Global Companion Diagnostics Market is expected to grow at a healthy rate of ~13{7b6cc35713332e03d34197859d8d439e4802eb556451407ffda280a51e3c41ac} by 2027 : Transforming the Modern Medicine
Medi-Tech Insights

Medi-Tech Insights

Medi-Tech Insights: An Increasing need for personalized medicine, rapid advancements in medical technology both for the diagnosis and the treatment of patients, reduced costs of genetic-based CDx tests which allows broader market access, rising cases of adverse drug reactions and side effects, and growing demand for next-generation sequencing are some of the major factors driving the companion diagnostics market.

Global Companion Diagnostics Market (2022-2027)

Global Companion Diagnostics Market

Global Companion Diagnostics Market


Companion diagnostic (CDx) is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a person. It involves multiple monitoring methods to provide highly valuable information, allowing patients, health practitioners, and payers to decide with a higher level of certainty on the potential benefits of a treatment or care pathway.

An Increasing Demand for NGS-Based Technology Drives the Companion Diagnostics Market

The growing demand for next-generation sequencing technology particularly its capability to identify rare variants is critical to the continued success and the wider distribution of companion diagnostics solutions in the companion diagnostics market. The use of NGS panels in one test has the potential to help in the treatment of many different types of cancers.

For instance,

Companion Diagnostics for the Targeted Cancer Drugs Fuels Its Global Market Demand

Clinical studies indicate that as many as 75{7b6cc35713332e03d34197859d8d439e4802eb556451407ffda280a51e3c41ac} of cancer patients do not respond favorably to the same prescribed cancer drug. In such cases, companion diagnostic tests help to indicate the presence of a molecular target and can also reveal the off-target effects of a therapeutic, predicting toxicities and adverse effects associated with a drug.

Over 90{7b6cc35713332e03d34197859d8d439e4802eb556451407ffda280a51e3c41ac} of globally approved CDx tests are associated with targeted cancer therapeutics. CDx approach to cancer genomic characterization also helps physicians to reveal the alterations driving the growth of a patient’s cancer and identify targeted treatment options that may not have been otherwise considered. Some of the FDA-approved oncology drugs available in the companion diagnostics market are listed below:

Indication Type

Drug Trade Name (Generic)

Biomarker(s) Details

Approval Date

Acute Myeloid Leukemia – Peripheral Blood or Bone Marrow

Rezlidhia (olutasidenib) NDA 215814

R132 mutations (R132C, R132H, R132G, R132S, and R132L)


Non-Small Cell Lung Cancer (NSCLC) – Plasma

Krazati (adagrasib) NDA 216340



Potential Role of Companion Diagnostics in Precision Medicine Drives the Growth of the Companion Diagnostics Market

Personalized medicine refers to the practice of administering the right dosage of the right drug at the right time. Companion diagnostics, which are used to identify eligible patients for a specific therapy, are a key driver to enable personalized treatment choices and precision medicine. Companion diagnostics is providing many advantages in progressing personalized medicine and improving preclinical and clinically targeted drug development.

Upcoming Market Challenges: Companion Diagnostics Market

The high costs of drug development therapies, associated clinical trials, the introduction of new stringent regulations for scientific validity, and analytical and clinical performance for in-vitro diagnostics (IVD) are likely to hamper the growth of the global companion diagnostics market in the upcoming years.

North America is expected to hold a larger share of the Companion Diagnostics Market

From a geographical perspective, North America holds a larger market share in the global companion diagnostics market. This can be mainly attributed to the growing number of diseases like cancer & HIV, improvements in regulatory guidelines, and potential economic benefits for drug developers early in drug development in the region.

Competitive Landscape Analysis: Companion Diagnostics Market

Some of the well-established and key players operating in the companion diagnostics market are Thermo Fischer Scientific Inc., Illumina Inc., Bayer AG, Danaher Corporation, Invitae, and Agilent Technologies, Inc, among others.

Organic and Inorganic Growth Strategies Adopted by the Leading Market Players to Establish Their Strong Foothold in the Companion Diagnostics Market

All top players operating in the global companion diagnostics market are adopting both organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to garner a higher market share.

For instance,

  • In October 2022, Roche announced they have received approval from the FDA for the first companion diagnostic to identify patients with HER2-low metastatic breast cancer.

  • In May 2022, Illumina, Inc. announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test.

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