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市場調查報告書

學名藥的全球市場

Global Markets for Generic Drugs

出版商 BCC Research 商品編碼 210210
出版日期 內容資訊 英文 155 Pages
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學名藥的全球市場 Global Markets for Generic Drugs
出版日期: 2017年02月13日 內容資訊: 英文 155 Pages
簡介

全球學名藥市場規模,預計從2016年到2021年以8.7%的年複合成長率發展,從2016年的3,520億美元到2021年達到5,330億美元。

本報告以全球學名藥市場為研究主題,提供由於全球市場概要,世界市場趨勢分析與市場規模的估計、預測,主要企業的策略,各產品分類、主要國家市場的重要的趨勢的議論,及主要企業簡介等資訊。

第1章 簡介

第2章 摘要

  • 市場規模與發展

第3章 概要

  • 學名藥部門的近幾年的歷史
    • ROCHE-BOLAR
    • GENERICS LOBBY
    • ICH

第4章 新學名藥的時代

  • 專利失效
  • 學名藥的種類
    • 一般學名藥
    • 超級學名藥
    • 生技仿製藥
    • 特別的課題
    • 生技仿製藥市場

第5章 主要學名藥的問題

  • 法規環境
    • 美國
    • EU
    • 日本
    • 生技仿製藥的法規
    • 「大型製藥企業」的守備策略
    • 認證學名藥
      • 用戶的費用
      • 學名藥變化的環境
      • 歐洲的情形
  • 專利、IP
    • 補充保護證書(SPC)

第6章 學名藥市場

  • 全球醫藥品、學名藥市場
    • 全球學名藥市場
    • 學名藥市場主要國家
  • 市場機會:各產品類別
    • 主要的學名藥的分子
      • 抗感染藥
      • 心血管產品
      • 抗關節炎藥
      • 呼吸系統產品
      • 抗癌劑

第7章 學名藥市場、預測:各國

  • 南北美洲
    • 美國
    • 加拿大
    • 巴西
  • 亞洲
    • 日本
    • 印度
    • 中國
  • 歐洲
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
    • 俄羅斯

第8章 全球學名藥產業

  • 趨勢
  • 學名藥產業結構
  • 近幾年的M&A活動
  • 品牌企業的參與
  • 主要學名藥企業簡介
    • 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.
  • 其他的國際學名藥企業
    • DR. REDDY'S LABORATORIES LTD.
    • AUROBINDO PHARMA LTD.
    • EGIS PHARMACEUTICALS PLC
    • KRKA
    • PAR PHARMACEUTICAL, INC.
    • STADA ARZNEIMITTEL
    • STRIDES SHASUN LTD.
    • WOCKHARDT LTD.
    • ZYDUS CADILA

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
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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