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Originally Published IVD Technology November/December 2001

Clinical applications lead growth in immunoassay testing

Richard Park

Makers of immunoassays may have a solid niche in clinical applications but, according to one recent report, other areas could offer growing opportunities for sales in coming years.

Clinical applications are by far the dominant player in immunoassay testing, with revenues estimated to total $13.8 billion in 2001, according to an October report by Business Communications Company, Inc. (BCC; Norwalk, CT). The report, titled Immunoassays: Technologies, Markets, projects that revenues generated from clinical immunoassay testing will reach $16.8 billion by 2006 at an average annual growth rate (AAGR) of 4.1% (see table).

Application 2001 2006 AAGR%
2001–2006
Clinical 13,800 16,800 4.1
Food 414 760 12.9
Environment 17.8 23.1 5.4
Total 14,232 17,583 4.4
Projected worldwide sales of clinical, food, and environmental immunoassay applications, 2001 and 2006 (million $). Source: BCC.

In 1999, sales of actual immunoassay test kits and other related products exceeded $3.9 billion, according to a 2000 report by Theta Reports (New York City). Theta found that these immunoassay tests are used mostly in commercial and hospital-based laboratories, accounting for about 80% of all diagnostic testing conducted each year.

The BCC study estimates that global revenues of immunoassay testing in the clinical, food safety, and environmental areas will total $14.2 billion in 2001. At a growth rate of 4.4%, revenues from testing are anticipated to reach $17.6 billion by 2006 (see table).

The BCC report says that revenues from food safety and environmental immunoassay testing are also expected to show growth during the 5-year forecast period. For food safety immunoassay testing, revenues are estimated to increase from $414 million in 2001 to $760 million in 2006, at a growth rate of 12.9%. Revenues of environmental immunoassay testing are projected to rise at a growth rate of 5.4% from $17.8 million in 2001 to $23.1 million in 2006.

The BCC study points to the continuing need for immunoassay testing, as well as ongoing genetic research, as factors contributing to the growth of the immunoassay market.

“The number of different sample types between and within each field of clinical, food safety, and environmental immunoassay testing reflects the need for immunoassay testing methods and the versatility of immunoassay technology,” says the BCC report. “As the human genome–sequencing project nears completion and other organisms’ genomes are sequenced, the number of known proteins and potential number of proteins are increasing. The increase in the number of proteins available increases the potential number of diagnostic immunoassays in clinical, food, and environmental applications using current and developing technologies.”

Analysts generally agree with the BCC report’s findings that the immunoassay market will continue to grow.

“The global market for immunoassays continues to expand as new disease states are identified, new therapies become available, and the worldwide standard of living and access to healthcare improve,” says Joanne Stephenson, vice president for business development at Response Biomedical Corp. (Burnaby, BC, Canada). “This is the largest growth segment of the diagnostics market primarily due to the advent of portable immunoassay systems.”

Other analysts concur with the study’s conclusion that advances in genetic research will have a beneficial effect on the immunoassay market.

“There is opportunity for new diagnostic assays in the clinical, food, and environmental markets. The veterinary market is also a significant market segment that should be considered,” says Paul Wernke, an independent consultant in Strongsville, OH.

“The development of proteomics as an outgrowth of genomics will contribute to the growth of the immunoassay market,” adds Wernke. “However, proteomics will likely benefit the clinical and veterinary diagnostics markets more than the environmental and food markets. While information regarding genetic traits may be valuable for the clinical and veterinary markets, it is the expression of genes into proteins that will provide the most data about a subject’s current disease status.”

For more information about the report, contact BCC at 203/853-4266 or via e-mail at publisher@bccresearch.com.

Copyright ©2001 IVD Technology