【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. Introduction to Biosimilars and Biosimilar Drug Development
2.1 Biologics: Large, Complex Products which can be Very Effective, but also Very Expensive
2.2 Brief History of Biological Drug Development
2.3 What is a Biosimilar?
2.4 Brief History of Biosimilars
2.5 What are Interchangeable Biological Products and how Do They Differ from Biosimilars?
2.6 Prescription of Interchangeables vs Biosimilars and How This Sets the FDA Apart from the EMA
2.7 Main Segments of the Overall Biosimilars Market

3. The Global Biosimilars Market 2015-2025
3.1 The Global Biosimilars Market
3.2 Global Biosimilars Market Forecast 2015-2025
3.3 What Will Drive Growth in the Biosimilars Market?
3.3.1 Biosimilars Can Bring about Savings of Billions – $44bn for the US by 2024 and $33bn for Europe by 2020
3.3.2 Over $67bn worth of Biologic Patents due to Expire by 2020
3.3.3 US Approves First Biosimilar – Zarxio. Will this Open the Floodgates? Interchangeability Can also Drive Growth
3.3.4 Other Developed and Emerging Markets Will also Provide Opportunities for Growth
3.3.5 Competitive Landscape Emerging for Biosimilars
3.4 What Factors can Restrain Sales Growth in the Biosimilars Market?
3.4.1 Complexity of Biologics Means that Biosimilar Development Faces Many Challenges
3.4.2 Opposition from Originator Companies and Patent Issues
3.4.3 Fragmentation in the Market as Many Companies Chase the Same Targets
3.4.4 The Threat of Biobetters and Next-Generation Biologics
3.5 Summary of Drivers and Restraints for the Global Biosimilars Market
3.6 Biosimilar Market Forecast by Segment, 2015-2025
3.7 Leading Segments in the Biosimilars Market, 2014
3.8 Biosimilars as a Share of the Biologics Market, 2014
3.8.1 Outlook for the Overall Biologics Market
3.8.2 Seven Biologics Account for 31.8% of Total Market Revenue

4. Outlook for Biosimilars in Leading Developed Markets, 2015-2025
4.1 Regional Forecasts for the Global Biosimilars Market, 2015-2025
4.2 The US Biosimilars Market Outlook, 2015-2025
4.2.1 Current Status of the US Market
4.2.2 FDA Finalises Three New Guidelines on 351(k) Applications in April 2015
4.2.2.1 The History of the US’ Biosimilar Guidelines
4.2.3 Individual States Can Pass their Own Biosimilar Substitution Laws
4.2.4 US Biosimilars Market Forecast, 2015-2025
4.3 The European Biosimilar Market: History and Current Status
4.3.1 History of EMA Guidelines and Updates 2012-2014
4.3.2 Biosimilar Uptake in Europe Varies between Nations
4.3.3 European Biosimilars Market Forecast, 2015-2025
4.3.4 Inflectra and Remsima in Europe – Demonstrates a Path for Other Biosimilar MAbs
4.3.5 German Biosimilar Market Outlook, 2015
4.3.5.1 German Biosimilar Market Forecast, 2015-2025
4.3.6 French Biosimilars Market Outlook, 2015
4.3.6.1 Biosimilar Substitution Law Likely to Come into Effect in 2015
4.3.6.2 French Biosimilar Market Forecast, 2015-2025
4.3.7 UK Biosimilar Market Outlook, 2015
4.3.7.1 UK Biosimilar Market Forecast, 2015-2025
4.3.8 Italian Biosimilars Market Outlook, 2015
4.3.8.1 Italian Biosimilars Market Forecast, 2015-2025
4.3.9 Spanish Biosimilars Market Outlook, 2015
4.3.9.1 Spanish Biosimilar Market Forecast, 2015-2025
4.3.10 Biosimilar Regulation in Japan and Currently Approved Biosimilars
4.3.10.1 Differences between the European and Japanese Guidelines
4.3.10.2 Currently Approved Biosimilars in Japan
4.3.10.3 Japanese Biosimilar Market Forecast, 2015-2025

5. Outlook for Biosimilars in Emerging Markets, 2015-2025
5.1 China and India Lead Biosimilar Revenues
5.2 Biosimilar Growth in Emerging National Markets, 2015-2025
5.3 Chinese Biosimilars Market Outlook, 2015
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, 2015-2025
5.4 Indian Biosimilars Market Outlook, 2015
5.4.1 CDSCO Guidelines Released in 2012
5.4.2 Indian Biosimilars Market Forecast, 2015-2025
5.5 South Korea’s Established Biosimilar Guidelines
5.5.1 Currently Approved Biosimilars in South Korea, 2015
5.5.2 South Korean Biosimilars Market Forecast, 2015-2025
5.6 Russian Biosimilars Market Outlook and Forecast, 2015-2025
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, 2015-2025

6. Biosimilar Monoclonal Antibodies and Fusion Proteins: Submarket Forecast and Pipeline, 2015-2025
6.1 Monoclonal Antibodies (mAbs): The Largest Biologics Market Sector, Individual Drugs Accumulating Multi-Billion Dollar Revenues
6.2 Biosimilar MAbs and FPs Market Forecast, 2015-2025
6.3 Drivers for the Biosimilar MAbs and FPs Market
6.3.1 New Launches of Biosimilar MAbs and FPs in Developed and Emerging Markets
6.3.2 Rising Incidence of Cancer will Drive Demand
6.3.3 The Need for Lower Cost Therapies
6.3.4 Partnering to Launch Biosimilar MAbs
6.4 Restraints for the Biosimilar MAbs and FPs Market
6.4.1 Novel MAb Developers Choosing to Develop Biobetters and Next-Generation Therapies in Face of Biosimilar Competition
6.4.1.1 Hope for Biosimilars when Competing Against Next-Generation Therapies
6.4.2 Challenges in Antibody Development and Manufacturing
6.4.3 Patent Issues, Market Fragmentation and Perception of Biosimilars
6.5 Leading Targets for Biosimilar Development, 2015-2025
6.6 Biosimilar Rituximab
6.6.1 Approved Biosimilars
6.6.1.1 Reditux (Dr. Reddy’s Laboratories)
6.6.1.2 MabTas (Intas Pharmaceutical)
6.6.1.3 AcellBia (Biocad)
6.6.1.4 Kikuzubam (PROBIOMED) – Challenges
6.6.2 Biosimilar Rituximab Pipeline, 2015-2025
6.6.2.1 Terminated Developments
6.6.2.2 GP2013 (Sandoz)
6.6.2.3 BI 695500 (Boehringer Ingelheim)
6.6.2.4 MabionCD20 (Mabion)
6.6.2.5 CT-P10 (Celltrion)
6.6.2.6 PF-05280586 (Pfizer)
6.6.3 Biosimilar Rituximab Outlook, 2015-2025
6.7 Biosimilar Infliximab
6.7.1 Approved Biosimilars
6.7.1.1 Inflectra and Remsima (Hospira and Celltrion)
6.7.1.2 Inflimab and BOW015 (Epirus Biopharmaceuticals and Ranbaxy Laboratories)
6.7.2 Biosimilar Infliximab Pipeline, 2015-2025
6.7.2.1 NI-071 (Nichi-Iko)
6.7.2.2 ABP 710 (Amgen) and BX2922 (BioXpress Therapeutics)
6.7.3 Biosimilar Infliximab Outlook, 2015-2025
6.8 Biosimilar Trastuzumab
6.8.1 Approved Biosimilars
6.8.1.1 Hertraz and CanMab (Mylan and Biocon)
6.8.1.2 Herzuma (Celltrion)
6.8.2 Biosimilar Trastuzumab Pipeline, 2015-2025
6.8.2.1 BCD-022 (Biocad)
6.8.2.2 ABP 980 (Amgen and Actavis)
6.8.2.3 PF-05280014 (Pfizer)
6.8.3 Biosimilar Trastuzumab Outlook, 2015-2025
6.9 Biosimilar Adalimumab
6.9.1 Humira – The World’s Leading Antibody Therapy
6.9.2 Exemptia (Zydus Cadila)
6.9.3 Biosimilar Adalimumab R&D Pipeline, 2015-2025
6.9.3.1 ABP 501 (Amgen and Actavis)
6.9.3.2 GP2017 (Sandoz)
6.9.3.3 BI 695501 (Boehringer Ingelheim)
6.9.4 Biosimilar Adalimumab Outlook, 2015-2025
6.10 Biosimilar Etanercept
6.10.1 Enbrel is the Leading Fusion Protein
6.10.2 Enbrel Granted Extended Patent Protection in the US until 2029
6.10.3 Biosimilars are Available in Emerging Markets
6.10.3.1 Yisaipu (Shanghai CP Guojian Pharmaceutical) and Qiangke (Shanghai Celgen Biopharmaceutical)
6.10.3.2 Etacept (Cipla) and Intacept (Intas Pharmaceuticals)
6.10.3.3 Davictrel and HD-203 (Hanwha Chemical)
6.10.4 Biosimilar Etanercept Pipeline, 2015-2025
6.10.4.1 GP2015 (Sandoz)
6.10.4.2 CHS-0214 (Coherus Biosciences and Baxter)
6.10.5 Biosimilar Etanercept Outlook, 2015-2025
6.11 Avastin: Patents Not Set to Expire until 2019 in the US and 2022 in Europe
6.11.1 Biosimilar Bevacizumab Pipeline, 2015-2025
6.11.1.1 BCD-021 (Biocad)
6.11.1.2 ABP 215 (Amgen)

7. Biosimilar Insulin Submarket Outlook, 2015-2025
7.1 Insulin as Part of the Biological Drug Sector, 2015
7.2 30 Million People Expected to be Diagnosed with Diabetes by 2030
7.3 Approved Insulin Biosimilars
7.4 Abasaglar and Insulin Glargine BS – The First Insulin Biosimilars to be Approved in Developed Markets
7.5 EMA Releases Finalised Insulin Biosimilars Guideline
7.6 Tentative Approval for Basaglar in the US, but Launch Delayed until Mid-2016
7.7 Biosimilar Insulin Forecast, 2015-2025
7.8 Drivers for the Biosimilar Insulin Market, 2015-2025
7.9 Restraints for the Biosimilar Insulin Market, 2015-2025
7.10 Biosimilar Human Insulin Submarket, 2015-2025
7.10.1 A Submarket Mostly Restricted to Emerging Markets?
7.10.2 Biosimilar Human Insulin in China
7.10.3 Biosimilar Human Insulin in India
7.10.3.1 Wockhardt and Biocon – Given up on their Desire to Target the US and Europe?
7.10.4 Biosimilar Human Insulin Outlook, 2015-2025
7.11 Biosimilar Insulin Analogues
7.11.1 Available Biologic Insulin Analogues – Sanofi’s Lantus Tops Revenues
7.11.2 Insulin Glargine is the Main Biosimilar Target
7.11.2.1 Limited Development for the Other Targets
7.11.3 Insulin Market Leaders are Developing Ultra-Rapid Acting Insulin Analogues
7.11.3.1 Ultra-Long Acting Insulin also in Development
7.11.4 Mylan Partners with Biocon for Insulin Analogues
7.11.5 Biosimilar Insulin Analogue Outlook, 2015-2025
7.12 Biosimilar Insulin Glargine
7.12.1 Two Biosimilars are Available in India
7.12.2 Biosimilar Insulin Glargine Pipeline, 2015-2025
7.12.2.1 MK-1293 (Merck & Co. and Samsung BioLogics)
7.12.2.2 Mylan’s Insulin Glargine (Mylan)
7.12.3 Biosimilar Insulin Glargine Outlook, 2015-2025
7.13 Biosimilar Insulin Lispro
7.13.1 One Biosimilar Currently Available – Prandilin
7.13.2 Small Pipeline for the Future
7.13.3 Ultra-Rapid Acting Insulin: New Options

8. Biosimilar Erythropoietins Submarket Outlook, 2015-2025
8.1 Three Products Lead the Biologic EPO Therapy Market
8.2 Safety Concerns for Erythropoietin-Stimulating Agents
8.3 The Challenge from Oral Therapies is Coming
8.4 Treating Anaemia in Patients with CKD – the Leading Use of EPO Therapies
8.5 Biosimilar Epoetin Approvals in Europe
8.6 Epoetin Alfa Pipeline for the European Market, 2015
8.7 Trends in Uptake for Biosimilar Epoetins in Europe
8.8 Epoetin Alfa Pipeline for the US – Companies Preparing for Launch
8.9 Biosimilar Epoetin in Japan
8.10 Biosimilar Epoetin in South Korea
8.11 Biosimilar Epoetin in India and China
8.12 Second-Generation EPO Biosimilars
8.13 No Mircera Biosimilars in Clinical Development
8.14 Biosimilar EPO Market Forecast, 2015-2025

9. Biosimilar G-CSF Submarket Outlook, 2015-2025
9.1 Biologic Market Outlook: Amgen Leads the Biologic G-CSF Market
9.2 Teva Launches Long-Acting Pegfilgrastim
9.3 Selected Filgrastim Biosimilars Approved Worldwide
9.3.1 The European G-CSF Biosimilars Market
9.3.2 Tevagrastim (Teva): The First Biosimilar in Europe, Launched as Granix in the US
9.3.3 Nivestim (Hospira)
9.3.4 Zarzio (Sandoz): The Most Prescribed Biosimilar Therapy in Europe
9.3.4.1 Zarxio Becomes the First Biosimilar in the US
9.3.5 Multiple Launches in Japan 2013-2014
9.3.6 Biosimilar Filgrastim and Pegfilgrastim in India
9.3.6.1 Biosimilars in Russia and Other Emerging Markets
9.4 Biosimilar G-CSF Market Forecast, 2015-2025
9.4.1 Drivers and Restraints for the Biosimilar G-CSF Market
9.4.2 Trends in Biosimilar Uptake Across Europe

10. Biosimilar Interferons Submarket Outlook, 2015-2025
10.1 Competition for the Multiple Sclerosis Market – Challenges for Interferon Beta Therapies
10.2 All-Oral Regimens will Challenge Interferon Alfa Therapy
10.2.1 However Oral Therapies Will be Expensive
10.3 Biologic Interferon Therapy Market Outlook
10.4 There Are No Approved Biosimilars in Developed Markets
10.5 Biosimilar Interferons Market Forecast, 2015-2025
10.6 Biosimilar Interferon Alfa
10.6.1 Biosimilar Interferon Alfa – a Common Target in Developing Countries, Leading to Fragmented Markets
10.6.2 Biosimilar Peginterferon Alfa
10.6.3 Hepatitis Treatment Rates are Low
10.6.4 Biosimilar Interferon Alfa Outlook, 2015-2025
10.7 Biosimilar Interferon Beta
10.7.1 Biosimilars are Well-Established in Emerging Markets
10.7.2 Biosimilar Interferon Beta Pipeline
10.7.3 EMA Guidance
10.7.4 Long-Acting Interferon Beta
10.7.5 Biosimilar Interferon Beta Outlook, 2015-2025

11. Biosimilar Recombinant Hormones Submarket Outlook, 2015-2025
11.1 Biologic Growth Hormone Market in 2014 – Novo Nordisk and Pfizer Dominate
11.1.1 Biologic Growth Hormone Market Outlook, 2015-2025
11.2 Biosimilar Growth Hormones
11.2.1 Omnitrope – Well Established in Developed Markets
11.2.2 Multiple Biosimilars Available Worldwide
11.2.3 Biosimilar Growth Hormones in Asia
11.2.4 Biosimilar Uptake Varies by Region
11.2.5 Biosimilar Growth Hormones Market Forecast, 2015-2025
11.3 Fertility Hormones
11.3.1 Two Products Lead the Biologic Fertility Hormone Market
11.3.2 Long-Acting Follicle Stimulating Hormone (FSH)
11.3.3 Biologic Fertility Hormones Market Outlook
11.3.4 Available Biosimilar Fertility Hormones
11.3.4.1 Ovaleap (Teva) and Bemfola (Finox) Approved in Europe
11.3.5 Rising Infertility to Drive Demand to 2025
11.3.6 Biosimilar Fertility Hormones Forecast, 2015-2025

12. Biosimilars: Qualitative Analysis and Industry Trends, 2015
12.1 SWOT Analysis of the Biosimilars Market
12.2 Biosimilars Market: Strengths
12.2.1 Biosimilars Can Offer Huge Cost Savings
12.2.2 The US Finally Joins the Global Biosimilars Market
12.2.3 Biosimilars are Already Well-Established in Many National Markets
12.2.4 Outsourcing Offers the Chance for Further Cost Savings
12.3 Biosimilars Market: Weaknesses
12.3.1 Biosimilars are High Cost to Develop and Manufacture
12.3.2 Complexity Means that Development Timelines are Long
12.3.3 Uptake for Biosimilars Varies and is Low in Some Regions
12.4 Biosimilars Market: Opportunities
12.4.1 Blockbuster Biologics Face Patent Expiry
12.4.2 Rising Disease Prevalence
12.4.3 Licensing Agreements for Biosimilars
12.5 Threats
12.5.1 Biobetters and Next-Generation Biologics
12.5.2 Patent Issues and Product Life Cycle Management from Originator Companies
12.5.3 Fragmentation in the Market
12.5.4 Long Market and Data Exclusivity Periods
12.5.5 Biosimilars Require Marketing and Education

13. Research Interviews from Our Survey
13.1 Interview with Sandra Sánchez y Oldenhage, MBA, Deputy CEO of PROBIOMED
13.1.1 Introduction to PROBIOMED
13.1.2 PROBIOMED’s Most Prominent Biosimilars and its Future Pipeline
13.1.3 Withdrawal of Kikuzubam and Changes in Mexican Biosimilar Regulation
13.1.4 On Standing out from the Competition
13.1.5 On How the Biosimilars Market will Develop over the Next Ten Years and its Main Strengths
13.2 Interview with Dr Ralph Warsinsky, Executive Director of Product Communications at Boehringer Ingelheim
13.2.1 On Boehringer Ingelheim’s Current Biosimilar Pipeline and its Reasons for Entering the Biosimilars Space
13.2.2 On Boehringer Ingelheim’s Track Record with Biopharmaceuticals and the Factors Needed to Become Successful in the Biosimilars Industry
13.2.3 Advantages over Competitors and Thoughts on the US Market

14. Conclusions from Visiongain’s Research and Analysis
14.1 Rapid Growth Expected for this High-Potential Market
14.2 Biosimilar Monoclonal Antibodies to be the Fastest Growing Segment
14.3 A Range of Factors Will Stimulate Demand
14.4 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:モノクローナル抗体、融合タンパク質、インスリン、エリスロポエチン、G-CSF、インターフェロン、ヒト成長ホルモン、生殖ホルモン
■ 英文:Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2015-2025
■ 発行日:2015年6月
■ 調査会社:visiongain
■ 商品コード:VGAIN50612
■ 調査対象地域:グローバル
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