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Global Markets for Generic Drugs

Global Markets for Generic Drugs

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.

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
AUROBINDO PHARMA LTD.
DR. REDDY'S LABORATORIES LTD.
EGIS PHARMACEUTICALS PLC
APIs
KRKA
Products
PAR PHARMACEUTICAL, INC.
Generics
STADA ARZNEIMITTEL
Generics
Biosimilars
STRIDES SHASUN LTD.
WOCKHARDT LTD.
ZYDUS CADILA

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