ReportsnReports – US Biologics Market - 2015


Published on

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.

Published in: Technology, Business
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

ReportsnReports – US Biologics Market - 2015

  1. 1. US Biologics adds Freedonia Group Market Research Report ―US Biologics Market’’to its storeUS demand to exceed $100 billion by 2015Demand for biologics will exceed $100 billion in 2015, experiencing continuing stronggrowth following a decade of double-digit annual increases. Continued growth will be drivenby dramatic shifts in production technology and expansion of targeted diseases, andchallenged by the introduction of biosimilar products following patent expiry of majorbiologic products.Monoclonal antibodies to benefit from biotech boomBiologics 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 awide range of new products with very specific applications. Monoclonal antibodies are aprime example of this important shift. Proteins that destroy targeted antigens can now bepurified, cloned and introduced into patients to instigate immune responses. These productshave quickly established themselves as effective therapies for many forms of cancer,rheumatoid arthritis, macular degeneration and other conditions. New antibodies are underintensive investigation, and will be introduced to market within the forecast period.Routine immunizations to boost vaccines demandBiologics 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 producershave targeted small, niche populations with rare or difficult to treat conditions. However, asthe market has grown and matured, many new applications are being found for theseproducts. Vaccines, for example, were once focused on a small number of infectiousdiseases of early childhood. The number of recommended immunizations has grownsignificantly over the past decade, however, and since 2006, the Centers for Disease Controlhas encouraged adolescent and adult boosters and new immunizations, including oneagainst the human papilloma virus associated with cervical cancer. Influenza shots are nowrecommended 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 immunityagainst widespread pandemic infection. Several new vaccines are available or in late-stageclinical trials for use both as preventives and as therapies against several forms of cancer.Biosimilar products offer good opportunitiesImpending expiry of patents for a number of biopharmaceuticals and consumer demand toreduce treatment costs are encouraging a global market for biosimilar products. Biosimilars
  2. 2. are made by new sponsors innovating biopharmaceuticals that reference the original drug.Manufacturers will have access to the original, commercialized products, but not to theoriginal molecular clones and cell banks, fermentation and purification processes, or activedrug substances. Biosimilars are subject to careful regulation. Europe has led the globalregulatory process, requiring a strict demonstration that the ―similar‖ product is highlycomparable to the original. In the US, the FDA has allowed only a few biosimilars for salefollowing procedures for small molecule generics, but new regulations are underdevelopment and biosimilars are expected to become a dominant force by 2020.Study coverageDetails 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) plusforecasts for 2015 and 2020 by product and application. This study also considers marketenvironment factors, evaluates company market share and profiles US industry competitors.Table Of ContentsINTRODUCTION ixI. EXECUTIVE SUMMARY 1II. MARKET ENVIRONMENT 4General 4Demographic 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 43
  3. 3. Monoclonal 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 67Calcitonin 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 106
  4. 4. IV. APPLICATIONS 109General 109Human Healthcare 110Cancer 114Autoimmune Diseases 119Infectious Diseases 121Blood Disorders 123Diabetes 126Other Conditions 128Biologics for Other Uses 131Animal Health 131Research & All Other Applications 132V. 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 214
  5. 5. Enzon 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 228Inverness 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 306
  6. 6. Vivante GMP Solutions, see Lonza GroupWiCell Research Institute 307Wisconsin International Stem Cell Bank, see WiCellResearch 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 1352 Selected Acquisitions & Divestitures 1513 Selected Cooperative Agreements 156
  7. 7. Latest Market Research Reports: LTE Solutions and Market Opportunities LTE Strategy 2012 – 2017 Broadband Wireless Solutions and Market Opportunities The World Market for Cancer Therapeutics and Biotherapeutics, 4th Edition Point of Care Diagnostics for Emerging Infectious Disease Threats (Market Analysis and Technical Considerations) Wireless Opportunities in Healthcare 2011 (The Market for Bluetooth, RFID, Zigbee, UWB WWAN, WMAN, WLAN and other technologies) Global Solar Inverter Markets Global Home Energy Management Systems Products MarketAbout Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: Facebook Page: Priyank7557 Rambler road,Suite 727, Dallas, TX 75231Tel: + 1 888 391 5441E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comVisit Our Blog: Market Research Reports