Companion Diagnostics Market Size (2024 - 2029)

Companion Diagnostics Market Analysis

The Companion Diagnostics Market size is estimated at USD 7.74 billion in 2024, and is expected to reach USD 13.90 billion by 2029, growing at a CAGR of 12.42% during the forecast period (2024-2029).

The promotion of personalized medicine and targeted therapy as a new treatment option by key players, increasing cases of adverse drug reactions, and the development of new drug and diagnostic technology are expected to boost the market’s growth over the forecast period.

The increasing focus on personalized medicine product approvals and new technology development is propelling the market’s growth. For instance, according to an article published by Healthcare Radius in January 2023, companion diagnostics were observed to be integral to the rising focus on personalized medicine, enabling targeted treatment by identifying specific genetic markers associated with diseases. Their role in co-developing drug and diagnostic technologies ensures a synergistic approach to treatment, maximizing efficacy and minimizing adverse effects. Thus, the benefits offered by companion diagnostics are expected to increase their adoption for treating cancer patients globally.

The increasing cases of adverse drug reactions due to medication inefficacy also drive the need for companion diagnostics in the market, thus aligning therapeutic approaches with patients' genetic profiles to optimize treatment outcomes. For instance, according to an article published by Healthcare Radius in January 2023, companion diagnostics offer a strategic approach to mitigate the potential risks associated with drug treatments and help effectively identify patients predisposed to experiencing adverse effects during therapy. This targeted identification enhances patient safety and optimizes treatment outcomes, thus aligning with medical and business objectives within the healthcare industry. Companion diagnostics can help physicians adjust the dosage or switch to a different treatment option, thus improving patients' overall quality of life.

The rising burden of cancer increases the demand and awareness for personalized medicines among the population globally. For instance, according to the report published by the American Cancer Society in January 2024, about 2 million new cancer cases are projected to be diagnosed in the United States in 2024, compared to 1.9 million cases in 2023. Additionally, according to the report by Red Española de Registros de Cáncer published in January 2023, the incidence rate of cancer cases estimated in Spain for 2023 was 279,260. Clinical diagnostics are integral to implementing personalized medicine, thus leveraging individuals' genetic profiles to enhance precision and efficacy in cancer treatment. This approach ensures tailored strategies that align with specific patient needs, fostering optimal outcomes within oncology care. 

Companies are strategically enhancing collaborations to advance biomarkers and diagnostic technologies, particularly focusing on cost efficiency and regulatory compliance. This trend has generated numerous opportunities for diagnostic applications in critical medical indications such as cancer, cardiovascular diseases, and neurological disorders. For instance, in January 2024, Agilent Technologies Inc. signed an agreement with Incyte, bringing together Agilent’s expertise in developing companion diagnostics (CDx) to support the development and commercialization of Incyte’s hematology and oncology portfolio. This agreement allows Agilent to expand its companion diagnostics portfolio with novel biomarkers.

Major companies are actively advancing innovative technologies and formulating strategic growth plans to tackle a broader range of unmet needs in cancer care. For instance, in October 2023, Foundation Medicine Inc. received approval from the US Food and Drug Administration for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for Pfizer’s BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

In February 2023, Roche signed a collaboration with Janssen Biotech Inc. (Janssen) to create companion diagnostics for targeted therapies, further strengthening research and innovation activities.

Thus, the increasing promotion of personalized medicine and targeted therapy by key players, rising cases of adverse drug reactions, and the development of new drug and diagnostic technologies are impacting the companion diagnostics market’s growth. However, the high cost of drug development and associated clinical trials and reimbursement issues among many countries are expected to restrain the market over the forecast period.

Companion Diagnostics Industry Segmentation

As per the scope of the report, companion diagnostic tests provide information essential for safely and effectively using a corresponding drug or biological product.

The companion diagnostics market is segmented by technology, indication, and geography. The technology segment is divided into immunohistochemistry (IHC), polymerase chain reaction (PCR), in-situ hybridization (ISH), real-time PCR (RT-PCR), gene sequencing, and other technologies. The indication segment is divided into lung cancer, breast cancer, colorectal cancer, leukemia, melanoma, and other indications. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value in USD for these segments.