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市場調査レポート

ジェネリック医薬品の世界市場

Global Markets for Generic Drugs

発行 BCC Research 商品コード 210210
出版日 ページ情報 英文 155 Pages
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ジェネリック医薬品の世界市場 Global Markets for Generic Drugs
出版日: 2017年02月13日 ページ情報: 英文 155 Pages
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概要

世界のジェネリック医薬品市場規模は、2016年から2021年にかけて8.7%のCAGR (年間複合成長率) で推移し、2016年の3,520億米ドルから2021年までに5,330億米ドルに達すると予測されています。

当レポートでは、世界のジェネリック医薬品市場について取り上げ、世界市場の概要、世界市場の動向分析と市場規模の推計・予測、主要企業の戦略、製品分類・主要国市場別による重要な動向の議論、および主要企業のプロファイルなどを提供しています。

第1章 イントロダクション

第2章 サマリー

  • 市場規模と発展

第3章 概要

  • ジェネリック医薬品部門の近年の歴史
    • ROCHE-BOLAR
    • GENERICS LOBBY
    • ICH

第4章 新しいジェネリック医薬品の時代

  • 特許失効
  • ジェネリック医薬品の種類
    • 一般的なジェネリック医薬品
    • スーパージェネリック医薬品
    • バイオシミラー
    • 特別な課題
    • バイオシミラー市場

第5章 主なジェネリック医薬品の問題

  • 規制環境
    • 米国
    • EU
    • 日本
    • バイオシミラーの規制
    • 「大手製薬企業」による守備的戦略
    • 認可ジェネリック医薬品
      • ユーザーの料金
      • ジェネリック医薬品の変化する環境
      • 欧州における状況
  • 特許・IP
    • 追加保護証明書(SPC)

第6章 ジェネリック医薬品市場

  • 世界の医薬品・ジェネリック医薬品市場
    • 世界のジェネリック医薬品市場
    • ジェネリック医薬品市場の主要国
  • 市場機会:製品クラス別
    • 主なジェネリック医薬品の分子
      • 抗感染薬
      • 心血管製品
      • 抗関節炎薬
      • 呼吸器製品
      • 抗がん剤

第7章 ジェネリック医薬品市場・予測:国別

  • 南北アメリカ
    • 米国
    • カナダ
    • ブラジル
  • アジア
    • 日本
    • インド
    • 中国
  • 欧州
    • フランス
    • ドイツ
    • イタリア
    • スペイン
    • 英国
    • ロシア

第8章 世界のジェネリック医薬品産業

  • 動向
  • ジェネリック医薬品産業の構造
  • 近年のM&A活動
  • ブランド企業の関与
  • 主要ジェネリック医薬品企業のプロファイル
    • ACTAVIS (TEVA)
    • ASPEN PHARMACARE HOLDINGS LTD.
    • CIPLA LTD.
    • FRESENIUS KABI
    • HOSPIRA INC.
    • LUPIN, LTD.
    • MYLAN INC.
    • SANDOZ INTERNATIONAL GMBH
    • SANOFI
    • SUN PHARMACEUTICAL INDUSTRIES LTD.
    • TEVA PHARMACEUTICAL INDUSTRIES LTD.
  • その他の国際的ジェネリック医薬品企業
    • DR. REDDY'S LABORATORIES LTD.
    • AUROBINDO PHARMA LTD.
    • EGIS PHARMACEUTICALS PLC
    • KRKA
    • PAR PHARMACEUTICAL, INC.
    • STADA ARZNEIMITTEL
    • STRIDES SHASUN LTD.
    • WOCKHARDT LTD.
    • ZYDUS CADILA

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目次
Product Code: PHM009H

The global market for generic drugs should reach $533 billion by 2021 from $352 billion in 2016 at a compound annual growth rate (CAGR) of 8.7%, from 2016 to 2021.

Report Includes

  • An overview of the global markets for generic drugs, including coverage of therapeutics such as antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs (e.g., hypolipidaemics and antihypertensives), and drugs for respiratory conditions, including asthma and COPD
  • Analyses of global market trends, with data from 2015, estimates for 2016, and projections of compound annual growth rates (CAGRs) through 2021
  • Examination of strategies employed by companies specializing in generics to meet the challenges of this highly competitive market, while also summarizing strategies employed by "originator" companies to forestall generic competition
  • Discussion of important trends by product categories and major country markets, acknowledging that Brazil, China, India, Mexico, and Russia are among the rising markets for generic activity
  • Profiles of major players and leading generics companies
  • A look at recent merger and acquisition activity

Report Scope

This report discusses the implications of all the above-mentioned trends, in the context of the current size and growth of the generics market, both in global terms and analyzed by the most important national markets. The nature and structure of the generics industry is discussed, with profiles of the leading 20+ generics companies and an update on M&A activity. Five-year sales forecasts are provided for the national markets and the major therapeutic categories of products involved.

Analyst Credentials

Paul Evers has been involved in analyzing pharmaceutical and medical markets for 20 years. He is the author of three previous reports on the generics marketplace as well as analyses of major therapeutic categories and the pharmaceutical regulatory environment.

Table of Contents

CHAPTER 1 INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • SCOPE OF REPORT
  • MARKET ANALYSES AND FORECASTS
  • METHODOLOGY
  • INTENDED AUDIENCE
  • INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 SUMMARY

  • MARKET SIZE AND EVOLUTION
  • SUMMARY TABLE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, THROUGH 2021 ($ BILLIONS)
  • SUMMARY FIGURE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, 2014-2021 ($ BILLIONS)

CHAPTER 3 OVERVIEW

  • TABLE 1 GLOBAL PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS)
  • RECENT HISTORY OF THE GENERICS SECTOR
    • ROCHE-BOLAR
    • GENERICS LOBBY
    • ICH

CHAPTER 4 THE NEW GENERICS ERA

  • THE PATENT CLIFF
  • TABLE 2 MAJOR RECENT AND UPCOMING PATENT EXPIRIES, 2014-2020
  • TABLE 3 BRAND SALES BEFORE AND AFTER PATENT EXPIRY ($ MILLIONS)
  • TYPES OF GENERICS
    • SIMPLE GENERICS
      • Adequate Market Size
      • Patent-expired Therapies
      • Older Products Still Used
      • Long-term Use
      • Straightforward Production Technology
      • Drugs Used in Primary Care
    • SUPERGENERICS
    • BIOSIMILARS
    • TABLE 4 BIOTHERAPEUTICS AMONG TOP 40 PRESCRIPTION PHARMACEUTICALS, 2015 ($ BILLIONS)
    • TABLE 5 BIOLOGICS WITH RECENT OR UPCOMING LOSS OF PATENT PROTECTION
    • SPECIAL CHALLENGES
    • THE BIOSIMILARS MARKET
      • Biosimilar Developments and Introductions
        • EPO
        • G-CSF
        • Interferons
        • hGH
        • Monoclonal Antibodies

CHAPTER 5 MAJOR GENERIC ISSUES

  • REGULATORY ENVIRONMENT
    • UNITED STATES
    • TABLE 6 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS
    • EUROPEAN UNION
      • EU Marketing Authorization Systems
      • The Centralized Procedure
      • Decentralized and Mutual Recognition Procedures
      • Mutual Recognition Procedure
      • Types of Applications
      • Applications Under Article 10 (Generic Products)
    • JAPAN
      • Approval of Pharmaceuticals
    • REGULATION OF BIOSIMILARS
      • EU Provisions
      • Evolving Situation in the U.S.
        • User Fees
      • Hatch-Waxman and Bolar
    • DEFENSIVE STRATEGIES BY "BIG PHARMA"
    • AUTHORIZED GENERICS
      • User Fees
      • Changing Climate for Generics
      • Situation in Europe
  • PATENTS AND IP
    • SUPPLEMENTARY PROTECTION CERTIFICATES

CHAPTER 6 THE GENERICS MARKET

  • GLOBAL PHARMACEUTICAL AND GENERICS MARKET
    • GLOBAL GENERICS MARKET
    • MAIN NATIONAL GENERICS MARKETS
    • TABLE 7 GLOBAL MARKET FOR PHARMA AND GENERIC DRUGS, THROUGH 2021 ($ BILLIONS)
    • TABLE 8 GLOBAL MARKET FOR GENERIC DRUGS, BY COUNTRY, THROUGH 2021 ($ BILLIONS)
  • MARKET OPPORTUNITIES BY PRODUCT CLASS
    • LEADING GENERIC MOLECULES
    • TABLE 9 TOP 20 GENERIC MOLECULES, BY PRESCRIPTION SALES, 2015 ($ BILLIONS)
    • TABLE 10 GLOBAL TOP-SELLING PRESCRIPTION PHARMACEUTICALS
      • Anti-infectives
      • TABLE 11 LEADING ANTI-INFECTIVE PRODUCT SALES, 2015 ($ MILLIONS)
        • CNS Therapies
        • Antidepressants
        • Antipsychotics
        • TABLE 12 LEADING CNS PRODUCT SALES, 2015 ($ MILLIONS)
        • Anxiolytics
        • Sleep Disorders
        • Epilepsy
        • Parkinson's Disease
        • Migraine
      • Cardiovascular Products
      • TABLE 13 LEADING CARDIOVASCULAR PRODUCT SALES, 2015 ($ MILLIONS)
      • Anti-arthritis Products
        • Steroids
        • NSAIDs
        • COX-II Inhibitors
        • DMARDs
        • TABLE 14 LEADING ANTI-ARTHRITIS PRODUCT SALES, 2015 ($ MILLIONS)
      • Respiratory Products
        • Asthma
        • COPD
        • Allergic Rhinitis
        • Bronchodilators
          • Inhaled bronchodilators
          • Anticholinergics
          • Oral bronchodilators
          • Leukotriene antagonists
          • Steroids
          • FIGURE 1 GLOBAL MARKET SHARE OF ASTHMA PRODUCT CATEGORIES (%)
          • TABLE 15 LEADING RESPIRATORY PRODUCT SALES, 2015 ($ MILLIONS)
      • Anticancer Products
        • Cytotoxic Drugs
        • Hormonal Therapy
        • Biologic Response Modifiers
        • Anti-angiogenesis Drugs
        • Monoclonal Antibodies
        • TABLE 16 LEADING ANTICANCER PRODUCT SALES, 2015 ($ MILLIONS)

CHAPTER 7 GENERICS MARKETS AND FORECASTS BY COUNTRY

  • AMERICAS
    • UNITED STATES
      • Vital Statistics
      • Health and Healthcare
      • Pharmaceutical Market
      • TABLE 17 U.S. PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
      • Generics Market
        • Biosimilars
        • Generic Prices
        • Carve-outs
        • Generics Industry
        • The Future
    • CANADA
      • Vital Statistics
      • Pharmaceutical Market
        • TABLE 18 CANADA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
          • Generics Market
            • Prices of Generics
            • How Generics Are Supplied
    • BRAZIL
      • Vital Statistics
      • Pharmaceutical Market
      • TABLE 19 BRAZIL'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Generics Market
        • M&A Activity
        • Future Prospects
        • ProGenericos
  • ASIA
    • JAPAN
      • Vital Statistics
      • Health and Healthcare
      • Pharmaceutical Market
      • TABLE 20 JAPAN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
      • TABLE 21 TOP 25 JAPANESE PHARMA COMPANIES ($ MILLIONS/%)
      • Generics Market
        • Generics Industry
    • INDIA
      • Vital Statistics
      • Health and Healthcare
        • Growing Affluence - Changing Medical Needs
      • Pharmaceutical Market
      • TABLE 22 INDIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Pharma Industry
        • Patent Reform
        • Generics Industry
        • TABLE 23 LEADING PHARMA COMPANIES IN INDIA, 2012 ($ MILLIONS)
    • CHINA
      • Vital Statistics
      • Health and Healthcare
      • Pharmaceutical Market
        • TABLE 24 CHINA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Domestic Industry
        • Foreign Company Involvement
        • Importance of R&D
        • Challenges
        • Market Trends
        • Regulatory Changes
        • Generics Exports
        • Domestic Generics Market
        • Local Dominance
  • EUROPE
    • FRANCE
      • Vital Statistics
      • Health and Healthcare
        • Healthcare Provision
        • FIGURE 2 HEALTH EXPENDITURE IN MAJOR EUROPEAN MARKETS AND THE U.S., 2014 (PERCENTAGE OF GDP)
      • Pharmaceutical Market
      • TABLE 25 FRANCE'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Generics Market
    • GERMANY
      • Vital Statistics
      • Health and Healthcare
        • Provision of Healthcare
      • Pharmaceutical Market
        • Price Controls
        • TABLE 26 GERMANY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Generics Market
    • ITALY
      • Vital Statistics
      • Health and Healthcare
      • Healthcare System
      • Pharmaceutical Market
      • TABLE 27 ITALY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Pharmaceutical Industry
        • Generics Market
    • SPAIN
      • Vital Statistics
      • Health and Healthcare
        • Healthcare Provision
        • Pharmaceutical Services
      • Pharmaceutical Market
      • TABLE 28 SPAIN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • Generics Market
          • Generics Industry
          • TABLE 29 LEADING GENERICS COMPANIES IN SPAIN, 2015 ($ MILLIONS)
    • UNITED KINGDOM
      • Vital Statistics
      • Health and Healthcare
        • Healthcare Provision
          • Private Sector Involvement
        • Pharmaceuticals
      • Pharmaceutical Market
      • TABLE 30 LEADING PHARMA COMPANIES IN THE U.K., BY MARKET SHARE, 2013 (%)
        • Generics Market
        • TABLE 31 U.K.'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
    • RUSSIA
      • Vital Statistics
      • Health and Healthcare
        • Healthcare Delivery
      • Pharmaceutical Market
        • Pharma 2020
        • TABLE 32 RUSSIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
        • TABLE 33 LEADING PHARMA COMPANIES IN RUSSIA, BY MARKET SHARE, 2012 (%)
        • Generics Market

CHAPTER 8 THE GLOBAL GENERICS INDUSTRY

  • TABLE 34 LEADING GENERICS COMPANIES, BY SALES, 2015 ($ BILLIONS)
  • TRENDS
  • STRUCTURE OF THE GENERICS INDUSTRY
  • RECENT M&A ACTIVITY
  • BRAND COMPANY INVOLVEMENT
  • PROFILES OF THE LEADING GENERICS COMPANIES
    • ACTAVIS (TEVA)
    • ASPEN PHARMACARE HOLDINGS LTD.
    • CIPLA LTD.
    • FRESENIUS KABI
    • HOSPIRA INC.
      • Biogenerics
      • Financials
    • LUPIN, LTD.
    • MYLAN INC.
    • SANDOZ INTERNATIONAL GMBH
      • Products
    • SANOFI
    • SUN PHARMACEUTICAL INDUSTRIES LTD.
    • TEVA PHARMACEUTICAL INDUSTRIES LTD.
      • Financials
  • OTHER INTERNATIONAL GENERICS COMPANIES
    • DR. REDDY'S LABORATORIES LTD.
    • AUROBINDO PHARMA LTD.
    • EGIS PHARMACEUTICALS PLC
      • APIs
    • KRKA
      • Products
    • PAR PHARMACEUTICAL, INC.
      • Generics
    • STADA ARZNEIMITTEL
      • Generics
      • Biosimilars
    • STRIDES SHASUN LTD.
    • WOCKHARDT LTD.
    • ZYDUS CADILA

LIST OF TABLES

  • SUMMARY TABLE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, THROUGH 2021 ($ BILLIONS)
  • TABLE 1 GLOBAL PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS)
  • TABLE 2 MAJOR RECENT AND UPCOMING PATENT EXPIRIES, 2014-2020
  • TABLE 3 BRAND SALES BEFORE AND AFTER PATENT EXPIRY ($ MILLIONS)
  • TABLE 4 BIOTHERAPEUTICS AMONG TOP 40 PRESCRIPTION PHARMACEUTICALS, 2015 ($ BILLIONS)
  • TABLE 5 BIOLOGICS WITH RECENT OR UPCOMING LOSS OF PATENT PROTECTION
  • TABLE 6 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS
  • TABLE 7 GLOBAL MARKET FOR PHARMA AND GENERIC DRUGS, THROUGH 2021 ($ BILLIONS)
  • TABLE 8 GLOBAL MARKET FOR GENERIC DRUGS, BY COUNTRY, THROUGH 2021 ($ BILLIONS)
  • TABLE 9 TOP 20 GENERIC MOLECULES, BY PRESCRIPTION SALES, 2015 ($ BILLIONS)
  • TABLE 10 GLOBAL TOP-SELLING PRESCRIPTION PHARMACEUTICALS
  • TABLE 11 LEADING ANTI-INFECTIVE PRODUCT SALES, 2015 ($ MILLIONS)
  • TABLE 12 LEADING CNS PRODUCT SALES, 2015 ($ MILLIONS)
  • TABLE 13 LEADING CARDIOVASCULAR PRODUCT SALES, 2015 ($ MILLIONS)
  • TABLE 14 LEADING ANTI-ARTHRITIS PRODUCT SALES, 2015 ($ MILLIONS)
  • TABLE 15 LEADING RESPIRATORY PRODUCT SALES, 2015 ($ MILLIONS)
  • TABLE 16 LEADING ANTICANCER PRODUCT SALES, 2015 ($ MILLIONS)
  • TABLE 17 U.S. PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 18 CANADA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 19 BRAZIL'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 20 JAPAN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 21 TOP 25 JAPANESE PHARMA COMPANIES ($ MILLIONS/%)
  • TABLE 22 INDIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 23 LEADING PHARMA COMPANIES IN INDIA, 2012 ($ MILLIONS)
  • TABLE 24 CHINA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 25 FRANCE'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 26 GERMANY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 27 ITALY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 28 SPAIN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 29 LEADING GENERICS COMPANIES IN SPAIN, 2015 ($ MILLIONS)
  • TABLE 30 LEADING PHARMA COMPANIES IN THE U.K., BY MARKET SHARE, 2013 (%)
  • TABLE 31 U.K.'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 32 RUSSIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021 ($ BILLIONS/%)
  • TABLE 33 LEADING PHARMA COMPANIES IN RUSSIA, BY MARKET SHARE, 2012 (%)
  • TABLE 34 LEADING GENERICS COMPANIES, BY SALES, 2015 ($ BILLIONS)

LIST OF FIGURES

  • SUMMARY FIGURE GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, 2014-2021 ($ BILLIONS)
  • FIGURE 1 GLOBAL MARKET SHARE OF ASTHMA PRODUCT CATEGORIES (%)
  • FIGURE 2 HEALTH EXPENDITURE IN MAJOR EUROPEAN MARKETS AND THE U.S., 2014 (PERCENTAGE OF GDP)
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