The major feature of the companion diagnostic testing market is the current domination of tests for mutations important in the prognosis and diagnosis of non-small cell lung cancer (NSCLC), with the two market leaders being Roche and Qiagen. According to Publisher’s forecast, in 2014, NSCLC companion diagnostic tests account for 55% of the market by value. While more human epidermal growth factor receptor 2 (HER2) tests are carried out, because the NSCLC tests have been principally more expensive molecular tests, rather than the cheaper immunohistochemistry (IHC) test that typifies HER2 testing, the value of the NSCLC market is considerably higher.
The companion diagnostic tests market is still evolving, but the market is led by Roche, Qiagen, Ventana, Dako, and Leica. Roche and Qiagen dominate the molecular testing market, while Ventana, Dako, and Leica also have a significant presence within the important IHC market. In most segments, there is little competition for tests, since only a few approved companion diagnostic tests are marketed. Laboratory decisions as to which brand of test to use are driven by clinical efficacy, which may vary considerably by regions. The exception is breast cancer HER2 testing, which, as the longest-established segment, has attracted the most competition.
Significant Unmet Needs
A need to improve cancer treatment remains a significant unmet need. Besides providing a means to identify patients who will most benefit from the emerging targeted therapies, there is also a need to be able to better utilize existing therapies, including chemotherapies, or even surgical interventions, through the use of companion diagnostic tests to better stratify patients.
While the existing tests are well regarded by physicians, for many, the differences in hardware remain trivial and as such, there is a clear need for tests to enable easier decision-making. This especially applies to IHC tests, which are considered too subjective, and prone to error.
While new tests for new needs, such as a need to prescribe a new drug, face easy entry to the market, beyond the reimbursement challenges, new tests to replace existing companion diagnostic tests face challenges in adoption by laboratories, since they may not provide a clear performance improvement. New tests typically undergo exhaustive comparison studies by hospitals, rather than benefiting from published literature studies.
A significant barrier to increased adoption is reimbursement. Approval of new companion diagnostic tests does not signify adoption. Adoption is highly dependent upon reimbursement policies. If the molecular test cannot be reimbursed, there will be low adoption. If the new therapy cannot be reimbursed, there will be no need for uptake of the companion diagnostic test, unless a secondary use can be found that is of utility to the physician in managing the patient’s condition.
The emergence of new companion diagnostic tests is also highly dependent on the success of the drug pipeline. As a result of increased regulation, new companion diagnostic tests are developed in parallel to a new drug, and thus, the fate of the companion diagnostic is tied to the success of the drug during clinical trials. Diagnostic test manufacturers can de-risk this process through multiple partnerships, or by developing new companion diagnostic tests that are also aimed at stratifying patients for existing therapies. If the therapy is one for which there are already companion diagnostic tests, then the new test faces adoption challenges. If the therapy has no existing stratification route, then the test may gain a considerable advantage, especially if stratification provides a clear benefit to the patient or the healthcare provider.
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