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Point of Care Testing: Evaluating the Return to Evidence Based Medicine, Novel Technologies and the Competitive Landscape

Business Insights, Jan 2010, Pages: 283


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Diagnostic practice is undergoing a quiet revolution, with IVD tests moving out of the centralized hospital laboratory to point of care testing (POCT) locations. POC tests are more expensive than lab-based tests, but promise to reduce the overall cost of healthcare while improving the quality of outcomes. They are thus attractive to manufacturers and increasingly in demand by physicians, patients, and healthcare providers.

This report explores the opportunities for POC testing provided by recent technology improvements, disease trends, and new marketing channels. It examines established and emerging health-related applications of POC diagnostics based on immunoassays, clinical chemistry, and nucleic acid testing. Within each POCT market sector, leading companies and their strategies and products are examined.

Key features of this report

- Examines different types of POC testing technologies and information they provide in clinical situations.

- Assesses current market satisfaction, areas of need and competition for POC testing in the areas of: diabetes; fertility; hemostasis; cardiology; infectious disease; drugs of abuse; automated urine/blood analysis; and cancer screening.

- Surveys analytes/biomarkers incorporated in commercial POCT products on the market and in commercial development in all the major application areas.

Scope of this report

- Understand the role of POC tests in diagnosis and monitoring in different clinical situations.

- Gain an insight into how the market for POC tests is shaping up in each of the major application areas.

- Identify competitors or potential collaborators developing improved or novel POC technologies and products.

- Assess established and emerging marketing channels for POC tests.

Key Market Issues

- In most countries, the average spending on IVDs is a very low percentage of the healthcare budget, but spending on POC IVDs which offer speed, convenience, and improved outcomes is set to grow at an increased rate.

- Since 2006, wider adoption of POC testing in the US has been driven by the issuance of testing guidelines by the National Academy of Clinical Biochemistry; the US market now represents more than half of the global POC testing market.

- Expanding medical and non-medical POC testing locations, which include fast-growing retail health clinics in the US, provide new marketing opportunities for manufacturers of POC tests.

Key findings from this report

- The POC testing market is forecast to grow from $13.4 billion in 2008 to $22.5 billion in 2013. The POCT market currently represents 25% of the total IVD market.

- There are many players in the POCT market and many diverse products. Examples of leading companies include Abbott Laboratories (glucose monitoring and blood analysis products), Inverness Medical Innovations (various consumer and professional products), Quidel (pregnancy and infectious disease products), and Cepheid (first POC molecular tests on the market).

- 130 companies have had their POC products CLIA waived by the FDA in the 3 year period prior to November 2009. Amongst these companies were 53 companies with glucose monitoring products and 39 companies with pregnancy testing products.

- Sales of glucose monitoring products accounted for 76% of the POCT market in 2008 and this sector is expected to remain the leading sector in 2013. However, POC testing for HbA1c is assuming increasing importance in diabetes.

Key questions answered

- What are the applications for POCT technologies in healthcare?

- Which are the prominent companies and products within each POCT market sector?

- How are the key players making an impact on the POCT market?

- Which POC tests have been CLIA waived in the last 3 years?


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