Global Companion Diagnostics Market Report and Forecast 2025-2034

The global companion diagnostics market is witnessing robust growth due to advancements in precision medicine and increasing demand for targeted therapies. Rising cancer prevalence, the need for biomarker-based diagnostics, and regulatory support for new test approvals drive market expansion. Moreover, the growing adoption of next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies further enhances diagnostic accuracy, enabling personalised treatment strategies.

Companion Diagnostic Overview

Companion diagnostic tests help in the diagnosis of diseases and determines the most effective drug for a specific patient. These tests are crucial in cancer treatment, identifying biomarkers that indicate a patient’s suitability for individualised treatment. Pharmaceutical companies integrate companion diagnostics into drug development to enhance efficacy, ensuring that only patients most likely to benefit receive targeted therapies.

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Market Drivers and Adoption Trends

The companion diagnostic market is expanding due to rising demand for precision cancer treatments. Companies like Foundation Medicine lead innovations with products like FOUNDATIONONE CDx, which analyses cancer-related genes in solid tumors. Increasing regulatory approvals and advancements in companion diagnostic tests further support market growth. The rising prevalence of cancer has prompted greater adoption of companion diagnostics, ensuring effective treatment selection.

Regulatory Approvals and COVID-19 Impact

The U.S. FDA is approving novel companion diagnostic (CDx) tests, such as the Oncomine Dx Target Test by Thermo Fisher Scientific Inc., designed to detect HER2 (ERBB2) activating mutations in non-small cell lung cancer. However, the COVID-19 pandemic initially reduced demand for companion diagnostics products, delaying novel diagnostic tests. Despite this, the global companion diagnostics market is expected to recover and expand significantly during the forecast period.

Global Companion Diagnostics Market Trends

Companion Diagnostics Market Growth Factors

Rising Cancer Incidence to Drive the Demand for Companion Diagnostics

The increasing global burden of cancer is a key factor propelling the growth of the companion diagnostics market. According to the American Cancer Society, cancer cases are projected to reach 35 million by 2050, primarily due to population growth and ageing demographics. This surge in cases necessitates advanced diagnostic solutions for early detection, effective treatment, and improved patient outcomes. Companion diagnostics play a crucial role in guiding targeted therapies, ensuring personalised treatment strategies, and enhancing the efficacy of cancer therapies.

Additionally, technological advancements such as next-generation sequencing (NGS) and liquid biopsy techniques have further bolstered market expansion. These innovations facilitate rapid genetic profiling, helping oncologists identify specific biomarkers associated with different cancer types. The rising adoption of precision medicine by healthcare providers and pharmaceutical companies is also a significant growth driver. As demand for customised cancer treatments increases, the market for companion diagnostics is expected to expand rapidly.

Regulatory Approvals for Novel Diagnostic Tests to Fuel Market Expansion

The approval of new companion diagnostic tests for various indications is another critical factor driving market growth. Regulatory bodies such as the U.S. FDA, European Medicines Agency (EMA), and other global health authorities continue to approve innovative diagnostic solutions for targeted therapies. These approvals validate the clinical efficacy of companion diagnostics, increasing their adoption across healthcare facilities. The expanding pipeline of biomarker-driven therapies further encourages diagnostic companies to develop novel tests, contributing to overall market expansion.

Moreover, regulatory support ensures that new diagnostics meet stringent safety and accuracy standards, enhancing physician confidence in their effectiveness. Recent approvals of companion diagnostic assays for lung, breast, and colorectal cancers have provided patients with access to personalised treatment options. As pharmaceutical firms continue to collaborate with diagnostic developers, the market is poised for sustained growth, driven by innovation and regulatory advancements.

Restraining Factors

Challenges in Reimbursement Policies and Strict Regulatory Requirements Hindering Market Growth

The companion diagnostics market faces significant challenges due to complex reimbursement policies. Many healthcare systems lack well-defined reimbursement frameworks for companion diagnostic tests, making it difficult for patients and healthcare providers to afford these tests. The high cost of developing and validating these diagnostics further complicates accessibility, limiting their widespread adoption. Additionally, variations in reimbursement policies across different countries create inconsistencies in market growth.

Stringent regulatory requirements act as another major barrier, as companion diagnostics must undergo rigorous approval processes to ensure accuracy and efficacy. Regulatory bodies such as the U.S. FDA, EMA, and other global agencies enforce strict guidelines, leading to prolonged approval timelines. Compliance with these complex regulations requires substantial investment and expertise, delaying market entry for new players.

The high cost of companion diagnostics is another critical factor restricting market expansion. Next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies involve expensive equipment and specialised expertise, making these diagnostics unaffordable for many healthcare institutions. The financial burden on smaller laboratories and emerging markets further limits accessibility, restricting the overall growth of the market.

Furthermore, limited awareness and adoption rates in developing regions pose additional challenges. A lack of trained professionals, inadequate infrastructure, and limited integration of precision medicine hinder the widespread implementation of companion diagnostics. Addressing these barriers requires increased investment in education, regulatory simplifications, and improved reimbursement models to unlock the market’s full potential.

Companion Diagnostics Market Segmentation Analysis

By Technology Analysis

Polymerase Chain Reaction Segment Leads with New Product Launches and Regulatory Approvals

The companion diagnostics market is driven by advancements in key technologies, with polymerase chain reaction (PCR) and next-generation sequencing (NGS) leading the segment. PCR remains a widely used technique due to its high sensitivity and ability to detect specific genetic mutations, making it essential for targeted therapies. Meanwhile, NGS is revolutionising the field by offering comprehensive genomic profiling, allowing for precise identification of mutations across multiple genes in a single test. The growing adoption of NGS-based companion diagnostics is driven by increasing demand for personalised medicine and its ability to enhance treatment selection for cancer and genetic disorders.
Other technologies such as in-situ hybridisation (ISH) and immunohistochemistry (IHC) play a crucial role in biomarker detection. In-situ hybridisation is particularly valuable for identifying chromosomal abnormalities, while immunohistochemistry is commonly used to detect protein expressions in tissue samples. The expanding role of these technologies, along with emerging innovations, is expected to strengthen the companion diagnostics market.

By Indication Analysis

Rising Cancer Cases and Technological Innovations Drive Segment Dominance

Cancer is expected to lead the market share based on indications. Lung cancer constitutes for a significant share of overall cancer cases, thus, leading to increased adoption of targeted therapies. Biomarker tests for EGFR, ALK, and PD-L1 improve treatment decisions and outcomes. Breast cancer also holds a significant share, driven by HER2, BRCA1/2, and PIK3CA testing, supporting personalised treatments and boosting demand for emerging targeted drugs.

The use of companion diagnostics is on the rise, driven by the rising incidence of colorectal cancer, with KRAS, NRAS, and BRAF mutation tests guiding therapy selection. Additionally, ovarian, prostate, and gastric cancers are adopting biomarker-based diagnostics, broadening market opportunities. Advancements in novel biomarkers continue to enhance precision medicine across oncology.

By End-user Analysis

Strategic Collaborations Boost Market Share of Pharmaceutical and Biopharmaceutical Companies

Pharmaceutical and biopharmaceutical companies are expected to dominate the companion diagnostics market, leveraging strategic collaborations to enhance drug development. They invest in companion diagnostics to improve treatment efficacy and secure regulatory approvals, driving precision medicine adoption.

Reference laboratories and CROs support biomarker testing and diagnostic validation. Academic institutions and specialty diagnostic centres aid clinical trials and biomarker research, accelerating global companion diagnostics adoption.

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Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Regional Insights

North America dominates the companion diagnostics market due to high adoption of precision medicine, strong regulatory support, and major pharmaceutical collaborations. For instance, in January 2025, Foundation Medicine, Inc. secured FDA approval for FoundationOne® CDx as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA. This approval marks a significant advancement in treating pediatric low-grade glioma (pLGG).

Europe holds a significant market share, supported by regulatory advancements and expanding clinical applications. Germany, France, and the UK are investing in molecular diagnostics. For instance, in March 2025, Agilent Technologies Inc. announced that its PD-L1 IHC 28-8 pharmDx kit received two new companion diagnostic indications under EU IVDR, expanding treatment eligibility for non-small cell lung cancer (NSCLC) and advanced melanoma.

The Asia Pacific region is experiencing rapid growth due to increasing cancer prevalence and rising healthcare investments. For instance, in March 2024, Chugai Pharmaceutical Co., Ltd. received approval from Japan's MHLW for FoundationOne® CDx Cancer Genomic Profile as a companion diagnostic for AstraZeneca K.K.'s Truqap (capivasertib) with Faslodex (fulvestrant) in treating HR-positive, HER2-negative breast cancer with specific genetic alterations.

The companion diagnostics market in Latin America, the Middle East, and Africa is gradually expanding due to improving healthcare infrastructure. Brazil, Mexico, and South Africa are key markets, but regulatory challenges and high costs hinder adoption. However, government initiatives and global partnerships aim to improve diagnostic access, supporting market growth.

List of Key Companies in Companion Diagnostics Market

Other companies in the market include Abbott, Illumina, Inc., Guardant Health, Myriad Genetics, Inc., and BIOMERIEUX.

Key Industry Developments

• In October 2024, Roche secured FDA approval for its VENTANA® Claudin 18 (43-14A) RxDx Assay, making it the first immunohistochemistry (IHC) companion diagnostic for CLDN18 protein expression in gastric and gastroesophageal junction adenocarcinoma patients. This breakthrough enabled eligible patients to receive Astellas’ targeted therapy VYLOY® (zolbetuximab), enhancing treatment precision in gastrointestinal cancers.
• In August 2024, Illumina, Inc. announced FDA approval of its TruSight™ Oncology (TSO) Comprehensive test, a single in vitro diagnostic (IVD) that can profile over 500 genes in solid tumors. This test is designed to identify both adult and pediatric patients with solid tumors that have neurotrophic tyrosine receptor kinase (NTRK) gene fusions. If the test detects this, the patient may benefit from Bayer’s VITRAKVI® (larotrectinib). The test is also approved for identifying adult patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has rearranged during transfection (RET) gene fusions. These patients may benefit from treatment with Lilly’s RETEVMO® (selpercatinib).
• In August 2024, QIAGEN expanded its collaboration with AstraZeneca to develop companion diagnostics (CDx) for chronic diseases. Using QIAGEN’s QIAstat-Dx platform, the partnership aimed at create a genotyping assay that facilitates real-time patient screening, helping healthcare providers determine patient eligibility for AstraZeneca’s genomically targeted medicines, ultimately improving treatment accessibility and clinical decision-making.
• In July 2024, BD and Quest Diagnostics entered a global collaboration to develop flow cytometry-based companion diagnostics (CDx) for cancer and other diseases. This partnership aimed at providing an end-to-end CDx solution pharmaceutical companies. It ranged from exploratory panel development to FDA-approved diagnostic kit distribution, so as to advance precision medicine for better treatment selection.
• In April 2024, Labcorp announced FDA approval for its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic for Pfizer’s gene therapy, BEQVEZ™ (fidanacogene elaparvovec-dzkt). This neutralizing antibody assay ensures patients undergoing hemophilia B treatment are pre-screened for preexisting antibodies, helping optimise treatment safety and efficacy for gene therapy candidates.
• In February 2024, Roche partnered with PathAI to expand digital pathology capabilities for companion diagnostics. This collaboration aimed at integrating AI-powered digital pathology algorithms with Roche Tissue Diagnostics. It also intended to enhance precision medicine in cancer treatment by enabling more accurate biomarker identification and targeted therapy selection.
• In January 2024, Agilent Technologies joined forces with Incyte to advance companion diagnostics in oncology and haematology. The partnership combined Agilent’s expertise in in-vitro diagnostic assays with Incyte’s therapeutic innovations, enhancing targeted treatment options and improving patient outcomes in precision medicine.
• In October 2023, QIAGEN and Myriad Genetics collaborated to develop advanced companion diagnostics for personalised cancer treatments. By leveraging next-generation sequencing and QIAGEN’s digital PCR platform, QIAcuity, the partnership aimed at creating cutting-edge diagnostic assays for multiple cancer types, thus, improving targeted therapy selection and patient outcomes.

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Global Companion Diagnostics Market Segmentation