Abstract
Market Trends, New Product Trends, Technology Trends, Distribution Structure and 15 Notable Company Case Studies
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, BioMerieux 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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