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Noninvasive Approaches Offer Substantial Market Potential in Liver Disease Diagnostics

Authors
Aaron Woolsey, Ph.D.
Spectrum -- July 2008

  Introduction:

Novel noninvasive liver diagnostics are poised to revolutionize the diagnosis of liver disease and increase drug-treatment rates in this indication. In this report, we discuss current liver disease diagnostic techniques and summarize thought-leader perceptions of noninvasive approaches, gathered in a series of interviews with leading hepatologists. We provide a general view of the market potential for noninvasive liver diagnostics and the challenges and opportunities for companies seeking to commercialize them. To present a picture of the hypothetical market potential for noninvasive liver diagnostics in the HCV patient population, we built a simple market model based on estimations of the size of the treatment-eligible hepatitis C patient population in the United States, France, Germany, Italy, Spain, and the United Kingdom in 2008 and in 2012.

  Get the Answers You Need to Shape Your Strategy:

Liver biopsy is widely considered the diagnostic standard for the assessment of liver fibrosis in patients with viral hepatitis. However, the invasive procedure is not appropriate for all patients with liver disease. What are the advantages and disadvantages of this widely used procedure? What are the key unmet needs in the diagnosis and treatment of liver disease?

Noninvasive liver diagnostics have the potential to play a significant role in the management of patients with liver disease and dramatically expand the drug-treated population in this indication. What are the key noninvasive liver diagnostic approaches that offer an alternative to invasive liver biopsy, and what are their advantages and disadvantages? What do physicians have to say about these novel approaches? What is their market potential?

Algorithms that combine the use of two or more noninvasive diagnostic tests are under investigation. How do these algorithms promise to improve the ability of noninvasive diagnostic tests to determine the extent of liver disease in patients?

  Scope:

Liver disease: overview of liver disease.

Liver function diagnostics: discussion of the liver biopsy procedure; coverage of key noninvasive diagnostics.

Diagnostics algorithms: coverage of key liver diagnostics algorithms.

Thought-leader insight: in-depth discussion of physicians’ perceptions of the use of noninvasive diagnostics in liver disease.

Market potential of noninvasive liver diagnostics: market model provides a picture of the hypothetical market potential of these approaches in the hepatitis C virus population in the United States, France, Germany, Italy, Spain, and the United Kingdom in 2008 and 2012.

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Noninvasive Tests:

FibroScan

FIBROSpect II

FibroTest

FibroTest-ActiTest

HCV-FibroSure

Companies:

BioPredictive

EchoSens

LabCorp

Prometheus Laboratories

Indications:

Alcoholic liver disease

Cirrhosis

End-stage liver disease

Fibrosis

Hepatitis B

Hepatitis C

Hepatocellular carcinoma

HIV

Nonalcoholic fatty liver disease




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