Abstract
REPORT HIGHLIGHTS
THIS REPORT CONTAINS
- An examination of the strategies employed by companies specializing in
generics to meet the challenges of this highly competitive market as well as
those utilized by "originator" companies to forestall generic competition;
this report will focus on the markets in Asia
- Analyses of market trends, with data from 2010, estimates for 2011, and
projections of compound annual growth rates (CAGRs) through 2016
- Discussion of how fierce price competition has put some companies in
difficulties because of slashed profit margins, and of the resulting wave of
merger-and-acquisition activity, and the rise of "supergenerics" that offer
added value as well as low prices
- A breakdown of the nature and structure of the generics industry, with
profiles of several leading generics companies, and an update of M&A activity
- Patent analyses.
REPORT SCOPE
INTRODUCTION
STUDY GOALS AND OBJECTIVES
The aim of this report is to provide detailed market, technology, and industry
analyses to help readers quantify and qualify the market for prescription
generic drugs. Important trends are identified and sales forecasts by product
categories and major country markets are provided through 2016; these are
based on industry sources and considered assessment of the regulatory
environment, healthcare policies, demographics, and other factors that
directly affect the generic drug market. The wider economic environment is
also taken into account.
The report examines 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.
REASONS FOR DOING THE STUDY
This is a time of growth and change for the generic pharmaceuticals sector.
Major aspects that combine to create an opportunity for an up-to-date market
analysis include the following:
- The demand for generics is increasing steadily because of pressure to
control healthcare costs. At the same time, fierce price competition in this
area has created difficulties for some companies because of slashed profit
margins. The main result has been a wave of merger and acquisition (M&A)
activity, and the rise of "supergenerics," offering added value as well as low
prices. Not all traditional companies are positioned to exploit this trend.
- A major growth driver for the generics sector is the fact that several
blockbuster pharmaceutical brands are coming off-patent and are therefore open
to generic competition - the phenomenon widely known as the "patent cliff."
But the originator companies are deploying formidable strategies to protect
their franchises, including marketing their own branded generics.
- With first-generation biopharmaceutical products reaching the end of their
patent lives, a whole new market field - biogenerics or biosimilars - is
opening up for those generics companies capable of (or prepared to buy-into)
the technological expertise required.
- The international landscape is changing for generics as for all
pharmaceuticals. China, India, Russia, Mexico, and Brazil are among the
rising markets for generic activity.
SCOPE OF REPORT
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.
The report presents overall market size estimates and analysis for the overall
global market, as well as more detailed market coverage of the three major
segments of the global market: the American market, the European market, and
the Asian market. The American market coverage focuses on the largest markets
of North and Latin America (the U.S., Canada, Brazil, and Mexico); European
market coverage focuses on the markets in France, Germany, Italy, Spain, and
the United Kingdom, as well as an analysis of the Russian market; and Asia
market coverage focuses on the three major markets of Japan, China, and India.
MARKET ANALYSES AND FORECASTS
Market figures are based on revenues at the manufacturer level and are
projected based on 2011 dollar value without attempting to predict the effect
of inflation/deflation. Therapeutic categories quantified and forecast include
antibacterials, antidepressants, anticancer agents, anti-arthritics,
cardiovascular drugs (e.g., hypolipidaemics and antihypertensives), and drugs
for respiratory conditions, including asthma and COPD.
METHODOLOGY
Both primary and secondary research methodologies were used in preparing this
study. Primary research includes interviews with leading individuals in
generics companies, industry associations, and regulatory bodies. Sources of
published data include company annual reports, SEC filings, government and
industry publications, literature searches, industry journals, and other
commercial publications. Data for market estimates and forecasts are pooled
from a range of sources, and are critically assessed by BCC Research.
INTENDED AUDIENCE
This report is designed to satisfy the information needs of a wide variety of
individuals involved in the generics marketplace, including company senior
management executives seeking to base their strategic decisions on the best
available information on market forces and trends. However, it is also aimed
at managers and executives in marketing, research, planning, and sales
departments who need readable, comprehensive, and up-to-date background on the
marketplace in which they are operating.
INFORMATION SOURCES
Sources of information included marketing strategists, industry executives,
government agencies and regulatory bodies, and surveys of physicians and
pharmacists. Company annual reports and SEC filings, journal articles, and
data from healthcare institutions were also mined, as well as publications of
relevant trade associations such as the Generic Pharmaceutical Association
(GPhA) and the European Generic Medicines Association (EGA).
ANALYST CREDENTIALS
Paul Evers has been involved in analyzing pharmaceutical and medical markets
for 20 years. He is the author of two 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 - Complimentary
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THE STUDY
- SCOPE OF REPORT
- MARKET ANALYSES AND FORECASTS
- METHODOLOGY
- INTENDED AUDIENCE
- INFORMATION SOURCES
- ANALYST CREDENTIALS
- RELATED REPORTS
- BCC ONLINE SERVICES
- DISCLAIMER
Chapter- 2: SUMMARY
- MARKET SIZE AND EVOLUTION
- Table 0 : MAJOR GENERICS MARKETS, THROUGH 2016
- Figure 0 : MAJOR GENERICS MARKETS, THROUGH 2016
Chapter- 3: OVERVIEW
- RECENT HISTORY OF THE GENERICS SECTOR
Chapter- 4: THE NEW GENERICS ERA
- THE PATENT CLIFF
- TYPES OF GENERICS
- MAJOR GENERIC ISSUES
- PATENTS AND IP
Chapter- 5: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKET
- GLOBAL GENERICS MARKET
- MAIN NATIONAL GENERICS MARKETS
- MARKET OPPORTUNITIES BY PRODUCT CLASS
Chapter- 6: THE ASIAN REGION
Chapter- 7: PROFILES OF THE TOP TEN GENERICS COMPANIES
- TRENDS
- STRUCTURE OF THE GENERICS INDUSTRY
- PROFILES OF TOP 10 GENERICS COMPANIES
Chapter- 8: PROFILES OF OTHER INTERNATIONAL GENERICS COMPANIES
List of Tables
- Summary Table : MAJOR GENERICS MARKETS, THROUGH 2016
- Table 1 : GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016
- Table 2 : FIRST PATENT EXPIRIES, 2012 - 2023
- Table 3 : BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, 2001 - 2006
- Table 4 : REQUIREMENTS FOR NDA AND ANDA APPLICATIONS
- Table 5 : WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016
- Table 6 : CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH 2016
- Table 7 : WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPE
- Table 8 : LEADING ANTI-INFECTIVE PRODUCTS SALES ESTIMATES WITH YEAR OF
PATENT EXPIRY, 2010
- Table 9 : CNS MARKET BY MAJOR INDICATIONS, 2010
- Table 10 : LEADING CNS PRODUCT SALES ESTIMATES, 2010
- Table 11 : LEADING CARDIOVASCULAR PRODUCT SALES, 2009
- Table 12 : LEADING ANTI-ARTHRITIS PRODUCT SALES ESTIMATES, 2009
- Table 13 : LEADING RESPIRATORY PRODUCT SALES ESTIMATES, 2009
- Table 14 : LEADING ANTICANCER PRODUCT SALES ESTIMATES, 2009
- Table 15 : TOP 5 JAPANESE PHARMA COMPANIES, 2008
- Table 16 : JAPANESE PHARMACEUTICAL AND GENERICS MARKET, 2011 - 2016
- Table 17 : LEADING PHARMA COMPANIES IN INDIA, 2010
- Table 18 : PHARMACEUTICAL AND GENERICS MARKET IN INDIA, THROUGH 2016
- Table 19 : PHARMACEUTICAL AND GENERICS MARKET, CHINA, THROUGH 2016
- Table 20 : LEADING GENERICS MANUFACTURERS, 2010
- Table 21 : PFIZER' S U.S. PATENT EXPIRIES, THROUGH 2021
List of Figures
- Summary Figure : MAJOR GENERICS MARKETS, THROUGH 2016
- Figure 1 : CNS MARKET SHARES BY MAJOR INDICATIONS, 2010
- Figure 2 : USAGE OF MAIN PRODUCT CATEGORIES BASED REVENUES
- Figure 3 : GENERICS MARKET THERAPEUTIC CATEGORIES 2008
