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Biologic Therapeutic Drugs: Technologies and Global Markets

Biologic Therapeutic Drugs: Technologies and Global Markets

The global biologics market totaled $200.6 billion in 2013 and is expected to grow to nearly $234 billion in 2014. The total market is expected to grow to $386.7 billion by the end of 2019 at compound annual growth rate (CAGR) of 10.6%.

This report provides:

An overview of the global market for biologic therapeutic drugs

Analyses of global market trends, with data from 2013, estimates for 2014, and projections of compound annual growth rates (CAGRs) through 2019

Coverage of large market segments such as monoclonal antibodies (mAb), therapeutic proteins, and vaccines

Examination of the competitive environment with a special focus on how new products and technologies are influencing the current standard of care

Comprehensive profiles of current market leaders, as well as companies with innovative products poised to advance within the forecast period.


SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2014 to 2019) are discussed. In addition, new products approved in 2013 and 2014 by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as those products expected to be approved within the forecast period are projected within their respective segment. Figures for 2014 are projected estimates, except where actual results have been reported due to the release timing of the report. For large markets segments such as monoclonal antibodies (mAb), therapeutic proteins and vaccines, specific mechanisms of action are discussed in detail. For example, the trend of increased use of vascular endothelial growth factor (VEGF) inhibitors as a first-line therapy for multiple disease states such as colorectal cancer and the ophthalmic disease wet age-related macular degeneration (AMD) are discussed.

The report includes analysis of leading and emerging competitors in the current worldwide market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define their specific product strategies employed. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products and technologies are influencing the current standard of care. Detailed profiles of current market leaders are discussed, as well as companies with innovative products poised to advance within the forecast period.

Market figures are based on revenues at the manufacturers’ level and are projected at 2014 dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence, diagnosis, and scripting rates for certain diseases.

Included in this report are forecasts by product, product category and by company from 2014 through 2019. The study is arranged to offer an overview of the biologics market accompanied by product, company, geography and mechanism of action with forecasts broken down and covered by geographic region or country. The revenues stated in the tables represent only actual sales of biologic drug products. They do not contain revenues from reagents, special administration equipment/devices, or other services associated with the use of the drug. Virtually the entire globe is covered to include prevalence data for each disease subsegment.

Excluded from this report are over-the-counter (OTC) medications and other consumables that do not require a physician’s prescription.

Sales figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.

All market share data presented are on a global basis unless specifically noted.

CHAPTER 1 INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 EXECUTIVE SUMMARY
SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2019 ($ MILLIONS)
SUMMARY FIGURE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2012-2019 ($ MILLIONS)
CHAPTER 3 OVERVIEW
BIOLOGICS NEW PRODUCTS IN DISEASE TREATMENT
TABLE 1 SUBCLASSES OF BIOLOGICS DRUGS
MONOCLONAL ANTIBODIES
FIGURE 1 DIAGRAM OF TYPICAL ANTIBODY STRUCTURE
THERAPEUTIC PROTEINS
HEMOPOIETIC GROWTH FACTORS (HGFS)
Cytokines
Blood Factors
VACCINES
Traditional Vaccines
Novel Vaccine Technologies
Nanoparticle Delivery of Vaccines
MAJOR BIOLOGICS PRODUCT CLASSES
TABLE 2 MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS
SUBCLASSES
TABLE 3 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2019 ($ MILLIONS)
CHALLENGES WITH RNAI
ORPHAN DRUG DESIGNATION
CHAPTER 4 BIOPHARMACEUTICAL INDUSTRY AND COMPETITIVE
ANALYSIS
BIOPHARMACEUTICAL INDUSTRY STRUCTURE
THE ORIGINS OF BIOTECHNOLOGY
INVOLVEMENT OF LARGE PHARMACEUTICAL COMPANIES
CHAPTER 5 BIOLOGICS MARKET OVERVIEW
TABLE 4 MAJOR PHARMA/BIOPHARMA PLAYERS BY REVENUE, 2013 ($ MILLIONS)
TABLE 5 FDA CLEARED BIOPHARMACEUTICAL PRODUCTS AS OF 2013
TOP 25 BIOPHARMACEUTICAL PRODUCT REVENUES
TABLE 6 GLOBAL TOP 25 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2011-2013 ($MILLIONS)
FDA APPROVED BIOLOGICALS FIRST HALF 2014
TABLE 7 FDA APPROVED BIOLOGICALS, JAN. TO JULY 2014
TOP 25 BEST SELLING DRUGS 2013
TABLE 8 TOP 25 BEST SELLING DRUGS, 2013 ($ MILLIONS)
MONOCLONAL ANTIBODIES
TABLE 9 GLOBAL MARKET FORECAST FOR MABS, THROUGH 2019 ($ MILLIONS)
TABLE 10 TOP FIVE LEADING MONOCLONAL ANTIBODY PRODUCTS, 2013 ($ MILLIONS)
TABLE 11 VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2014 AND 2019
CONJUGATED ANTIBODIES
ANTIBODY FRAGMENTS
LARGE PHARMACEUTICAL COMPANIES AND BIOPHARMA
LARGE PHARMACEUTICAL COMPANY CONSORTIUM FORMED
THERAPEUTIC PROTEINS
TABLE 12 REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET, THROUGH 2019 ($ MILLIONS)
HEMOPOIETIC GROWTH FACTORS
TABLE 13 LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS, 2013 ($ MILLIONS)
Hemopoietic Growth Factor Clinical Trials
TABLE 14 CLINICAL TRIALS ON G-CSF RECEPTORS, 2013-2014
CYTOKINES
Cytokine Clinical Trials
TABLE 15 CLINICAL TRIALS ON CYTOKINES IN 2013 AND 2014
ANTIHEMOPHILIA PRODUCTS
TABLE 16 TOP REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2013 ($ MILLIONS)
VACCINES
Vaccine Market Revenues
TABLE 17 VACCINE REVENUES, THROUGH 2019 ($ MILLIONS)
Vaccine Clinical Trials
TABLE 18 CLINICAL TRIALS ON VACCINES, 2013-2014
CHAPTER 6 IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET
IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET
TABLE 19 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLING BIOLOGICS, 2009-2018
TABLE 20 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING 2014-2019
TABLE 21 TOP 10 BIOLOGICS DRUGS IN WITH GREATEST LEVEL OF BIOSIMILAR COMPETITION, 2013 ($ MILLIONS)
RATIONALE FOR BIOSIMILAR DEVELOPMENT
ERYTHROPOIETIN
GRANULOCYTE-COLONY STIMULATING FACTOR
INTERFERONS
HUMAN GROWTH HORMONE
OPPORTUNITY AND THREAT FROM BIOSIMILARS
MARKET TRENDS: GROWTH DRIVERS AND RESISTORS
BIOSIMILARS: REGULATORY UPDATE
U.S. FDA
EUROPEAN BIOSIMILAR REGULATORY GUIDANCE
Comparability Testing
Potential Problems
CHAPTER 7 MAJOR PLAYERS IN BIOLOGIC AND BIOSIMILARS DRUG
MARKET
MONOCLONAL ANTIBODIES
TABLE 22 TOP 10 SELLING MABS, 2013 ($ MILLIONS)
TABLE 23 MAJOR PLAYERS IN MAB MARKET, BY REVENUE, 2013 ($ MILLIONS)
THERAPEUTIC PROTEINS
TABLE 24 TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2013 ($ MILLIONS)
TABLE 25 MAJOR PLAYERS IN THE THERAPEUTIC PROTEINS MARKET BY REVENUE, 2013 ($ MILLIONS)
VACCINES
TABLE 26 TOP 10 VACCINES BY REVENUE, 2013 ($ MILLIONS)
CHAPTER 8 GEOGRAPHIC DISTRIBUTION OF BIOLOGICS MARKET
GEOGRAPHIC MARKET ANALYSIS
CHAPTER 9 PIPELINE ANALYSIS
TABLE 27 NEW BIOLOGIC DRUGS APPROVED, 2014
TABLE 28 BIOLOGIC DRUGS OBTAINING FDA APPROVAL, 2011-2013
BIOSIMILAR DRUGS
TABLE 29 RECENT EMA APPROVED BIOSIMILAR DRUGS
BIOLOGICS/BIOSIMILARS IN COMPANY PIPELINES, 2013
AMGEN
TABLE 30 AMGEN BIOLOGICS PIPELINE, 2013
TABLE 31 MARKETED AMGEN BIOLOGICALS
SANDOZ PHARMACEUTICALS
TABLE 32 SANDOZ BIOLOGICS PIPELINE, 2013
RELIANCE LIFE SCIENCES
TABLE 33 RELIANCE LIFE SCIENCES PIPELINE, 2013
BOEHRINGER INGELHEIM
TABLE 34 BOEHRINGER INGELHEIM BIOLOGICS PIPELINE, 2013
MERCK
TABLE 35 MERCK BIOLOGICS PIPELINE, 2013
PFIZER
TABLE 36 PFIZER BIOLOGICS PIPELINE, 2013
SAMSUNG BIOEPIS
TABLE 37 SAMSUNG BIOEPIS BIOLOGICS PIPELINE, 2013
CLINICAL TRIALS ON BIOLOGICS/BIOSIMILARS
TABLE 38 BIOLOGICAL/BIOSIMILAR DRUGS IN CLINICAL TRIALS, 2013-2014
CHAPTER 10 BIOLOGICS CLINICAL TRIALS
TABLE 39 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL (PERCENTAGE SUCCESS RATE)
CANCER BIOLOGIC DRUGS
TABLE 40 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER TREATMENT, 2013-2014
GASTROINTESTINAL AND RELATED DISEASES
TABLE 41 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED DISEASE TREATMENT, 2013-2014
NEUROLOGICAL DISEASE
TABLE 42 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR NEUROLOGICAL DISEASE TREATMENT, 2013-2014
CHAPTER 11 MERGERS AND ACQUISITIONS IN BIOLOGICS AREA
TABLE 43 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2014 (YTD)
TABLE 44 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2013
CHAPTER 12 PATENTS FOR BIOLOGIC DRUGS
MONOCLONAL ANTIBODY PATENTS
TABLE 45 U.S. PATENTS FOR MONOCLONAL ANTIBODIES
THERAPEUTIC PROTEIN PATENTS
TABLE 46 PATENTS ISSUED FOR THERAPEUTIC PROTEINS
VACCINE PATENTS
TABLE 47 PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS) ASSOCIATED WITH BIOLOGICALS
CHAPTER 13 BIOLOGICS MANUFACTURING
BIOLOGICS MANUFACTURING
BIOPHARMACEUTICAL MANUFACTURING PROCESS
THE PREPARATION PROCESS
Cell Banking and Seed Culture
Production
Cell Culture Formats
Batch and Continuous Processing
Perfusion and Fed-Batch Mode
TABLE 48 BIOLOGICS PRODUCTS USING PERFUSION METHOD
Perfusion Methods
Fed-Batch Methods
TABLE 49 BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH
METHOD
Harvest and Concentration
THE FINISHING PROCESS
PURIFICATION OF BIOPHARMACEUTICALS
AUTOMATED PROCESSING SYSTEMS-SKIDS
FORMULATION
Lyophilization
Cryogranulation
Spray Drying
Undercooling
PROCESS INTEGRATION: THE CRITICAL ACTIVITY
EXPRESSION SYSTEMS FOR THERAPEUTIC PROTEIN PRODUCTION
MICROBIAL THERAPEUTIC PROTEIN PRODUCTION
E. COLI ADVANTAGES FOR MICROBIAL PRODUCTION
Fast Accumulation
Safety Advantage
Growth on Inexpensive Carbon Sources
Propensity for High-Cell-Density Fermentations
Simple Process Scale-Up
TABLE 50 MARKETED BIOPHARMACEUTICALS USING E. COLI EXPRESSION SYSTEM, 1997-2014
MAMMALIAN CELL THERAPEUTIC PROTEIN PRODUCTION
TABLE 51 MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE
EXPRESSION SYSTEM
EMERGING PRODUCTION SYSTEMS
PICHIA AND FILAMENTOUS FUNGI
TRANSGENIC PROTEIN PRODUCTION SYSTEMS
TRANSGENIC PLANTS
TABLE 52 PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF RECOMBINANT PROTEINS
TRANSGENIC ANIMALS
TABLE 53 THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC
ANIMALS
TABLE 54 MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE)
HYBRIDOMA EXPRESSION SYSTEM
CHAPTER 14 COMPANY PROFILES
ABBVIE INC.
BIOLOGICAL PRODUCTS
ABBOTT LABORATORIES
BIOLOGICAL PRODUCTS
ADVAXIS INC.
BIOLOGICAL PRODUCTS
AGENNIX AG
AKEBIA THERAPEUTICS INC.
BIOLOGICAL PRODUCTS
AMGEN INC.
BIOLOGICAL PRODUCTS
APOGENIX
BIOLOGICAL PRODUCTS
APTALIS PHARMACEUTICAL
BIOLOGICAL PRODUCTS
CHINA BIOLOGIC PRODUCTS
BIOLOGICAL PRODUCTS
BAXTER BIOSCIENCE INC.
BIOLOGICAL PRODUCTS
BAYER SCHERING PHARMA AG
BIOLOGICAL PRODUCTS
BIOGEN IDEC INC.
BIOLOGICAL PRODUCTS
BIOINVENT INTERNATIONAL AB
BIOLOGICAL PRODUCTS
BIOVITRUM AB (SWEDISH ORPHAN BIOVITRUM AB, SOBI)
BIOLOGICAL PRODUCTS
CELLDEX THERAPEUTICS INC.
BIOLOGICAL PRODUCTS
CHUGAI PHARMACEUTICALS
BIOLOGICAL PRODUCTS
CSL BEHRING
BIOLOGICAL PRODUCTS
DEBIOPHARM GROUP
BIOLOGICAL PRODUCTS
DENDREON CORP.
BIOLOGICAL PRODUCTS
DYAX CORP.
BIOLOGICAL PRODUCTS
ELI LILLY & CO.
BIOLOGICAL PRODUCTS
ERYTECH PHARMA
BIOLOGICAL PRODUCTS
GENENTECH INC.
BIOLOGICAL PRODUCTS
GENMAB A/S
BIOLOGICAL PRODUCTS
GENZYME
BIOLOGICAL PRODUCTS
GLAXOSMITHKLINE
BIOLOGICAL PRODUCTS
GLYCOTOPE GMBH
BIOLOGICAL PRODUCTS
H. LUNDBECK A/S
CURRENT PRODUCTS
HAWAII BIOTECH INC.
HELIX BIOPHARMA CORP.
BIOLOGICAL PRODUCTS
HUMAN GENOME SCIENCES INC.
BIOLOGICAL PRODUCTS
IMCLONE SYSTEMS INC.
BIOLOGICAL PRODUCTS
IMMUNOGEN INC.
BIOLOGICAL PRODUCTS
IMMUNOVACCINE TECHNOLOGIES INC.
BIOLOGICAL PRODUCTS
IMMUTEP S.A.
BIOLOGICAL PRODUCTS
INNATE PHARMA
BIOLOGICAL PRODUCTS
INTERCELL AG
BIOLOGICAL PRODUCTS
IPSEN
BIOLOGICAL PRODUCTS
JANSSEN PHARMACEUTICALS
BIOLOGICAL PRODUCTS
MEDAREX INC.
BIOLOGICAL PRODUCTS
MERCK
BIOLOGICAL PRODUCTS
MERCK SERONO
BIOLOGICAL PRODUCTS
NOVARTIS AG
BIOLOGICAL PRODUCTS
NOVO NORDISK A/S
BIOLOGICAL PRODUCTS
OCTAPHARMA AG
BIOLOGICAL PRODUCTS
PFIZER INC.
BIOLOGICAL PRODUCTS
PHARMASTANDARD JSC
BIOLOGICAL PRODUCTS
PHOSPHAGENICS LTD.
BIOLOGICAL PRODUCTS
PROTEON THERAPEUTICS INC.
RELIANCE LIFE SCIENCES
BIOLOGICAL PRODUCTS
ROCHE LTD.
BIOLOGICAL PRODUCTS
SAMSUNG BIOPESIS
BIOLOGICAL PRODUCTS
SANOFI-AVENTIS
BIOLOGICAL PRODUCTS
SEATTLE GENETICS INC.
BIOLOGICAL PRODUCTS
SHIRE PLC
BIOLOGICAL PRODUCTS
TEVA PHARMACEUTICAL INDUSTRIES LTD.
BIOLOGICAL PRODUCTS
THROMBOGENICS NV
BIOLOGICAL PRODUCTS
UCB S.A.
BIOLOGICAL PRODUCTS
WILEX AG
XCELLEREX INC.
ZYMOGENETICS INC.
BIOLOGICAL PRODUCTS

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