Molecular diagnostics represents a revolution postponed, perhaps, but one that is now clearly underway. DNA Testing has emerged fully from research into clinical practice and becoming a dominant platform in clinical medicine.

From Emerging to Emergent Technology

Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. At each step of the way, Kalorama Information has reported on its progress, and in this latest market research report we look at the present state of the market, and the advances that have made DNA testing routine.

Many molecular tests are CE Marked and FDA-cleared and many more are in development. The result is that molecular testing is indicated in many areas of health care.

Molecular Testing Compiled and Analyzed and Explained by a Leading Expert

Authored by lead Kalorama diagnostic analyst Shara Rosen, Kalorama Information’s World Market for Molecular Diagnostics is the most comprehensive global market report available on the emergent field of molecular diagnostics.

This report covers key platforms of molecular diagnostics, including the following :

• Polymerase Chain Reaction (PCR)
• Non-PCR Amplification Technologies, including:
  • bDNA
  • TMA
  • SDA
  • LIPA
  • NASBA
  • Invader
  • Others
• In-situ Hybridization
• Sequencing
• Microarrays
• Laser Capture Microdissection (LCM) and Tissue Arrays
• Mass Spectroscopy
• Other Molecular Platforms

This report provides market estimates and analysis for molecular diagnostics in the following categories:

• Infectious Diseases (including HIV, Hepatitis GC/Chlamydia,Organism ID, MRSA, HAI et al, Mycobacteria, TB Respiratory, Others)
• Blood Screening
• Histology
• Oncology
• Prenatal
• Coagulation
• Tissue Typing
• Inherited Diseases
• Pharmacodiagnostics

The various clinical techniques and trends are discussed from the point of view of their present and potential market impact.

Market analysis in this report covers world markets for in vitro diagnostics, with focus on the developed areas of the globe — North America and Western Europe. However public health and infectious disease are a growing global problem and where possible the report covers IVD products related to the globalization of diseases.

As part of its exhaustive coverage of nucleic acid testing, the report includes the following:

• Market Sizes and Forecasts
• Profile and Assessment of Over 140 Key Competitors
• Breakout of Molecular Diagnostic Market by Region (N. America, W. Europe, Asia, ROW)
• Medical and Technological Trends
• Discussion of Globalization of Markets and Diseases
• Information on Reimbursement of New Technologies
• Review of Novel Test Platforms
• Review of New Market Developments, Such as Consumer Genomics and Testing Services
• Discussion of Market Impact of Home Brew Tests
• Discussion of Diagnostic Biomarkers and Genetic Indicators

All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the molecular test market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and techniques presented in the report are expected to replace the standard of care in 2007/08, but with healthcare systems’ emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.

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As Kalorama Information’s lead diagnostic analyst finds, the point of care concept is at a crossroads: the technologies needed to make rapid testing a reality have arrived. But is healthcare ready?

Kalorama believes that the drive for wellness and the attention surrounding healthcare reform will focus attention on rapid diagnostics. However, according to Shara Rosen, RT, M.B.A., there are many challenges which must be overcome for point of care solutions to be fully utilized, and those companies willing to pivot strategies and best adjust to tomorrow’s healthcare marketplace may be rewarded.

This report, Point of Care Diagnostics 2010: Rapid Testing at a Crossroads represents the most current analysis of the role POC Diagnostics in today’s in vitro industry. Other reports have looked at products, companies and revenue numbers, as this report does. But in her analysis Shara Rosen takes a bold look into the markets, technologies, and trends in decentralized testing with a special focus on the economics of rapid test use in critical care and emergency medicine. The report includes:

• Markets for POC Diagnostics (Diabetes, Cardiac markers, Clinical Chemistry/Critical Care, Hematology, Coagulation, Drugs of Abuse/Therapeutic Drug Monitoring, Infectious Diseases, Pharmacodiagnostics, Sepsis, Oncology, Women’s health / Pregnancy/Fertility)
• By Venue Revenue Estimates for Hospital POC, Physician POC and Other Venue
• Review of Products in the Market
• Forecasts to 2013
• Markets and Forecasts for Self-Testing (OTC)
• The role of EMR in the Point of Care Market
• Possible Effects of Healthcare Reform
• POLs, Home Monitoring, Alternate Samples and Other Trends
• Successful Strategies of POC Companies
• Profiles of Over 100 Companies Competing in this Market

There are many factors in the growth of POC testing- increasing numbers of diagnosed diabetics, people with cardiovascular disease, and other chronic conditions. It is also expected to play a role in a trend in health care to evaluate provider organizations for quality in care delivery. While this quality imperative is most apparent in pay-for-performance systems, it also provides a framework by which public funds can be used more rationally. This is an especially relevant technology given the U.S. healthcare reform efforts.

All countries are feeling the brunt of aging populations and an increased burden of chronic disease management. Employers and insurance companies are interested in improving the health of customers, and there are some innovative tactics developing in this area. The report is conservative in its predictions and offers a calculated look into the future, based on events currently taking place.

The report offers a quantitative assessment of specific markets in US dollars for 2008 and forecasted out to 2013. These data are provided in order to set the status quo of tests and technologies. However the report concentrates on how these will impact the economics of healthcare over the near term and longer when possible.

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Summary

“The Future of the In-Vitro Diagnostics Market to 2016 – Increasing Diagnostic Procedures Drive Demand” provides key data, information and analysis on the global in-vitro diagnostics market, a key segment within the medical equipment industry. This medical device report provides market landscape, competitive landscape and market trends information on seven in-vitro diagnostics market categories – Clinical Chemistry, Genetic Testing, Histology and Cytology, Immuno Chemistry, Infectious Immunology, Microbiology Culture and Haematology. The report provides comprehensive information on the key trends affecting these categories, and key analytical content on the market dynamics. The report also reviews the competitive landscape, key pipeline products and technology offerings.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

Scope

- Key geographies including the US (United States), Canada, the UK (United Kingdom), Germany, France, Italy, Spain, Belgium, Netherlands, Japan, China, India, Australia, Taiwan, republic of Korea, Brazil, Argentina, Mexico, Israel and South Africa.
- Global Market size and company share data for seven In-Vitro Diagnostics market categories – clinical chemistry, genetic testing, histology and cytology, immuno chemistry, infectious immunology, microbiology culture and haematology.
- Annualized market revenues data from 2002 to 2009, forecast forward for 7 years to 2016. Company shares data for 2008.
- Qualitative analysis of key market trends, market drivers and restraints by categories and segments.
- Competitive landscape and key company profiles. Key players covered include Roche, Siemens Healthcare, Abbott, Beckman Coulter, Biomerieux, Ortho-Clinical Diagnostics, Becton, Dickinson (BD), Bio-Rad Laboratories, Inverness Medical Innovations, Sysmex, Gen-Probe and Dade Behring.
- Key in-pipeline products and technologies expected to hit the global In-Vitro Diagnostics market in the near future.

Reasons to buy

- Develop business strategies by understanding the trends and developments that are driving the In-Vitro Diagnostics market globally.
- Design and develop your product development, marketing and sales strategies.
- Exploit M&A opportunities by identifying market players with the most innovative pipeline. Develop market-entry and market expansion strategies.
- Identify key players best positioned to take advantage of the emerging market opportunities.
- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return.
- What’s the next big thing in the In-Vitro Diagnostics market landscape? – Identify, understand and capitalize
- Make more informed business decisions from the insightful and in-depth analysis of the In-Vitro Diagnostics market and the factors shaping it.

Companies Mentioned

F. Hoffmann-La Roche Ltd
Siemens Medical Solutions
Abbott Laboratories
Beckman Coulter, Inc.
bioMerieux Sa
Ortho-Clinical Diagnostics
Becton, Dickinson and Company
Bio-Rad Laboratories, Inc.
Inverness Medical Innovations, Inc

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