Monitoring Health Through Novel Technologies: Where Are We with Point-of-Care Diagnostics?

Monitoring Health Through Novel Technologies: Where Are We with Point-of-Care Diagnostics? published by Decision Resources, Inc. in August, 2009. This report consists of 25 Pages and the price starts from US $ 4600.

Introduction

Abstract

Introduction

The point-of-care (POC) diagnostics segment of the in vitro diagnostics field once largely consisted of glucosemonitoring devices. With billions of dollars generated in revenue in the United States alone, POC testing has blossomed into a market that incorporates diverse indications and purposes. How has the push for personalized medicine affected change in diagnostics and pharmaceutical companies to warrant a need to align themselves with POC diagnostic test makers? Monitoring health at both acute and chronic disease stages of a patient' s life, POC tests can be adapted as clinical and personal tools to improve medical care. However, implementing POC testing to improve health outcomes can be tricky unless regulatory and reimbursement kinks are ironed out in the commercialization strategy for the product. Several prospects exist for advancing POC testing, particularly as the quality of products continues to improve and as efforts to raise awareness of the tests increase.

Get the Answers You Need to Shape Your Strategy

• Total revenues in 2008 for the top ten personalized medicine drugs exceeded $6 million. What are the leading drugs of this type? How do the revenues compare with 2007, 2006, and 2005?
• Biomarker-based diagnostics are the Achilles' heel of personalized medicine. Simple diagnostic methods that produce reliable results can help build a new drug market, while diagnostic methods that are challenging or too costly or do not easily lead to conclusive options for therapeutic follow-up can constrain the market. Where are POC diagnostics positioned in this scheme? How are they furthering personalized medicine efforts?
• POC diagnostic tests are getting more sophisticated and more powerful. Improved analytical quality, faster turnaround times, and easier-to-use interfaces are three key features of the next generation of POC tests. How are POC diagnostics changing medical practice? What market disruptions will impede further growth?
• Dealmaking activity for POC diagnostics over the last few years has not been particularly robust, yet more than 300 open studies are listed in clinicaltrials.gov as of July 29, 2009. What links these two findings?

Scope

• Key uses of POC diagnostic tests and underlying technologies: Diagnosing and screening, informing treatment decisions, safety testing, severity subtyping, multiplexing, miniaturization, immunoassays, PCR.
• Therapeutic focus: Cardiovascular disease, coagulation diagnostics, infl uenza screening, hospitalacquired infections, blood-glucose screening.
• Companies and partnering: Diagnostics companies, consortia, collaborations since 2006 to develop POC tests.
• Major challenges faced: Wooing physicians, navigating the regulatory maze, mitigating payer infl uences.
• Future of POC tests as a way to monitor health: Constraints, opportunities, thoughts on the outlook of the POC testing market.

Mentioned in This Report

• Abbott
• Abbott Diagnostics
• AstraZeneca
• AutoGenomics
• Axis Shield
• Bayer
• Becton Dickinson
• Biogen Idec
• bioMerieux
• bioLytical Laboratories
• Bio-Rad
• Biosite
• Bristol-Myers Squibb
• Cepheid
• Clinical Data
• Combimatrix
• DexCom
• eHIT
• Enigma Diagnostics
• Genelex
• Genentech
• Genethon
• GenoSafe
• GlaxoSmithKline
• Grove Instruments
• Health Frontiers
• Heart Watch
• HemoSense
• InLight Solutions
• Inverness Medical
• IQuum
• ITC
• Kimball Genetics/Third Wave Technologies
• Luminex Molecular Diagnostics (formerly Tm Biosciences)
• Medtronic
• Merck
• Meso Scale Discovery
• Nanogen (formerly Spectral Diagnostics)
• Nanosphere
• Novartis
• Novo Nordisk
• OSI Pharmaceuticals
• Osmetech Molecular Diagnostics
• Paragon Dx
• Pfizer
• Response Biomedical
• Roche
• Roche Diagnostics
• Sensys Medical
• Siemens Medical Solutions (formerly Dade Behring)
• Takeda/Millennium Pharmaceuticals
• Transgene

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Paradigm Shift in Health Monitoring
  • Pursuit of Personalized Medicine
  • Solid Groundwork in Multiplexing Technology
• Driving Innovation for Bedside Use
• Therapeutic Areas for POC Testing
  • Cardiovascular Disease
  • Coagulation Diagnostics
  • Infl uenza Screening
  • MRSA Infections
  • Blood-Glucose Screening
• Key Movers and Shakers
• Advancing the POC Testing Market
• Main Challenges
  • Physician-Patient Pathway
  • Regulatory Maze
  • Payer Infl uence
• Outlook

Tables

• 1. Select Commercially Available Point-of-Care Tests for Cardiovascular Disease
• 2. Genetic Warfarin Sensitivity Tests
• 3. Dealmaking in the Point-of-Care Diagnostics Field, 2006-June 2009
• 4. Select Companies Marketing or Developing Pharmacogenetic Screening Tests

Figures

• 1. Market Segmentation of Point-of-Care Diagnostics
• 2. Top Ten Drugs in Personalized Medicine, 2005-2008
• 3. Ability of the Pharmacogenetic and Clinical Algorithms to Correctly Identify Patients Requiring Warfarin
• 4. Attainment and Remaining Opportunity in MRSA Infections

Related Reports