Companion Diagnostics Market: Introduction


According to the report, the global companion diagnostics market was valued at US$ 5.24 Bn in 2020 and is projected to expand at a CAGR of 9% from 2021 to 2028. The global companion diagnostics market witnessed steady growth in the past few years, owing to surge in incidence rate of oncology diseases. Supportive clinical trials and advanced assay technologies offer promising and accurate results in the diagnostics industry. Furthermore, regulatory guidelines and its best practices have helped overcome the challenges and uncertainties in the companion diagnostics market. This is expected to boost the growth of the global market during the forecast period.


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Increase in Demand and Development of Personalized Medicine to Drive Global Companion Diagnostics Market


The demand for personalized medicine has increased due to advancements in genomics research and biomarkers. This can be attributed to the efficiency and target-specific nature of personalized medicine with better patient outcomes. Additionally, targeted therapies have minimal or no side effects compared to conventional therapies. The paradigm shift in the drug discovery and development process has induced pharmaceutical companies to shift focus toward the development of novel targeted therapies (genotype or phenotype specific therapies). This has marked the gradual termination of the traditional “blockbuster model”. These factors increase the demand and uptake of personalized medicine, which, in turn, drives the global companion diagnostics market.


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Key Strategies Adopted by Prominent Players to Drive Global Companion Diagnostics Market


  • In July 2021, Labcorp launched innovative companion diagnostic product, therascreen KRAS PCR Mutation Analysis, to identify the patients with non-small cell lung cancer (NSCLC), who are further eligible for LUMAKRA (sotorasib), developed by Amgen. LUMAKRA is a newly approved lung cancer therapy developed by Amgen, which together with Labcorp, would develop an oncology platform for early diagnosis of these patients
  • In May 2020, Myriad Genetics, Inc., a leader in precision medicine & molecular diagnostics, received the FDA approval for myChoice companion diagnostic test for identifying patients suffering from advanced ovarian cancer, which may become eligible for first line treatment with Lynparza and bevacizumab
  • In September 2021, Illumina, Inc. and Merck (MSD) entered into partnership to develop and commercialize companion diagnostic tests to identify the genetic mutation in patients with HRD-positive tumor who are eligible for the PARP inhibitor targeted treatment
  • In December 2021, Foundation Medicine, Inc. received the U.S. FDA approval for its FoundationOne CDx test used to detect the BRAFV600E or V600K mutations in patients eligible for the targeted therapies FDA approved for melanoma


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Breast Cancer Segment to Lead Global Companion Diagnostics Market


In terms of indication, the global companion diagnostics market has been classified into breast cancer, lung cancer, colorectal cancer, gastric cancer, melanoma, and others. The breast cancer segment accounted for the largest market share in 2020, owing to rise in prevalence & incidence rate of breast cancer across the globe. Companion diagnostics play a pivotal role in detecting the specific biomarkers for diagnosis of breast cancer and pave the way for associated therapy. Companion diagnostics have become a popular choice for clinicians, regulatory officers, and laboratory personnel. Furthermore, companion diagnostics are used to identify the response of oncology patients to the targeted drug therapy. This helps in developing better personalized medicine for cancer treatment for specific patients or patient groups.


North America to Gain Companion Diagnostics Market Share


North America dominated the global companion diagnostics market in 2020, accounting for the largest share. The region is projected to gain market share during the forecast period due to rise in awareness about the prevalence of cancer, increase in patient population, surge in investments in research & development for personalized medicine & drug development, expansion of the pharmaceutical industry in the U.S., increase in baby boomers, and well-developed healthcare infrastructure. Faster FDA approval for companion diagnostic tests & assays and rich pipeline are likely to propel the market in the region in next few years.


Europe accounted for a major share of the global companion diagnostic market in 2020. The market in the region is expected to grow at a moderate pace during the forecast period. Presence of prominent players and rise in awareness about companion diagnostics in improving the human health and early need of diagnosis of cancer & other chronic diseases are likely to propel the companion diagnostics market in Europe.


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Competition Landscape


The global companion diagnostics market is consolidated due to the presence of prominent players in the market. Key players operating in the market are Labcorp Drug Development, Agilent Technologies, Myriad Genetic Laboratories, Inc., Qiagen, Roche Molecular Systems, Inc., Dako, Inc., Abbott, Foundation Medicine, Inc., MolecularMD Corporation, Ventana Medical Systems, Inc., Illumina, Inc., Life Technologies Corporation, Invivoscribe Technologies, Inc., ARUP Laboratories, Inc., Leica Biosystems, Biogenex Laboratories, Inc., bioMérieux, Inc., GE Healthcare, Agendia N.V, Exact Sciences Corp, and Genomic Health.


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