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The Future of Molecular Diagnostics: Innovative technologies driving market opportunities in personalized medicine
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Caracteristicas de este estudio de mercado: | 191 paginás | |||||||||
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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 gro.....
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? Report Highlights Abbott Molecular, Adnavance Technologies Inc., Affymetrix, Asuragen Inc. , AutoGenomics Inc., Beckman Coulter Inc., Becton Dickinson, Biocartis SA, BioHelix , bioMérieux 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, [Cerrar las informaciones del articulo de mercado] |
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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 bioMérieux 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 [Cerrar la tabla de contenidos] |
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