The World Market for Molecular Diagnostics, 4th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas): Potential and Reality, What's Hot and What's Not

This report The World Market for Molecular Diagnostics: Potential and Reality, What's Hot and What's Not estimates the market for molecular diagnostics and provides a realistic look at the role of molecular testing and its future in various market segments. Kalorama Information's lead diagnostics analyst Shara Rosen, R.T., MBA, also reviews the competitors in the market and their latest moves.

There have been many predictions made about a molecular revolution in diagnostics. Indeed some are now taking place, while other predictions have not turned out to be true. How can companies sort out what is effective and what is not in this market?

World Market for Molecular Diagnostics: Potential and Reality, What's Hot and What's Not provides the insights needed to gain a clear picture of the industry, helping you to make better strategic decisions. It not only contains current market data for business planning but also goes beyond the numbers to fully assess what is going on in the market. For over a decade, Shara Rosen has reviewed the molecular diagnostics market. A lot has changed, and a lot has stayed the same. There is intense competition but also opportunities for entrants in some areas.

What are the important developments in the market? Who are the small innovators in this industry and how are the big players reacting to them? Which developments are "hot" and which trends have not caught on? In this report, Rosen provides answers to these questions.

The Rewards, Pitfalls and Competition of This High Potential Market

As we enter the second decade of the 21st century the investments in molecular biology, in bioinformatics, in disease management research and the unraveling of the human genome are bearing fruit. Almost every day the discovery of new molecular markers for cancer, cardiac disease, diabetes, arthritis, neurological diseases and psychiatric conditions are being announced.

Far from being a cheerleader of what is clearly a growth market, The World Market for Molecular Diagnostics -Potential and Reality, What's Hot and What's Not provides a detailed examination of molecular testing today. Among the data points the report provides are the following:

• Current Market Size and Forecast for Molecular Segments (Infectious Disease, Blood Screening, Histology, Oncology, Prenatal, Coagulation, Tissue Typing, Inherited Diseases, Pharmacodiagnostics and Other)
• Infectious Disease Molecular Sales by Disease (Hepatitis, HIV, GC/Chlamydia, HAI, Respiratory, Organism ID, Mycobacteria/TB, others)
• Revenues of Top Molecular Diagnostic Companies
• Recent Mergers and Acquisitions
• Revenues of Test Service Companies
• Geographic Breakout of the Molecular Diagnostics Market by Region (North America, Europe, Asia, ROW)
• Sample Prep Market, 2010 and 2015
• Breakout of Molecular Histology/Cytology Market (in situ hybridization, HPV, Tissue Microarrays), 2010 and 2015
• Important CLIA Lab Developments, 2008-2010

More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and have agreed to pay for them.

This renewed interest in IVD in general and more particularly in molecular diagnostics has lead to the commercialization of a number of technological tools that make more sensitive and specific tests possible. Some of these technological innovations include: cost-effective, multiplexed testing platforms coupled with high-powered software capabilities. In addition analyses using saliva, urine, and blood instead of biopsied tissue make for more patient-friendly test systems.

Extensive Company Profiles

Kalorama provides profiles of over 110 companies participating in the market. All of these companies have different strategies and compete in different areas, and Kalorama acknowledges this by separating the companies in a triage system based on where they stand in the molecular in vitro diagnostics market.

• "The Majors" - the top IVD companies participating in multiple IVD markets
• "The Participants"- Molecular diagnostic companies that are by now established in the market
• "The Stars"- Those companies that have shown better than average results
• "Newcomers"- Companies that have novel or interesting approaches to keep an eye on
• "High Potentials"- Companies that could show explosive growth but also could fall based on market developments
• "Specialists" in various areas (microbiology, histology, quality control, sample prep)

A Realistic Look at The Need-To-Know Trends

Molecular diagnostics is a complicated market that requires a thorough analysis to understand. Many reports make bold predictions which later are proved incorrect by market events. In this report, Kalorama Information provides revenues and market forecasts, but also looks deeply at some of the trends in the market and what might impact results in the future. The report summarizes what is working and what is not working in the past few years. Shara Rosen, RT, MBA, looks at the 'Hot' Trends and the 'Lukewarm' Trends, including:

• New Platforms Making Their Mark based on Miniaturization and Biochips
• The Growing Significance of Quality Control Products and Innovations in this area
• The Sequence Begins: Innovations in DNA Sequencing, Key Players and its Future in Clinical Medicine
• Pharmacodiagnostics and Where it Stands in 2011
• The Latest Growth Numbers of LDTs, regulatory activity, and their impact on the Market
• The $1000 Genome - If and When
• Miniaturization and Multiplexing
• The Ongoing Saga of Patents
• Healthcare Reform and Reimbursement Trends
• Integrated Sample Preparation and System Automation - A Growing Number of Competitors
• Developments in Mass Spectroscopy
• Screening for Wellness: the Latest on Consumer Tests

Market size and forecasts in the report are for manufacturer's revenues. Secondary and primary resources, including: trade publications, annual report and interviews with key executives in molecular diagnostics were used for this study.

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Kalorama Sees Fast, But Not Explosive, Growth in Molecular Diagnostics

Since 2000, sales of molecular tests have increased five-fold, and the number of companies and tests on the market has literally exploded. According to healthcare market research publisher Kalorama Information in its newly updated title, World Market for Molecular Diagnostics: Potential and Reality, What's Hot and What's Not, some 350 companies are actively involved in molecular diagnostics today, and although growth in the market for molecular assays has been very strong, it hasn't been quite as robust as anticipated in 2007.

The world market for molecular tests grew its share of the IVD market from 2% in 1995 to about 10% in 2009. This is quite an achievement and stands as a testament to the spirit of innovation in the IVD industry. But recently, growth was somewhat slower than originally anticipated due in part to the economic recession, a lack of trained lab technicians, and increasing cost pressures. Kalorama forecasts growth of about 11% annually through 2015. That's healthy growth, according to the report, but a little shy of the boldest predictions in the media and among industry analysts of twenty percent or more.

"Molecular diagnostics--one of the fastest growing segments in diagnostics--is becoming the dominant platform in clinical medicine and it has made rapid and timely information about infectious diseases and bacterial infections a reality," notes Shara Rosen, R.T., MBA, Kalorama Information's senior diagnostics analyst and author of the report. "New molecular tests are being launched all the time, many of which are CE Marked and FDA-cleared."

The primary growth drivers in the molecular diagnostics market overall, are the continued discovery of genetic markers with proven clinical utility, the increasing adoption of genetic based diagnostic tests, and the expansion of reimbursement programs to include a greater number of approved diagnostic tests. The most attractive growth areas are molecular tests for women's health, infectious diseases, organ transplant testing and oncology. Advances in cancer therapies and the allure of personalized medicine provide another compelling argument for growth in the market for molecular tests and technologies.

However, the contribution that these tests can make to patient outcomes faces some barriers including reimbursement programs that still lag behind the speed of innovation, competition from test services in some segments, complexity, and limited quality control products and programs, according to Kalorama.

"One of the major challenges facing molecular diagnostics is getting stakeholders--including payers, physicians, researchers and regulators--to work together to close the gap between research and clinical applicability," notes Rosen.

World Market for Molecular Diagnostics: Potential and Reality, What's Hot and What's Not, separates fast-growth areas of molecular diagnostics from those that are slower-paced. It estimates the market and provides a realistic look at its role and its future in various market segments. The report discusses tests and technologies that are currently available and those in the pipeline. It also reviews the competitors in the market and their latest moves.