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Global Markets and Manufacturing Technologies for Protein Drugs

Global Markets and Manufacturing Technologies for Protein Drugs

The global protein drugs market reached nearly $174.7 billion in 2015 and should reach nearly $248.7 billion by 2020 at a compound annual growth rate (CAGR) of 7.3% through 2020.

Report Includes
An overview of the markets for each major class of protein in the segments therapeutic monoclonal antibodies, cytokines, peptide hormones, vaccines, and blood products
Analyses of global market trends, with data from 2014, estimates for 2015, and projections of compound annual growth rates (CAGRs) through 2020
Discussion covering the strength and weaknesses of each type of technology in light of the new technologies, growing competition, and changing customer needs
Examinations of current successes, including the size and sales forecast for each class in the next five years
Evaluation of challenges such as delivery methods and side effects
Consideration of issues regarding add-on products and patent protection
Company profiles of major players


Report Scope
The scope of this study covers manufacturing of protein drugs technologies. BCC Research analyzed each market and its applications, regulatory environment, technology, market projections and market shares. Technological issues include the latest trends and developments. This report covers the currently used six techniques in manufacturing of protein therapeutics, which includes fractionation from natural human/animal sources, microbial fermentation, cell culture, chemical synthesis, transgenics and embryonated eggs. The emerging market for enzyme inhibitors includes countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand. The protein drugs that are covered in this report are monoclonal antibodies, cytokines, peptide antibiotics, vaccines, enzymes and blood factors. The market is also analyzed on the basis of the manufacturing process used in making therapeutic protein drugs.

Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the manufacturing of the protein drug industry. Some of the major players of the market include Eli Lilly & Co., Abbvie Inc., F. Hoffmann-La Roche Ltd., Sanofi S.A., Novo Nordisk AG, Novartis AG, Merck & Co., Merck KGaA and Amgen Inc..

CHAPTER 1 INTRODUCTION
STUDY OBJECTIVES
REASONS FOR DOING THIS STUDY
CONTRIBUTIONS OF THE STUDY AND FOR WHOM
SCOPE OF THE STUDY
METHODOLOGY
INFORMATION SOURCES
ANALYSTS' CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 EXECUTIVE SUMMARY
SUMMARY TABLE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH 2020 ($ MILLIONS)
SUMMARY FIGURE GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, 2013-2020 ($ MILLIONS)
CHAPTER 3 OVERVIEW
HISTORY
TABLE 1 EVOLUTION OF THERAPEUTIC PROTEINS
PHARMACOLOGICAL CLASSIFICATION OF THERAPEUTIC PROTEINS
PROTEIN THERAPEUTICS WITH ENZYMATIC OR REGULATORY ACTIVITY
By Replacing the Deficient or Abnormal Protein
By Augmenting an Existing Pathway
By Providing a Novel Function or Activity
PROTEIN THERAPEUTICS WITH SPECIAL TARGETING ACTIVITY
Interfering with a Molecule or Organism
Delivering Other Compounds or Proteins
PROTEIN VACCINES
MOLECULAR CLASSIFICATION OF THERAPEUTIC PROTEINS
CYTOKINES
Interferons
Interleukins
Colony Stimulating Factors
MONOCLONAL ANTIBODIES
BLOOD PRODUCTS
Alpha 1 Proteinase Inhibitor
Anti-Hemophilic Factor
Anti-Thrombin
C1-Esterase Inhibitor
Coagulation Factors
Immuno Globulins
Protein C
Thrombin
PEPTIDE ANTIBIOTICS
VACCINES
Live, Attenuated Vaccines
Inactivated/Killed Vaccines
Toxoid
Subunit/Conjugate
ENZYMES
Digestive Enzymes
Metabolic Enzymes/Lysosomal Enzymes
Other Enzymes
PEPTIDE HORMONES
Follicle Stimulating Hormone and Luteinizing Hormone
Growth Hormones
Erythropoietin
Insulin
MANUFACTURING TECHNOLOGIES
FRACTIONATION/ EXTRACTION FROM NATURAL SOURCES (HUMAN/ANIMAL)
TABLE 2 PROTEIN DRUGS MADE BY FRACTIONATION
MICROBIAL FERMENTATION AND BIOREACTORS
Bioreactors
TABLE 3 THERAPETIC DRUGS PRODUCED BY MICROBIAL
FERMENTATION
TRANSGENICS
TABLE 4 PROTEIN DRUGS PRODUCED BY TRANSGENIC ANIMALS, PLANTS AND MICROORGANISMS
MAMMALIAN CELL CULTURE
TABLE 5 PROTEIN DRUGS MADE BY CELL CULTURE
CHAPTER 4 REGULATORY ASPECTS
MONOCLONAL ANTIBODIES
TABLE 6 NEW APPROVALS OF MONOCLONAL ANTIBODIES, 2013-OCTOBER
2015
THERAPEUTIC ENZYMES
TABLE 7 NEW APPROVALS IN THERAPEUTIC ENZYMES, 2013-OCTOBER 2015
CYTOKINES
TABLE 8 NEW APPROVALS OF CYTOKINES, 2013-OCTOBER 2015
PEPTIDE HORMONES
TABLE 9 NEW APPROVALS OF PEPTIDE HORMONES, 2013-OCTOBER 2015
VACCINES
TABLE 10 NEW APPROVALS OF VACCINES, 2013-OCTOBER 2015
BLOOD PRODUCTS
TABLE 11 NEW APPROVALS OF BLOOD PRODUCTS, 2013-OCTOBER 2015
PEPTIDE ANTIBIOTICS
TABLE 12 NEW APPROVALS OF PEPTIDE ANTIBIOTICS, 2013-OCTOBER 2015
RECALLS
TABLE 13 RECALLS, 2013-OCTOBER 2015
SAFETY ALERTS
TABLE 14 SAFETY ALERTS, 2013-OCTOBER 2015
CHAPTER 5 NEW DEVELOPMENTS
MONOCLONAL ANTIBODIES
TABLE 15 PIPELINE PRODUCTS OF MONOCLONAL ANTIBODIES
VACCINES
TABLE 16 PIPELINE PRODUCTS OF VACCINES
CYTOKINES
TABLE 17 PIPELINE PRODUCTS OF CYTOKINES
PEPTIDE HORMONES
TABLE 18 PIPELINE PRODUCTS IN PEPTIDE HORMONES
PEPTIDE ANTIBIOTICS
TABLE 19 PIEPLINES IN PEPTIDE ANTIBIOTICS
THERAPEUTIC ENZYMES
TABLE 20 PIPELINE PRODUCTS IN THERAPEUTIC ENZYMES
BLOOD PRODUCTS
TABLE 21 PIPELINE PRODUCTS IN BLOOD PRODUCTS
MERGERS AND ACQUISITIONS
TABLE 22 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL
COMPANIES
CHAPTER 6 MARKET ANALYSIS BY TYPE
MARKET BY TYPE
MARKET OVERVIEW
MARKET REVENUE
TABLE 23 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 1 GLOBAL REVENUE FOR PROTEIN DRUGS BY TYPE, 2013-2020 ($ MILLIONS)
MARKET SHARE
TABLE 24 MARKET SHARE OF PROTEIN DRUGS BY TYPE, 2014 (%)
FIGURE 2 MARKET SHARE OF PROTEIN DRUGS BY TYPE, 2014 (%)
PEPTIDE HORMONES
Market Overview
Market Revenue
TABLE 25 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 3 GLOBAL REVENUE FOR PEPTIDE HORMONES BY TYPE, 2013-2020 ($ MILLIONS)
VACCINES
Market Overview
Market Revenue
TABLE 26 GLOBAL REVENUE FOR VACCINES BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 4 GLOBAL REVENUE FOR VACCINES BY TYPE, 2013-2020 ($ MILLIONS)
THERAPEUTIC ENZYMES
Market Overview
Market Revenue
TABLE 27 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 5 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY TYPE, 2013-2020 ($ MILLIONS)
MONOCLONAL ANTIBODIES
Market Overview
Market Revenue
TABLE 28 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 6 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY TYPE, 2013-2020 ($ MILLIONS)
CYTOKINES
Market Overview
Market Revenue
TABLE 29 GLOBAL REVENUE FOR CYTOKINES BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 7 GLOBAL REVENUE FOR CYTOKINES BY TYPE, 2013-2020 ($ MILLIONS)
BLOOD FACTORS
Market Overview
Market Revenue
TABLE 30 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 8 GLOBAL REVENUE FOR BLOOD FACTORS BY TYPE, 2013-2020 ($ MILLIONS)
PEPTIDE ANTIBIOTICS
Market Overview
Market Revenue
TABLE 31 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 9 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY TYPE, 2013-2020 ($ MILLIONS)
MARKET BY REGION
MARKET OVERVIEW
MARKET REVENUE
TABLE 32 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 10 GLOBAL REVENUE FOR PROTEIN DRUGS BY REGION, 2013-2020 ($ MILLIONS)
MARKET SHARE
TABLE 33 MARKET SHARE OF PROTEIN DRUGS BY REGION, 2014 (%)
FIGURE 11 MARKET SHARE OF PROTEIN DRUGS BY REGION, 2014 (%)
PEPTIDE HORMONES
Market Overview
Market Revenue
TABLE 34 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 12 GLOBAL MARKET FOR PEPTIDE HORMONES BY REGION, 2013-2020 ($ MILLIONS)
VACCINES
Market Overview
Market Revenue
TABLE 35 GLOBAL REVENUE FOR VACCINES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 13 GLOBAL REVENUE FOR VACCINES BY REGION, 2013-2020 ($ MILLIONS)
THERAPEUTIC ENZYMES
Market Overview
Market Revenue
TABLE 36 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 14 GLOBAL MARKET FOR THERAPEUTIC ENZYMES BY REGION, 2013-2020 ($ MILLIONS)
MONOCLONAL ANTIBODIES
Market Overview
Market Revenue
TABLE 37 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 15 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY REGION, 2013-2020 ($ MILLIONS)
CYTOKINES
Market Overview
Market Revenue
TABLE 38 GLOBAL REVENUE FOR CYTOKINES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 16 GLOBAL REVENUE FOR CYTOKINES BY REGION, 2013-2020 ($ MILLIONS)
BLOOD FACTORS
Market Overview
Market Revenue
TABLE 39 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 17 GLOBAL REVENUE FOR BLOOD FACTORS BY REGION, 2013-2020 ($ MILLIONS)
PEPTIDE ANTIBIOTICS
Market Overview
Market Revenue
TABLE 40 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 18 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY REGION, 2013-2020 ($ MILLIONS)
CHAPTER 7 MARKET ANALYSIS BY MANUFACTURING PROCESS
MARKET BY MANUFACTURING PROCESS
MARKET OVERVIEW
MARKET REVENUE
TABLE 41 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 19 GLOBAL REVENUE FOR PROTEIN DRUGS BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
MARKET SHARE
TABLE 42 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014 (%)
FIGURE 20 MARKET SHARE OF PROTEIN DRUGS BY MANUFACTURING PROCESS, 2014 (%)
PEPTIDE HORMONES
Market Overview
Market Revenue
TABLE 43 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 21 GLOBAL REVENUE FOR PEPTIDE HORMONES BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
VACCINES
Market Overview
Market Revenue
TABLE 44 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 22 GLOBAL REVENUE FOR VACCINES BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
THERAPEUTIC ENZYMES
Market Overview
Market Revenue
TABLE 45 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 23 GLOBAL REVENUE FOR THERAPEUTIC ENZYMES BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
MONOCLONAL ANTIBODIES
Market Overview
Market Revenue
TABLE 46 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 24 GLOBAL REVENUE FOR MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
CYTOKINES
Market Overview
Market Revenue
TABLE 47 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 25 GLOBAL REVENUE FOR CYTOKINES BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
BLOOD FACTORS
Market Overview
Market Revenue
TABLE 48 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 26 GLOBAL REVENUE FOR BLOOD FACTORS BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
PEPTIDE ANTIBIOTICS
Market Overview
Market Revenue
TABLE 49 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING PROCESS, THROUGH 2020 ($ MILLIONS)
FIGURE 27 GLOBAL REVENUE FOR PEPTIDE ANTIBIOTICS BY MANUFACTURING PROCESS, 2013-2020 ($ MILLIONS)
CHAPTER 8 INDUSTRY STRUCTURE
PEPTIDE HORMONES
MARKET LEADERS
TABLE 50 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE HORMONES, 2014
MARKET SHARE
TABLE 51 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE HORMONES, 2014 (%)
FIGURE 28 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE HORMONES, 2014 (%)
VACCINES
MARKET LEADERS
TABLE 52 LEADING MANUFACTURERS/SUPPLIERS OF VACCINES, 2014
MARKET SHARE
TABLE 53 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014 (%)
FIGURE 29 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR VACCINES, 2014 (%)
THERAPEUTIC ENZYMES
MARKET LEADERS
TABLE 54 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC ENZYMES, 2014
MARKET SHARE
TABLE 55 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, 2014 (%)
FIGURE 30 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR THERAPEUTIC ENZYMES, 2014 (%)
MONOCLONAL ANTIBODIES
MARKET LEADERS
TABLE 56 LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODIES, 2014
MARKET SHARE
TABLE 57 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, 2014 (%)
FIGURE 31 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR MONOCLONAL ANTIBODIES, 2014 (%)
CYTOKINES
MARKET LEADERS
TABLE 58 LEADING MANUFACTURERS/SUPPLIERS OF CYTOKINES, 2014
MARKET SHARE
TABLE 59 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014 (%)
FIGURE 32 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR CYTOKINES, 2014 (%)
BLOOD FACTORS
MARKET LEADERS
TABLE 60 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC BLOOD PRODUCTS, 2014
MARKET SHARE
TABLE 61 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, 2014 (%)
FIGURE 33 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR RECOMBINANT BLOOD PRODUCTS, 2014 (%)
PEPTIDE ANTIBIOTICS
MARKET LEADERS
TABLE 62 LEADING MANUFACTURERS/SUPPLIERS OF PEPTIDE ANTIBIOTICS, 2014
MARKET SHARE
TABLE 63 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, 2014 (%)
FIGURE 34 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR PEPTIDE ANTIBIOTICS, 2014 (%)
CHAPTER 9 PATENT ANALYSIS
PATENTS BY YEAR
TABLE 64 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER 2015
FIGURE 35 NUMBER OF PATENTS BY YEAR, 2013-OCTOBER 2015
PATENTS BY TYPE
TABLE 65 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER 2015
FIGURE 36 NUMBER OF PATENTS BY TYPE, 2013-OCTOBER 2015
PATENTS BY COMPANY
TABLE 66 NUMBER OF PATENTS BY COMPANY, 2013-OCTOBER 2015
PATENTS BY COUNTRY
TABLE 67 NUMBER OF PATENTS BY COUNTRY, 2013-OCTOBER 2015
TABLE 68 PATENT SHARES BY COUNTRY, 2013-OCTOBER 2015 (%)
FIGURE 37 PATENT SHARES BY COUNTRY, 2013-OCTOBER 2015 (%)
PATENTS BY ASSIGNEE
TABLE 69 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER 2015
FIGURE 38 NUMBER OF PATENTS BY ASSIGNEE, 2013-OCTOBER 2015
CHAPTER 10 CURRENT SITUATION
FACTORS AFFECTING THE PROTEIN THERAPEUTIC MARKET
DRIVERS OF THE PROTEIN THERAPEUTIC MARKET
Prevalence of Chronic Diseases
Growing Aging Population
Advancements in Manufacturing Technologies
New Product Launches
Licensing Agreements
RESTRAINTS AND CHALLENGES OF THE MARKET
Price Controls
Regulatory Pressures
Entry of Biosimilars
Mergers and Acquisitions
CHAPTER 11 COMPANY PROFILES
ABBVIE INC.
ACTAVIS INC.
ALEXION PHARMACEUTICALS
ALLERGAN PLC
AMGEN INC
APOTEX INC.
BAXALTA INC
BAYER PHARMA AG
BIOGEN INC.
BIOMARIN PHARMACEUTICAL INC
BIOTEST PHARMACEUTICALS CORP.
BRISTOL-MYERS SQUIBB
CSL LIMITED
ELI LILLY
F. HOFFMANN-LA ROCHE AG
FRESENIUS KABI USA
GLAXOSMITHKLINE
GRIFOLS USA LLC
HOSPIRA INC
JOHNSON & JOHNSON
MEDIMMUNE LLC
MERCK & CO, INC
MERCK KGAA
MYLAN INC.
NOVARTIS AG
NOVO NORDISK AG
OCTAPHARMA AG
PFIZER INC
PROTEIN SCIENCES CORP.
rEVO BIOLOGICS INC.
SANDOZ
SANOFI INC
SEATTLE GENETICS INC.
SPECTRUM PHARMACEUTICALS INC
TAKEDA PHARMACEUTICAL U.S.A., INC
UCB COMPANY
SHIRE PLC (VIROPHARM INC.)
VERTEX PHARMACEUTICALS
CHAPTER 12 APPENDIX I - ABBREVIATIONS

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