Companion Diagnostics Market 2030: A New Era in Oncology

The global companion diagnostics market was valued at USD 9,058.1 million in 2024 and is expected to reach USD 15,977.6 million by 2030, growing at a CAGR of 10.5% from 2025 to 2030. Companion diagnostics play a vital role in customizing treatments by identifying biomarkers that predict how patients will respond to specific therapies.

The increasing prevalence of diseases such as cancer, cardiovascular disorders, and autoimmune conditions has intensified the demand for targeted therapies, where companion diagnostics are essential for selecting the most effective treatments. This personalized approach reduces adverse side effects and improves treatment success rates, thereby enhancing patient outcomes. The transition from uniform treatment methods to personalized medicine stands as a major growth driver. Additionally, pharmaceutical companies are integrating companion diagnostics into their drug development processes to increase the chances of success for new therapeutics, further propelling market growth.

Technological advancements are another key factor contributing to market expansion. Innovations in next-generation sequencing (NGS), polymerase chain reaction (PCR), and digital pathology have greatly improved the speed and accuracy of biomarker detection. These technologies allow for rapid and precise identification of genetic mutations and protein expressions, which are crucial for informed personalized treatment decisions. Furthermore, the incorporation of artificial intelligence (AI) and machine learning (ML) enhances diagnostic accuracy and aids in interpreting complex data, empowering healthcare providers to make better treatment choices. The growing adoption of these advanced tools in research and healthcare settings is driving the market forward, as providers aim to optimize patient care with data-driven insights.

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Regulatory frameworks and favorable reimbursement policies also support the growth of the companion diagnostics market. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established clear approval pathways for companion diagnostic tests used alongside targeted therapies. The rising number of FDA-approved companion diagnostics highlights the increasing acceptance of personalized medicine. For example, in October 2024, Roche announced FDA approval of its VENTANA Assay, the first immunohistochemistry (IHC) companion diagnostic for detecting CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction adenocarcinoma. This approval allows eligible patients to be treated with Astellas' targeted drug, VYLOY. Additionally, evolving reimbursement policies are making these advanced diagnostics more accessible. Continued regulatory support for co-developing drugs and diagnostics is encouraging pharmaceutical and biotech companies to invest heavily in companion diagnostic innovation to improve treatment precision and market reach.

Key Market Trends & Insights:

• North America was the largest revenue-generating region in 2024.
• The companion diagnostics market in the U.S. is expected to witness substantial growth.
• By product and service, the assays, kits, and reagents segment led with a 59.1% share in 2024.
• By sample type, tissue samples accounted for the largest share of 62.7% in 2024.
• By end use, the hospitals and physician laboratories segment held the largest share at 38.6% in 2024.

Market Size & Forecast:

• 2024 Market Size: USD 9,058.1 Million
• 2030 Projected Market Size: USD 15,977.6 Million
• CAGR (2025-2030): 10.5%
• North America: Largest market in 2024

Key Companion Diagnostics Company Insights:

Leading players like Agilent Technologies, Inc., Illumina Inc., and Merck KGaA are heavily investing in the development of innovative NGS products, panels, kits, and IHC systems that focus on improved portability and sequencing efficiency. These companies prioritize research and development and often collaborate with pharmaceutical and biotech firms to launch cutting-edge technologies, maintaining strong product portfolios.

Emerging companies such as Biosystems, Guardant Health, Inc., and EntroGen, Inc. are gaining traction by partnering with larger and regional firms. They focus on geographic expansion and the development of companion diagnostics, NGS platforms, and laboratory services to boost clinical testing capabilities.

Leading Companies in the Companion Diagnostics Market:

• QIAGEN
• Agilent Technologies, Inc.
• Abbott
• Thermo Fisher Scientific, Inc.
• F. Hoffmann La Roche Ltd
• Foundation Medicine
• Myriad Genetics
• Illumina, Inc. 

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Conclusion:

The companion diagnostics market is poised for strong growth, with an expected CAGR of 10.5% between 2025 and 2030, reaching nearly USD 16 billion by 2030. The rising prevalence of chronic diseases and the shift towards personalized medicine are major factors driving demand. Advances in diagnostic technologies such as NGS, PCR, AI, and ML are enhancing biomarker detection and treatment decision-making. Furthermore, supportive regulatory frameworks and reimbursement policies are making companion diagnostics more accessible, encouraging pharmaceutical and biotech companies to invest heavily in this space. Collectively, these trends indicate that companion diagnostics will play an increasingly critical role in precision medicine, improving patient outcomes and transforming therapeutic approaches globally.