Global Companion Diagnostics Market

As stated in our extensive report; the Global Companion Diagnostics Market accounted for USD 5.2 Billion in the year 2021.

It is now known that drugs can have varying effects on different persons because of advancements in hereditary sequencing and genomics. The task of overseeing “the proper medication, with flawless timing, at the ideal portion, for the perfect individual” might be advanced by better understanding a person’s inherited characteristics or biomarkers. Pharmaceutical and biopharmaceutical companies always work to implement patient-choice analytic systems in the early stages of medicine development to provide targeted treatments to the appropriate rival. These provide additional support for the market for Companion Diagnostics.

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NGS-based Companion symptomatic diagnostics aims to make atomic data from each patient’s growth genome available to inform disease treatment decisions. Compared to other sequencing techniques, cutting-edge sequencing identifies several biomarkers for various drug therapies in a shorter time. The use of NGS boards for biomarker assessment in a single test can aid in the treatment of many different diseases. The various cutting-edge developments in NGS also give market companies a swift advantage over competitors offering other innovations like PCR, ICH, and ISH. Because of NGS, most market competitors concentrate on developing companion demonstration products.

Key factors influencing Companion Diagnostics Market Growth

The growth of the global Companion Diagnostics market can be attributable to the following:

  1. The incidence of cancer has considerably increased in recent years. Because genomic testing paints a comprehensive image of patients’ tumors and gives clinicians precise information about recommended treatment regimens, the prevalence of cancer cases is rising, which increases the need for efficient CDx assays.
  2. As a result, CDx product sales are increasing as cancer incidence rises. 229,200 new cancer cases were reported in Canada in November 2021, according to data on the disease.
  3. Additionally, 2.26 million new instances of breast cancer and 2.21 million new cases of lung cancer, respectively, were reported by the World Health Organization (WHO) in 2022. Novel assays are also being developed to diagnose certain types of mutations in order to meet a growing need.
  4. Guardant360 CDx received FDA approval in August 2020. This first liquid biopsy companion diagnostic identifies individuals with certain types of epidermal growth factor receptor (EGFR) gene mutations in metastatic non-small cell lung cancer using Next-Generation Sequencing (NGS) technology (NSCLC).
  5. This feature has sparked a need for these tests on a global scale and will drive the market’s expansion throughout the course of the forecast period.
  6. There have been many innovative products approved in the Companion Diagnostics sector. The market is growing faster due to the adoption of many tests as the number of new goods being approved rises.
  7. Additionally, major producers concentrate on creating innovative tests that fuel the expansion of the Companion Diagnostics industry. For instance, Illumina’s TruSight oncology (TSO) complete test was given CE clearance in May 2022. This kit evaluates a number of tumor biomarkers to pinpoint a particular cancer patient’s molecular profile.
  8. Additionally, Agilent Technologies Inc.’s PD-L1 IHC 22C3 pharmDx, a high-quality immunohistochemistry test, was authorized in May 2022.
  9. With the help of this assay, cervical cancer patients may be selected for treatment with KEYTRUDA (anti-PD-1 therapy). As a result, these characteristics will actively encourage market expansion. 

North America Region to Lead the Market 

North America Companion Diagnostics market is getting more significant with maximum market share during the forecast period. The growth of the North America region Companion Diagnostics market can be attributed to many influential private and public clinical research facilities, the easy accessibility of technologically advanced devices and tools, and the significantly advanced medical services infrastructure in the US and Canada.


The overall Companion Diagnostics market growth can be attributed to factors like an increase in cancer prevalence. Due to this, the market is expected to gain ground.

Some of the key players in the Global Companion Diagnostics Market include-  Abbott Laboratories Molecular Inc. (U.S.), Agilent (Dako Denmark A/S) (U.S.), ARUP Laboratories Inc. (U.S.), BioMerieux (France), Danaher Corporation (Leica Microsystems) (Germany), Foundation Medicine Inc. (U.S.) and others.