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U.S. Blood Pathogen Reduction Markets

Published by: Frost & Sullivan

Published: Feb. 20, 2003


Table of Contents


1. Overview
A. Executive Summary
1. Executive Summary
B. Introduction
1. Focus of the Report and Methodology
2. Blood Pathogen and Immunological Transfusion Risks
a. Immunological Risks
3. Introduction to Main Industry Participants
a. Cerus Corp.
b. VI Technologies, Inc.
c. Gambro Pathogen Reduction Technologies, Inc.



2. Product and Technology Analysis
A. Technology Platform Overview
1. Introduction
2. Adoption of Marketed Technologies and Pipeline Outlook
B. Marketed Technologies
1. Solvent/Detergent
2. Filtration
3. Gamma Irradiation
4. Methylene Blue
C. Cerus and Baxter: Helinx S-59 Psoralen Compound for Platelets and Plasma
1. Technology Overview
a. Development
b. Mechanism of Action and Treatment Process
c. Blood Component Target
2. Efficacy Against Pathogens and White Blood Cells
3. Toxicity and Damage to Blood Products
D. Cerus and Baxter: S-303 FRALE Compound for Red Blood Cells
1. Technology Overview
a. Development
b. Mechanism of Action and Treatment Process
c. Blood Component Target
2. Efficacy Against Pathogens and White Blood Cells
3. Toxicity and Damage to Blood Products
E. Vitex: Inactine PENN110 for Red Blood Cells
1. Technology Overview
a. Development
b. Mechanism of Action and Treatment Process
c. Blood Component Target
2. Efficacy Against Pathogens and White Blood Cells
3. Toxicity and Damage to Blood Products
F. Gambro PRT: Riboflavin for Platelets Plasma and Red Blood Cells
1. Technology Overview
a. Development
b. Mechanism of Action and Treatment Process
c. Blood Component Target
2. Efficacy Against Pathogens and White Blood Cells
3. Toxicity and Damage to Blood Products
G. Other Technology Platforms
1. American Red Cross: Dimethylmethylene Blue for Platelets Plasma and Red Blood Cells
2. Maxwell Technologies: Broad Spectrum Pulse Light
3. Altachem: Bionex
H. Substitutes and Complementary Products
1. Blood Tests
a. So what will be the dynamics between NAT and pathogen reduction technologies?
2. Artificial Blood
3. Biopharmaceuticals



3. Market Analysis
A. Market Overview
1. Introduction
2. Total Pathogen Reduction Market Revenue Forecasts and Assumptions
B. Demand Analysis and Regulatory Issues
1. Blood Banks and FDA Mandate
a. Blood Bank Operational Issues
2. Physicians
C. Drivers of Market Adoption
1. Closing the Testing Window: Zero Risk Blood Supply
a. Push toward Zero Risk Blood Supply Drives Market Adoption
2. Demonstrated Safety and Efficacy
a. Strong Safety and Efficacy Data will Drive Market Penetration
3. Broad Range of Pathogen Kill without Damage to Blood Products
a. Broad Range of Pathogen Kill without Damage to Blood Products Drives Penetration
4. Cost Reductions at Blood Banks
a. Cost Reductions at Blood Banks Facilitates Market Adoption
D. Restraints to Market Adoption
1. Blood Banker and Physician Hesitancy
a. Physician and Blood Banker Hesitancy Slows Adoption
2. Testing for Pathogens
a. Blood Bank Tests Reduce Urgency of Pathogen Reduction Adoption
3. Reimbursement Issues
a. Prospect of Low Reimbursement Restrains Profit Potential
E. Segment Analysis and Revenue Forecasts
1. Red Blood Cells
2. Plasma
3. Platelets
4. Ancillary Markets



4. Strategy Analysis
A. Competitive Analysis
1. Industry Structure
a. Five Forces Analysis
2. Business Models and Partnership Deal Structure
a. Business Models
b. Cerus/Baxter Partnership Deal Structure
c. Vitex/Pall Partnership Deal Structure
3. Competitive Factors
a. Broad Kill
b. Safety
c. Price
d. Ease of Use
e. Marketing Strength
f. Time to Market
4. R&D Expenditures and Cash Positions
5. Selected Industry Deals
B. Challenges and Strategies
1. Market Adoption
a. Safety Concerns and Lack of Resources Threaten Market Adoption
b. Developer and Marketing Partner Strategies Aimed at Overcoming Adoption Challenges
2. Fast Regulatory Approval
a. Long Regulatory Process Impedes Market Entry
b. Communication with the FDA Expedites Process
C. Awards
1. Market Engineering Leadership Award
a. Award Winner
2. Technology Leadership Award
a. Award Winner



List of Figures



Chapter 2



Pathogen Reduction Market: Blood Pathogen Tests (U.S.), 2002
Pathogen Reduction Market: Substitute Blood Products (U.S.), 2002



Chapter 3



Total Pathogen Reduction Market: Revenue Forecasts (U.S.), 2003-2013
Total Pathogen Reduction Market: Revenue Forecasts (Except U.S.), 2003-2013
Total Pathogen Reduction Market: Revenue Forecasts (World), 2003-2013
Pathogen Reduction Market: RBC Revenue Forecasts (U.S.), 2003-2013
Pathogen Reduction Market: RBC Revenue Forecasts (Except U.S.), 2003-2013
Pathogen Reduction Market: RBC Revenue Forecasts (World), 2003-2013
Pathogen Reduction Market: Plasma Revenue Forecasts (U.S.), 2003-2013
Pathogen Reduction Market: Plasma Revenue Forecasts (Except U.S.), 2003-2013
Pathogen Reduction Market: Plasma Revenue Forecasts (World), 2003-2013
Pathogen Reduction Market: Platelets Revenue Forecasts (U.S.), 2003-2013
Pathogen Reduction Market: Platelets Revenue Forecasts (Except U.S.), 2003-2013
Pathogen Reduction Market: Platelets Revenue Forecasts (World), 2003-2013
Total Pathogen Reduction Market: Total Available Market for Biologics Manufacturing (World), 2000-2006

Abstract

Push toward Zero-Risk Blood Supply Drives Market Adoption

The growing patient demand for a zero-risk blood supply is driving enormous investment into the development of pathogen reduction solutions by both small biotechnology firms as well as large medical device manufacturers. Promising data related to the efficacy and safety levels of pathogen inactivation systems emerging from both research labs and clinical settings are likely to provide an impetus for improved market penetration. The development of technologies capable of killing a broad range of pathogens without causing damage to blood products is also expected to encourage market expansion.

This Frost & Sullivan research examines the U.S. Pathogen Reduction Markets and includes world forecasts. It focuses on broadly applicable second-generation technologies linked to the red blood cell, plasma, platelets, and biologics manufacturing sub-segments. The study also discusses the prevailing market challenges and provides strategic recommendations to overcome them.

Immense, Untapped Potential Exists in Pathogen Reduction Market

Even though technologies are currently in development, the pathogen reduction market is essentially devoid of competition. Older technologies, such as solvent/detergent plasma, were regarded as being unsafe and did not have broad applicability, while newer testing technologies do not significantly decrease the window of time between the initial infection and the point at which a pathogen can be detected.

"Thus, blood banks eagerly anticipate a safe technology that will easily integrate into their processing systems, and reduce the risk of transfusion-related infections virtually to zero," says the analyst. Market success will be determined by the ability to offer cost-effective technologies with a broad kill range, strong safety profile, and ease of use. The facility to influence buyer decision-making processes coupled with first-mover advantage will also be critical to gaining a competitive edge.

Demonstrated Safety and Efficacy of Technologies Key to Enhanced Uptake

Commercialization is likely to suffer a setback if the number of cases of infection following the installation of pathogen reduction technologies equals the number of cases prior to installation. In such a scenario, there will be no motivation to pay a premium for technologies that fail to increase the safety of blood. Similarly, adverse effects resulting from toxicity or damaged blood products are certain to hamper commercialization. Therefore, demonstrating the safety and efficacy of pathogen reduction technologies will be crucial to boosting deployment.

"Although only one pathogen reduction system has been approved for marketing in Europe, incoming technologies, which are currently in trials, have thus far shown outstanding data regarding safety and efficacy, "states the analyst." This promising data, should it hold as trials continue, is likely to underline rapid and broad market adoption."

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