Biologics

As Quoted In Drug Discovery & Development

Gains will be driven by dramatic shifts in production technology and an expansion in the number of targeted diseases, including cancer, diabetes and other serious medical conditions.

US demand to rise 6.5% annually through 2015

US demand for biologics is expected to grow 6.5 percent per year to $102 billion in 2015, driven by dramatic shifts in production technology and an expansion in the number of targeted diseases. New biologics are being developed for the treatment of cancer, diabetes and other serious medical conditions, many of which are seeing their incidence rise in the US population. While growth in market value will slow from the doubledigit advances registered during the past decade, this is primarily a function of restrained pricing, which will mask to some extent continued robust gains in market penetration.

Monoclonal antibodies to remain key segment

Biologics such as insulin, vaccines and various blood products have been available for many years. However, the more recent introduction of recombinant DNA technology has allowed manufacturers to develop a wide range of new products with very specific applications. For example, monoclonal antibodies that destroy targeted antigens -- such as cancer cells -- can now be purified, cloned and introduced into patients to instigate immune responses. Of more than 40 brand-named monoclonal antibodies currently available in the US, 26 have received FDA approval since 2000, and 15 of the 26 since 2005.

These products have quickly established themselves as effective therapies for many forms of cancer, macular degeneration, rheumatoid arthritis and other diseases. New antibodies are under intensive investigation, and are expected to be introduced to market during the forecast period.

US approval of biosimilars to spur new biologics

A growing global market for biosimilars (also known as follow-on biologics) is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs. Europe has led the global regulatory process to make biosimilars available but to date US approvals have lagged behind those in the international community. The FDA has allowed only a few biosimilars for sale in the US, generally following procedures for small molecule generics. However, the FDA has announced plans to release new regulatory guidelines by the end of 2011 that will clarify the approval process for follow-on biologics.

Once biosimilars can be approved for US sale, they are expected to make lower-cost biologic treatments more widely available, presenting a challenge to some longstanding proprietary products. The push for approval of biosimilars is also expected to spur the creation of new biologic products and applications.

Study Scope

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.

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  1. Biologics

    $4,900.00

  2. INTRODUCTION - BIOLOGICS TO 2015

    $0.00

  3. Methodology & Sources of Information

    $0.00

  4. EXECUTIVE SUMMARY - BIOLOGICS TO 2015

    $95.00

  5. Overview

    $35.00

  6. BIOLOGICS DEMAND BY TYPE (million dollars) 2005 - 2020

    $60.00

  7. MARKET ENVIRONMENT - BIOLOGICS TO 2015

    $1,495.00

  8. General

    $35.00

  9. Demographic Patterns (1 of 3)

    $35.00

  10. Demographic Patterns (2 of 3)

    $35.00

  11. Demographic Patterns (3 of 3)

    $35.00

  12. POPULATION & HOUSEHOLDS (million persons) 2000 - 2020

    $60.00

  13. Macroeconomic Outlook (1 of 3)

    $35.00

  14. Macroeconomic Outlook (2 of 3)

    $35.00

  15. Macroeconomic Outlook (3 of 3)

    $35.00

  16. MACROECONOMIC INDICATORS (billion 2005 dollars) 2000 - 2020

    $60.00

  17. Healthcare Trends

    $35.00

  18. National Health Expenditures (1 of 2)

    $35.00

  19. National Health Expenditures (2 of 2)

    $35.00

  20. NATIONAL HEALTH EXPENDITURES BY TYPE & SOURCE OF PAYMENT (billion dollars) 2000 - 2020

    $60.00

  21. PHARMACEUTICAL SUPPLY & DEMAND 2000 - 2020

    $60.00

  22. Pharmaceutical Shipments by Therapeutic Class

    $35.00

  23. PHARMACEUTICAL SHIPMENTS BY THERAPEUTIC CLASS (billion dollars) 2000 - 2020

    $60.00

  24. Patient Activity (1 of 2)

    $35.00

  25. Patient Activity (2 of 2)

    $35.00

  26. PATIENT ACTIVITY (million) 2000 - 2020

    $60.00

  27. Medical Conditions - Acute & Chronic (1 of 3)

    $35.00

  28. Medical Conditions - Acute & Chronic (2 of 3)

    $35.00

  29. Medical Conditions - Acute & Chronic (3 of 3)

    $35.00

  30. MEDICAL CONDITIONS (million) 2000 - 2020

    $60.00

  31. Animal Health Industry Outlook (1 of 2)

    $35.00

  32. Animal Health Industry Outlook (2 of 2)

    $35.00

  33. ANIMAL POPULATION & VETERINARY HEALTH EXPENDITURES 2000 - 2020

    $60.00

  34. Technological Overview of Biologics

    $35.00

  35. Recombinant DNA Biologics

    $35.00

  36. Biosimilars (1 of 3)

    $35.00

  37. Biosimilars (2 of 3)

    $35.00

  38. Biosimilars (3 of 3)

    $35.00

  39. Regulation of Human Biologic Therapies (1 of 3)

    $35.00

  40. Regulation of Human Biologic Therapies (2 of 3)

    $35.00

  41. Regulation of Human Biologic Therapies (3 of 3)

    $35.00

  42. Regulation of Biosimilar Products

    $35.00

  43. Regulation of Biologics Research & Testing Products

    $35.00

  44. Regulation of Animal Biologics

    $35.00

  45. PRODUCTS - BIOLOGICS TO 2015

    $2,665.00

  46. General

    $35.00

  47. Biologics - Demand by Type (1 of 2)

    $35.00

  48. Biologics - Demand by Type (2 of 2)

    $35.00

  49. BIOLOGICS DEMAND BY TYPE (million dollars) 2000 - 2020

    $60.00

  50. Monoclonal Antibodies - Overview (1 of 2)

    $35.00

  51. Monoclonal Antibodies - Overview (2 of 2)

    $35.00

  52. MONOCLONAL ANTIBODIES DEMAND (million dollars) 2000 - 2020

    $60.00

  53. Monoclonal Antibodies - Cancer Treatment

    $35.00

  54. Monoclonal Antibodies - Rheumatoid Arthritis

    $35.00

  55. Monoclonal Antibodies - Macular Degeneration

    $35.00

  56. Monoclonal Antibodies - Psoriasis

    $35.00

  57. Monoclonal Antibodies - Infectious Disease

    $35.00

  58. Monoclonal Antibodies - Other Applications

    $35.00

  59. Vaccines & Toxoids

    $35.00

  60. VACCINES DEMAND (million dollars) 2000 - 2020

    $60.00

  61. Vaccines for Human Health (1 of 3)

    $35.00

  62. Vaccines for Human Health (2 of 3)

    $35.00

  63. Vaccines for Human Health (3 of 3)

    $35.00

  64. Animal Vaccines

    $35.00

  65. Hormones - Overview

    $35.00

  66. HORMONES DEMAND (million dollars) 2000 - 2020

    $60.00

  67. Hormones - Insulin (1 of 2)

    $35.00

  68. Hormones - Insulin (2 of 2)

    $35.00

  69. Hormones - Human Growth Hormone (1 of 2)

    $35.00

  70. Hormones - Human Growth Hormone (2 of 2)

    $35.00

  71. Hormones - Teriparatide & Follicle-Stimulating Hormone

    $35.00

  72. Hormones - Estrogen

    $35.00

  73. Hormones - Calcitonin

    $35.00

  74. Hormones - Thyrotropin & Corticotropin

    $35.00

  75. Other Hormones

    $35.00

  76. Growth Factors - Overview

    $35.00

  77. GROWTH FACTORS DEMAND (million dollars) 2000 - 2020

    $60.00

  78. Growth Factors - Erythropoietins

    $35.00

  79. Growth Factors - Colony-Stimulating Factors

    $35.00

  80. Growth Factors - Bone Morphogenetic Proteins

    $35.00

  81. Other Growth Factors

    $35.00

  82. Immunomodulators - Overview

    $35.00

  83. IMMUNOMODULATORS DEMAND (million dollars) 2000 - 2020

    $60.00

  84. Immunomodulators - Immunosuppressing Agents

    $35.00

  85. Immunomodulators - Interferons

    $35.00

  86. Other Immunomodulators

    $35.00

  87. Blood & Blood Products - Overview (1 of 2)

    $35.00

  88. Blood & Blood Products - Overview (2 of 2)

    $35.00

  89. BLOOD & BLOOD PRODUCTS DEMAND (million dollars) 2000 - 2020

    $60.00

  90. Blood & Blood Products - Plasma & Plasma Fractions (1 of 2)

    $35.00

  91. Blood & Blood Products - Plasma & Plasma Fractions (2 of 2)

    $35.00

  92. Blood & Blood Products - Whole Blood & Cellular Components (1 of 3)

    $35.00

  93. Blood & Blood Products - Whole Blood & Cellular Components (2 of 3)

    $35.00

  94. Blood & Blood Products - Whole Blood & Cellular Components (3 of 3)

    $35.00

  95. Enzymes - Overview

    $35.00

  96. ENZYMES DEMAND (million dollars) 2000 - 2020

    $60.00

  97. Enzyme Replacement Therapies (1 of 3)

    $35.00

  98. Enzyme Replacement Therapies (2 of 3)

    $35.00

  99. Enzyme Replacement Therapies (3 of 3)

    $35.00

  100. Enzymes - Neuromodulators (1 of 2)

    $35.00

  101. Enzymes - Neuromodulators (2 of 2)

    $35.00

  102. Digestive Enzymes (1 of 2)

    $35.00

  103. Digestive Enzymes (2 of 2)

    $35.00

  104. Enzymes - Thrombolytics

    $35.00

  105. Enzymes - Diagnostics

    $35.00

  106. Other Enzymes

    $35.00

  107. Coagulation Factors - Overview

    $35.00

  108. COAGULATION FACTORS DEMAND (million dollars) 2000 - 2020

    $60.00

  109. Coagulation Factors - Antihemophilics (1 of 2)

    $35.00

  110. Coagulation Factors - Antihemophilics (2 of 2)

    $35.00

  111. Other Coagulation Factors

    $35.00

  112. Other Biologics (1 of 2)

    $35.00

  113. Other Biologics (2 of 2)

    $35.00

  114. OTHER BIOLOGICS DEMAND (million dollars) 2000 - 2020

    $60.00

  115. APPLICATIONS - BIOLOGICS TO 2015

    $1,220.00

  116. Overview

    $35.00

  117. BIOLOGICS DEMAND BY APPLICATION (million dollars) 2000 - 2020

    $60.00

  118. Human Healthcare Applications for Biologics

    $35.00

  119. BIOLOGICS DEMAND FOR HUMAN HEALTHCARE BY CONDITION (million dollars) 2000 - 2020

    $60.00

  120. BIOLOGICS DEMAND FOR HUMAN HEALTHCARE BY USE (million dollars) 2000 - 2020

    $60.00

  121. Cancer - Biologics Demand (1 of 4)

    $35.00

  122. Cancer - Biologics Demand (2 of 4)

    $35.00

  123. Cancer - Biologics Demand (3 of 4)

    $35.00

  124. Cancer - Biologics Demand (4 of 4)

    $35.00

  125. CANCER BIOLOGICS DEMAND (million dollars) 2000 - 2020

    $60.00

  126. Autoimmune Diseases - Biologics Demand

    $35.00

  127. AUTOIMMUNE BIOLOGICS DEMAND (million dollars) 2000 - 2020

    $60.00

  128. Infectious Diseases - Biologics Demand (1 of 2)

    $35.00

  129. Infectious Diseases - Biologics Demand (2 of 2)

    $35.00

  130. INFECTIOUS DISEASES BIOLOGICS DEMAND (million dollars) 2000 - 2020

    $60.00

  131. Blood Disorders - Biologics Demand (1 of 2)

    $35.00

  132. Blood Disorders - Biologics Demand (2 of 2)

    $35.00

  133. BLOOD DISORDERS BIOLOGICS DEMAND (million dollars) 2000 - 2020

    $60.00

  134. Diabetes - Biologics Demand

    $35.00

  135. DIABETES BIOLOGICS DEMAND (million dollars) 2000 - 2020

    $60.00

  136. Other Conditions - Biologics Demand (1 of 2)

    $35.00

  137. Other Conditions - Biologics Demand (2 of 2)

    $35.00

  138. OTHER HUMAN HEALTH BIOLOGICS DEMAND BY CONDITION (million dollars) 2000 - 2020

    $60.00

  139. OTHER HUMAN HEALTH BIOLOGICS DEMAND BY PRODUCT (million dollars) 2000 - 2020

    $60.00

  140. BIOLOGICS DEMAND FOR OTHER APPLICATIONS (million dollars) 2000 - 2020

    $60.00

  141. Animal Health - Biologics Demand

    $35.00

  142. Research & All Other Applications - Biologics Demand

    $35.00

  143. INDUSTRY STRUCTURE - BIOLOGICS TO 2015

    $1,025.00

  144. General

    $35.00

  145. US BIOLOGICS SALES BY COMPANY, 2010 (million dollars)

    $60.00

  146. Market Share (1 of 2)

    $35.00

  147. Market Share (2 of 2)

    $35.00

  148. US BIOLOGICS MARKET SHARE BY TOP COMPANIES, 2010 (percent)

    $60.00

  149. Market Leaders (1 of 8)

    $35.00

  150. Market Leaders (2 of 8)

    $35.00

  151. Market Leaders (3 of 8)

    $35.00

  152. Market Leaders (4 of 8)

    $35.00

  153. Market Leaders (5 of 8)

    $35.00

  154. Market Leaders (6 of 8)

    $35.00

  155. Market Leaders (7 of 8)

    $35.00

  156. Market Leaders (8 of 8)

    $35.00

  157. Competitive Strategies

    $35.00

  158. Mergers & Acquisitions (1 of 2)

    $35.00

  159. Mergers & Acquisitions (2 of 2)

    $35.00

  160. SELECTED ACQUISITIONS & DIVESTITURES

    $60.00

  161. Licensing & Related Agreements (1 of 2)

    $35.00

  162. Licensing & Related Agreements (2 of 2)

    $35.00

  163. SELECTED COOPERATIVE AGREEMENTS (1 of 3)

    $60.00

  164. SELECTED COOPERATIVE AGREEMENTS (2 of 3)

    $60.00

  165. SELECTED COOPERATIVE AGREEMENTS (3 of 3)

    $60.00

  166. Research & Development

    $35.00

  167. Manufacturing

    $35.00

  168. Marketing & Distribution

    $35.00

  169. COMPANY PROFILES - BIOLOGICS TO 2015

    $2,800.00

  170. Company Profiles Methodology

    $35.00

  171. Abbott Laboratories (Facet Biotech) (1 of 2)

    $35.00

  172. Abbott Laboratories (Facet Biotech) (2 of 2)

    $35.00

  173. Alere Incorporated (BBI Enzymes) (Inverness Medical)

    $35.00

  174. Alexion Pharmaceuticals

    $35.00

  175. Allergan Incorporated

    $35.00

  176. American Red Cross

    $35.00

  177. Amgen Incorporated (BioVex) (1 of 3)

    $35.00

  178. Amgen Incorporated (BioVex) (2 of 3)

    $35.00

  179. Amgen Incorporated (BioVex) (3 of 3)

    $35.00

  180. Aptalis Pharma (Axcan) (Eurand)

    $35.00

  181. AstraZeneca plc (MedImmune)

    $35.00

  182. Baxter International

    $35.00

  183. Bayer AG

    $35.00

  184. Biogen Idec

    $35.00

  185. BioMarin Pharmaceutical (ZyStor Therapeutics)

    $35.00

  186. Blood Systems

    $35.00

  187. Bristol-Myers Squibb Company (Medarex)

    $35.00

  188. CSL Limited (1 of 2)

    $35.00

  189. CSL Limited (2 of 2)

    $35.00

  190. EKR Therapeutics

    $35.00

  191. Eli Lilly & Company (Alnara Pharmaceuticals) (1 of 2)

    $35.00

  192. Eli Lilly & Company (Alnara Pharmaceuticals) (2 of 2)

    $35.00

  193. Emergent BioSolutions (Trubion Pharmaceuticals) (1 of 3)

    $35.00

  194. Emergent BioSolutions (Trubion Pharmaceuticals) (2 of 3)

    $35.00

  195. Emergent BioSolutions (Trubion Pharmaceuticals) (3 of 3)

    $35.00

  196. GlaxoSmithKline plc (Theravance) (GSK Biologicals) (1 of 3)

    $35.00

  197. GlaxoSmithKline plc (Theravance) (GSK Biologicals) (2 of 3)

    $35.00

  198. GlaxoSmithKline plc (Theravance) (GSK Biologicals) (3 of 3)

    $35.00

  199. Halozyme Therapeutics (1 of 2)

    $35.00

  200. Halozyme Therapeutics (2 of 2)

    $35.00

  201. Intercell AG (1 of 2)

    $35.00

  202. Intercell AG (2 of 2)

    $35.00

  203. Ipsen (Tercica)

    $35.00

  204. Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (1 of 4)

    $35.00

  205. Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (2 of 4)

    $35.00

  206. Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (3 of 4)

    $35.00

  207. Johnson & Johnson (Crucell) (Mentor) (Percivia) (Ortho-McNeil-Janssen) (4 of 4)

    $35.00

  208. Lonza Group (Vivante GMP) (TL Biopharmaceutical) (1 of 2)

    $35.00

  209. Lonza Group (Vivante GMP) (TL Biopharmaceutical) (2 of 2)

    $35.00

  210. Lundbeck (H.) A/S (Ovation Pharmaceuticals)

    $35.00

  211. Massachusetts Biologic Laboratories

    $35.00

  212. Medtronic Incorporated

    $35.00

  213. Merck & Company (Organon Teknika) (1 of 4)

    $35.00

  214. Merck & Company (Organon Teknika) (2 of 4)

    $35.00

  215. Merck & Company (Organon Teknika) (3 of 4)

    $35.00

  216. Merck & Company (Organon Teknika) (4 of 4)

    $35.00

  217. Merck KGaA (EMD Serono)

    $35.00

  218. New York Blood Center

    $35.00

  219. Novartis AG (Sandoz) (1 of 4)

    $35.00

  220. Novartis AG (Sandoz) (2 of 4)

    $35.00

  221. Novartis AG (Sandoz) (3 of 4)

    $35.00

  222. Novartis AG (Sandoz) (4 of 4)

    $35.00

  223. Novo Nordisk

    $35.00

  224. Pfizer Incorporated (Wyeth) (1 of 4)

    $35.00

  225. Pfizer Incorporated (Wyeth) (2 of 4)

    $35.00

  226. Pfizer Incorporated (Wyeth) (3 of 4)

    $35.00

  227. Pfizer Incorporated (Wyeth) (4 of 4)

    $35.00

  228. Questcor Pharmaceuticals

    $35.00

  229. Roche Holding (Ventana) (Genentech) (1 of 5)

    $35.00

  230. Roche Holding (Ventana) (Genentech) (2 of 5)

    $35.00

  231. Roche Holding (Ventana) (Genentech) (3 of 5)

    $35.00

  232. Roche Holding (Ventana) (Genentech) (4 of 5)

    $35.00

  233. Roche Holding (Ventana) (Genentech) (5 of 5)

    $35.00

  234. Sanofi-Aventis (Merial) (Genzyme) (1 of 6)

    $35.00

  235. Sanofi-Aventis (Merial) (Genzyme) (2 of 6)

    $35.00

  236. Sanofi-Aventis (Merial) (Genzyme) (3 of 6)

    $35.00

  237. Sanofi-Aventis (Merial) (Genzyme) (4 of 6)

    $35.00

  238. Sanofi-Aventis (Merial) (Genzyme) (5 of 6)

    $35.00

  239. Sanofi-Aventis (Merial) (Genzyme) (6 of 6)

    $35.00

  240. Shire plc

    $35.00

  241. sigma-tau Group (Enzon Pharmaceuticals)

    $35.00

  242. Solvay SA

    $35.00

  243. Stryker Corporation

    $35.00

  244. Teva Pharmaceutical Industries (ratiopharm) (TL Biopharmaceutical)

    $35.00

  245. US WorldMeds (Solstice Neurosciences)

    $35.00

  246. ViaCyte Incorporated

    $35.00

  247. WiCell Research Institute (Wisconsin International Stem Cell Bank)

    $35.00

  248. Other Companies Mentioned in Study (1 of 2)

    $35.00

  249. Other Companies Mentioned in Study (2 of 2)

    $35.00

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