Diagnostics Industry / Molecular Diagnostics

Fast Growth in Molecular Diagnostics

Since 2000, sales of molecular tests have increased five-fold, and the number of companies and tests on the market has literally exploded. According to healthcare market research publisher Kalorama Information in its newly updated title, World Market for Molecular Diagnostics: Potential and Reality, What’s Hot and What’s Not, some 350 companies are actively involved in molecular diagnostics today, and although growth in the market for molecular assays has been very strong, it hasn’t been quite as robust as anticipated in 2007.

The world market for molecular tests grew its share of the IVD market from 2% in 1995 to about 10% in 2009. This is quite an achievement and stands as a testament to the spirit of innovation in the IVD industry. But recently, growth was somewhat slower than originally anticipated due in part to the economic recession, a lack of trained lab technicians, and increasing cost pressures. Kalorama forecasts growth of about 11% annually through 2015. That’s healthy growth, according to the report, but a little shy of the boldest predictions in the media and among industry analysts of twenty percent or more.

“Molecular diagnostics–one of the fastest growing segments in diagnostics–is becoming the dominant platform in clinical medicine and it has made rapid and timely information about infectious diseases and bacterial infections a reality,” notes Shara Rosen, R.T., MBA, Kalorama Information’s senior diagnostics analyst and author of the report. “New molecular tests are being launched all the time, many of which are CE Marked and FDA-cleared.”

The primary growth drivers in the molecular diagnostics market overall, are the continued discovery of genetic markers with proven clinical utility, the increasing adoption of genetic based diagnostic tests, and the expansion of reimbursement programs to include a greater number of approved diagnostic tests. The most attractive growth areas are molecular tests for women’s health, infectious diseases, organ transplant testing and oncology. Advances in cancer therapies and the allure of personalized medicine provide another compelling argument for growth in the market for molecular tests and technologies.

However, the contribution that these tests can make to patient outcomes faces some barriers including reimbursement programs that still lag behind the speed of innovation, competition from test services in some segments, complexity, and limited quality control products and programs, according to Kalorama.

“One of the major challenges facing molecular diagnostics is getting stakeholders–including payers, physicians, researchers and regulators–to work together to close the gap between research and clinical applicability,” notes Rosen.

World Market for Molecular Diagnostics: Potential and Reality, What’s Hot and What’s Not, separates fast-growth areas of molecular diagnostics from those that are slower-paced. It estimates the market and provides a realistic look at its role and its future in various market segments. The report discusses tests and technologies that are currently available and those in the pipeline. It also reviews the competitors in the market and their latest moves. For more information, please visit: http://www.kaloramainformation.com/redirect.asp?progid=81200&productid=2879023.

Molecular Diagnostic Solutions from Randox

Randox is revolutionising healthcare worldwide through continuously improving diagnostic solutions. An increasing range of our product offering includes Molecular Diagnostics. The demand for such diagnostics is rapidly rising and we are providing the highest quality solutions in order to improve the screening and diagnosis of individuals globally. Our range includes solutions for infectious diseases, respiratory diseases and colorectal cancer, with many more revolutionary arrays in development.

We have developed Biochip Array Technology, which allows the simultaneous detection of multiple analytes from a single sample. This provides significant time and cost savings. Our Molecular Arrays utilise this innovative technology to provide accurate, rapid and reliable results. Ranplex CRC Array is a mutation detection assay for the simultaneous detection of up to 28 mutations involved in the progression of colon cancer, targeting 4 CRC associated genes which are; KRAS, BRAF, APC and TP53.

The Randox STI Array is capable of simultaneously detecting 10 of the most common Sexually Transmitted Infections (STIs) from a single urine or urogenital swab. Simultaneous screening for multiple STI pathogens will identify specific viral, protozoan or bacterial pathogens, permitting targeted antibiotic therapy. This will also identify secondary infections, which may otherwise have been missed.

The Randox Respiratory Pathogens Array is capable of simultaneously identifying 22 viral or bacterial infectious agents of the respiratory tract from a single patient sample. Simultaneous detection of the most prevalent pathogens will provide a rapid and cost effective diagnostic tool, benefiting the patient by reducing the time from presentation to treatment and minimising sample requirements. Appropriate and timely treatment will reduce bed stays and will also improve antibiotic usage.


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