From Kalorama Information a unique tool for assessing the diagnostic business today. Working in conjunction with premier diagnostic survey database Emmes Group, Kalorama Information presents the summarized results from a recent survey of a critical mass of diagnostic labs in the U.S, with analysis from Kalorama’s leading diagnostic analyst, Shara Rosen.

Far more than any other market research report, this report provides the most current and accurate picture of what is truly going on in molecular diagnostics in the United States.

Quantitative Data

Analyzed by the best-selling author of The Worldwide Market for In Vitro Diagnostics, now in its sixth edition, this new report includes surveys of molecular diagnostics focusing on these tests:

• Chlamydia and Gonorrhea
• HBV Viral Load
• HCV Viral Load, HCV Genotyping
• HIV Viral Load, HIV Genotyping
• HPV, HPV Genotyping
• Hospital Acquired Infections – MRSA, VRE
• Coagulation Factors – Factor II, Factor V Leiden
• Herpes Simplex Virus (HSV)
• Oncology Tests – BCR/ABL, Bladder Cancer, Her2Neu, MTHFR
• Transplant Medicine – HLA Typing
• Hereditary Disorders – Cystic Fibrosis (CF), Fragile X
• Respiratory Infections – Influenza A/B, Group A Strep, MTB (Tuberculosis), Bordetella pertussis, Adenovirus, Respiratory Virus
• Communicable Diseases – CMV (Cytomegalovirus), EBV (Epstein-Barr Virus), Group B Strep, Enterovirus

What Labs Do Now, What They are Planning in the Future

There has been much analysis in recent years about the inroads that DNA testing has made. This unique resource offers a way to measure that progress, and test assumptions aobut the evolution of DNA testing, critical information to adjust business stratetgies. This report looks at the following topics:

• What type of reagents are labs using (Commercial, ASR, Homebrew)
• Where tests are performed (Central/Core Testing Lab, Chemistry Lab, Cytology Lab, Genetics Lab, Hematology Lab, Microbiology Lab, Molecular Lab, Pathology Lab, Serology/Immunology Lab, Virology Lab)
• What Vendors are Labs Using
• What are there Purchasing Plans
• What Tests Do They Want in the Future
• Do They Outsource and at what Rate?
• Do They plan Vendor Changes?

A Representative Sample of the US Hospital Lab Industry

Emmes Group reached an extensive sample group – interviewing 14% of US hospital labs, 14% of public labs and 8% of US reference lab, where Emmes respondent numbers are compared to the Americian Hospital Directory. Such an undertaking would cost an individual company tens of thousands of dollars. This information is available to purchasers of this report at a fraction of the cost.

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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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Since Kalorama Information last updated our comprehensive market report on cancer testing, changes in the industry abound. Developments that were novel two years ago such as the commercialization of service products , PGx testing and tissue microarrays are showing an increased presence. Some companies who promised much in the past have not produced results. And new entrants have entered the field.

These changes and more are addressed in Kalorama Information’s Worldwide Market for Cancer Diagnostics, 4th. Edition. This report authored by Kalorama Diagnostic Analyst Shara Rosen, contains detailed market data on the following IVD segments for their use in cancer diagnostics:

• Histology/Cytology
• Immunoassays
• Flow Cytometry
• Rapid Tests
• Molecular Assays
• Tissue Arrays
• Circulating Tumor Cells
• Pharmacodiagnostics

Diagnostic tests for effective cancer screening are obviously needed more than ever. As cancer becomes more treatable, diagnostics are finding multiple expanded roles, including pharmacodiagnostics for matching the targeted treatment to the patient and ongoing disease monitoring as treatable cancer enters the realm of the chronic disease. Kalorama Information’s Worldwide Market for Cancer Diagnostics, 4th Edition represents the fourth time Kalorama has engaged in an exhaustive study on the status of this important diagnostic market. Among the market data provided in this report, readers will find:

• Immunoassay Lab Based Cancer Test Sales
• Pap Smear Testing Volumes
• World Cancer Statistics
• POC Tests
• DNA Reagents for Cancer Testing
• CTC Testing Markets
• Biochip Innovations
• New Companies with Novel Approaches
• “Laggard” Companies Who Have Not Met Expectations
• Major Protein and Molecular Markers Used in Tissue Staining
• Biomarkers Under Investigation
• Acquisitions and Mergers
• Status of PGx Testing
• Microarray Markets in Clinical Labs
• Lists of Vendors and Major Products
• Unmet Needs of the Marketplace

This report includes market analysis of the following screening tests: The Cancer Profile, CTC, Fecal Occult Blood, PSA, H. pylori, IHC, ISH As well as tests for specific cancers:

• Bladder Cancer
• Breast Cancer
• Cervical Cancer
• Colon Cancer
• Lung Cancer
• Ovarian Cancer
• Prostate Cancer

This latest edition of Kalorama Information’s study takes a fresh look at all of these developments both qualitatively and quantitatively. The report provides revenue and growth forecasts through 2014 and, as in the previous edition, analyzes the market in two ways:

• Tests for specific cancers, and
• Cancer tests in specific IVD segments

This allows the reader to match his or her own situation to the market at large.

In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles.

Top Tier Companies

• Abbott Diagnostics
• Beckman Coulter Inc.
• Becton, Dickinson and Company (BD)
• bioMerieux Inc.
• Bio-Rad Laboratories Inc.
• Dako A/S
• Fujirebio Diagnostics, Inc.
• Gen-Probe Inc.
• Hologic, Inc.
• Inverness Medical Innovations
• Ortho Clinical Diagnostics
• QIAGEN N.V.
• Roche Diagnostics
• Siemens Medical Solutions Diagnostics
• Sysmex Corporation

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