Companion Diagnostics Market Forecast Report 2025-2034 | Next-Generation Sequencing Enhancing Accuracy, Precision Medicine Advancements Propel Growth

Dublin, July 23, 2025 (GLOBE NEWSWIRE) -- The "Companion Diagnostics Market Report and Forecast 2025-2034" report has been added to ResearchAndMarkets.com's offering.

The global companion diagnostics market was valued at USD 7.03 Billion in 2024, driven by the rising prevalence of cancer across the globe. The market is anticipated to grow at a CAGR of 12.50% during the forecast period of 2025-2034 to achieve a value of USD 22.83 Billion by 2034.

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.

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.

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

Expanding Indications

The market is broadening beyond oncology to include neurological, cardiovascular, and infectious diseases. Regulatory approvals for new indications enable the development of biomarker-driven therapies, improving patient outcomes. This trend enhances diagnostic applications, supporting pharmaceutical innovations and expanding the market's potential across diverse therapeutic areas.

Focus on Precision Medicine

The shift towards precision medicine is driving the demand for companion diagnostics, ensuring targeted drug selection. Advances in genomic profiling allow for personalised treatment plans, reducing adverse reactions and enhancing efficacy. Pharmaceutical companies increasingly integrate biomarker-based diagnostics to develop tailored therapies, improving patient care and optimising treatment strategies.

Rising Healthcare Expenditures

Increasing healthcare investments globally support the growth of companion diagnostics, with governments and private entities funding research and development. The demand for early disease detection and advanced diagnostics drives higher spending, ensuring improved diagnostic capabilities and expanding access to innovative treatments, particularly in emerging economies.

Advancements in Technologies

Cutting-edge technologies like next-generation sequencing (NGS), artificial intelligence (AI), and digital pathology enhance the efficiency of companion diagnostics. Automated platforms enable faster, more accurate biomarker detection, supporting precision medicine. Continuous innovation in diagnostic tools strengthens the market, improving patient outcomes through highly specialised, data-driven diagnostics.

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.

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 TruSightT 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.

Key Attributes:

Supplier Landscape

• Abbott
• F. Hoffmann-La Roche Ltd.
• Agilent Technologies, Inc.
• Illumina, Inc.
• Guardant Health
• Thermo Fisher Scientific Inc.
• BIOMERIEUX
• QIAGEN
• Myriad Genetics, Inc.

Global Companion Diagnostics Market Segmentation

Market Breakup by Offerings

• Products
• Assays, Kits and Reagents
• Instruments & Systems
• Software
• Services

Market Breakup by Technology

• Polymerase Chain Reaction
• Immunohistochemistry
• In Situ Hybridization
• Next-Generation Sequencing
• Others

Market Breakup by Indication

• Cancer
• Neurological Diseases
• Infectious Diseases
• Others

Market Breakup by End User

• Pharmaceutical & Biopharmaceutical Companies
• Reference Laboratories
• Contract Research Organizations
• Others

Market Breakup by Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

For more information about this report visit https://www.researchandmarkets.com/r/fq1fyf

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• Companion Diagnostics Market