Biologic Therapeutic Drugs: Technologies and Global Markets


January 1, 2013
168 Pages - SKU: WA4937796
License type:
Countries covered: Global

This report provides:

An overview of the global market for biologic therapeutic drugs

Analyses of global market trends, with data from 2011, estimates for 2012, and projections of compound annual growth rates (CAGRs) through 2017

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.


Additional Information

INTRODUCTION

STUDY 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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