The number of Americans suffering from cancer is escalating at a substantial rate. This is significantly increasing the demand for diagnostic tests. As the new guidelines for cancer management in the United States mandate more quantitative and non-invasive testing as part of therapeutic management, all types of cancer in-vitro diagnostic (IVD) tests are witnessing growing demand.
New analysis from Frost and Sullivan, U.S. Cancer In-Vitro Diagnostics Markets, reveals that the market accrued revenues of $881.5 million in 2005 and estimates it to reach $2.3 billion by 2012.
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Introduction of several new testing technologies is creating opportunities in the areas of cancer risk assessment, screening, prognosis, and treatment monitoring.
Centers for Medicare and Medicaid Services (CMS) and private payer reimbursement schemes include many types of nucleic acid test (NAT) diagnostic tests. This increases payer adoption, which in turn drives physician adoption of NATs, impelling the cancer IVD market.
Market participants are increasing installed base and establishing long-term reagent contracts for their instruments. This value proposition also includes servicing instruments installed in laboratories.
“These reagent revenues can account for long-term and stable sources of income for market participants,” observes Frost & Sullivan Research Analyst Martin Nejat.
However, the U.S. clinical laboratory is facing several types of pressure. These include labor and staff shortage, cost pressures, keeping pace with technical advances, and producing timely results.
Automated and integrated platforms can provide some relief to the clinical laboratory by increasing throughput while requiring less dedicated technician time. Integrated platforms can also reduce workload, improve data analysis and storage, and reduce the complexity that is inherent in working with different types of instruments.
“Market participants can take advantage of this opportunity to garner larger revenues by developing and introducing automated platforms for the immunoassay and advanced staining segments of the cancer IVD market,” cites Nejat.
There is active involvement of market participants in the development and validation of new molecular, immunoassay, and advanced staining tests. However, validation of new assays along with development costs associated with biomarker validation and attainment of patient samples can significantly challenge market participants.
Clinical utility of the assay, reimbursement, breadth of instrument menu, cost, quality, and reliability of assay are other areas market participants need to focus on. The assay must prove to be affordable and provide value to the patient and physician. It is also essential that the company demonstrate the product’s economic benefit to insurance payers.
Market participants are formulating relationships or collaborations with institutions along the entire IVD market value chain. Collaboration with clinical reference laboratories is crucial to penetrate the market.
Partnerships with academic and research institutions are principal for biomarker development and validation of new assays. Small companies that offer innovative technologies, assays, or other diagnostic products can benefit by these partnerships to acquire larger revenues.
The U.S. Cancer In-Vitro Diagnostics Markets is part of the Clinical Diagnostics subscription, which also includes research in the following markets: immunoassay diagnostics, molecular diagnostics, point-of-care diagnostics, and infectious diseases diagnostics. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants. Analyst interviews are available to the press.
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