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Biosimilars (2009 - 2014)

By: marketsandmarkets.com
Publishing Date: September 2009
Report Code: BT 1030

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Report description

The increasing demand from patients, insurers, and government agencies to reduce the costs of blockbuster biopharmaceuticals has created numerous opportunities in the global biosimilar market. Regulatory developments favoring the biosimilar market in countries such as the U.S. are expected to increase the market shares and profit margins of the market players.

The global biosimilars market is expected to be worth $19.4 billion by 2014, growing at a CAGR of 89.1% from 2009 to 2014. The early commercialization and high absorption rate of biosimilars products have made Asia the dominant market in 2008 with 34.1% share of the global biosimilars product market. Americas is the second-largest market and is expected to be dominate in 2014, after the U.S. market opens up in 2010.

The biosimilars market is highly fragmented with major market players such as Biocon, Dr. Reddy’s Laboratories, Intas, LG LifeSciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and Wockhardt.

Scope of the report

This report aims to identify and analyze the biosimilars market on the basis of products, services, technologies, and applications. The report has segmented the global biosimilars market as follows:

  1. Biosimilar products market - Peptides, recombinant glycosylated proteins, recombinant non-glycosylated proteins, and others
  2. Biosimilar services market - Contract research and manufacturing services, clinical trial services
  3. Biosimilar applications market - Oncology, infectious diseases, chronic and autoimmune diseases, and other diseases
  4. Biosimilar technologies market - Recombinant DNA technology, monoclonal antibodies technologies, protein sequencing, bioassay, chromatography, nuclear magnetic resonance (NMR), and mass spectrometry

Each section provides market data, market drivers, trends and opportunities, top-selling products, key players, and competitive landscape. This report also provides more than 60 market tables for the biosimilar micro-markets in four main geographic regions, i.e. the Americas (North and South America), Europe, Asia, and ROW (includes all the countries not covered in the above categories). In addition, the report also provides 40 company profiles as part of the competitive landscape in the biosimilar market.

What makes our reports unique?

  1. We provide the longest market segmentation chain in the industry with our three-level market breakdown and our analysis of minimum 40 collectively exhaustive and mutually exclusive micro markets.
  2. We provide 10% customization to ensure that our clients find the specific market intelligence they need.
  3. Each report is about 150 pages, featuring 30+ market data tables, 30+ company profiles, and an analysis of 200 patents.
  4. No single report by any other publisher provides market data for all market segments (i.e. products, services, applications, ingredients, and technology) covering the four geographies of North America, Europe, Asia Pacific, and ROW.
  5. 15 pages of high level analysis identifying opportunities, best practices, entry strategies, benchmarking strategies, market positioning, product positioning, and competitive positioning.

Key questions answered

  1. Which are the high-growth segments and how is the market segmented in terms of applications, products, services, ingredients, technologies, stakeholders?
  2. What are market estimates and forecasts; which markets are doing well and which are not?
  3. Where are the gaps and opportunities; what factors are driving market growth?
  4. Which are the key playing fields and winning-edge imperatives?
  5. What is the competitive landscape; who are the main players in each segment; what are their strategic directives, operational strengths, key selling products, and product pipelines? Who is doing what?

Powerful Research and analysis

The analysts working with MarketsandMarkets come from renowned publishers and market research firms globally, adding their expertise and domain understanding. We get the facts from over 22,000 news and information sources, a huge database of key industry participants and draw on our relationships with more than 900 market research companies.

TABLE OF CONTENTS

1 INTRODUCTION
  1.1 Key take-aways
  1.2 Report description
  1.3 Scope of the report
  1.4 Stakeholders

2 SUMMARY
  2.1 Glossary

3 MARKET OVERVIEW
  3.1 Issues related with biosimilar
  3.2 Defining the global biosimilar market
  3.3 Driving factor analysis
      3.3.1 Demand-side drivers
      3.3.2 Supply-side drivers
      3.3.3 Restraints & opportunities
      3.3.4 Key competitive points
  3.4 Potential matrix for global biosimilar products
  3.5 Potential matrix for global biosimilar applications
  3.6 Biosimilar market dynamics
  3.7 Comparison of biosimilar and generic drugs
  3.8 Pricing of biosimilar drug
  3.9 Supply side stakeholders
      3.9.1 Innovator drug manufacturers
      3.9.2 Drug Device manufacturers & next-generation innovators
  3.10 Biosimilar products geographical trend
  3.11 Cycle of innovation and competition

4 BIOSIMILAR PRODUCTS
  4.1 Recombinant non-glycosylated protein
      4.1.1 Drivers
      4.1.2 Insulin
            4.1.2.1 Drivers & opportunities
                    4.1.2.1.1 Increasing demand from huge patient-base
                    4.1.2.1.2 Improvements in drug delivery method
      4.1.3 Recombinant human growth hormone
      4.1.4 Lepirudin
      4.1.5 Interleukin – 2 (Il-2)
      4.1.6 Interferons
            4.1.6.1 Interferon alfa
            4.1.6.2 Interferon beta-1a
            4.1.6.3 Interferon gamma
      4.1.7 Granulocyte colony-stimulating factor (G-CSF)
      4.1.8 Interleukin-11
      4.1.9 Anakinra
  4.2 Recombinant glycosylated proteins
      4.2.1 Drivers & restraints
            4.2.1.1 Applications in many therapeutic indications
            4.2.1.2 Segment covers major drug categories
            4.2.1.3 Requires high degree of clinical and manufacturing expertise
      4.2.2 Erythropoietin (EPO)
      4.2.3 Follitropin
      4.2.4 Thyrotropin
      4.2.5 Urokinase
      4.2.6 Glucocerebrosidase
      4.2.7 Becaplermin
      4.2.8 Granulocyte-macrophage-CSF (GM-CSF)
      4.2.9 Recombinant Human DNASE (RHDNASE)
      4.2.10 Factor VIIA
      4.2.11 Factor VIII
      4.2.12 Factor IX
      4.2.13 Activated protein-c
      4.2.14 Tissue plasminogen activator
      4.2.15 Monoclonal antibodies
             4.2.15.1 Chimaeric antibodies
             4.2.15.2 Humanized / cdr-grafted / reshaped antibodies
             4.2.15.3 Human antibodies and fusion protein
  4.3 Peptides
      4.3.1 Drivers
            4.3.1.1 Development of synthetic and biological peptide libraries
            4.3.1.2 Fewer side effects and maximum therapeutic index
      4.3.2 Restraints & opportunities
            4.3.2.1 Short half-life of peptide molecules
            4.3.2.2 Costly manufacturing and purification process
            4.3.2.3 Approval of drug candidates in phase II & III
      4.3.3 Octreotide
      4.3.4 Desmopressin
      4.3.5 Cyclosporine
      4.3.6 Calcitonin
      4.3.7 Eptifibatide
      4.3.8 LH-RH (Leuprolide)
      4.3.9 Nesiritide
      4.3.10 Teriparatide
      4.3.11 Bivalirudin
      4.3.12 Enfuvirtide
      4.3.13 Glucagon

5 BIOSIMILAR SERVICE MARKET
  5.1 Contract research and manufacturing services
      5.1.1 Drivers
            5.1.1.1 Outsourcing non-core activities to low cost destinations
            5.1.1.2 Time consuming nature of drug manufacturing
      5.1.2 Restraints & opportunities
            5.1.2.1 Long inception period
            5.1.2.2 Low returns
            5.1.2.3 Emergence of biosimilars
  5.2 Clinical trials
      5.2.1 Drivers & restraints
            5.2.1.1 Extensive information about new drug candidate
            5.2.1.2 Central role in drug development
            5.2.1.3 High cost
      5.2.2 Phase I
      5.2.3 Phase II
      5.2.4 Phase III
 
6 BIOSIMILAR APPLICATION MARKET
  6.1 Introduction
      6.1.1 Drivers
            6.1.1.1 Prevalence of incurable diseases
            6.1.1.2 Expanding patient population
            6.1.1.3 Developed technology
            6.1.1.4 Increased life expectancy
      6.1.2 Restraints
            6.1.2.1 Failure of clinical research
            6.1.2.2 Adverse effects of therapies
  6.2 Oncology
      6.2.1 Drivers
            6.2.1.1 Unraveling of the genetics behind cancer
            6.2.1.2 Significance and variants
            6.2.1.3 Availability of new treatments
            6.2.1.4 Increase in the ageing population
      6.2.2 Restraints & opportunities
            6.2.2.1 Lack of early stage diagnostic
            6.2.2.2 Unawareness and lack of penetration of therapeutics
            6.2.2.3 Large product pipeline
      6.2.3 Lung cancer
      6.2.4 Colorectal cancer
      6.2.5 Breast cancer
      6.2.6 Cervical cancer
      6.2.7 Leukemia
            6.2.7.1 Drivers
                    6.2.7.1.1 Huge market potential
                    6.2.7.1.2 Rising awareness
     6.2.8 Prostate cancer
 6.3 Infectious diseases
     6.3.1 HIV/Aids
           6.3.1.1 Drivers
                   6.3.1.1.1 Continual research to increase market size
                   6.3.1.1.2 Biological drugs increase life expectancy
                   6.3.1.1.3 Less expensive than biological drugs
                   6.3.1.1.4 Lack of awareness and access among low income population
     6.3.2 Hepatitis B
     6.3.3 Hepatitis C
 6.4 Chronic and autoimmune diseases
     6.4.1 Diabetes
           6.4.1.1 Drivers
                   6.4.1.1.1 Awareness & early diagnosis prevents disease development
                   6.4.1.1.2 Changing approach of patients towards medication
     6.4.2 Neutropenia
     6.4.3 Multiple sclerosis
           6.4.3.1 Drivers
                   6.4.3.1.1 Rising awareness
                   6.4.3.1.2 Increases the life expectancy
           6.4.3.2 Inhibitors and opportunities
     6.4.4 Cystic fibrosis
     6.4.5 Rheumatoid arthritis (RA)
           6.4.5.1 Drivers
                   6.4.5.1.1 Large patient population
                   6.4.5.1.2 Need for continued treatment
           6.4.5.2 Restraints
     6.4.6 Acromegaly
           6.4.6.1 Driver
                   6.4.6.1.1 Risk of getting other diseases
                   6.4.6.1.2 Worldwide prevalence of the disease
     6.4.7 Leprosy
 6.5 Hematology
     6.5.1 Drivers
           6.5.1.1 Prevalence of blood-related disorders
           6.5.1.2 Availability of cheaper treatment alternatives
           6.5.1.3 Early Start of medication and longer treatment time
     6.5.2 Chemotherapy induced anemia
           6.5.2.1 Drivers
                   6.5.2.1.1 Chemotherapy has become the preferred treatment
                   6.5.2.1.2 Availability of new treatment alternatives
                   6.5.2.1.3 Early and easy diagnostics drives the market
           6.5.2.2 Restraints and opportunities
     6.5.3 Hemophilia
     6.5.4 Pulmonary embolism
           6.5.4.1 Drivers
                   6.5.4.1.1 Availability of large number of diagnosis tools
                   6.5.4.1.2 Need for immediate medication
 6.6 Growth hormone deficiency (GHD)
     6.6.1 Drivers
           6.6.1.1 Natural deficiency of GH and destruction of normal pituitary gland       
           6.6.1.2 Need for body mass management
           6.6.1.3 Changes in the body composition
 6.7 Other diseases
     6.7.1 Gaucher disease
     6.7.2 Osteoporosis
     6.7.3 Fertility disorders (Infertility)
     6.7.4 Skin ulcer
     6.7.5 Hypoglycemia
     6.7.6 Nocturnal enuresis
     6.7.7 Congestive heart failure (CHF)
     6.7.8 Systemic sepsis
     6.7.9 Others

7 BIOSIMILAR TECHNOLOGY
  7.1 Monoclonal antibodies (MAB) technology
      7.1.1 Drivers
            7.1.1.1 Broad range of therapeutic, diagnostic, and research applications
            7.1.1.2 Low cost of development
            7.1.1.3 Higher success rate
      7.1.2 Top player analysis
  7.2 Recombinant dna technology (RDNA technology)
      7.2.1 Drivers
            7.2.1.1 Human therapeutics application
            7.2.1.2 Agricultural genetic engineering application
            7.2.1.3 Increase in demand of biopharmaceutical products
      7.2.2 Restraints & opportunities
            7.2.2.1 High cost
            7.2.2.2 Risk of failure
            7.2.2.3 Role in production of edible vaccines
  7.3 Chromatography
      7.3.1 Drivers & opportunities
            7.3.1.1 High resolution refinement
            7.3.1.2 Efficacy of end product
            7.3.1.3 Wide applications
            7.3.1.4 Emergence of biosimilars
      7.3.2 Top player analysis
      7.3.3 Liquid chromatography (LC)
      7.3.4 Gas chromatography (GC)
  7.4 Protein sequencing
      7.4.1 Drivers
            7.4.1.1 Applications in life saving drug development
            7.4.1.2 Applications in protein classification
            7.4.1.3 Use in diagnosis
  7.5 Nuclear magnetic resonance (NMR) technology
      7.5.1 Drivers
            7.5.1.1 Leading technology for 3-D structure
            7.5.1.2 Eliminates risk of x-radiation
            7.5.1.3 Application in drug delivery system
  7.6 Electrophoresis
      7.6.1 Drivers
            7.6.1.1 Genomic application
            7.6.1.2 Most reliable technique
            7.6.1.3 Separation efficacy
      7.6.2 Restraints & opportunities
            7.6.2.1 High sample runtime
      7.6.3 GEL electrophoresis
      7.6.4 Capillary electrophoresis
  7.7 Mass spectrometry
      7.7.1 Drivers
            7.7.1.1 Simple quantification of protein structures
            7.7.1.2 Supporting element for growing technologies:
            7.7.1.3 Gaining popularity of hybrid mass spectrometry instruments
      7.7.2 Restraints
            7.7.2.1 Fails to analyze small quantities of proteins
            7.7.2.2 Manual interruption necessary, increasing the error rate
  7.8 Western blotting
      7.8.1 Drivers
            7.8.1.1 Application in molecular biology disciplines
            7.8.1.2 Application in diagnosis of diseases
            7.8.1.3 High efficacy at low cost
  7.9 Bioassay
      7.9.1 Drivers
            7.9.1.1 Central role in new drug development
            7.9.1.2 Monitoring environmental pollutants
            7.9.1.3 Cost benefits and error reduction
            7.9.1.4 Shrinking pipelines of new drug candidates
            7.9.1.5 Increasing price pressures in the U.S. and Europe
      7.9.2 Restraints
            7.9.2.1 Accuracy of experiment not guaranteed
            7.9.2.2 Time-consuming, laborious, and organism-specific activity
      7.9.3 Techniques in bioassay
            7.9.3.1 Six point assay
            7.9.3.2 Multiple point assays
            7.9.3.3 Interpolation method
            7.9.3.4 Bracketing method
            7.9.3.5 Matching bioassays

8 GEOGRAPHIC ANALYSIS
  8.1 American biosimilar market
      8.1.1 Large patient base and high Medicare expenditure
      8.1.2 Largest biopharmaceutical market
  8.2 European biosimilar market
  8.3 Asian biosimilar market
  8.4 ROW biosimilar market

9 REGULATORY GUIDELINES
  9.1 AMERICA
      9.1.1 CANADA
      9.1.2 U.S.
  9.2 ASIA
      9.2.1 JAPAN
      9.2.2 CHINA
      9.2.3 INDIA
  9.3 EUROPE
  9.4 ROW
 
10 COMPANY PROFILES
   10.1 3SBIO (SHENYANG SUNSHINE PHARMACEUTICAL CO. LTD)
   10.2 ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
   10.3 BHARAT BIOTECH
   10.4 BIOCLONES (PTY) LTD.
   10.5 BIOCON
   10.6 BIOGNERIX AG
   10.7 BIOPARTNERS
   10.8 CANGENE
   10.9 CINNAGEN INC.
   10.10 CLARIS LIFESCIENCES
   10.11 DONG-A PHARMACEUTICAL
   10.12 DR. REDDY’S LABORATORIES
   10.13 DSM BIOLOGICS
   10.14 DYNAVAX TECHNOLOGIES
   10.15 EMCURE
   10.16 GENESCIENCE PHARMACEUTICALS CO LTD.
   10.17 GLENMARK PHARMACEUTICALS
   10.18 GTC BIOTHERAPEUTICS LTD.
   10.19 HOSPIRA INC.
   10.20 INTAS BIOPHARMACEUTILCALS LTD.
   10.21 LG LIFE SCIENCES
   10.22 MAXYGEN
   10.23 MERCK
   10.24 MOMENTA
   10.25 PANACEA BIOTECH
   10.26 PHAGE BIOTECH CORPORATION
   10.27 PHARMACLON
   10.28 PROLONG PHARMACEUTICALS
   10.29 RANBAXY
   10.30 RELIANCE GENEMEDIX PLC
   10.31 SANDOZ (NOVARTIS PHARMACEUTICAL)
   10.32 SCIGEN
   10.33 SCINOPHARM TAIWAN, LTD.
   10.34 SHANTHA BIOTECH
   10.35 SHENZHEN NEPTUNUS INTERLONG
   10.36 SHREYA LIFE SCIENCES LTD.
   10.37 STADA ARZNEIMITTEL AG
   10.38 TEVA PHARMACEUTICAL INDUSTRIES LTD.
   10.39 VIROPRO INTERNATIONAL INC.
   10.40 WOCKHARDT LIMITED
 
11 PATENT ANALYSIS
   11.1 Patent expiration in 2008 and before
   11.2 Patent expiration in 2009 and after
 
APPENDIX
Patent expiry in 2008 and before
U.S. Biopharmaceutical patents
European biopharmaceutical patents
Asian biopharmaceutical patents
Patent expiry in 2009 and after
U.S. Biopharmaceutical patents
European biopharmaceutical patents
Asian biopharmaceutical patents
 
LIST OF TABLES 
 
Summary Table Global Biosimilar Market, By Products 2007 – 2014 ($Thousands) 
1 Global biosimilar non-glycosylated protein market, by product 2007 – 2014 ($Thousands)
2 Global biosimilar recombinant non-glycosylated protein market, by geography 2007 – 2014 ($Thousands)
3 Major players and their respective developments
4 Global biosimilar recombinant insulin market, by geography 2007 – 2014 ($Thousands)
5 Global biosimilar RHGH market, by geography 2007 – 2014 ($Thousands)
6 Global biosimilar lepirudin market, by geography 2007 – 2014 ($Thousands)
7 Global biosimilar recombinant interleukin–2 market, by geography 2007 – 2014 ($Thousands)
8 Global biosimilar recobinant interferons market, by product 2007 – 2014 ($Thousands)
9 Global biosimilar recombinant interferons market, by geography 2007 – 2014 ($Thousands)
10 Global biosimilar recombinant interferon alfa market by geography 2007 – 2014 ($Thousands)
11 Global biosimilar recombinant interferon beta–1a market, by geography 2007 – 2014 ($Thousands)
12 Global biosimilar recombinant interferon gamma market, by geography 2007 – 2014 ($Thousands)
13 Global biosimilar recombinant granulocyte colony-stimulating factor (G-CSF) market, by geography 2007 – 2014 ($Thousands)
14 Global biosimilar recombinant interleukin–11 market, by geography 2007 – 2014 ($Thousands)
15 Global biosimilar recombinant anakinra market, by geography 2007 – 2014 ($Thousands)
16 Global biosimilar glycosylated protein market, by products 2007 – 2014 ($Thousands)
17 Global biosimilar glycosylated protein market, by geography 2007 – 2014 ($Thousands)
18 Major players and their respective developments
19 Global biosimilar recombinant epo market, by geography 2007 – 2014 ($Thousands)
20 Global biosimilar follitropin market, by geography 2007 – 2014 ($Thousands)
21 Global biosimilar thyrotropin market, by geography 2007 – 2014 ($Thousands)
22 Global biosimilar urokinase market, by geography 2007 – 2014 ($Thousands)
23 Global biosimilar glucocerebrosidase market, by geography 2007 – 2014 ($Thousands)
24 Global biosimilar becaplermin market, by geography 2007 – 2014 ($Thousands)
25 Global biosimilar recombinant GM-CSF market, by geography 2007 – 2014 ($Thousands)
26 Global biosimilar rhdnase market, by geography 2007 – 2014 ($Thousands)
27 Global biosimilar factor VIIA market, by geography 2007 – 2014 ($Thousands)
28 Global biosimilar factor VIII market, by geography 2007 – 2014 ($Thousands)
29 Global biosimilar factor IX market, by geography 2007 – 2014 ($Thousands)
30 Global biosimilar activated protein c market, by geography 2007 – 2014 ($Thousands)
31 Global biosimilar TPA market, by geography 2007 – 2014 ($Thousands)
32 Global biosimilar monoclonal antibodies market, by geography 2007 – 2014 ($Thousands)
33 Global biosimilar peptide market, by products 2007 – 2014 ($Thousands)
34 Global biosimilar peptide market, by geography 2007 – 2014 ($Thousands)
35 Major players and their respective developments
36 Global biosimilar octreotide peptide market, by geography 2007 – 2014 ($Thousands)
37 Global biosimilar desmopressin peptide market, by geography 2007 – 2014 ($Thousands)
38 Global biosimilar cyclosporine peptide market, by geography  2007 – 2014 ($Thousands)
39 Global biosimilar calcitonin peptide market, by geography 2007 – 2014 ($Thousands)
40 Global biosimilar eptifibatide peptide market, by geography 2007 – 2014 ($Thousands)
41 Global biosimilar LH-RH peptide market, by geography 2007 – 2014 ($Thousands)
42 Global biosimilar nesiritide pepetide market, by geography 2007 – 2014 ($Thousands)
43 Global biosimilar teriparatide peptide market, by geography 2007 – 2014 ($Thousands)
44 Global biosimilar bivalirudin peptide market, by geography 2007 – 2014 ($Thousands)
45 Global biosimilar enfuvirtide peptide market, by geography 2007 – 2014 ($Thousands)
46 Global biosimilar glucagon peptide market, by geography 2007 – 2014 ($Thousands)
47 Major players and developments
48 Global biosimilar market, by applications 2007 – 2014 ($Thousands)
49 Global biosimilar oncology market, by types 2007 – 2014 ($Thousands)
50 Global biosimilar infectious diseases market, by types 2007 – 2014 ($Thousands)
51 Global biosimilar chronic and autoimmune disease market, by types 2007 – 2014 ($Thousands)
52 Global biosimilar hematology market, by types 2007 – 2014 ($Thousands)
53 Global biosimilar other disieases market, by types 2007 – 2014 ($Thousands)
54 Major players and developments
55 Major players and developments
56 Global biosimilar market, by geography 2007 – 2014 ($Thousands)
57 American biosimilar market, by segments 2007 – 2014 ($Thousands)
58 European biosimilar market, by segments 2007 – 2014 ($Thousands)
59 Asian biosimilar market, by segments 2007 – 2014 ($Thousands)
60 ROW biosimilar market, by segments 2007 – 2014 ($Thousands)
 
LIST OF FIGURES 
 
1 Market transition impacting biosimilar market
2 Issues related with biosimilar
3 Biosimilar market definition
4 Driving factor analysis of global biosimilar market
5 Market potential matrix for global biosimilar product market, 2009
6 Market potential matrix for global biosimilar application market, 2009
7 Global biosimilar market dynamics
8 Comparison of biosimilar and generic drugs
9 Pricing of biosimilar drug
10 Supply side stakeholders
11 Biosimilar products geographical trend
12 Cycle of innovation and competition
13 Biosimilar product market trend
14 European biosimilar market dynamics
15 Global biopharmaceutical patents, by segment
16 Global biopharmaceutical patents, by geography
17 U.S. biopharmaceutical patents, by segment
18 Europe biopharmaceutical patents, by segment
19 Asia biopharmaceutical patents, by segment
20 Global biopharmaceutical patents, by segment
21 Global biopharmaceutical patents, by geography
22 U.S. biopharmaceutical patents, by segment
23 Europe biopharmaceutical patents, by segment
24 Asia biopharmaceutical patents, by segment

The biotechnology has changed the outlook of pharmaceutical market. Pharmaceutical in combination with biotechnology has evolved a new branch called biopharmaceutical. Presently biopharmaceutical contributes 15% of entire pharmaceutical market. The expiration of patents of a number of blockbuster biopharmaceutical drugs; increasing pressure from patients, insurers and Government to reduce the expenditure has created a large number of opportunities for biosimilar products; imparting challenges for innovative drug manufacturers.

Currently the biosimilar market is highly fragmented and huge opportunities available in the market, are attractive new players. Favorable regulatory developments in the biosimilar sector are expected to increase the market share, profit margins and reduce the medical expenditure, in turn from an important developing pharmaceutical market.

Biosimilar market is getting boost from increasing user acceptance and emerging Indian and Chinese markets. The major challenge for the biosimilar market is risk involved with the high investment and possible failure of the drug during development stages. However, opportunities for biosimilar market is immense, as biologics worth $25 billion are going to be off patent by 2016 and an anticipated approval pathway in U.S. will open up potentially largest market.

The global biosimilar market is expected to be worth $19.4 billion by 2014, growing at an expected CAGR of 89.1% from 2009 to 2014. The biosimilar market is segmented into peptides, Recombinant glycosylated proteins, Recombinant non-glycosylated proteins and others. Among all the products, Biosimilar erythropoietins are expected to emerge as the best product with a market worth $6.1 billion by 2014.

While America and Asia hold a major share of the global biosimilar market, Europe is also gaining momentum after the approval of its first biosimilar Omnitrope in 2006. Moreover, U.S. market is expected to open up in 2010 which will give a major thrust to the growth of biosimilar market.

Global Biosimilar Market by Products, 2009

biosimilars

Source: MarketsandMarkets
In 2009, biosimilar recombinant non glycosylated protein products form the largest market segment; and are expected to reach $11.5 billion by 2014 at a CAGR of 87.9% from the year 2009 to 2014. This is mainly because most of the branded blockbuster biopharmaceutical drug such as interferon, human growth hormone-Somatropin, insulin and G-CSF; belong to this class and have wide range of applications.

The key players in biosimilar market include Biocon, Dr. Reddy’s lab, Intas, LG Life Sciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and Wockhardt, etc.
Our analysis indicates that companies taking the first mover advantage by quick commercialization with extensive R&D will have an edge over their competitors. Agreements and collaborations as well as new product launches are some of the most popular strategies adopted by market players to stay ahead of the competition and to expand into new geographies.

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