Research and Markets has announced the addition of Frost & Sullivan’s new report "U.S. Inherited Disease Molecular Diagnostics Markets" to their offering.

This research service analyzes the market for the inherited disease molecular diagnostics markets. FDA-cleared genetic tests for CF and inherited thrombophilia are included. Key market drivers and restraints are ranked and discussed. Key technology and trends that will impact the market are identified. Revenue forecasts, a market share analysis, and a product analysis are also provided. The competitive structure is provided for cystic fibrosis test vendors, inherited thrombophilia test vendors, and laboratories that offer of cystic fibrosis testing. The major market challenges are outlined along with strategic recommendations to address them.

Research Overview

This Frost & Sullivan research service titled US Inherited Disease Molecular Diagnostics Markets focuses on the inherited disease molecular diagnostics (IDMDx) market, which includes the genetic test products for cystic fibrosis (CF) and thrombophilia that have achieved food & drug administration (FDA) clearance. This research service identifies the challenges facing diagnostic providers and offers recommendations for overcoming a competitive and uncertain market.

Market Overview

Greater Awareness and Enhanced Training among Physicians Drive Genetic Screening, Boosting the US IDMDx Markets

The US IDMDx market is one of the most developed markets in molecular diagnostics, encouraging the successful expansion and commercialization of future genetic tests. Increased awareness among physicians, along with enhanced training, is promoting genetic screening and driving this market. Genetic testing and molecular diagnostic techniques are being introduced in medical schools for the next generation of physicians entering the healthcare system, says the analyst of this research. These outreach efforts increase the overall awareness of the benefits of genetic testing and promote adoption.

The efforts of several advocacy groups were the key to achieving nation-wide screening of cystic fibrosis (CF) in newborns, a mandate that was recently implemented in December 2009. Based on the testing algorithm, which consists of an inexpensive enzymatic assay followed by a genetic test for confirmation, the new mandates will introduce approximately 100,000 additional genetic tests used for newborn screening. Such efforts help increase the frequency of CF genetic testing conducted in the United States.

The IDMDx market is also showing signs of maturity. The competitive landscape consists of a few market giants and several smaller niche firms. Additionally, the market is fairly saturated and limited due to the lack of repeat testing. Although market participants will continue to participate in this market, they will restrict their spending on resources and focus on maintaining market share, explains the analyst. There is a high degree of product standardization and new genetic tests in this market typically demonstrate minimal or incremental product improvements.

Vendors should adhere to internal quality standards, establish responsible marketing practices, and commit to benefiting patient care, despite molecular diagnostics being an uncharted market. The reputation of striving beyond basic federal requirements is a strong branding approach that can enable a company or product to survive the fierce competition of a maturing market. Integrating self-evaluation and internal standards will help build trust with the public and counteract the negativity about genetic testing that is rampant in the media, concludes the analyst. In addition, vendors should understand workflow pain points, current test volumes, and send-out practices of diagnostic tests for every individual client.