US Biologics  Market

• Publication date: October 2011

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 anti...

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.

Biopharmaceutical Industry in the United States

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

LIST OF CHARTS

SECTION III -- PRODUCTS
1 Biologics Demand by Product Type, 2010 46
SECTION IV -- APPLICATIONS
1 Human Healthcare Biologics Demand by Condition
& Use, 2010 113
SECTION V -- INDUSTRY STRUCTURE
1 US Biologicals Market Share, 2010 138