Demand for biologics will exceed $100 billion in 2015, experiencing continuing strong growth following a decade of double-digit annual increases. Continued growth will be driven by dramatic shifts in production technology and expansion of targeted diseases, and challenged by the introduction of biosimilar products following patent expiry of major biologic products.
US Biologics Market Published:October 2011 No.Of Pages:316 Price:US $ 4900 Report Summary US demand to exceed $100 billion by 2015 Demand for biologics will exceed $100 billion in 2015, experiencing continuing strong growth following a decade of double-digit annual increases. Continued growth will be driven by dramatic shifts in production technology and expansion of targeted diseases, and challenged by the introduction of biosimilar products following patent expiry of major biologic products. Monoclonal antibodies to benefit from biotech boom Biologics such as insulin and red blood cell stimulants have been available for many years, but since the introduction of recombinant DNA technology, manufacturers have developed a wide range of new products with very specific applications. Monoclonal antibodies are a prime example of this important shift. Proteins that destroy targeted antigens can now be purified, cloned and introduced into patients to instigate immune responses. These products have quickly established themselves as effective therapies for many forms of cancer, rheumatoid arthritis, macular degeneration and other conditions. New antibodies are under intensive investigation, and will be introduced to market within the forecast period. Routine immunizations to boost vaccines demand Biologics are also being targeted for a wider range of diseases and population segments. Biologics are complex materials that must be produced by living cells, and their producers have targeted small, niche populations with rare or difficult to treat conditions. However, as the biologics market has grown and matured, many new applications are being found for these products. Vaccines, for example, were once focused on a small number of infectious diseases of early childhood. The number of recommended immunizations has grown significantly over the past decade, however, and since 2006, the Centers for Disease Control has encouraged adolescent and adult boosters and new immunizations, including one against the human papilloma virus associated with cervical cancer. Influenza shots are now recommended not only for the immunocompromised, but for all adults and young children, and investigation is well underway for vaccines that can protect against several core strains, effectively offering herd immunity against widespread pandemic infection. Several new vaccines are available or in late-stage clinical trials for use both as preventives and as therapies against several forms of cancer. Browse All Biotechnology Market Research Reports Biosimilar products offer good opportunities Impending expiry of patents for a number of biopharmaceuticals and consumer demand to reduce treatment costs are encouraging a global market for biosimilar products. Biosimilars are made by new sponsors innovating biopharmaceuticals that reference the original drug. Manufacturers will have access to the original, commercialized products, but not to the original molecular clones and cell banks, fermentation and purification processes, or active drug substances. Biosimilars are subject to careful regulation. Europe has led the global regulatory process, requiring a strict demonstration that the “similar” product is highly comparable to the original. In the US, the FDA has allowed only a few biosimilars for sale following procedures for small molecule generics, but new regulations are under development and biosimilars are expected to become a dominant force by 2020. Study coverage Details on these and other findings are contained in a new Freedonia industry study, Biologics, available for $4900. It presents historical demand data (2000, 2005, 2010) plus forecasts for 2015 and 2020 by product and application. This study also considers market environment factors, evaluates company market share and profiles US industry competitors. Table Of Contents 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 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 About Us: ReportsnReports is an online library of over 100,000+ market research reports and in-depth market research studies & analysis of over 5000 micro markets. 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