Announcement US 08


We are pleased to inform you that the study entitled The Plasma Proteins Market in the United States - 2010 is now available.

This report provides estimated sales in units and dollars of all the therapeutic plasma protein products by major competitor, as well as of recombinant clotting proteins. It analyzes the recent developments regarding plasma supply and fractionation, the distribution of finished products, and profiles the major fractionators.

Price available upon request. The following table of contents of the report is provided for your information.


Sincerely,

Patrick L. Robert
President



Table of Contents

EXECUTIVE SUMMARY 1
1) PLASMA COLLECTIONS 16
1.1)Consolidation of the Plasma Collection Sector 17
1.2)Plasma Quality Enhancement 26
1.2.1) Quarantine of “Donor Applicant’s” Plasma 26
1.2.2) Inventory Hold 26
1.2.3) First-Time Donors 27
1.2.4) NAT testing 27
1.2.5) Donor Selection

27
1.3) Major Plasma Collection Organizations 28
1.3.1) Independent Plasma Collection Companies 28
1.3.2) Fractionators’ Plasma Collection Subsidiaries 29
1.3.3) Plasma Collected by the Blood Banking Sector 32
1.3.4) The Plasma Supply and Demand Cycle 35
1.3.5) Plasma Export 38
1.3.6) Plasma Prices

44
2) PLASMA FRACTIONATION 50
2.1) Processing Capacity and Throughput 50
2.2) Production Yields

52
3) MARKET OVERVIEW 65
3.1) The Plasma Fractions Market by Product 65
3.1.1.) Polyvalent Intravenous Immune Globulin (IVIG) and
Sub-Cutaneous
 65
3.1.2) Albumin and Plasma Protein Fraction (PPF) 66
3.1.3) Factor VIII and von Willebrand Factor 66
3.1.4) Factor IX 67
3.1.5) Prothrombin Complex Concentrates (PCC) 67
3.1.6) Inhibitor Products (Factor VIII/IX Bypassing Agents) 68
3.1.7) Alpha-1 Antitrypsin 68
3.1.8) Protein C 68
3.1.9) Antithrombin III 68
3.1.10) Thrombin 68
3.1.11) Fibrin Sealant 69
3.1.12) Fibrinogen 69
3.1.13) C-1 Esterase Inhibitor 69
3.1.14) Hyperimmune Globulin Products 69
3.2) Pricing Trends 70
3.3) Product Mix 70
3.4) The Plasma Fractions Market by Company 71
3.5) Historical Development 73
3.6) Recent Products Approvals

79
4) IMMUNE GLOBULIN MARKET 83
4.1) Intramuscular Polyvalent Immune Globulin Market and
Hyperimmune Globulin Products		 83
4.1.1) Polyvalent Intramuscular Immune Globulin 83
4.1.2) Tetanus Immune Globulin 83
4.1.3) Rabies Immune Globulin 84
4.1.4) Hepatitis B Immune Globulin 84
4.1.5) Rho(D) Immune Globulin 85
4.1.6) Cytomegalovirus Immune Globulin 86
4.1.7 Varicella-Zoster Immune Globulin 86
4.1.8) Immune Thrombocytopenic Purpura 87
4.1.9) Botulism Immune Globulin

95
4.2) Polyvalent Intravenous and Subcutaneous Immune Globulin
(IVIG/SCIG) Market		 95
4.2.1) Octagam’s Withdrawal 95
4.2.2) Procoagulant Activity in Immune Globulin Products 96
4.2.3) History of IVIG 97
4.2.4) Subcutaneous Immune Globulin 101
4.2.5) Clinical Use of IVIG 103
4.2.6) Market Development 104
4.2.7) Results by Company 106
4.2.8) IV/SCIG Pricing and Reimbursement 109
4.2.9) IV/SCIG Distribution 113
4.2.10) IVIG and Alzheimer’s Disease

 114
5) ALBUMIN MARKET 121
5.1) History of Albumin
 121
5.2) Clinical Use of Albumin 121
5.3) Colloids vs. Crystalloids 124
5.4) The 1998 Cochrane Review, the 2004 SAFE Study 124
5.5) New Indications for Albumin: Septic Shock/Acute Ischemic Stroke 125
5.6) Non-Therapeutic Use of Albumin and Recombinant Albumin 126
5.7) Therapeutic Apheresis Market 127
5.8) Market Development 127
5.9) Albumin Research Avenues

 132
6) HEMOPHILIA CARE MARKET 136
Introduction 136
6.2) Historical Development 136
6.3) Hemophilia Patient Population 138
6.4) Hemophilia Treatment Centers and Home Care 142
6.5) Historical Development 143

6.5.1) Factor VIII Concentrates

144

6.5.2) Factor IX Concentrates

149
6.6) FACTOR VIII MARKET 150

6.6.1) Market Development

150

6.6.2) Pricing and Reimbursement

151
6.7) FACTOR IX 153
6.8) Prothrombin Complex Concentrate Market 166
6.9) Von Willebrand Disease Market 166
6.10) Inhibitor Market 174
6.10.1) Prevalence and Treatment 174
6.10.2) Market Development 177
6.10.3) R & D in Inhibitor Treatment 182
6.11) Other Bleeding Disorders

182
7) ALPHA-ONE ANTITRYPSIN MARKET 183
7.1) Historical Development 183
7.2) Alpha-1 Antitrypsin Products Available in the U.S. 184
7.3) Market Development


186
8) ANTITHROMBIN MARKET

187
9) FIBRIN SEALANT MARKET 189
9.1) Market Development 189
9.2) Historical Development 189
9.3) Competitive Products and Technologies


191
10) OTHER PLASMA PRODUCTS

192
11) DISTRIBUTION OF PLASMA PRODUCTS 199
11.1) Overview of the Distribution Channels for Biologicals 199
11.1.1) Product Distribution by Product Type 200
11.1.2) Group Purchase Organizations 201
11.1.3) Wholesalers and Distributors 204
11.1.4) Dealers and Distributors 205
11.1.5) Wholesalers & Dealers Contact Information 206
11.2) Home Care Companies

210
12) PROFILES OF THE MAJOR FRACTIONATORS 211
12.1) BAXTER BIOSCIENCE 211
12.1.1) Corporate Overview 211
12.1.2) Historical Development 212
12.1.3) Sales Results 214
12.1.4) Product Line 215
12.1.5) Manufacturing - Research & Development


217
12.2) BAYER HEALTHCARE 218
12.2.1) Corporate Overview 218
12.2.2) Product Line 218
12.2.3) Sales Results 219
12.2.4) Manufacturing - Research & Development

219
12.3) BIOTEST BIOPHARMACEUTICALS 220
12.3.1) Corporate Overview 220
12.3.2) Sales Results 220
12.3.3) Product Line 221
12.3.4) Manufacturing - Research & Development

221
12.4) CANGENE BioPHARMA 222
12.4.1) Corporate Overview 222
12.4.2) Sales Results 222
12.4.3) Product Kine 222
12.4.4) Manufacturing - Research & Development

 222
12.5) CSL BEHRING 223
12.5.1) Historical Development 223
12.5.2) Sales Results 226
12.5.3) Product Line 227
12.5.4) Manufacturing - Research & Development

 229
12.6) GRIFOLS USA 230
12.6.1) Corporate Overview 230
12.6.2) Historical Development 232
12.6.3) Plasma Collections and Biomat USA 232
12.6.4) Sales Results 233
12.6.5) Product Line 234
12.6.6) Manufacturing - Research & Development

234
12.7) OCTAPHARMA USA 235
12.7.1) Corporate Overview 235
12.7.2) U.S. Sales Results 237
12.7.3) Product Line 237
12.7.4) Manufacturing - Research & Development

 237
12.8) TALECRIS BIOTHERAPEUTICS 238
12.8.1) Corporate Overview 238
12.8.2) Historical Development 238
12.8.3) Sales Results 239
12.8.4) Product Line 240
12.8.5) Manufacturing - Research & Development 241


 

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