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Protein Drugs: Global Markets and Manufacturing Technologies

BCC Research
October 1, 2008
154 Pages - SKU: WA1926713

Abstract Table of Contents Related Reports

Countries covered: Global

STUDY GOALS AND OBJECTIVES

Protein drugs have received enormous attention from pharmaceutical companies due to a combination of their bioreactivity, specificity, safety and overall success rate. Yet there are still improvements to be made, especially with respect to their formulation and delivery method. Advances in protein drug delivery are certain to increase patient compliance and expand many drug markets.

REASONS FOR DOING THE STUDY

Although the drug development industry still focuses primarily on small molecules, in recent years protein and peptide therapeutics comprise a significant percent of the product line and pipeline for most major pharmaceutical companies. Peptide and protein therapeutics, especially antibody drugs, are attractive due to their high specificity and potency and low incidence of toxicity. Developments in manufacturing, including transgenic, recombinant and synthetic methods, have been key as protein drugs have moved into the mainstream. A previous report by BCC, Protein Drugs in 2003, discussed the early days of these manufacturing improvements and focused on emerging recombinant methods of protein production.

Recombinant protein technologies are now standard and the current focus has shifted from the method of bulk production to post-production techniques that promise to enhance stability and delivery. In the effort to produce orally available therapeutics, formulation issues have become critical.

CHAPTER ONE: INTRODUCTION: STUDY GOALS AND OBJECTIVES; REASONS FOR DOING THE STUDY; SCOPE OF REPORT; INTENDED AUDIENCE; INFORMATION SOURCES; ANALYST CREDENTIALS; RELATED REPORTS; BCC ONLINE SERVICES; DISCLAIMER
CHAPTER TWO: SUMMARY: SUMMARY TABLE GLOBAL MARKET FOR PROTEIN THERAPEUTICS, THROUGH 2013 ($ MILLIONS); SUMMARY TABLE (CONTINUED); SUMMARY FIGURE GLOBAL MARKET FOR PROTEIN THERAPEUTICS, 2007-2013 ($ MILLIONS)
CHAPTER THREE: OVERVIEW: DEFINING THE TERMS: PROTEINS AND PEPTIDES; PROTEIN DRUGS: THEN AND NOW; DRUG ADMINISTRATION: MILESTONES AND CHALLENGES; PEGYLATION; PEPTIDE-MEDIATED RECEPTOR TARGETING; PATIENT COMPLIANCE; Patient Compliance (Continued)
CHAPTER FOUR: MARKETS BY PRODUCTS: ANTIBODY DRUGS; PRODUCTION OF ANTIBODIES FOR THERAPY; Murine Monoclonal Antibodies; Chimeric and Humanized Monoclonal Antibodies; Human Monoclonal Antibodies; Antibody-directed Enzyme Prodrug Therapy (ADEPT); HOW ANTIBODY DRUGS WORK; How Antibody Drugs Work (Continued); THE ANTIBODY DRUG MARKET; CHANGES IN A DYNAMIC MARKET; Possible new indications for Campath; EGF-R Antibodies: Still Investigational Therapies; Side Effects Could Affect Tysabri’s Future; CYTOKINES; THE CYTOKINE MARKET; Granulocyte-colony Stimulating Factors; Interferon â; Interferon á; Interferon ã; Interleukins; PEPTIDE HORMONES; VACCINES; KINDS OF VACCINES; Killed Whole Organisms; Attenuated Organisms; Toxoids; Surface Proteins; Inactivated Virus; Attenuated Virus; THE GLOBAL PROTEIN VACCINE MARKET; BLOOD PRODUCTS; WHAT DRIVES DEMAND FOR BLOOD PRODUCTS; THE GLOBAL MARKET FOR BLOOD PRODUCTS; Recombinant Albumin; Factor VIII; Factor IX; Hemoglobin; Second Generation Hemoglobins in Development; Protein C; PEPTIDE ANTIBIOTICS; TYPES OF PEPTIDE ANTIBIOTICS; THE RESISTANCE PROBLEM; THERAPEUTIC ENZYMES; Glucocerebrosidase; Tissue Plasminogen Activator; Pancreatin; Thrombin
CHAPTER FIVE: MANUFACTURING TECHNOLOGY: NATURAL SOURCING AND EXTRACTION; HUMAN SOURCING; SPECIAL FEATURES OF HUMAN-SOURCING MANUFACTURE; SPECIAL FEATURES OF ANIMAL SOURCING MANUFACTURE; MICROBIAL FERMENTATION; MAMMALIAN CELL CULTURE; BIOREACTORS; Bioreactors (Continued); OTHER CELL CULTURE SYSTEMS: INSECT CELLS; TRANSGENICS: PLANTS AND ANIMALS; TRANSGENIC PLANTS PHARMING; TRANSGENIC ANIMALS; Founder Animal Production; History in the Making: the First Transgenic Drugs; On the Horizon: Gene Therapy with Transgenics?; CHEMICAL SYNTHESIS; HOW IT WORKS; COST AND SCALING- UP
CHAPTER SIX: TECHNOLOGY: MANUFACTURING, PROCESSING AND FORMULATION; PROCESSING AND DOWNSTREAM; PROTEIN AGGREGATION HAS CLINICAL RAMIFICATIONS; FOCUS ON FORMULATION; FREEZE-THAW; Challenges in the Freezing Process; Thawing; Freeze-Thaw Technologies; FORMULATION STEP; Formulation Step (Continued); FILTRATION; DRUG PRODUCT FILLING; LYOPHILIZATION; Lyophilization (Continued); Lyophilization (Continued); INSPECTION AND PACKAGING; DRUG STORAGE, TRANSPORT AND DELIVERY; Protein-Silicone Oil Interactions; Leachables and Extractables; TRANSPORTATION; PHOTOSTABILITY
CHAPTER SEVEN: PATENT ANALYSIS: PATENTS BY PRODUCT TYPE; PATENTS BY REGION; IMPORTANT PATENT ISSUES FOR FOLLOW-ON BIOLOGICS; PATENTS OF INTEREST IN THE PROTEIN DRUGS FIELD; TREATMENTS USING TRANSGENIC GOAT PRODUCED ANTITHROMBIN III; HIGHLY PHOSPHORYLATED AND SULFATED RECOMBINANT FACTOR IX; HEPATITIS C RECEPTOR PROTEIN CD81; PURIFICATION OF POLYPEPTIDES; Purification of Polypeptides (Continued)
CHAPTER EIGHT: INTERNATIONAL ASPECTS: UNITED STATES; WESTERN EUROPE; JAPAN; CHINA
CHAPTER NINE: MARKET SHARE
CHAPTER TEN: COMPANY PROFILES: ABBOTT LABORATORIES; AEGIS THERAPEUTICS; ALEXION PHARMACEUTICALS; AMGEN; BAYER DIAGNOSTICS; BIOGEN IDEC, INC; CENTOCOR; ELI LILLY & CO; GENENTECH, INC.; GENZYME CORP.; JOHNSON & JOHNSON INC.; MEDIMMUNE, INC.; MEDAREX; MERCK & CO., INC.; MERCK SERONO; NOVARTIS PHARMA AG; NOVO NORDISK A/S; NOVO NORDISK A/S (CONTINUED); ROCHE HOLDINGS, LTD.; SANGART; SANOFI-AVENTIS; UNIGENE LABORATORIES, INC; UNIGENE LABORATORIES, INC. (CONTINUED); VACCINOGEN INC; WYETH; WYETH (CONTINUED); TABLE 50 WYETH’ PROTEIN DRUGS
APPENDIX: WEB RESOURCES FOR PROTEIN DRUG DESIGN: THE NATIONAL CANCER INSTITUTE 3D STRUCTURE DATABASE; KIBANK; COMBINATORIAL CHEMISTRY REVIEW; GDB: STRUCTURES
LIST OF TABLES: SUMMARY TABLE GLOBAL MARKET FOR PROTEIN THERAPEUTICS, THROUGH 2013 ($ MILLIONS); TABLE 1 NEW DRUGS ENTERING CLINICAL TRIALS, BY TYPE, 2007; TABLE 2 GLOBAL SIZE OF PROTEIN DRUGS MARKET BY PRODUCTS, THROUGH 2013 ($ MILLIONS); TABLE 3 FDA-APPROVED MONOCLONAL ANTIBODIES, 2008; TABLE 4 GLOBAL MARKET FORECAST FOR ANTIBODY DRUG PRODUCTS, THROUGH 2013 ($ MILLIONS); TABLE 5 FDA-APPROVED MONOCLONAL ANTIBODIES FOR CANCER TREATMENT, 2008; TABLE 6 GLOBAL MARKET FORECAST FOR CYTOKINE PRODUCTS, THROUGH 2013 ($ MILLIONS); TABLE 7 GLOBAL MARKET FORECAST FOR PEPTIDE HORMONES, THROUGH 2013 ($ MILLIONS); TABLE 8 VACCINE PREPARATIONS, BY DISEASE; TABLE 9 VACCINE-PREVENTABLE DISEASE IN THE U.S., PRE- AND POST- VACCINATION PROGRAMS; TABLE 10 GLOBAL MARKET FORECAST FOR VACCINES, THROUGH 2013 ($ MILLIONS); TABLE 11 NEW AND EMERGING VACCINE PRODUCTS; TABLE 12 GLOBAL MARKET FORECAST FOR BLOOD PRODUCTS, THROUGH 2013 ($ MILLIONS); TABLE 13 COMPANIES INVOLVED IN FACTOR VIII DEVELOPMENT; TABLE 14 COMPANIES INVOLVED IN RECOMBINANT HEMOGLOBIN MANUFACTURE; TABLE 15 GLOBAL MARKET FORECAST FOR PEPTIDE ANTIBIOTICS, THROUGH 2013; TABLE 16 GLOBAL MARKET FORECAST FOR THERAPEUTIC ENZYMES, THROUGH 2013; TABLE 17 PROTEIN DRUGS MADE BY HUMAN-SOURCE EXTRACTION; TABLE 18 PROTEIN DRUGS MADE BY NATURAL ANIMAL-SOURCE EXTRACTION; TABLE 19 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION, BY PRODUCT, THROUGH 2013 ($ MILLIONS); TABLE 20 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY PRODUCT, THROUGH 2013 ($ MILLIONS); TABLE 21 TYPES OF BIOREACTORS; TABLE 22 PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, BY PRODUCT, THROUGH 2013 ($ MILLIONS); TABLE 23 TRANSGENIC PLANT PHARMACEUTICALS UNDER DEVELOPMENT; TABLE 24 PROTEIN DRUGS MANUFACTURED BY TRANSGENICS, BY PRODUCT, THROUGH 2013 ($ MILLIONS); TABLE 25 PROTEIN DRUGS DERIVED FROM TRANSGENIC ANIMALS, 2008; TABLE 26 PEPTIDE PHARMACEUTICALS MANUFACTURED BY CHEMICAL SYNTHESIS; TABLE 27 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT TYPE, THROUGH 2013 ($ MILLIONS); TABLE 28 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY TECHNOLOGY, AUGUST 2005 TO AUGUST 2008; TABLE 29 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY REGION, AUGUST 2005 TO AUGUST 2008; TABLE 30 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY TECHNOLOGY, AUGUST 2005 TO AUGUST 2008; TABLE 31 GLOBAL PROTEIN THERAPEUTIC MARKET PRODUCTION BY REGION, 2008 ($ MILLIONS); TABLE 32 MARKET SHARE OF COMPANIES INVOLVED IN ANTIBODY DRUGS, 2008 (UNIT, %); TABLE 33 MARKET SHARE OF COMPANIES INVOLVED IN CYTOKINES, 2008 (UNIT, %); TABLE 34 MARKET SHARE OF COMPANIES INVOLVED IN PEPTIDE HORMONES, 2008 (UNIT, %); TABLE 35 MARKET SHARE OF COMPANIES INVOLVED IN VACCINES, 2008 (UNIT, %); TABLE 36 MARKET SHARE OF COMPANIES INVOLVED IN BLOOD PRODUCTS, 2008 (UNIT, %); TABLE 37 MARKET SHARE OF COMPANIES INVOLVED PEPTIDE ANTIBIOTICS, 2008 (UNIT, %); TABLE 38 MARKET SHARE OF COMPANIES INVOLVED ENZYMES, 2008 (UNIT, %); TABLE 39 ABBOTT LABS PROTEIN DRUGS; TABLE 40 AMGEN’S PROTEIN DRUGS; TABLE 41 BIOGEN IDEC’S PROTEIN DRUGS; TABLE 42 LILLY’S PROTEIN DRUGS; TABLE 43 GENENTECH’S PROTEIN DRUGS; TABLE 44 GENZYME CORPORATION PROTEIN DRUGS; TABLE 45 MEDAREX’S PIPELINE PROTEIN DRUGS; TABLE 46 MERCK’S PROTEIN DRUGS; TABLE 47 MERCK-SERONO’S PROTEIN DRUGS; TABLE 48 NOVARTIS’ PROTEIN DRUGS; TABLE 49 ROCHE’S PROTEIN DRUGS; TABLE 50 WYETH’ PROTEIN DRUGS
LIST OF FIGURES: SUMMARY FIGURE GLOBAL MARKET FOR PROTEIN THERAPEUTICS, 2007-2013 ($ MILLIONS); FIGURE 1 GLOBAL SIZE OF PROTEIN DRUGS MARKET BY PRODUCTS, 2008 AND 2013 ($ MILLIONS); FIGURE 2 GLOBAL SHARE OF PROTEIN DRUGS MARKET BY PRODUCT, 2008 (%); FIGURE 3 GLOBAL SHARE OF PROTEIN DRUGS MARKET BY PRODUCT, 2013 (%); FIGURE 4 GLOBAL MARKET FOR ANTIBODY DRUGS, 2008 (%); FIGURE 5 GLOBAL MARKET FOR ANTIBODY DRUGS, 2013 (%); FIGURE 6 GLOBAL MARKET FOR CYTOKINE DRUGS, 2008 (%); FIGURE 7 FORECAST GLOBAL MARKET FOR CYTOKINE DRUGS, 2013 (%); FIGURE 8 GLOBAL MARKET FORECAST FOR PEPTIDE HORMONES, 2008 AND 2013 ($ MILLIONS); FIGURE 9 GLOBAL MARKET FORECAST FOR PEPTIDE HORMONES, 2008 (%); FIGURE 10 GLOBAL MARKET FORECAST FOR VACCINES, 2008 AND 2013 ($ MILLIONS); FIGURE 11 GLOBAL MARKET FORECAST FOR BLOOD PRODUCTS, 2008 AND 2013 ($ MILLIONS); FIGURE 12 GLOBAL MARKET FOR BLOOD PRODUCTS, 2008 (%); FIGURE 13 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION, BY PRODUCT, 2008 AND 2013 ($ MILLIONS); FIGURE 14 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION, BY PRODUCT 2008 (%); FIGURE 15 PROTEIN DRUGS MANUFACTURED BY NATURAL SOURCING AND EXTRACTION, BY PRODUCT, 2013 (%); FIGURE 16 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY PRODUCT, 2008 AND 2013 ($ MILLIONS); FIGURE 17 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY PRODUCT, 2008 (%); FIGURE 18 PROTEIN DRUGS MANUFACTURED BY MICROBIAL FERMENTATION, BY PRODUCT, 2013 (%); FIGURE 19 PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, BY PRODUCT, 2008 AND 2013 ($ MILLIONS); FIGURE 20 PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, 2008 (%); FIGURE 21 PROJECTED PROTEIN DRUGS MANUFACTURED BY CELL CULTURE, 2013 (%); FIGURE 22 PROTEIN DRUGS MANUFACTURED BY TRANSGENICS, BY PRODUCT, THROUGH 2013; FIGURE 23 PROTEIN DRUGS MANUFACTURED BY TRANSGENICS, BY PRODUCT, 2013 (%); FIGURE 24 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT TYPE, THROUGH 2013 ($ MILLIONS); FIGURE 25 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT TYPE, 2008; FIGURE 26 PROTEIN DRUGS MANUFACTURED BY CHEMICAL SYNTHESIS, BY PRODUCT TYPE, 2013; FIGURE 27 MANUFACTURING PROCESS FLOW CHART; FIGURE 28 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY PRODUCT, AUGUST 2005 TO AUGUST 2008; FIGURE 29 PROTEIN PHARMACEUTICALS, ISSUED PATENTS BY TECHNOLOGY, AUGUST 2005 TO AUGUST 2008 (%)

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Protein Drugs: Global Markets and Manufacturing Technologies

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