Companion Diagnostic Market is poised to grow at a rate of ~13% by 2027. Rising need for personalized medicine, continuous advancement in medical technology both for the diagnosis and the treatment of patients, decreased costs of genetic-based CDx tests which allow broader market access, growing cases of adverse drug reactions and side effects, and rising demand for next-generation sequencing are some of the key factors driving the global companion diagnostics market.
Companion diagnostic (CDx) is a diagnostic test used as a companion to a therapeutic drug to discover its applicability to a person. It requires multiple monitoring methods to provide extremely valuable data, allowing patients, health practitioners, and payers to decide with a higher level of certainty on the possible advantages of a treatment or care pathway.
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Growing Demand for NGS-Based Technology Drives the Companion Diagnostics Market
The increasing demand for next-generation sequencing technology especially its capability to identify rare variants is crucial to continuing success and the wider distribution of companion diagnostics solutions in the 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,
- In July 2022, Almac Diagnostic partnered with AstraZeneca to develop and commercialize a variety of companion diagnostic (CDx) products based on NGS and qPCR-based technologies
Demand for Companion Diagnostics for Targeted Cancer Drugs Drives the Companion Diagnostics Market
According to clinical research, up to 75% of cancer patients do not respond well to the same cancer treatment. 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.
More than 90% of all globally certified CDx tests are associated with targeted cancer therapeutics. Some of the FDA-approved oncology drugs available in the market are:
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) | P170041/S006 (12/01/2022)
Non-Small Cell Lung Cancer (NSCLC) — Plasma | Krazati (adagrasib) NDA 216340 | KRAS G12C | P210040 (12/12/2022)
Potential Role of Companion Diagnostics in Precision Medicine Drives the Companion Diagnostics Market
Personalized medicine is the practice of giving the correct dosage of the correct medicines at the correct time. Companion diagnostics, which are used to identify eligible patients for a particular therapy, are a significant driver to enable personalized treatment choices and precision medicine. Companion diagnostics offers numerous advantages in the advancement of personalized medicine and the improvement of preclinical and clinically focused drug development.
Key Constraints/ Challenges in Companion Diagnostics Market
The high cost 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 expected to stifle growth in the companion diagnostics market in the next years.
North America is expected to hold a large share of the Companion Diagnostics Market
From a geographical standpoint, North America holds a dominant market share of the companion diagnostics market. This can be primarily attributed to the rising prevalence 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: Companion Diagnostics Market
Some of the significant players operating in the market’s include Thermo Fischer Scientific Inc., Illumina Inc., Bayer AG, Danaher Corporation, Invitae, and Agilent Technologies, Inc, among others.
Organic and Inorganic Growth Strategies Deployed by Players for Gaining a Foothold in the Companion Diagnostics Market
Players operating in this market are adopting organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to gain 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 incorporation of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test
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