The global market for biosimilars reached $1.7 billion in 2010 and $2.5
billion in 2011. The market is expected to reach $3.6 billion by 2016, a
compound annual growth rate (CAGR) of 7.7%.
The market in the APAC region for biosimilars reached $605 million in 2010 and
$683 million in 2011. The market is expected to reach $1.1 billion by 2016, a
CAGR of 10.3%.
The market in the United States for biosimilars reached $507 million in 2010
and $1.1 billion in 2011. The market is expected to reach $1.3 billion by
2016, a CAGR of 4.1%.
REPORT SCOPE
INTRODUCTION
Biosimilars are comparable versions of original biopharmaceuticals. Since
biologics are highly complex molecules, it is not possible to make identical
copies of them. Hence, these products are not technically biogenerics. The
differences of the biosimilar products from the reference biologic drug can be
attributed to various manufacturing details including differences in
expression systems, cell cultures, and many other bioprocessing conditions in
the process.
Since it is scientifically impossible to make identical copies of biologic
drugs, biologic drugs often enjoy an extended market exclusivity period.
However, the need to deal with rising healthcare costs has made it necessary
to develop regulatory guidelines to analyze and approve copies of biologic
drugs. The European Medicines Agency (EMA) has been the pioneer and the
leading regulatory agency to establish guidelines for the approval of
biosimilars. Several other regulatory agencies including the World Health
Organization (WHO) have followed the EMA guidelines to a great extent in
establishing their own guidelines.
The recent expiry of data protection or patents for the first group of
biopharmaceuticals has opened up the possibility of developing biological
products similar to these original products and to rely for licensing in part
on the extensive knowledge gained with the originator products. Although copy
versions of original biopharmaceuticals are already available in different
parts of the world, there are no consistent regulatory processes applied
worldwide for the market authorization of these products. The governments in
semi- and unregulated markets are slowly adopting regulatory policies for
improving the quality standards of these products. Unlike in the small
molecule generic drugs sector, the biosimilar market is expected to grow at a
relatively slow pace due to the safety concerns associated with them.
STUDY GOAL AND OBJECTIVES
Rising healthcare costs are driving the need for affordable yet effective
biologic drugs for the treatment of various therapeutic conditions. Even
though regulatory framework for the approval of biosimilars was in place in
Europe for over five years, the market penetration has been slow. The safety
concerns and the relatively lower cost advantages are the main restraints for
this sector in regulated markets. In semi- and unregulated markets, the
affordability is poor even for biologic drugs including biosimilars. However,
progress in the scientific understanding of biologic drugs and improvements in
the bioprocessing and analytical testing methodologies indicate high potential
for significant cost reduction in the development of biosimilars. This is
creating a situation that is challenging the market exclusivity being enjoyed
by biologic innovator brands even after losing their patent protection. Since
more blockbuster biologic drugs are losing patent protection, the interest in
the sector is increasing worldwide. Aspirant companies include even
multinational pharmaceutical and biotechnology companies as indicated by the
recent investment trends in the sector. Even multinationals in the
electronics industry are making strategic entry with huge investments. In
this context, it is interesting to analyze the market trends and future growth
potentials.
This BCC report provides an in-depth look at the demand for biosimilar drugs
that have entered the market worldwide and forecasts the growth prospects for
these products. It also analyses the biosimilar pipeline worldwide and
includes their potential for getting approved and gaining significant market
shares during the forecast period. Important product classes are considered
separately while analyzing the market trends, and a bottoms-up approach is
adopted for estimating the market size. Semi- and unregulated markets are
also studied thoroughly and included in the report even though the products
developed and marketed in these markets are not considered comparable in
quality with the biosimilars marketed in regulated markets. Ignoring the
potential of these products while studying the market dynamics is a mistake
since key players in these markets are entering into tie-ups with partners
with experience in regulated markets. Moreover, years of market experience in
less regulated markets are likely to provide invaluable safety and efficacy
insights, which will be an added advantage for these products.
Since regulation is the main factor that is driving and restraining the
biosimilar market, regulatory framework in all the key markets is analyzed
thoroughly. This report also analyses the future regulatory trends in all the
key markets. Other aspects of the market analyzed in the report include
pricing trends, technology advancements and their effects in affordability of
biosimilars, key players in various regional markets and their capabilities,
and the rising investments and the financial environment of the sector.
INTENDED AUDIENCE OF THE STUDY
This study provides valuable perspective on the regulatory framework worldwide
that is playing a key role in shaping the biosimilar market. The scientific
improvements and their influence in shaping the market are also analyzed in
depth. Valuable insights on the investment trends and business models adopted
by different key players in various parts of the world are provided. Various
product classes that are getting attention from the biosimilar players and
their therapeutic areas are analyzed and their future market trends are
forecast.
Business strategies adopted by different categories of industry players
including big pharmaceutical companies, biotech companies, start-up biotech
and technology platform companies have been analyzed. These detailed
analyses are targeted to help strategy developers and decision makers of
biotech and pharmaceutical companies as well as other stakeholders including
payers, venture capitalists, regulatory authorities, physicians and
pharmacies. This is especially suitable for legislators involved in
government policy development programs as well as law firms involved in IP
matters of the healthcare industry. Technology trend analysis gives an
overview of successful technologies, which is helpful for research managers in
charge of project identification and development.
MARKET DEFINITION, SCOPE AND FORMAT
The market definition is important to consider in this report. There are
several copies of biologic drugs sold for many years in semi- and unregulated
markets before the establishment of biosimilar guidelines by the European
Medicines Agency (EMA). The regulatory processes in these regions for the
approval of these products are considerably less stringent compared to that of
EMA. However, these companies are targeting regulated markets, and are
adopting various strategies to enter highly regulated markets such as Europe
and the U.S. Hence, the approach taken for this report is to include all the
products for which EMA has already published guidelines for market
authorization or for which guidelines are under development. The scope of
this report includes the product segments such as somatropin, erythropoietin,
Colony Stimulating Factors (CSFs), interferons, interleukins, insulin and
insulin analogues, follicle stimulating hormones (FSHs), monoclonal antibodies
(MAbs), and low molecular weight heparins (LMWH). It is often argued that
LMWH is not essentially a biosimilar product since it is derived from dead
tissues. However, considering the complexity of LMWH, EMA has developed
specific guidelines for LMWH; hence, this is included as one of the product
segment in this report. The global market size estimation includes the above
mentioned product segments.
Both EMA and World Health Organization (WHO) exclude vaccines from
consideration as biosimilars. The EMA guideline says: "Due to complexity and
the likelihood that they cannot be thoroughly characterized at the molecular
level, vaccines must be considered on a case-by-case basis." Besides
vaccines, plasma-derived products and their recombinant analogues are also
excluded from biosimilar guidelines by EMA due to their complex and variable
physicochemical, biological and functional characteristics. Therefore,
vaccines and blood products are not included as product segments in this
report. Other biologic drug segments excluded in the market estimation of
this report include streptokinase, hyaluronidase, etc., since biosimilar
guidelines neither exist at present nor under development by EMA.
This report contains:
An overview of biosimilar product classes in various regions worldwide.
Biosimilar products approved by EMA.
A look at the biosimilar pipeline worldwide.
Detailed analysis of the emerging regulatory framework in regulated
markets.
Comparison of biosimilar guidelines in Europe, the U.S., Japan, Canada,
and the guidelines developed by WHO.
Detailed analysis of the market and key players in Europe and
country-by-country analysis of key markets in Europe and the market forecasts
for the region for various product classes
Detailed analysis of U.S. market regulation, key players and emerging
trends.
Detailed analysis of the APAC market with analysis of key national markets
(including Australia, Singapore, Korea, India, China and Japan), local
players, investment trends and regulatory developments.
Detailed analysis of the rest of world (ROW) market size, trends, country
analysis of promising markets (including Brazil, Russia, and Canada), regional
players, and emerging regulatory and market trends.
Technology trends and patent analysis.
Profiles of over 70 key players.
Global and regional sales projections through 2016 for various product
classes and regions.
INFORMATION SOURCES AND METHODOLOGY
Both primary and secondary research methodologies were used in preparing this
study. The base year is 2011. The market size reflects the global revenues
of drugs within the product classes recognized as biosimilars by EMA.
Advanced pipeline products with high chances of entering the market during the
forecast period are considered for market forecasts. The sales represent
total revenues, which include the sales of these products in the respective
markets.
Market figures are based on revenues at the manufacturer level and are
projected at 2011 dollar values (i.e., inflation is not computed into the
projection figures). Forecasts are based on the projections of the
marketers, regulatory trends, patent expiry of innovator brands, strategies of
innovator companies, concerns of various stakeholders including physicians and
patients in each region, competitiveness of the market in terms of numbers of
biosimilar products in each category, and marketing strategies of key players.
The information and data to prepare this study were derived from regulatory
agencies, trade literature, patient support groups, annual reports of
companies and industry-related databases. The analysis presented is based on
an extensive survey of the biopharmaceutical industry as well as a detailed
examination of published literature and reports obtained from regulatory
authorities, medical research institutions, and national and world health
organizations. Key information from the literature was used to obtain expert
opinion and insights on commercial potential and market sizes from industry
professionals, academic researchers and government agency spokespersons.
AUTHOR'S CREDENTIALS
Syamala Ariyanchira is actively involved in technology assessment, strategic
planning, competitor analysis, due diligence, and market analysis. She
combines her technical background with current business sector issues with
ease. Her clients include investment firms, government agencies, and chemical
and pharmaceutical companies. She holds a Ph.D. from Indian Institute of
Science, Bangalore, India, and has over sixteen years of experience in the
industry.
Table of Contents
Table of Contents
Chapter- 1: INTRODUCTION - Complimentary
STUDY GOAL AND OBJECTIVES
INTENDED AUDIENCE OF THE STUDY
MARKET DEFINITION, SCOPE AND FORMAT
INFORMATION SOURCES AND METHODOLOGY
AUTHOR'S CREDENTIALS
RELATED REPORTS FROM BCC RESEARCH
BCC ONLINE SERVICES
DISCLAIMER
Chapter- 2: SUMMARY
Table Summary : GLOBAL DEMAND FOR BIOSIMILARS BY VALUE, THROUGH 2016
Figure Summary : GLOBAL BIOSIMILAR DEMAND BY VALUE AND PRODUCT TYPE, 2011
Chapter- 3: MARKET OVERVIEW
THE TERMINOLOGY
THE BIOSIMILAR OPPORTUNITY
WORLDWIDE MARKETS FOR BIOSIMILARS - CURRENT STATUS
THE EVOLVING BIOSIMILAR REGULATORY LANDSCAPE
DATA EXCLUSIVITY
AN OVERVIEW OF THE CURRENT REGULATORY PRACTICES IN U.S., EUROPE, AND
SEMI-REGULATED MARKETS
PARTNERSHIPS, COLLABORATIONS, LICENSING AND ACQUISITIONS DRIVING
BIOSIMILAR DEVELOPMENT
BIG PHARMA KEEN TO TAP THE BIOSIMILAR OPPORTUNITY
Table 1 : SIMILAR BIOLOGICAL PRODUCTS: TERMINOLOGIES AND THEIR DEFINITIONS
AS USED BY VARIOUS REGULATORY AGENCIES
Chapter- 4: BIOSIMILAR MARKETS IN EUROPE
LEGISLATION AND POLICIES IN THE EU AND MEMBER STATES
REFERENCE PRODUCTS AND THEIR MARKET EXCLUSIVITY PERIODS IN THE EU
THE MARKET AUTHORIZATION PROCESS OF BIOSIMILARS IN THE EU
AVAILABILITY OF BIOSIMILARS IN MEMBER STATES
THE BIOSIMILAR MARKET IN EU
HEALTH CONCERNS REGARDING INTERCHANGEABILITY - A KEY CHALLENGE
COMPLEXITY ASSOCIATED WITH BIOSIMILAR PRODUCTION IS LEADING TO SUPPLY
SHORTAGES IN EUROPE
ABBREVIATION OF REGULATORY ASSESSMENTS OF BIOSIMILARS
THE PRICING AND REIMBURSEMENT (P&R) POLICIES ACROSS THE MEMBER STATES
GERMANY
FRANCE
SPAIN
ITALY
THE UNITED KINGDOM
REST OF THE EU
Table 25 : MAIN BIOSIMILAR REGULATORY TEXTS IN EU
Table 26 : BIOSIMILAR GUIDELINES PUBLISHED IN THE EU
Chapter- 5: BIOSIMILAR MARKETS IN THE U.S.
BIOSIMILAR REGULATION STATUS IN THE U.S.
Table 49 : KEY LEGISLATIONS SHAPING THE REGULATORY FRAMEWORK OF THE
EVOLVING BIOSIMILARS MARKET IN THE U.S.
Table 50 : DIFFERENCES BETWEEN HATCH-WAXMAN PATENT ENFORCEMENT AND THE
BPCIA PATENT FRAMEWORK
Chapter- 6: BIOSIMILAR MARKETS IN THE ASIA-PACIFIC REGION
THE BIOSIMILAR MARKET SIZE IN ASIA-PACIFIC
JAPAN
SOUTH KOREA
CHINA
INDIA
REST OF APAC
Table 59 : THE BIOSIMILAR MARKETS IN APAC, BY PRODUCT CLASSES THROUGH 2016
Table 60 : THE BIOSIMILAR MARKETS IN APAC BY COUNTRY, THROUGH 2016
Chapter- 7: REST OF THE WORLD (ROW) MARKETS
CANADA
CUBA
BRAZIL
MEXICO
ISRAEL
RUSSIA
Chapter- 8: TECHNOLOGY TRENDS
TRENDS IN BIOSIMILAR MANUFACTURING PROCESSES
Chapter- 9: PATENT ANALYSIS
Table 91 : U.S. PATENTS OF MOMENTA PHARMACEUTICALS ON ANALYTICAL METHODS
FOR LMWH CHARACTERIZATION
Table 92 : INTERNATIONAL PATENTS ON BIOSIMILAR PRODUCTS BY SELECTED
INDUSTRY PLAYERS
Summary Table : GLOBAL DEMAND FOR BIOSIMILARS BY VALUE, THROUGH 2016
Table 1 : SIMILAR BIOLOGICAL PRODUCTS: TERMINOLOGIES AND THEIR DEFINITIONS
AS USED BY VARIOUS REGULATORY AGENCIES
Table 2 : BIOSIMILARS VERSUS SMALL MOLECULE GENERICS
Table 3 : GLOBAL REVENUES OF LEADING BIOPHARMACEUTICALS
Table 4 : BIOLOGIC DRUGS LOSING PATENT PROTECTION BETWEEN 2012 AND 2017
Table 5 : POPULAR REFERENCE PRODUCTS TARGETED BY KEY PLAYERS
Table 6 : ANNUAL COSTS FOR THE TREATMENT USING SOME OF THE BIOLOGIC DRUGS
Table 7 : COST COMPARISON FOR RENAL DISEASE-ASSOCIATED ANEMIA TREATMENT IN
EUROPE
Table 8 : BIOSIMILARS APPROVED BY EMA, 2011
Table 9 : BIOSIMILARS APPROVED IN OTHER REGULATED MARKETS - AUSTRALIA,
CANADA, JAPAN, AND THE U.S.
Table 10 : TOP PLAYERS IN THE GLOBAL BIOSIMILAR MARKET
Table 11 : THE GLOBAL AND REGIONAL BIOSIMILAR MARKETS BY VALUE THROUGH 2016
Table 12 : THE GLOBAL MARKETS FOR VARIOUS PRODUCT CLASSES OF BIOSIMILARS
BY VALUE, THROUGH 2016
Table 13 : SCIENTIFIC AND REGULATORY CONCERNS RELATED TO BIOSIMILAR
AUTHORIZATION
Table 14 : COMMON BIOLOGICS AND THEIR IMMUNOGENICITY POTENTIALS
Table 15 : DATA EXCLUSIVITY PERIODS OF REFERENCE FOR BIOLOGIC DRUGS IN EU,
U.S. AND JAPAN
Table 16 : BIOSIMILAR REGULATION: CURRENT STATUS IN EU AND U.S.
Table 17 : BIOSIMILAR GUIDELINES FEATURES ADOPTED BY JAPAN, CANADA AND WHO
Table 18 : BIOSIMILAR TARGETED BUSINESS DEALS SIGNED IN 2011
Table 19 : RECENT BIOSIMILAR DEALS MADE BY MULTINATIONAL PHARMACEUTICAL
COMPANIES
Table 20 : KEY CHALLENGES OF THE GLOBAL BIOSIMILAR MARKET
Table 21 : KEY CONCERNS OF CHMP REGARDING THE INSULIN BIOSIMILAR
APPLICATIONS BY MARVEL LIFE SCIENCES
Table 22 : FACTORS INFLUENCING THE PRICING STRATEGIES FOR BIOSIMILARS
Table 23 : BIOSIMILAR PRODUCTS IN ADVANCED STAGES OF DEVELOPMENT WORLDWIDE
Table 24 : DETAILS OF BIOSIMILAR APPROVALS IN THE EU
Table 25 : MAIN BIOSIMILAR REGULATORY TEXTS IN EU
Table 26 : BIOSIMILAR GUIDELINES PUBLISHED IN THE EU
Table 27 : NUMBER OF YEARS OF EFFECTIVE MARKET EXCLUSIVITY ENJOYED BY SOME
OF THE INNOVATOR BRANDS ACROSS EU5
Table 28 : SUMMARY OF THE MARKET AUTHORIZATION PROCESS OF BIOSIMILARS IN
THE EU
Table 29 : LAUNCHING DATES OF BIOSIMILAR BRANDS ACROSS VARIOUS EU MEMBER
STATES
Table 30 : THE BIOSIMILAR MARKET IN THE EU BY VALUE, THROUGH 2016
Table 31 : THE RISING MARKET SHARE OF BIOSIMILARS IN THE EU MARKET,
2007-2011
Table 32 : THE MARKET PENETRATION OF SOMATROPIN, ERYTHROPOIETIN AND
FILGRASTIM BIOSIMILARS ACROSS EU5, 2011
Table 33 : BIOSIMILAR ACCEPTANCE IN SELECTED NON-EU5 MEMBER STATES
Table 34 : POLICIES REGARDING AUTOMATIC SUBSTITUTION OF BIOSIMILARS ACROSS
THE EU
Table 35 : POTENTIAL INFLUENCE OF THE PRICE APPROVAL DELAYS ON LAUNCHING
PRIORITIES BY BIOSIMILAR COMPANIES IN SELECTED EU MEMBER STATES
Table 36 : REFERENCE PRICING SYSTEMS IMPLEMENTED IN EU MEMBER STATES
Table 37 : COMPARISON OF THE POLICIES INFLUENCING THE P&R SCENARIO OF
BIOSIMILARS ACROSS EU5
Table 38 : PHARMACEUTICAL P&R POLICIES AND PROCESSES IN SELECTED NON-EU5
MEMBER STATES
Table 39 : THE IMPACT OF EPO BIOSIMILAR ENTRY IN GERMANY
Table 40 : DRIVERS OF THE BIOSIMILAR MARKET IN GERMANY
Table 41 : REGIONAL PRESCRIPTION QUOTAS FOR EPO BIOSIMILARS IN GERMANY
Table 42 : REGULATORY AUTHORITIES/ORGANIZATIONS INVOLVED IN MARKET
AUTHORIZATION OF MEDICINES IN FRANCE
Table 43 : ORGANIZATIONS AND COMMITTEES INVOLVED IN THE PHARMACEUTICAL
REGULATION PROCESSES IN ITALY
Table 44 : NEGOTIATED PRICE REDUCTIONS FOR BIOSIMILARS COMMERCIALIZED IN
ITALY
Table 45 : BIOSIMILARS AVAILABLE IN ITALY
Table 46 : AUSTERITY MEASURES WITH POTENTIAL IMPACT ON BIOSIMILARS MARKET
IN ITALY
Table 47 : AUTHORITIES OF PHARMACEUTICAL REGULATION AND P&R PROCESSES IN
THE U.K.
Table 48 : LAUNCHING DATES OF SELECTED EPO AND FILGRASTIM BIOSIMILARS IN
AUSTRIA, GERMANY, SWEDEN AND THE NETHERLANDS
Table 49 : KEY LEGISLATIONS SHAPING THE REGULATORY FRAMEWORK OF THE
EVOLVING BIOSIMILARS MARKET IN THE U.S.
Table 50 : DIFFERENCES BETWEEN HATCH-WAXMAN PATENT ENFORCEMENT AND THE
BPCIA PATENT FRAMEWORK
Table 51 : REGULATORY PATHWAYS FOR THE APPROVAL OF SMALL MOLECULE DRUGS
AND BIOLOGIC DRUGS
Table 52 : SIMILAR RECOMBINANT BIOLOGIC PRODUCTS APPROVED BY THE FDA
Table 53 : THE EVOLVING BIOSIMILAR PATH TO APPROVAL IN THE U.S.
Table 54 : THE PROPOSED USER FEE PROGRAM FOR BIOSIMILARS BY THE FDA FOR
FISCAL YEARS 2013-2017
Table 55 : PERFORMANCE GOALS PROPOSED FOR THE FDA FOR APPLICATION REVIEWS
Table 56 : PERFORMANCE GOALS PROPOSED FOR FDA FOR MEETINGS WITH THE
BIOSIMILAR APPLICANT
Table 57 : COMPARISON OF BIOSIMILAR REGULATORY APPROACHES OF EMA AND FDA
Table 58 : THE BIOSIMILAR MARKET SIZE IN THE U.S., THROUGH 2016
Table 59 : THE BIOSIMILAR MARKETS IN APAC, BY PRODUCT CLASSES THROUGH 2016
Table 60 : THE BIOSIMILAR MARKETS IN APAC BY COUNTRY, THROUGH 2016
Table 61 : DRIVERS AND RESTRAINTS OF THE BIOSIMILAR MARKET IN JAPAN
Table 62 : IMPORTANT POINTS OF THE BIOSIMILAR REGULATION IN JAPAN
Table 63 : RECENT ACQUISITIONS AND PARTNERSHIPS IN JAPAN IN THE BIOSIMILAR
SECTOR
Table 64 : REGIONAL BIOCLUSTERS IN SOUTH KOREA
Table 65 : HIGHLIGHTS OF THE BIOSIMILAR REGULATION IN KOREA
Table 66 : RELEVANT AUTHORITIES AND INDUSTRY ASSOCIATIONS IN KOREA
Table 67 : LIST OF RECENT INVESTMENTS IN THE BIOSIMILAR SECTOR IN KOREA
Table 68 : KEY KOREAN PLAYERS IN THE BIOSIMILAR MARKET WITH COMMERCIALIZED
PRODUCTS
Table 69 : KOREAN COMPANIES WITH BIOSIMILAR PRODUCTS IN ADVANCED STAGES OF
DEVELOPMENT
Table 70 : BIOSIMILARS OF MONOCLONAL ANTIBODY BLOCKBUSTERS UNDER
DEVELOPMENT IN KOREA
Table 71 : CHINESE BIOSIMILAR MARKET: KEY CHARACTERISTICS
Table 72 : MAB PRODUCTS LAUNCHED IN CHINA BY DOMESTIC COMPANIES
Table 73 : KEY MAB MANUFACTURERS AND THEIR PRODUCTION CAPACITIES IN CHINA
Table 74 : VENTURE CAPITAL FIRMS WITH HEALTHCARE/BIOTECHNOLOGY COMPANIES
IN THEIR PORTFOLIO IN CHINA
Table 75 : GOVERNMENT PROGRAMS TARGETING PROMOTION OF INNOVATION IN
SCIENCE AND TECHNOLOGY (S&T) IN CHINA
Table 76 : BIOSIMILAR COMPANIES AND THEIR PRODUCTS IN CHINA
Table 77 : DRIVERS OF INDIAN BIOSIMILAR MARKET
Table 78 : BIOSIMILAR-RELATED INVESTMENTS AND BUSINESS DEALS BY INDIAN
COMPANIES
Table 79 : THE BIOTECH PARKS IN INDIA
Table 80 : IMPORTANT REGULATIONS INFLUENCING BIOSIMILAR INDUSTRY GROWTH IN
INDIA
Table 81 : AUTHORITIES IN INDIA RELATED TO BIOSIMILAR INDUSTRY REGULATIONS
AND THEIR RESPONSIBILITIES
Table 82 : TECHNOLOGICAL CHALLENGES OF BIOSIMILAR COMPANIES IN INDIA
Table 83 : KEY PLAYERS AND THEIR PRODUCTS IN THE INDIAN BIOSIMILAR MARKET
Table 84 : BIOTECHNOLOGY FOCUSED SCIENCE PARKS IN TAIWAN
Table 85 : THE MARKET SIZE OF BIOSIMILARS IN ROW BY VALUE, THROUGH 2016
Table 86 : AGENCIES/ OFFICES INVOLVED IN PHARMACEUTICAL REGULATION IN
BRAZIL
Table 87 : KEY REGULATIONS SHAPING THE PHARMACEUTICAL INDUSTRY IN BRAZIL
Table 88 : EMERGING TECHNOLOGY PLATFORMS FOR BIOSIMILAR CELL LINE
DEVELOPMENT
Table 89 : CHALLENGES OF ANALYTICAL CHARACTERIZATION OF BIOSIMILAR PRODUCTS
Table 90 : ANALYTICAL METHODS RECOGNIZED BY REGULATORY BODIES FOR
COMPARABILITY EXERCISE AND RISK MITIGATION
Table 91 : U.S. PATENTS OF MOMENTA PHARMACEUTICALS ON ANALYTICAL METHODS
FOR LMWH CHARACTERIZATION
Table 92 : INTERNATIONAL PATENTS ON BIOSIMILAR PRODUCTS BY SELECTED
INDUSTRY PLAYERS
Table 93 : BIOSIMILAR PRODUCTS MARKETED BY 3SBIO
Table 94 : SOME OF THE RECENT PARTNERSHIP, ACQUISITION, AND DIVESTMENT
DEALS BY BIOCON
Table 95 : PIPELINE BIOSIMILAR MABS OF BIOXPRESS THERAPEUTICS SA
Table 96 : BIOTON GROUP COMPANIES WORLDWIDE
Table 97 : MARKETING AND CRO PARTNERS OF CELLTRION IN VARIOUS COUNTRIES
Table 98 : BIOSIMILAR PIPELINE OF CELLTRION
Table 99 : BIOPHARMACEUTICALS DEVELOPED AND MARKETED BY BIOCAD
Table 100 : BIOSIMILAR PRODUCTS OF DONG-A PHARMACEUTICALS
Table 101 : BIOSIMILAR PRODUCTS MARKETED BY DR. REDDY'S LABORATORIES
Table 102 : BIOSIMILAR-RELATED INVESTMENTS BY HOSPIRA
Table 103 : BIOSIMILAR PIPELINE OF HOSPIRA
Table 104 : IBPL'S BIOSIMILAR PRODUCTS IN THE MARKET
Table 105 : MARKETING PARTNERSHIPS ESTABLISHED BY INTAS IN VARIOUS MARKETS
Table 106 : RECOMBINANT BIOSIMILAR PIPELINE OF JCR PHARMACEUTICALS
Table 107 : BIOLOGIC DRUGS DEVELOPED AND MARKETED BY LGLS
Table 108 : BIOSIMILAR PRODUCTS UNDER DEVELOPMENT BY NIPPON KAYAKU, JAPAN
Table 109 : BIOSIMILARS DEVELOPED AND MARKETED BY RELIANCE LIFE SCIENCES
Table 110 : PARTNERING COMPANIES INVOLVED IN THE ESTABLISHMENT OF SAMSUNG
BIOLOGICS
Table 111 : MARKETED AND PIPELINE BIOSIMILAR PRODUCTS OF TEVA
PHARMACEUTICALS
Table 112 : PARTNERING DEALS/ACQUISITIONS BY TEVA TARGETING THE
DEVELOPMENT OF BIOPHARMACEUTICAL PIPELINE
Table 113 : BIOSIMILAR PRODUCTS MARKETED BY WOCKHARDT
Table 114 : GLOSSARY
List of Figures
Summary Figure : GLOBAL BIOSIMILAR DEMAND BY VALUE AND PRODUCT TYPE, 2011
Figure 1 : DEMAND TRENDS OF FILGRASTIM IN THE U.K. AFTER THE LAUNCH OF
BIOSIMILARS, NOVEMBER. 2008-JUNE 2011
Figure 2 : THE JAPANESE BIOSIMILAR MARKET
Figure 3 : THE KOREAN BIOSIMILAR MARKET BY VALUE 2010-2016
Figure 4 : THE CHINESE BIOSIMILAR MARKET BY VALUE, 2010-2016
Figure 5 : THE INDIAN BIOSIMILAR MARKET BY VALUE, 2010-2016
Figure 6 : THE BIOSIMILAR MARKET FOR THE REST OF APAC, THROUGH 2016
Biosimilars: Global Markets published by BCC Research in May 24, 2012. This report consists of 289 Pages and the price starts from US $ 5450.
Press Release
First-Generation Biologic Drug Patent Expiries Open Opportunities for Biosimilars, Demand Expected to Reach $3.6 Billion in 2016
May 28th, 2012
Global Information Inc. would like to present a new market research report, "Biosimilars: Global Markets" by BCC Research.
Biopharmaceuticals are making substantial contributions in several therapeutic areas by providing drugs with improved effectiveness. The high costs associated with these products limit their affordability, however, and challenges healthcare budgets of the payers. The fact that many of these blockbuster drugs are facing patent expiry is providing an opportunity for biosimilars.
This expiry of patents of the first-generation biologic drugs has opened up a new market opportunity to develop biosimilars, drugs based on the extensive scientific and clinical learning available from long experience with the original products. But this new opportunity has also brought in significant scientific as well as regulatory challenges.
Key findings:
Global demand for biosimilars totaled nearly $2.5 billion in 2011 and should reach $3.6 billion in 2016, a compound annual growth rate (CAGR) of 7.7% over the five-year period.
The biosimilars market can be broken down into four regions: APAC (Asia-Pacific), the United States, Europe, and the rest of the world.
The APAC region accounted for $683 million in 2011 and should reach $1.1 billion in 2016, a CAGR of 10.3%.
The United States accounted for nearly $1.1 billion in 2011 and should increase at a CAGR of 4.1% to reach $1.3 billion in 2016.
Europe, worth $377 million in 2011, should reach $625 million in 2016, increasing at a CAGR of 10.6%.
The rest of the world accounted for $335 million in 2011 and in 2016 should total $522 million, a CAGR of 9.3%.
This report is targeted to help strategy developers and decision-makers of biotech and pharmaceutical companies as well as other stakeholders, including payers, venture capitalists, regulatory authorities, physicians, and pharmacists. The report is especially suitable for legislators involved in government policy development programs as well as law firms involved in IP matters of the healthcare industry. Technology trend analysis gives an overview of successful technologies, which is helpful for research managers in charge of project identification and development.
