The global tissue diagnostics market size was estimated at USD 8.72 billion in 2024 and is projected to reach USD 14.03 billion by 2030, reflecting a strong CAGR of 8.41% from 2025 to 2030. This growth trajectory is mainly supported by the escalating burden of cancer worldwide, continuous advancements in diagnostic instrumentation, and the expanding adoption of personalized medicine approaches. As cancer incidence rises globally, the need for accurate and early tissue-based diagnosis becomes critical to guide treatment planning. According to the Pan American Health Organization (PAHO), around 20 million new cancer cases and 10 million cancer-related deaths were anticipated in 2023, and annual reported cases are expected to increase substantially to 30 million by 2040, underscoring the urgency for sophisticated diagnostic solutions. Additional factors such as rapidly aging populations, greater focus on early disease detection, and technological improvements in immunohistochemistry (IHC) and in situ hybridization (ISH) methods further support market expansion. Moreover, increased healthcare spending, rising awareness of cancer screening programs, and initiatives promoting early diagnosis across both developed and developing regions continue to stimulate market growth.

The rise of targeted and personalized therapies has amplified the need for companion diagnostics, which help identify specific biomarkers to determine patient eligibility for particular treatments. This shift is accelerating the integration of companion tests into routine tissue diagnostic workflows. A significant example is the FDA approval of Agilent Technologies, Inc.'s PD-L1 IHC 22C3 pharmDx assay in January 2024. This assay functions as a companion diagnostic for Jemperli (dostarlimab-gxly), an immunotherapy used to treat endometrial cancer. Developed in partnership with GlaxoSmithKline, the test provides critical insights into PD-L1 protein expression within tumor tissues, enabling clinicians to make more precise and informed treatment decisions. This approval underscores the growing importance of highly specific and actionable diagnostic tools in oncology, which support accurate disease characterization and ultimately improve patient outcomes by enabling personalized therapeutic strategies.

Key Market Trends & Insights:

  • In North America, the tissue diagnostics market held a significant 44.76% share in 2024, driven by strong demand for advanced diagnostic technologies and the high prevalence of cancer and other chronic diseases. Robust healthcare infrastructure, increased adoption of innovative diagnostic solutions, and favorable reimbursement policies also contribute to the region’s leadership in the global landscape.
  • In the Asia Pacific, the tissue diagnostics market is witnessing rapid and sustained growth. The rising incidence of cancer in major countries such as China, India, Japan, and South Korea is prompting increased utilization of advanced diagnostic tools to facilitate early detection and improve treatment outcomes. Growing investments in healthcare infrastructure, expanding laboratory networks, and greater awareness of screening and diagnostic services further support the region’s expansion.
  • Based on application, the breast cancer segment accounted for the largest share at 50.45% in 2024 and is also projected to grow at the fastest CAGR, owing to the widespread implementation of breast cancer screening programs and the continuous development of biomarker-based diagnostic tests. The non-small cell lung cancer (NSCLC) segment is similarly expected to experience notable growth, supported by increasing demand for early testing and biomarker-driven treatment strategies.
  • In terms of modality, the clinical market segment dominated the overall market in 2024 and is projected to expand at the fastest CAGR of 8.83% throughout the forecast period. Meanwhile, the pharma / CRO / research market segment is expanding rapidly due to the rising reliance of pharmaceutical companies and contract research organizations on tissue diagnostics for drug discovery, translational research, and clinical trial development. These stakeholders increasingly utilize advanced diagnostic tools to study tumor biology, validate biomarkers, and assess therapeutic responses.
  • Based on end-use, hospitals led the market with the largest revenue share of 37.82% in 2024, supported by their central role in conducting surgical biopsies, pathology evaluations, and comprehensive diagnostic testing. The CRO segment is projected to grow at the fastest CAGR over the forecast period, driven by their essential function in assisting pharmaceutical and biotechnology companies throughout the drug development process, from early research stages to late-phase clinical trials.

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Market Size & Forecast:

  • 2024 Market Size: USD 8.72 Billion
  • 2030 Projected Market Size: USD 14.03 Billion
  • CAGR (2025-2030): 8.41%
  • North America: Largest market in 2024
  • Asia Pacific: Fastest growing market

Key Players

  • Hoffmann-La Roche Ltd.
  • Abbott Laboratories
  • Thermo Fisher Scientific Inc.
  • Siemens
  • Danaher
  • bioMérieux SA
  • QIAGEN
  • BD
  • Merck KGaA
  • GE Healthcare
  • BioGenex
  • Cell Signaling Technology, Inc.
  • Bio SB
  • DiaGenic ASA
  • Agilent Technologies

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Conclusion:

The global tissue diagnostics market is poised for strong growth, supported by rising cancer incidence, advancements in diagnostic technologies, and increasing adoption of personalized medicine. Expanding use of companion diagnostics and biomarker-driven testing continues to enhance the precision and effectiveness of cancer treatment. Key regions such as North America and Asia Pacific are expected to maintain robust demand due to improved healthcare infrastructure and higher awareness of early detection. Additionally, growing reliance on tissue diagnostics by hospitals, pharmaceutical companies, and CROs will further accelerate market expansion. Overall, the market is set to benefit from continuous innovation and the rising global emphasis on early and accurate disease diagnosis.