Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2015-2025

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

◆タイトル:Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2015-2025
◆商品コード:VGAIN50612
◆調査・発行会社:visiongain
◆発行日:2015年6月
◆ページ数:239
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【レポートの概要】

当調査レポートでは、バイオシミラーおよび後発生物製剤の世界市場について調査・分析し、以下の構成でお届けいたします。

・レポートの概要
・イントロダクション
・バイオシミラーおよび後発生物製剤の世界市場
 (市場規模予測、市場の成長要因・阻害要因など)
・主要先進国におけるバイオシミラー市場規模予測
・主要新興国におけるバイオシミラー市場規模予測
・バイオシミラーの世界市場:セグメント別市場分析
 (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)
・バイオシミラー市場の定性分析および市場動向
・専門家の見解
・結論

Biosimilar Drugs – Discover Revenue Potential Now, Benefiting Your Authority
Do you want to fully understand the sales potentials for biosimilars? This new analysis provides you with revenue forecasts to 2025 at overall world market, therapeutic class and national level. For those therapies you will receive financial data, R&D trends, opportunities and commercial prospects.

Visiongain’s updated study gives you revenue predictions for those follow-on biological drugs from 2015, helping you stay ahead. You can also explore trends, technologies and expected products, benefiting your reputation for technological and commercial insight.

You will learn about the promising future for biosimilars. Those agents include follow-on biologics (FOB) and subsequent entry biologics (SEB).

So read on to explore what shapes the biosimilars market, also seeing predicted revenue.

Forecasts and other analysis show you where the best sales opportunities exist
Our new report shows revenue forecasting to 2025, recent results, growth rates and market shares. You can explore quantitative and qualitative analyses, business news, research and development. You will gain 66 tables, 34 charts and two interviews with the industry.

You will be able to assess clinical, technological and commercial trends, results and potentials:
• Why will the biosimilars market expand so rapidly – with predicted double-digit growth from 2015 to 2025 – and therefore what revenues are possible?
• When will the worldwide industry achieve overall sales in tens of billion dollars?
• What compounds give the most promise for developers, producers and sellers?
• Who are the best-placed companies in that healthcare industry from 2015?
• Where are the most lucrative countries for selling those biological drugs?
• How will those drug producers serve regulators, doctors, patients and payers?

Many opportunities exist for those competitors of original biologics. You will discover which segments are most likely to prosper, seeing the potential sales from 2015 to 2025.

Why struggle to find data, losing time and missing out? Instead help your research, analyses, plans, proposals and presentations. With this new report you will save time and benefit your reputation for commercial insight.

See what the future holds for follow-on protein products. The following sections explain how our new investigation helps your work.

Predictions for the world market and submarkets – see what sales growth is possible
Along with revenue prediction for the overall world market for biosimilars, our investigation shows forecasts to 2025 for eight individual therapeutic submarkets:
• Monoclonal antibodies (mAbs) and fusion proteins (FPs) – including rituximab, infliximab, trastuzumab, adalimumab, etanercept and bevacizumab
• Insulins – including analogues, glargine and lispro compounds
• Erythropoietins (EPO)
• Granulocyte colony-stimulating factors (G-CSF)
• Interferons – including alpha and beta agents
• Human growth hormone
• Fertility hormones
• Other biosimilars (grouped prediction).

Our report shows you the sales potentials of those biopharmaceuticals, helping you find ways to develop your business. Our new study will benefit your authority on those treatments, expanding your reputation for commercial knowledge.

Our investigation also discusses what stimulates and restrains sales of those subsequent entry biologics. You can explore that industry, seeing which products can achieve the greatest success. You will discover what revenues are possible, learning how companies can prosper.

Our study also divides the overall world market forecast into geographical segments.

National markets for those therapeutic proteins – where will highest sales and growth occur?
Developments worldwide will influence that follow-on biologics market, raising demand for biosimilars in developed and developing countries. Discover where that success will occur.

Our analyses show you individual revenue forecasts to 2025 for 12 national markets:
• United States (US)
• Germany, France, United Kingdom (UK), Italy and Spain (EU5 group)
• BRIC countries – Brazil, Russia, India and China
• South Korea
• Japan.

Here you will discover the market progress and outlooks. You can assess the biosimilars industry’s future – needs, developments, demands and their significance. Our work explains, exploring issues affecting those biologics companies, influencing their results.

Forces affecting that biopharmaceutical business – what shapes its present and future?
Our new report discusses the pressures, opportunities and other events affecting the biosimilars industry and market from 2015, including these influences:
• Strategies for developing biosimilars – needs, demand, challenges and opportunities
• Guidelines from regulators (FDA, EMA and others) and what they mean for those drug developers and producers
• Patent challenges and data exclusivity for biopharmaceuticals
• Needs and opportunities in developing biosimilar mAbs, including rising incidence of cancers increasing demand for lower-cost biological medicines
• Developments in technology and operations for biosimilar drug production.

Our study also discusses other aspects of those successor biologics, including these forces:
• Economics stimulating demand for cheaper substitute biological medicines
• Outlooks for the overall biologics market – effects of biosimilar competition
• Biobetters as rivals of biosimilars – technological races and battles
• Collaborations for those biopharmaceutical molecules
• Outsourcing – using contract manufacturing organisations (CMOs) – to gain expertise in pharma biotechnology, production efficiencies and cost savings.

You will be able to assess the industry’s strengths, weaknesses, opportunities and threats. That way you can explore what restricts and stimulates companies in the industry.

From 2015 discover what the future holds for those drugs and their makers.

Companies and 2019 market value – what is the overall revenue potential?
From 2015, product launches there hold great potential for investments, demand and sales. Our study predicts the world market for biosimilars and related biologics will reach $16bn in 2019, multiplying in size many times from 2015 to 2025. See how high revenues can go.

You can assess what biosimilar technologies, products and companies hold the greatest potential. Our analyses cover these firms and many other developers, producers, marketers and sellers:
• Sandoz
• Pfizer
• Amgen
• Teva Pharmaceutical Industries
• Boehringer Ingelheim
• Dr. Reddy’s Laboratories.

And you can assess these biopharma specialists, among others:
• Intas Pharmaceutical
• Actavis
• Mabion
• Hospira
• Celltrion.

You will also gain two interviews with organisations – Probiomed and Boehringer Ingelheim.

From 2015 there will arise many opportunities. Our work shows you the commercial possibilities for those biological drugs, helping you stay ahead in knowledge and to succeed.

【レポートの目次】

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



【掲載企業】

3SBio
AbbVie
Accord Healthcare
Aché
Actavis
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
Agila Biotech
AIFA (Agenzia Italiana del Farmaco)
Allozyne
Alteogen
Alvogen
Amarey Novamedical
Ambrx
Amega Biotech
Amgen
Antares Pharma
ANVISA (Agência Nacional de Vigilância Sanitária)
Apotex
Astellas Pharma
Avesthagen
Baxter
Bayer
Beijing Four Rings
Beijing SL Pharmaceutical
Biocad
Biocon
Biogen Idec
BioGeneriX
BioGenomics
Biolab
Bionovis
BioPartners
Biosidus
BioXpress Therapeutics
Boehringer Ingelheim
Brazilian Ministry of Health
Cardiovascular and Renal Drugs Advisory Committee
Cardiovascular Drugs Advisory Committee
CCL Pharmaceuticals
CCM Duopharma
Celltrion
Centers of Medicare & Medicaid Services
China CDE (Centre for Drug Evaluation)
China Food and Drug Administration
Chong Kun Dang
Chugai Pharmaceutical
CinnaGen
Cipla
ClinicalTrials.gov
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)
Coherus BioSciences
Compass Biotechnologies
Cristália
CT Arzneimittel
Daiichi Sankyo
Delhi High Court
Dong-A Pharmaceutical
Dr. Reddy’s Laboratories
Drug Controller General of India
Drug Regulatory Authority of Pakistan.
Egis Pharmaceuticals
Eisai
Eli Lilly
Elpen Pharmaceutical
EMA (European Medicines Agency)
Emcure Pharmaceuticals
EMS
Epirus Biopharmaceuticals
EU CHMP (Committee for Medicinal Products for Human Use)
Eurofarma
Europharm
Express Scripts
FibroGen
Finox Biotech
Fuji Pharma
Gan & Lee
Genentech
Genexine
Gennova
GenSci
Geropharm
Gilead
GSK
Hangzhou Jiuyuan Gene Engineering Co.
Hanwha Chemical
Haselmeier
Health Canada
Helius Biotech
Hexal
Hindustan Antibiotic
Hospira
Hualida Biotech
Hypermarcas
IGES Institute
Indian Central Drugs Standard Control Organisation
Indian Department of Biotechnology
Innovare R&D
Intas Biopharmaceuticals
inVentiv Health
IPAB (Intellectual Property Appellate Board)
Iranian Ministry of Health and Medical Education
ISSSTE (State Employees’ Social Security and Social Services Institute)
Janssen
JCR Pharmaceuticals
Johnson & Johnson
Kabi
Kemwell Biopharma
Kissei Pharmaceutical
Koçak Farma
Kwizda Pharma
Kyowa Hakko Kirin
Laboratorios Delta
Landsteiner Scientific
LG Life Sciences
Libbs
Lonza
Mabion
MannKind
Marvel Life Sciences
MEDICE Arzneimittel Pütter
Merck & Co.
Merck KGaA
Merck Serono
Mexican Supreme Court
MHLW (The Ministry for Health Labour and Welfare)
MHRA (The UK Medicines and Healthcare Products Regulatory Agency)
Minapharm
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Mylan
NHS (National Health Service)
NICE (National Institute for Health and Care Excellence)
Nichi-Iko
Nippon Kayaku
Norwegian Ministry of Health
Novartis
Novo Nordisk
Nuron Biotech
Oncobiologics
OPKO Health
Ortho Pharmaceutical
Orygen
Pan American Health Organization
PanGen Biotech
Pfenex
Pfizer
Pharmapark
Pharmstandard
PMDA (Pharmaceuticals and Medical Devices Agency)
PRA International
Pro Generika
PROBIOMED
Prolor Biotech
Qilu Pharmaceutical
Quintiles
Ranbaxy Laboratories
Ratiopharm
Reliance GeneMedix
Reliance Life Sciences
Rentschler Biotechnologie
Roche
Samsung Bioepis
Samsung BioLogics
Sandoz
Sanofi
SciGen
Shandong Kexing Pharma
Shanghai Celgen Biopharmaceutical
Shanghai CP Guojian Pharmaceutical
Shanghai Fosun
Shantha Biotechnics
Sicor Biotech
SMC (Scottish Medicines Consortium)
Sothema Laboratories
South Korean MFDS (The Ministry of Food and Drug Safety)
Spectrum Pharmaceuticals
STADA Arzneimittel
Stanford University
Stragen Pharma
Strides Arcolab
Syngene International
Synthon Biopharmaceuticals
Takeda
Teva
TGA (Australian Therapeutic Goods Administration)
The National Conference of State Legislatures
The RAND Corporation
The United Laboratories
Tianjin Hualida Biotechnology
Tonghua Dongbao
Toronto University
UCSF (University of California, San Francisco)
União Química
US Center for Disease Prevention and Control
US Court of Appeals
US FDA (Food and Drug Administration)
US Patent and Trademark Office
USV Biologics
Wanbang Biopharmaceuticals
WHO (World Health Organisation)
Wockhardt
Xiamen Amoytop Biotech
Ypsomed
Zenotech
Zhejian Huahai Pharmaceutical
Zuventus
Zydus Cadila

【レポートのキーワード】

バイオシミラー(バイオ後続品)、後発生物製剤、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、顆粒球コロニー刺激因子(G-CSF)、インターフェロン、ヒト成長ホルモン、生殖ホルモン、製薬、医薬品

★調査レポート[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] ( Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2015-2025 / VGAIN50612) 販売に関する免責事項
[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] ( Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2015-2025 / VGAIN50612) についてEメールでお問い合わせ


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