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US Biologics Market

NEW YORK, Oct. 5, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

US Biologics  Market  Market.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

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 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.

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 industry study, Biologics, which 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.





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


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


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


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 &


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



Summary Table 3


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


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


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


1 US Biologics Sales by Company, 2010 135

2 Selected Acquisitions & Divestitures 151

3 Selected Cooperative Agreements 156



1 Biologics Demand by Product Type, 2010 46


1 Human Healthcare Biologics Demand by Condition

& Use, 2010 113


1 US Biologicals Market Share, 2010 138

To order this report:

Biopharmaceutical Industry: US Biologics  Market

Biopharmaceutical Business News

More  Industry Analysis and Insights

Nicolas Bombourg
US: (805)652-2626
Intl: +1 805-652-2626

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