Global Generic Drugs Market Size:
The Global Generic Drugs Market should reach USD 533 billion by 2021 from USD 352 billion in 2016 at a compound annual growth rate (CAGR) of 8.7%, from 2016 to 2021.
Global Generic Drugs Market Overview:
As patents expire, pharmaceutical brand companies can hardly focus on extending the life cycle of products. Therefore, the generic market has developed and is expected to grow considerably, especially between 2012 and 2018. Generic drugs are drugs with the same chemical composition and performance characteristics like those of their variants. Unlike flagship or branded drugs, generic drugs are marketed under the name of their chemical titles without marketing.
The market report provides a holistic picture of the global generic drugs market. The market is evaluated in terms of different product segments, retail distribution channels, supply chain networks, and consumer groups to provide strategic and specific business recommendations. The data and the revealing statistics presented in the report improve stakeholders' understanding of the dynamics of the existing market and how they are likely to affect their future action plan.
Drivers and Restraints:
The cheap prices of generic drugs give added advantage over branded drugs in the market. Generic drugs are governed by the same framework as branded drugs. The generic market is based on the premise that patented drugs have a shelf life of 20 years beginning with the clinical trials phase. This reduces the commercial life of patented medicines to around 15 years. After the expiration of the patent, manufacturers of branded drugs face fierce competition from contemporary generics.
In addition, participants in the network of the supply chain of the industry, such as wholesalers, retailers, pharmacies and profit managers, also benefit from the sale of generic drugs, as they significantly increase their profit margin. This has become a key growth factor for the generic drug market.
As generic competition represents a significant threat to the branded drug industry, innovative companies have adopted stronger defense strategies than ever before to protect their market share and profits. However, this has not prevented the main players in the generic market advance in their plans to expand the market. By looking closely at the defensive strategies carried out by brand name pharmaceutical companies, the generic industry is not only armed to survive patent battles but is also adopting licensing and association strategies to launch new products. These factors should boost sales of generic drugs in the coming years.
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 are 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.
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., hypolipidaemic 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
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
Chapter 3 OVERVIEW
Chapter 4 THE NEW GENERICS ERA
Chapter 5 MAJOR GENERIC ISSUES
Chapter 6 THE GENERICS MARKET
Chapter 7 GENERICS MARKETS AND FORECASTS BY COUNTRY
Chapter 8 THE GLOBAL GENERICS INDUSTRY
MARKET SIZE AND EVOLUTION
RECENT HISTORY OF THE GENERICS SECTOR
ROCHE-BOLAR
GENERICS LOBBY
ICH
THE PATENT CLIFF
TYPES OF GENERICS
SIMPLE GENERICS
SUPERGENERICS
BIOSIMILARS
SPECIAL CHALLENGES
THE BIOSIMILARS MARKET
Adequate Market Size
Patent-expired Therapies
Older Products Still Used
Long-term Use
Straightforward Production Technology
Drugs Used in Primary Care
Biosimilar Developments and Introductions
EPO
G-CSF
Interferons
hGH
Monoclonal Antibodies
REGULATORY ENVIRONMENT
PATENTS AND IP
UNITED STATES
EUROPEAN UNION
JAPAN
REGULATION OF BIOSIMILARS
DEFENSIVE STRATEGIES BY "BIG PHARMA"
"AUTHORIZED GENERICS"
SUPPLEMENTARY PROTECTION CERTIFICATES
EU Marketing Authorization Systems
The Centralized Procedure
Decentralized and Mutual Recognition Procedures
Mutual Recognition Procedure
Types of Applications
Applications Under Article 10 (Generic Products)
Approval of Pharmaceuticals
EU Provisions
Evolving Situation in the U.S.
Hatch-Waxman and Bolar
User Fees
Changing Climate for Generics
Situation in Europe
User Fees
GLOBAL PHARMACEUTICAL AND GENERICS MARKET
MARKET OPPORTUNITIES BY PRODUCT CLASS
GLOBAL GENERICS MARKET
MAIN NATIONAL GENERICS MARKETS
LEADING GENERIC MOLECULES
Anti-infectives
CNS Therapies
Cardiovascular Products
Anti-arthritis Products
Respiratory Products
Anticancer Products
Antidepressants
Antipsychotics
Anxiolytics
Sleep Disorders
Epilepsy
Parkinson's Disease
Migraine
Steroids
NSAIDs
COX-II Inhibitors
DMARDs
Asthma
COPD
Allergic Rhinitis
Bronchodilators
Cytotoxic Drugs
Hormonal Therapy
Biologic Response Modifiers
Anti-angiogenesis Drugs
Monoclonal Antibodies
Inhaled bronchodilators
Anticholinergics
Oral bronchodilators
Leukotriene antagonists
Steroids
AMERICAS
ASIA
EUROPE
UNITED STATES
CANADA
BRAZIL
JAPAN
INDIA
CHINA
FRANCE
GERMANY
ITALY
SPAIN
UNITED KINGDOM
RUSSIA
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Generics Market
Vital Statistics
Pharmaceutical Market
Vital Statistics
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Generics Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Healthcare System
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Vital Statistics
Health and Healthcare
Pharmaceutical Market
Biosimilars
Generic Prices
"Carve-outs"
Generics Industry
The Future
Generics Market
Generics Market
M&A Activity
Future Prospects
ProGenericos
Generics Industry
Growing Affluence - Changing Medical Needs
Pharma Industry
Patent Reform
Generics Industry
Domestic Industry
Foreign Company Involvement
Importance of R&D
Challenges
Market Trends
Regulatory Changes
Generics Exports
Domestic Generics Market
Local Dominance
Healthcare Provision
Generics Market
Provision of Healthcare
Price Controls
Generics Market
Pharmaceutical Industry
Generics Market
Healthcare Provision
Pharmaceutical Services
Generics Market
Healthcare Provision
Pharmaceuticals
Generics Market
Healthcare Delivery
Pharma 2020
Generics Market
Prices of Generics
How Generics Are Supplied
Generics Industry
Private Sector Involvement
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.
LUPIN, LTD.
MYLAN INC.
SANDOZ INTERNATIONAL GMBH
SANOFI
SUN PHARMACEUTICAL INDUSTRIES LTD.
TEVA PHARMACEUTICAL INDUSTRIES LTD.
OTHER INTERNATIONAL GENERICS COMPANIES
AUROBINDO PHARMA LTD.
DR. REDDY'S LABORATORIES LTD.
EGIS PHARMACEUTICALS PLC
KRKA
PAR PHARMACEUTICAL, INC.
STADA ARZNEIMITTEL
STRIDES SHASUN LTD.
WOCKHARDT LTD.
ZYDUS CADILA
Biogenerics
Financials
Products
Financials
APIs
Products
Generics
Generics
Biosimilars
List of Tables
Summary Table : GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, THROUGH 2021
Table 1 : GLOBAL PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 2 : MAJOR RECENT AND UPCOMING PATENT EXPIRIES, 2014-2020
Table 3 : BRAND SALES BEFORE AND AFTER PATENT EXPIRY
Table 4 : BIOTHERAPEUTICS AMONG TOP 40 PRESCRIPTION PHARMACEUTICALS, 2015
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
Table 8 : GLOBAL MARKET FOR GENERIC DRUGS, BY COUNTRY, THROUGH 2021
Table 9 : TOP 20 GENERIC MOLECULES, BY PRESCRIPTION SALES, 2015
Table 10 : GLOBAL TOP-SELLING PRESCRIPTION PHARMACEUTICALS
Table 11 : LEADING ANTI-INFECTIVE PRODUCT SALES, 2015
Table 12 : LEADING CNS PRODUCT SALES, 2015
Table 13 : LEADING CARDIOVASCULAR PRODUCT SALES, 2015
Table 14 : LEADING ANTI-ARTHRITIS PRODUCT SALES, 2015
Table 15 : LEADING RESPIRATORY PRODUCT SALES, 2015
Table 16 : LEADING ANTICANCER PRODUCT SALES, 2015
Table 17 : U.S. PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 18 : CANADA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 19 : BRAZIL'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 20 : JAPAN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 21 : TOP 25 JAPANESE PHARMA COMPANIES
Table 22 : INDIA’S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 23 : LEADING PHARMA COMPANIES IN INDIA, 2012
Table 24 : CHINA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 25 : FRANCE'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 26 : GERMANY’S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 27 : ITALY'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 28 : SPAIN'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 29 : LEADING GENERICS COMPANIES IN SPAIN, 2015
Table 30 : LEADING PHARMA COMPANIES IN THE U.K., BY MARKET SHARE, 2013
Table 31 : U.K.'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 32 : RUSSIA'S PHARMACEUTICALS AND GENERICS MARKET, THROUGH 2021
Table 33 : LEADING PHARMA COMPANIES IN RUSSIA, BY MARKET SHARE, 2012
Table 34 : LEADING GENERICS COMPANIES, BY SALES, 2015
List of Figures
Summary Figure : GLOBAL MARKET FOR GENERIC DRUGS, BY REGION, 2014-2021
Figure 1 : GLOBAL MARKET SHARE OF ASTHMA PRODUCT CATEGORIES
Figure 2 : HEALTH EXPENDITURE IN MAJOR EUROPEAN MARKETS AND THE U.S., 2014