ALK tests, also known as anaplastic lymphoma kinase tests, are tests used for the detection and evaluation of ALK gene rearrangements in certain types of cancer, particularly non-small cell lung cancer (NSCLC). ALK gene rearrangements account for 5%–6% of NSCLC cases. According to GlobalData analysis, the ALK test market was valued at $22.1m in 2023 and is projected to reach $27.5m by 2033, with a compound annual growth rate (CAGR) of 2.22%.

Due to the rising prevalence of lung cancer, the increasing popularity of targeted therapies, and the wide availability of genetic testing, the volume of ALK tests is expected to increase in the next five years. With numerous detection methods currently in clinical use, the consensus is that an ideal assay should be sensitive, effectively covering all clinically relevant targets with the use of limited samples and cost-efficient.

Immunohistochemistry (IHC) and in situ hybridisation (ISH) are commonly used in ALK tests. Demand for ISH is expected to remain strong as ISH is more accurate and reliable than IHC in the determination of ALK status in lung cancer specimens. In general, ISH is more time-consuming and costlier than IHC analysis, with this technique requiring expensive equipment for signal detection and recognition. As such, participants and key opinion leaders (KOLs) indicate that in some institutions, NSCLC patients are first screened for ALK rearrangements using IHC, with positive cases then confirmed via ISH. GlobalData predicts the use of IHC will decline in the forecast period. Several clinical testing guidelines in lung cancer all indicate against the use of IHC in ALK mutational testing. Additionally, IHC is largely dependent upon an observer’s ability in assay interpretation as well as inter-laboratory variability in assay performance.

Nucleic acid amplification tests (NAATs) are used to identify both common ALK gene mutations and also low-frequency mutant alleles. GlobalData expects that sales of NAATs for ALK will increase during the forecast period due to advantages such as cost efficiency, mutation coverage, method flexibility, ease of use, and high accuracy. Market growth may be slightly affected by the method’s ability to detect only the pre-specified mutations for which it was designed.

Next-generation sequencing (NGS) allows an entire genome to be sequenced at once by fragmenting DNA and sequencing those fragments in an automated, parallel manner. NGS is gradually replacing traditional methods of ALK mutation testing, due to its higher sensitivity and ability to detect mutations with low allele frequency. As it is now standard to test for a high number of mutations to personalize treatment decisions, the use of NGS panels that can evaluate tumour biopsies for a wide range of potentially targetable mutations is increasing. GlobalData predicts that a rise in NGS tests will occur as rapid and low-cost sequencing continues to provide physicians with the necessary tools to translate genomic information into clinically actionable results.

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