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ROCKVILLE, Md., Sept. 22, 2017 /PRNewswire/ -- Immunoassays have long been the traditional testing type in in vitro diagnostics, and have been less of a focus of testing industry watchers while molecular approaches have received much attention. But this is changing according to a report from Kalorama Information. There is change in the $20.8 billion market for immunoassays and the finding was made in Kalorama Information's report Immunoassay Markets.

"There are a number of new and emerging disease areas where immunoassay innovations are expanding the market," said Bruce Carlson, Publisher of Kalorama Information. "We detail these in our report. Three stand out in particular, GI and transplant management in the medical condition assays and generally saliva-based testing as a vehicle is an interesting innovation."

Immunoassays are tests that are based on the binding of antibodies to antigens to identify the presence of a substance (an analyte). Immunoassays have been used in clinical laboratory medicine since the 1960s, and are indispensable tools in clinical diagnostics. A wide range of types of immunoassays is now used to measure proteins (including antibodies), hormones, drugs, and other analytes. Fully automated immunoassay systems are now found in clinical laboratories. Even though the field of immunoassays is now mature, companies have continued to develop new immunoassays and immunoassay instrument platforms to improve the sensitivity of the assays. New developments are designed to make multiplexing possible, to miniaturize the platforms for point-of-care, and to identify and develop assays for novel biomarkers, thus further expanding the potential of immunoassays for the future.

Transplant Management

Organ transplants have saved more than 2 million years of life in the United States over 25 years, according to a study published January 28, 2015 online edition of the journal JAMA Surgery.  However, less than half of the people who needed a transplant in that time period got one, because of a shortage of donors. A major role for immunoassays in transplant medicine is to adjust anti-rejection drug dosage. More and more transplant patients are being treated with multi-drug regimens that include mycophenolic acid (MPA), and studies suggest that therapeutic drug monitoring of MPA levels is helpful in patient management. Therefore, having the ability to monitor any combination of MPA, cyclosporine, tacrolimus and sirolimus therapy on one integrated instrument helps patients receive the optimal balance of therapy. This may not only save the transplanted organ, but also the life of the patient. 

Siemens Healthineers has offered an assay to monitor the dosage of immunosuppressant drugs given to transplant patients. In 2012, Siemens announced the availability of the Mycophenolic Acid assay (MPAT) on the Dimension Integrated Chemistry Systems in the U.S. According to Siemens, with this addition, the company becomes the first company to offer the consolidation of four fully automated immunosuppressant drug (ISD) assays on a single integrated chemistry system. The four ISD tests—mycophenolic acid, cyclosporine, tacrolimus and sirolimus—are the most commonly prescribed immunosuppressants used by physicians to prevent organ rejection.

Saliva-Based Immunoassays

A number of companies have developed saliva, or oral fluid, collection devices.  Some companies, such as OraSure Technologies, use their proprietary collection devices to provide the specimen for their own diagnostic tests. Several additional companies offer saliva collection devices that are commercially available for diagnostic and research applications. Today, several companies that market drugs of abuse testing also offer tests to measure alcohol levels in saliva or oral fluids.  Some also market tests for drugs of abuse in saliva samples. Outside of drugs of abuse and alcohol testing, the most successful company in saliva diagnostics is OraSure Technologies. While saliva is currently used for only a limited number of types of analytes, research is ongoing to identify and validate biomarkers in saliva for many other types of diseases. 

Gastrointestinal Disorders

Current methods for the initial clinical diagnosis of colitis and Crohn's remain challenging.  Healthcare providers rely primarily on the use of colonoscopies and biopsies. The development of a stool-based diagnostic test for IBD provides a non-invasive, cost effective alternative. Inflammatory bowel diseases (IBD), including Crohn's disease, celiac disease, and ulcerative colitis, are a chronic inflammatory condition of the intestinal tract. The condition can be difficult to diagnose and manage clinically while consuming a substantial amount of healthcare resources in terms of physician time, procedures and medications.

Kalorama Information's report projects brisk growth in these new markets and low to mid revenue growth in more traditional immunoassays. In its report, segments are defined with segment revenues and forecasts and companies are profiled. 

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website.  

Please link any media or news references to our reports or data to http://www.kaloramainformation.com/.

Press Contact:                                                        
Bruce Carlson
212 807 2262                                                         
bcarlson@marketresearch.com

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SOURCE Kalorama Information