Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads

Nov 1, 2009
300 Pages - Pub ID: KLI2403357
Abstract Table of Contents Search Inside Report Related Reports

As Kalorama Information's lead diagnostic analyst finds, the point of care concept is at a crossroads: the technologies needed to make rapid testing a reality have arrived. But is healthcare ready?

Kalorama believes that the drive for wellness and the attention surrounding healthcare reform will focus attention on rapid diagnostics. However, according to Shara Rosen, RT, M.B.A., there are many challenges which must be overcome for point of care solutions to be fully utilized, and those companies willing to pivot strategies and best adjust to tomorrow’s healthcare marketplace may be rewarded.

This report, Point of Care Diagnostics 2010: Rapid Testing at a Crossroads represents the most current analysis of the role POC Diagnostics in today's in vitro industry. Other reports have looked at products, companies and revenue numbers, as this report does. But in her analysis Shara Rosen takes a bold look into the markets, technologies, and trends in decentralized testing with a special focus on the economics of rapid test use in critical care and emergency medicine. The report includes:

  • Markets for POC Diagnostics (Diabetes, Cardiac markers, Clinical Chemistry/Critical Care, Hematology, Coagulation, Drugs of Abuse/Therapeutic Drug Monitoring, Infectious Diseases, Pharmacodiagnostics, Sepsis, Oncology, Women’s health / Pregnancy/Fertility)
  • By Venue Revenue Estimates for Hospital POC, Physician POC and Other Venue
  • Review of Products in the Market
  • Forecasts to 2013
  • Markets and Forecasts for Self-Testing (OTC)
  • The role of EMR in the Point of Care Market
  • Possible Effects of Healthcare Reform
  • POLs, Home Monitoring, Alternate Samples and Other Trends
  • Successful Strategies of POC Companies
  • Profiles of Over 100 Companies Competing in this Market
There are many factors in the growth of POC testing- increasing numbers of diagnosed diabetics, people with cardiovascular disease, and other chronic conditions. It is also expected to play a role in a trend in health care to evaluate provider organizations for quality in care delivery. While this quality imperative is most apparent in pay-for-performance systems, it also provides a framework by which public funds can be used more rationally. This is an especially relevant technology given the U.S. healthcare reform efforts.

All countries are feeling the brunt of aging populations and an increased burden of chronic disease management. Employers and insurance companies are interested in improving the health of customers, and there are some innovative tactics developing in this area. The report is conservative in its predictions and offers a calculated look into the future, based on events currently taking place.

The report offers a quantitative assessment of specific markets in US dollars for 2008 and forecasted out to 2013. These data are provided in order to set the status quo of tests and technologies. However the report concentrates on how these will impact the economics of healthcare over the near term and longer when possible.

As part of Kalorama Information's comprehensive coverage, the following companies are discussed:

  • 23andMe
  • 3M Health Care
  • 77 Elektronika
  • A. Menarini
  • A/C Diagnostics
  • Abaxis, Inc.
  • Abbott Diagnostics
  • ABTECH Scientific
  • Accumetrics
  • ACIST Medical
  • Acrongenomics Inc.
  • Adeza Biomedical
  • ADIATEC
  • Aerscher Diagnostics
  • AgaMatrix, Inc.
  • Alfa Scientific
  • Alfa Wassermann
  • Alverix Inc.
  • American Bio Medica
  • Amic/Ortho
  • Amnisure International
  • Animas/J&J
  • ANP Technologies
  • Antigen Discovery Inc.
  • Apollo Hospitals
  • Arkray
  • AspenBio Pharma
  • Astron Clinica
  • AT First Diagnostic
  • Audit Diagnostics
  • Axis-Shield plc
  • Bayer Diabetes Care
  • Beckman Coulter
  • Becton Dickinson
  • Bedfont Scientific
  • Biohit Oy
  • BioIQ
  • bioLytical Labs
  • Biomagnetics Diagnostics
  • Biomerica, Inc.
  • bioMérieux
  • Bionime Corp.
  • Bio-Rad Laboratories
  • BIOSAFE Medical Technologies
  • Biosite/Inverness
  • Boditech Med
  • BodyTel Scientific
  • Branan Medical Corp
  • Burnet Institute
  • Calypte Biomedical
  • Careside Medical
  • Carolina Liquid Chemistries
  • Celerus Diagnostics
  • Chelsea Technologies
  • Chembio Diagnostic
  • Chempaq A/S
  • Chemtron Biotech
  • Cholestech Corp.
  • Claros Diagnostics
  • CLX Medical, Inc.
  • Combimatrix
  • Common Sense, Ltd.
  • Commonwealth Labs
  • Connectyx Technologies
  • ContraVac, Inc.
  • Decision Biomarkers
  • DexCom, Inc.
  • Diabetech, LP
  • Diabetes Sentry
  • Diaglobal GmbH
  • Diagnostic Devices
  • Diagnostics for All
  • Diagnostics for the Real World
  • Diazyme Laboratories
  • Digital Bio Tech
  • Diversa Limited
  • DNA Direct, Inc.
  • DNAFORM
  • DxNA
  • Echo Therapeutics
  • EKF-diagnostic GmbH
  • Enfora
  • Enigma Diagnostics
  • Enterix Inc.
  • Entra Health
  • Epocal, Inc.
  • EPS Bio Technology
  • ESA Biosciences
  • eScreen, Inc.
  • ExpressMD Solutions
  • EyeMarker Systems
  • Flexsite Diagnostics
  • Focus Diagnostics
  • Fora Care
  • GE Healthcare
  • GenBio
  • Gene Smart Wellness
  • Genexel-Sein Inc.
  • Gentag Inc.
  • Genzyme Diagnostics
  • Global Detection & Reporting
  • Glucometrics, Inc.
  • Google, Inc.
  • Guided Therapeutics
  • Hai Kang Life Corp.
  • Hain Lifescience GmbH
  • HandyLab, Inc.
  • HealthPia America
  • HealthPort
  • Helena Laboratories
  • Hema Diagnostic Systems
  • Hema Metrics
  • HemoCue AB
  • Hero Network Network
  • HMM GmbH
  • Hoana Medical
  • Home Access Health
  • Home Diagnostics
  • Horiba ABX
  • Idaho Technology
  • IDenta Corp
  • Identigene
  • IDEXX Laboratories
  • incentaHEALTH LLC
  • Innovative Biosensors
  • Instrumentation Laboratory
  • Insulet Corporation
  • Integrity Applications
  • Intel Corporation
  • International Technidyne
  • Inverness Medical Innovations
  • Knome
  • Lab Express
  • LifeAssays AB
  • Lifescan
  • LifeSign LLC
  • LifeStat
  • Lifestream Technologies, Inc.
  • Lifestyle Choices
  • Luminex
  • Luminous Medical
  • MACHEREY-NAGEL
  • Masimo Corp
  • Matritech
  • M-Biotech
  • Medical Automation Systems
  • MedMira Inc.
  • Medtronic Inc.
  • Menssana Research, Inc.
  • Meretek Diagnostics Inc.
  • Meridian Bioscience
  • Micromem Technologies
  • Micronics Inc.
  • MicroPhage, Inc.
  • MinuteClinic
  • Mitsubishi Kagaku Iatron
  • MP Biomedicals
  • Multilyte Limited
  • MycroLab Pty
  • Nanogen
  • Nanomix, Inc.
  • Nanosphere, Inc.
  • National Jewish Health
  • Navigenics, Inc.
  • Network Biosystems
  • Neuroptix Corp
  • Nihon Kohden
  • Noninvasive Medical Tech
  • Nova Biomedical
  • OPTI Medical Systems
  • OraSure Technologies
  • Orion Diagnostica
  • OrSense Ltd.
  • Ortho Clinical Diagnostics
  • OvumOptics, Inc.
  • Oxford Biosensors
  • Oxonica Diagnostics
  • Phadia AB
  • Philips Handheld Immunoassays
  • PlaCor, Inc.
  • PointCare Technologies
  • Polymedco
  • Practice Fusion
  • PreMD Inc.
  • PrimeraDx
  • Probe Scientific Ltd
  • Prometheus Laboratories
  • Psynomics
  • QBC Diagnostics
  • Qiagen
  • Q-linea
  • Quadraspec
  • QualSec, Inc
  • QuantRx Biomedical Corporation
  • Quidel Corp
  • Quotient Diagnostics
  • Radiometer A/S
  • Raman spectroscopy
  • Rapid Pathogen Screening
  • Rennesens GmbH
  • Response Biomedical
  • Rite Aid
  • Roche Diagnostics
  • Royal Philips Electronics
  • Safeway, Inc.
  • Screening Devices Canada
  • SEMOFS
  • Sentinel Bioactive Paper Network
  • SeraCare Life Sciences
  • Serotec
  • Siemens Healthcare Diagnostics
  • SIENCO
  • Smiths Detection
  • Smiths Medical MD
  • Soar BioDynamics
  • Solei Systems, Inc
  • Solianis Monitoring
  • SpectraScience, Inc.
  • Sphere Medical Ltd.
  • SpheroSense Technologies
  • Stanbio Laboratory
  • StatSure Diagnostic Systems
  • STD Test Express
  • STMicroelectronics
  • Synova Healthcare
  • Sysmex Corp
  • T2 Biosystems
  • Taidoc Technology
  • TelCare
  • Telus Corporation
  • Textronics, Inc.
  • Thermo Fisher Scientific
  • Tosoh Corp
  • Trinity Biotech
  • TwistDx, Ltd.
  • Tyrian Diagnostics
  • UnitedHealth Group
  • Veralight, Inc.
  • Veredus Laboratories
  • VeriChip Corporation
  • Via Medical Corp
  • Vital Diagnostics
  • Vivacta Limited
  • Walgreens
  • Wal-Mart Stores
  • Webahn Inc.
  • Ypsomed


Additional Information

New York, March 10, 2010 — Glycated hemoglobin (HbA1c) testing is one of the success stories of point-of-care diagnostics, and an area that will experience higher growth rates than other POC tests as a result of expert recommendations, new cases and booming mail-in test sales, according to the new report Point-of-care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads, by healthcare market research publisher Kalorama Information.

The test measures glucose attached to the blood protein hemoglobin, a well-established analyte related to the long-term evaluation of blood sugar control. Ideally, every insulin dependent diabetic should be tested for HbA1c every three months. The test will show its fastest growth in the U.S., and Kalorama estimates some 87% of diabetics aged 65 and over have been monitored with an HbA1c test.

“HbA1c tests offer a picture of the patient’s blood sugar control over the past two or three months, which can be useful in consulting with the patient,” said Shara Rosen, analyst for Kalorama Information. “It can be conducted at any time of day without fasting, and the value of hemoglobin glucose varies less than fasting plasma glucose (FPG) values.”

Kalorama estimates the global market for POC HbA1c tests was $230 million in 2009, but should rise to $350 million by 2013. This growth rate is fifty percent faster than the average POC testing product, according to the report. The self-testing portion, performed primarily by mail-in lab services, is only a small percentage of those revenues now, but it is showing faster sales growth than lab-based tests. Kalorama expects mail-in testing to grow at 25% for the next five years.

HbA1c testing products have been available for two decades and there are several competitors in the market. At least thirty companies now offer HbA1c assays for automated systems - Bio-Rad, Abbott Laboratories, Bayer/Siemens, Beckman Coulter, Siemens, and Roche Diagnostics among them. The market is growing in the United States but faces challenges worldwide, including high device costs for some diabetic world populations, inadequate consumer education, psychological and physical discomfort, and patient inconvenience.

In 2009, a committee of experts from the American Diabetes Association, the European Association for the Study of Diabetes, and the International Diabetes Association concluded that the A1C test should be the primary test used to diagnose pre-diabetes, type 1, and type 2 diabetes. The recommendations were reported at a symposium at the ADA 69th Scientific Sessions, held in New Orleans last year.

“These recommendations won’t impact the use of the established FPG tests immediately, but long-term they have the potential to make a major change in the way diabetes is diagnosed,” according to Rosen.

Kalorama Information‘s Point-of-care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads has forecasts of every significant area of point-of-care diagnostics, a discussion of industry trends, and extensive profiles of companies in the market. It is available at: http://www.kaloramainformation.com/redirect.asp?progid=77545&productid=2403357.

About Kalorama Information
Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services. Follow us on Twitter and LinkedIn

Please direct all media inquiries to:
Andrea Hiller
press@kaloramainformation.com
www.kaloramaInformation.com

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