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市場調查報告書

PharmaSphere:全球各國的生技仿製藥市場的規範體制及生產線產品

PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market

出版商 GlobalData 商品編碼 307122
出版日期 內容資訊 英文 173 Pages
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PharmaSphere:全球各國的生技仿製藥市場的規範體制及生產線產品 PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market
出版日期: 2014年06月30日 內容資訊: 英文 173 Pages
簡介

本報告書為、全球主要國家、地區的生技仿製藥市場的最新結構、趨勢的分析、生技仿製藥開發的全球性潮流及各國內部的規範架構及支援對策、主要企業和生產線產品的概要、今後的市場發展展望等調查、推算。

第1章 目錄

第2章 介紹

第3章 市場概況

  • 生技仿製藥:高價的必要品
  • 先發(品牌)生物醫藥品的銷售額之實績值和預測值
  • 遲遲無法進展的生物醫藥品生產線
  • 為何是生技仿製藥?
    • 醫療費支出額的增大
    • 醫療機構的對應領域擴大和微經濟成長的推動
  • 生技仿製藥:不簡單的事業
    • 複雜的製造工程
    • 嚴格的規範條件
    • 不可能為自動化、替代化的生產方式
  • 臨床試驗環境

第4章 生技仿製藥相關的資本交易趨勢

  • 主要資本交易的概要(全5件)
  • 其他資本交易資訊

第5章 生技仿製藥的規範

  • 生技仿製藥:不同名稱的相同主題
  • 全球保健機構(WHO)的SBP(生物學的類似治療產物)的相關導覽

第6章 美國的生技仿製藥市場

  • 概要
  • 生技仿製藥專用規範體制的進化
    • FDC法(食品、醫藥品、化妝品)505條(b)(2)的大型製藥企業的反對
    • 歐巴馬健保法案
    • FDA(食品藥物管理局)的最新生技仿製藥相關導覽
  • 生技仿製藥的產品替代:美國的業界相關者之複雜心境
  • 主要企業和其生產線
    • Hospira
    • Actavis
    • Pfizer
  • 美國的生技仿製藥市場的未來展望
    • 促進業界發展的規範架構整備的計畫
    • 隨著醫療費的增加、生技仿製藥的替代推動
    • 大型生物醫藥品、製藥企業:確保市場佔有率之故積極的計畫
    • 暢銷藥物、生物醫藝品的專利失效、生技仿製藥開發的推動

第7章 歐洲的生技仿製藥市場

  • 概要
  • EU所認可的生技仿製藥產品
  • EU區域內的生技仿製藥開發導覽
    • Sandoz:歐洲的生技仿製藥開發導覽的契機
    • 歐洲地區內生技仿製藥適用導覽
    • 非臨床檔案和臨床研究
  • 主要企業和其生產線
    • Sandoz
    • Stada Arzneimittel
    • Gedeon Richter
  • 歐洲的生技仿製藥市場:概況
    • 隨著財政緊縮對策、生技仿製藥使用率提升
    • 各企業將EU市場作為進入美國的跳台

第8章 日本的生技仿製藥市場

  • 概要
  • 規範體制
    • 組織結構造
    • 生技仿製藥的檢證過程
    • 規範導覽
  • 主要企業和其他生產線
    • KYOWA KIRIN
    • JCR製藥
  • 日本的生技仿製藥市場的未來展望
    • 隨著醫療費抑制政策、生物感染み促進開發
    • 委託製造業者(CMO):生技仿製藥市場加入的既存設備之活用

第9章 印度的生技仿製藥市場

  • 準規範市場到規範市場的階段性轉換
  • 印度國內的未上市生技仿製藥
  • 印度國內的生技仿製藥規範體制
    • 類似的生物製劑之相關導覽(2012年)
  • 主要企業和生產線
    • Biocon
    • Dr. Reddy's Laboratories
    • Ranbaxy Laboratories
    • Reliance Life Sciences
    • Cipla
  • 印度的生技仿製藥市場的未來展望
    • 近年的生技仿製藥、導覽、當局的認證沒有保障
    • 副廠醫療藥的生產技術、生技仿製藥開發的適用
    • EU、印度間自由貿易協定(FTA)之歐洲市場的連結確保

第10章 韓國的生技仿製藥市場

  • 概要
  • 生技仿製藥開發促進的政府計畫
  • 合併事業、事業合作之開發能力的活用
  • 生物製劑企業不存在之故、上市為止需要很長的時間
  • 生技仿製藥的規範體制
    • 症狀的推測
  • 主要企業和其生產線
    • Celltrion
    • Hanwha Chemical
    • Samsung Bioepis
    • LG Life Sciences
  • 韓國的生技仿製藥市場的未來展望
    • 隨著政府的推動對策、國內的生技仿製藥業界的發展展望
    • 新的生產線產品:生技仿製藥業界的發展標誌

第11章 中國的生技仿製藥市場

  • 概要
    • 隨著醫療費急速的增加、對於便宜價格治療藥的需求擴大
    • 生技仿製藥和醫療費用的補貼
    • 智慧財產權(IP)保護的洞穴
  • 中國的生技仿製藥規範體制
  • 主要企業和其生產線
    • 3SBio
    • Shandong Kexing Bioproducts
  • 中國的生技仿製藥市場的未來展望
    • 目前進行中的改革之生技仿製藥業界的推動
    • 隨著醫療費用的增大生技仿製藥市場的成長
    • 多國籍企業和國內企業的合作關係之持續

第12章 個案研究:Teva Pharmaceutical Industries

  • 事業概要
  • 生技仿製藥事業
  • 產品檔案/生產線
  • SWOT分析

第13章 策略的展望

  • 專利失效之生技仿製藥市場的持續性發展
  • 法律規範活動的變動之生技仿製藥業界的正面影響
  • 短期的、中期的、龐大的設備投資作為加入障礙的功能
  • EU、印度間自由貿易協定(FTA):歐洲、印度雙方的生技仿製藥企業的優點
  • 隨著成本的抑制對策、生技仿製藥替代產品的市場推動

第14章 附錄

圖表一覽

目錄
Product Code: GDHC011PSR

GlobalData's report, "PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market", provides strategic analysis of the global biosimilars industry. It discusses key market trends, regulatory requirements in various markets, recent deals activity and trends, as well as describes the operations strategy of these companies. Furthermore, it includes a geographical segmentation of various markets including the EU and US, as well as emerging markets such as India - providing in-depth analysis of these markets' regulatory framework, key domestic players and their biosimilar pipelines, and strategic outlook.

Throughout the report, GlobalData's analysts provide you with expert insight, expanding on each strategy and factor discussed, with the aim of providing you with the tools needed for making informed business decisions.

Highlights

About the Report

GlobalData's PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market report is an essential source of information and analysis on the global biosimilars industry. Using detailed company data, financial analysis, corporate strategy, and market trends analysis, GlobalData provides in-depth analysis of the current and future growth drivers of the biosimilars industry. The report discusses the various regulatory frameworks under which biosimilars are currently reviewed and regulated. Furthermore, it discusses the key factors shaping and driving the biosimilars business, and provides insights on the competitive landscape and emerging strategies expected to significantly influence the market positions of companies currently involved in the development and commercialization of biosimilars.

Key Questions Answered

  • What are the drivers of the global biosimilars industry?
  • Who are the top players involved in the development of biosimilars in the developed markets of Europe and the US, as well as in emerging markets, including India and China?
  • What are the major barriers to entry into the biosimilars industry?
  • What specific strategies are companies utilizing to combat some of the challenges currently facing the development of the global biosimilars industry?
  • What is the current state of biosimilars regulation in the EU, US, Japan, India, China, and South Korea?

Scope

  • The report provides analysis of the key drivers and trends shaping the global biosimilars industry.
  • The report discusses the biosimilar regulatory landscape of various markets including developed markets of the US and EU, as well as emerging markets such as China and India. Furthermore, it identifies key domestic players in the various markets discussed and provides analysis of their strategy, manufacturing capacity, and clinical pipeline.
  • The report contains expert insights on the corporate strategies of current and prospective players in the global biosimilars industry.
  • The report contains a special case study on Teva Pharmaceutical Industries' biosimilars business, including an in-depth SWOT analysis of the company.

Reasons to buy

  • Understand the frameworks under which biosimilars are currently being reviewed and regulated across various developed and emerging markets
  • Identify the key domestic players in various biosimilar markets, including South Korea, Japan and emerging markets such as India and China
  • Understand the key drivers and trends in the global biosimilars industry
  • Analyze and track the strategies that companies are using to enter and/or strengthen their position in the rapidly evolving biosimilars industry, as well as efforts being made by innovator companies like Amgen to protect their market position
  • Use this information as an independent source for your due diligence and transaction strategy

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Report Scope
  • 2.2. Upcoming Related Reports
  • 2.3. Recently Published Reports

3. Market Overview

  • 3.1. Biologics: An Expensive Necessity
  • 3.2. Historical Branded Biologic Sales and Forecast
  • 3.3. A Trickling Biologics Pipeline
  • 3.4. Why Biosimilars?
    • 3.4.1. Rising Healthcare Expenditures
    • 3.4.2. The Need to Broaden Healthcare Coverage and Drive Macroeconomic Growth
  • 3.5. Biosimilars: Not an 'Easy' Venture
    • 3.5.1. Complex Manufacturing Processes
    • 3.5.2. Rigorous Regulatory Requirements
    • 3.5.3. No Automatic Substitution
  • 3.6. Clinical Trials Landscape

4. Biosimilar Deals Trends

  • 4.1. Highlighted Deals
    • 4.1.1. Baxter International and Coherus Biosciences Announce Biosimilars Collaboration
    • 4.1.2. Genor BioPharma and BioCND Form mAb Partnership for International Markets
    • 4.1.3. Pfenex Forms JV with Agila Biotech
    • 4.1.4. Viropro and Oncobiologics Sign Emerging Markets Biosimilars Deal
    • 4.1.5. Samsung Bioepis and Merck Expand Biosimilars Development Agreement
  • 4.2. Additional Deals

5. Biosimilars Regulation

  • 5.1. Biosimilars: Different Names, Common Themes
  • 5.2. WHO's Guidance on SBPs

6. Biosimilars in the US

  • 6.1. Overview
  • 6.2. The US' Evolving Regulatory Framework for Biosimilars
    • 6.2.1. Big Pharma's Adverse Reaction to Section 505(b)(2)
    • 6.2.2. The Patient Protection and Affordable Care Act
    • 6.2.3. Recent Guidances on Biosimilars by the FDA
  • 6.3. Mixed Feelings among Stakeholders as US States Embrace Biosimilar Substitution
  • 6.4. Key Players and Pipelines
    • 6.4.1. Hospira
    • 6.4.2. Actavis
    • 6.4.3. Pfizer
  • 6.5. Biosimilars in the US: Market Outlook
    • 6.5.1. Efforts to Establish a Regulatory Framework Favors the Development of the Industry
    • 6.5.2. Increasing Healthcare Expenditures Will Drive Biosimilars Substitution
    • 6.5.3. Large Biotechs and Pharmas Will Aggressively Defend their US Market Share
    • 6.5.4. Patent Expirations of Blockbuster Biologics Will Encourage Biosimilar Developers

7. Biosimilars in Europe

  • 7.1. Overview
  • 7.2. EU Approved Biosimilars
  • 7.3. Guidelines for Biosimilars Development in the EU
    • 7.3.1. Sandoz Triggered the Development of Guidelines for Biosimilars in Europe
    • 7.3.2. Applicable Guidance Documents on Biosimilars in Europe
    • 7.3.3. Non-Clinical Data and Clinical Studies
  • 7.4. Key Players and Pipelines
    • 7.4.1. Sandoz
    • 7.4.2. Stada Arzneimittel
    • 7.4.3. Gedeon Richter
  • 7.5. Biosimilars in Europe: Market Outlook
    • 7.5.1. Financial Austerity Measures Will Further Drive the Uptake of Biosimilars
    • 7.5.2. Companies Will Use the EU Biosimilars Market as a Springboard into the US Market

8. Biosimilars in Japan

  • 8.1. Overview
  • 8.2. Regulatory Framework
    • 8.2.1. Organizational Structure
    • 8.2.2. Biosimilars Review Process
    • 8.2.3. Regulatory Guidelines
  • 8.3. Key Players and Pipelines
    • 8.3.1. Kyowa Hakko Kirin Co. Ltd.
    • 8.3.2. JCR Pharmaceuticals
  • 8.4. Biosimilars in Japan: Market Outlook
    • 8.4.1. Cost Containment Measures Will Drive Biosimilars Development
    • 8.4.2. CMOs Will Leverage Existing Capabilities to Enter Biosimilars Space

9. Biosimilars in India

  • 9.1. Gradual Transition from a Semi-Regulated to a Regulated Market
  • 9.2. Marketed Biosimilars in India
  • 9.3. Regulatory Framework for Biosimilars in India
    • 9.3.1. Guidelines on Similar Biologics, 2012
  • 9.4. Key Players and Pipelines
    • 9.4.1. Biocon
    • 9.4.2. Dr. Reddy's Laboratories
    • 9.4.3. Ranbaxy Laboratories
    • 9.4.4. Reliance Life Sciences
    • 9.4.5. Cipla
  • 9.5. India Biosimilars Market Outlook
    • 9.5.1. Recent Biosimilar Guidelines Will Not Guarantee Approval by Regulators
    • 9.5.2. Expertise in Generics Will Encourage Biosimilars Development
    • 9.5.3. EU-India Free Trade Agreement Could Open Up Access to the European Market

10. Biosimilars in South Korea

  • 10.1. Overview
  • 10.2. Government Initiatives Aiding the Development of Biosimilars
  • 10.3. Joint Ventures and Collaborations Enable Leveraging of Capabilities
  • 10.4. Lack of Biologics' Market Exclusivity Decelerates Time-to-Market
  • 10.5. Regulatory Framework for Biosimilars
    • 10.5.1. Extrapolation of Indications
  • 10.6. Key Players and Pipelines
    • 10.6.1. Celltrion
    • 10.6.2. Hanwha Chemical
    • 10.6.3. Samsung Bioepis
    • 10.6.4. LG Life Sciences
  • 10.7. Biosimilars in South Korea: Market Outlook
    • 10.7.1. Government's Initiatives Look Poised to Spur the Local Biosimilars Industry
    • 10.7.2. Budding Pipeline Signals Boom for the Biosimilars Industry

11. Biosimilars in China

  • 11.1. Overview
    • 11.1.1. Soaring Healthcare Expenditures in China Drive Need for Cheaper Therapeutics
    • 11.1.2. Biosimilars and Reimbursement
    • 11.1.3. An Intellectual Property Loophole
  • 11.2. Regulatory Framework for Biosimilars in China
  • 11.3. Key Players and Pipelines
    • 11.3.1. 3SBio
    • 11.3.2. Shandong Kexing Bioproducts
  • 11.4. Biosimilars in China: Market Outlook
    • 11.4.1. Ongoing Reform Will Boost Biosimilars Industry
    • 11.4.2. Increase in Healthcare Access Bodes Well for Biosimilars in China
    • 11.4.3. Collaborations between Multinationals and Domestic Companies Will Continue

12. Case Study: Teva Pharmaceutical Industries

  • 12.1. Business Overview
  • 12.2. Biosimilars at Teva
  • 12.3. Product Portfolio/Pipeline
  • 12.4. Company SWOT Analysis
    • 12.4.1. Strengths
    • 12.4.2. Weaknesses
    • 12.4.3. Opportunities
    • 12.4.4. Threats

13. Strategic Outlook

  • 13.1. Patent Expiries Will Continually Fuel Biosimilars Development
  • 13.2. Flurry of Regulatory and Legislative Activities Bodes Well for Biosimilars
  • 13.3. Extensive Capabilities Needed Will Serve as a Barrier to Entry in the Near to Mid-term
  • 13.4. EU-India FTA Will Significantly Benefit European and Indian Biosimilars Companies
  • 13.5. Cost-containment Measures Are Expected to Drive Biosimilars Substitution

14. Appendix

  • 14.1. Bibliography
  • 14.2. Abbreviations
  • 14.3. Research Methodology
    • 14.3.1. Coverage
    • 14.3.2. Secondary Research
  • 14.4. About the Author
    • 14.4.1. Adam Dion, Industry Analyst
  • 14.5. Director of Healthcare Industry Dynamics
  • 14.6. Global Head of Healthcare
  • 14.7. About the Industry Dynamics Team
  • 14.8. About GlobalData
  • 14.9. Disclosure Information
  • 14.10. Disclaimer

List of Tables

  • Table 1: Major Biologic Products
  • Table 2: Ongoing Biosimilar Clinical Trials
  • Table 3: Overview of Biosimilars Deals Analyzed in This Report
  • Table 4: Baxter International and Coherus Biosciences Biosimilars Collaboration
  • Table 5: Genor BioPharma and BioCND Licensing Deal
  • Table 6: Pfenex's JV with Agila Biotech
  • Table 7: Viropro and Oncobiologics' Biosimilars Deal
  • Table 8: Samsung Bioepis and Merck Sign Biosimilars Development Agreement
  • Table 9: Biosimilar Evaluation Requirements - WHO, South Korea, EU, and Japan
  • Table 10: Hospira: Marketed Biosimilars
  • Table 11: Hospira: Biosimilars Developmental Pipeline
  • Table 12: Actavis' Biosimilars Pipeline
  • Table 13: Pfizer's Biosimilars Pipeline
  • Table 14: Authorized Biosimilars in the EU
  • Table 15: Sandoz: Marketed Biosimilars
  • Table 16: Sandoz: Pipeline of Developmental Biosimilars
  • Table 17: Stada Arzneimittel's Current Biosimilars Pipeline
  • Table 18: Gedeon Richter's Current Biosimilars Pipeline
  • Table 19: Kyowa Hakko Kirin's Late-stage Biologics Pipeline
  • Table 20: JCR Pharmaceuticals' Product Pipeline
  • Table 21: Currently Marketed Biosimilars in India
  • Table 22: Guidelines Applicable to the Research, Development and Marketing of Biosimilars in India
  • Table 23: Biocon: Marketed Biologics
  • Table 24: Biocon: Current Developmental Biologics Pipeline
  • Table 25: Dr. Reddy's: Marketed Biosimilars
  • Table 26: Ranbaxy's Current Biosimilars Pipeline
  • Table 27: Reliance Life Sciences: Marketed Biosimilars
  • Table 28: Reliance Life Sciences: Pipeline Biosimilars
  • Table 29: Cipla Combined Annual Manufacturing Capacities
  • Table 30: Some Biosimilars in Development by South Korean Drug Companies
  • Table 31: Deals in the South Korean Biosimilars Industry
  • Table 32: Celltrion Product Pipeline
  • Table 33: Hanwha Chemical's Current Product Pipeline
  • Table 34: LG Life Sciences' Current Product Pipeline
  • Table 35: 3SBio's Clinical Pipeline
  • Table 36: Teva Pharmaceutical Industries: Marketed and Developmental Biosimilars

List of Figures

  • Figure 1: Historical Sales of Branded Biologics, 2008-2013 and Forecast to 2019
  • Figure 2: New Biologics* Approvals by the FDA, 2006-2013
  • Figure 3: Groups of Companies Involved in Biosimilars Development
  • Figure 4: Trend in Deals in the Biosimilars Industry, 2007-2013
  • Figure 5: FDA-Recommended Stepwise Approach for Biosimilars' Development in the US
  • Figure 6: Current Guidelines on Biosimilars Regulation in the EU
  • Figure 7: Novartis' Capabilities being Leveraged by Sandoz
  • Figure 8: Public Debt and Budget Deficit-to-GDP Ratios in the Eurozone, 2013
  • Figure 9: PMDA's Current Organizational Chart
  • Figure 10: Review Process for Biosimilars in Japan
  • Figure 11: Indian Regulatory Pathway for Indigenously Manufactured Biologics
  • Figure 12: Indian Regulatory Pathway for Imported Biologics
  • Figure 13: South Korean's Three-tiered Regulatory System for Biosimilars
  • Figure 14: Celltrion Product Pipeline by Therapeutic Area
  • Figure 15: LG Life Sciences' R&D Investment, 2009-2013 (Estimated)
  • Figure 16: Total and Government Healthcare Expenditures* in China, 2001-2011
  • Figure 17: Application and Approval Procedure for Pharmaceuticals in China
  • Figure 18: Teva's Global Biosimilars Operation: A Recipe for Success
  • Figure 19: Teva Generics Sales in US vs. Rest-of-World (ROW), 2009-2012
  • Figure 20: Teva Pharmaceuticals: SWOT Analysis
  • Figure 21: Capabilities Needed for Biosimilars Development
  • Figure 22: US Healthcare Expenditure and GDP, 2001-2013
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