A companion diagnostic (CDx) test provides information that is essential for the safe and effective use of a corresponding drug or biological product. The companion diagnostics market is growing rapidly, driven by the increasing adoption of precision medicine and the development of targeted therapies.
CDx tests are extensively used to identify genetic mutations, protein expressions, or other biomarkers that indicate whether a patient will respond to targeted cancer therapies. For instance, HER2 testing in breast cancer patients determines eligibility for trastuzumab (Herceptin). According to GlobalData analysis, the HER2 tests market reached $123.6m in 2023 following the simultaneous approval of trastuzumab and the HercepTest in 1998. While oncology has been the primary focus, companion diagnostics are increasingly being developed for other therapeutic areas such as infectious diseases. CDx can identify bacterial strains that are resistant to certain antibiotics, guiding the selection of appropriate antimicrobial therapy.
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The pricing trend of CDx tests is generally towards decreasing costs, driven by technological advancements, economies of scale, and increased competition. However, the initial cost of new and innovative tests may be higher until they achieve broader adoption and market penetration. As the adoption of CDx tests grows, the higher volume of tests performed leads to economies of scale, reducing the per-test cost. By enabling more effective and tailored treatments, CDx tests can reduce overall healthcare costs by avoiding ineffective treatments and minimising adverse drug reactions.
Efforts are being made to improve access to affordable companion diagnostics, particularly in developing countries. The cost of companion diagnostics can vary widely depending on the type of test, technology complexity, and regulatory requirements. Protein expression tests such as immunohistochemistry are usually more cost-effective due to their simpler methodology, lower resource requirements, and wider applicability. They are commonly used to assess the presence of biomarkers such as HER2 and PDL-1 that guide targeted therapies. PCR-based tests are widely used and relatively inexpensive for detecting specific genetic mutations or alterations. They are often employed in single-gene testing, such as EGFR mutation analysis in non-small cell lung cancer (NSCLC) or KRAS mutation testing in colorectal cancer. FISH is moderately priced and is used to detect gene amplifications, deletions, and translocations. It is valuable for identifying actionable genetic changes in various cancers. The cost of next-generation sequencing has been decreasing significantly due to improvements in sequencing technology, higher throughput, and greater efficiency. This cost reduction is making multi-gene panels and comprehensive genomic profiling more affordable.
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