US Therapeutic Apheresis Industry

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US Therapeutic Apheresis Industry

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This report analyzes the US market for Therapeutic Apheresis in US$ Thousand by the following procedures: Photopheresis, Plasmapheresis, Erythrocytapheresis, Plateletpheresis, Leukapheresis, and Lipidpheresis. The specific end-use segments analyzed are Neurology Disorders, Hematology & Oncology Disorders, Rheumatology Disorders, and Others. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for this market. The report profiles 10 companies including many key and niche players such as CaridianBCT, Inc., Fenwal, Inc., Fresenius Medical Care North America, Haemonetics Corporation, HemaCare Corporation, and Therakos, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1

Study Reliability and Reporting Limitations 1

Disclaimers 2

Data Interpretation & Reporting Level 3

Quantitative Techniques & Analytics 3

Product Definitions and Scope of Study 3

Photopheresis 4

Plasmapheresis 4

Erythrocytapheresis 4

Plateletpheresis 4

Leukapheresis 4

Lipidpheresis 5

2. MARKET OUTLOOK 6

Market Trends at a Glance 6

Current & Future Analysis 7

Photopheresis: A Segment with High Growth Rate Owing to

Increasing Demand in Off-label Indications 7

Plasmapheresis: The Method of Choice for Plasma Collection 8

Table 1: Plasma Collection Methods: Percentage Breakdown by

Fractionation and Extraction from Whole Blood (2000 Vs. 2010)

(includes corresponding Graph/Chart) 8

Table 2: Leading Plasma Product Companies (2009): Market

Share Breakdown for Baxter, CSL, Grifols/ Talecris, Biotest,

and Others (includes corresponding Graph/Chart) 8

Plateletpheresis Emerges as the Treatment of Choice 9

Increase in Number of Platelet Donors Owing to Apheresis

Procedure 9

Pediatrics: An Unexplored Domain in Therapeutic Apheresis 9

Vendors' Attitude Hampers Growth Prospects of Therapeutic

Apheresis 10

Technological Advancements and Novel Indications to Augur well

for the Therapeutic Apheresis Market 10

Lack of Awareness among Patients Restrains Market Growth 10

Challenges in the Therapeutic Apheresis Market 11

Need to Develop Inexpensive Apheresis Therapies 11

Scarcity of Qualified Donors 11

Challenges in the Unexplored Pediatrics Segment 11

Therapeutic Apheresis: An Overview of Regulatory Environment

and Reimbursement Scenario 11

New Reimbursement Policies to Create Growth Opportunities for

Therapeutic Apheresis 12

Medicaid Coverage for Therapeutic Apheresis by Various

Conditions 12

Table 3: APC* Payment Rates For Different Therapeutic

Apheresis Procedures (2009-2010) 14

3. COMPETITIVE SCENARIO 15

Japan-based Terumo Corp. Acquires CaridianBCT, the Leading

Player in Therapeutic Apheresis Market 15

Market Share Trends 16

Therapeutic Apheresis in Neurology Disorders: Market Shares

by Revenues 16

Table 4: US Market for Therapeutic Apheresis in Neurological

Disorders (2010): Market Share Breakdown of Revenues by

Company for Caridian BCT, Fresenius- Kabi LLC, Haemonetics,

and Others (includes corresponding Graph/Chart) 16

Therapeutic Apheresis in Neurology Disorders: Market Shares

by Number of Procedures 17

Table 5: US Market for Therapeutic Apheresis in Neurological

Disorders (2010): Market Share Breakdown of Number of

Procedures by Company for CaridianBCT, Fresenius-Kabi,

Haemonetics, and Others (includes corresponding Graph/Chart) 17

Therapeutic Apheresis in Hematology and Oncology Disorders:

Market Share by Revenues 17

Table 6: US Market for Therapeutic Apheresis in Hematology

and Oncology Disorders (2010): Market Share Breakdown of

Revenues by Company for CaridianBCT, Therakos,

Fresenius-Kabi, and Others (includes corresponding

Graph/Chart) 17

Therapeutic Apheresis in Hematology and Oncology Disorders:

Market Share by Number of Procedures 18

Table 7: US Market for Therapeutic Apheresis in Hematology

and Oncology Disorders (2010): Market Share Breakdown of

Number of Procedures by Company for CaridianBCT,

Fresenius-Kabi, and Others (includes corresponding

Graph/Chart) 18

4. THERAPEUTIC APHERESIS: A SEGMENTAL OVERVIEW 19

Apheresis and Therapeutic Apheresis: The Difference 19

Therapeutic Apheresis: An Introduction 19

Applications of Therapeutic Apheresis 19

Emerging Applications of Therapeutic Apheresis 21

Uses of Apheresis and Therapeutic Apheresis 21

Overview of Therapeutic Apheresis 22

Blood Components 22

Therapeutic Apheresis Process 22

Duration, Frequency, and Efficiency of Therapeutic Apheresis 22

Segregation of Blood Components 23

Centrifugation 23

Filtration 23

History of Therapeutic Apheresis Market 23

Therapeutic Apheresis Versus Dialysis 24

Table 8: Global Hemodialysis Market by Leading Players

(2009): Market Share Breakdown for Fresenius Medical, Gambro,

Baxter, and Others (includes corresponding Graph/Chart) 25

Categories of Indications for Therapeutic Apheresis 25

Types of Therapeutic Apheresis Procedures 25

Photopheresis 26

Functioning of THERAKOS™, a Typical Photopheresis System 26

Plasmapheresis 26

Plasma Exchange and Plasmapheresis: The Difference 26

Therapeutic Plasma Exchange (TPE) or Plasma Exchange 27

TPE: Abnormal Components Removed from Blood 27

Plasmapheresis: Potential Uses Discovered in the Early Years 27

Potential Use of Plasmapheresis in Select Diseases

Discovered in the Early Years 27

Erythrocytapheresis 28

Plateletpheresis 28

Leukapheresis 28

Lipidpheresis 28

Cytapheresis 28

Therapeutic Apheresis is Remedial for Various Diseases 28

Cost of Select Therapeutic Apheresis Procedures: An Overview 29

1. Photopheresis in GVHD (Graft-Versus-Host Disease) 29

2. Lipid Apheresis (LDL Apheresis) 29

3. Plasmapheresis and Other Procedures 30

Therapeutic Apheresis: What is the Risk Involved? 30

Replacement Fluid in Therapeutic Apheresis 31

Replacement Fluids Used in Therapeutic Apheresis 31

Various Replacement Fluids 31

Select Replacement Fluids and their Limitations 31

Fluid Balance in Fluid Replacement 32

Table 9: Volume Exchange of Plasma Constituents 32

Table 10: Removal of IgM and IgG by Plasma Exchange Volume 32

Table 11: Therapeutic Apheresis: Percentage Decrease and

Restoration of Blood Components 32

Complications Involved and Suggested Treatment in the

Therapeutic Apheresis Procedure 33

Therapeutic Plasmapheresis with Fresh Frozen Plasma (FFP)

Replacement 34

Sources of Blood Plasma 34

Plasma Donations 34

Table 12: Number of Plasma Donation Centers in US and

Europe: 2006-2008 (includes corresponding Graph/Chart) 35

Table 13: Number of Plasma Donations in US and Europe (In

Thousands): 2006-2008 (includes corresponding Graph/Chart) 35

Table 14: Number of Plasma Donations Required Annually by

Disease Type in the US: 2009 (includes corresponding

Graph/Chart) 36

Pre-requisites for Plasma Donors 36

Select IQPP-authorized Plasma Collection Centers (US) 36

CFA - An Effective way to Pull Up Cold Hemagglutinin Disease 36

Trima Accel, the most Widely Used Platelet Collection

Equipment in the US 37

5. PRODUCT AND TECHNOLOGICAL DEVELOPMENTS 38

Health Canada Licenses CaridianBCT's new Protocol for Spectra

Optia® Apheresis System 38

Fenwal's Amicus System Obtains CE Mark Certification for a

Therapeutic Plasma Exchange Protocol 38

CaridianBCT Releases Spectra Optia Apheresis System Version 5 38

CaridianBCT Introduces Trima Accel® Version 6 39

CaridianBCT Introduces RBCX Protocol in Canada 39

CaridianBCT Introduces Spectra Optia® System Mononuclear Cell

Collection Protocol 39

Golden Meditech Company to Launch Model 3000H Plasma Exchange

System 40

HemoCleanse to Develop Novel Plasmapheresis Device 40

Aethlon Develops a New Device to Remove HIV 40

Therapeutic Plasmapheresis for Treatment of Autoimmune Diseases 41

6. RECENT INDUSTRY ACTIVITY 42

Fenwal's Amicus System Obtains CE Mark Certification for a

Therapeutic Plasma Exchange Protocol 42

Terumo Corp. Completes Acquisition of CaridianBCT 42

Fenwal Obtains FDA Approval for Collection of InterSol®

Preserved Platelets using Amicus® Cell Separator 42

FDA Clears Fenwal's Software for Autopheresis-C® System 43

HemaCare Inks Commercial Cell Therapy Collection Agreement

with Dendreon 43

Cerus Receives CE Mark Approval for the Latest Configuration

of INTERCEPT Blood System 43

Therakos Obtains FDA Approval for THERAKOS™ CELLEX™

Photopheresis System 44

Biotest Acquires Talecris' Plasma Collection Unit 44

CaridianBCT Receives CE Mark Approval for Expanded Mirasol

Pathogen Reduction Technology System 44

Gambro Changes Name to CaridianBCT 45

Therakos Obtains CE Mark for THERAKOS™ CELLEX™ Photopheresis

System in Europe 45

Verax Biomedical Gains CE Mark for Platelet PGD® Test 45

7. STRATEGIC CORPORATE DEVELOPMENTS IN THE RECENT PAST 46

OccuLogix Puts Off Clinical Development of RHEO™ System 46

Baxter Divests Transfusion Therapies Business 46

SCSG Gets Hold of Fresenius Medical Care Extracorporeal Alliance 47

Rheologics Technologies Takes Over Cardiodyne Electronics 47

Biotest Obtains Plasma and Protein Business Unit of Nabi

BioPharmaceuticals 47

Gambro BCT Receives FDA Clearance for Spectra Optia System 47

MedaSorb Receives Rights for Blood Processing 47

Fresenius Medical Care Takes Over Renal Care 48

Haemonetics Signs Acquisition Agreement with Arryx 48

Cerus Receives Rights for INTERCEPT Blood System 48

Blood Systems to Implement Gambro BCT 7-day platelets 48

Renal Care Pockets Bay Area Mobile Apheresis Program 48

Haemonetics Pacts with FMCEA 49

PhereSys and ACGT Ink Consulting Services Pact 49

CHF Forges a Service Provider Pact with FMCEA 49

Otsuka America Inks a Pact with HemaCare 49

Gambro Acquires Ivex 49

Fresenius HemoCare Becomes a Part of Fresenius Kabi 50

Alpha Therapeutic Sells Assets to Probitas Pharma and Baxter 50

Gambro Signs Agreement with The American Red Cross 50

Gambro Receives Contract from NBS 50

FMC-EA Inks Deal with Allina Hospitals 50

Gambro Starts a New Company, Navigant Biotechnologies 51

Gambro's Vista™ Receives Approval from FDA 51

Gambro's New Anticoagulant Solution Receives FDA Approval 51

Gambro BCT Receives FDA Clearance for New Filter Tubing Sets

Developed by Pall 51

Gambro Launches Trima Accel Automated Blood Collection System 52

Fresenius HemoCare Acquires PROSORBA® Column from Cypress

Bioscience 52

Gambro Buys the Assets of Sanguistech 52

Haemonetics Inks Purchase Agreement with Alpha Therapeutic Corp 52

Gambro Joins Forces with the Walter Reed Army Institute of

Research 52

Gambro Collaborates with Dendreon for Commercialization of

Therapeutic Vaccines 53

Gambro AB Enters into a Partnership with Sangart 53

WakeMed Awards a Contract to HemaCare's Subsidiary 53

HemaCare's Subsidiary Coral in Agreement with CMH 53

BioTransplant Inks an Exclusive Distribution Agreement with

Gambro BCT 54

Gambro BCT Receives US Patent for its Pathogen Inactivation

Technology 54

Gambro's Trima Receives Approval from The Japanese Red Cross

Society 54

Gambro BCT Test Launches the Vista™ Information System 54

8. FOCUS ON SELECT GLOBAL PLAYERS 55

CaridianBCT, Inc. 55

CaridianBCT's Product and Technological Innovations: 1988-2009 55

Fenwal, Inc. 56

Fresenius Medical Care North America (FMCNA) 56

Haemonetics Corp. 56

HemaCare Corp. 57

Therakos, Inc. 57

9. MARKET PERSPECTIVE 58

Table 15: The US Recent Past, Current & Future Market Analysis

for Therapeutic Apheresis by Procedure - Photopheresis,

Plasmapheresis, Erythrocytapheresis, Leukapheresis,

Lipidpheresis, and Plateletpheresis Markets Independently

Analyzed with Annual Revenues in US$ Thousand for Years 2009

through 2017 (includes corresponding Graph/Chart) 58

Table 16: The US Historic Review for Therapeutic Apheresis by

Procedure - Photopheresis, Plasmapheresis,

Erythrocytapheresis, Leukapheresis, Lipidpheresis,

Immunoadsorption, and Plateletpheresis Markets Independently

Analyzed with Annual Revenues in US$ Thousand for Years 2003

through 2008 (includes corresponding Graph/Chart) 59

Table 17: The US 15-Year Perspective for Therapeutic Apheresis

by Procedure - Percentage Breakdown of Revenues for

Photopheresis, Plasmapheresis, Erythrocytapheresis,

Lipidpheresis, Plateletpheresis, Leukapheresis, and

Immunoadsorption Markets Independently Analyzed for Years

2003, 2010 & 2017 (includes corresponding Graph/Chart) 60

Table 18: The US Recent Past, Current & Future Market Analysis

for Therapeutic Apheresis by Disorder Type - Hematology and

Oncology, Neurology, Rheumatology, and Other Markets

Independently Analyzed with Annual Revenues in US$ Thousand

for Years 2009 through 2017 (includes corresponding

Graph/Chart) 61

Table 19: The US Historic Review for Therapeutic Apheresis by

Disorder Type - Hematology and Oncology, Neurology,

Rheumatology, and Other Markets Independently Analyzed with

Annual Revenues in US$ Thousand for Years 2003 through 2008

(includes corresponding Graph/Chart) 62

Table 20: The US 15-Year Perspective for Therapeutic Apheresis

by Disorder Type - Percentage Breakdown of Revenues for

Hematology and Oncology, Neurology, Rheumatology, and Other

Markets Independently Analyzed for Years 2003, 2010 & 2017

(includes corresponding Graph/Chart) 63

10. APPENDIX 64

Reported Uses of Therapeutic Apheresis 64

COMPETITIVE LANDSCAPE

Total Companies Profiled: 10 (including Divisions/Subsidiaries - 11)

Region/Country Players

The United States 10

Japan 1

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