Clinical diagnostics is an attractive and growing industry, with the majority of major diagnostic companies experiencing sales growth of over 10% in 2008, despite significant pricing pressures. However, achieving market growth is becoming increasingly challenging due to the difficulty in developing novel diagnostics for new high value markets, or which can add appreciable clinical benefit in existing markets.

This report provides an in-depth analysis of emerging opportunities and potential clinical advances across the diagnostics markets of coronary heart disease, heart failure, bacterial infections and viral infections. This report explores the major trends and issues that are shaping the development of novel diagnostics and assesses the future prospects of leading innovations.

The market segments with the greatest growth opportunities are identified and the competitive landscape of the market is also assessed, with profiles of nine major diagnostics companies, based on market presence, R&D focus, acquisitions, historical sales and number of immunoanalyzers.

Key Findings:

MRSA screening is the single most important new market for molecular diagnostics. The market is currently valued at $1.2 billion in the US alone, and could extend to $2.2 billion if screening technologies can be applied in smaller hospitals, out-patients facilities and long-term care facilities.

Novel multiplex assays for respiratory viruses may become widely adopted if effective antivirals become available, especially for the treatment of respiratory syncytial virus infections in the elderly.

The growing prevalence of common chronic conditions will increase immunoassay testing volumes. It is notable that one of the most promising new markets is for troponin, a cardiac biomarker which was originally approved in the US in 1996.

Novel technologies with enhanced sensitivities will open up new areas of research, although the clinical applications are still to be determined. Conventional immunoassays and polymerase chain reaction are likely to remain the most commercially significant technologies for the foreseeable future.

Negative pressure on growth is a barrier to the development of novel immunoassays. New test approvals by the FDA have fallen from a peak of 867 in 1997 to 248 in 2008.

Use this report to:

- Identify which novel diagnostics offer the greatest potential clinical advances within the cardiovascular, viral, and bacterial markets and compare their efficacy against conventional diagnostic techniques

- Understand the market dynamics that are shaping the in-vitro diagnostics market with this report’s analysis of key issues including pricing, barriers to innovation, factors driving testing volumes, regulatory changes and trends in 510(k) approvals

- Evaluate the growth prospects of key new markets such as nosocomial infections and respiratory virus multiplex panels, with this report’s estimates of potential market sizes and drivers/resistors to market growth

- Assess the competitive positions of leading diagnostics companies with this report’s analysis of the performances, market presence and R&D focus of Roche, Siemens Healthcare Diagnostics, Abbott, Ortho-Clinical Diagnostics, Beckman Coulter, Becton Dickinson, Bio-Rad, bioMérieux and Inverness Medical Solutions.

Explore issues including:

Incremental improvements in coronary heart disease detection. Novel markers in development, such as PAPP-A and PGF, may add incremental improvements in risk stratification and prognostic assessment. It is possible that new cardiac panels will emerge, which combine markers of inflammation, ischemia, plaque instability and necrosis.

Limited adoption of respiratory virus multiplex panels. Although several multiplex RVPs have been launched, it appears unlikely that they will become widely adopted until additional evidence demonstrates their cost-effectiveness. The market for RVPs may expand more rapidly if effective anti-virals become available, especially for respiratory syncytial virus.

Growth prospects in mature markets. The molecular diagnostic market has shown steady growth since the start of the decade, serving a high unmet clinical need. However, all the major existing submarkets, such as blood screening, sexually transmitted disease testing and clinical virology are now mature with modest growth prospects.

Discover:

- What are the future growth prospects for the in-vitro diagnostics market?

- Which areas offer the most promising growth?

- Which segments promise the most innovation?

- Which companies are in the strongest position?

- Which smaller companies are attractive?

- What are the current unmet needs in the market?

- What are the greatest areas of market uncertainty?



Table of Contents



134 pages

Publication Date : June 2009