DNA-based diagnostics are established in laboratory medicine with many of the top tests run for infectious disease. The U.S. market for DNA-based infectious disease tests is today a $1.1 billion industry. Nucleic acid testing (NAT) is used to screen blood supplies; DNA-based tests are rapidly emerging as an oncology standard as well; and newer tests are more slowly developing as a way to treat other non-infectious diseases such as chronic diseases and diseases of aging. However, they still operate largely outside of core medical practice today - which is the doctor’s office and hospital lab. Evidence that DNA-based testing can appreciably improve the quality of healthcare is still murky, but policymakers and scientific researchers believe that DNA-based diagnostics (also called genomics-based molecular diagnostics) will change the way medicine is practiced in the coming decades.
This Fuji-Keizai USA report examines the key players and issues in commercializing DNA-based diagnostics in the United States. It covers the market for testing products for infectious diseases, human cancers and pharmacogenomics, and the instrumentation needed to perform the tests. It analyzes U.S. market structure and size by major product segments. It covers distribution structure; development trends and technology advances; regulations and policies for genetic privacy, insurance coverage and DNA counseling; and a future market outlook through 2012 - including market drivers and obstacles.
The report contains profiles of 15 companies including U.S.-based public and private companies: Abbott Molecular Diagnostics, Celera, Genomic Health, Myriad Genetics, Gen-Probe and Life Technologies (formerly Applied Biosystems). For key players such as Siemens Healthcare, BioMérieux and Qiagen, whose core business operates in non-U.S. regions, we cover their U.S.-oriented activities and product portfolios. Others covered: Novartis V&D, Becton Dickinson, Interleukin Genetics, Hologic/Third Wave Technologies, and Decode. Most of the market-leading companies cater to the traditional medical channel and regulatory path, although companies having great success with largely unregulated laboratory-developed tests also factor into this report. Newer companies selling personal genomic scans directly to consumers are growing in number but are not the primary focus here, although they are covered briefly in the section C ( 27 companies).
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