Nucleic Acid Testing: Technologies and Markets
Diagnostics Technologies
With the focus of R&D in the diagnostics industry currently geared towards nucleic acid testing (NAT), the global market is forecast to grow strongly � an average CAGR of 20.5% � to 2006. Update your knowledge with
this report and gain in-depth insights into this rapidly changing marketplace � from trends and opportunities in NAT technologies and clinical applications, to the major players and their strategies.
Nucleic Acid Testing: Technologies and Markets will enable you to:
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CONTENTS
LIST OF TABLES
EXECUTIVE SUMMARY
ABBREVIATIONS AND GLOSSARY
SCOPE AND METHODOLOGY
CHAPTER 1 INTRODUCTION TO NUCLEIC ACID TESTING
1.1 Introduction to nucleic acids
1.2 Introduction to probe-based nucleic acid testing
1.2.1 Probes used in nucleic acid testing
1.3 Probe-based nucleic acid testing and immunoassays
1.4 Probe-based nucleic acid testing protocols
1.4.1 Sample preparation
1.4.2 Nucleic acid amplification
1.4.3 Nucleic acid detection
1.4.4 Qualitative versus quantitative tests
1.4.5 Automation
1.5 Individualised medicine and nucleic acid testing
1.5.1 Genotyping
1.5.1.1 Drug resistance tests
1.5.1.2 Predisposition tests
1.5.1.3 Theranostic tests
1.5.2 Genotyping technologies
1.5.2.1 Probe-based technologies
1.5.2.2 Sequencing technologies
1.6 Nucleic acid testing costs and the drive towards miniaturization
1.7 Regulation and use of commercial nucleic acid testing products
CHAPTER 2 PRODUCT DEVELOPMENTS AND CLINICAL APPLICATIONS
2.1 Target amplification technologies
2.1.1 Thermocycling-dependent amplification
2.1.1.1 Polymerase chain reaction
2.1.1.2 Ligase chain reaction
2.1.2 Isothermal amplification
2.1.2.1 Strand displacement amplification
2.1.2.2 Transcription-mediated amplification
2.1.2.3 Nucleic acid sequence-based amplification
2.2 Signal amplification technologies
2.2.1 Branched DNA
2.2.2 Hybrid Capture
2.2.3 Cycling probe technology
2.2.4 Multiple Triplex Reporter Formation
2.3 Target and signal amplification
2.3.1 Rolling circle amplification technology
2.4 Alternatives to amplification
2.4.1 Tessera array technology
2.4.2 Target protection assay
2.4.3 ORIGEN technology
2.4.4 Zinc finger DNA-binding proteins
2.5 Multiprobe assays and biochips
2.5.1 Multiprobe assays
2.5.2 Biochips
2.5.2.1 Microarrays
2.5.2.2 Microfluidics
2.6 High throughput screening
2.6.1 Traditional amplification-based systems
2.6.2 Microarrays and microfluidics
2.6.3 Automated sample preparation
2.7 Fluorescence in situ hybridisation and comparative genomic hybridisation
2.8 Diagnosis of infectious diseases
2.8.1 Sexually transmitted bacterial diseases
2.8.2 HIV
2.8.2.1 HIV viral load
2.8.2.2 HIV drug resistance
2.8.3 Hepatitis B and hepatitis C
2.8.3.1 Viral load
2.8.3.2 Hepatitis B and hepatitis C drug resistance
2.8.4 Other viruses
2.8.5 Blood testing for viruses
2.8.6 Human papillomavirus and cervical cancer
2.8.7 Tuberculosis
2.8.8 Other pathogenic organisms
2.8.8.1 Bacteria, fungi and protozoa
2.8.8.2 Bacterial drug resistance
2.9 Genetic testing
2.9.1 Molecular diagnostics
2.9.2 Fluorescence in situ hybridisation and comparative genomic hybridisation
2.10 Forensic and identity testing
2.11 Transplant organ rejection prediction
2.12 Cancer
2.12.1 Diagnostic tests
2.12.1.1 Fluorescence in situ hybridisation-based tests
2.12.1.2 Colorectal cancer
2.12.1.3 Lung cancer
2.12.2 Predisposition tests
2.12.2.1 Hereditary breast cancer
2.12.2.2 Hereditary colorectal cancer
2.12.2.3 Hereditary kidney cancer
2.12.3 Theranostic tests
2.13 Predictive tests for non-cancer diseases
2.13.1 Cardiovascular disease
2.13.2 Alzheimer's disease
2.13.3 Other diseases and conditions
2.14 Tests for predicting drug toxicity
2.15 Evolution of rapid NAT formats
CHAPTER 3 THE WORLD MARKET FOR NUCLEIC ACID TEST-BASED DIAGNOSTICS
3.1 Introduction
3.2 Overview of nucleic acid testing trends
3.2.1 Diverse approaches to target amplification
3.2.2 Development of novel nucleic acid detection methods
3.2.3 Appearance of multiprobe assay formats
3.2.4 Evolution of biochip-based diagnostics
3.2.5 Exploration of point-of-care formats
3.2.6 Simplification of sequencing technology
3.2.7 Development of automated systems
3.2.7.1 Automation of amplification and detection
3.2.7.2 Automation of sample preparation
3.2.7.3 Automation of fluorescence in situ hybridisation-based diagnostics
3.2.7.4 Automation of biochip-based diagnostics
3.3 Overview of national markets
3.3.1 Population trends
3.3.2 Economic climate
3.3.3 Geographical opportunities
3.3.4 Quantitative breakdown
3.4 Nucleic acid testing market segments and forecasts
3.4.1 Introduction
3.4.2 Total nucleic acid testing market
3.4.3 Infectious diseases
3.4.3.1 Bacteria
3.4.3.2 Viral detection and load
3.4.3.3 Viral genotyping tests
3.4.3.4 Screening of blood donations
3.4.4 Cancer
3.4.4.1 Overall incidence
3.4.4.2 Cervical cancer screening
3.4.4.3 Chromosomal aberrations
3.4.5 Genetic testing
3.4.6 Forensic and identity testing
3.4.7 Disease predisposition and theranostics
3.4.8 Forecasts
3.5 Key players in the market and their strategies
3.5.1 Multinationals committed to nucleic acid testing diagnostics
3.5.2 Established biotechnology companies
3.5.3 Innovative start-ups
3.6 Intellectual property considerations and the nucleic acid testing market
CHAPTER 4 THE US MARKET
4.1 Introduction
4.2 Demographic details
4.3 Health services
4.4 Major diseases
4.4.1 Overview
4.4.2 HIV/AIDS
4.4.3 Hepatitis
4.4.4 Cervical cancer
4.5 Screening programmes
4.6 Diagnostics regulation
4.7 Diagnostics market
4.8 Imports and exports
CHAPTER 5 THE JAPANESE MARKET
5.1 Introduction
5.2 Demographics
5.3 Health services
5.4 Major diseases
5.4.1 Overview
5.4.2 HIV
5.4.3 Hepatitis
5.5 Screening programs
5.6 Diagnostic regulation
5.7 Diagnostic market
5.8 Imports and exports
CHAPTER 6 THE EUROPEAN MARKET
6.1 Prologue
6.1.1 Scope of this chapter
6.1.2 The European Community in vitro diagnostics Directive
6.1.3 European Community haemovigilance statement
6.2 United Kingdom
6.2.1 Introduction
6.2.2 Demographics
6.2.3 Health services
6.2.4 Major diseases
6.2.4.1 Overview
6.2.4.2 HIV
6.2.4.3 Hepatitis
6.2.4.4 Cervical cancer
6.2.5 Screening programmes
6.2.6 Diagnostics regulation
6.2.7 Diagnostics market
6.2.8 Imports and exports
6.3 France
6.3.1 Introduction
6.3.2 Demographics
6.3.3 Health services
6.3.4 Major diseases
6.3.4.1 Overview
6.3.4.2 HIV
6.3.4.3 Hepatitis
6.3.4.4 Cervical cancer
6.3.5 Screening programmes
6.3.6 Diagnostics regulation
6.3.7 Diagnostics market
6.3.8 Imports and exports
6.4 Germany
6.4.1 Introduction
6.4.2 Demographics
6.4.3 Health services
6.4.4 Major diseases
6.4.4.1 Overview
6.4.4.2 HIV
6.4.4.3 Hepatitis
6.4.4.4 Cervical cancer
6.4.5 Screening programmes
6.4.6 Diagnostics regulation
6.4.7 Diagnostics market
6.4.8 Imports and exports
6.5 Italy
6.5.1 Introduction
6.5.2 Demographics
6.5.3 Health services
6.5.4 Major diseases
6.5.4.1 Overview
6.5.4.2 HIV
6.5.4.3 Hepatitis
6.5.5 Screening programmes
6.5.6 Diagnostics regulation
6.5.7 Diagnostics market
6.5.8 Imports and exports
6.6 Spain
6.6.1 Introduction
6.6.2 Demographics
6.6.3 Health services
6.6.4 Major diseases
6.6.4.1 Overview
6.6.4.2 HIV
6.6.4.3 Hepatitis
6.6.5 Diagnostics regulation
6.6.6 Diagnostics market
6.6.7 Imports and exports
CHAPTER 7 KEY COMPANIES IN THE NUCLEIC ACID TESTING MARKET
7.1 Abbott Laboratories
7.1.1 Summary financial data
7.1.2 Company overview
7.1.3 Company strategy
7.1.4 Nucleic acid testing technology
7.1.4.1 Ligase chain reaction
7.1.4.2 Repair chain reaction
7.1.5 Nucleic acid testing diagnostic products
7.1.6 Nucleic acid testing-related collaborations
7.1.6.1 Digene
7.1.6.2 Vysis
7.2 Affymetrix
7.2.1 Summary financial data
7.2.2 Company overview
7.2.3 Company strategy
7.2.4 Nucleic acid testing technology
7.2.4.1 GeneChip system
7.2.4.2 Spotted arrays
7.2.4.3 Polymorphism analysis
7.2.5 Nucleic acid testing products
7.2.5.1 HIV GeneChip
7.2.5.2 CYP450 GeneChip
7.2.5.3 p53 GeneChip
7.2.5.4 HuSNP GeneChip
7.2.6 Nucleic acid testing-related collaborations
7.2.6.1 Beckman Coulter
7.2.6.2 Gemini Genomics
7.2.6.3 BioM�rieux-Pierre Fabre Vitek
7.2.6.4 Roche Molecular Systems
7.2.7 Nucleic acid testing-related litigation
7.3 Bayer
7.3.1 Summary financial data
7.3.2 Company overview
7.3.3 Company strategy
7.3.4 Nucleic acid testing technology
7.3.4.1 Branched DNA signal amplification technology
7.3.5 Nucleic acid testing products
7.3.5.1 Viral load tests
7.3.5.2 Other viral tests and systems
7.3.6 Nucleic acid testing-related collaborations
7.3.6.1 Innogenetics
7.4 Chiron Corporation
7.4.1 Summary financial data
7.4.2 Company overview
7.4.3 Company strategy
7.4.4 Nucleic acid testing-related collaborations
7.4.4.1 Gen-Probe
7.4.5 Nucleic acid testing products (Chiron/Gen-Probe)
7.4.5.1 Procleix HIV-1/HCV assay
7.4.5.2 Other Procleix assays
7.4.6 Nucleic acid testing-related litigation
7.5 CyGene
7.5.1 Summary financial data
7.5.2 Company overview
7.5.3 Company strategy
7.5.4 Nucleic acid testing technology
7.5.4.1 Target protection assay
7.5.4.2 Haystack Processing
7.5.4.3 Multiple triplex reporter formation
7.5.5 Nucleic acid testing products
7.6 Digene Corporation
7.6.1 Summary financial data
7.6.2 Company overview
7.6.3 Company strategy
7.6.4 Nucleic acid testing technology
7.6.4.1 Hybrid Capture signal amplification
7.6.5 Nucleic acid testing products
7.6.5.1 Women's cancers and infectious diseases
7.6.5.2 Blood viruses
7.6.6 Nucleic acid testing-related collaborations
7.6.6.1 Abbott Laboratories
7.6.6.2 Roche Molecular Diagnostics
7.7 Enzo Biochem
7.7.1 Summary financial data
7.7.2 Company overview
7.7.3 Company strategy
7.7.4 Nucleic acid testing technology
7.7.5 Nucleic acid testing products
7.7.5.1 PathoGene glass slide kits
7.7.5.2 Pathogen-specific microplate kits
7.7.5.3 Labelled probes
7.8 EXACT Sciences Corporation
7.8.1 Summary financial data
7.8.2 Company overview
7.8.3 Company strategy
7.8.4 Nucleic acid testing technology
7.8.4.1 Multiple mutation
7.8.4.2 Deletion technology
7.8.4.3 DNA integrity assay
7.8.4.4 Enumerated loss of heterozygosity
7.8.5 Nucleic acid testing products
7.8.5.1 Colorectal cancer DNA screening test
7.9 SEQUENOM
7.9.1 Summary financial data
7.9.2 Company overview
7.9.3 Company strategy
7.9.4 Nucleic acid testing technology
7.9.5 Nucleic acid testing products
7.10 Genaissance Pharmaceuticals
7.10.1 Summary financial data
7.10.2 Company overview
7.10.3 Company strategy
7.10.4 Nucleic acid testing technology
7.10.5 Nucleic acid testing products
7.10.5.1 Genetic test for responsiveness to albuterol/salbutamol
7.10.5.2 Genetic test for responsiveness to statins
7.11 Genetic Vectors
7.11.1 Summary financial data
7.11.2 Company overview
7.11.3 Company strategy
7.11.4 Nucleic acid testing technology
7.11.5 Nucleic acid testing products
7.11.5.1 EpiDNA product line
7.11.5.2 EasyID product line
7.11.5.3 EasyID pathogen-specific OligoPlate kits
7.11.5.4 EasyID diabetes risk evaluation
7.11.5.5 EasyID cardiovascular disease risk evaluation
7.11.6 Nucleic acid testing services
7.11.6.1 Thiopurine S-methyltransferase genotyping
7.11.6.2 CYP2D6 genotyping
7.12 Gen-Probe
7.12.1 Summary financial data
7.12.2 Company overview
7.12.3 Company strategy
7.12.4 Nucleic acid testing technology
7.12.4.1 Ribosomal RNA targeting
7.12.4.2 Transcription-mediated amplification
7.12.4.3 Hybridisation protection assay
7.12.4.4 Target capture
7.12.4.5 Dual kinetic assay
7.12.5 Nucleic acid testing products and services
7.12.5.1 Chlamydia trachomatis and Neisseria gonorrhoea tests
7.12.5.2 Mycobacterium tuberculosis test
7.12.5.3 Group A streptococcus test
7.12.5.4 Miscellaneous pathogen tests
7.12.5.5 Procleix HIV-1/HCV assay
7.12.5.6 Other Procleix assays
7.12.6 Nucleic acid testing-related collaborations
7.12.6.1 Chiron
7.12.6.2 Bayer
7.12.6.3 BioM�rieux
7.12.7 Nucleic acid testing-related litigation
7.13 IGEN International
7.13.1 Summary financial data
7.13.2 Company overview
7.13.3 Company strategy
7.13.4 Nucleic acid testing technology
7.13.5 Nucleic acid testing products
7.13.5.1 NucliSens infectious disease tests
7.13.5.2 Cancer gene screening
7.13.6 Nucleic acid testing-related collaborations
7.13.6.1 Organon Teknika
7.13.6.2 Roche
7.14 Innogenetics
7.14.1 Summary financial data
7.14.2 Company overview
7.14.3 Company strategy
7.14.4 Nucleic acid testing technology
7.14.5 Nucleic acid testing products
7.14.5.1 HIV and hepatitis B tests
7.14.5.2 Other nucleic acid testing products
7.14.6 Nucleic acid testing-related collaborations
7.14.6.1 Bayer
7.14.6.2 Roche
7.15 Myriad Genetics
7.15.1 Summary financial data
7.15.2 Company overview
7.15.3 Company strategy
7.15.4 Nucleic acid testing technology
7.15.4.1 Integrated proteomics platform
7.15.4.2 Population genetics
7.15.4.3 Single-reaction sequencing of double-stranded DNA
7.15.5 Nucleic acid testing products and services
7.15.5.1 Predictive medicine tests
7.15.5.2 Personalised medicine tests
7.15.6 Nucleic acid testing-related collaborations
7.16 Quest Diagnostics
7.16.1 Summary financial data
7.16.2 Company overview
7.16.3 Company strategy
7.16.4 Nucleic acid testing technology
7.16.5 Nucleic acid testing products and services
7.17 Roche Holding
7.17.1 Summary financial data
7.17.2 Company overview
7.17.3 Company strategy
7.17.4 Nucleic acid testing technology
7.17.5 Nucleic acid testing products
7.17.5.1 HIV
7.17.5.2 Hepatitis
7.17.5.3 Sexually transmitted diseases
7.17.5.4 Tuberculosis
7.17.5.5 Instrumentation
7.17.6 Nucleic acid testing-related collaborations
7.17.6.1 Affymetrix
7.17.6.2 deCODE Diagnostics
7.17.6.3 Digene
7.17.6.4 IGEN
7.17.6.5 Innogenetics
7.17.6.6 Applied Biosystems
7.17.7 Nucleic acid testing-related litigation
7.17.7.1 Chiron
7.18 Tibotec-Virco
7.18.1 Summary financial data
7.18.2 Company overview
7.18.3 Company strategy
7.18.4 Nucleic acid testing technology
7.18.5 Nucleic acid tests and services
7.18.5.1 VirtualPhenotype
7.18.5.2 Methylated methyl-guanine-DNA methyltransferase gene test
7.19 Visible Genetics
7.19.1 Summary financial data
7.19.2 Company overview
7.19.3 Company strategy
7.19.4 Nucleic acid testing technology
7.19.4.1 CLIP bi-directional DNA sequencing
7.19.4.2 OpenGene system
7.19.5 Nucleic acid testing products and services
7.19.5.1 TRUGENE HIV-1 GeneKit
7.19.5.2 GeneKits for other infectious agents
7.20 Vysis
7.20.1 Summary financial data
7.20.2 Company overview
7.20.3 Company strategy
7.20.4 Nucleic acid testing technology
7.20.4.1 Technologies for detection of genetic abnormalities
7.20.4.2 Ampli-Onc microarray
7.20.5 Nucleic acid testing products
7.20.5.1 Cellular Genomics products
7.20.5.2 Genomic microarray products
7.20.6 Nucleic acid testing-related collaborations
7.20.7 Nucleic acid testing-related litigation
References
LIST OF TABLES
Table 3.1 Worldwide in vitro diagnostic sales by country, 1998�2003
Table 3.2 European in vitro diagnostic market estimates, 2000
Table 3.3 Nucleic acid testing market segments
Table 3 4 Global estimates of people living with AIDS/HIV, end of 1999
Table 3.5 Worldwide cancer incidence and mortality
Table 3.6 Total population incidence of genetically determined disease
Table 3.7 Annual incidence of genetic disease in the European Community
Table 3.8 Nucleic acid testing market by application, 2000�2006 ($ million)
Table 3.9 Nucleic acid testing market by geographical region, 2000�2006 ($ million)
Table 4.1 US population and population projections, 1993�2020
Table 5.1 Demographic population and predicted demographic trend for Japan, 1990�2025 (thousand)
Table 6.1 The UK in vitro diagnostic market by sector, 1999
Table 6.2 The French in vitro diagnostic market by sector, 1999
Table 6.3 The French medical equipment import market, 1998
Table 6.4 The French medical equipment exports, 1998
Table 6.5 Germany's population and predicted demographic development, 1995�2020
Table 6.6 The German in vitro diagnostic market by sector, 1999
Table 6.7 AIDS incidence in Italy, 1985�1996
Table 6.8 Hepatitis incidence in Italy, 1990�1995
Table 6.9 The Italian in vitro diagnostic market sales by subgroup, 1999
Table 6.10 The Spanish in vitro diagnostic market by sector, 1999
Table 7.1 Abbott financial data, 1998�2000 ($ million)
Table 7.2 Affymetrix financial data, 1998�2000 ($ million)
Table 7.3 Bayer Group financial data, 1998�2000 ($ million)
Table 7.4 Chiron financial data, 1998�2000 ($ million)
Table 7.5 Digene Corporation financial data, 1998�2000 ($ million)
Table 7.6 Enzo Biochem financial data, 1998�2000 ($ million)
Table 7.7 EXACT Sciences Corporation financial data, 1998�2000 ($ million)
Table 7.8 SEQUENOM financial data, 1998�2000 ($ million)
Table 7.9 Genaissance Pharmaceuticals financial data, 1998�2000 ($ million)
Table 7.10 Genetic Vectors financial data, 1997�1999 ($ million)
Table 7.11 Gen-Probe financial data, 1998�2000 ($ million)
Table 7.12 IGEN International financial data, 1998�2000 ($ million)
Table 7.13 Innogenetics financial data, 1998�2000 ($ million)
Table 7.14 Myriad Genetics financial data, 1998�2000 ($ million)
Table 7.15 Quest Diagnostics financial data, 1998�2000 ($ million)
Table 7.16 Roche financial data, 1998�2000 ($ million)
Table 7.17 Visible Genetics financial data, 1998�2000 ($ million)
Table 7.18 Vysis financial data, 1998�2000 ($ million)
LIST OF FIGURES
Figure 1.1 Diagram showing base pairing in DNA
EXECUTIVE SUMMARY
The focus of research and development within the diagnostics industry is currently geared towards nucleic acid testing (NAT) assays, which offer greater specificity and sensitivity than immunoassays. The overall diagnostics industry is now worth $19 billion, and is growing slowly, but the NAT segment is very dynamic. One of the objectives of this report is to identify key growth areas now and also in the longer-term
We predict that the NAT market, which consisted mainly of infectious disease tests in 2000 (70% by value), will increase from $660 million to $2,017 million by 2006, an average CAGR of 20.5%. Most growth will occur in the infectious disease sector and will be driven by viral and bacterial detection, viral load testing, viral genotyping and blood screening. Genotyping tests are intended to detect clinically relevant characteristics, such as drug resistance. We also expect very strong growth, albeit from a low startpoint, in the disease predisposition/theranostics sector.
Relatively strong growth in Europe will cause the market share of the US to fall slightly, and indeed Europe will become the world's largest NAT market. Growth of NAT will be weaker in Japan, because of lingering economic difficulties and increasing cost-containment pressures. The highest growth rates will be seen in Latin America, although this will remain a small market in global terms.
One factor that will contribute to the expansion of the NAT market is the growing diversity of nucleic acid amplification techniques. The majority of infectious disease testing products currently on the market use target nucleic acid amplification. The dominant target amplification technology is Roche's PCR, but it is not available to most companies developing commercial diagnostic tests because of licence restrictions. A number of products based on competing target amplification technologies are now on the market. Most of these products utilise isothermal technologies that do not need thermal cycling and complicated instrumentation.
Signal amplification methods enable the detection of a specific nucleic acid sequence based on amplification of the signal emitted by the assay label. Products based on signal amplification technologies have begun to appear and will impact the market during the forecast period, as will products based on novel approaches to increasing NAT assay sensitivity that do not utilise amplification.
Growth is predicted mainly in the infectious disease sector, currently the most dynamic. This category includes both qualitative and quantitative tests. Tests are typically probe-based, and utilise amplification to increase their sensitivity. These include tests for bacteria (chlamydia, gonorrhoea and tuberculosis), and viral detection and load monitoring (predominantly HIV, hepatitis B (HBV), hepatitis C (HCV) and human papillomavirus (HPV)). HPV tests are used in conjunction with cervical cancer screening, as almost all cervical tumours contain the virus.
In chronic viral infections, drug resistance can emerge due to mutations of the virus. Genotyping tests can examine the viral nucleic acid from the infected individual to detect emerging drug resistance, thereby enabling therapy to be tailored to the individual patient. There is a growing clinical acceptance that genotyping is important in the treatment of viral infections such as HIV, HBV and HCV.
HIV genotyping tests have been developed which utilise either DNA probe or DNA sequencing technologies. Recently several significant new products have been launched, including the first genotyping kit based on sequencing, and a unique new test for resistance monitoring that combines and extends the best features of HIV genotyping and phenotyping. HBV and HCV also show high genetic variability and further growth in HIV, HBV and HCV genotyping is predicted. Ultimately, the concept of genotyping will be extended to a wider range of infections.
Unlike traditional single-probe assays, multiprobe assays allow the simultaneous detection of a number of target nucleic acid sequences. Multiprobe assays, which allow either simultaneous detection of key mutations associated with emerging resistance to the antivirals or simultaneous detection of viral subtypes, have appeared on the market.
The emergence of NAT technology for major blood-borne viruses, such as HIV, HBV and HCV, has stimulated growth in the blood screening market, with many developed countries now testing for these viruses. These tests are more sensitive and reduce the gap period between infection and detection.
Steady growth is forecast in the traditional areas of genetic testing � where most tests are still offered by specialist laboratories on a service basis, rather than in kit form � and in fluorescence in situ hybridization (FISH)-based cancer diagnostic tests. Instruments and reagents comprise only a small part of the fees for testing services, and only these costs are included in the market analyses. Similar considerations apply to forensic and paternity testing.
Developed countries are starting to embrace the concept of individualised (or personalised) medicine based on genetic profiling of patients, pathogens that infect them, and tumours they harbour. Advances in genomics are making it possible to predict individual disease predisposition (giving rise to predisposition tests) and to choose the therapy appropriate to individual patients' genetic make-up (giving rise to theranostic tests). Predisposition testing in cancer (such as hereditary breast cancer and hereditary colorectal cancer) and other diseases, such as cardiovascular disease, is currently available on a service basis. Theranostic tests are also becoming available in areas such as cancer, cardiovascular disease and Alzheimer's disease, as well as for predicting drug toxicity.
Escalating costs, the emergence of managed care and declining government funding have resulted in a price-sensitive market demanding simpler, more automated diagnostic methods. Automated sample preparation remains the last major hurdle in creating fully integrated nucleic acid analysis systems. Several companies already provide instruments for integrated DNA amplification and detection. Automation is a key issue for many other companies seeking to make an impact on the NAT market.
A number of companies are working to develop biochips (DNA microarrays and related microfluidics) suitable for clinical diagnostic applications. It is likely that in 5�10 years, biochips products will begin to make a significant impact on the clinical diagnostic market.
Although the NAT market is dominated by Roche, other large players, notably Abbott and Bayer, are committed to maintaining their leadership position. Many established biotechnology companies with significant intellectual property in this area are also playing to their strengths to claim an increased share of the market; examples include Gen-Probe, Chiron, Innogenetics, Digene, IGEN International, Organon Teknika, Affymetrix, Myriad Genetics and Vysis. In addition, a number of development-stage companies, such as Genetic Vectors, Visible Genetics, Sequenom, Tibotec-Virco, EXACT Sciences, Genaissance Pharmaceuticals and CyGene, have promising proprietary technologies that are expected to deliver the next generation of NAT products.
© PJB Publications Ltd. 2001
All rights reserved.