The Future of Molecular Diagnostics: Innovative Technologies Driving Market Opportunities in Personalized Medicine
NEW YORK, Nov. 8, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Molecular diagnostics, essentially the analysis of DNA and RNA at the molecular level, is a fast-growing business, made possible by the growing understanding of the human genome, which has spurred growth in the diagnostic business. Given the established importance of DNA in molecular biology and its central role in determining the fundamental operation of cellular processes, molecular diagnostics is making it possible to detect infectious disease and cancer more accurately at an earlier stage than before. The technology also is optimizing testing for sexually transmitted diseases and genetic testing. Molecular diagnostics is also addressing the need for tests that monitor the therapeutic efficacy of pharmaceuticals. In this way, it has evolved into an important business opportunity for in-vitro diagnostics makers.
Molecular diagnostics is expanding beyond just the identification of infections. It is becoming an integral part of disease management and therapy, finding such applications as patient stratification, drug regimen selection, toxicity avoidance, therapeutic monitoring, and detection of predisposition to disease. Hospitals and diagnostic laboratories using molecular diagnostic techniques need products that guarantee the highest levels of reliability and the greatest speed. Reliability is essential, because an inaccurate or missed diagnosis can be a matter of life and death. Another issue driving the need for new molecular diagnostics involves the ability of microorganisms to evade and even inactivate potent antibiotics, causing health care givers to be faced with substantial infectious disease challenges. The variety of technologies used in molecular diagnostics has transformed clinical laboratory medicine.
Key features of this report
• Explanation of how molecular diagnostics represents a business opportunity for the IVD industry. What is causing this growth -- increasing diagnostic efficiency, optimizing treatment with drugs.
• Evaluation of the drivers and trends behind the growth of molecular diagnostics…how the science and technology of molecular diagnostics is becoming more important to clinical labs and drug companies with its increasing sensitivity and new platform technologies.
• Key challenges facing molecular diagnostic manufacturers and those companies looking to enter the market: The need for developing simple to use, automated products; dealing with a complex regulator environment; gaining access to financing and innovation.
• Analysis of markets by key types of testing, products, and by country; analysis showing the top products and opportunities.
Scope of this report
• Understand each market in terms of size as well as its future potential.
• Understand which key products are already in the market place for each market segment analyzed.
• Evaluate in which segment future opportunities may lie for companies.
• Understand some of the key issues and challenges facing molecular diagnostics makers and their component suppliers. Potential entrants into the market can see what types of issues they will be facing.
• Learn about possible products from recent market developments mentioned in the report.
Key Market Issues
• To facilitate routine testing across a wider range of hospitals and reference laboratories, the market is demanding cost effective and simple-to-perform tests that have cleared the many regulatory hurdles. Automation is playing a key role in the development of tests that are easier and less expensive to operate.
• Infectious disease testing represents a large portion of the current market, given the re-emergence of infectious threats, including multidrug-resistant TB, new strains of HIV, and H1N1.
• Many drug companies are investing significantly in pharmacogenomics in anticipation of shaving years off the drug discovery and approval process, bringing potentially lucrative drugs to market much sooner.
• Through 2015, the molecular diagnostics market will grow at a double-digit pace, achieving an overall 14% compound annual growth rate to meet increasing demand for personalized medicine.
• Key areas of growth include infectious diseases, oncology, genetic testing and blood banking. A wide variety of drugs in late preclinical and early clinical development are being targeted to disease-specific gene and protein defects that will require coapproval of diagnostic and therapeutic products by regulatory agencies.
Key findings from this report
• Two important growth drivers in the clinical setting for molecular diagnostics include the need for new biomarker assays as well as for techniques that lower the cost per test, and which improve ease of use, data quality and turnaround time.
• Pharmacogenomics may be the most immediate new opportunity in the field. The ability or inability to metabolize a drug is genetically determined. Laboratories will be able to test an individual for variations in particular drug response genes. The test results would help the physician prescribe the right drug at the right dose in a regimen specifically tailored to that individual, maximizing the chances of therapeutic success. Pharmacogenomics offers the potential for reducing the average cost of developing a new drug, now well over $1bn.
• By far, most of the established market for molecular diagnostics lies in the North American region. The market is building in Europe, but is still at relatively an early stage in the rest of the world (Table 4.3) and (Figure 4.7). Geographically, the US and European markets are the most advanced in terms of adoption of molecular testing and make up the majority of the existing market.
• In the current market for HPV, only about 20% of women over the age of 30 are screened for HPV using DNA-based tests in conjunction with a standard Pap smear, which leaves a lot of room for market growth.
• Screening of blood products for HIV has largely eliminated transmission through blood transfusions or infected blood products in the developed world. From its discovery in 1981 until 2006, AIDS has killed more than 25m people. HIV infects about 0.6% of the world's population. In 2005 alone, AIDS claimed an estimated 2.4m to 3.3m lives, of which more than 570,000 were children. Molecular based technologies enable the sensitive identification of pathogens within a few hours, and quantitative techniques are particularly valuable in the management of chronic viral infections caused by HCV and HIV, when an assessment of viral load can be used to guide therapy and prognosis.
Key questions answered
• What are the advantages offered by molecular diagnostics over traditional diagnostics?
• How is molecular diagnostics gaining a growing role in clinical diagnostics?
• What are some of the factors driving the market for molecular diagnostic testing?
• What some important issues ad concerns facing manufacturers of molecular diagnostics?
• In which segments do business opportunities lie in the molecular diagnostics field?
• What type of market growth is expected for molecular diagnostics overall through 2015?
Table of Contents
Advances in molecular diagnostics
Executive summary 12
Introduction 12
Trends and drivers 13
Market developments 14
Markets 15
Chapter 1 Introduction 18
Summary 18
Perspective 19
Perspective 19
An emerging science 19
Understanding the human genome 21
Molecular level analysis 22
Personalized care 22
Individualized response 23
Early-stage diagnosis 25
Infectious disease 26
Viruses 27
Oncology 28
Diagnostics business opportunity 30
A growing role in diagnostics 30
Companion diagnostics and therapies 31
Diagnostics allowing early detection and treatment 32
Increased efficiency 33
Optimizing drug therapy 33
Significant regulatory concerns 34
Strengthening oversight 34
Improving patient outcomes 36
Optimizing instrumentation and chemistries 38
Advances in sample preparation needed 39
Automation 41
Chapter 2 Trends and drivers 48
Summary 48
Integral to traditional labs 49
Improved assay/test efficiencies 50
Targeting antibiotic resistance 52
Next generation ultrasensitive molecular diagnostics 54
Platform variety 55
PCR 56
Microfluidics 58
Biochips/microarrays 59
Others 60
Challenges and issues 62
Re-emergence of infectious diseases and other threats 64
Establishing accepted regulatory processes 66
Reimbursement 68
Medicare coverage 69
Chapter 3 Market developments 72
Summary 72
Extracting microRNAs from tissue 73
Cystic fibrosis genetic screening 74
PET scanning 75
Expanded medicare coverage 76
Ionian Technologies-Roche collaboration 77
Leukemia diagnostic kit cleared 77
New lung cancer test 78
AMD diagnostic 79
Key biomarker gene 80
Point of care instrumentation 81
Genotyping test launch 82
Innovative colon cancer diagnostic 83
Innovative pancreatic cancer diagnostic 84
Brain cancer companion diagnostic 85
Rapid thermocycling 86
Acquisition of AcroMetrix 87
Real-time PCR 87
APiX detection kit 88
Biomarker analysis 88
Genetic dermatology 89
Genome sequencing agreement 90
Chapter 4 Markets 92
Summary 92
Overview 93
Growth drivers 94
Future opportunities 95
World market forecasts 99
Geographical segmentation 101
Type of testing 103
Blood screening 103
HPV testing 105
Hospital acquired infections 108
HIV/HCV testing 110
Genetic testing 113
Oncology 116
STD testing 118
Chapter 5 Corporate profiles 124
Abbott Molecular 124
Company description 124
AcroMetrix 125
Company description 125
Adnavance Technologies Inc. 126
Company description 126
Affymetrix 127
Company description 127
Asuragen Inc. 128
Company description 128
AutoGenomics Inc. 129
Company description 129
Beckman Coulter Inc. 130
Company description 130
Becton Dickinson 131
Company description 131
Biocartis SA 132
Company description 132
BioHelix 133
Company description 133
bioMerieux SA 134
Company description 134
Bio-Rad Laboratories Inc. 135
Company description 135
Celera 136
Company description 136
Cepheid 137
Company description 137
CombiMatrix Corp. 138
Company description 138
Cytocell Ltd. 139
Company description 139
DiagnoCure Inc. 140
Company description 140
Diasorin SpA 141
Company description 141
Dx Assays 142
Company description 142
EliTech Group 143
Company description 143
Enzo Biochem 144
Company description 144
EraGen Biosciences 145
Company description 145
Fujirebio Diagnostics Inc. 146
Company description 146
Gen-Probe Inc. 147
Company description 147
Gene Express Inc. 148
Company description 148
GE Healthcare 149
Company description 149
Genomic Health Inc. 150
Company description 150
IBT Laboratories 151
Company description 151
Illumina Inc. 152
Company description 152
IntelligentMDx 153
Company description 153
InVivoScribe Technologies Inc. 154
Company description 154
IRIS International Inc. 155
Company description 155
Kreatech Diagnostics 156
Company description 156
Luminex Molecular Diagnostics Inc. 157
Company description 157
Myriad Genetics Inc. 158
Company description 158
Nanosphere Inc. 159
Company description 159
Norgen Biotek 160
Company description 160
Novartis International AG 161
Company description 161
OncoVista Inc. 162
Company description 162
Pall Gene Systems 163
Company description 163
Pathwork Diagnostics 164
Company description 164
PrimeraDx 165
Company description 165
Orion Genomics 166
Company description 166
Osmetech Molecular Diagnostics 167
Company description 167
Qiagen NV 168
Company description 168
RedPath Integrated Pathology Inc. 169
Company description 169
Roche Diagnostics 170
Company description 170
Rosetta Genomics Ltd. 171
Company description 171
Seegene 172
Company description 172
Siemens Healthcare 173
Company description 173
Singulex 174
Company description 174
Thorne Diagnostics Inc. 175
Company description 175
TrovaGene Inc. 176
Company description 176
Veridex LLC 177
Company description 177
Vita Genomics Inc. 178
Company description 178
Chapter 6 Appendix 180
Methodology 180
Glossary 181
Endnotes 184
Index 191
List of Figures
Figure 1.1: Molecular diagnostics: predicting response, early treatment of disease 25
Figure 2.2: Molecular Diagnostics 29
Figure 2.3: Integrating molecular diagnostics with therapeutics 32
Figure 2.4: Changing treatment protocols in clinical practice 42
Figure 3.5: Clinical potential of molecular diagnostics 49
Figure 3.6: Molecular diagnostics: challenges for developers 64
Figure 5.7: World Market for molecular diagnostics by geography, 2010 103
Figure 5.8: World Market for molecular diagnostics by application, 2010 103
Figure 5.9: Molecular diagnostics diagnosing cancer 117
ix
List of Tables
Table 5.1: Key players in molecular diagnostics 100
Table 5.2: World market for molecular diagnostics, 2009-2015, ($m) 101
Table 5.3: World Market for molecular diagnostics by geography, 2010, ($m) 102
Table 5.4: World Market for molecular diagnostics by application, 2010, ($m) 102
Table 5.5: Molecular diagnostics blood screening market, breakup by competition, ($m) 105
Table 5.6: Molecular diagnostics HPV testing market, breakup by competition, ($m) 108
Table 5.7: Molecular diagnostics hospital acquired infections testing market, breakup by competition, ($m) 109
Table 5.8: Molecular diagnostics HIV/HCV testing market, breakup by competition, ($m) 112
Table 5.9: Molecular diagnostics genetic testing market, breakup by competition, ($m) 116
Table 5.10: Molecular diagnostics oncology testing market, breakup by competition, ($m) 118
Table 5.11: Molecular diagnostics STD testing market, breakup by company, ($m) 122
Companies mentioned
Abbott Molecular, Adnavance Technologies Inc., Affymetrix, Asuragen Inc., AutoGenomics Inc., Beckman Coulter Inc., Becton Dickinson, Biocartis SA, BioHelix , bioMerieux SA , Celera , Cepheid, CombiMatrix Corp., DiagnoCure Inc., Diasorin SpA, EliTech Group, Fujirebio Diagnostics Inc., Genomic Health Inc., Gen-Probe Inc., IBT Laboratories, Illumina Inc., IntelligentMDx, InVivoScribe Technologies Inc., IRIS International Inc., Luminex Molecular Diagnostics Inc., Myriad Genetics Inc., Pathwork Diagnostics, PrimeraDx,
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