IMMUNODIAGNOSTICS AND NUCLEIC ACID
TESTING KITS FOR THE VETERINARY INDUSTRY:
CURRENT STATUS AND FUTURE PROSPECTS
TABLE OF CONTENTS
LIST OF TABLES
LIST OF ABBREVIATIONS
EXECUTIVE SUMMARY
CHAPTER 1 TECHNICAL BACKGROUND TO THE INDUSTRY
1.1 Chapter aims and contents
1.2 Immunoassays
1.2.1 Introduction
1.2.2 Competitive immunoassays
1.2.3 Sandwich immunoassays
1.2.4 Animal-site rapid immunoassays
1.3 Nucleic acid testing (NAT)
1.3.1 Introduction
1.3.2 Probe-based NAT protocols
1.3.3 NAT formats
1.3.4 NAT options
1.4 Immunoassays versus NAT
CHAPTER 2 THE WORLD MARKET FOR ANIMAL IMMUNODIAGNOSTICS
AND NAT
2.0 Chapter aims and contents
2.1 Market drivers and constraints
2.1.1 Overall growth in the companion animal sector
2.1.2 Increased public concern over food safety
2.1.3 Shift to preventive animal healthcare
2.2 Market constraints
2.2.1 Unpredictability of disease outbreaks
2.2.2 High (but decreasing) costs of NAT
2.3 Market opportunities
2.3.1 Companion animal sector
2.3.1.1 Combination screening
2.3.1.2 Integrated disease management
2.3.2 Production animal sector
2.3.2.1 Disease eradication programs
2.3.3 Control of zoonotic infections
2.3.4 Technological breakthroughs
2.3.4.1 Quantitative lateral flow assays
2.3.4.2 DNA microarrays and microfluidics
2.3.4.3 Whole genome sequencing projects
2.4 Market analysis
2.4.1 Market overview
2.4.2 Supplier structure
2.4.3 Customer characteristics
2.4.4 Quantitative analysis
2.4.5 Market projections by geographical region
and target animal
2.4.6 Regulatory issues
CHAPTER 3 THE MAJOR ANIMAL SPECIES AND THEIR ASSOCIATED
DIAGNOSTICS
3.1 Chapter contents and aims
3.2 Role of conventional diagnostics
3.2.1 Serological tests
3.3 Role of vaccination programs
3.4 Diagnostics including immunodiagnostics
3.4.1 Large farm animals
3.4.1.1 Economic significance
3.4.1.2 Diseases and diagnostics (by species)
3.4.2 Farm fish
3.4.2.1 Economic significance
3.4.2.2 Diseases and diagnostics
3.4.3 Horses
3.4.3.1 Economic significance
3.4.3.2 Diseases and diagnostics
3.4.4 Companion animals
3.4.4.1 Economic importance
3.4.4.2 Diseases and diagnostics
3.4.5 Reproductive status in various species
3.4.6 Food safety
3.4.6.1 Foodborne bacteria
3.4.6.2 Drug residues in foods
3.5 Emerging applications of NAT
3.5.1 Detection of pathogens.
3.5.3 Selection of animals for breeding
3.5.3.1 DNA identity
3.5.3.2 Testing for genetic diseases
3.5.3.3 Identification of desirable traits
CHAPTER 4 IMMUNODIAGNOSTIC AND NAT COMPANIES
4.0 Chapter aims and contents
4.1 Agen Biomedical Pty Ltd
4.2 Agrolabo SpA
4.3 ALerCHEK Inc
4.4 Avecon Diagnostics Inc
4.5 Biogal-Galed Labs
4.6 Bionor AS
4.7 Biovet Inc
4.8 Bio-X Sprl
4.9 Chembio Diagnostic Systems Inc
(subsidiary: Sinovus Biotech Inc)
4.10 Cypress Diagnostics CV
4.11 Diagnostic Products Corporation
4.12 DiagXotics Inc
4.13 DMS Laboratories, Inc
4.14 DRG Instruments GmbH
4.15 Euro-Diagnostica BV
4.16 Gene Check Inc
4.17 GeneSeek
4.18 Genetic Solutions Pty Ltd
4.19 Guildhay Ltd
4.20 HealthGene Corporation
4.21 Heska Corporation
4.22 IDEXX Laboratories Inc
4.23 MegaCor Diagnostik GmbH
4.24 Neogen Inc
4.25 Prionics AG
4.26 Synbiotics Corporation
4.27 TEST-Line Clinical Diagnostics Ltd
4.28 VetGen LLC
4.29 VITA-TECH Laboratories
4.30 VMRD Inc
CHAPTER 5 PRODUCT SURVEY
(This chapter consists of an extended table.)
APPENDIX 1 EXAMPLES OF ZOONOSES
APPENDIX 2 SPECIES AND DISEASES CONTROLLED BY VACCINES (UK)
LIST OF TABLES
Table 2.1: Global animal health market values, 1998-2002
Table 2.2: World animal health product sales by region, 2002
Table 2.3: World market structure by major product sector, 2002
Table 2.4: Sales of the leading animal health companies in 2002
Table 2.5: Animal health diagnostics market sizes,
$ million, 2002
Table 2.6: Veterinary diagnostic market in 2002 by geographical
region, $ million
Table 2.7: Veterinary diagnostic market by business segment,
2002, $ million
Table 2.8: Veterinary immunodiagnostic and NAT market to 2008,
by region, $ million
Table 2.9: Veterinary immunodiagnostic and NAT market to 2008,
by business segment, $ million
Table 3.1: Cattle: Diseases and diagnostics
Table 3.2: Pigs: Diseases and diagnostics
Table 3.3: Poultry: diseases and diagnostics
Table 3.4: Sheep/Goat: Diseases and Diagnostics
Table 3.5: Dog: diseases and diagnostics
Table 3.6: Cats: diseases and diagnostics
Table 3.7: Important Genetic Disorders of Dogs
Table 4.1 Financials, Agenix Ltd, $ million
Table 4.2: Agrolabo immunodiagnostics test kits
Table 4.3: Biogal immunodiagnostics test kits
Table 4.4: Bionor immunodiagnostics test kits
Table 4.5: Bionor immunodiagnostics test kits
Table 4.6: Bio-X Sprl immunodiagnostics products
Table 4.7: Cypress Diagnostics immunodiagnostic products
Table 4.8: Diagnostic Products Corporation,
financial data, $ million
Table 4.9: Diagnostic Products Corporation,
immunodiagnostics products
Table 4.10: DiagXotics, immunodiagnostics products
Table 4.11: DiagXotics, animal NAT products and services
Table 4.12: DMS Laboratories, immunodiagnostics products
Table 4.13: DRG Instruments, immunodiagnostics products
Table 4.14: Euro-Diagnostica, immunodiagnostics products
Table 4.15: Gene Check, immunodiagnostics products
Table 4.16: GeneSeek, immunodiagnostics products
Table 4.17: Genetic Solutions, immunodiagnostics products
Table 4.18: Guildhay, immunodiagnostics products
Table 4.19: HealthGene, immunodiagnostics products
Table 4.20: Heska Corporation, financials, $ million
Table 4.21: Heska: immunodiagnostics products
Table 4.22: Idexx Laboratories Inc, financial information,
$ million
Table 4.23: Idexx sales by operating division, 2001 and 2002
Table 4.24: Neogen Inc, financial data, $ million
Table 4.25: Neogen: Acquisitions, 1997-2003
Table 4.26: Neogen: animal immunodiagnostic and NAT products
Table 4.27: Synbiotics Corporation, financial details, $ million
Table 4.28: Synbiotics immunodiagnostics kits
Table 4.29: TEST-Line Clinical Diagnostics,
immunodiagnostics products
Table 4.30: VetGen animal NAT products
Table 4.31: VITA-TECH NAT
Table 4.32: VMRD products
Table 5.1: Laboratory immunodiagnostics for cattle
Table 5.2: Laboratory immunodiagnostics for pigs
Table 5.3: Laboratory immunodiagnostics for poultry
Table 5.4: Labaroatory immunodiagnostics for sheep and goats
Table 5.5: Laboratory Immunodiagnostics for fish
Table 5.6: Laboratory immunodiagnostics for horses
Table 5.7: Laboratory immunodiagnostics for dogs
Table 5.8: Laboratory immunodiagnostics for cats
Table 5.9: Laboratory immodiagnostics for miscellaneous species
Table 5.10: Laboratory Immunodiagnostic test for food borne
bacteria and drug residues
Table 5.11: Animal side rapid immodiagnostics
EXECUTIVE SUMMARY
Two in vitro testing technologies - immunoassays and nucleic acid testing
(NAT) - have significant applications for the animal health and breeding
industries. This report analyses the market for both types of tests and
identifies trends and opportunities in each area. It also profiles a
representative cross-section of companies offering immunoassay and/or NAT
products and services, and presents extensive lists of commercial
immunoassay and NAT products on a species-by-species basis.
In 2002, diagnostics 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 the
veterinary immunodiagnostics and nucleic acid testing market is forecast to
grow 33% in real terms during the period to 2008, an annualised growth rate
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 exhibit
relatively high growth rates, rising from its current value of 60% to 66%
share of the total market by 2008. The cattle market will remain
significant, although better growth is expected in the pig and poultry
product sectors.
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
limited supplier competition. Certain immunodiagnostic product areas are
very competitive: they include tests for heartworm (canine and feline),
Brucella abortus (bovine), bovine leukaemia, equine infectious 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 endeavour to
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 pet's owner leaves the clinic. Increased use
of rapid immunoassays may take some business away from testing
laboratories, but it also has a stimulatory effect, since rapid
immunoassays are primarily 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 doubling of
the market will be driven by the increased use (and better performance) of
NAT products for the rapid and reliable identification and monitoring of
infectious diseases. Much of this growth will occur by the displacement of
other products, including immunoassays, and, of course, it starts from a
rather low baseline. As microarray technologies mature, many more
opportunities will be created in programmes aimed at identification of
virulent strains, 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 and
services which are enabling breeders to select animals which are free of
genetic disease and/or endowed with economically important traits. A steep
increase in commercial activity in this area is eventually anticipated, but
much work remains to be done to interpret the data emerging from the
various animal genome sequencing projects.
The true prevalence of many infectious diseases is still unknown,
particularly in the case of companion animals. Since many diseases are
asymptomatic, subclinical, or have long latency periods, large numbers of
animals may need to be screened. There is every reason for veterinary
diagnostic companies to become involved in this endeavour, since screening
may result in validation of new commercial tests, both immunoassays and
NATs.
The increased number of zoonotic diseases being recognised worldwide makes
it imperative that human diagnostic companies become involved in veterinary
testing aimed at the identification of animal reservoirs of zoonotic
pathogens. This could lead to the development of new commercial tests, in
particular NAT-based tests, for pathogens which are currently not subjected
to screening.
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