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Study #: 2792

Published: 09/2011

Pages: 316

Full Study Price: US$ 4,900

Per Page Price: US$ 35.00 (text) | 60.00 (table)

Biologics to 2015 - Market Research, Market Share, Market Size, Sales, Demand Forecast, Market Leaders, Company Profiles, Industry Trends

US demand for biologics is expected to grow 6.5 percent annually through 2015, driven by dramatic shifts in production technology and more targeted diseases such as cancer, diabetes and other serious medical conditions. Monoclonal antibodies will remain the largest category and be one of the fastest growing segments, outpaced only by hormones.

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.

				    TABLE OF CONTENTS

     SECTION									    PAGE

		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

    TABLE NUMBER								    PAGE


		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

    CHART NUMBER								    PAGE



		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