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Biosimilars: Global Markets

Biosimilars: Global Markets

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.


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.

CHAPTER 1 INTRODUCTION
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
SUMMARY TABLE GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019 ($ MILLIONS)
SUMMARY FIGURE GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019 ($ MILLIONS)
CHAPTER 3 OVERVIEW
WHO TERMINOLOGY RELATED TO BIOSIMILARS
BIOSIMILAR
BIOSIMILARITY
COMPARABILITY EXERCISE
EQUIVALENT
HEAD-TO-HEAD COMPARISON
ORIGINATOR PRODUCT
PHARMACOVIGILANCE
REFERENCE BIOTHERAPEUTIC PRODUCT (RBP)
SIMILAR BIOTHERAPEUTIC PRODUCT (SBP)
WELL-ESTABLISHED BIOTHERAPEUTIC PRODUCT
FDA TERMINOLOGY RELATED TO BIOSIMILARS
BIOLOGIC LICENSE APPLICATION (BLA)
BIOLOGICAL PRODUCT
BIOSIMILAR
BRAND NAME
THERAPEUTIC BIOLOGICAL PRODUCT
THERAPEUTIC EQUIVALENCE (TE)
TABLE 1 BIOSIMILARS TERMINOLOGY
DIFFERENCES BETWEEN SMALL-MOLECULE DRUGS AND BIOLOGICS
TABLE 2 DIFFERENCES BETWEEN SMALL MOLECULES AND BIOLOGICS
BIOSIMILARS VERSUS GENERICS
TABLE 3 BIOSIMILARS VERSUS SMALL MOLECULE GENERICS
MANUFACTURING OF BIOLOGICS
NATURAL SOURCING AND EXTRACTION
MICROBIAL FERMENTATION
TRANSGENICS
CELL CULTURE
Mammalian Cell Culture
Other Cell Culture Systems
DEVELOPMENT OF BIOSIMILARS
DEVELOPMENT OF A HIGHLY SIMILAR PRODUCT
VALIDATING A BIOSIMILAR
CLASSES OF APPROVED BIOSIMILARS
HUMAN GROWTH HORMONES
TABLE 4 BIOSIMILAR HUMAN GROWTH HORMONES
GRANULOCYTE COLONY-STIMULATING FACTOR
TABLE 5 G-CSF BIOSIMILARS
ERYTHROPOIETIN
TABLE 6 ERYTHROPOIETIN BIOSIMILARS
INSULIN
TABLE 7 INSULIN BIOSIMILARS
MONOCLONAL ANTIBODIES
TABLE 8 MONOCLONAL ANTIBODY BIOSIMILARS
FOLLICLE-STIMULATING HORMONE
TABLE 9 FSH BIOSIMILAR
CHAPTER 4 REGULATORY ASPECTS
EUROPE REGULATIONS
UNITED STATES REGULATIONS
BIOSIMILAR REGULATIONS IN EMERGING MARKETS
GUIDELINES FOR BIOSIMILAR DEVELOPMENT IN JAPAN
GUIDELINES FOR BIOSIMILAR DEVELOPMENT IN INDIA
NAMING OF BIOSIMILARS
SIGNIFICANT REGULATORY ACTIVITIES
TABLE 10 NEW MARKETING AUTHORIZATION OF BIOSIMILARS IN THE EUROPEAN UNION, 2010-AUGUST 2014
CHAPTER 5 NEW DEVELOPMENTS
TABLE 11 COMPANIES WITH BIOSIMILARS IN THE PIPELINE
MOST POPULAR BIOSIMILAR TARGETS
ADALIMUMAB
TABLE 12 HUMIRA (ADALIMUMAB) BIOSIMILARS IN CLINICAL TRIALS
INFLIXIMAB
TABLE 13 REMICADE (INFLIXIMAB) BIOSIMILARS IN CLINICAL TRIALS
RITUXIMAB
TABLE 14 RITUXAN (RITUXIMAB) BIOSIMILARS IN CLINICAL TRIALS
BEVACIZUMAB
TABLE 15 AVASTIN (BEVACIZUMAB) BIOSIMILARS IN CLINICAL TRIALS
TRASTUZUMAB
TABLE 16 HERCEPTIN (TRASTUZUMAB) BIOSIMILARS IN CLINICAL TRIALS
OTHER BIOSIMILARS IN CLINICAL TRIALS
TABLE 17 OTHER BIOSIMILARS IN CLINICAL TRIALS
CHAPTER 6 TECHNOLOGY TRENDS
EMERGING TRENDS IN BIOSIMILAR MANUFACTURING PROCESSES
EMERGING TRENDS IN ANALYTICAL TECHNOLOGIES
TABLE 18 ANALYTICAL METHODS RECOGNIZED BY REGULATORY BODIES FOR COMPARABILITY EXERCISE AND RISK MITIGATION
POLYACRYLAMIDE GEL ELECTROPHORESIS (PAGE) AND WESTERN
BLOTTING
ISOELECTRIC FOCUSING (IEF)/PROTEIN BLOTTING
CAPILLARY ZONE ELECTROPHORESIS (CZE)
HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
SPECTROSCOPIC TECHNIQUES
MASS SPECTROMETRY (MS)
IN VITRO ASSAYS
EPITOPE MAPPING
DIFFERENTIAL SCANNING CALORIMETRY (DSC)
CHAPTER 7 MARKET ANALYSIS
MARKET BY TYPE
MARKET OVERVIEW
MARKET REVENUE
TABLE 19 GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, THROUGH 2019 ($ MILLIONS)
FIGURE 1 GLOBAL REVENUES FOR BIOSIMILARS BY TYPE, 2012-2019 ($ MILLIONS)
MARKET SHARE
TABLE 20 MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013 (%)
FIGURE 2 MARKET SHARE OF BIOSIMILARS BY TYPE, IN 2013 (%)
MARKET BY REGION
MARKET OVERVIEW
MARKET REVENUE
TABLE 21 GLOBAL REVENUES FOR BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 3 GLOBAL REVENUES FOR BIOSIMILARS BY REGION, 2012-2019 ($ MILLIONS)
MARKET SHARE
TABLE 22 MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013 (%)
FIGURE 4 MARKET SHARE OF BIOSIMILARS BY REGION, IN 2013 (%)
ERYTHROPOIETINS (EPO)
Market Overview
Market Revenue
TABLE 23 REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 5 REVENUE FOR BIOSIMILAR ERYTHROPOIETINS BY REGION, 2012-2019 ($ MILLIONS)
Market Share
TABLE 24 MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013 (%)
FIGURE 6 MARKET SHARE OF BIOSIMILAR ERYTHROPOIETINS BY REGION, 2013 (%)
HUMAN GROWTH HORMONES (HGH)
Market Overview
Market Revenue
TABLE 25 REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 7 REVENUE FOR BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2012-2019 ($ MILLIONS)
Market Shares
TABLE 26 MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013 (%)
FIGURE 8 MARKET SHARE OF BIOSIMILAR HUMAN GROWTH HORMONES BY REGION, 2013 (%)
GRANULOCYTE COLONY-STIMULATING FACTORS (G-CSF)
Market Overview
Market Revenue
TABLE 27 REVENUE FOR G-CSF BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 9 REVENUE FOR G-CSF BY REGION, 2012-2019 ($ MILLIONS)
Market Share
TABLE 28 MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013 (%)
FIGURE 10 MARKET SHARE OF BIOSIMILAR G-CSF BY REGION, IN 2013 (%)
LOW-MOLECULAR-WEIGHT HEPARIN (LMWH)
Market Overview
Market Revenue
TABLE 29 REVENUE FOR LMWH BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 11 REVENUE FOR LMWH BY REGION, THROUGH 2019 ($ MILLIONS)
Market Share
TABLE 30 MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013 (%)
FIGURE 12 MARKET SHARE OF BIOSIMILAR LMWH BY REGION, 2013 (%)
OTHER BIOSIMILARS
Market Overview
Market Revenue
TABLE 31 REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 13 REVENUE FOR OTHER BIOSIMILARS BY REGION, THROUGH 2019 ($ MILLIONS)
Market Share
TABLE 32 MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013 (%)
FIGURE 14 MARKET SHARE OF OTHER BIOSIMILARS BY REGION, 2013 (%)
CHAPTER 8 INDUSTRY STRUCTURE
ERYTHROPOIETINS
MARKET LEADERS
TABLE 33 LEADING MANUFACTURERS/ SUPPLIERS OF ERYTHROPOIETIN (EPO) BIOSIMILARS, 2013
MARKET SHARE
TABLE 34 MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013 (%)
FIGURE 15 MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR EPO BIOSIMILARS, 2013 (%)
HUMAN GROWTH HORMONES
MARKET LEADERS
TABLE 35 LEADING MANUFACTURERS/SUPPLIERS OF HUMAN GROWTH HORMONES (HGH) BIOSIMILARS, 2013
MARKET SHARE
TABLE 36 MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013 (%)
FIGURE 16 MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR HGH BIOSIMILARS, 2013 (%)
GRANULOCYTE COLONY-STIMULATING FACTOR
MARKET LEADERS
TABLE 37 LEADING MANUFACTURERS/ SUPPLIERS OF G-CSF BIOSIMILARS, 2013
MARKET SHARE
TABLE 38 MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013 (%)
FIGURE 17 MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR G-CSF BIOSIMILARS, 2013 (%)
LOW-MOLECULAR-WEIGHT HEPARINS
MARKET LEADERS
TABLE 39 LEADING MANUFACTURERS/SUPPLIERS OF LMWH BIOSIMILARS, 2013
MARKET SHARES
TABLE 40 MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR LMWH BIOSIMILARS, 2013 (%)
FIGURE 18 MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR LMWH BIOSIMILARS, 2013 (%)
OTHER BIOSIMILARS
MARKET LEADERS
TABLE 41 LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2013
MARKET SHARES
TABLE 42 MARKET SHARES OF MANUFACTURERS/SUPPLIERS FOR OTHER BIOSIMILARS, 2013 (%)
FIGURE 19 MARKET SHARES OF MANUFACTURERS/ SUPPLIERS FOR OTHER BIOSIMILARS, 2013 (%)
CHAPTER 9 PATENT ANALYSIS
UNITED STATES PATENTS
PATENTS BY YEAR
TABLE 43 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
FIGURE 20 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
PATENTS BY TYPE/CATEGORY
TABLE 44 NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
FIGURE 21 NUMBER OF U.S. PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
PATENTS BY COMPANY
TABLE 45 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
PATENTS BY COUNTRY
TABLE 46 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
TABLE 47 PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (NO./%)
FIGURE 22 PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (%)
EUROPEAN PATENTS
PATENTS BY YEAR
TABLE 48 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
FIGURE 23 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-AUGUST 2014
PATENTS BY TYPE/ CATEGORY
TABLE 49 NUMBER OF PATENTS BY CATEGORY, JANUARY 2010-AUGUST 2014
PATENTS BY COMPANY
TABLE 50 NUMBER OF PATENTS BY COMPANY, JANUARY 2010-AUGUST 2014
PATENTS BY COUNTRY
TABLE 51 NUMBER OF PATENTS BY COUNTRY, JANUARY 2010-AUGUST 2014
TABLE 52 PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (NO./%)
FIGURE 24 PATENT SHARES BY COUNTRY, JANUARY 2010-AUGUST 2014 (%)
CHAPTER 10 CURRENT SITUATION
INCREASING DISEASE BURDEN DRIVING THE MARKET
AGING POPULATION
STRONG GOVERNMENT SUPPORT
PATENT EXPIRATION
TABLE 53 SIGNIFICANT PATENT EXPIRATIONS OF BIOLOGICS
COLLABORATIONS/ PARTNERSHIPS
ELECTRONIC COMPANIES ENTERING THE BIOSIMILARS SECTOR WITH
SIGNIFICANT INVESTMENTS
MARKET FACTORS IN EMERGING MARKETS
LESS STRINGENT REGULATORY REQUIREMENTS
COMPETITION
HIGH COST AND AVAILABILITY ISSUES
LACK OF EXPERTISE IN THE PRODUCTION OF HIGHLY DEMANDING
PRODUCTS SUCH AS MONOCLONAL ANTIBODIES
RISING INVESTMENTS IN INDIAN BIOSIMILARS SECTOR
CHAPTER 11 COMPANY PROFILES
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

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