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World Biosimilars/Follow-on-Biologics Market

- Opportunities and Forecasts, 2013 - 2020
 Report Code: LI 14162
 Pages: 184
 Format: PDF Exel CD_rom
pub_n Published: Jul 2014
tab_nTables: 54
aut_nAuthor(s):
   Attention: View Updated Version Of The Report

Biosimilars or follow-on-biologics are the “copied” version of reference biologics, which are protected by intellectual rights that will expire soon. Patent expiration is the major driving factor of the biosimilars market. Most of the blockbuster patents will expire by the end of 2014, which would provide a competitive edge to local pharmaceutical manufacturers over the global players. For instance, patents for insulin glargine will expire by the end of this year, which would give an opportunity for the growth of insulin biosimilars market. Global biosimilars/follow-on-biologics market accounted for $1,358 million in 2013 and it is anticipated to generate $35,032 million by 2020, growing at a CAGR of 60.8% from 2014 to 2020.

Regulations for biosimilars plays a vital role in maintaining the viability and balance between original and biosimilar products. Various regulatory authorities, namely EMA and the U.S. FDA are actively regulating the biosimilars market. Regulations in the European union are considered benchmark around the world, as the guidelines proposed are most stringent for validation and commercialization of biosimilars. High profitability is the attractive aspect that is enticing companies to invest in the biosimilars industry. 

Geographically, Biosimilars market is segmented into North America, Europe, Asia-Pacific and LAMEA. Due to favorable regulatory policies designed by the European Medical Association, the European market has been maximizing on the biosimilars market. Asia-Pacific and LAMEA market would witness a substantial rise in the use of biosimilars, as the demand for cost effective treatment is growing due to the prevalence of chronic diseases. Collaboration with local players would be a key opportunity that could be fully explored by the biosimilars manufacturers in developing economies. Many companies such as Amgen and Novartis are collaborating with Asian players to gain a foothold in the biopharmaceutical market. 

Europe was the first region to draft guidelines for approval of biosimilars in 2006. Nevertheless, in 2008, the first biosimilars version of Granulocyte colony-stimulating factor (G-CSF) was introduced in the European Union under the regulatory guidance of European Medical Association (EMA). Currently, there are three biosimilar versions of G-CSF available in the European market, namely Ratiograstim/Tevagrastim/Biograstim, Zarzio/Filgrastim Hexal and Nivestim/Pliva/Mayne filgrastim. Adding to the G-CSF biosimilars, the insulin biosimilars also showcase tremendous potential in the future. 

Global Biosimilars Market

Key Benefits

  • The study is segmented in a strategic divisions to gain deeper insights into the market dynamics and understand the competitive environment of the overall market 
  • Financial market forecast is provided for the next eight years by considering 2013 as the base year
  • Comprehensive and quantitative data about changing market trends, intensifying competition and opportunities in biosimilars market are provided to make better business decisions
  • Porter’s Five Forces model and SWOT analysis of the overall market is provided to help stakeholders gain strategic insights of the market
  • Deep dive analysis of key market players and strategies adopted by them are expounded to provide valuable information on the top contenders in the market
  • Identification of key investment pockets for the biosimilars market is strategically dealt to assist the stakeholders 

Key Deliverables

Global biosimilars/follow-on-biologics market is categorized into technology, product types, applications, services and geography.

MARKET BY TECHNOLOGY

  • Monoclonal Antibodies (MAb) Technology
  • Recombinant DNA Technology (rDNA technology)
  • Nuclear magnetic resonance (NMR) technology
  • Chromatography
  • Electrophoresis
  • Mass Spectrometry
  • Western Blotting
  • Bioassay

MARKET BY TYPES

  • Recombinant Non-Glycosylated Protein
    • Human Growth Hormone
    • Insulin
    • Interferon
    • Granulocyte colony stimulating factor (G-CSF)
    • Others
  • Recombinant Glycosylated Protein
    • Erythropoietin
    • Monoclonal antibodies
    • Others
  • Peptides
    • Octreotide
    • Desmopressin
    • Cyclosporine
    • Calcitonin
    • Eptifibatide
    • LH-RH (Leuprolide)
    • Nesiritide
    • Teriparatide
    • Bivalirudin
    • Enfuvirtide
    • Glucagon

MARKET BY APPLICATIONS

  • Blood disorders
    • Chemotherapy induce Anaemia
    • Hemophilia
    • Pulmonary embolism
  • Oncology diseases
    • Lungs cancer
    • Colorectal cancer
    • Breast cancer
    • Cervical cancer
    • Leukemia
    • Prostate cancer
  • Chronic and autoimmune diseases
    • Neutropenia
    • Multiple sclerosis
    • Cystic Fibrosis
    • Rheumatoid arthritis (RA)
    • Acromegaly
    • Leprosy
  • Growth hormone deficiencies
  • Others

MARKET BY SERVICES

  • Contract Research and Manufacturing Services (CRAMS)
  • Clinical Trials

MARKET BY GEOGRAPHY

  • North America
  • Europe
  • Asia-Pacific
  • LAMEA
Table Of Content
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Title/ Chapter Name Price

Chapter: 1 INTRODUCTION

1.1 Key Benefits
1.2 Key Market Segment
1.3 Key Audiences

1.3.1 Research Methodology
1.3.2 Primary Research
1.3.3 Secondary Research
1.3.4 Analyst tools and models

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Chapter: 2 EXECUTIVE SUMMARY

2.1 CXO perspective
2.2 Market beyond: what to expect by 2025

2.2.1 Moderate growth scenario
2.2.2 Rapid growth scenario
2.2.3 Diminishing growth scenario

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Chapter: 3 MARKET OVERVIEW

3.1 Market Definition
3.2 Diverse approach of global regulators towards biosimilars
3.3 Safety issues of  biosimilar drugs
3.4 Key Findings

3.4.1 Top factors impacting Biosimilars/Follow-On-Biologics market
3.4.2 Top winning strategies in the Biosimilars/Follow-On-Biologics market
3.4.3 Top investment pockets in Biosimilars/Follow-On-Biologics market

3.5 Regulation and Reimbursement scenario

3.5.1 Regulations in United States
3.5.2 Regulations in Europe
3.5.3 Regulation in Asia
3.5.4 Comparison of Biosimilar medicine guidelines

3.6 Emerging economies a hotspot for biosimilars market

3.6.1 “Brazil” a treasure for the biosimilar manufacturers
3.6.2 “China” the dragon market for biosimilars
3.6.3 “India” an early adopter of biosimilars

3.7 Porters five force analysis

3.7.1 Moderate bargaining of suppliers due to moderate switching cost
3.7.2 Moderate bargaining power of buyers due to lesser cost of switching
3.7.3 Higher threats from substitutes due to lower switching cost
3.7.4 Lower threats from new entrants due to technological and political barriers
3.7.5 Higher competition among players

3.8 Value chain analysis

3.8.1 Primary activities
3.8.2 Impact analysis of stakeholders involved in primary activities (2014-2020)
3.8.3 Supportive activities

3.9 Clinical trials

3.9.1 Title: Efficacy Study of Two Formulations of Erythropoietin
3.9.2 Title: Biosimilar RetacritTM (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anemia in Hematology and Oncology
3.9.3 Title: MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
3.9.4 Title: An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

3.10 Market Share analysis, 2013
3.11 Market Dynamics

3.11.1 Drivers

3.11.1.1 Growing pressure to reduce healthcare expenditure
3.11.1.2 Various blockbusters going off patent
3.11.1.3 High prevalence of chronic diseases among ageing population
3.11.1.4 Favorable intervention from the developing economies
3.11.1.5 Lower cost biosimilars drugs than original biologics

3.11.2 Restraints

3.11.2.1 High initial investment in research and development
3.11.2.2 Stringent regulations in developed economies to restrict investment
3.11.2.3 Medical Efficacy and Patient Safety

3.11.3 Opportunities

3.11.3.1 opportunities in Emerging economies
3.11.3.2 Emergence of bio-betters drugs

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Chapter: 4 GLOBAL BIOSIMILARS/FOLLO-ON-BIOLOGICS MARKET BY TECHNOLOGY

4.1 Monoclonal Antibodies (MAb) Technology

4.1.1 Drivers

4.2 Recombinant DNA Technology (rDNA technology)

4.2.1 Drivers
4.2.2 Restraints & Opportunities

4.3 Chromatography

4.3.1 Drivers & Opportunities
4.3.2 Liquid chromatography (LC)
4.3.3 Gas Chromatography (GC)
4.3.4 Protein sequencing
4.3.5 Drivers

4.4 Nuclear magnetic resonance (NMR) technology

4.4.1 Drivers

4.5 Electrophoresis

4.5.1 Drivers
4.5.2 Restraints & Opportunities
4.5.3 Gel Electrophoresis
4.5.4 Capillary Electrophoresis

4.6 MASS SPECTROMETRY

4.6.1 DRIVERS
4.6.2 RESTRAINTS

4.7 Western Blotting

4.7.1 Drivers

4.8 Bioassay

4.8.1 Drivers
4.8.2 Restraints
4.8.3 Techniques in Bioassay

4.8.3.1 Multiple Point Assays
4.8.3.2 Interpolation Method
4.8.3.3 Bracketing Method
4.8.3.4 Matching Bioassays

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Chapter: 5 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET BY PRODUCT TYPE

5.1 Recombinant Non-Glycosylated Protein

5.1.1 Drivers
5.1.2 Human Growth Hormone

5.1.2.1 Key market trends
5.1.2.2 Key growth factors and opportunities
5.1.2.3 Market size & forecast

5.1.3 Insulin

5.1.3.1 Drivers & Opportunities
5.1.3.2 Key market trends
5.1.3.3 Key growth factors and opportunities
5.1.3.4 Market size & forecast

5.1.4 Interferon

5.1.4.1 Interferon Alfa
5.1.4.2 Interferon beta-1a
5.1.4.3 Interferon gamma
5.1.4.4 Key growth factors and opportunities
5.1.4.5 Market size & forecast

5.1.5 Granulocyte colony stimulating factor (G-CSF)

5.1.5.1 Key market trends
5.1.5.2 Market size & forecast

5.1.6 Others

5.1.6.1 Lepirudin
5.1.6.2 Interleukin – 2 (IL-2)
5.1.6.3 Anakinra

5.2 Recombinant Glycosylated Proteins

5.2.1 Drivers & Restraints
5.2.2 Erythropoietin

5.2.2.1 Key market trends
5.2.2.2 Key growth factors and opportunities
5.2.2.3 Market size & forecast

5.2.3 Monoclonal antibodies

5.2.3.1 Key market trends
5.2.3.2 Key growth factors and opportunities
5.2.3.3 Market size & forecast

5.2.4 Others

5.2.4.1 Follitropin
5.2.4.2 Thyrotropin
5.2.4.3 Urokinase
5.2.4.4 Glucocerebrosidase
5.2.4.5 Becaplermin
5.2.4.6 Factor VIIa
5.2.4.7 Factor VIII
5.2.4.8 Factor IX

5.2.5 Key market trends
5.2.6 Competitive scenario

5.3 Peptide s

5.3.1 Drivers
5.3.2 Restraints & Opportunities
5.3.3 Octreotide
5.3.4 Desmopressin
5.3.5 Cyclosporine
5.3.6 Calcitonin
5.3.7 Eptifibatide
5.3.8 LH-RH (Leuprolide)
5.3.9 Nesiritide
5.3.10 Teriparatide
5.3.11 Bivalirudin
5.3.12 Enfuvirtide
5.3.13 Glucagon

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Chapter: 6 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET BY APPLICATIONS

6.1 Blood disorders

6.1.1 Drivers
6.1.2 Chemotherapy induce Anaemia

6.1.2.1 Drivers
6.1.2.2 RESTRAIN AND OPPORTINITIES

6.1.3 Hemophilia
6.1.4 Pulmonary embolism

6.1.4.1 DRIVER

6.2 Oncology diseases

6.2.1 Driver
6.2.2 Opportunities and restraints
6.2.3 Lungs 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

6.2.8 Prostate cancer

6.3 Chronic and autoimmune diseases

6.3.1 Diabetes

6.3.1.1 Drivers

6.3.2 Neutropenia
6.3.3 Multiple sclerosis

6.3.3.1 Drivers
6.3.3.2 Restraints and opportunities

6.3.4 Cystic Fibrosis
6.3.5 Rheumatoid arthritis (RA)

6.3.5.1 Drivers
6.3.5.2 Restraints

6.3.6 Acromegaly

6.3.6.1 Drivers

6.3.7 Leprosy

6.4 Growth hormone deficiency

6.4.1 Drivers

6.5 Others

6.5.1 Gaucher disease
6.5.2 Osteoporosis

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Chapter: 7 GLOBAL BIOSIMILARS / FOLLOW-ON-BIOLOGICS MARKET BY SERVICES

7.1 Contract Research and Manufacturing Services

7.1.1 Drivers
7.1.2 Restraints & Opportunities

7.2 Clinical trials

7.2.1 Drivers & Restraints
7.2.2 Phase I
7.2.3 Phase II
7.2.4 Phase III

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Chapter: 8 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET BY GEOGRAPHIES

8.1 North America

8.1.1 Key market trends
8.1.2 Key growth factors and opportunities
8.1.3 Market size & forecast

8.2 Europe

8.2.1 Key market trends
8.2.2 Key growth factors and opportunities
8.2.3 Market size & forecast

8.3 Asia-Pacific

8.3.1 Key market trends

8.3.1.1 India

8.3.1.1.1 COMPETITIVE SCENARIO

8.3.1.2 China

8.3.1.2.1 COMPETITIVE SCENARIO

8.3.1.3 Australia

8.3.1.3.1 COMPETITIVE SCENARIO

8.3.2 Market size & forecast

8.4 LAMEA

8.4.1 Key market trends
8.4.2 Competitive scenario
8.4.3 Market size & forecast

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Chapter: 9 KEY PRODUCTS AND RECENT ACTIVITIES BY GEOGRAPHY

9.1 US

9.1.1 Hospira

9.1.1.1 Recent Activities

9.2 Europe

9.2.1 Stada Arzneimittel AG

9.2.1.1 Recent Activities

9.2.2 Hexal AG
9.2.3 Ratiopharm GmbH
9.2.4 Bioton

9.2.4.1 Recent Activities

9.2.5 Sandoz GmbH

9.2.5.1 Recent Activities

9.3 India

9.3.1 Dr.Reddy's Labs (DRL)

9.3.1.1 Recent Activities

9.3.2 Intas Pharmaceuticals Ltd.

9.3.2.1 Recent Activities

9.3.3 Wockhardt Limited

9.3.3.1 Recent Activities

9.3.4 Biocon Limited

9.3.4.1 Recent Activities

9.3.5 Shantha Biotechnics Limited

9.3.5.1 Recent Activities

9.3.6 Reliance Life Sciences

9.4 Korea

9.4.1 Dong-A Pharmaceutical Co., Ltd

9.4.1.1 Recent Activities

9.4.2 LG Life Sciences

9.4.2.1 Recent Activities

9.4.3 Celltrion Pharm, Inc.

9.4.3.1 Recent Activities

9.5 Others

9.5.1 Teva Pharmaceutical Industries Ltd.

9.5.1.1 Recent Activities

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Chapter: 10 COMPANY PROFILES

10.1 Novartis (Sandoz)

10.1.1 Company Overview
10.1.2 Company Snapshot
10.1.3 Business Performance
10.1.4 Key Strategies

10.1.4.1 Primary Strategies: Clinical Trials
10.1.4.2 secondary Strategies: approval

10.1.5 SWOT analysis

10.2 Synthon Pharmaceuticals, Inc.

10.2.1 Company Overview
10.2.2 Company Snapshot
10.2.3 Key Strategies

10.2.3.1 Primary Strategies: agreement
10.2.3.2 secondary Strategies: clinical trials

10.2.4 SWOT analysis

10.3 Teva Pharmaceutical Industries Ltd.

10.3.1 Company Overview
10.3.2 Company Snapshot
10.3.3 Business Performance
10.3.4 Key Strategies

10.3.4.1 Primary Strategies: approval
10.3.4.2 secondary Strategies: clinical trials

10.3.5 SWOT analysis

10.4 LG Life Sciences

10.4.1 Company Overview
10.4.2 Company Snapshot
10.4.3 Business Performance
10.4.4 Key Strategies

10.4.4.1 Primary Strategies: Collaboration

10.4.5 SWOT analysis

10.5 Celltrion

10.5.1 Company Overview
10.5.2 Company Snapshot
10.5.3 Business Performance
10.5.4 Key Strategies

10.5.4.1 Primary Strategies: approval

10.5.5 SWOT analysis

10.6 Biocon

10.6.1 Company Overview
10.6.2 Company Snapshot
10.6.3 Business Performance
10.6.4 Key Strategies

10.6.4.1 secondary Strategy: clinical trial

10.6.5 SWOT analysis

10.7 Hospira

10.7.1 Company Overview
10.7.2 Company Snapshot
10.7.3 Business Performance
10.7.4 Key Strategies

10.7.4.1 Primary Strategies: approval
10.7.4.2 secondary Strategies: clinical trials

10.7.5 SWOT analysis

10.8 Merck Serono (Merck Group)

10.8.1 Company Overview
10.8.2 Company Snapshot
10.8.3 Business Performance
10.8.4 Key Strategies

10.8.4.1 Primary Strategies: partnership and product launch

10.8.5 SWOT analysis

10.9 Biogen idec Inc.

10.9.1 Company Overview
10.9.2 Company Snapshot
10.9.3 Business Performance
10.9.4 Key Strategies

10.9.4.1 Primary Strategies: agreement and joint venture

10.9.5 SWOT analysis

10.10 Genentech (Roche Group)

10.10.1 Company Overview
10.10.2 Company Snapshot
10.10.3 Key Strategies

10.10.3.1 Primary Strategies: Investment and license

10.10.4 SWOT analysis

LIST OF TABLES
TABLE 1 BLOCKBUSTER PATENTS EXPIRATION BY 2014
TABLE 2 BIOSIMILARS MODERATE GROWTH SCENARIO MARKET REVENUE BY GEOGRAPHY, 2020-2025 ($MILLION)
TABLE 3 BIOSIMILARS RAPID GROWTH SCENARIO MARKET REVENUE BY GEOGRAPHY, 2020-2025 ($MILLION)
TABLE 4 BIOSIMILARS DIMINISHING GROWTH SCENARIO MARKET REVENUE BY GEOGRAPHY, 2020-2025 ($MILLION)
TABLE 5 BIOSIMILARS GUIDELINES ADOPTED BY REGIONS
TABLE 6 COMPARISON OF BIOSIMILAR MEDICINE GUIDELINES BY GEOGRAPHY (2013)
TABLE 7 BIOSIMILARS DEVELOPMENT 2013 (LATIN AMERICA)
TABLE 8 OFF GOING PATENTS 2013-2016
TABLE 9 PREVALENCE OF TOP TWO CHRONIC DISEASES (2013)
TABLE 10 BIOSIMILAR DEVELOPMENT STATUS (2013)
TABLE 11 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY PRODUCT TYPES 2013-2020 ($MILLION)
TABLE 12 GLOBAL NON-GLYCOSYLATED PROTEIN BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY PRODUCT TYPES 2013-2020 ($MILLION)
TABLE 13 PATENTS STATUS FOR THE HUMAN GROWTH HORMONE (BIOLOGICS)
TABLE 14 PATENT EXPIRATION STATUS FOR HUMAN GROWTH HORMONE DURING 2014-2020 (BIOLOGICS)
TABLE 15 GLOBAL HGH BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2013-2020 ($MILLION)
TABLE 16 PATENTS APPROVED FOR INSULIN (BIOLOGICS)
TABLE 17 GLOBAL INSULIN BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2013-2020 ($MILLION)
TABLE 18 PATENTS APPROVED FOR INTERFERON (BIOLOGICS)
TABLE 19 PATENT EXPIRATION STATUS FOR INTERFERON DURING, 2014-2020 (BIOLOGICS)
TABLE 20 GLOBAL INTERFERON BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2013-2020 ($MILLION)
TABLE 21 PATENT EXPIRATION STATUS FOR G-CSF BIOSIMILARS DURING, 2014-2020 (BIOLOGICS)
TABLE 22 GLOBAL G-CSF BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2013-2020 ($MILLION)
TABLE 23 GLOBAL OTHER NON-GLYCOSYLATED PROTEIN BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2013-2020 ($MILLION)
TABLE 24 GLOBAL GLYCOSYLATED PROTEIN

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Global biosimilars/follow-on-biologics market in this report is segmented based on their functional bonding in which they are found such as glycosylated and non-glycosylated. Several pharmaceutical manufacturers are exploiting the lucrative opportunities available in this market. Presently, reference biologics are protected by IP (Intellectual Property) rights; however, the property protections for blockbuster drugs will soon expire, this will open up a platform for biosimilars manufacturers to gain dominance. Growing demand for over-the-counter (OTC) and prescription-based drugs would also cement the growth of the biosimilars industry in developing economies. Biosimilars versions of some monoclonal antibodies and granulocyte colony stimulating factors commercialized in the market have gained substantial foothold in the market in terms of revenue and growth. These medicines have outperformed their reference versions in terms of cost, performance and output. After successful market entry, the players operating in this market are now assured of its potential. This has lead to increase in their interest  for the research and development of novel biosimilar versions of the blockbuster drugs, which have soon to expire property protections. The biosimilars market would have a double digit growth rate and garner billions of dollars from the reference biopharmaceutical industry during 2013-2020. Developing economies such as China and India would act as the principle contributors to the growth of the biosimilar industry. This is due to the increase in healthcare expenditure, change in the quality of lifestyle and prevalence of chronic diseases in these regions. Additionally, under-developed economies such as those in Africa are also allowing biosimilars to be commercialized under the guidance of government regulations. Demand for biosimilar drugs in developed economies is still yet to gain popularity, as the consumer base in these countries shows an inclination towards branded drugs instead of biosimilars; hence, the biosimilars market is expecting sluggish growth in developed countries during the analysis period.

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