Clinical diagnostics have contributed to the pharmaceutical industry with specialty diagnostics tests and biomarkers. These tests and biomarkers have become relevant in the practice of medicine owing to improved and early diagnosis, treatment and monitoring of disease areas. Companion diagnostics are assays intended to assist physicians in making effective treatment decisions based on the patient response to the ongoing treatment with a targeted therapy. These diagnostics tests are gaining popularity owing to numerous benefits such as increase in drug approval rates, and reduced R&D costs. This, in turn, will enhance the drug development cycle and improves patient outcomes. Furthermore, increase in demand for personalized medicine and surging volume of clinical trials will drive the demand for companion diagnostics tests.

Technologies such as immunohistochemistry (IHC), in situ hybridization (ISH), and polymerase chain reaction (PCR) have been used traditionally for the diagnosis and detection of relevant biomarkers for specific disease indication. However, emergence of high-throughput sensitive approaches such as next-generation sequencing, digital pathology, quantitative histopathology, single molecule real-time sequencing have led to a shift in technology platforms for companion diagnostics. Next-generation sequencing identifies those patients most likely to respond to a given precision medicine treatment, thereby improving patient survival by avoiding fewer effective treatments. Reduced costs, improved safety and efficacy offered by the companion diagnostic tests will drive the growth of the market in the coming few years.

Rapid rise in incidence of cancer will lead to increased demand for companion diagnostics tests in the future. Moreover, major industry players are focused on co-development strategies for developing companion diagnostics along with the targeted therapeutic. For instance, In May 2019, Qiagen N.V. launched its first FDA-approved companion diagnostic therascreen PIK3CA RGQ PCR Kit that helps to identify breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

The global companion diagnostics market has been segmented based on products & services, application, technology and region. Based on products & services, the market is categorized into assays, kits & reagents, and software & services. Assays, kits and reagents segment held substantial share of the global market in 2018. Increase in adoption of assays and diagnostic kits owing to rise in volume of companion diagnostics tests in laboratories is anticipated to propel the growth of the market over the forecast years.

Application-wise, the global companion diagnostics market is segmented into cancer, cardiovascular diseases, infectious diseases, neurological diseases, and others. Cancer is further sub-segmented into lung cancer, breast cancer, colorectal cancer, melanoma, leukemia and others. Cancer held the largest share of the global companion diagnostics market in 2018. High prevalence of cancer, increase in demand for personalized medicine along with availability of wide range of companion diagnostic tests for breast cancer, lung cancer and other cancers that enable early diagnosis and treatment is expected to drive the growth of the segment in the coming few years.

On the basis of technology, the global companion diagnostics market is categorized into next-generation sequencing (NGS), immunohistochemistry (ICH), in situ hybridization (ISH), polymerase chain reaction (PCR) and others. Polymerase chain reaction (PCR) held the majority of the market share in 2018. However, next-generation sequencing (NGS) is expected to grow at a rapid pace over the coming few years. Next-generation sequencing is used to identify multiple specific mutations in a tumor and helps in the selection of targeted therapy. Advantages of NGS such as its ability to sequence hundreds to thousands of genes simultaneously, higher sensitivity and specificity to detect variants, faster turnaround time for high sample volumes are factors anticipated to drive the growth of the segment in the coming years.

The global companion diagnostics market is cumulative to North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America dominated the global companion diagnostics market in 2018, however Asia Pacific is expected to grow at a highest pace through 2025.

Wide availability of companion diagnostics tests and increase in demand for personalized medicine, favorable reimbursement scenario in the U.S. are major factors expected to drive the companion diagnostics market in the region. Furthermore, increase in clinical trials for range of disease indications, growing partnerships in pharmaceutical and diagnostics companies coupled with adoption of drug diagnostics co-development model by key industry players and presence of well-established healthcare infrastructure are other major factors likely to boost the growth of the market in North America.

However, Asia Pacific is expected to grow at a rapid pace over the next few years. Increasing incidence of cancer, large population base, growing economies, increase in adoption of companion diagnostics in healthcare facilities in China and Japan along with growing focus on personalized medicine are major factors anticipated to drive the growth of the market in the region.