Global Market for POC Diagnostics

07 July 2004

Espicom Healthcare Intelligence
December 7, 2007
564 Pages - Pub ID: ESPI1635947

Covering

• Blood Glucose
• Cardiology
• Coagulation
• Blood Gas/Electrolytes
• Infectious Diseases
• Pregnancy/Fertility
• Clinical Chemistry/Urinalysis
• Haematology
• Drugs of Abuse
• Tumour Markers
• Data Management
• Emerging Research Trends

Additional Information

The global point of care (POC) testing market is currently estimated to be worth US$11.3 billion in 2007 and is growing at 11% a year. POC testing accounts for approximately 34% of the US$33.6 billion global in-vitro diagnostic (IVD) testing market. Diagnostic testing accounts for only between 1-2% of government healthcare expenditures worldwide, yet influences between 60-70% of healthcare decisions.

The changing face of the POC industry Double digit growth expectancy for POC testing has spurred considerable investment and interest from the industry. Although the POC sector is, in many respects, relatively immature it is already characterised by a great deal of M&A activity.

The most active acquirer at present is Inverness Medical Innovations which has made multiple acquisitions in recent years, buying up leading companies such as Biosite, Cholestech and Hemosense among others, and providing the company with a significant presence in cardiology and other segments.

Unsurprisingly, the POC market has also seen moves by large multinationals which previously had no presence in the IVD market. Siemens, for example, made major acquisitions to establish its diagnostics division, with Diagnostics Products Corporation and Bayer Diagnostics coming under the Siemens umbrella in 2006 at a cost of US$5.7 billion. The company has also just completed the acquisition of leading diagnostics company, Dade Behring, in a transaction valued at approximately US$7 billion.

3M Health Care also established a new medical diagnostics business in March 2007 and has already entered alliances with Response Biomedical and Gen-Probe in its aim to become a leader in screening for hospital and community-acquired infectious diseases. Strategic alliances such as this are a key feature of this rapidly evolving market, with many combining the innovations of smaller companies with the strong established distribution channels of large multinationals. A positive outlook for this rapidly growing sector Drivers of growth

Healthcare Trends

Rising health costs have created new expectations in hospitals including shortened patient stays, and a movement from an inpatient to an outpatient or ambulatory setting.

As hospitals become treatment centres for the acutely ill and no longer serve primarily as diagnostic centres, the subsequent change in the patient's hospital stay and patient acuity have placed demands on the laboratory to deliver information in a manner which will facilitate rapid diagnosis and treatment. Because these demands have compressed the timeframe for performing testing, shorter turn around times and an increase in the volume of stat testing have become a necessity.

Social Pressure

Many patients today have greater medical knowledge, more money and greater expectations of healthcare services. They are demanding faster, more effective treatment and want greater control of their health.

Industry Pressure

Manufacturers are driving growth through the development of diagnostics instruments and tests that are simple and easy to use specifically for the POC environment. Many of the devices have data management capabilities to enable them to be linked to hospital information systems for the capture of patient data.

Technology Advancements

High-quality lab tests are now available at the point of care with smaller test systems suitable for POC environments and automated features of new POC instruments. Wider test menus - a greater variety of tests have been developed for POC instruments. Increase in the availability of home-testing devices. Increased use of data management tools to handle POC test data and costs throughout the healthcare system. Quality Control - advances in software to either automate quality control or alert operators to perform QC before a patient sample is analysed. Future multiplex systems offering the promise of more cost-effective testing with several parameters measured from just one sample.

Future developments...

It is clear that technological advancements in POC equipment will be a future growth driver in the POC market. Various companies are developing multiplex assay systems which enable the simultaneous measurement of numerous analytes from one small sample. This represents a major advancement in POC testing and offers the opportunity of lower costs and a reduction in the number of tests performed.

Broad interest in pharmacogenetic testing is developing rapidly as clinical laboratories, physicians, payers, patients, and pharmaceutical companies seek to provide the most appropriate treatment for each patient, while mitigating the high costs of healthcare and drug development. Advances in nucleic acid testing technologies have contributed to this growing interest by enabling rapid, multiplex genotyping analysis, which is required for widespread adoption of pharmacogenetic testing by clinical laboratories.

Volume I: Company Analyses

Volume I of the report provides extensive company information on 80 leading companies focusing on:

• Product portfolio
• Research programmes
• Whos working with whom?

The POC testing market comprises three high growth sectors:

• Consumer self-testing
• Primary care laboratory testing
• Hospital testing

The POC market for rapid diagnostic products consists primarily of small and medium sized, non-centralised laboratories and testing locations such as POL's, specialist mobile clinics, emergency rooms and some rapid-response laboratories in larger medical centres. This market is dominated by leading manufacturers such as Roche Diagnostics, Bayer Healthcare, Inverness Medical Innovations and Abbott Laboratories.

LEADING COMPANIES COVERED IN VOLUME I

• 3M Medical Diagnostics
• Abaxis
• Abbott Diagnostics
• Acrongenomics
• Aerscher Diagnostics
• Alfa Scientific Designs
• Amnisure International
• Analyte Works Ltd.
• Arkray
• At First Diagnostic
• Audit Diagnostics
• Axis Shield
• British Biocell International
• BBI Enzymes
• BD Diagnostics
• Beckman Coulter
• Biolytical Laboratories
• Biomerica
• Biomérieux
• Bio-Rad Laboratories
• Biosafe
• Branan Medical
• Care Products
• Chembio Diagnostics
• Chempaq
• Church & Dwight
• Diagnostic Test Group
• (RAC Medical)
• Eumed Biotechnology
• Fisher Healthcare
• Flexsite Diagnostics
• Genzyme Diagnostics
• Helena Laboratories
• Hema Diagnostic Systems
• Home Access Health Corp
• Horiba Abx
• IND Diagnostic
• Instrumentation Laboratory
• International Technidyne Corp
• Inverness Medical Innovations
• Iris Diagnostics
• Jant Pharmacal
• Lifestyle Choices Ltd
• Medmira Laboratories
• Menarini Diagnostics
• Medtronic
• Nanogen
• Nova Biomedical
• Omega Pharma
• Orion Diagnostica
• Orsense
• Ortho-Clinical Diagnostics
• Opti Medical
• Polymedco
• Polymer Technology Systems
• Prima Biomedical
• PreMD Inc
• Princeton Biomeditech
• Probe Scientific
• Proteome Systems
• Quest Diagnostics
• Quidel Corporation
• Radiometer
• Remel
• Response Biomedical Corp
• Roche Diagnostics
• Rohto Pharmaceutical
• Runbio Biotech
• SA Scientific
• Siemens Medical Solutions Diagnostics
• Sienco
• Stanbio Laboratory
• Syntron Bioresearch
• Sysmex
• Telcor
• Tosoh Bioscience
• Trinity Biotech
• Via Medical
• Waypoint Biomedical

Volume II: Market Sectors

Volume II of the report looks more closely at the issues and markets as a whole and focuses on current and novel development in the following key sectors:

• Blood Glucose
• Cardiology
• Blood Gas/Electrolytes
• Coagulation
• Haematology
• Infectious Diseases
• Pregnancy/Fertility
• Drugs of Abuse
• Tumour Markers
• Clinical Chemistry/Urinalysis

Currently, the consumer self-testing market is by far the largest segment of the POC diagnostics market, and mainly comprises blood glucose testing and pregnancy testing, with blood glucose testing accounting for the lions share. Fuelled by an ageing population and obesity, the number of people with diabetes is rising worldwide and it is now the fourth leading cause of death in most developed countries.

Beyond blood glucose monitoring we believe the fastest growing segments in the POC testing market are infectious disease testing and cardiac testing owing to the increased number of tests available and greater demand for such tests. The infectious disease testing market is primarily being driven by the increasing incidence of certain diseases, including viral hepatitis, respiratory syncytial virus (RSV), influenza, tuberculosis, HIV and other STDs, as well as the rapid rise in hospital-acquired infections (HAIs).

In the cardiac segment, the global need for anticoagulation treatment and monitoring is expected to double within the next decade. Currently, an estimated 7-8 million patients worldwide, including 3.9 million in the US, take oral anticoagulants such as warfarin to help reduce the body's chances of forming harmful blood clots. In addition to the companies in Vol I, there is development coverage of companies in Vol. II which include: