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The Future of Molecular Diagnostics: Innovative Technologies Driving Market Opportunities in Personalized Medicine
Business Insights, June 2010, Pages: 191
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?
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