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市場調查報告書

全球生技仿製藥產業分析

Analyzing the Global Biosimilars Industry 2016

出版商 Aruvian's R'search 商品編碼 363412
出版日期 內容資訊 英文 285 Pages
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全球生技仿製藥產業分析 Analyzing the Global Biosimilars Industry 2016
出版日期: 2016年07月01日 內容資訊: 英文 285 Pages
簡介

本報告提供全球生技仿製藥產業結構、趨勢相關分析,生技仿製藥概要和特徵,整體市場規模的變化,主要的推動及阻礙市場要素,各國市場的管理體制與市場規模趨勢,主要產品及主要企業簡介,今後的市場趨勢預測等的調查評估。

摘要整理

生技仿製藥的概要

  • 生技仿製藥是什麼?
  • 產業定義:歐洲、美國、日本的情況
  • 生技仿製藥的開發
  • 生技藥品的價格競爭和「革新法」
  • 歐巴馬健保案法案的生技仿製藥相關的實驗資料保護制度
  • 生技仿製藥的特殊性質
  • 生技藥品種類與,生技仿製藥所扮演的角色
  • 為何生技仿製藥重要?
  • 生技仿製藥和仿製藥

生物醫藥品產業的概要

全球生技仿製藥產業分析

  • 市場規模 (以金額為準)
  • 市場規模 (以金額為準)
  • 品牌生技藥品的專利到期:市場規模
  • 生技仿製藥、廠商與其報酬率
  • 生技仿製藥相關市場上的不安

產業的推動因素與課題

  • 強有力的成果意向的策略
  • 企業方面的技術訣竅
  • 健全的財政平台
  • 廠商方面的收益擴大能力
  • 強有力的研究開發 (R&D) 能力
  • 行銷、銷售、流通管道
  • 醫療費削減的請求
  • 生技藥品高額的開發成本能帶來的影響
  • 主要的生技藥品的專利到期
  • 生技仿製藥和仿製藥的收益率
  • 生技藥品的成本的高度
  • 品牌生技藥品的利用數量的增加
  • 在美國、日本的認證過程
  • EMA (歐洲藥品管理局)的生技仿製藥MAb相關競標指南
  • 花費時間的競標過程
  • 參照價格
  • 回扣的不足
  • 包含醫療費負擔的必要性
  • 新興國家市場購買力小
  • 自動替代功能所扮演的角色
  • 開發成本的高度
  • 進入障礙高
  • 第二世代的生技藥品

已開發國家的生技仿製藥產業

金磚四國的生技仿製藥產業

認證途徑和管理體制

  • 概要
  • 生技仿製藥法規的目的
  • 歐洲的生技仿製藥法規
  • 日本的生技仿製藥法規
  • 美國的生技仿製藥法規
  • 歐洲的法規和美國法規比較

全球生技仿製藥產業的進入

  • 長期性的臨床實驗的時間軸
  • 生技仿製藥的認證過程的處理
  • 高額的開發費用
  • 已開發國家的生技仿製藥的價格設定
  • 在新興國家的生技仿製藥製造
  • 知識產權 (IP)的問題
  • 品牌生技藥品與市場的排他性
  • 企業間的產業聯盟的重要性
  • 企業合併、收購 (M&A) 交易

產業內地的競爭狀態

  • 現有企業
  • 供應商
  • 學名藥廠商
  • 大投資者
  • 主要的利害關係者 (相關利益者)
  • 先進國家市場與新興國家市場差異
  • 主要產品的銷售趨勢
  • 市場分析
    • 澳洲
    • 金磚四國
    • 歐洲聯盟 (法國、德國、義大利、西班牙、英國)
    • 日本
    • 美國

主要的生技仿製藥分析

  • 紅血球生成素
  • Filgrastim
  • 生長激素

專利到期伴隨的生技仿製藥的市場機會

  • 概要
  • 生技仿製藥單株抗體的市場機會
  • 第二世代生技仿製藥的市場機會

大型製藥企業對生技仿製藥的威脅的反應

  • 概要
  • Roche的策略
  • 應對胰島素生技仿製藥的威脅
  • 胰島素注射筆的創新技術
  • 胰島素、生技仿製藥的登場
  • 生技仿製藥對Sanofi SA及Novo Nordisk的影響

生技仿製藥市場分析

  • 法國
  • 德國
  • 印度
  • 義大利
  • 日本
  • 西班牙
  • 英國
  • 美國

主要企業分析

  • Biocon Limited
    • 企業分析
    • 生技仿製藥產業上的作用
    • SWOT分析
  • Dr. Reddy's Laboratories Limited
  • Hospira Inc.
  • Sandoz International
  • STADA Arzneimittel AG
  • Teva Pharmaceutical Industries
  • Watson Pharmaceuticals
  • 3SBio Inc.
  • Biopartners Gmbh
  • Celltrion Inc.
  • Intas Biopharmaceuticals
  • Kyowa Hakko Kirin
  • Reliance Life Sciences
  • Shanghai Fosun Pharmaceutical (Group) Co., Ltd
  • Wockhardt

未來展望:全球生技仿製藥產業

  • 產業預測
  • 美國的生技仿製藥市場未來展望
  • 歐洲的生技仿製藥市場未來展望
  • 日本的生技仿製藥市場未來展望
  • 產業的未來預測:生技仿製藥領域分析
  • 癌症的單株抗體
  • 促血紅細胞生長素 (EPO)的生技仿製藥的市場
  • 人體生長荷爾蒙 (hGH)的生技仿製藥的市場
  • 顆粒球 (白血球):細胞聚落刺激因子 (G-CSF)的生技仿製藥的市場
  • 胰島素/胰島素類似物的生技仿製藥
  • 干擾素α生技仿製藥
  • 干擾素β生技仿製藥
  • TNFα阻礙要素的生技仿製藥

詞彙表

圖表一覽

目錄

Biosimilars are the officially approved versions of biopharmaceutical products that are manufactured by a different company following the patent expiry of the original product. Also known as subsequent entry biologics or follow-on biologics, biosimilar drugs are gaining popularity around the world as the development cost of biosimilars is not as high as the original drug.

Also, the regulatory frameworks put in place by many countries are aiding the growth of biosimilars in the world, not to mention the lengthy tendering process of biologics that delays the actual launch of the drug. Meanwhile, biosimilar tendering is becoming more and more commonplace as the uptake of biosimilars is growing.

Aruvian Research analyzes the global biosimilars industry in its research report Analyzing the Global Biosimilars Industry 2016.

In this research report, we analyze what biosimilars are through an industry definition in the EU, US and Japan. We look at the development of biosimilars, the role of the Biologics Price Competition and Innovation Act, and the role of data exclusivity in the Patient Protection & Affordable Care Act for Biosimilars.

The specific nature of biosimilars and the types of biologics available and role of biosimilars are also analyzed, along with the importance of biosimilars and a comparison between biosimilars and generic drugs.

An overview of the biopharmaceutical industry in included in order to understand the growing importance of biosimilars.

Moving to the analysis of the global biosimilars industry, we analyze the market value, market size, upcoming patent expiries for branded biologics and the operating margins of biosimilar manufacturers. Market concerns regarding biosimilars is also included.

Factors driving the market for biosimilars, challenges and impacts on the industry, and industry growth factors, are all analyzed in this in-depth report.

We also take a look at the biosimilar market in developed markets and BRIC countries. Approval pathways and regulatory frameworks in the US, Europe, and Japan are analyzed, along with a comparison of European versus US legislation.

For companies wanting to enter the global biosimilars market, we carry out a market entry analysis through our section K of the report, Entering the Global Biosimilar Industry.

Analysis of competition in the industry is carried out through an analysis of the major industry players, industry suppliers, generic drug manufacturers, investors and stakeholders, major launches, and a country-wise analysis of the biosimilar industry. Biosimilar markets are analyzed in Australia, BRIC nations, EU, Japan, and the United States.

An analysis of Epoetin, Filgrastim, and Somatropin - the major biosimilars - is carried out, along with a look at the emerging opportunities for biosimilars due to the upcoming patent expiries.

The response of Big Pharma against the rise of biosimilars is detailed, followed by an analysis of the major markets and major industry players.

An industry forecast for the global biosimilars industry concludes our comprehensive and cutting-edge analysis of the Global Biosimilars Industry.

Table of Contents

A. Executive Summary

B. Introduction to Biosimilars

  • B.1. What are Biosimilars?
  • B.2. Industry Definition in the EU, US, & Japan
  • B.3. Development of Biosimilars
  • B.4. Biologics Price Competition and Innovation Act
  • B.5. Data Exclusivity in the Patient Protection & Affordable Care Act for Biosimilars
  • B.6. Specific Nature of Biosimilars
  • B.7. Types of Biologics & Role in Biosimilars
  • B.8. Why Biosimilars are Important?
  • B.9. Biosimilars versus Generics

C. Introduction to the Biopharmaceutical Industry

D. Analysis of the Global Biosimilars Industry

  • D.1. Market Value
  • D.2. Market Size
  • D.3. Patent Expiries for Branded Biologics: Market Value
  • D.4. Biosimilar Manufacturers & Operating Margins
  • D.5. Market Concerns Regarding Biosimilars

E. Industry Drivers & Challenges

  • E.1. Having a Strong Performance-oriented Strategy
  • E.2. Competitor Know-How
  • E.3. Sound Financial Platform
  • E.4. Having the Economics for Manufacturing Competencies
  • E.5. Strong R&D Capabilities
  • E.6. Marketing, Sales and Distribution Channels
  • E.7. Requirement for Cutting Healthcare Costs
  • E.8. High Development Costs of Biologics Having an Impact
  • E.9. Patent Expiries for Major Biologics
  • E.10. Biosimilars Profitability versus Generics
  • E.11. High Cost of Biologics
  • E.12. Increase in Use of Branded Biologics
  • E.13. US, Japan Approval Pathways
  • E.14. EMA Draft Guidelines for Biosimilar MAb
  • E.15. Lengthy Tendering Process
  • E.16. Reference Pricing
  • E.17. Lack of Rebates
  • E.18. Need to Contain Healthcare Costs
  • E.19. Low Purchasing Power in Emerging Markets
  • E.20. Role of Automatic Substitution
  • E.21. High Development Costs
  • E.22. High Entry Barriers
  • E.23. Second Generation Biologic Drugs

F. Biosimilar Industry in Developed Markets

G. Biosimilars Industry in BRIC Countries

H. Approval Pathways & Regulatory Framework

  • H.1. Overview
  • H.2. Objectives of Biosimilar Legislations
  • H.3. Biosimilar Regulations in Europe
  • H.4. Biosimilar Regulations in Japan
  • H.5. Biosimilar Regulations in the US
  • H.6. European Regulations versus US Legislation

I. Entering the Global Biosimilar Industry

  • I.1. Long Clinical Development Timeline
  • I.2. Dealing with Biosimilar Approval Pathways
  • I.3. High Cost of Development
  • I.4. Pricing of Biosimilars in Developed Markets
  • I.5. Biosimilars Manufacturing in Emerging Markets
  • I.6. Intellectual Property Issues
  • I.7. Branded Biologics and Market Exclusivity
  • I.8. Importance of Corporate Partnerships
  • I.9. Merger & Acquisition Deals

J. Competition in the Industry

  • J.1. Players in the Industry
  • J.2. Industry Suppliers
  • J.3. Generic Drug Manufacturers
  • J.4. Large Investors
  • J.5. Major Stakeholders
  • J.6. Differences between Developed and Emerging Markets
  • J.7. Major Launches
  • J.8. Market Analysis
    • J.8.1. Australia
    • J.8.2. BRIC Nations
    • J.8.3. European Union (France, Germany, Italy, Spain, the UK)
    • J.8.4. Japan
    • J.8.5. United States

K. Analyzing Major Biosimilars

  • K.1. Epoetin
  • K.2. Filgrastim
  • K.3. Somatropin

L. Opportunities for Biosimilars with the Patent Expiries

  • L.1. Overview
  • L.2. Opportunities for Biosimilar Monoclonal Antibodies
  • L.3. Opportunities for Second Generation Biosimilars

M. Big Pharma Responds to Biosimilar Threat

  • M.1. Overview
  • M.2. Strategy of Roche
  • M.3. Dealing with the Threat of Insulin Biosimilars
  • M.4. Cutting-edge Technology of Insulin Injector Pens
  • M.5. Emergence of Insulin Biosimilars
  • M.6. Impact of Biosimilars on Sanofi SA and Novo Nordisk

N. Biosimilar Market Analysis

  • N.1. France
  • N.2. Germany
  • N.3. India
  • N.4. Italy
  • N.5. Japan
  • N.6. Spain
  • N.7. United Kingdom
  • N.8. United States

O. Analyzing the Major Players

  • O.1. Biocon Limited
    • O.1.1. Corporate Analysis
    • O.1.2. Role in the Biosimilars Industry
    • O.1.3. SWOT Analysis
  • O.2. Dr. Reddy's Laboratories Limited
    • O.2.1. Corporate Analysis
    • O.2.2. Role in Biosimilars Industry
    • O.2.3. SWOT Analysis
  • O.3. Hospira Inc.
    • O.3.1. Corporate Analysis
    • O.3.2. Role in the Biosimilars Industry
    • O.3.3. SWOT Analysis
  • O.4. Sandoz International
    • O.4.1. Corporate Analysis
    • O.4.2. Role in the Biosimilars Industry
    • O.4.3. SWOT Analysis
  • O.5. STADA Arzneimittel AG
    • O.5.1. Corporate Analysis
    • O.5.2. Role in the Biosimilars Industry
    • O.5.3. SWOT Analysis
  • O.6. Teva Pharmaceutical Industries
    • O.6.1. Corporate Analysis
    • O.6.2. Role in the Biosimilars Industry
    • O.6.3. SWOT Analysis
  • O.7. Watson Pharmaceuticals
    • O.7.1. Corporate Analysis
    • O.7.2. Role in the Biosimilars Industry
    • O.7.3. SWOT Analysis
  • O.8. 3SBio Inc.
  • O.9. Biopartners Gmbh
  • O.10. Celltrion Inc.
  • O.11. Intas Biopharmaceuticals
  • O.12. Kyowa Hakko Kirin Co., Ltd.
  • O.13. Reliance Life Sciences
  • O.14. Shanghai Fosun Pharmaceutical (Group) Co., Ltd
  • O.15. Wockhardt

P. Future Perspective: Global Biosimilars Industry

  • P.1. Industry Forecast
  • P.2. US Biosimilars Market Outlook
  • P.3. European Biosimilars Market Outlook
  • P.4. Japan Biosimilars Market Outlook
  • P.5. Forecast for the Industry: Analysis of Biosimilar Segments
  • P.6. Monoclonal Antibodies against Cancer
  • P.7. Erythropoietin (EPO) Biosimilars Markets
  • P.8. Human Growth Hormone (hGH) Biosimilars Markets
  • P.9. Granulocyte - Colony Stimulating Factor (G-CSF) Biosimilars Markets
  • P.10. Insulin and Insulin Analogs Biosimilars
  • P.11. Interferon alfa Biosimilars
  • P.12. Interferon beta Biosimilars
  • P.13. TNF alfa Inhibitor Biosimilars

Q. Glossary

List of Figures

  • Figure 1: Comparison of Biosimilars with Biosimilar Antibodies
  • Figure 2: Categories of Biosimilars Players
  • Figure 3: Characteristics of Biosimilar Players
  • Figure 4: Chromatographic Differences between a Monoclonal Antibody and its Biosimilar
  • Figure 5: Complexity of Biologics
  • Figure 6: Medicare Coverage for Biologic Drugs
  • Figure 7: Imminent Biosimilar Opportunities, 2015
  • Figure 8: Comparison of Biosimilars with Generics
  • Figure 9: Development Costs and Timelines for a Biosimilar
  • Figure 10: Global Biologics Market Forecast, (in USD Billion), 2010-2019
  • Figure 11: Share of Top 25 Biologics by Therapeutic Class, 2015
  • Figure 12: Growth for Biologics
  • Figure 13: Share of Top 25 Biologics by Production System, 2015
  • Figure 14: Biologics under Development by Therapeutic Class, Global, 2015
  • Figure 15: Biologics under Development by Disease Category, Global (%), 2015
  • Figure 16: Difference between the Distribution Chains for Small Molecule and Biologic Drugs
  • Figure 17: Challenges and their Solutions in Biopharmaceutical Manufacturing
  • Figure 18: Biosimilar Market Size: US, France, Germany, Italy, Spain & the UK (in USD Million), 2015
  • Figure 19: Value of Branded Biologics that have Lost Patent between 2008-2015
  • Figure 20: Success Factors in the Biosimilar Industry
  • Figure 21: Biosimilar Market Drivers & Challenges
  • Figure 22: Rising Expenditure on Pharmaceuticals (Historical)
  • Figure 23: Increase in Elderly Population Indicates Rising Healthcare Expenses
  • Figure 24: Inflation in Prescription Drug Prices in the US (Historical)
  • Figure 25: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, (in USD Million)
  • Figure 26: Factors Impacting the Global Biosimilar Industry
  • Figure 27: Factors Impacting the Biosimilar Market in BRIC Countries
  • Figure 28: Objectives of Biosimilar Legislation and Regulatory Frameworks
  • Figure 29: Drug Approval Process in Europe
  • Figure 30: Evolution of Regulatory Pathway for Approval of Biosimilars in Europe
  • Figure 31: Approval Process for Biosimilars in Europe
  • Figure 32: Data and Market Exclusivity Periods in Europe
  • Figure 33: Comparability Exercises
  • Figure 34: Number of Biosimilar Applications in Europe (2009-2014)
  • Figure 35: Evolution of Regulatory Pathway in Japan
  • Figure 36: Regulatory Bodies for Biologics in the US
  • Figure 37: Drug Development and Approval Process in the US
  • Figure 38: Evolution of Regulatory Pathway in the US
  • Figure 39: Patent Litigation Provisions in BPCIA - Round 1
  • Figure 40: Patent Litigation Provisions in BPCIA - Round 2
  • Figure 41: Development Timeline for Biosimilars in the EU
  • Figure 42: Issues Facing Biosimilars Manufacturing in Emerging Countries
  • Figure 43: Comparison of Capabilities of Market Entrants
  • Figure 44: Breakdown of the Biosimilars Market in 2015 (€250m total)
  • Figure 45: Approvals of Biosimilars in BRIC Countries, 2015
  • Figure 46: Region-wise Sales of Major Biologics - Expired & to come Off-patent (2011-2015)
  • Figure 47: Expected Sales of Major Biologics - Expired & to come Off-patent (2011-2015)
  • Figure 48: Biosimilars Under Development (by type) Worldwide
  • Figure 49: Biosimilars under Development (by Region) Worldwide
  • Figure 50: Factors Impacting Market Entry of Biosimilar Monoclonal Antibody
  • Figure 51: Sales in Europe / USA of Roche's Biological Products (first 9 months of 2015; in CHF million)
  • Figure 52: Patent Expiries per Year (Europe / USA Sales of Biologics, in CHF million)
  • Figure 53: Insulin Market With and Without Biosimilars ($m)
  • Figure 54: Novo Nordisk's Diabetes Franchise Sales (DKKm)
  • Figure 55: Sales in the Lantus Franchise (€m)
  • Figure 56: Drivers & Challenges for Biosimilars in the French Market
  • Figure 57: Drivers & Challenges for Biosimilars in the German Market
  • Figure 58: Drivers & Challenges for Biosimilars in the Italian Market
  • Figure 59: Drivers & Challenges for Biosimilars in the Japanese Market
  • Figure 60: Drivers & Challenges for Biosimilars in the Spanish Market
  • Figure 61: Drivers & Challenges for Biosimilars in the UK Market
  • Figure 62: Drivers & Challenges for Biosimilars in the US Market
  • Figure 63: US Biosimilar Market Forecast, ($m), 2013-2020
  • Figure 64: European Biosimilar Market Forecast, ($m), 2013-2020
  • Figure 65: Japanese Biosimilar Market Forecast, ($m), 2013-2020
  • Figure 66: Market Opportunities for mAb against Cancer Biosimilars, ($m), 2013-2020
  • Figure 67: Expected Market Share in 2020 (%)
  • Figure 68: EPO Biosimilars Market Forecasts, ($m), 2013-2020
  • Figure 69: hGH Biosimilars Market Forecasts, ($m), 2013-2020
  • Figure 70: G-CSF Biosimilars Market Forecasts, ($m), 2013-2020
  • Figure 71: Market Opportunities for Insulin and Insulin Analogs Biosimilars, ($m), 2013-2020
  • Figure 72: Market Opportunities for Interferon alfa Biosimilar, ($m), 2013-2017
  • Figure 73: Market Opportunities for Interferon beta Biosimilar, ($m), 2013-2017
  • Figure 74: Market Opportunities for TNF alfa Inhibitor Biosimilars, ($m), 2013-2020

List of Tables

  • Table 1: Major Categories of Biological Products
  • Table 2: Key Patent Expiries
  • Table 3: Medicare Formulary Coverage for Top-Selling Biologics
  • Table 4: Comparison of Small Molecule Drugs and Biologics
  • Table 5: Biosimilar Market Size: US, France, Germany, Italy, Spain, & the UK, (in USD Billion), 2015
  • Table 6: Operating Margins for Branded Biologics, Branded Prescription Drugs, & Generic Companies
  • Table 7: Cost Comparison for a Biosimilar
  • Table 8: Patent Expiry for Major Biologic Drugs, 2010-2016
  • Table 9: Approximated Savings to be gained with the use of Biosimilar Drugs
  • Table 10: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, (in USD Million)
  • Table 11: Patients in Clinical Trials for Marketed Biosimilars
  • Table 12: Existing Guidelines for Biosimilars in Europe
  • Table 13: Biosimilar Approvals in Europe
  • Table 14: Applications Rejected or Withdrawn (Historical)
  • Table 15: Biosimilar Approval Pathways
  • Table 16: Costs Associated with Biosimilars Development and Registration in EU. Japan, US, and BRIC Countries (in USD Million, 2015)
  • Table 17: Differences in Discount compared to Reference Brand Costs in Key Markets (%), 2015
  • Table 18: Biosimilar Deals of Pharma Companies
  • Table 19: Success Criteria for Generic Drug Producers
  • Table 20: Growth Strategies at Sandoz
  • Table 21: Cost-Sharing Practices by Health Insurers in the US
  • Table 22: Leading Biosimilar Players in Japan, France, Germany, Italy, Spain and the UK, 2015
  • Table 23: Leading Biosimilars Companies in India and China, 2015
  • Table 24: Approvals of Biosimilars in Australia
  • Table 25: Status of Biosimilars in 5 EU Markets
  • Table 26: Approvals of Biosimilars in Japan
  • Table 27: Patent Expiries of Biologics in the US
  • Table 28: Patent Expiries of Biologics in EU 5
  • Table 29: Patent Expiries of Biologics in Japan
  • Table 30: Roche's Strategy for Ensuring the Long-Term Survival of its Biological Products
  • Table 31: Roche Treatment Protocols
  • Table 32: Phase II Results for T-DM1
  • Table 33: Patent Expiries on the Main Insulins
  • Table 34: Biosimilar Product Portfolio of Hospira
  • Table 35: Biosimilar Product Portfolio of Sandoz/Hexal
  • Table 36: Biosimilar Product Portfolio of STADA
  • Table 37: Biosimilar Product Portfolio of Teva
  • Table 38: US Biosimilar Market Forecast, ($m), 2013-2020
  • Table 39: European Biosimilar Market Forecast, ($m), 2013-2020
  • Table 40: Japanese Biosimilar Market Forecast, ($m), 2013-2020
  • Table 41: Market Opportunities for mAb against Cancer Biosimilars, ($m), 2013-2020
  • Table 42: EPO Biosimilars Market Forecasts, ($m), 2013-2020
  • Table 43: hGH Biosimilars Market Forecasts, ($m), 2013-2020
  • Table 44: G-CSF Biosimilars Market Forecasts, ($m), 2013-2020
  • Table 45: Market Opportunities for TNF alfa Inhibitor Biosimilars, ($m), 2013-2020
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