Us biologics market


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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.

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Us biologics market

  1. 1. US Biologics MarketPublished:October 2011No.Of Pages:316Price:US $ 4900Report SummaryUS demand to exceed $100 billion by 2015Demand for biologics will exceed $100 billion in 2015, experiencingcontinuing strong growth following a decade of double-digit annualincreases. Continued growth will be driven by dramatic shifts in productiontechnology and expansion of targeted diseases, and challenged by theintroduction of biosimilar products following patent expiry of major biologicproducts.Monoclonal antibodies to benefit from biotech boomBiologics such as insulin and red blood cell stimulants have been availablefor many years, but since the introduction of recombinant DNA technology,manufacturers have developed a wide range of new products with veryspecific applications. Monoclonal antibodies are a prime example of thisimportant shift. Proteins that destroy targeted antigens can now be purified,cloned and introduced into patients to instigate immune responses. Theseproducts have quickly established themselves as effective therapies formany forms of cancer, rheumatoid arthritis, macular degeneration and otherconditions. New antibodies are under intensive investigation, and will beintroduced to market within the forecast period.Routine immunizations to boost vaccines demandBiologics are also being targeted for a wider range of diseases andpopulation segments. Biologics are complex materials that must be producedby living cells, and their producers have targeted small, niche populationswith rare or difficult to treat conditions. However, as the biologics markethas grown and matured, many new applications are being found for theseproducts. Vaccines, for example, were once focused on a small number ofinfectious diseases of early childhood. The number of recommendedimmunizations has grown significantly over the past decade, however, andsince 2006, the Centers for Disease Control has encouraged adolescent and
  2. 2. adult boosters and new immunizations, including one against the humanpapilloma virus associated with cervical cancer. Influenza shots are nowrecommended not only for the immunocompromised, but for all adults andyoung children, and investigation is well underway for vaccines that canprotect against several core strains, effectively offering herd immunityagainst widespread pandemic infection. Several new vaccines are availableor in late-stage clinical trials for use both as preventives and as therapiesagainst several forms of cancer.Browse All Biotechnology Market Research ReportsBiosimilar products offer good opportunitiesImpending expiry of patents for a number of biopharmaceuticals andconsumer demand to reduce treatment costs are encouraging a globalmarket for biosimilar products. Biosimilars are made by new sponsorsinnovating biopharmaceuticals that reference the original drug.Manufacturers will have access to the original, commercialized products, butnot to the original molecular clones and cell banks, fermentation andpurification processes, or active drug substances. Biosimilars are subject tocareful regulation. Europe has led the global regulatory process, requiring astrict demonstration that the “similar” product is highly comparable to theoriginal. In the US, the FDA has allowed only a few biosimilars for salefollowing procedures for small molecule generics, but new regulations areunder development and biosimilars are expected to become a dominantforce by 2020.Study coverageDetails on these and other findings are contained in a new Freedoniaindustry study, Biologics, available for $4900. It presents historical demanddata (2000, 2005, 2010) plus forecasts for 2015 and 2020 by product andapplication. This study also considers market environment factors, evaluatescompany market share and profiles US industry competitors.Table Of ContentsINTRODUCTION ixI. EXECUTIVE SUMMARY 1II. MARKET ENVIRONMENT 4General 4
  3. 3. Demographic Patterns 5Macroeconomic Outlook 9Healthcare Trends 12National Health Expenditures 13Pharmaceutical Supply & Demand 17Pharmaceutical Shipments by Therapeutic Class 18Patient Activity 20Medical Conditions 23Acute Conditions 26Chronic Conditions 26Animal Health Industry Outlook 28Technological Overview of Biologics 31Recombinant DNA Biologics 32Biosimilars 33Regulation 36Regulation of Human Biologic Therapies 36Regulation of Biosimilar Products 39Regulation of Biologics Research & Testing Products 40Regulation of Animal Biologics 41III. PRODUCTS 42General 42Demand by Type 43Monoclonal Antibodies 46Cancer Treatment 49Rheumatoid Arthritis 50Macular Degeneration 51Psoriasis 52Infectious Disease 53Other Applications 53Vaccines & Toxoids 54Vaccines for Human Health 56Routine Immunizations 57Influenza 58Therapeutic Vaccines 58Other Vaccines 59Animal Vaccines 60Hormones 60Insulin 62Human Growth Hormone 64Teriparatide 66Follicle-Stimulating Hormone 66Estrogen 67
  4. 4. Calcitonin 68Thyrotropin 68Corticotropin 69Other Hormones 69Growth Factors 70Erythropoietins 72Colony-Stimulating Factors 73Bone Morphogenetic Proteins 74Other Growth Factors 75Immunomodulators 76Immunosuppressing Agents 78Interferons 79Other Immunomodulators 80Blood & Blood Products 82Plasma & Plasma Fractions 84Whole Blood 86Cellular Components 86Enzymes 90Enzyme Replacement Therapies 91Neuromodulators 94Digestive Enzymes 96Thrombolytics 98Diagnostics 99Other Enzymes 101Coagulation Factors 102Antihemophilics 103Other Coagulation Factors 105Other Biologics 106IV. APPLICATIONS 109General 109Human Healthcare 110Cancer 114Autoimmune Diseases 119Infectious Diseases 121Blood Disorders 123Diabetes 126Other Conditions 128Biologics for Other Uses 131Animal Health 131Research & All Other Applications 132
  5. 5. V. INDUSTRY STRUCTURE 134General 134Market Share 136Competitive Strategies 147Mergers & Acquisitions 149Licensing & Related Agreements 154Research & Development 169Manufacturing 171Marketing & Distribution 172Company Profiles 174Abbott Laboratories 175Alere Incorporated 179Alexion Pharmaceuticals Incorporated 181Allergan Incorporated 182Alnara Pharmaceuticals, see Eli LillyAmerican Red Cross 184Amgen Incorporated 185Aptalis Pharma Incorporated 191AstraZeneca plc 192Axcan Intermediate Holdings, see Aptalis PharmaBaxter International Incorporated 195Bayer AG 197BBI Enzymes, see AlereBiogen Idec Incorporated 199BioMarin Pharmaceutical Incorporated 200BioVex Group, see AmgenBlood Systems Incorporated 202Bristol-Myers Squibb Company 203Crucell, see Johnson & JohnsonCSL Limited 206EKR Therapeutics Incorporated 209Eli Lilly & Company 210EMD Serono, see Merck KGaAEmergent BioSolutions Incorporated 214Enzon Pharmaceuticals, see sigma-tau GroupEurand, see Aptalis PharmaFacet Biotech, see Abbott LaboratoriesGenentech, see Roche HoldingGenzyme, see Sanofi-AventisGlaxoSmithKline plc 219GSK Biologicals, see GlaxoSmithKlineHalozyme Therapeutics Incorporated 225Intercell AG 228
  6. 6. Inverness Medical Innovations, see AlereIpsen 232Johnson & Johnson 234Lonza Group Limited 241Lundbeck (H.) A/S 245Massachusetts Biologic Laboratories 247Medarex, see Bristol-Myers SquibbMedImmune, see AstraZenecaMedtronic Incorporated 248Mentor Worldwide, see Johnson & JohnsonMerck & Company Incorporated 250Merck KGaA 257Merial, see Sanofi-AventisNew York Blood Center 259Novartis AG 261Novo Nordisk A/S 268Organon Teknika, see Merck & CompanyOrtho-McNeil-Janssen Pharmaceuticals, see Johnson &JohnsonOvation Pharmaceuticals, see H. Lundbeck A/SPercivia, see Johnson & JohnsonPfizer Incorporated 270Questcor Pharmaceuticals Incorporated 277ratiopharm, see Teva Pharmaceutical IndustriesRoche Holding Limited 278Sandoz International, see NovartisSanofi-Aventis 286Shire plc 296sigma-tau Group 298Solstice Neurosciences, see US WorldMedsSolvay SA 300Stryker Corporation 301Teva Pharmaceutical Industries Limited 302Theravance, see GlaxoSmithKlineTL Biopharmaceutical, see Lonza Group & TevaPharmaceutical IndustriesTrubion Pharmaceuticals, see Emergent BioSolutionsUS WorldMeds LLC 305Ventana Medical Systems, see Roche HoldingViaCyte Incorporated 306Vivante GMP Solutions, see Lonza GroupWiCell Research Institute 307Wisconsin International Stem Cell Bank, see WiCell
  7. 7. Research InstituteWyeth, see PfizerZyStor Therapeutics, see BioMarin PharmaceuticalOther Companies Mentioned in Study 309List Of TablesSECTION I -- EXECUTIVE SUMMARYSummary Table 3SECTION II -- MARKET ENVIRONMENT1 Population & Households 82 Macroeconomic Indicators 123 National Health Expenditures by Type & Source of Payment 164 Pharmaceutical Supply & Demand 175 Pharmaceutical Shipments by Therapeutic Class 206 Patient Activity 237 Medical Conditions 258 Animal Population & Veterinary Health Expenditures 30SECTION III -- PRODUCTS1 Biologics Demand by Type 452 Monoclonal Antibodies Demand 493 Vaccines Demand 564 Hormones Demand 625 Growth Factors Demand 716 Immunomodulators Demand 777 Blood & Blood Products Demand 848 Enzymes Demand 919 Coagulation Factors Demand 10310 Other Biologics Demand 108SECTION IV -- APPLICATIONS1 Biologics Demand by Application 1102 Biologics Demand for Human Healthcare by Condition & Use 1123 Cancer Biologics Demand 1154 Autoimmune Biologics Demand 1215 Infectious Diseases Biologics Demand 1236 Blood Disorders Biologics Demand 1267 Diabetes Biologics Demand 1288 Other Human Health Biologics Demandby Condition & Product 1309 Biologics Demand for Other Applications 131SECTION V -- INDUSTRY STRUCTURE1 US Biologics Sales by Company, 2010 135
  8. 8. 2 Selected Acquisitions & Divestitures 1513 Selected Cooperative Agreements 156About Us:ReportsnReports is an online library of over 100,000+ market researchreports and in-depth market research studies & analysis of over 5000 micromarkets. We provide 24/7 online and offline support to our customers. Getin touch with us for your needs of market research reports.Follow us on Twitter: Facebook Page: Rambler road,Suite727,Dallas,TX75231Tel: + 1 888 391 5441E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comVisit our Market Research Blog