Companion Diagnostic Market set for ~13% CAGR growth amid expanding precision medicine use by 2027

The Global Companion Diagnostic Market is expected to grow at a healthy rate of ~13% by 2027. Growing need for personalized medicine, consistent innovations in medical technology both for the diagnosis and the treatment of patients, reduced costs of genetic-based CDx tests which allow broader market access, rising cases of adverse drug reactions and side effects, and demand for next-generation sequencing are some of the key factors driving the companion diagnostics market growth.

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.

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Growing 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. Next-generation sequencing helps to detect multiple biomarkers for multiple drug therapies in a shorter time frame. 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 September 2022, Thermo Fisher Scientific announced that they have received FDA approval for the Oncomine Dx target test as the first NGS-based companion diagnostic to aid in therapy selection for patients with RET mutations/fusions in thyroid cancers.
• In July 2022, Almac Diagnostic partnered with AstraZeneca to develop and commercialize multiple companion diagnostic (CDx) products based on NGS and qPCR-based technologies.

Companion Diagnostics for the Targeted Cancer Drugs Fuels Its Market Demand

The advancing knowledge of cancer biology has led to a shift toward a more precise or targeted approach to oncology treatments. Clinical studies indicate that as many as 75% 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% 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 as follows:

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. Precision medicine has become a top priority for many pharma and diagnostics companies. 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 benefits in progressing personalized medicine and improving preclinical and clinically targeted drug development. Early adoption of CDx, as well as development alongside the drug, brings the best opportunities for rapid agent approval and learning the most about the drug/diagnostic pairing. Furthermore, companion diagnostics is expected to impact many disease treatments and could usher in the long-promised age of precision medicine.

Key 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 companion diagnostics market in the coming 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 of the companion diagnostics market. This can be mainly attributed to the growing prevalence of diseases like cancer & HIV, improvements in regulatory guidelines, an increasing need for targeted therapies, and potential economic benefits for drug developers early in drug development in the region. However, the Asia-Pacific region is expected to ascend at the fastest CAGR over the forecast period because of the surging popularity of precision medicine, rising incidence of cancer, COVID-19 PCR testing, and growing demand for customized therapeutics for the increasing geriatric population in the region.

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Competitive Landscape Analysis: Companion Diagnostics Market

Some of the key and well-established players operating in the global companion diagnostics market are as follows:-

• Thermo Fischer Scientific Inc.
• Illumina Inc.
• Bayer AG
• F. Hoffmann-La Roche AG
• Siemens Healthineers AG
• Danaher Corporation
• Invitae
• Agilent Technologies, Inc
• Almac Diagnostics
• Qiagen Inc.
• Abbott Laboratories
• bioMérieux SA
• Bio-Rad Laboratories
• Quidel Corporation
• Foundation Medicine, Inc.
• Myriad Genetics, Inc.

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

All the leading 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 larger market share.

For instance,

• In October 2022, Roche announced they have received approval from the Food and Drug Administration 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. The CDx pan-cancer indication will allow the identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3.

The companion diagnostics market is a growing market that is expected to gain further momentum in the upcoming years due to a strong emphasis on developing innovative predictive diagnostics to target specific therapies, investment in R&D to introduce several advanced products, building low-cost NGS technology, and aggressive organic and inorganic growth strategies followed by the market players.

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