Biologic Therapeutic Drugs: Technologies and Global MarketsBCC ResearchJanuary 1, 2013 168 Pages - SKU: WA4937796 |
Additional Information
INTRODUCTIONSTUDY GOALS AND OBJECTIVES
This study provides a comprehensive analysis of biologics, or biopharmaceuticals, on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the market for therapeutic drug products in the biologics segment. Segments are forecast on a global basis. Forecasts and trends are developed from a cross-reference of data points, gleaned from proprietary industry sources, company publications, industry benchmarking and other divergent data sources to arrive at a cogent and coordinated forecast.
REASONS FOR DOING THE STUDY
The biologics, or biopharmaceutical, therapeutic market is wide ranging and has important implications for the future of medicine and industry advancement. For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.
Market growth has been spurred by the need for a more extensive pipeline by drug companies, attractive targets against challenging diseases, a push by companies to pursue biosimilars and enabling manufacturing technologies that reduce the cost to produce profitable products.
This study deeply investigates one of the most important market drivers: individual products. Specific product reviews of key drug programs that are expected to dominate the biopharmaceutical marketplace in the coming years are reviewed.
This report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and technologies, strategies for accessing emerging markets, and specific disease segments and geographies in order to allocate resources and make effective decisions.
SCOPE OF REPORT
Current and projected product forecasts during the forecast period (2012 to 2017) are discussed. As well, new products approved in 2009 and 2012 by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) and those products expected to be approved within the forecast period are projected within their respective segment. Figures for 2012 are projected estimates, except where actual results have been reported due to the release timing of the report. For large markets segments such as 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 2012 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 2009 through 2017. 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. 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.
INTENDED AUDIENCE
This report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants, and anyone interested in the biologics market, its products, its industry participants and its future.
The importance of identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities, and insights that provide guidance for sales growth or defensive moves cannot be overstated for a variety of constituents, including:
Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development, and research and development (R&D).
Emerging biopharma and biotechnology players in the segment must understand specific opportunities for out-licensing, originating from the elements of differentiation of their therapeutic drug as compared to leading, competitive and emerging therapies. As well, market forecasts can support investment, provided a thorough and detailed substantiation is provided for the market forecast, as is found in this study.
Investment firms evaluating candidates for venture capital or hedged investments will gain insights as to the opportunity and risks that are being encountered in the industry in a product and company specific analysis.
Equity analysts are provided detailed forecasts for the next five years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methodologies were used in preparing this report. In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts and leading medical practitioners in the field.
Information to prepare this report was obtained from participating and emerging companies in the biologics area; various institutes of the National Institutes of Health (NIH) and published data in medical journals such as Nature Biotech, Genetic and Engineering News, Journal of Experimental Medicine, European Journal of Immunology, Oncology, Clinical and Diagnostic Laboratory Immunology, Immunobiology, Nature Immunology, and many others. Other information was from the World Health Organization and other government agencies, literature searches, and others. Population estimates are based on those reported by the international database of the U.S. Census Bureau.
Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain; annual reports, 10Ks, investor briefings or from government sources.
- 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 REPORTS
- BCC ON-LINE SERVICES
- DISCLAIMER
- CHAPTER 2 EXECUTIVE SUMMARY
- SUMMARY TABLE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2017 ($ MILLIONS)
- SUMMARY FIGURE GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2009-2017 ($ 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
- MAJOR BIOLOGICS PRODUCT CLASSES
- TABLE 2 MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES
- TABLE 3 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2017 ($ 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 BIOPHARMACEUTICAL PLAYERS BY REVENUE, 2011 ($ MILLIONS)
- TABLE 5 TOP 25 BIOPHARMACEUTICAL PRODUCTS BY REVENUE, 2011 ($ MILLIONS)
- TABLE 6 TOP 50 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2010 ($ MILLIONS)
- MONOCLONAL ANTIBODIES
- TABLE 7 GLOBAL MARKET FORECAST FOR MABS, THROUGH 2017 ($ MILLIONS)
- TABLE 8 LEADING MONOCLONAL ANTIBODY PRODUCTS, 2011 ($ MILLIONS)
- TABLE 9 VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2012 AND 2017
- CONJUGATED ANTIBODIES
- ANTIBODY FRAGMENTS
- LARGE PHARMACEUTICAL COMPANIES AND BIOPHARMA
- LARGE PHARMACEUTICAL COMPANY CONSORTIUM FORMED
- THERAPEUTIC PROTEINS
- TABLE 10 REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET, THROUGH 2017 ($ MILLIONS)
- HEMOPOIETIC GROWTH FACTORS
- TABLE 11 LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS ($ MILLIONS)
- Hemopoietic Growth Factor Clinical Trials
- TABLE 12 CLINICAL TRIALS ON G-CSF RECEPTORS IN 2012
- CYTOKINES
- TABLE 13 CLINICAL TRIALS ON CYTOKINES UNDERWAY IN 2012
- ANTIHEMOPHILIA PRODUCTS
- TABLE 14 TOP 30 REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2011 ($ MILLIONS)
- VACCINES
- VACCINE MARKET REVENUES
- TABLE 15 VACCINE REVENUES, THROUGH 2017 ($ MILLIONS)
- TABLE 16 CLINICAL TRIALS ON VACCINES, 2012
- CHAPTER 6 IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET
- TABLE 17 PATENT AND MARKETING EXCLUSIVITY EXPIRATION FOR TOP SELLING BIOLOGICS
- TABLE 18 NUMBER OF BIOSIMILARS PREDICTED TO BE LAUNCHED DURING PERIOD 2012-2019
- TABLE 19 TOP 10 BIOLOGICS DRUGS IN (2011 REVENUES) WITH GREATEST LEVEL OF BIOSIMILAR COMPETITION ($ 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
- CHAPTER 7 MAJOR PLAYERS IN BIOLOGIC AND BIOSIMILARS DRUG MARKET
- MONOCLONAL ANTIBODIES
- TABLE 20 TOP 10 SELLING MABS IN 2011
- TABLE 21 MAJOR PLAYERS (BY REVENUE) IN MAB MARKET IN 2011 ($ MILLIONS)
- THERAPEUTIC PROTEINS
- TABLE 22 TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2011 ($ MILLIONS)
- TABLE 23 MAJOR PLAYERS (BY REVENUE) IN THE THERAPEUTIC PROTEINS MARKET, 2011 ($ MILLIONS)
- VACCINES
- TABLE 24 TOP 10 VACCINES BY REVENUE, 2011 ($ MILLIONS)
- CHAPTER 8 GEOGRAPHIC DISTRIBUTION OF BIOLOGICS MARKET
- GEOGRAPHIC MARKET ANALYSIS
- TABLE 25 GEOGRAPHIC DISTRIBUTION OF TOTAL BIOLOGICS MARKET, THROUGH 2017 ($ MILLIONS, % OF TOTAL)
- CHAPTER 9 PIPELINE ANALYSIS
- TABLE 26 BIOLOGIC DRUGS OBTAINING FDA APPROVAL FROM 2010 TO 2012
- BIOLOGICS IN COMPANY PIPELINES 2012
- AMGEN
- TABLE 27 AMGEN BIOLOGICS PIPELINE, 2012
- ROCHE
- TABLE 28 ROCHE/GENENTECH/CHUGAI BIOLOGICS PIPELINE, 2012
- BAYER
- TABLE 29 BAYER BIOLOGICS PIPELINE, 2012
- NOVO NORDISK
- TABLE 30 NOVO NORDISK BIOLOGICS PIPELINE, 2012
- MERCK
- TABLE 31 MERCK BIOLOGICS PIPELINE, 2012
- PFIZER
- TABLE 32 PFIZER BIOLOGICS PIPELINE, 2012
- BIOGEN IDEC
- TABLE 33 BIOGEN IDEC BIOLOGICS PIPELINE, 2012
- SANOFI
- TABLE 34 SANOFI BIOLOGICS PIPELINE, 2012
- CHAPTER 10 BIOLOGICS CLINICAL TRIALS
- TABLE 35 DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL
- CANCER BIOLOGIC DRUGS
- TABLE 36 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER TREATMENT, 2012
- GASTROINTESTINAL AND RELATED DISEASES
- TABLE 37 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED DISEASE TREATMENT, 2012
- HEART DISEASE
- TABLE 38 LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR HEART AND RELATED DISEASE TREATMENT, 2012
- CHAPTER 11 MERGER AND ACQUISITIONS IN BIOLOGICS AREA
- TABLE 39 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS
- TABLE 40 LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS (CONTINUED)
- CHAPTER 12 PATENTS FOR BIOLOGIC DRUGS
- MONOCLONAL ANTIBODY PATENTS
- TABLE 41 U.S. PATENTS FOR MONOCLONAL ANTIBODIES
- THERAPEUTIC PROTEIN PATENTS
- TABLE 42 PATENTS ISSUED FOR THERAPEUTIC PROTEINS
- VACCINE PATENTS
- TABLE 43 PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS)
- ASSOCIATED WITH BIOLOGICALS
- CHAPTER 13 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 44 BIOLOGICS PRODUCTS USING PERFUSION METHOD
- Perfusion Methods
- Fed-Batch Methods
- TABLE 45 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 46 MARKETED BIOPHARMACEUTICALS USING E.COLI EXPRESSION SYSTEM
- MAMMALIAN CELL THERAPEUTIC PROTEIN PRODUCTION
- TABLE 47 MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION
- SYSTEM
- EMERGING PRODUCTION SYSTEMS
- PICHIA AND FILAMENTOUS FUNGI
- TRANSGENIC PROTEIN PRODUCTION SYSTEMS
- TRANSGENIC PLANTS
- TABLE 48 PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF RECOMBINANT PROTEINS
- TRANSGENIC ANIMALS
- TABLE 49 THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS
- TABLE 50 MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA
- EXPRESSION SYSTEM
- CHAPTER 14 COMPANY PROFILES
- ABBOTT LABORATORIES
- BIOLOGICAL PRODUCTS
- ADVAXIS INC.
- BIOLOGICAL PRODUCTS
- AGENNIX AG
- AKEBIA THERAPEUTICS INC.
- AMGEN INC.
- BIOLOGICAL PRODUCTS
- APOGENIX GMBH
- BAXTER BIOSCIENCE INC.
- BIOLOGICAL PRODUCTS
- BAYER SCHERING PHARMA AG
- BIOLOGICAL PRODUCTS
- BIOGEN IDEC INC.
- BIOLOGICAL PRODUCTS
- BIOINVENT INTERNATIONAL AB
- BIOLOGICAL PRODUCTS
- BIOVITRUM AB
- CELLDEX THERAPEUTICS INC.
- BIOLOGICAL PRODUCTS
- CHUGAI PHARMACEUTICALS
- BIOLOGICAL PRODUCTS
- CSL BEHRING
- BIOLOGICAL PRODUCTS
- CYTHERIS SA
- DEBIOPHARM GROUP
- DENDREON CORPORATION
- DYAX CORP.
- BIOLOGICAL PRODUCTS
- ELI LILLY & CO.
- BIOLOGICAL PRODUCTS
- ERYTECH PHARMA
- BIOLOGICAL PRODUCTS
- GENENTECH INC.
- BIOLOGICAL PRODUCTS
- GENMAB A/S
- BIOLOGICAL PRODUCTS
- GENZYME CORPORATION
- BIOLOGICAL PRODUCTS
- GLAXOSMITHKLINE PLC
- BIOLOGICAL PRODUCTS
- GLYCOTOPE GMBH
- BIOLOGICAL PRODUCTS
- H. LUNDBECK A/S
- CURRENT PRODUCTS
- HAWAII BIOTECH INC.
- HELIX BIOPHARMA CORPORATION
- 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
- MEDAREX INC.
- BIOLOGICAL PRODUCTS
- MERCK & CO. INC. USA
- BIOLOGICAL PRODUCTS
- MERCK SERONO S.A.
- BIOLOGICAL PRODUCTS
- NOVARTIS AG
- BIOLOGICAL PRODUCTS
- NOVO NORDISK A/S
- BIOLOGICAL PRODUCTS
- OCTAPHARMA AG
- BIOLOGICAL PRODUCTS
- PFIZER INC.
- BIOLOGICAL PRODUCTS
- PHOSPHAGENICS LIMITED
- PROTEON THERAPEUTICS INC.
- ROCHE LTD.
- BIOLOGICAL PRODUCTS
- SANOFI-AVENTIS
- BIOLOGICAL PRODUCTS
- SEATTLE GENETICS INC.
- BIOLOGICAL PRODUCTS
- SHIRE PLC
- BIOLOGICAL PRODUCTS
- SOLIGENIX INC.
- TEVA PHARMACEUTICAL INDUSTRIES LTD.
- BIOLOGICAL PRODUCTS
- THROMBOGENICS NV
- BIOLOGICAL PRODUCTS
- TOLERX INC.
- TRIPEP AB
- TRUBION PHARMACEUTICALS INC.
- UCB S. A.
- BIOLOGICAL PRODUCTS
- VICAL INC.
- BIOLOGICAL PRODUCTS
- WILEX AG
- XCELLEREX INC.
- ZYMOGENETICS INC.
- BIOLOGICAL PRODUCTS
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