Biologics to 2015

As Quoted In Drug Discovery & Development
Study #: 2792
Document Type: Industry Study
Date Published: Sep-2011
Format:    Full study: PDF    Section, Pages, Tables and Charts: HTML
Pages: 316
Full Study Price: $4,900.00

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US demand for biologics is expected to grow 6.5 percent annually through 2015, driven by dramatic shifts in production technology and more targeted diseases such as cancer, diabetes and other serious medical conditions. Monoclonal antibodies will remain the largest category and be one of the fastest growing segments, outpaced only by hormones. This study analyzes the $74.3 billion US biologics industry. It presents historical demand data for the years 2000, 2005 and 2010, and forecasts for 2015 and 2020 by product (e.g., monoclonal antibodies, vaccines and toxoids, hormones, growth factors, immunomodulators, blood and blood products, enzymes, coagulation factors) and application (e.g., human health care, animal health, research). The study also considers market environment factors, details industry structure, evaluates company market share and profiles 44 industry competitors, including Roche, Amgen and Sanofi-Aventis.         TABLE OF CONTENTS SECTION PAGE INTRODUCTION ix I. EXECUTIVE SUMMARY 1 II. MARKET ENVIRONMENT 4 General 4 Demographic Patterns 5 Macroeconomic Outlook 9 Healthcare Trends 12 National Health Expenditures 13 Pharmaceutical Supply & Demand 17 Pharmaceutical Shipments by Therapeutic Class 18 Patient Activity 20 Medical Conditions 23 Acute Conditions 26 Chronic Conditions 26 Animal Health Industry Outlook 28 Technological Overview of Biologics 31 Recombinant DNA Biologics 32 Biosimilars 33 Regulation 36 Regulation of Human Biologic Therapies 36 Regulation of Biosimilar Products 39 Regulation of Biologics Research & Testing Products 40 Regulation of Animal Biologics 41 III. PRODUCTS 42 General 42 Demand by Type 43 Monoclonal Antibodies 46 Cancer Treatment 49 Rheumatoid Arthritis 50 Macular Degeneration 51 Psoriasis 52 Infectious Disease 53 Other Applications 53 Vaccines & Toxoids 54 Vaccines for Human Health 56 Routine Immunizations 57 Influenza 58 Therapeutic Vaccines 58 Other Vaccines 59 Animal Vaccines 60 Hormones 60 Insulin 62 Human Growth Hormone 64 Teriparatide 66 Follicle-Stimulating Hormone 66 Estrogen 67 Calcitonin 68 Thyrotropin 68 Corticotropin 69 Other Hormones 69 Growth Factors 70 Erythropoietins 72 Colony-Stimulating Factors 73 Bone Morphogenetic Proteins 74 Other Growth Factors 75 Immunomodulators 76 Immunosuppressing Agents 78 Interferons 79 Other Immunomodulators 80 Blood & Blood Products 82 Plasma & Plasma Fractions 84 Whole Blood 86 Cellular Components 86 Enzymes 90 Enzyme Replacement Therapies 91 Neuromodulators 94 Digestive Enzymes 96 Thrombolytics 98 Diagnostics 99 Other Enzymes 101 Coagulation Factors 102 Antihemophilics 103 Other Coagulation Factors 105 Other Biologics 106 IV. APPLICATIONS 109 General 109 Human Healthcare 110 Cancer 114 Autoimmune Diseases 119 Infectious Diseases 121 Blood Disorders 123 Diabetes 126 Other Conditions 128 Biologics for Other Uses 131 Animal Health 131 Research & All Other Applications 132 V. INDUSTRY STRUCTURE 134 General 134 Market Share 136 Competitive Strategies 147 Mergers & Acquisitions 149 Licensing & Related Agreements 154 Research & Development 169 Manufacturing 171 Marketing & Distribution 172 Company Profiles 174 Abbott Laboratories 175 Alere Incorporated 179 Alexion Pharmaceuticals Incorporated 181 Allergan Incorporated 182 Alnara Pharmaceuticals, see Eli Lilly American Red Cross 184 Amgen Incorporated 185 Aptalis Pharma Incorporated 191 AstraZeneca plc 192 Axcan Intermediate Holdings, see Aptalis Pharma Baxter International Incorporated 195 Bayer AG 197 BBI Enzymes, see Alere Biogen Idec Incorporated 199 BioMarin Pharmaceutical Incorporated 200 BioVex Group, see Amgen Blood Systems Incorporated 202 Bristol-Myers Squibb Company 203 Crucell, see Johnson & Johnson CSL Limited 206 EKR Therapeutics Incorporated 209 Eli Lilly & Company 210 EMD Serono, see Merck KGaA Emergent BioSolutions Incorporated 214 Enzon Pharmaceuticals, see sigma-tau Group Eurand, see Aptalis Pharma Facet Biotech, see Abbott Laboratories Genentech, see Roche Holding Genzyme, see Sanofi-Aventis GlaxoSmithKline plc 219 GSK Biologicals, see GlaxoSmithKline Halozyme Therapeutics Incorporated 225 Intercell AG 228 Inverness Medical Innovations, see Alere Ipsen 232 Johnson & Johnson 234 Lonza Group Limited 241 Lundbeck (H.) A/S 245 Massachusetts Biologic Laboratories 247 Medarex, see Bristol-Myers Squibb MedImmune, see AstraZeneca Medtronic Incorporated 248 Mentor Worldwide, see Johnson & Johnson Merck & Company Incorporated 250 Merck KGaA 257 Merial, see Sanofi-Aventis New York Blood Center 259 Novartis AG 261 Novo Nordisk A/S 268 Organon Teknika, see Merck & Company Ortho-McNeil-Janssen Pharmaceuticals, see Johnson & Johnson Ovation Pharmaceuticals, see H. Lundbeck A/S Percivia, see Johnson & Johnson Pfizer Incorporated 270 Questcor Pharmaceuticals Incorporated 277 ratiopharm, see Teva Pharmaceutical Industries Roche Holding Limited 278 Sandoz International, see Novartis Sanofi-Aventis 286 Shire plc 296 sigma-tau Group 298 Solstice Neurosciences, see US WorldMeds Solvay SA 300 Stryker Corporation 301 Teva Pharmaceutical Industries Limited 302 Theravance, see GlaxoSmithKline TL Biopharmaceutical, see Lonza Group & Teva Pharmaceutical Industries Trubion Pharmaceuticals, see Emergent BioSolutions US WorldMeds LLC 305 Ventana Medical Systems, see Roche Holding ViaCyte Incorporated 306 Vivante GMP Solutions, see Lonza Group WiCell Research Institute 307 Wisconsin International Stem Cell Bank, see WiCell Research Institute Wyeth, see Pfizer ZyStor Therapeutics, see BioMarin Pharmaceutical Other Companies Mentioned in Study 309 LIST OF TABLES TABLE NUMBER PAGE SECTION I -- EXECUTIVE SUMMARY Summary Table 3 SECTION II -- MARKET ENVIRONMENT 1 Population & Households 8 2 Macroeconomic Indicators 12 3 National Health Expenditures by Type & Source of Payment 16 4 Pharmaceutical Supply & Demand 17 5 Pharmaceutical Shipments by Therapeutic Class 20 6 Patient Activity 23 7 Medical Conditions 25 8 Animal Population & Veterinary Health Expenditures 30 SECTION III -- PRODUCTS 1 Biologics Demand by Type 45 2 Monoclonal Antibodies Demand 49 3 Vaccines Demand 56 4 Hormones Demand 62 5 Growth Factors Demand 71 6 Immunomodulators Demand 77 7 Blood & Blood Products Demand 84 8 Enzymes Demand 91 9 Coagulation Factors Demand 103 10 Other Biologics Demand 108 SECTION IV -- APPLICATIONS 1 Biologics Demand by Application 110 2 Biologics Demand for Human Healthcare by Condition & Use 112 3 Cancer Biologics Demand 115 4 Autoimmune Biologics Demand 121 5 Infectious Diseases Biologics Demand 123 6 Blood Disorders Biologics Demand 126 7 Diabetes Biologics Demand 128 8 Other Human Health Biologics Demand by Condition & Product 130 9 Biologics Demand for Other Applications 131 SECTION V -- INDUSTRY STRUCTURE 1 US Biologics Sales by Company, 2010 135 2 Selected Acquisitions & Divestitures 151 3 Selected Cooperative Agreements 156 LIST OF CHARTS CHART NUMBER PAGE SECTION III -- PRODUCTS 1 Biologics Demand by Product Type, 2010 46 SECTION IV -- APPLICATIONS 1 Human Healthcare Biologics Demand by Condition & Use, 2010 113 SECTION V -- INDUSTRY STRUCTURE 1 US Biologicals Market Share, 2010 138 Related Links Vaccines to 2014 Pet Health to 2014: Products & Services Enzymes to 2014 World In Vitro Diagnostics to 2014 Excipients to 2015 Cosmeceuticals to 2015 Click here to view PDF of study brochure in full screen.                        Biologics to 2015 $4,900.00 INTRODUCTION - BIOLOGICS TO 2015 $0.00 Methodology & Sources of Information $0.00 EXECUTIVE SUMMARY - BIOLOGICS TO 2015 $95.00 Overview $35.00 BIOLOGICS DEMAND BY TYPE (million dollars) 2005 - 2020 $60.00 MARKET ENVIRONMENT - BIOLOGICS TO 2015 $1,495.00 General $35.00 Demographic Patterns (1 of 3) $35.00 Demographic Patterns (2 of 3) $35.00 Demographic Patterns (3 of 3) $35.00 POPULATION & HOUSEHOLDS (million persons) 2000 - 2020 $60.00 Macroeconomic Outlook (1 of 3) $35.00 Macroeconomic Outlook (2 of 3) $35.00 Macroeconomic Outlook (3 of 3) $35.00 MACROECONOMIC INDICATORS (billion 2005 dollars) 2000 - 2020 $60.00 Healthcare Trends $35.00 National Health Expenditures (1 of 2) $35.00 National Health Expenditures (2 of 2) $35.00 NATIONAL HEALTH EXPENDITURES BY TYPE & SOURCE OF PAYMENT (billion dollars) 2000 - 2020 $60.00 PHARMACEUTICAL SUPPLY & DEMAND 2000 - 2020 $60.00 Pharmaceutical Shipments by Therapeutic Class $35.00 PHARMACEUTICAL SHIPMENTS BY THERAPEUTIC CLASS (billion dollars) 2000 - 2020 $60.00 Patient Activity (1 of 2) $35.00 Patient Activity (2 of 2) $35.00 PATIENT ACTIVITY (million) 2000 - 2020 $60.00 Medical Conditions - Acute & Chronic (1 of 3) $35.00 Medical Conditions - Acute & Chronic (2 of 3) $35.00 Medical Conditions - Acute & Chronic (3 of 3) $35.00 MEDICAL CONDITIONS (million) 2000 - 2020 $60.00 Animal Health Industry Outlook (1 of 2) $35.00 Animal Health Industry Outlook (2 of 2) $35.00 ANIMAL POPULATION & VETERINARY HEALTH EXPENDITURES 2000 - 2020 $60.00 Technological Overview of Biologics $35.00 Recombinant DNA Biologics $35.00 Biosimilars (1 of 3) $35.00 Biosimilars (2 of 3) $35.00 Biosimilars (3 of 3) $35.00 Regulation of Human Biologic Therapies (1 of 3) $35.00 Regulation of Human Biologic Therapies (2 of 3) $35.00 Regulation of Human Biologic Therapies (3 of 3) $35.00 Regulation of Biosimilar Products $35.00 Regulation of Biologics Research & Testing Products $35.00 Regulation of Animal Biologics $35.00 PRODUCTS - BIOLOGICS TO 2015 $2,665.00 General $35.00 Biologics - Demand by Type (1 of 2) $35.00 Biologics - Demand by Type (2 of 2) $35.00 BIOLOGICS DEMAND BY TYPE (million dollars) 2000 - 2020 $60.00 Monoclonal Antibodies - Overview (1 of 2) $35.00 Monoclonal Antibodies - Overview (2 of 2) $35.00 MONOCLONAL ANTIBODIES DEMAND (million dollars) 2000 - 2020 $60.00 Monoclonal Antibodies - Cancer Treatment $35.00 Monoclonal Antibodies - Rheumatoid Arthritis $35.00 Monoclonal Antibodies - Macular Degeneration $35.00 Monoclonal Antibodies - Psoriasis $35.00 Monoclonal Antibodies - Infectious Disease $35.00 Monoclonal Antibodies - Other Applications $35.00 Vaccines & Toxoids $35.00 VACCINES DEMAND (million dollars) 2000 - 2020 $60.00 Vaccines for Human Health (1 of 3) $35.00 Vaccines for Human Health (2 of 3) $35.00 Vaccines for Human Health (3 of 3) $35.00 Animal Vaccines $35.00 Hormones - Overview $35.00 HORMONES DEMAND (million dollars) 2000 - 2020 $60.00 Hormones - Insulin (1 of 2) $35.00 Hormones - Insulin (2 of 2) $35.00 Hormones - Human Growth Hormone (1 of 2) $35.00 Hormones - Human Growth Hormone (2 of 2) $35.00 Hormones - Teriparatide & Follicle-Stimulating Hormone $35.00 Hormones - Estrogen $35.00 Hormones - Calcitonin $35.00 Hormones - Thyrotropin & Corticotropin $35.00 Other Hormones $35.00 Growth Factors - Overview $35.00 GROWTH FACTORS DEMAND (million dollars) 2000 - 2020 $60.00 Growth Factors - Erythropoietins $35.00 Growth Factors - Colony-Stimulating Factors $35.00 Growth Factors - Bone Morphogenetic Proteins $35.00 Other Growth Factors $35.00 Immunomodulators - Overview $35.00 IMMUNOMODULATORS DEMAND (million dollars) 2000 - 2020 $60.00 Immunomodulators - Immunosuppressing Agents $35.00 Immunomodulators - Interferons $35.00 Other Immunomodulators $35.00 Blood & Blood Products - Overview (1 of 2) $35.00 Blood & Blood Products - Overview (2 of 2) $35.00 BLOOD & BLOOD PRODUCTS DEMAND (million dollars) 2000 - 2020 $60.00 Blood & Blood Products - Plasma & Plasma Fractions (1 of 2) $35.00 Blood & Blood Products - Plasma & Plasma Fractions (2 of 2) $35.00 Blood & Blood Products - Whole Blood & Cellular Components (1 of 3) $35.00 Blood & Blood Products - Whole Blood & Cellular Components (2 of 3) $35.00 Blood & Blood Products - Whole Blood & Cellular Components (3 of 3) $35.00 Enzymes - Overview $35.00 ENZYMES DEMAND (million dollars) 2000 - 2020 $60.00 Enzyme Replacement Therapies (1 of 3) $35.00 Enzyme Replacement Therapies (2 of 3) $35.00 Enzyme Replacement Therapies (3 of 3) $35.00 Enzymes - Neuromodulators (1 of 2) $35.00 Enzymes - Neuromodulators (2 of 2) $35.00 Digestive Enzymes (1 of 2) $35.00 Digestive Enzymes (2 of 2) $35.00 Enzymes - Thrombolytics $35.00 Enzymes - Diagnostics $35.00 Other Enzymes $35.00 Coagulation Factors - Overview $35.00 COAGULATION FACTORS DEMAND (million dollars) 2000 - 2020 $60.00 Coagulation Factors - Antihemophilics (1 of 2) $35.00 Coagulation Factors - Antihemophilics (2 of 2) $35.00 Other Coagulation Factors $35.00 Other Biologics (1 of 2) $35.00 Other Biologics (2 of 2) $35.00 OTHER BIOLOGICS DEMAND (million dollars) 2000 - 2020 $60.00 APPLICATIONS - BIOLOGICS TO 2015 $1,220.00 Overview $35.00 BIOLOGICS DEMAND BY APPLICATION (million dollars) 2000 - 2020 $60.00 Human Healthcare Applications for Biologics $35.00 BIOLOGICS DEMAND FOR HUMAN HEALTHCARE BY CONDITION (million dollars) 2000 - 2020 $60.00 BIOLOGICS DEMAND FOR HUMAN HEALTHCARE BY USE (million dollars) 2000 - 2020 $60.00 Cancer - Biologics Demand (1 of 4) $35.00 Cancer - Biologics Demand (2 of 4) $35.00 Cancer - Biologics Demand (3 of 4) $35.00 Cancer - Biologics Demand (4 of 4) $35.00 CANCER BIOLOGICS DEMAND (million dollars) 2000 - 2020 $60.00 Autoimmune Diseases - Biologics Demand $35.00 AUTOIMMUNE BIOLOGICS DEMAND (million dollars) 2000 - 2020 $60.00 Infectious Diseases - Biologics Demand (1 of 2) $35.00 Infectious Diseases - Biologics Demand (2 of 2) $35.00 INFECTIOUS DISEASES BIOLOGICS DEMAND (million dollars) 2000 - 2020 $60.00 Blood Disorders - Biologics Demand (1 of 2) $35.00 Blood Disorders - Biologics Demand (2 of 2) $35.00 BLOOD DISORDERS BIOLOGICS DEMAND (million dollars) 2000 - 2020 $60.00 Diabetes - Biologics Demand $35.00 DIABETES BIOLOGICS DEMAND (million dollars) 2000 - 2020 $60.00 Other Conditions - Biologics Demand (1 of 2) $35.00 Other Conditions - Biologics Demand (2 of 2) $35.00 OTHER HUMAN HEALTH BIOLOGICS DEMAND BY CONDITION (million dollars) 2000 - 2020 $60.00 OTHER HUMAN HEALTH BIOLOGICS DEMAND BY PRODUCT (million dollars) 2000 - 2020 $60.00 BIOLOGICS DEMAND FOR OTHER APPLICATIONS (million dollars) 2000 - 2020 $60.00 Animal Health - Biologics Demand $35.00 Research & All Other Applications - Biologics Demand $35.00 INDUSTRY STRUCTURE - BIOLOGICS TO 2015 $1,025.00 General $35.00 US BIOLOGICS SALES BY COMPANY, 2010 (million dollars) $60.00 Market Share (1 of 2) $35.00 Market Share (2 of 2) $35.00 US BIOLOGICS MARKET SHARE BY TOP COMPANIES, 2010 (percent) $60.00 Market Leaders (1 of 8) $35.00 Market Leaders (2 of 8) $35.00 Market Leaders (3 of 8) $35.00 Market Leaders (4 of 8) $35.00 Market Leaders (5 of 8) $35.00 Market Leaders (6 of 8) $35.00 Market Leaders (7 of 8) $35.00 Market Leaders (8 of 8) $35.00 Competitive Strategies $35.00 Mergers & Acquisitions (1 of 2) $35.00 Mergers & Acquisitions (2 of 2) $35.00 SELECTED ACQUISITIONS & DIVESTITURES $60.00 Licensing & Related Agreements (1 of 2) $35.00 Licensing & Related Agreements (2 of 2) $35.00 SELECTED COOPERATIVE AGREEMENTS (1 of 3) $60.00 SELECTED COOPERATIVE AGREEMENTS (2 of 3) $60.00 SELECTED COOPERATIVE AGREEMENTS (3 of 3) $60.00 Research & Development $35.00 Manufacturing $35.00 Marketing & Distribution $35.00 COMPANY PROFILES - BIOLOGICS TO 2015 $2,800.00 Company Profiles Methodology $35.00 Abbott Laboratories (Facet Biotech) (1 of 2) $35.00 Abbott Laboratories (Facet Biotech) (2 of 2) $35.00 Alere Incorporated (BBI Enzymes) (Inverness Medical) $35.00 Alexion Pharmaceuticals $35.00 Allergan Incorporated $35.00 American Red Cross $35.00 Amgen Incorporated (BioVex) (1 of 3) $35.00 Amgen Incorporated (BioVex) (2 of 3) $35.00 Amgen Incorporated (BioVex) (3 of 3) $35.00 Aptalis Pharma (Axcan) (Eurand) $35.00 AstraZeneca plc (MedImmune) $35.00 Baxter International $35.00 Bayer AG $35.00 Biogen Idec $35.00 BioMarin Pharmaceutical (ZyStor Therapeutics) $35.00 Blood Systems $35.00 Bristol-Myers Squibb Company (Medarex) $35.00 CSL Limited (1 of 2) $35.00 CSL Limited (2 of 2) $35.00 EKR Therapeutics $35.00 Eli Lilly & Company (Alnara Pharmaceuticals) (1 of 2) $35.00 Eli Lilly & Company (Alnara Pharmaceuticals) (2 of 2) $35.00 Emergent BioSolutions (Trubion Pharmaceuticals) (1 of 3) $35.00 Emergent BioSolutions (Trubion Pharmaceuticals) (2 of 3) $35.00 Emergent BioSolutions (Trubion Pharmaceuticals) (3 of 3) $35.00 GlaxoSmithKline plc (Theravance) (GSK Biologicals) (1 of 3) $35.00 GlaxoSmithKline plc (Theravance) (GSK Biologicals) (2 of 3) $35.00 GlaxoSmithKline plc (Theravance) (GSK Biologicals) (3 of 3) $35.00 Halozyme Therapeutics (1 of 2) $35.00 Halozyme Therapeutics (2 of 2) $35.00 Intercell AG (1 of 2) $35.00 Intercell AG (2 of 2) $35.00 Ipsen (Tercica) $35.00 Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (1 of 4) $35.00 Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (2 of 4) $35.00 Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (3 of 4) $35.00 Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (4 of 4) $35.00 Lonza Group (Vivante GMP) (TL Biopharmaceutical) (1 of 2) $35.00 Lonza Group (Vivante GMP) (TL Biopharmaceutical) (2 of 2) $35.00 Lundbeck (H.) A/S (Ovation Pharmaceuticals) $35.00 Massachusetts Biologic Laboratories $35.00 Medtronic Incorporated $35.00 Merck & Company (Organon Teknika) (1 of 4) $35.00 Merck & Company (Organon Teknika) (2 of 4) $35.00 Merck & Company (Organon Teknika) (3 of 4) $35.00 Merck & Company (Organon Teknika) (4 of 4) $35.00 Merck KGaA (EMD Serono) $35.00 New York Blood Center $35.00 Novartis AG (Sandoz) (1 of 4) $35.00 Novartis AG (Sandoz) (2 of 4) $35.00 Novartis AG (Sandoz) (3 of 4) $35.00 Novartis AG (Sandoz) (4 of 4) $35.00 Novo Nordisk $35.00 Pfizer Incorporated (Wyeth) (1 of 4) $35.00 Pfizer Incorporated (Wyeth) (2 of 4) $35.00 Pfizer Incorporated (Wyeth) (3 of 4) $35.00 Pfizer Incorporated (Wyeth) (4 of 4) $35.00 Questcor Pharmaceuticals $35.00 Roche Holding (Ventana) (Genentech) (1 of 5) $35.00 Roche Holding (Ventana) (Genentech) (2 of 5) $35.00 Roche Holding (Ventana) (Genentech) (3 of 5) $35.00 Roche Holding (Ventana) (Genentech) (4 of 5) $35.00 Roche Holding (Ventana) (Genentech) (5 of 5) $35.00 Sanofi-Aventis (Merial) (Genzyme) (1 of 6) $35.00 Sanofi-Aventis (Merial) (Genzyme) (2 of 6) $35.00 Sanofi-Aventis (Merial) (Genzyme) (3 of 6) $35.00 Sanofi-Aventis (Merial) (Genzyme) (4 of 6) $35.00 Sanofi-Aventis (Merial) (Genzyme) (5 of 6) $35.00 Sanofi-Aventis (Merial) (Genzyme) (6 of 6) $35.00 Shire plc $35.00 sigma-tau Group (Enzon Pharmaceuticals) $35.00 Solvay SA $35.00 Stryker Corporation $35.00 Teva Pharmaceutical Industries (ratiopharm) (TL Biopharmaceutical) $35.00 US WorldMeds (Solstice Neurosciences) $35.00 ViaCyte Incorporated $35.00 WiCell Research Institute (Wisconsin International Stem Cell Bank) $35.00 Other Companies Mentioned in Study (1 of 2) $35.00 Other Companies Mentioned in Study (2 of 2) $35.00