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World Biosimilars/Follow-on-Biologics Market - Opportunities and Forecasts, 2014 - 2020

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Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth. The upcoming patent expiration for blockbuster drugs has revolutionized the aspect of commercialization whilst triggering a large scale adoption of biosimilars. Biosimilars industry is facing problems relating to production efficiency and quantity. The lack of economies of scale for small scale manufacturers and absence of regulatory guidelines in lucrative regions such as China, US are hindering the growth of biosimilars market. However, strong government initiatives pertaining to production and approval is a key factor that would eventually reduce the impact of these restraints over the forecast period. Global biosimilars/follow-on-biologics market accounted for an overall revenue of $2,552.0 million in 2014 and it is estimated to generate an approximate revenue of $26,551.3 million by 2020, registering a CAGR of 49.1% from 2015 to 2020.

The product segment in the biosimilars market comprises of Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin, Interferon, Colony Stimulating Factors and others. Biosimilars erythropoietin is the highest revenue generating biosimilars drug candidate owing to its high approval rate for commercialization. Interferon biosimilars are the fastest growing drugs in the biosimilars market. This growth is supplemented by the use of interferon biosimilars across a wide range of applications.

The biosimilars applications market is segmented into blood disorders, oncology diseases, chronic and autoimmune diseases and growth hormone deficiency. The application of biosimilars in blood disease treatment is the highest revenue generating segment owing to the high-priced reference biologics and frequent application. However, biosimilars applications in autoimmune and chronic diseases exhibit the highest potential due to the changing off patent scenario.

Based on geography, the biosimilars market is segmented across North America, Europe, Asia-Pacific and LAMEA. Asia Pacific and LAMEA exhibit a large scale demand for biosimilars due to the growing prevalence of chronic diseases in these regions. Collaboration with local players is a key opportunity for biosimilars in developing economies. Many companies such as, Amgen and Novartis are collaborating with Asian players to reach to the depth of the biopharmaceutical market. The absence of effective regulatory guidelines for product approval and commercialization limit the growth of the biosimilars market in North America. However, recent draft published by US FDA has approved first biosimilar in United States. This would eventually standardized the procedure of approval and commercialization of biosimilars in United States.

This report provides a comprehensive market share analysis of leading companies and highlights the competition in the market. Product launch is the key strategy adopted by the leading player of biosimilars industry. The key companies profiled in this report are Novartis (Sandoz), Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono (Merck Group), Biogen idec, Inc., and Genentech (Roche Group).

Key Benefits

This report provides a detailed analysis of drivers and factors that limit the market expansion

The report provides a financial market forecast for the next eight years by considering the 2014 as the base year for evaluation.

Comprehensive and quantitative data about changing market trends, competition and opportunities in biosimilars market are provided in the report

Use of Porters Five Forces model and SWOT analysis would help stakeholders in making strategic decisions

Deep dive analysis of leading market players and their key strategies, helps in better understanding the market dynamics

Identification of key investment pockets in the biosimilars market would help the stakeholders in making informed decisions

Key Deliverables

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

MARKET BY TYPES
Human growth hormone
Erythropoietin
Monoclonal antibodies
Insulin
Interferon
Granulocyte-Colony Stimulating Factor
Peptide
Others
MARKET BY APPLICATIONS
Blood disorders
Oncology diseases
Chronic and autoimmune diseases
Growth hormone deficiencies
Others
MARKET BY GEOGRAPHY
North America
Europe
Asia-Pacific
LAMEA

CHAPTER 1 INTRODUCTION

1.1 Key Benefits
1.2 Key Market Segment
1.3 Research Methodology

1.3.1 Primary Research
1.3.2 Secondary Research
1.3.3 Analyst tools and models

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

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 impacting factors
3.4.2 Top winning strategies
3.4.3 Top investment pockets

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 bulkmarket for biosimilars
3.6.3 India an early adopter of biosimilars

3.7 Porters five force analysis

3.7.1 Higher bargaining of suppliers
3.7.2 Moderate bargaining power of buyers
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 Supportive activities

3.9 Clinical trials

3.9.1 MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
3.9.2 Efficacy Study of Two Formulations of Erythropoietin
3.9.3 Biosimilar RetacritTM (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anemia in Hematology and Oncology
3.9.4 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, 2014
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

CHAPTER 4 GLOBAL 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 Protein sequencing
4.3.2 Liquid chromatography (LC)
4.3.3 Gas Chromatography (GC)
4.3.4 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

CHAPTER 5 GLOBAL BIOSIMILARS MARKET BY PRODUCT

5.1 Human Growth Hormone

5.1.1 Key market trends
5.1.2 Key growth factors and opportunities
5.1.3 Market size & forecast

5.2 Insulin

5.2.1 Key market trends
5.2.2 Key growth factors and opportunities
5.2.3 Market size & forecast

5.3 Interferon

5.3.1 Key market trends
5.3.2 Key growth factors and opportunities
5.3.3 Market size & forecast

5.4 Granulocyte colony stimulating factor (G-CSF)

5.4.1 Key market trends
5.4.2 Key growth factors and opporunities
5.4.3 Market size & forecast

5.5 Erythropoietin

5.5.1 Key market trends
5.5.2 Key growth factors and opportunities
5.5.3 Market size & forecast

5.6 Monoclonal antibodies

5.6.1 Key market trends
5.6.2 Key growth factors and opportunities
5.6.3 Market size & forecast

5.7 Peptides
5.8 Others

5.8.1 Key market trends
5.8.2 Key growth factors and opportunity

CHAPTER 6 GLOBAL 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 Breast cancer
6.2.5 Cervical cancer
6.2.6 Colorectal cancer
6.2.7 Prostate cancer
6.2.8 Leukaemia

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

CHAPTER 7 GLOBAL 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

CHAPTER 8 GLOBAL BIOSIMILARS MARKET BY GEOGRAPHY

8.1 North America

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


List Of Tables

TABLE 1 BIOSIMILARS MODERATE GROWTH SCENARIO MARKET REVENUE BY GEOGRAPHY, 2020-2025 ($MILLION)
TABLE 2 BIOSIMILARS RAPID GROWTH SCENARIO MARKET REVENUE BY GEOGRAPHY, 2020-2025 ($MILLION)
TABLE 3 BIOSIMILARS DIMINISHING GROWTH SCENARIO MARKET REVENUE BY GEOGRAPHY, 2020-2025 ($MILLION)
TABLE 4 BIOSIMILARS GUIDELINES ADOPTED BY REGIONS
TABLE 5 COMPARISON OF BIOSIMILAR MEDICINE GUIDELINES BY GEOGRAPHY (2013)
TABLE 6 BIOSIMILARS DEVELOPMENT 2013 (LATIN AMERICA)
TABLE 7 OFF GOING PATENTS 2013-2016
TABLE 8 PREVALENCE OF TOP TWO CHRONIC DISEASES (2013)
TABLE 9 BIOSIMILAR DEVELOPMENT STATUS (2013)
TABLE 10 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY PRODUCT TYPES 2014-2020 ($MILLION)
TABLE 11 PATENTS STATUS FOR THE HUMAN GROWTH HORMONE (BIOLOGICS)
TABLE 12 PATENT EXPIRATION STATUS FOR HUMAN GROWTH HORMONE DURING 2014-2020 (BIOLOGICS)
TABLE 13 GLOBAL HGH BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2014-2020 ($MILLION)
TABLE 14 PATENTS APPROVED FOR INSULIN (BIOLOGICS)
TABLE 15 GLOBAL INSULIN BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY 2014-2020 ($MILLION)
TABLE 16 PATENTS APPROVED FOR INTERFERON (BIOLOGICS)
TABLE 17 PATENT EXPIRATION STATUS FOR INTERFERON DURING, 2014-2020 (BIOLOGICS)
TABLE 18 GLOBAL INTERFERON BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 19 PATENT EXPIRATION STATUS FOR G-CSF BIOSIMILARS DURING, 2014-2020 (BIOLOGICS)
TABLE 20 GLOBAL G-CSF BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 21 PATENTS STATUS FOR ERYTHROPOIETIN (BIOLOGICS)
TABLE 22 PATENT EXPIRATION STATUS FOR ERYTHROPOIETIN DURING 2014-2020 (BIOLOGICS)
TABLE 23 GLOBAL ERYTHROPOIETIN BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 24 DRUG PATENT EXPIRATION FOR MONOCLONAL ANTIBODIES (BIOLOGICS)
TABLE 25 PATENT EXPIRATION STATUS FOR MONOCLONAL ANTIBODIES DURING, 2014-2020 (BIOLOGICS)
TABLE 26 GLOBAL MAB BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 27 GLOBAL PEPTIDE BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014 -2020 ($MILLION)
TABLE 28 HIRUDIN BIOSIMILAR CANDIDATE STATUS
TABLE 29 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY APPLICATIONS, 2014-2020 ($MILLION)
TABLE 30 GLOBAL BLOOD DISORDERS BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 31 GLOBAL ONCOLOGY DISORDER BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 32 GLOBAL CHRONIC AND AUTOIMMUNE DISORDER BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 33 GLOBAL GROWTH HORMONE DEFICIENCY DISORDER BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 34 GLOBAL OTHER DISORDERS BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 35 GLOBAL BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY GEOGRAPHY, 2014-2020 ($MILLION)
TABLE 36 NORTH AMERICA BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY APPLICATION, 2014-2020 ($MILLION)
TABLE 37 BIOSIMILARS COMMERCIALLY AVAILABLE IN EUROPEAN UNION
TABLE 38 EUROPE BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY APPLICATIONS, 2014-2020 ($MILLION)
TABLE 39 ASIA-PACIFIC BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY APPLICATIONS, 2014-2020 ($MILLION)
TABLE 40 LAMEA BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET REVENUE, BY APPLICATIONS, 2014-2020 ($MILLION)


List Of Figures

FIG. 1 TOP FACTORS IMPACTING BIOSIMILARS MARKET (2014-2020)
FIG. 2 TOP WINING STRATEGIES FOR BIOSIMILARS MARKET DURING (2010-2015)
FIG. 3 TOP WINING STRATEGIES BY SUBTYPE OF DEVELOPMENTS (2010-2015)
FIG. 4 TOP INVESTMENT POCKETS OF BIOSIMILARS/FOLLOW-ON-BIOLOGICS MARKET PRODUCTS, 2014-2020
FIG. 5 KEY ACHIEVEMENTS FOR BIOSIMILAR REGULATORS (2010)
FIG. 6 REGULATORY FRAMEWORK FOR BIOSIMILAR PRODUCTS IN CHINA
FIG. 7 PORTERS FIVE FORCE ANALYSIS OF BIOSIMILARS MARKET
FIG. 8 VALUE CHAIN ANALYSIS OF BIOSIMILARS MARKET
FIG. 9 IMPACT ANALYSIS OF STAKEHOLDERS INVOLVED IN PRIMARY ACTIVITIES (2014-2020)
FIG. 10 MARKET SHARE ANALYSIS OF BIOSIMILARS MARKET (2014)
FIG. 11 IMPACT ANALYSIS OF PRODUCT MARKET SEGMENTS (2014, 2020-2025)
FIG. 12 NUMBER OF INCIDENCES OF DIABETES GLOBALLY, BY GEOGRAPHY (2000, 2011 & 2030)
FIG. 13 IMPACT ANALYSIS OF APPLICATION MARKET SEGMENTS (2014-2020-2025)
FIG. 14 IMPACT OF REGULATION ON VARIOUS GEOGRAPHIES, 2012
FIG. 15 NET REVENUE GENERATION BY GEOGRAPHY (2013)
FIG. 16 NET REVENUE GENERATION BY BUSINESSES (2013)
FIG. 17 SWOT ANALYSIS OF NOVARTIS (SANDOZ)
FIG. 18 SWOT ANALYSIS OF SYNTHON PHARMACEUTICALS
FIG. 19 NET REVENUE GENERATION BY GEOGRAPHY (2013)
FIG. 20 NET REVENUE GENERATION BY BUSINESSES (2013)
FIG. 21 SWOT ANALYSIS OF TEVA PHARMACEUTICAL INDUSTRIES LTD.
FIG. 22 NET REVENUE GENERATION (2011-2013)
FIG. 23 SWOT ANALYSIS OF LG LIFE SCIENCES
FIG. 24 NET PROFIT DURING 2011-2013
FIG. 25 SWOT ANALYSIS OF CELLTRION
FIG. 26 REVENUE GENERATED BY BUSINESS UNITS (2013)
FIG. 27 SWOT ANALYSIS OF BIOCON
FIG. 28 NET SALES BY GEOGRAPHY (2013)
FIG. 29 NET SALES BY BUSINESS UNITS (2013)
FIG. 30 SWOT ANALYSIS OF HOSPIRA
FIG. 31 NET SALES BY GEOGRAPHY (2013)
FIG. 32 NET SALES BY BUSINESS UNITS (2013)
FIG. 33 SWOT ANALYSIS OF MERCK SERONO
FIG. 34 NET SALES BY GEOGRAPHY (2013)
FIG. 35 NET SALES BY BUSINESS UNITS (2013)
FIG. 36 SWOT ANALYSIS OF BIOGEN IDEC INC.
FIG. 37 SWOT ANALYSIS OF GENENTECH


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Reports Details

Published Date : Sep 2015
No. of Pages :120
Country :Global
Category :Healthcare
Publisher :Allied Market Research
Report Delivery By :Email
Report Delivery Time :12 to 24 hours after placing the order.

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