Biologic Therapeutic Drugs: Technologies and Global Markets

  • January 2015
  • -
  • BCC Research
  • -
  • 172 pages

REPORT HIGHLIGHTS

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.

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 BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER

Chapter- 2: EXECUTIVE SUMMARY 2

Table Summary : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2019
Figure Summary : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2012-2019

Chapter- 3: OVERVIEW 12 $696

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 3 $174

BIOPHARMACEUTICAL INDUSTRY STRUCTURE
THE ORIGINS OF BIOTECHNOLOGY
INVOLVEMENT OF LARGE PHARMACEUTICAL COMPANIES

Chapter- 5: BIOLOGICS MARKET OVERVIEW 24 $1392

TOP 25 BIOPHARMACEUTICAL PRODUCT REVENUES
FDA APPROVED BIOLOGICALS FIRST HALF 2014
TOP 25 BEST SELLING DRUGS 2013
MONOCLONAL ANTIBODIES
LARGE PHARMACEUTICAL COMPANIES AND BIOPHARMA
LARGE PHARMACEUTICAL COMPANY CONSORTIUM FORMED
THERAPEUTIC PROTEINS
Table 4 : MAJOR PHARMA/BIOPHARMA PLAYERS BY REVENUE, 2013
Table 5 : FDA CLEARED BIOPHARMACEUTICAL PRODUCTS AS OF 2013

Chapter- 6: IMPACT OF BIOSIMILAR DRUGS ON BIOLOGICS MARKET 9 $522

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

Chapter- 7: MAJOR PLAYERS IN BIOLOGIC AND BIOSIMILARS DRUG MARKET 4 $232

MONOCLONAL ANTIBODIES
THERAPEUTIC PROTEINS
VACCINES

Chapter- 8: GEOGRAPHIC DISTRIBUTION OF BIOLOGICS MARKET 2 $116

GEOGRAPHIC MARKET ANALYSIS

Chapter- 9: PIPELINE ANALYSIS 19 $1102

BIOSIMILAR DRUGS
BIOLOGICS/BIOSIMILARS IN COMPANY PIPELINES, 2013
CLINICAL TRIALS ON BIOLOGICS/BIOSIMILARS
Table 27 : NEW BIOLOGIC DRUGS APPROVED, 2014
Table 28 : BIOLOGIC DRUGS OBTAINING FDA APPROVAL, 2011-2013

Chapter- 10: BIOLOGICS CLINICAL TRIALS 7 $406

CANCER BIOLOGIC DRUGS
GASTROINTESTINAL AND RELATED DISEASES
NEUROLOGICAL DISEASE
Table 39 : DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL

Chapter- 11: MERGERS AND ACQUISITIONS IN BIOLOGICS AREA 7 $406

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 9 $522

MONOCLONAL ANTIBODY PATENTS
THERAPEUTIC PROTEIN PATENTS
VACCINE PATENTS

Chapter- 13: BIOLOGICS MANUFACTURING 20 $1160

BIOLOGICS MANUFACTURING
BIOPHARMACEUTICAL MANUFACTURING PROCESS
MAMMALIAN CELL THERAPEUTIC PROTEIN PRODUCTION
EMERGING PRODUCTION SYSTEMS
TRANSGENIC PROTEIN PRODUCTION SYSTEMS

Chapter- 14: COMPANY PROFILES 50 $2900

ABBVIE INC.
ABBOTT LABORATORIES
ADVAXIS INC.
AGENNIX AG
AKEBIA THERAPEUTICS INC.
AMGEN INC.
APOGENIX
APTALIS PHARMACEUTICAL
CHINA BIOLOGIC PRODUCTS
BAXTER BIOSCIENCE INC.
BAYER SCHERING PHARMA AG
BIOGEN IDEC INC.
BIOINVENT INTERNATIONAL AB
BIOVITRUM AB (SWEDISH ORPHAN BIOVITRUM AB, SOBI)
CELLDEX THERAPEUTICS INC.
CHUGAI PHARMACEUTICALS
CSL BEHRING
DEBIOPHARM GROUP
DENDREON CORP.
DYAX CORP.
ELI LILLY and CO.
ERYTECH PHARMA
GENENTECH INC.
GENMAB A/S
GENZYME
GLAXOSMITHKLINE
GLYCOTOPE GMBH
H. LUNDBECK A/S
HAWAII BIOTECH INC.
HELIX BIOPHARMA CORP.
HUMAN GENOME SCIENCES INC.
IMCLONE SYSTEMS INC.
IMMUNOGEN INC.
IMMUNOVACCINE TECHNOLOGIES INC.
IMMUTEP S.A.
INNATE PHARMA
INTERCELL AG
IPSEN
JANSSEN PHARMACEUTICALS
MEDAREX INC.
MERCK
MERCK SERONO
NOVARTIS AG
NOVO NORDISK A/S
OCTAPHARMA AG
PFIZER INC.
PHARMASTANDARD JSC
PHOSPHAGENICS LTD.
PROTEON THERAPEUTICS INC.
RELIANCE LIFE SCIENCES
ROCHE LTD.
SAMSUNG BIOPESIS
SANOFI-AVENTIS
SEATTLE GENETICS INC.
SHIRE PLC
TEVA PHARMACEUTICAL INDUSTRIES LTD.
THROMBOGENICS NV
UCB S.A.
WILEX AG
XCELLEREX INC.
ZYMOGENETICS INC.

List of Tables

Summary Table : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, THROUGH 2019
Table 1 : SUBCLASSES OF BIOLOGICS DRUGS
Table 2 : MONOCLONAL ANTIBODY AND THERAPEUTIC PROTEIN DRUGS SUBCLASSES
Table 3 : GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2019
Table 4 : MAJOR PHARMA/BIOPHARMA PLAYERS BY REVENUE, 2013
Table 5 : FDA CLEARED BIOPHARMACEUTICAL PRODUCTS AS OF 2013
Table 6 : GLOBAL TOP 25 REVENUE GENERATING BIOPHARMACEUTICAL PRODUCTS, 2011-2013
Table 7 : FDA APPROVED BIOLOGICALS, JAN. TO JULY 2014
Table 8 : TOP 25 BEST SELLING DRUGS, 2013
Table 9 : GLOBAL MARKET FORECAST FOR MABS, THROUGH 2019
Table 10 : TOP FIVE LEADING MONOCLONAL ANTIBODY PRODUCTS, 2013
Table 11 : VOLUME OF MAMMALIAN CELL CULTURE PRODUCED MABS, 2014 AND 2019
Table 12 : REVENUE FOR THERAPEUTIC PROTEINS SEGMENT OF BIOLOGICS MARKET, THROUGH 2019
Table 13 : LEADING HEMOPOIETIC GROWTH FACTOR BIOLOGIC PRODUCTS, 2013
Table 14 : CLINICAL TRIALS ON G-CSF RECEPTORS, 2013-2014
Table 15 : CLINICAL TRIALS ON CYTOKINES IN 2013 AND 2014
Table 16 : TOP REVENUE-GENERATING THERAPEUTIC PROTEIN PRODUCTS, 2013
Table 17 : VACCINE REVENUES, THROUGH 2019
Table 18 : CLINICAL TRIALS ON VACCINES, 2013-2014
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
Table 22 : TOP 10 SELLING MABS, 2013
Table 23 : MAJOR PLAYERS IN MAB MARKET, BY REVENUE, 2013
Table 24 : TOP 10 THERAPEUTIC PROTEIN PRODUCTS, 2013
Table 25 : MAJOR PLAYERS IN THE THERAPEUTIC PROTEINS MARKET BY REVENUE, 2013
Table 26 : TOP 10 VACCINES BY REVENUE, 2013
Table 27 : NEW BIOLOGIC DRUGS APPROVED, 2014
Table 28 : BIOLOGIC DRUGS OBTAINING FDA APPROVAL, 2011-2013
Table 29 : RECENT EMA APPROVED BIOSIMILAR DRUGS
Table 30 : AMGEN BIOLOGICS PIPELINE, 2013
Table 31 : MARKETED AMGEN BIOLOGICALS
Table 32 : SANDOZ BIOLOGICS PIPELINE, 2013
Table 33 : RELIANCE LIFE SCIENCES PIPELINE, 2013
Table 34 : BOEHRINGER INGELHEIM BIOLOGICS PIPELINE, 2013
Table 35 : MERCK BIOLOGICS PIPELINE, 2013
Table 36 : PFIZER BIOLOGICS PIPELINE, 2013
Table 37 : SAMSUNG BIOEPIS BIOLOGICS PIPELINE, 2013
Table 38 : BIOLOGICAL/BIOSIMILAR DRUGS IN CLINICAL TRIALS, 2013-2014
Table 39 : DESCRIPTION OF PHASES OF CLINICAL TRIALS REQUIRED FOR NEW DRUG APPROVAL
Table 40 : LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR CANCER TREATMENT, 2013-2014
Table 41 : LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR GI AND RELATED DISEASE TREATMENT, 2013-2014
Table 42 : LIST (PARTIAL) OF BIOLOGIC DRUGS IN CLINICAL TRIAL FOR NEUROLOGICAL DISEASE TREATMENT, 2013-2014
Table 43 : LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2014 (YTD)
Table 44 : LICENSING, DEVELOPMENT AGREEMENTS, ACQUISITIONS AND PARTNERSHIPS IN BIOLOGICS, 2013
Table 45 : U.S. PATENTS FOR MONOCLONAL ANTIBODIES
Table 46 : PATENTS ISSUED FOR THERAPEUTIC PROTEINS
Table 47 : PATENTS ISSUED FOR VACCINES (OR VACCINE RELATED PRODUCTS) ASSOCIATED WITH BIOLOGICALS
Table 48 : BIOLOGICS PRODUCTS USING PERFUSION METHOD
Table 49 : BIOLOGICS THERAPEUTIC PRODUCTS USING FED-BATCH METHOD
Table 50 : MARKETED BIOPHARMACEUTICALS USING E. COLI EXPRESSION SYSTEM, 1997-2014
Table 51 : MARKETED BIOPHARMACEUTICALS USING ANIMAL CELL LINE EXPRESSION SYSTEM
Table 52 : PLANT-BASED TRANSGENIC COMPANIES AND THEIR PIPELINES OF RECOMBINANT PROTEINS
Table 53 : THERAPEUTIC PROTEINS PRODUCED IN TRANSGENIC ANIMALS
Table 54 : MARKETED BIOPHARMACEUTICALS USING MURINE (MOUSE) HYBRIDOMA EXPRESSION SYSTEM
List of Figures

Summary Figure : GLOBAL BIOLOGICS MARKET FORECAST BY TYPE OF PRODUCT, 2012-2019
Figure 1 : DIAGRAM OF TYPICAL ANTIBODY STRUCTURE

View This Report »

Find all the market research you need - instantly, in one place.

+1.2 Million Research Documents & Statistics +200,000 Trusted Public Sources 350 Industries With Global Coverage

24/7 Customer Support

Talk to Amrita

+1 718 303 2019

Purchase Reports From Reputable Market Research Publishers

Global Markets for Bioengineered Protein Drugs

Global Markets for Bioengineered Protein Drugs

  • $ 6 650
  • Industry report
  • August 2014
  • by BCC Research

This BCC Research report explores the present and future strategies within the bioengineered protein drugs market. It analyzes each market and its applications, regulatory environment, technologies involved, ...

Nucleic Acid Aptamers for Diagnostics and Therapeutics: Global Markets

Nucleic Acid Aptamers for Diagnostics and Therapeutics: Global Markets

  • $ 6 650
  • Industry report
  • September 2014
  • by BCC Research

An in-depth analysis of the global nucleic acid aptamer market by technologies, applications and geographic regional markets. This report includes key technologies involved, analyzes the capabilities and ...

Biopharmaceutical and Vaccine Production Markets

Biopharmaceutical and Vaccine Production Markets

  • $ 3 995
  • Industry report
  • August 2014
  • by Kalorama Information

Though biotechnology has created many new therapies and vaccines - including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders - there are still huge challenges during the final stages ...


ReportLinker is an award-winning market research solution that finds, filters and organizes the latest industry data so you get all the market research you need - quickly, in one place.