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Biosimilars: Global Markets

  • January 2015
  • -
  • BCC Research
  • -
  • 136 pages

REPORT HIGHLIGHTS

The global biosimilars market was valued at $1.8 billion in 2013 and nearly $2.0 billion in 2014. The market is expected to reach nearly $4.0 billion by 2019, with a compound annual growth rate (CAGR) of 15% from 2014 through 2019.

This report provides:

An overview of the global market for biosimilars.
Analyses of global market trends, with data from 2012 through 2014, and projections of CAGRs through 2019.
A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars.
Detailed analysis of the emerging regulatory framework in regulated markets as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO.
Technology trends and patent analysis.
Comprehensive profiles of key players in the market.

STUDY OBJECTIVES

Biosimilars are an affordable alternative to well-established therapeutic interventions. Biosimilars are similar to but not identical copies of the already approved biologics. BCC Research’s goal in conducting this study is to provide an overview of the current and future characteristics of the market for biosimilars. The key objective is to present
a comprehensive analysis and future direction of biosimilars. Present and future approaches within the biosimilars market are investigated in this report. For the purpose of this report, the biosimilars market is categorized into, erythropoietins, human growth hormone (HGH), granulocyte colony-stimulating factors (G-CSF), low-molecular-weight heparins (LMWH) and other biosimilars. The improvisations of the market, and the setbacks and the needs of the market are discussed in this report. Current market trends for biosimilars are also reported. A thorough analysis of the structure of the biosimilar industry is provided. Revenues are broken down by region. Sales figures are estimated for the five-year period from 2014 through 2019. The report also covers significant patents and their allotments in each category.

REASONS FOR DOING THIS STUDY

In recent years, significant changes in the regulatory aspects of biosimilars plus their cost effectiveness are driving new energy in the biosimilars market. Even though the market is in its infancy, opportunities are set to expand as patents expire on leading biologics. This is pointing the way for accelerated market growth. An increasingly aging population, growth in chronic illness and expanding need for healthcare worldwide will help drive the growth of biosimilars over the next few years, especially due to their affordability.
Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type/market in light of new technologies, growing competition and changing customer needs.

SCOPE OF THE STUDY

The scope of this study encompasses biosimilars in pharmaceutical and biotechnology markets. BCC Research analyzes each market and its applications, regulatory environment, technology, market projections, and market shares.
In semi- and unregulated markets, various copies of biologics were sold for many years before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). The regulatory processes are considerably less stringent in less regulated markets as compared to that of EMA; hence, a number of biosimilars are available in these regions. However, manufacturers are now targeting regulated markets, and are adopting various strategies to enter highly regulated markets such as Europe and the U.S. Therefore, the report includes all the products for which EMA has already published guidelines for market authorization or for which guidelines are under development.
This report includes product segments such as somatropin, erythropoietin, colony-stimulating factors (CSFs), interferons, interleukins, insulin and insulin analogues, follicle-stimulating hormones (FSHs), monoclonal antibodies (MAbs) and low-molecular-weight heparins (LMWHs). This report is a comprehensive study on the demand for biosimilar drugs that have entered the market worldwide. Technological issues include the latest trends and developments.
The emerging markets for biosimilars include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

Table Of Contents

Biosimilars: Global Markets
Chapter- 1: INTRODUCTION - Complimentary 4

STUDY OBJECTIVES
REASONS FOR DOING THIS STUDY
INTENDED AUDIENCE
SCOPE OF THE STUDY
METHODOLOGY
INFORMATION SOURCES
ANALYSTS' CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER

Chapter- 2: EXECUTIVE SUMMARY 3

Table Summary : GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019
Figure Summary : GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019

Chapter- 3: OVERVIEW 18

WHO TERMINOLOGY RELATED TO BIOSIMILARS
FDA TERMINOLOGY RELATED TO BIOSIMILARS
DIFFERENCES BETWEEN SMALL-MOLECULE DRUGS AND BIOLOGICS
BIOSIMILARS VERSUS GENERICS
MANUFACTURING OF BIOLOGICS
DEVELOPMENT OF BIOSIMILARS
CLASSES OF APPROVED BIOSIMILARS

Chapter- 4: REGULATORY ASPECTS 9

EUROPE REGULATIONS
UNITED STATES REGULATIONS
BIOSIMILAR REGULATIONS IN EMERGING MARKETS
NAMING OF BIOSIMILARS
SIGNIFICANT REGULATORY ACTIVITIES

Chapter- 5: NEW DEVELOPMENTS 7

MOST POPULAR BIOSIMILAR TARGETS
OTHER BIOSIMILARS IN CLINICAL TRIALS
Table 11 : COMPANIES WITH BIOSIMILARS IN THE PIPELINE

Chapter- 6: TECHNOLOGY TRENDS 8

EMERGING TRENDS IN BIOSIMILAR MANUFACTURING PROCESSES
EMERGING TRENDS IN ANALYTICAL TECHNOLOGIES

Chapter- 7: MARKET ANALYSIS 27

MARKET BY TYPE
MARKET BY REGION

Chapter- 8: INDUSTRY STRUCTURE 10

ERYTHROPOIETINS
HUMAN GROWTH HORMONES
GRANULOCYTE COLONY-STIMULATING FACTOR
LOW-MOLECULAR-WEIGHT HEPARINS
OTHER BIOSIMILARS

Chapter- 9: PATENT ANALYSIS 10

UNITED STATES PATENTS
EUROPEAN PATENTS

Chapter- 10: CURRENT SITUATION 5

INCREASING DISEASE BURDEN DRIVING THE MARKET
AGING POPULATION
STRONG GOVERNMENT SUPPORT
PATENT EXPIRATION
COLLABORATIONS/ PARTNERSHIPS
ELECTRONIC COMPANIES ENTERING THE BIOSIMILARS SECTOR WITH SIGNIFICANT INVESTMENTS
MARKET FACTORS IN EMERGING MARKETS

Chapter- 11: COMPANY PROFILES 32

3SBIO INC.
ACTAVIS INC. LTD.
AMOYTOP BIOTECH CO., LTD.
ANHUI ANKE BIOTECHNOLOGY (GROUP) CO. LTD.
APOTEX INC.
AVESTHAGEN LIMITED
BHARAT SERUMS AND VACCINES LTD.
BIOCON LTD.
BIOXPRESS THERAPEUTICS SA
BIOTON S. A.
BLAU FARMACEUTICA S/A
BOEHRINGER INGELHEIM
CELLTRION GROUP
CHINA NATIONAL BIOTECH CORP. (CNBC)
CIPLA LIMITED
CINNAGEN
CJSC BIOCAD
DONG-A PHARMACEUTICAL CO. LTD.
DR. REDDY'S LABORATORIES LTD.
EMCURE PHARMACEUTICALS LTD.
FERON LIMITED
FINOX BIOTECH
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
GEDEON RICHTER PLC
GENESCIENCE PHARMACEUTICALS CO. LTD.
GENEXINE INC.
GH GENHELIX S A
GREEN CROSS LIFE SCIENCE CORP.
HANALL PHARMACEUTICALS
HANGZHOU JIUYUAN GENE ENGINEERING CO. LTD.
HANWHA CHEMICAL CORP.
HOSPIRA INC.
INTAS BIOPHARMACEUTICALS LTD
JCR PHARMACEUTICALS CO. LTD.
KISSEI PHARMACEUTICAL CO. LTD.
LG LIFE SCIENCES
MEDICE ARZNEIMITTEL PUTTER GMBH AND CO. KG
MERCK BIOVENTURES
MJ BIOPHARM PVT. LTD.
MOMENTA PHARMACEUTICALS
MYCENAX BIOTECH INC.
NANOGEN BIOPHARMACEUTICAL
NCPC GENETECH BIOTECHNOLOGY CO. LTD.
NEUCLONE
NIPPON KAYAKU CO. LTD.
PHARMAPARK LLC
PLANTFORM CORP.
PROBIOMED, S.A. DE C.V.
RANBAXY LABORATORIES LTD.
RELIANCE LIFE SCIENCES
SAMSUNG BIOLOGICS
SANDOZ INTERNATIONAL GMBH
SCINOPHARM TAIWAN LTD.
SOTEX PHARMACEUTICALS
STADA ARZNEIMITTEL AG
TEVA PHARMACEUTICALS INDUSTRIES LTD
TIANJIN HUALIDA BIOTECHNOLOGY LTD
USV LIMITED
WOCKHARDT LIMITED
ZHONGSHANHYGENE BIOPHARMA CO. LTD.

Chapter- 12: APPENDIX I-ABBREVIATIONS 3

List of Tables

Summary Table : GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019
Table 1 : BIOSIMILARS TERMINOLOGY
Table 2 : DIFFERENCES BETWEEN SMALL MOLECULES AND BIOLOGICS
Table 3 : BIOSIMILARS VERSUS SMALL MOLECULE GENERICS
Table 4 : BIOSIMILAR HUMAN GROWTH HORMONES
Table 5 : G-CSF BIOSIMILARS
Table 6 : ERYTHROPOIETIN BIOSIMILARS
Table 7 : INSULIN BIOSIMILARS
Table 8 : MONOCLONAL ANTIBODY BIOSIMILARS
Table 9 : FSH BIOSIMILAR
Table 10 : NEW MARKETING AUTHORIZATION OF BIOSIMILARS IN THE EUROPEAN UNION, 2010-AUGUST 2014
Table 11 : COMPANIES WITH BIOSIMILARS IN THE PIPELINE
Table 12 : HUMIRA (ADALIMUMAB) BIOSIMILARS IN CLINICAL TRIALS
Table 13 : REMICADE (INFLIXIMAB) BIOSIMILARS IN CLINICAL TRIALS
Table 14 : RITUXAN (RITUXIMAB) BIOSIMILARS IN CLINICAL TRIALS
Table 15 : AVASTIN (BEVACIZUMAB) BIOSIMILARS IN CLINICAL TRIALS
Table 16 : HERCEPTIN (TRASTUZUMAB) BIOSIMILARS IN CLINICAL TRIALS
Table 17 : OTHER BIOSIMILARS IN CLINICAL TRIALS
Table 18 : ANALYTICAL METHODS RECOGNIZED BY REGULATORY BODIES FOR COMPARABILITY EXERCISE AND RISK MITIGATION
Table 19 : GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019
Table 20 : MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013
Table 21 : GLOBAL REVENUES FOR BIOSIMILARS BY REGION, THROUGH 2019
Table 22 : MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013
Table 23 : REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, THROUGH 2019
Table 24 : MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013
Table 25 : REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, THROUGH 2019
Table 26 : MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013
Table 27 : REVENUE FOR G-CSF BY REGION, THROUGH 2019
Table 28 : MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013
Table 29 : REVENUE FOR LMWH BY REGION, THROUGH 2019
Table 30 : MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013
Table 31 : REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019
Table 32 : MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013
Table 33 : LEADING MANUFACTURERS/ SUPPLIERS OF ERYTHROPOIETIN (EPO) BIOSIMILARS, 2013
Table 34 : MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013
Table 35 : LEADING MANUFACTURERS/SUPPLIERS OF HUMAN GROWTH HORMONES (HGH) BIOSIMILARS, 2013
Table 36 : MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013
Table 37 : LEADING MANUFACTURERS/ SUPPLIERS OF G-CSF BIOSIMILARS, 2013
Table 38 : MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013
Table 39 : LEADING MANUFACTURERS/SUPPLIERS OF LMWH BIOSIMILARS, 2013
Table 40 : MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR LMWH BIOSIMILARS, 2013
Table 41 : LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2013
Table 42 : MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR OTHER BIOSIMILARS, 2013
Table 43 : NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
Table 44 : NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
Table 45 : NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
Table 46 : NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
Table 47 : PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014
Table 48 : NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
Table 49 : NUMBER OF PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
Table 50 : NUMBER OF PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
Table 51 : NUMBER OF PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
Table 52 : PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014
Table 53 : SIGNIFICANT PATENT EXPIRATIONS OF BIOLOGICS

List of Figures

Summary Figure : GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019
Figure 1 : GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019
Figure 2 : MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013
Figure 3 : GLOBAL REVENUES FOR BIOSIMILARS BY REGION, 2012-2019
Figure 4 : MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013
Figure 5 : REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, 2012-2019
Figure 6 : MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013
Figure 7 : REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2012-2019
Figure 8 : MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013
Figure 9 : REVENUE FOR G-CSF BY REGION, 2012-2019
Figure 10 : MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013
Figure 11 : REVENUE FOR LMWH BY REGION, THROUGH 2019
Figure 12 : MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013
Figure 13 : REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019
Figure 14 : MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013
Figure 15 : MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013
Figure 16 : MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013
Figure 17 : MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013
Figure 18 : MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR LMWH BIOSIMILARS, 2013
Figure 19 : MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR OTHER BIOSIMILARS, 2013
Figure 20 : NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
Figure 21 : NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
Figure 22 : PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014
Figure 23 : NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
Figure 24 : PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014

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