Biologic Therapeutic Drugs: Technologies and Global Markets

Published: January 2013
No. of Pages: 142
  

REPORT HIGHLIGHTS

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.

REPORT SCOPE

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.

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.

Biologic Therapeutic Drugs: Technologies and Global Markets

TABLE OF CONTENTS

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
Table Summary : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2017
Figure Summary : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2009-2017

Chapter- 3: OVERVIEW
BIOLOGICS NEW PRODUCTS IN DISEASE TREATMENT
MONOCLONAL ANTIBODIES
THERAPEUTIC PROTEINS
MAJOR BIOLOGICS PRODUCT CLASSES
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
MONOCLONAL ANTIBODIES
LARGE PHARMACEUTICAL COMPANIES AND BIOPHARMA
LARGE PHARMACEUTICAL COMPANY CONSORTIUM FORMED
THERAPEUTIC PROTEINS
ANTIHEMOPHILIA PRODUCTS
VACCINE MARKET REVENUES
Table 4 : MAJOR BIOPHARMACEUTICAL PLAYERS BY REVENUE, 2011
Table 5 : TOP 25 BIOPHARMACEUTICAL PRODUCTS BY REVENUE, 2011
Table 6 : TOP 50 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2010

Chapter- 6: IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET
RATIONALE FOR BIOSIMILAR DEVELOPMENT
OPPORTUNITY AND THREAT FROM BIOSIMILARS
MARKET TRENDS: GROWTH DRIVERS AND RESISTORS
BIOSIMILARS: REGULATORY UPDATE
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

Chapter- 7: MAJOR PLAYERS IN BIOLOGIC AND BIOSIMILARS DRUG MARKET
MONOCLONAL ANTIBODIES
THERAPEUTIC PROTEINS
VACCINES

Chapter- 8: GEOGRAPHIC DISTRIBUTION OF BIOLOGICS MARKET
GEOGRAPHIC MARKET ANALYSIS

Chapter- 9: PIPELINE ANALYSIS
BIOLOGICS IN COMPANY PIPELINES 2012
Table 26 : BIOLOGIC DRUGS OBTAINING FDA APPROVAL FROM 2010 TO 2012

Chapter- 10: BIOLOGICS CLINICAL TRIALS
CANCER BIOLOGIC DRUGS
GASTROINTESTINAL AND RELATED DISEASES
HEART DISEASE
Table 35 : DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL

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
THERAPEUTIC PROTEIN PATENTS
VACCINE PATENTS

Chapter- 13: BIOLOGICS MANUFACTURING
BIOPHARMACEUTICAL MANUFACTURING PROCESS
MAMMALIAN CELL THERAPEUTIC PROTEIN PRODUCTION
EMERGING PRODUCTION SYSTEMS
TRANSGENIC PROTEIN PRODUCTION SYSTEMS

Chapter- 14: COMPANY PROFILES
ABBOTT LABORATORIES
ADVAXIS INC.
AGENNIX AG
AKEBIA THERAPEUTICS INC.
AMGEN INC.
APOGENIX GMBH
BAXTER BIOSCIENCE INC.
BAYER SCHERING PHARMA AG
BIOGEN IDEC INC.
BIOINVENT INTERNATIONAL AB
BIOVITRUM AB
CELLDEX THERAPEUTICS INC.
CHUGAI PHARMACEUTICALS
CSL BEHRING
CYTHERIS SA
DEBIOPHARM GROUP
DENDREON CORPORATION
DYAX CORP.
ELI LILLY & CO.
ERYTECH PHARMA
GENENTECH INC.
GENMAB A/S
GENZYME CORPORATION
GLAXOSMITHKLINE PLC
GLYCOTOPE GMBH
H. LUNDBECK A/S
HAWAII BIOTECH INC.
HELIX BIOPHARMA CORPORATION
HUMAN GENOME SCIENCES INC.
IMCLONE SYSTEMS INC.
IMMUNOGEN INC.
IMMUNOVACCINE TECHNOLOGIES INC.
IMMUTEP S.A.
INNATE PHARMA
INTERCELL AG
IPSEN
MEDAREX INC.
MERCK & CO. INC. USA
MERCK SERONO S.A.
NOVARTIS AG
NOVO NORDISK A/S
OCTAPHARMA AG
PFIZER INC.
PHOSPHAGENICS LIMITED
PROTEON THERAPEUTICS INC.
ROCHE LTD.
SANOFI-AVENTIS
SEATTLE GENETICS INC.
SHIRE PLC
SOLIGENIX INC.
TEVA PHARMACEUTICAL INDUSTRIES LTD.
THROMBOGENICS NV
TOLERX INC.
TRIPEP AB
TRUBION PHARMACEUTICALS INC.
UCB S. A.
VICAL INC.
WILEX AG
XCELLEREX INC.
ZYMOGENETICS INC.

LIST OF TABLES

Summary Table : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2017
Table 1 : SUBCLASSES OF BIOLOGICS DRUGS
Table 2 : MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES
Table 3 : GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2017
Table 4 : MAJOR BIOPHARMACEUTICAL PLAYERS BY REVENUE, 2011
Table 5 : TOP 25 BIOPHARMACEUTICAL PRODUCTS BY REVENUE, 2011
Table 6 : TOP 50 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2010
Table 7 : GLOBAL MARKET FORECAST FOR MABS, THROUGH 2017
Table 8 : LEADING MONOCLONAL ANTIBODY PRODUCTS, 2011
Table 9 : VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2012 AND 2017
Table 10 : REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET, THROUGH 2017
Table 11 : LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS
Table 12 : CLINICAL TRIALS ON G-CSF RECEPTORS IN 2012
Table 13 : CLINICAL TRIALS ON CYTOKINES UNDERWAY IN 2012
Table 14 : TOP 30 REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2011
Table 15 : VACCINE REVENUES, THROUGH 2017
Table 16 : CLINICAL TRIALS ON VACCINES, 2012
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
Table 20 : TOP 10 SELLING MABS IN 2011
Table 21 : MAJOR PLAYERS (BY REVENUE) IN MAB MARKET IN 2011
Table 22 : TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2011
Table 23 : MAJOR PLAYERS (BY REVENUE) IN THE THERAPEUTIC PROTEINS MARKET, 2011
Table 24 : TOP 10 VACCINES BY REVENUE, 2011
Table 25 : GEOGRAPHIC DISTRIBUTION OF TOTAL BIOLOGICS MARKET, THROUGH 2017
Table 26 : BIOLOGIC DRUGS OBTAINING FDA APPROVAL FROM 2010 TO 2012
Table 27 : AMGEN BIOLOGICS PIPELINE, 2012
Table 28 : ROCHE/GENENTECH/CHUGAI BIOLOGICS PIPELINE, 2012
Table 29 : BAYER BIOLOGICS PIPELINE, 2012
Table 30 : NOVO NORDISK BIOLOGICS PIPELINE, 2012
Table 31 : MERCK BIOLOGICS PIPELINE, 2012
Table 32 : PFIZER BIOLOGICS PIPELINE, 2012
Table 33 : BIOGEN IDEC BIOLOGICS PIPELINE, 2012
Table 34 : SANOFI BIOLOGICS PIPELINE, 2012
Table 35 : DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL
Table 36 : LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER TREATMENT, 2012
Table 37 : LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED DISEASE TREATMENT, 2012
Table 38 : LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR HEART AND RELATED DISEASE TREATMENT, 2012
Table 39 : LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS
Table 40 : LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS (CONTINUED)
Table 41 : U.S. PATENTS FOR MONOCLONAL ANTIBODIES
Table 42 : PATENTS ISSUED FOR THERAPEUTIC PROTEINS
Table 43 : PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS) ASSOCIATED WITH BIOLOGICALS
Table 44 : BIOLOGICS PRODUCTS USING PERFUSION METHOD
Table 45 : BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH METHOD
Table 46 : MARKETED BIOPHARMACEUTICALS USING E.COLI EXPRESSION SYSTEM
Table 47 : MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION SYSTEM
Table 48 : PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF RECOMBINANT PROTEINS
Table 49 : THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS
Table 50 : MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA EXPRESSION SYSTEM

LIST OF FIGURES

Summary Figure : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2009-2017
Figure 1 : DIAGRAM OF TYPICAL ANTIBODY STRUCTURE

Published By: BCC Research
Product Code: BCC Research1013


Did you find what you are/were looking for ? If not, read below and browse through other relevant pages for similar market research reports OR get in touch with us through the form/contact info in your right navigation panel and we’ll share relevant market report titles for you to explore.

Related Reports:


Connect With Us
Email: sales@reportsandreports.com Call : + 1 888 391 5441
Subscription Option

Using our subscription option, you get access to market research reports and industry data of Biotechnology market as per your needs. Get the best of Biotechnology research reports by utilizing your research budgets in an optimum way.

More about our Subscription option
Email Alerts

Get Email alerts about market research reports from industries and publishers of your interest:

Live Chat
Live Chat by Comm100