Immunodiagnostics and Nucleic Acid Testing Kits for the Veterinary Industry: Current status and future prospects

SUMMARY

EXECUTIVE SUMMARY

Two i vitro testing technologies - immunoassays and nucleic acid testing (NAT) - have significant applications for the animal health and breedingindustries. This report analyses the market for both types of testis and identifies trends and opportunities in each area. It also profiles arepresentative cross-section of companies offering immunoassay and/or NAT products and services, and presents extensive lists of commercialimmunoassay and NAT products on a species-by-species basis.

In 2002, diagnostics accounted for accounted for around 10% of the total animal health market, ie $1,100 million. Within the diagnostics segment,immunodiagnostics account for 35-40% of sales ($440 million) and nucleic acid-based tests account for around 4% ($44 million). The size of theveterinary immunodiagnostics and nucleic acid testing market is forecast to grow 33% in real terms during the period to 2008, an annualised growthrate of just under 5%.

The companion animal health sector continues to be the most successful segment of the animal health industry, and this sector will exhibitrelatively high growth rates, rising from its current value of 60% to 66% share of the total market by 2008. The cattle market will remainsignificant. Although better growth is expected in the pig and poultry product sector.

The veterinary immunoassay field continues to provide niche opportunities for diagnostic companies. In addition to infectious disease diagnosis,immunoassay-based testing plays an important role in areas such as allergies, endocrine dysfunction. Reproductive and post-natal care, blood typing,detection of drugs of abuse and food safety. The range of analytes is extensive, but most are niche products with low sales volumes and limitedsupplier competition. Certain immunodiagnostic product areas are very competitive: they include tests for heartworm (canine and feline), Brucellaabortus (bovine), bovine leukaemia, equine infections anaemia, progesterone (various species), Borrelia burgdorferi (canine), feline leukaemia virus,and feline immunodeficiency virus.

Currently more than half of all diagnostic testing by US veterinarians is still done at outside reference laboratories. However, as vets endeavourto provide better preventive healthcare in clinics increasingly devoted to small animal medicine, the uptake of in-clinic tests is likely to increase.Rapid immunoassays provide veterinarians with important information, which can be acted upon before the pet7s owner leaves the clinic. Increased useof rapid immunoassays may take some business away from testing laboratories, but it also has a stimulatory effect, since rapid immunoassays areprimarily screening assays and often require further confirmatory testing in a laboratory.

Sales of nucleic acid-based tests are predicted by Animal Pharm Reports to increase from $44 million in 2002 to $88 million by 2008. This doublingof the market will be driven by the increased use (and better performance) of NAT products for the rapid and reliable identification and monitoring ofinfectious diseases. Much of this growth will occur by the displacement of other products, including immunoassays, and, of course, it stars from arather low baseline. As microarray technologies mature, many more opportunities will be created in programmes aimed at identification of virulentstrains, disease eradication, and food safety improvement.

NAT is fundamentally transforming the animal breeding industry. A number of pioneering companies have already launched genetic testing products andservices that are enabling breeders to select animals which are free of genetic disease and/or endowed with economically important traits. A steepincrease in commercial activity in this area is eventually anticipated, but much work remains to be done to interpret the data emerging from thevarious animal genome sequencing projects.

The true prevalence of many infectious diseases is still unknown, particularly in the case of companion animals. Since many diseases areasymptomatic, subclinical, or have long latency periods, large numbers of animals may need to be screened. There is every reason for veterinarydiagnostic companies to become involved in this endeavour, since screening may result in validation of new commercial tests, both immunoassays andNATs.

The increased number of zoonotic diseases being recognised worldwide makes it imperative that human diagnostic companies become involved inveterinary testing aimed at the identification of reservoirs of zoonotic pathogens. This could lead to the development of new commercial tests, inparticular NAT-BASED TESTS, for pathogens that are currently not subjected to screening.