HOME Top Market Reports Biosimilars Market Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018

Biosimilars Market Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018

By: marketsandmarkets.com
Publishing Date: November 2013
Report Code: BT 2160

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Biosimilars are therapeutically similar copies of biologic drugs. The European Medicines Agency (EMA) defines biosimilars as drugs that claim to be “similar” to their reference biological medicinal products. The active drug substance of biosimilars is derived from a living organism by means of recombinant DNA or controlled gene expression methods. In the coming years, biosimilars will continue to act as a catalyst for the biopharmaceutical industry. The most significant reason for the increasing adoption of biosimilars is their cost benefits to patients as these products are available in the market at 10% to 30% lower prices compared to their parent products. The global market is estimated to reach $2.0 billion by 2018 at a CAGR of more than 20% between 2013 and 2018.

The biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further segmented as insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormone, whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Recombinant peptide market is divided into Calcitonin and Glucagon.

Of all the segments, the key traction segment that is estimated to grow at a faster rate of 25% by 2018 is the recombinant glycosylated proteins segment. This growth can mainly be attributed to investments by drug manufacturers to develop biosimilar versions of monoclonal antibodies (more than 50 biosimilars of monoclonal antibodies are in the pipeline), the introduction of the new biosimilar drug ‘Ovaleap’ (follitropin) to treat infertility, and the growing demand for erythropoietin and monoclonal antibodies to treat cancer.

Monoclonal antibody is one of the lucrative markets for drug manufacturers, for x future investment to develop MAb at a large scale and is also estimated to be the fastest growing market at an estimated CAGR of 41.9% from 2013 to 2018. About eight biologic MAb drugs are expected become off-patent products from 2013 to 2018. The drugs that are expected to lose their patent protections are Rituxan/MabThera, Remicade, Herceptin, Humira, Avastin, Synagis, Erbitux, and Lucentis. The three most targeted products for biosimilars are Rituximab, Infliximab, and Adalimumab due to their high worldwide sales and approvals for multiple indications. Various key industry players of the generics market have started working on the manufacturing and clinical trial activities of MAbs. At present, approximately 50 biosimilar MAbs are in the pipeline. Bioexpress Therapeutic (Switzerland) has 16 biosimilar candidates of MAbs that are in the pipeline. The other players that have invested in the production of MAbs are GeneTechno Science (Japan), Celltrion (South Korea), Zydus-Cadila (India), Biocon (India), and Samsung Biologics (South Korea).

Following monoclonal antibodies, insulin will be the fastest growing segment and is estimated to grow at a CAGR of 35.6% from 2013 to 2018. The growth is attributed to the rise in incidences of diabetes, on-going patent expirations of biologic drugs such as Lantus, Humalog, and Novorapid, and the cost effectiveness of the biosimilars of insulin. Other factors that drive the global market is the rise in the number of off-patented biologic drugs, rise in incidences of chronic disorders, growing pressure to cut healthcare expenditure, rise in aging populations, and government support and initiatives.

On the other hand, the factors that restrict the growth of the market are high manufacturing complexities and costs, the stringent regulatory environment in the U.S. and Europe, innovative strategies used by biologic drug manufacturers to protect their intellectual property, costly purification process, arrival of biobetters, and the presence of low priced biogenerics that compete with biosimilars in the market.

Across countries, China and India are considered attractive destinations for R&D outsourcing of foreign biosimilar manufacturing companies that look to reduce their growing R&D costs and increase the number of drug applications and approvals.  Both the countries are expected to grow at the fastest CAGR of 30.2% and 29% from 2013 to 2018. Factors responsible for the high growth rate in India and China are the lack of government regulations with regards to the approval of biosimilars, the low IP protection of biologic compounds in China, semi regulatory environment to approve biosimilars in India, and low manufacturing costs, that have enabled domestic manufacturers to market the generic version of biologic compounds at a low price.

Sandoz has emerged as the market leader in the global market and is likely to maintain this leadership position in the coming years. Sandoz entered the biosimilars market in 2006, with the launch of Omnitrope (human growth hormone)-a biosimilar drug-in the European market. Sandoz’s biosimilar product offerings include Zarzio (G-CSF), Omnitrope (Human Growth Hormone), and Binocrit (epoeitin-alpha). Thus, the broad product portfolio enables the company to gain a competitive advantage over other players in the market. The company focuses on strengthening their market position by significantly investing in research and development activities. It has a robust biosimilar pipeline with about 10 drugs.

Teva, another major player, has the capability to provide a stiff competition to Sandoz In 2000, Teva entered the biosimilars market by setting up a clear long term biosimilar strategy. Since then Teva has undergone several acquisitions and agreements with contract manufacturing organizations as well as various strategic alliances to strengthen their manufacturing unit and R&D capabilities.

Other notable players are Hospira (U.S.), Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and Intas Biopharmaceultical Ltd. (India).

Table Of Contents 
 
1 Introduction (Page No. - 26)
  1.1 Objectives Of The Study
  1.2 Report Description
  1.3 Markets Covered
  1.4 Stakeholders
  1.5 Market Scope
  1.6 Research Methodology
      1.6.1 Market Size Estimation And Data Triangulation
      1.6.2 Market Share
      1.6.3 Key Data Points From Secondary Sources
      1.6.4 Key Data Points From Primary Sources
      1.6.5 Assumptions

2 Executive Summary (Page No. - 38)

3 Premium Insights (Page No. - 42)
  3.1 Biosimilars Market Vs. Biologic Market
  3.2 Global Biosimilars Market
      3.2.1 Market Dynamics
      3.2.2 Product Market
      3.2.3 Application Market
  3.3 Geographic Analysis, By Country
  3.4 Market Share Analysis

4 Market Overview (Page No. - 49)
  4.1 Introduction
  4.2 Evolution
  4.3 Market Segmentation
  4.4 Market Dynamics
      4.4.1 Drivers
            4.4.1.1 Growing Pressure To Cut Healthcare Expenditure, An Impetus To The Demand Of Biosimilars
            4.4.1.2 Off-Patent Biologic Products To Boost The Biosimilars Market
            4.4.1.3 Rise In Aging Population Triggers The Incidences Of Chronic Disorders And Thus Boosts The Biosimilars Market
            4.4.1.4 Growing Demand For Biosimilars Drugs Due To Their Cost Effectiveness
            4.4.1.5 Rising Incidences Of Various Diseases To Boost The Biosimilars Market
            4.4.1.6 Strategic Collaborations Lead To Increased Productivity And Clinical Trial Activities For Biosimilars
            4.4.1.7 Government Support And Initiatives Propel The Biosimilars Market
      4.4.2 Restraints
            4.4.2.1 High Manufacturing Complexities And Costs, A Significant Entry Barrier For Companies
            4.4.2.2 Stringent Regulatory Requirements In Countries To Adversely Affect Investments In Biosimilars
            4.4.2.3 Innovative Strategies By Biologic Drug Manufacturers To Restrict Entry Into The Biosimilars Market
      4.4.3 Opportunities
            4.4.3.1 Emerging Countries
            4.4.3.2 Untapped Indications
      4.4.4 Challenges
            4.4.4.1 Requirement Of Complex Infrastructure For Manufacturing As Well As Extensive Clinical Trials For Obtaining Approval
            4.4.4.2 Bulk Production To Meet Market Demand Is A Challenge For Smaller Manufacturers
  4.5 Winning Imperatives
      4.5.1 Partnerships & Agreements To Gain Competitive Advantage
      4.5.2 Sandoz’s In-House Capabilities Made It The Global Leader
  4.6 Burning Issues
      4.6.1 Opportunities For New Entrants In The Biosimilars Market
      4.6.2 Product Withdrawals Provide Significant Opportunities For New Entrants
      4.6.3 Termination Of Joint Ventures Allows Companies To Focus On Core Competencies
      4.6.4 Discontinuation Of Patent By Roche Provides Opportunities To Other Players
  4.7 Biosimilars Pipeline Analysis
      4.7.1 About 50 Biosimilars Of Monoclonal Antibody In The Pipeline

5 Industry Analysis (Page No. - 82)
  5.1 Introduction
  5.2 Research & Development Investment Analysis
  5.3 Industry Trend Analysis
      5.3.1 Forthcoming Patent Expirations
      5.3.2 Manufacturing Agreement
  5.4 Porter’s Five Forces Analysis
      5.4.1 Threat Of New Entrants
      5.4.2 Threat Of Substitutes
      5.4.3 Competitor Rivalry
      5.4.4 Bargaining Power Of Suppliers
      5.4.5 Bargaining Power Of Buyers

6 Global Biosimilars Market, By Product (Page No. - 90)
  6.1 Introduction
      6.1.1 Biosimilars Demand To Grow Owing To High Efficacies & Low Prices
  6.2 Recombinant Non-Glycosylated Proteins
      6.2.1 Insulin Biosimilars Will Drive The Recombinant Non-Glycosylated Proteins Segment
      6.2.2 Insulin
            6.2.2.1 Insulin Glargine, Lispro, And Aspart Will Go Off-Patent In 2014
      6.2.3 Recombinant Human Growth Hormone (RHGH)
      6.2.4 Granulocyte Colony-Stimulating Factor (Filgrastim)
            6.2.4.1 Strong Biosimilars Pipeline To Boost The Filgrastim Market
      6.2.5 Interferons
            6.2.5.1 Biosimilars Of Interferon Available Only In Asia-Pacific And Row Regions Due To Less Stringent Regulatory Pathway
  6.3 Recombinant Glycosylated Proteins
      6.3.1 Erythropoietin (EPO)
            6.3.1.1 Cost Effectiveness Of Epo Biosimilars, One Of The Major Driving Factors
      6.3.2 Monoclonal Antibodies (MAB)
            6.3.2.1 Monoclonal Antibodies Market, A Lucrative Opportunity For Companies
      6.3.3 Follitropin
            6.3.3.1 New Biosimilars Of Follitropin ‘Ovaleap’ Received Marketing Authorization In Europe In 2014
  6.4 Recombinant Peptides
      6.4.1 Glucagon
            6.4.1.1 Glucagen, The First Fop Approved In U.S.
      6.4.2 Calcitonin
            6.4.2.1 U.S. Fda Does Not Support Miacalcin As A Treatment For Osteoporosis

7 Global Biosimilars Market, By Application   (Page No. - 122)
  7.1 Introduction
  7.2 Oncology
      7.2.1 Growing Cost Burden Of Cancer Will Stimulate The Demand For Mabs & Filgrastim
  7.3 Blood Disorders
      7.3.1 Rise In Incidences Of Anemia, Leukemia, Myeloma & Lymphoma Will Enhance The Need For Biosimilars
  7.4 Chronic And Autoimmune Diseases
      7.4.1 Monoclonal Antibodies To Boost The Application Of Biosimilars In Autoimmune Diseases
  7.5 Growth Hormone Deficiency
      7.5.1 About 10,000 New Patients Are Diagnosed Annually With Growth Hormonal Disorders
  7.6 Infectious Diseases
      7.6.1 Growing Cases Of Hepatitis, A Boost For The Interferon Biosimilars Market
  7.7 Others (Female Infertility, Hypoglycaemia, Myocardial Infarction, Postmenopausal Osteoporosis & Chronic Kidney Failure)

8 Global Biosimilars Service Market  (Page No. - 138)
  8.1 Introduction
      8.1.1 R&D And Manufacturing Issues Provide Significant Opportunities To CRO & CMO
  8.2 Contract Manufacturing Organizations
      8.2.1 CMO Provide Considerable Opportunities To Companies Planning To Enter Biosimilars Market
  8.3 Contract Research Organizations
      8.3.1 Lack Of Expertise With The Biosimilars Players, A Prospect For Cro
  8.4 Others (Non-Clinical & Bioinformatics)

9 Geographic Analysis  (Page No. - 148)
  9.1 Introduction
      9.1.1 Europe Dominates The Global Biosimilars Market Due To Its Well Defined Regulatory Guidelines
  9.2 North America
      9.2.1 Rise In Pressure To Cut Healthcare Cost & A Leading Biologic Market Will Increase The Demand For Low Priced Biosimilars
      9.2.2 Regulatory Outlook
            9.2.2.1 U.S.
            9.2.2.2 Canada
      9.2.3 Market Analysis
            9.2.3.1 U.S.
                    9.2.3.1.1 Financial Support By U.S. Government To FDA For Review Of Biosimilars Will Add Significant Growth To Biosimilars Industry
            9.2.3.2 Canada
  9.3 Europe
      9.3.1 Europe Is The Pioneer For The Development Of Biosimilars
      9.3.2 Regulatory Outlook
      9.3.3 Market Analysis
            9.3.3.1 U.K.
                    9.3.3.1.1 Well-Developed Generics Market & Growing Pressure To Decrease Drug Prices To Drive The Biosimilars Market
            9.3.3.2 Germany
                    9.3.3.2.1 Reference Pricing System Of Germany Leads To Faster Adoption Of Biosimilars
            9.3.3.3 France
                    9.3.3.3.1 Biosimilars Not Considered As Generic Drugs & Are Excluded From The French Substitution List
            9.3.3.4 Spain
                    9.3.3.4.1 Effect Of Recession On Branded Drugs Will Shift The Market Towards Biosimilars Drugs
            9.3.3.5 Italy
                    9.3.3.5.1 Adoption Of Biosimilars Low Compared To Branded Versions
            9.3.3.6 Rest Of Europe (ROE)
                    9.3.3.6.1 Substitution Status Varies In Different Countries
                    9.3.3.6.2 Reference Pricing System Of Denmark Will Proliferate The Biosimilars Market
  9.4 Asia-Pacific
      9.4.1 APAC, A Blue-Eyed Market For Investors In Biosimilars Owing To Less Stringent Regulatory Pathway
      9.4.2 Growing Medical Tourism & Low Manufacturing Cost Will Propel The Biosimilars Market
      9.4.3 Regulatory Outlook
            9.4.3.1 China
            9.4.3.2 India
            9.4.3.3 Japan
            9.4.3.4 South Korea
      9.4.4 Market Analysis
            9.4.4.1 China
                    9.4.4.1.1 Lack Of Government Regulation & Low Ip Protection For Biologic Compounds Will Drive The Biosimilars Market
            9.4.4.2 India
                    9.4.4.2.1 Semi-Regulatory Environment For Approving Similar Biologic Drugs Propels The Biosimilars Market
            9.4.4.3 Japan
            9.4.4.4 South Korea
                    9.4.4.4.1 Government Support & Strong Biosimilar Pipeline, An Impetus To The Biosimilars Market
            9.4.4.5 Rest Of Asia-Pacific (ROAP)
                    9.4.4.5.1 Australia & Malaysia To Aggressively Promote The Adoption Of Biosimilars
  9.5 Rest Of The World (ROW)
      9.5.1 Latam Provides High Growth Opportunities For Biosimilars Player 
      9.5.2 Regulatory Outlook
            9.5.2.1 Brazil
            9.5.2.2 Mexico
            9.5.2.3 Argentina
            9.5.2.4 Saudi Arabia
      9.5.3 Market Analysis
            9.5.3.1 Latin America
                    9.5.3.1.1 Strong Economic Condition & Government Support Will Strengthen The Biosimilar Industry In Brazil
            9.5.3.2 Africa
            9.5.3.3 Middle East

10 Competitive Landscape  (Page No. - 218)
  10.1 Introduction
      10.1.1 Agreements & Partnerships Was The Key Strategy Adopted By Biosimilar Players
  10.2 Market Share Analysis
  10.3 Agreements, Joint Ventures, Partnerships, & Collaborations
  10.4 Acquisitions
  10.5 New Product Launches
  10.6 Others (Regulatory Approvals)

11 Company Profiles (Overview, Financials, Products & Services, Strategy, & Developments)*  (Page No. - 238)
  11.1 Actavis, Inc.
  11.2 Amgen, Inc.
  11.3 Biocon Ltd.
  11.4 Celltrion, Inc.
  11.5 Cipla Ltd.
  11.6 Dr. Reddy’s Laboratories Ltd.
  11.7 Emcure Pharmaceuticals Ltd.
  11.8 Hospira, Inc.
  11.9 Lg Life Sciences Ltd.
  11.1 Merck Kgaa
  11.11 Mylan, Inc.
  11.12 Ranbaxy Laboratories Ltd.
  11.13 Roche Holding Ltd.
  11.14 Sandoz International GMBH (Division Of Novartis International Ag)
  11.15 Stada Arzneimittel Ag
  11.16 Synthon
  11.17 Teva Pharmaceutical Industries Ltd.
  11.18 Wockhardt Ltd.

*Details On Financials, Product & Services, Strategy, & Developments Might Not Be Captured In Case Of Unlisted Companies. 


List Of Tables  (80 Tables)

Table 1 Region-Specific Terminology Of Biosimilars
Table 2 Key Attractive Biologics Under Threat Of Patent Expiry, 2012 – 2018 
Table 3 Key Alliances Of The Biosimilars Industry
Table 4 Global Biosimilars Market, By Product, 2011 – 2018 ($Million)
Table 5 Global Biosimilars Market: Recombinant Non-Glycosylated Proteins, By Product, 2011 – 2018 ($Million)
Table 6 Biologic Insulin Going Off-Patent, 2010 – 2015
Table 7 Biosimilars Market: Insulin, By Geography, 2011 – 2018 ($Million) 
Table 8 Biosimilars Market: Recombinant Human Growth Hormone, By Geography, 2011 – 2018 ($Million) 
Table 9 Biosimilars Market: Granulocyte Colony-Stimulating Factor, By Geography, 2011 – 2018 ($Million)
Table 10 Biosimilars Market: Interferon, By Geography, 2011 – 2018 ($Million) 
Table 11 Global Biosimilars Market: Recombinant Glycosylated Proteins, By Product, 2011 – 2018 ($Million)
Table 12 Biosimilars Market: Erythropoietin, By Geography, 2011 – 2018 ($Million) 
Table 13 Biologic Recombinant Monoclonal Antibodies Going Off-Patent, 2010 – 2019 
Table 14 Biosimilars Market: Monoclonal Antibodies, By Geography, 2011 – 2018 ($Million)
Table 15 Biosimilars Market: Follitropin, By Geography, 2011 – 2018 ($Million) 
Table 16 Global Biosimilars Market: Recombinant Peptides, By Product,2011 – 2018 ($Million) 
Table 17 Biosimilars Market: Glucagon, By Geography, 2011 – 2018 ($Million) 
Table 18 Biosimilars Market: Calcitonin, By Geography, 2011 – 2018 ($Million) 
Table 19 Global Biosimilar Market, By Application, 2011 – 2018 ($Million) 
Table 20 Biosimilars Drugs Used To Treat Cancer
Table 21 Oncology Biosimilars Market, By Geography, 2011 – 2018 ($Million) 
Table 22 Biosimilars Drugs Used To Treat Blood Disorders
Table 23 Blood Disorders Biosimilars Market, By Geography, 2011 – 2018 ($Million) 
Table 24 Biosimilars Drugs Used To Treat Chronic And Autoimmune Disorder
Table 25 Chronic And Autoimmune Disorders Biosimilars Market, By Geography, 2011 – 2018 ($Million) 
Table 26 Growth Hormonal Disorder Biosimilars Market, By Geography, 2011 – 2018 ($Million) 
Table 27 Biosimilars Drugs Used To Treat Infectious Diseases
Table 28 Infectious Diseases Biosimilars Market, By Geography, 2011 – 2018 ($Million) 
Table 29 Biosimilars Drugs Used To Treat Various Other Diseases
Table 30 Biosimilars Manufacturing Strategies Of Leading Players
Table 31 Joint Ventures Of Cmos & Pharmaceutical Companies For Biosimilars
Table 32 Joint Ventures Of Cros & Pharmaceutical Companies For Biosimilars
Table 33 Global Biosimilars Market, By Geography, 2011 – 2018 ($Million) 
Table 34 Biosimilar Drugs In North America
Table 35 Biologic Drugs Going Off-Patent In The U.S., 2012 – 2018
Table 36 Regulatory Status In North America
Table 37 North America: Biosimilars Market, By Product, 2011 – 2018 ($Million) 
Table 38 North America: Recombinant Non-Glycosylated Protein Market, By Product, 2011 – 2018 ($Million)
Table 39 North America: Recombinant Peptides Market, By Product, 2011 – 2018 ($Million)
Table 40 North America: Biosimilars Market, By Application, 2011 – 2018 ($Million) 
Table 41 North America: Biosimilars Market, By Country, 2011 – 2018 ($Million) 
Table 42 North America:Recombinant Non-Glycosylated Market, By Country, 2011 – 2018 ($Million) 
Table 43 North America: Recombinant Peptides Market, By Country, 2011 – 2018 ($Million)
Table 44 Biosimilars Drugs In The European Market
Table 45 Biologic Drugs Going Off-Patent, 2013 – 2018
Table 46 Substitution Status In European Coutries
Table 47 Europe: Biosimilars Markets, By Product, 2011 – 2018 ($Million) 
Table 48 Europe: Recombinant Non-Glycosylated Protein Market, By Product, 2011 – 2018 ($Million) 
Table 49 Europe: Recombinant Glycosylated Protein Market, By Product, 2011 – 2018 ($Million) 
Table 50 Europe: Recombinant Peptides Market, By Product, 2011 – 2018 ($Million) 
Table 51 Europe: Biosimilars Market, By Application, 2011 – 2018 ($Million) 
Table 52 Europe: Biosimilars Market, By Country, 2011 – 2018 ($Million) 
Table 53 Europe: Recombinant Non-Glycosylated Market, By Country, 2011 – 2018 ($Million)
Table 54 Europe: Recombinant Glycosylated Market, By Country, 2011 – 2018 ($Million) 
Table 55 Europe: Recombinant Peptides Market, By Country, 2011 – 2018 ($Million) 
Table 56 Similar Biologic Drugs In Asia-Pacific Region
Table 57 Status Of Regulatory Pathway In Asia-Pacific Region
Table 58 APAC: Biosimilars Market, By Product, 2011 – 2018 ($Million)
Table 59 APAC: Recombinant Non-Glycosylated Protein Market, By Product, 2011 – 2018 ($Million) 
Table 60 APAC: Recombinant Glycosylated Protein Market, By Product, 2011 – 2018 ($Million)
Table 61 APAC: Recombinant Peptides Market, By Product, 2011 – 2018 ($Million) 
Table 62 APAC: Biosimilars Market, By Application, 2011 – 2018 ($Million) 
Table 63 APAC:Biosimilars Market, By Country, 2011 – 2018 ($Million)
Table 64 APAC: Recombinant Non-Glycosylated Market, By Country, 2011 – 2018 ($Million)
Table 65 APAC: Recombinant Glycosylated Market, By Country, 2011 – 2018 ($Million) 
Table 66 APAC: Recombinant Peptide Market, By Country, 2011 – 2018 ($Million) 
Table 67 Biosimilars Drugs In Row
Table 68 Regulatory Status In The Row Biosimilars Market
Table 69 Row: Biosimilars Market, By Product, 2011 – 2018 ($Million)
Table 70 Row: Recombinant Non-Glycosylated Protein Market, By Product, 2011 – 2018 ($Million) 
Table 71 Row: Recombinant Glycosylated Protein Market, By Product, 2011 – 2018 ($Million)
Table 72 Row: Recombinant Peptides Market, By Product, 2011 – 2018 ($Million) 
Table 73 Row: Biosimilars Market, By Application, 2011 – 2018 ($Million) 
Table 74 ROW:Biosimilars Market, By Region, 2011 – 2018 ($Million)
Table 75 Row: Recombinant Non-Glycosylated Market, By Region, 2011 – 2018 ($Million) 
Table 76 Row: Recombinant Glycosylated Market, By Region, 2011 – 2018 ($Million) 
Table 77 Row: Recombinant Peptide Market, By Region, 2011 – 2018 ($Million) 
Table 78 Acquisitions, 2011 – 2013
Table 79 New Product Launches, By Company, 2011 – 2013
Table 80 Regulatory Approvals, By Company, 2011 – 2013
 
 
List Of Figures   (80 Figures)
 
Figure 1 Market Estimation & Data Triangluation For Biosimilars Market
Figure 2 Global Biosimilars Market Forecasting Model
Figure 3 Global Biosimilars Market Revenue, 2013 – 2018 ($Million)
Figure 4 Global Biosimilars Market, By Geography, 2013 – 2018 ($Million) 
Figure 5 Comparison Of Biosimilars &. Biologics Markets, Geographic Share, 2013 
Figure 6 Global Biosimilars Market, Revenue & Growth Rate, 2013 – 2018 
Figure 7 Global Biosimilars Market Dynamics
Figure 8 Global Biosimilars Market, By Product, 2013 – 2018
Figure 9 Global Biosimilars Market, By Application, 2013 – 2018
Figure 10 Biosimilars Market: Geographic Analysis, 2013 ($Million)
Figure 11 Global Biosimilars Market Share Analysis, By Key Players, 2013
Figure 12 Evolution Of The Biosimilars Market, 2005 – 2013
Figure 13 Global Biosimilars Market Segmentation
Figure 14 Biosimilars Under Pipeline, By Player
Figure 15 Number Of Biosimilar Monoclonal Antibodies In The Pipeline, By Company
Figure 16 Biosimilars In Preclinical Stage
Figure 17 Biosimilars In Phase I Clinical Trial
Figure 18 Biosimilars In Phase Ii Clinical Trial
Figure 19 Biosimilars In Phase Iii Clinical Trial
Figure 20 Global Biosimilars Market: Research & Development Analysis
Figure 21 Global Biosimilars Market: Porter’s Five Forces Analysis
Figure 22 Global Biosimilars Market: Opportunity Matrix, By Product, 2013 
Figure 23 Global Biosimilars Market, By Product, 2011 – 2018 ($Million)
Figure 24 Global Biosimilars Market: Recombinant Non-Glycosylated Protein Biosimilars, By Product, 2011 – 2018 ($Million)
Figure 25 Global Biosimilars Market: Recombinant Glycosylated Proteins, By Product, 2011 – 2018 ($Million)
Figure 26 Global Biosimilars Market: Recombinant Peptides, By Product,2011 – 2018 ($Million) 
Figure 27 Global Biosimilars Services Market Share, 2013 Vs. 2018
Figure 28 Opportunity Matrix: Biosimilars Market, By Country, 2013
Figure 29 Key Growth Strategies, 2010 – 2013
Figure 30 Global Biosimilars Market Share Analysis, By Key Player, 2013 
Figure 31 Agreements, Joint Ventures, Partnerships, & Collaborations, By Company, 2010 – 2013
Figure 32 Agreements, Joint Ventures, Partnerships, & Collaborations, 2010 – 2013
Figure 33 Acquisitions, By Company, 2011 – 2013
Figure 34 New Product Launches, 2011 – 2013
Figure 35 Approvals, 2011 – 2013
Figure 36 Actavis: Total Revenue ($Billion) & Operating Margin (%), 2010 – 2012
Figure 37 Actavis: Business Revenue Mix, 2012
Figure 38 Actavis: Market Strategy, 2011 – 2013
Figure 39 Amgen, Inc.: Total Revenue ($Billion), 2010 – 2012
Figure 40 Amgen, Inc.: Geographic Revenue Mix, 2012
Figure 41 Amgen, Inc.: Market Strategy, 2011 – 2013
Figure 42 Biocon Ltd.: Total Revenue ($Million) & Operating Margin (%), 2011 – 2013
Figure 43 Celltrion, Inc.: Total Revenue ($Million) & Operating Margin (%), 2010 – 2012
Figure 44 Celltrion:Market Strategy, 2011 – 2013
Figure 45 Cipla Ltd.: Total Revenue ($Billion), 2011 – 2013
Figure 46 Cipla Ltd.: Geographic Revenue Mix, 2012
Figure 47 Dr.Reddy’s Laboratories Ltd.: Total Revenue ($Billion) &Operating Margin (%), 2011 – 2013
Figure 48 Dr.Reddy’s Laboratories Ltd.: Business Revenue Mix, 2013
Figure 49 Dr.Reddy’s Laboratories Ltd.: Geographic Revenue Mix, 2013
Figure 50 Dr. Reddy’s Laboratories Ltd.: Market Strategy, 2011 – 2013
Figure 51 Hospira, Inc.: Total Revenue ($Million) & Operating Margin (%), 2010 – 2012
Figure 52 Hospira, Inc.: Segment Revenue Mix, 2012
Figure 53 Hospira, Inc.: Geography Revenue Mix, 2012
Figure 54 Hospira, Inc. Market Strategy, 2011 – 2013
Figure 55 Lg Life Sciences: Total Revenue ($Million) & Operating Margin (%), 2010 – 2012
Figure 56 Merck: Total Revenue ($Billion) &Operating Margin (%), 2010 – 2012
Figure 57 Merck: Business Revenue Mix, 2012
Figure 58 Merck: Geographic Revenue Mix, 2012
Figure 59 Mylan, Inc.: Total Revenue ($Billion) & Operating Margin (%), 2010 – 2012
Figure 60 Mylan Inc.: Business Revenue Mix, 2012
Figure 61 Mylan Inc.: Geographic Revenue Mix, 2012
Figure 62 Mylan, Inc.: Market Strategy, 2011 – 2013
Figure 63 Ranbaxy Laboratories Ltd.: Total Revenue ($Billion) & Operating Margin (%), 2010 – 2012
Figure 64 Ranbaxy Laboratories Ltd.: Geographic Revenue Mix, 2011
Figure 65 Ranbaxy, Market Strategy, 2007 – 2013
Figure 66 Roche: Total Revenue ($Billion) & Operating Margin (%), 2010 – 2012 
Figure 67 Roche: Business Revenue Mix, 2012
Figure 68 Roche: Geographic Revenue Mix, 2012
Figure 69 Sandoz International: Total Revenue ($Million) & Operating Margin (%), 2010 – 2012
Figure 70 Sandoz International: Segment Revenue Mix, 2012
Figure 71 Sandoz International: Geography Revenue Mix, 2012
Figure 72 Stada: Total Revenue ($Billion) & Operating Margin (%), 2010 – 2012 
Figure 73 Stada: Business Revenue Mix, 2012
Figure 74 Stada: Geographic Revenue Mix, 2012
Figure 75 Teva Pharmaceutical Industries Ltd.: Total Revenue ($Million) & Operating Margin (%), 2010-2012
Figure 76 Teva Pharmaceutivcals Industrutries Ltd.: Segment Revenue Mix, 2012
Figure 77 Teva Pharmaceutical Industries Ltd.: Geographic Revenue Mix, 2012
Figure 78 Teva Pharmaceuticals Ltd.: Market Strategy, 2011 – 2013
Figure 79 Wockhardt: Total Revenue ($Billion) & Operating Margin (%), 2011 – 2013
Figure 80 Wockhardt: Geographic Revenue Mix, 2013

The global market is segmented on the basis of products, applications, and services. By product, the global biosimilars market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further classified into insulin, granulocyte colony-stimulating factor (G-CSF), interferon, and human growth hormone; whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Glucagon and calcitonin are considered under the recombinant peptides segment. The recombinant glycosylated proteins segment is the largest segment with a share of 40% of the global market in 2013. Of all the products, monoclonal antibodies will be the fastest-growing segment at an estimated CAGR of 41.9% from 2013 to 2018. Following this, insulin will be the second-fastest growing market from 2013 to 2018.The growth is attributed to the rise in incidences of diabetes; the ongoing patent expiration of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost effectiveness of biosimilars of insulin.

By application, the market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and others (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure). Oncology is the largest and fastest-growing segment of the global biosimilars market. This is attributed to the increasing prevalence of oncology along with the rise in aging population and the changing lifestyles. The global market will be worth $2.0 billion by 2018, growing at a CAGR of 20.1% during the forecast period (2013 to 2018). The major factors driving the growth of the market are the launch of new biosimilars (monoclonal antibodies, filgrastim, and follitropin); ongoing clinical research on potential pipeline products; patent expirations of various biologics such as Neupogen, Humira, and Lantus; and the increasing demand for first-wave biosimilar products such as somatropin, filgrastim, and erythropoietin.

The global market is highly consolidated with the top three players, namely, Sandoz (Germany), Hospira (U.S.), and Teva (Israel) occupying 90% of the market share. Other key players include Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and Intas Biopharmaceutical Ltd. (India).

GLOBAL BIOSIMILARS MARKET SCENARIO

Biosimilars Market

Source: Annual Reports, SEC Filings, Expert Interviews, and MarketsandMarkets Analysis

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