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バイオシミラー(バイオ後続品)の世界市場2014-2024年

Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024

出版元:Visiongain(英国)出版元情報LinkIcon
発行年:2014年5月
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【レポート紹介】
Visiongain社では、バイオシミラー(バイオ後続品)の世界市場は2018年に92億ドルに達し、2024年にその市場規模は現在の3倍になると予測しています。
当レポートでは同市場の2024年に至る市場予測、詳細なセグメント別予測分析に加え、市場動向、研究開発動向、リーディング企業情報などを概略以下の構成でお届けしています。

【レポート構成概要】
・バイオシミラー(バイオ後続品)の世界市場予測2014-2024年
・全263ページ、104個のデータ表、76個のチャートで分析定量化
・業界専門家オピニオンインタビュー:
- Dr Don Stewart, CEO, PlantForm
- Biosidus

・セグメント別市場予測2014-2024年
• モノクローナル抗体(mAb)および融合タンパク質(FPS)including rituximab, infliximab, trastuzumab, adalimumab and etanercept segments
• インスリンinc. submarkets of human insulin and analogues, as well as insulin glargine and insulin lispro
• エリスロポエチン(EPO)VGN224_Biosimilars and Follow-On Biologics World Industry and Market Prospects 2014-2024 Cover.jpgレポート表紙
•顆粒球コロニー刺激因子(G-CSF)
• インターフェロンinc. alpha and beta segments
• 成長ホルモン(hGH, somatropin)
• 生殖ホルモンFertility hormones

・主要12ヶ国、国別市場予測2014-2024
• 米国
• 日本
• EU全体およびドイツ、フランス、英国、イタリア、スペイン(国別)
• ブラジル、ロシア、インド、中国
• 韓国

・市場動向分析
• 開発中のバイオシミラー:課題と機会
• 規制当局のガイドライン
• バイオシミラー・モノクローナル抗体mAbs開発のニーズと課題
• バイオシミラー医薬品生産の支援技術の進展
• バイオ医薬品分子製造企業同士の提携
• 治療ニーズに影響を及ぼす疾患の発生率と有病率
• 代替バイオ医薬品需要を刺激する採算経済性
• バイオシミラーの競合としてのバイオベター
• バイオ医薬品の特許上の課題とデータ独占
• アウトソーシングによる生産効率化とバイオ技術の獲得

・リーディング企業情報
• Sandoz (Novartis)
• Hospira
• Mylan
• Pfizer
• Merck & Co.
• Boehringer Ingelheim
• Dr. Reddy's Laboratories
• Teva Pharmaceutical Industries.

Visiongain is a trading partner with the US Federal Government
【レポート詳細目次は当ページ下を参照ください】

英文詳細目次(table of contents)

【原文詳細目次】

Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024

Table of Contents

1. Executive Summary

1.1 Biosimilars: World Market Review 2014
1.2 Report Contents
1.2.1 Benefits of this Report
1.3 Report Methods
1.3.1 Financial Information in this Report
1.3.2 Who is this Report for?
1.4 An Introduction to Biosimilars and Biosimilar Drug Development
1.4.1 A Brief History of Biological Drug Development
1.4.2 The Advent of Biosimilars
1.4.2.1 What Is a Biosimilar?
1.4.3 What Is Driving Demand for Biosimilar Development?
1.4.4 What Has Slowed Biosimilar Drug Development?
1.4.5 Important Sectors of the Biosimilar Market

2. The World Biosimilars Market: Outlook and Forecast 2014-2024

2.1 The World Biosimilars Market 2013
2.1.1 Biosimilars as a Share of the Biologics Market, 2013
2.1.2 Eleven Drugs Account for More than 50% of Biological Drug Revenues
2.1.3 Leading Biologics Sectors Represent Leading Targets for Biosimilars
2.2 Outlook for the World Biosimilars Market 2014-2024
2.2.1 Revenue Growth in the Biologics Market 2014-2024
2.2.2 Biosimilars Market Forecast 2014-2024
2.2.3 Changing Market Shares for Leading Segments 2014-2024
2.2.4 What Will Drive Growth in the Biosimilars Market to 2024?
2.2.5 Biosimilars Market Restraints, 2014-2024

3. Biosimilars in Leading Developed Markets 2014-2024

3.1 Which Were the Leading National Submarkets for Biosimilar Sales in 2013?
3.1.1 Growth in Leading Developed Markets to 2024
3.2 The Outlook for Biosimilars in the US 2014-2024
3.2.1 When Will Finalised FDA Development Guidelines be Released?
3.2.1.1 A Fourth Draft Guideline Released in 2013
3.2.2 US States Introduce their Own Biosimilar Rules
3.2.3 US Biosimilars Submarket Forecast, 2014-2024
3.2.3.1 What Rates of Uptake Can We Expect for Biosimilars in the US?
3.3 Biosimilars in the EU: Outlook 2014-2024
3.3.1 The EU Led the World in Biosimilar Regulation
3.3.2 The EMA Updates its Overarching Guidelines 2012-2014
3.3.3 Biosimilar Uptake in the EU 2008-2013
3.3.4 The EU Biosimilars Submarket Forecast 2014-2024
3.3.4.1 Biosimilar MAbs in the EU from 2014
3.3.5 Biosimilars in Germany: High Uptake for Current Biosimilars
3.3.5.1 German Biosimilars Submarket: Revenue Forecast 2014-2024
3.3.6 The French Biosimilars Submarket 2014-2024
3.3.6.1 New Rules Introduce the Possibility of Biosimilar Substitution
3.3.6.2 French Biosimilars Submarket Forecast 2014-2024
3.3.7 Biosimilars in the UK: High Uptake for Filgrastim
3.3.7.1 UK Biosimilars Submarket Forecast 2014-2024
3.3.8 The Italian Biosimilars Submarket Forecast 2014-2024
3.3.9 Outlook for Biosimilars in Spain: Submarket Forecast 2014-2024
3.4 The Japanese Biosimilars Submarket 2014-2024
3.4.1 Biosimilar Regulation in Japan 2014
3.4.1.1 Differences Exist Between EU and Japanese Guidelines
3.4.2 Collaboration Agreements Drive Biosimilar Development in Japan
3.4.3 Biosimilar MAbs Could be Launched in 2014
3.4.4 Japanese Biosimilars Submarket Forecast 2014-2024

4. Outlook for Biosimilars in Emerging Markets 2014-2024

4.1 China and India Lead in Biosimilar Range and Revenues 2014
4.1.1 Biosimilar Growth in Emerging National Markets 2014-2024
4.2 Outlook for the Chinese Biosimilars Submarket 2014-2024
4.2.1 Biosimilar Development Guidelines Set for Release
4.2.2 Biosimilars Account for Less than Half of Biotech Revenues in China
4.2.3 Chinese Biosimilars Submarket Forecast 2014-2024
4.3 Biosimilars in India: Regulatory and Commercial Outlook 2014-2024
4.3.1 CDSCO Guidelines Released in 2012: How will they Affect Developers?
4.3.2 Biosimilar Uptake in India 2014
4.3.3 Strong Growth Forecast for the Indian Biosimilars Submarket 2014-2024
4.4 The Brazilian Biosimilars Submarket 2014-2024
4.4.1 Biosimilar Regulations Are Similar to those in the EU
4.4.2 Promoting Domestic Biosimilar and Biologic Development
4.4.3 Brazilian Biosimilar Submarket Forecast 2014-2024
4.5 What Potential is there for Biosimilars in Russia to 2024?
4.5.1 No Specific Guidelines for Biosimilar Development
4.5.2 Russian Biosimilars Submarket Forecast 2014-2024
4.6 South Korea: A Leading Country for Biosimilar Development
4.6.1 Established Biologic and Biosimilar Guidelines
4.6.2 Local Players Are Keen on Biosimilar MAb Development
4.6.3 South Korean Biosimilars Submarket Forecast 2014-2024

5. Biosimilar Monoclonal Antibodies and Fusion Proteins: Submarket Forecast and Pipeline 2014-2024

5.1 Monoclonal Antibodies (MAbs): The Largest Biologics Market Sector in 2013
5.1.1 High Demand in Cancer and Autoimmune Disease
5.2 The MAbs Submarket Forecast 2014-2024
5.2.1 Rising Disease Incidence to Stimulate Sales Growth
5.2.2 MAbs: Product and Portfolio Lifecycle Management
5.3 Biosimilar MAbs Outlook 2014-2024
5.3.1 There Are Challenges in Antibody Development and Manufacturing
5.3.2 Partnering to Launch Biosimilar MAbs
5.3.3 Biosimilars MAbs Submarket Forecast 2014-2024
5.3.4 Multiple Product Launches Will Drive Submarket Growth
5.3.5 Biosimilar MAbs and FPs: Submarket Restraints 2014-2024
5.3.6 Leading Targets for Biosimilar Development 2014-2024
5.4 Biosimilar Rituximab 2014-2024
5.4.1 Three Biosimilars Available in 2014
5.4.1.1 Reditux (Dr. Reddy’s Laboratories)
5.4.1.2 Mabtas: A Second Indian Biosimilar
5.4.1.3 Kikuzubam: Removed from the Market, 2014
5.4.2 Biosimilar Rituximab: Revenue Forecast 2014-2024
5.4.3 Biosimilar Rituximab Pipeline 2014
5.4.3.1 A Reduced Late-Stage Pipeline 2012-2014
5.4.3.2 GP2013 (Sandoz): The Most Advanced Developed-Market Candidate
5.4.3.3 BI 695500 (Boehringer Ingelheim)
5.4.3.4 MabionCD20 (Mabion)
5.4.3.5 BCD020 (Biocad)
5.4.3.6 CT-P10 (Celltrion): Development Delayed
5.4.3.7 PF-05280586 (Pfizer)
5.5 Biosimilar Infliximab 2014-2024
5.5.1 Hospira and Celltrion: Biosimilars for Developed Markets
5.5.1.1 Egis Pharmaceuticals Launches Flammegis in Eastern Europe
5.5.2 Biosimilar Infliximab: Revenue Forecast 2014-2024
5.5.3 Biosimilar Infliximab Pipeline 2014
5.5.3.1 BOW-015 (Epirus Biopharmaceuticals)
5.5.3.2 R-TPR-015 (Reliance Life Sciences)
5.5.3.3 Nichi-Iko: A Second Biosimilar for Japan
5.6 Biosimilar Trastuzumab 2014-2024
5.6.1 Biocon/Mylan: Biosimilar Approval in India
5.6.1.1 Roche Sues Biocon and Mylan over Hertraz Launch
5.6.2 Herzuma: Approved in South Korea 2014
5.6.3 Biosimilar Trastuzumab: Revenue Forecast 2014-2024
5.6.4 Biosimilar Trastuzumab Pipeline: Four Clinical-Stage Candidates in 2014
5.6.4.1 Amgen and Actavis Advance to Phase III
5.6.4.2 PF-05280014 (Pfizer): Phase III Launched 2014
5.6.4.3 BCD-022 (Biocad): A Third Phase III Biosimilar
5.7 Biosimilar Adalimumab 2014-2024
5.7.1 Humira is the World’s Leading Antibody Therapy
5.7.2 AbbVie Seeks to Protect its Lead Asset
5.7.3 Biosimilar Adalimumab: Revenue Forecast
5.7.4 First Biosimilar to Launch in India
5.7.4.1 Amgen Advances to Phase III
5.7.4.2 GP2017 (Sandoz)
5.7.4.3 Phase I Biosimilar Adalimumab Candidates
5.8 Biosimilar Etanercept 2014-2024
5.8.1 Enbrel Is the Leading Fusion Protein
5.8.2 Extended Patent Protection in the US
5.8.3 Biosimilars Are Available in Emerging National Markets
5.8.4 Biosimilar Etanercept: Revenue Forecast 2014-2024
5.8.5 Biosimilar Etanercept Pipeline 2014
5.8.5.1 GP2015 (Sandoz)
5.8.5.2 CHS-0214 (Coherus BioSciences)
5.8.5.3 Hanwha Chemical: Submitted in South Korea
5.8.5.4 TuNEX (Mycenax Biotech)
5.9 Other Leading Antibody Targets 2014-2024
5.9.1 Avastin Loses Patent Protection in 2018

6. Biosimilar Insulin Submarket Outlook 2014-2024

6.1 Insulin: The Second-Largest Biological Drug Sector 2014
6.1.1 Insulin Submarket Forecast 2014-2024
6.1.2 Diabetes Prevalence Is Rising Worldwide
6.2 Biosimilar Insulin Submarket 2014-2024
6.2.1 There Are No Biosimilars in Developed Markets in 2014
6.2.2 Biosimilar Insulin Submarket Forecast 2014-2024
6.2.3 Launch of Biosimilar Insulin Analogues to Stimulate Growth from 2014-2024
6.2.4 Biosimilar Insulin Submarket Restraints 2014-2024
6.3 Biosimilar Human Insulin Submarket 2014-2024
6.3.1 A Submarket Restricted to Emerging Markets?
6.3.2 Biosimilar Human Insulin in China
6.3.2.1 Biosimilar Insulin Uptake in China 2014
6.3.3 Biosimilar Human Insulin in India
6.3.3.1 What Share Do Biosimilars Hold of the Indian Insulin Submarket?
6.3.3.2 Indian Developers Target the US and EU?
6.3.4 Biosimilar Human Insulin in Other Emerging Markets
6.3.5 Biosimilar Human Insulin Submarket Forecast 2014-2024
6.4 Biosimilar Insulin Analogues 2014-2024
6.4.1 Insulin Analogues Account for Three Quarters of Global Insulin Revenues
6.4.2 Insulin Glargine Is the Main Biosimilar Target
6.4.3 Biosimilar Insulin Analogue Revenue Forecast 2014-2024
6.4.4 Insulin Market Leaders Are Developing Ultra-Acting Insulin Analogues
6.5 Biosimilar Insulin Glargine 2014-2024
6.5.1 Two Biosimilars Are Available in India
6.5.1.1 Mylan Partners with Biocon for Insulin Analogues
6.5.2 Biosimilar Insulin Glargine: Revenue Forecast 2014-2024
6.5.3 Ultra-Long Acting Insulin Analogues in Development
6.5.4 Biosimilar Insulin Glargine Pipeline 2014
6.5.4.1 Eli Lilly and Boehringer Ingelheim Submit Approval Applications in the EU and US
6.5.4.2 Merck & Co. Partners with Samsung Bioepis
6.6 Biosimilar Insulin Lispro 2014-2024
6.6.1 One Biosimilar Available in 2014
6.6.2 Biosimilar Insulin Lispro Revenue Forecast 2014-2024
6.6.3 Ultra-Rapid Acting Insulin: New Options from 2014
6.6.4 Biosimilar Insulin Lispro Pipeline 2014
6.6.4.1 Insulin Lispro Biosimilars in India

7. Biosimilar Erythropoietins: Future Directions 2014-2024

7.1 Three Products Lead the EPO Therapy Submarket in 2014
7.1.1 Aranesp and Procrit: Falling Revenue 2011-2013
7.1.2 Safety Concerns for Erythropoietin-Stimulating Agents
7.2 EPO Submarket Forecast 2014-2024
7.2.1 The Challenge from Oral Therapies Is Coming
7.2.2 Prevalence of Chronic Kidney Disease Will Rise 2014-2024
7.3 The Biosimilar EPO Submarket 2014-2024
7.3.1 Biosimilar Epoetin in the EU 2006-2013
7.3.1.1 Pipeline Epoetin Alpha for the EU Submarket 2014
7.3.1.2 Trends in Uptake for Biosimilar Epoetins in the EU
7.3.2 Companies Preparing for US Launch in 2015
7.3.2.1 The US Is an Appealing Submarket for Developers
7.3.3 Biosimilar Epoetin: Japanese Submarket Overview 2010-2013
7.3.4 Biosimilar Epoetins in Emerging Markets: Multiple Players in a Fragmented Market
7.3.5 Second-Generation EPO Biosimilars
7.3.5.1 Biosimilar Darbepoetin Alpha Pipeline 2014
7.3.6 Biosimilar EPO Submarket Forecast 2014-2024

8. Biosimilar G-CSF: Outlook and Forecast 2014-2024

8.1 Amgen Leads the G-CSF Submarket in 2014
8.1.1 G-CSF Submarket Outlook and Forecast 2014-2024
8.1.2 Teva Launches Long-Acting Pegfilgrastim
8.1.2.1 Other Long-Acting Therapies in Development
8.2 The Biosimilar G-CSF Submarket 2014
8.2.1 One of the First Biosimilars in the EU and US
8.2.1.1 Zarzio Is the Most Prescribed Filgrastim Therapy in Europe
8.2.1.2 Tevagrastim: The First EU Biosimilar
8.2.1.3 Nivestim (Hospira)
8.2.2 Multiple Launches in Japan 2013-2014
8.2.3 Biosimilar Pegfilgrastim and Filgrastim in Emerging Markets
8.2.3.1 A Competitive Biosimilar Submarket in Russia
8.3 Biosimilar G-CSF Submarket 2014-2024
8.3.1 Biosimilar G-CSF Submarket Forecast 2014-2024
8.3.2 Biosimilar G-CSF Submarket: US Launches to Drive Growth 2014-2024
8.3.3 Trends in Biosimilar Uptake in the EU 2008-2013
8.3.4 Biosimilars Targeting the US Submarket
8.4 Biosimilar Pegfilgrastim: Pipeline 2014
8.4.1 Sandoz Leads the Way for Developed Markets
8.4.2 Hospira Gains Funding for Parallel Filgrastim and Pegfilgrastim Development

9. Biosimilar Interferons Submarket 2014-2024

9.1 Steady Growth in the Interferon Alpha and Beta Submarkets 2011-2013
9.1.1 Many Challengers Exist in the Multiple Sclerosis Market
9.1.2 All-Oral Regimens Will Challenge Interferon Alpha Therapy
9.1.2.1 Oral Therapies Will be High Cost
9.2 Interferon Submarket Forecast: Falling Revenue to 2024
9.3 Biosimilar Interferon Submarket 2013
9.3.1 There Are No Biosimilars Approved in Developed Markets
9.3.2 Biosimilar Interferon Submarket Forecast 2014-2024
9.4 Biosimilar Interferon Alpha 2014-2024
9.4.1 Biosimilar Interferon Alpha Is a Common Target in BRIC Nations
9.4.2 Biosimilar Peginterferon Alpha Pipeline 2014
9.4.3 Hepatitis Is a Growing Problem in Emerging Markets
9.4.4 Biosimilar Interferon Alpha Submarket Forecast 2014-2024
9.5 Biosimilar Interferon Beta 2014-2024
9.5.1 Biosimilars Are Well-Established in Emerging Markets
9.5.1.1 Biosimilar Interferon Beta Pipeline 2014
9.5.2 Will EMA Guidance Drive Development in the EU?
9.5.3 Long-Acting Interferon Beta to Launch in 2014
9.5.4 Biosimilar Interferon Beta Submarket Forecast 2014-2024

10. Recombinant Hormones: Biosimilar Submarket Outlook 2014-2024

10.1 Biosimilar Growth Hormones Submarket 2014-2024
10.1.1 Novo Nordisk and Pfizer Dominate the Growth Hormones Submarket
10.1.2 Product Lifecycle Management Will Maintain Revenues for Submarket Leaders 2014-2024
10.1.3 Biosimilar Growth Hormone Submarket 2013
10.1.3.1 Omnitrope: The World’s Bestselling Biosimilar
10.1.4 Many Biosimilars Are Available Worldwide
10.1.4.1 Biosimilar Growth Hormones in Japan and China
10.1.5 Biosimilar Uptake Varies by Region
10.1.6 Biosimilar Growth Hormone Submarket Forecast 2014-2024
10.2 Biosimilar Fertility Hormones Submarket 2014-2024
10.2.1 Two Products Lead the Fertility Hormone Submarket 2014
10.2.2 Long-Acting Follicle-Stimulating Hormone (FSH)
10.2.3 Fertility Hormone Submarket Forecast 2014-2024
10.2.4 Biosimilar Fertility Hormones 2014-2024
10.2.4.1 Two Biosimilars Approved in the EU 2013-2014
10.2.4.2 Biosimilars Beyond FSH 2014
10.2.5 Biosimilar Fertility Hormone Submarket Forecast 2014-2024
10.2.6 Rising Infertility to Drive Demand to 2024

11. Biosimilars and Follow-On Biologics: Industry Trends 2014-2024

11.1 Biosimilars Market: Strengths 2014
11.1.1 Biosimilars Are Available and Well-Established in Many National Markets
11.1.2 Leading Classes of Biological Drug Face Biosimilar Competition
11.1.3 Biosimilars Offer Cost Savings
11.1.4 Outsourcing Offers the Chance for Further Cost Savings
11.2 Biosimilars Market: Weaknesses 2014
11.2.1 Uptake for Most Biosimilars Remains Low in 2014
11.2.2 Biosimilars Are High Cost to Develop and Manufacture
11.2.3 Development Timelines for Biosimilars Are Long
11.2.4 Few Companies Dominate the Late-Stage Pipeline
11.2.5 Awareness of Biosimilars Remains Low
11.3 Biosimilars Market: Opportunities 2014-2024
11.3.1 The Pipeline for New Biosimilars Is Long
11.3.2 Blockbuster Biologics Face Patent Expiry
11.3.3 Rising Disease Chronic Disease Prevalence
11.3.4 Licensing Agreements for Biosimilars
11.3.5 The Opportunity for Biosimilar Substitution?
11.4 Biosimilars Market: Threats 2014-2024
11.4.1 The Threat of Biobetters and Next-Generation Biologics
11.4.2 Product Lifecycle Management to Extend Branded Revenues
11.4.3 Many Companies Are Chasing the Same Targets
11.4.4 Long Market and Data Exclusivity Periods Will Slow Biosimilar Development
11.4.5 Biosimilars Require Marketing
11.5 Porter’s Five Forces Analysis for the Biosimilars Market 2014-2024
11.5.1 Rivalry Among Competitors
11.5.2 Threat of New Entrants
11.5.3 Bargaining Power of Suppliers
11.5.4 Bargaining Power of Buyers
11.5.5 Threat of Substitutes

12. Research Interviews

12.1 Dr Don Stewart, CEO, PlantForm
12.1.1 Benefits in Plant-Based Systems
12.1.1.1 PlantForm Uses Tobacco Plants
12.1.2 Technological Challenges in Plant-Based Systems
12.1.3 Developing Biosimilars for North America and Europe
12.1.4 Differentiating Biosimilar Antibodies
12.1.5 The Threat of Biobetters
12.1.6 PlantForm’s Biosimilar Development
12.1.7 Biosimilar Development for Emerging Markets
12.2 Biosidus
12.2.1 Current Biosimilars Business and Product Portfolio
12.2.2 Regional Competition Facing Biosidus
12.2.3 Future Strategies for Growth and Company Threats

13. Conclusions of the Research and Analysis

13.1 The Biosimilars Market Will Grow Strongly to 2024
13.2 Biosimilar MAb Development Will Lead the Market
13.3 Rising Costs Will Drive Demand for Biosimilars
13.4 Challenges Remain in Developing and Successfully Launching Biosimilars

List of Tables

Table 1.1 Currency Exchange Rates
Table 1.2 First Approvals for Recombinant Protein Therapies, 1982-1993
Table 2.1 Biosimilars Market: Revenues ($bn), 2010-2013
Table 2.2 Biologics Market: Revenues ($bn) and Market Shares (%) by Sector, 2013
Table 2.3 Top 10 Biologics by Revenue ($bn), 2013
Table 2.4 Biosimilars Market: Revenues ($bn) and Market Shares (%) by Sector, 2013
Table 2.5 Biologics Market: Overall Market Forecast and Revenue Forecasts ($bn) by Sector, 2013, 2018, 2024
Table 2.6 Biosimilars Market: Overall Market Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 2.7 Biosimilars: Market Shares (%) by Sector, 2013-2024
Table 3.1 Biosimilars Market: Revenues ($bn) and Market Shares (%) by Region, 2013
Table 3.2 Biosimilars Market: Overall Market Forecast and Revenue Forecasts ($bn) by Region, 2013-2024
Table 3.3 Biosimilars: Market Shares (%) by Region, 2013-2024
Table 3.4 First Time Approvals for Leading Biosimilar Classes in the US, 2006-2028
Table 3.5 US Biosimilars Submarket Forecast ($bn), 2013-2024
Table 3.6 EU Biosimilar Approvals, 2006-2014
Table 3.7 EU Biosimilars Submarket: Revenues ($bn) and Market Shares (%) by Leading Country, 2013
Table 3.8 EU Biosimilars Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Leading Country, 2013-2024
Table 3.9 German Biosimilars Submarket Forecast ($bn), 2013-2024
Table 3.10 French Biosimilars Submarket Forecast ($bn), 2013-2024
Table 3.11 UK Biosimilars Submarket Forecast ($bn), 2013-2024
Table 3.12 Italian Biosimilars Submarket Forecast ($bn), 2013-2024
Table 3.13 Spanish Biosimilars Submarket Forecast ($bn), 2013-2024
Table 3.14 Japanese Biosimilar Development Collaborations, 2010-2014
Table 3.15 Japanese Biosimilars Submarket Forecast ($bn), 2013-2024
Table 4.1 Biosimilars Market: Revenues ($bn) and Market Shares (%) for Emerging Markets, 2013
Table 4.2 Biosimilars Market: Overall Market Forecast and Revenue Forecasts ($bn) for Top Emerging Markets, 2013-2024
Table 4.3 Chinese Biosimilars Submarket Forecast ($bn), 2013-2024
Table 4.4 Indian Biosimilars Submarket Forecast ($bn), 2013-2024
Table 4.5 Brazilian Biosimilars Submarket Forecast ($bn), 2013-2024
Table 4.6 Russian Biosimilars Submarket Forecast ($bn), 2013-2024
Table 4.7 South Korean Biosimilars Submarket Forecast ($bn), 2013-2024
Table 5.1 MAbs and FPs Submarket: Revenues ($bn) and Submarket Shares (%) by Drug, 2013
Table 5.2 Top 20 MAbs and FPs: Main Indications, 2014
Table 5.3 MAbs and FPs: Submarket Forecast ($bn), 2013-2024
Table 5.4 Types of Next-Generation Antibody Therapy, 2014
Table 5.5 Approved Biosimilar MAbs and FPs, 2014
Table 5.6 Biosimilar MAbs and FPs Submarket: Revenues ($bn) and Submarket Shares (%) by Sector, 2013
Table 5.7 Biosimilar MAbs and FPs Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 5.8 Biosimilar MAbs and FPs Submarket: Drivers and Restraints, 2014-2024
Table 5.9 Reditux: Revenue ($m), 2008-2013
Table 5.10 Biosimilar Rituximab: Revenue Forecast ($bn), 2013-2024
Table 5.11 Biosimilar Rituximab: Clinical and Commercial Pipeline, 2014
Table 5.12 Biosimilar Infliximab: Revenue Forecast ($bn), 2013-2024
Table 5.13 Biosimilar Infliximab: Clinical and Commercial Pipeline, 2014
Table 5.14 Biosimilar Trastuzumab: Revenue Forecast ($bn), 2013-2024
Table 5.15 Biosimilar Trastuzumab: Clinical and Commercial Pipeline, 2014
Table 5.16 Biosimilar Adalimumab: Revenue Forecast ($bn), 2013-2024
Table 5.17 Biosimilar Adalimumab: Clinical and Commercial Pipeline, 2014
Table 5.18 Fusion Proteins: Revenues ($bn) and Submarket Shares (%) by Drug, 2013
Table 5.19 Biosimilar Etanercept: Revenue Forecast ($bn), 2013-2024
Table 5.20 Biosimilar Etanercept: Clinical and Commercial Pipeline, 2014
Table 6.1 Insulin Submarket: Revenues ($bn) and Submarket Shares (%) by Sector, 2013
Table 6.2 Insulin Submarket Forecast ($bn), 2013-2024
Table 6.3 Diabetes Prevalence in Leading National Markets, 2014
Table 6.4 Selected Insulin Biosimilars Approved and Launched in Emerging Markets, 2014
Table 6.5 Biosimilar Insulin Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 6.6 Biosimilar Insulin Submarket: Drivers and Restraints, 2014-2024
Table 6.7 Biosimilar Human Insulin Submarket: Revenues ($bn) and Submarket Share (%) by Product, 2013
Table 6.8 Biosimilar Human Insulin Submarket Forecast ($bn), 2013-2024
Table 6.9 Biosimilar Insulin Analogues Submarket: Revenues ($bn) and Submarket Shares (%) by Sector, 2013
Table 6.10 Insulin Analogues Submarket: Revenues ($bn) and Submarket Share (%) by Product, 2013
Table 6.11 Biosimilar Insulin Analogues Submarket Forecast ($bn), 2013-2024
Table 6.12 Biosimilar Insulin Glargine: Revenue Forecast ($bn), 2013-2024
Table 6.13 Biosimilar Insulin Glargine: Clinical and Commercial Pipeline, 2014
Table 6.14 Biosimilar Insulin Lispro: Revenue Forecast ($bn), 2013-2024
Table 6.15 Ultra-Rapid Acting Insulin: Pre-Clinical and Clinical-Stage Pipeline, 2014
Table 7.1 EPO Submarket: Revenues ($bn) and Submarket Shares (%) by Product, 2013
Table 7.2 Aranesp and Procrit: Falling Revenue ($bn), 2011-2013
Table 7.3 EPO Submarket Forecast ($bn), 2013-2024
Table 7.4 Japanese Epoetin Alpha Submarket: Revenues ($bn) by Drug, 2010-2013
Table 7.5 Selected EPO Biosimilars Approved in India, 2014
Table 7.6 EPIAO: Revenue ($bn), 2008-2012
Table 7.7 Biosimilar EPO Submarket Revenue Forecast ($bn), 2013-2024
Table 7.8 Biosimilar EPO Submarket: Drivers and Restraints, 2014-2024
Table 8.1 G-CSF Submarket: Revenues ($bn) and Submarket Shares (%) by Product, 2013
Table 8.2 G-CSF Submarket Forecast ($bn), 2013-2024
Table 8.3 Selected Filgrastim Biosimilars Approved Worldwide, 2014
Table 8.4 Biosimilar G-CSF Submarket Forecast ($bn), 2013-2024
Table 8.5 Biosimilar G-CSF Submarket: Drivers and Restraints, 2014-2024
Table 9.1 Branded Interferon Therapies Approved, 2014
Table 9.2 Interferons Submarket: Revenues ($bn) by Sector, 2011-2013
Table 9.3 Interferons Submarket Forecast ($bn), 2013-2024
Table 9.4 Biosimilar Interferons Submarket: Revenues ($bn) and Submarket Shares (%) by Sector, 2013
Table 9.5 Biosimilar Interferons Submarket: Drivers and Restraints, 2014-2024
Table 9.6 Biosimilar Interferons Submarket: Overall Submarket Forecast and Revenue Forecasts ($bn) by Sector, 2013-2024
Table 9.7 Selected Interferon Alpha Biosimilars Approved Worldwide, 2014
Table 9.8 Chronic Hepatitis B and C: Global Prevalence by Region, 2014
Table 9.9 Biosimilar Interferon Alpha Submarket Forecast ($bn), 2013-2024
Table 9.10 Selected Interferon Alpha Biosimilars Approved Worldwide, 2014
Table 9.11 Biosimilar Interferon Beta Submarket Forecast ($bn), 2013-2024
Table 10.1 Growth Hormones Submarket: Revenues ($bn) and Submarket Shares (%) by Product, 2013
Table 10.2 Growth Hormones Submarket Forecast ($bn), 2013-2024
Table 10.3 Biosimilar Growth Hormones Submarket: Revenues ($bn) and Submarket Shares (%) by Product, 2013
Table 10.4 Biosimilar Growth Hormones Submarket Forecast ($bn), 2013-2024
Table 10.5 Biosimilar Growth Hormones Submarket: Drivers and Restraints, 2014-2024
Table 10.6 Fertility Hormones Submarket: Revenues ($bn) and Submarket Shares (%) by Product, 2013
Table 10.7 Fertility Hormones Submarket Forecast ($bn), 2013-2024
Table 10.8 Biosimilar Fertility Hormones Submarket Forecast ($bn), 2013-2024
Table 10.9 Biosimilar Fertility Hormones Submarket: Drivers and Restraints, 2014-2024
Table 11.1 World Biosimilars Market: Strengths, Weaknesses, Opportunities and Threats (SWOT), 2014-2024
Table 11.2 EMA Sector-Specific Biosimilar Guidelines, 2006-2013
Table 11.3 National Incidence and Prevalence of Leading Indications Treated with Biologics, 2014
Table 11.4 Prominent Biosimilar Collaborations, 2010-2014
Table 11.5 Next-Generation Biologics Developments, 2007-2018
Table 13.1 Biosimilars Market: Submarket Forecasts ($bn) and Market Shares (%), 2013, 2018, 2024

List of Figures

Figure 2.1 Biosimilars Market: Revenues ($bn), 2010-2013
Figure 2.2 Biologics Market Shares (%) by Sector, 2013
Figure 2.3 Biosimilars Market Shares (%) by Sector, 2013
Figure 2.4 Biologics Market: Revenue Forecast ($bn), 2013-2024
Figure 2.5 Biosimilars Market: Revenue Forecast ($bn), 2013-2024
Figure 2.6 Biosimilars Market Shares (%) by Sector, 2018
Figure 2.7 Biosimilars Market Shares (%) by Sector, 2024
Figure 2.8 Biosimilars Market Drivers, 2014-2024
Figure 2.9 Biosimilars Market Restraints, 2014-2024
Figure 3.1 Biosimilars Market Shares (%) by Region, 2013
Figure 3.2 Biosimilars Market Shares (%) by Region, 2013-2024
Figure 3.3 US Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.4 Biosimilars Submarket: Submarket Shares (%) for EU5 Countries, 2013
Figure 3.5 EU Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.6 German Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.7 French Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.8 UK Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.9 Italian Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.10 Spanish Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 3.11 Japanese Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 4.1 Biosimilars Market: Emerging Nation Market Shares (%), 2013
Figure 4.2 Chinese Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 4.3 Indian Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 4.4 Brazilian Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 4.5 Russian Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 4.6 South Korean Biosimilars Submarket Forecast ($bn), 2013-2024
Figure 5.1 MAbs and FPs Submarket Shares (%) by Drug, 2013
Figure 5.2 Top 20 MAbs and FPs: Main Indications, 2014
Figure 5.3 MAbs and FPs Submarket Forecast ($bn), 2013-2024
Figure 5.4 MAbs and FPs Submarket Shares (%) by Sector, 2013
Figure 5.5 Biosimilar MAbs and FPs Submarket Forecast ($bn), 2013-2024
Figure 5.6 Reditux: Revenue ($m), 2008-2013
Figure 5.7 Biosimilar Rituximab: Revenue Forecast ($bn), 2013-2024
Figure 5.8 Biosimilar Infliximab: Revenue Forecast ($bn), 2013-2024
Figure 5.9 Biosimilar Trastuzumab: Revenue Forecast ($bn), 2013-2024
Figure 5.10 Biosimilar Adalimumab: Revenue Forecast ($bn), 2013-2024
Figure 5.11 Biosimilar Etanercept: Revenue Forecast ($bn), 2013-2024
Figure 6.1 Insulin Submarket Shares (%) by Sector, 2013
Figure 6.2 Insulin Submarket Forecast ($bn), 2013-2024
Figure 6.3 Diabetes Prevalence in Leading National Markets, 2014
Figure 6.4 Biosimilar Insulin Submarket Forecast ($bn), 2013-2024
Figure 6.5 Biosimilar Human Insulin: Submarket Shares (%) by Product, 2013
Figure 6.6 Biosimilar Human Insulin Submarket Forecast ($bn), 2013-2024
Figure 6.7 Biosimilar Insulin Analogues: Submarket Shares (%) by Sector, 2013
Figure 6.8 Insulin Analogues: Submarket Shares (%) by Product, 2013
Figure 6.9 Biosimilar Insulin Analogues Submarket Forecast ($bn), 2013-2024
Figure 6.10 Biosimilar Insulin Glargine: Revenue Forecast ($bn), 2013-2024
Figure 6.11 Biosimilar Insulin Lispro: Revenue Forecast ($bn), 2013-2024
Figure 7.1 EPO Submarket Shares (%) by Product, 2013
Figure 7.2 Aranesp and Procrit: Falling Revenue ($bn), 2011-2013
Figure 7.3 EPO Submarket Forecast ($bn), 2013-2024
Figure 7.4 Japanese Epoetin Alpha Submarket: Revenues ($bn) by Drug, 2010-2013
Figure 7.5 EPIAO: Revenue ($bn), 2008-2012
Figure 7.6 Biosimilar EPO Submarket Forecast ($bn), 2013-2024
Figure 8.1 G-CSF Submarket Shares (%) by Product, 2013
Figure 8.2 G-CSF Submarket Forecast ($bn), 2013-2024
Figure 8.3 Biosimilar G-CSF Submarket Forecast ($bn), 2013-2024
Figure 9.1 Interferons Submarket: Revenues ($bn) by Sector, 2011-2013
Figure 9.2 Interferons Submarket Forecast ($bn), 2013-2024
Figure 9.3 Biosimilar Interferons: Submarket Shares (%) by Sector, 2013
Figure 9.4 Biosimilar Interferons Submarket: Revenue Forecast ($bn), 2013-2024
Figure 9.5 Chronic Hepatitis B and C: Global Prevalence by Region, 2014
Figure 9.6 Biosimilar Interferon Alpha Submarket Forecast ($bn), 2013-2024
Figure 9.7 Biosimilar Interferon Beta Submarket Forecast ($bn), 2013-2024
Figure 10.1 Growth Hormones Submarket Shares (%) by Product, 2013
Figure 10.2 Growth Hormones Submarket Forecast ($bn), 2013-2024
Figure 10.3 Biosimilar Growth Hormones Submarket Shares (%) by Product, 2013
Figure 10.4 Biosimilar Growth Hormones Submarket Forecast ($bn), 2013-2024
Figure 10.5 Fertility Hormones Submarket Shares (%) by Product, 2013
Figure 10.6 Fertility Hormones Submarket Forecast ($bn), 2013-2024
Figure 10.7 Biosimilar Fertility Hormones Submarket Forecast ($bn), 2013-2024
Figure 11.1 Biosimilar Development Costs by Stage, 2014
Figure 11.2 Biosimilar Development Timeline by Stage, 2014
Figure 11.3 Bestselling Biologics Facing Patent Expiry 2014-2019
Figure 11.4 Porter’s Five Forces Analysis of the Biosimilars Market, 2014-2024
Figure 13.1 Biosimilars Market: Submarket Forecasts ($bn), 2013, 2018, 2024

掲載企業リスト

Companies Listed

3SBio
AbbVie
Aché
Actavis
Adocia
AET BioTech
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) [France]
Agência Nacional de Vigilância Sanitária (ANVISA) [Brazil]
Agenzia Italiana del Farmaco (AIFA)
Agila Biotech (part of Strides Arcolab)
Alliance for Safe Biologic Medicines (ASBM)
Allozyne
Alteogen
Alvogen
Amarey Nova Medical
Ambrx
Amega Biotech
Amgen
Antares Pharma
Apotex
Aprogen
Aryogen Biopharma
Astellas Pharma
AstraZeneca
Avesthagen
Baxter International
Bayer
Beijing Four Rings Pharmaceutical
Beijing SL Pharmaceutical
Binex Co.
Biocad
Bioceuticals Arzneimittel (part of Stada)
Biocon
Biodel
Biogen Idec
BioGeneriX (part of Teva)
BioGenomics
Biolab Sanus Farmacêutica
Bionovis
Biopartners (part of Bioton)
Biosidus
Bioton
Boehringer Ingelheim
Brazilian Ministry of Health
Bristol-Myers Squibb
Cardiovascular and Renal Drugs Advisory Committee [US]
CCL Pharmaceuticals
CCM Duopharma Biotech
Celltrion
Centers of Medicare and Medicaid Services (CMS)
Central Drugs Standard Control Organisation (CDSCO) [India]
China Food and Drug Administration (CFDA)
Chong Kun Dang
Chugai Pharmaceutical (part of Roche)
CinnaGen
Cipla
Coherus BioSciences
Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) [Mexico]
Compass Biotechnologies
CT Arzneimittel (part of Teva)
Daewoong Pharmaceutical
Daiichi Sankyo
Dance Biopharm
Dem Pharmaceuticals
Department of Biotechnology [India]
Dong-A Pharmaceutical
Dr. Reddy's Laboratories
Drug Controller General of India (DCGI)
Drug Regulatory Authority of Pakistan (DRAP)
Egis Pharmaceuticals
Eli Lilly
Elpen Pharmaceutical
EMA Committee for Medicinal Products for Human Use (CHMP) [EU]
Emcure Pharmaceuticals
EMS
Epirus Biopharmaceuticals
Eurofarma Laboratórios
European Commission
European Medicines Agency (EMA)
Europharm
EvaluatePharma (now Evaluate)
Express Scripts
FDA Center for Drug Evaluation and Research (CDER) [US]
FibroGen
Finox
Fuji Pharma
Fujifilm
Fujifilm Kyowa Kirin Biologics
Gan & Lee Pharmaceutical
Gedeon Richter
Gene Techno Science
Genentech (part of Roche)
International Biotech Center Generium (Generium)
Genexine
Gennova Biopharmaceuticals (part of Emcure Pharmaceuticals)
GeneScience Pharmaceuticals (GenSci)
Genzyme (part of Sanofi)
Geropharm
Gilead Sciences
GlaxoSmithKline (GSK)
Halozyme Therapeutics
Hangzhou Jiuyuan Gene Engineering
Hanmi Pharmaceutical
Hanwha Chemical
Haselmeier
Health Canada
Henlius Biotech
Hexal (part of Novartis)
Hikma Pharmaceuticals
Hindustan Anti Biotech
Hospira
Hualida Biotech
Hypermarcas
IGES Institut [Germany]
Innovare R&D
Insmed
Instituto Vital Brazil
Intas Biopharmaceuticals
Intellectual Property Appellate Board (IPAB) [India]
International Diabetes Federation (IDF)
inVentiv Health
Isu Abxis
Johnson & Johnson (J&J)
JCR Pharmaceuticals
Kemwell Biopharma
Kissei Pharmaceutical
Koçak Farma
Kwizda Pharma
Kyowa Hakko Kirin
Laboratorios Delta
Landsteiner Scientific
LG Life Sciences
Libbs Farmacêutica
LMC
Lonza
Mabion
mAbxience
MannKind
Marvel Life Sciences
Medice
Medicines and Healthcare Products Regulatory Agency (MHRA) [UK]
Merck & Co.
Merck Serono
Minapharm Pharmaceuticals
Ministry of Food and Drug Safety (MFDS) [South Korea]
Ministry of Health and Medical Education [Iran]
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Momenta Pharmaceuticals
Mycenax Biotech
Mylan
National Health Service (NHS) [UK]
National Institute for Health and Care Excellence (NICE) [UK]
National Institute for the Control of Pharmaceutical and Biological Products [China]
Nichi-Iko Pharmaceutical
Nippon Kayaku
Norwegian Ministry of Health
NovaQuest Capital Management
Novartis
Novo Nordisk
Nuron Biotech
Oncobiologics
OPKO Health
Organon (part of Merck & Co.)
Ortho Pharmaceutical (now Janssen Pharmaceuticals)
Orygen Biotecnologia
PanGen Biotech
Parexel International
Pfenex
Pfizer
Pharmapark (part of Pharmstandard)
PharmaPraxis
Pharmstandard
PlantForm
Pliva (part of Teva)
PRA International
Pro Generika [Germany]
Probiomed
Prolor Biotech (part of OPKO Health)
Qilu Pharmaceutical
Quintiles
Ranbaxy Laboratories
ratiopharm (part of Teva)
Regeneron Pharmaceuticals
Reliance GeneMedix (part of Reliance Life Sciences)
Reliance Life Sciences
Rentschler Biotechnologie
Roche
Russian Ministry of Health
SAFC
Samsung
Samsung Bioepis
Samsung BioLogics
Sandoz (part of Novartis)
Sanofi
Sanwa Kagaku Kenkyusho
SciGen (part of Bioton)
Scottish Medicines Consortium (SMC)
Seattle Genetics
Shandong Kexing Bioproducts
Shanghai Celgen Biopharmaceutical
Shanghai CP Guojian Pharmaceutical
Shanghai Fosun Pharmaceutical
Shantha Biotechnics
Sicor Biotech (part of Teva)
Sothema Laboratories
Spectrum Pharmaceuticals
Stada Arzneimittel
Stanford University
State Employees’ Social Security and Social Services Institute (ISSSTE) [Mexico]
Stragen Pharma
Strides Arcolab
Syngene International
Synthon Biopharmaceuticals
Takeda Pharmaceutical Company
Teva Pharmaceutical Industries
The United Laboratories
Therapeutic Goods Administration (TGA) [Australia]
Thermalin Diabetes
Tianjin Hualida Biotechnology
Tonghua Dongbao
University of Toronto
TSH Pharma
UMN Pharma
União Química
University of California, Los Angeles (UCLA)
University of California, San Francisco (UCSF)
US Centers for Disease Prevention and Control (CDC)
US Food and Drug Administration (FDA)
US Patent and Trademark Office (USPTO)
USV Biologics
Virchow Biotech
Wangbang Biopharmaceuticals (part of Shanghai Fosun)
Wockhardt
World Bank Group
World Cancer Research Fund (WCRF)
World Health Organization (WHO)
Xeris Pharmaceuticals
Xiamen Amoytop Biotech
Yakult Honsha
Ypsomed
Zenotech Laboratories
Zhejiang Huahai Pharmaceutical
Zuventus Healthcare (part of Emcure Pharmaceuticals)
Zydus Cadila

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