Therapeutic Apheresis - Global Strategic Business Report

Global Industry Analysts, Inc, September 2011, Pages: 126

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.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks.

For information on site licence pricing please click on Enquire before buying

THERAPEUTIC APHERESIS

A US MARKET REPORT

CONTENTS

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
------------------------------------------

Use of Therapeutic Apheresis in the US has increased substantially over the years. The market is presently mature, primarily due to the apprehensions of vendors to infuse funds to further develop new applications. Nevertheless, with new opportunities unfolding for materials, services and apheresis technology devices, investments are likely to flow in. Further, with medical insurance companies customizing their reimbursement policies as per the treated conditions, the high cost of therapeutic apheresis is not likely to hamper market growth. Players are expected to develop technologically improved equipment through strategic collaborations, and are forecast to gain economies of scale, and reduction in the cost of therapy. The potential applications of Therapeutic Apheresis in infants and children remain to be explored, and are likely to offer a potential opportunity for the market expansion.

Although therapeutic apheresis is safe and effective, several users are ignorant of this therapy, and those suffering from chronic diseases go for conventional therapies, presuming it to be the best form of treatment. Even though some patients are aware, they have their own incorrect perceptions that prevent them from adopting apheresis therapy, which eventually restrain market growth. Further, high cost has remained a major market challenge as expensive nature of therapeutic apheresis procedures invariably affects the market shares of various procedures. Nevertheless, reimbursement policies of both government and private insurance companies play a major role in increasing the use of therapeutic apheresis procedures in several diseases.

Photopheresis represents the largest as well as the fastest growing segment in the therapeutic apheresis market, as stated by the new market research report on Therapeutic Apheresis. The segment is further projected to register a Compounded Annual Growth Rate (CAGR) of about 12% over the analysis period. Robust growth of Photopheresis is attributable to its growing demand in off-label indications, such as the prevention of solid organ transplant rejection, and treatment of Graft-Versus-Host Disease (GVHD). Furthermore, growth in the segment is primarily attributed to the clinical potential of photopheresis in autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis, lupus erythematosus, pemphigus, and scleroderma.

Patients develop bleeding disorders from cancer therapy and open-heart surgery. Platelets are an important blood component, particularly in such patients, as they are responsible for blood clotting. Owing to its benefits, platelets are in great demand, however, there is a scarcity of donors with high platelet counts. Single donor platelets are beneficial to blood centers as well as patients. Platelets extracted through apheresis procedure, Plateletpheresis, are the treatment of choice, since the patient is exposed to a single donor. Usage of pathogen reduction technology is another potential opportunity for the development of therapeutic apheresis market. Pathogen Reduction Technology removes disease causing parasites, viruses, and bacteria in transfusion blood.

The US therapeutic apheresis market is oligopolistic, with few key players and several niche players. Pricing pressures and high research and development costs are leading to the market restructuring. Key market alliances and acquisitions are likely to trigger the research and development of technologically advanced apheresis instruments, novel procedures, and more sophisticated therapeutic applications. With aggravating price compression, players are diversifying into blood bank technology and pathogen reduction market. Players profiled in the report include CaridianBCT Inc., Fenwal Inc., Fresenius Medical Care North America, Haemonetics Corp., HemaCare Corp., Therakos Inc., among others.

© Global Industry Analysts, Inc

- CaridianBCT Inc.
- Fenwal Inc.
- Fresenius Medical Care North America
- Haemonetics Corp.
- HemaCare Corp.
- Therakos Inc.

Customers who bought this item also bought

• Apheresis Market - (Therapeutic & Donor Apheresis/Automated Blood Component Collection), Applications (Plasmapheresis, Plateletpheresis,RBC/Erythrocytapheresis,Leukapheresis,Photopheresis), Devices & Disposables - Forecasts To 2017
• Medical Nutrition - A Global Market Overview
• Diabetes Diagnostics - Global Strategic Business Report
• Disinfectants - Global Strategic Business Report
• Gene Amplification Technologies - Global Strategic Business Report
• Proteomics - Global Strategic Business Report
• Global Biopharmaceutical Market Report & Forecast (2012-2017)
• Syringes (Disposable and Reusable) - Global Strategic Business Report
• Molecular Diagnostics - Global Strategic Business Report
• World Vaccines Market: Vaccine Segments Analysis, Vaccine Cases and Future Forecast