Tissue-based Genomic Profiling

Global Tissue-based Genomic Profiling Market to Reach US$1.9 Billion by 2030

The global market for Tissue-based Genomic Profiling estimated at US$1.4 Billion in the year 2024, is expected to reach US$1.9 Billion by 2030, growing at a CAGR of 5.0% over the analysis period 2024-2030. Sequencing Techniques, one of the segments analyzed in the report, is expected to record a 5.4% CAGR and reach US$1.2 Billion by the end of the analysis period. Growth in the Immunohistochemistry segment is estimated at 3.9% CAGR over the analysis period.

The U.S. Market is Estimated at US$386.4 Million While China is Forecast to Grow at 7.9% CAGR

The Tissue-based Genomic Profiling market in the U.S. is estimated at US$386.4 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$376.9 Million by the year 2030 trailing a CAGR of 7.9% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 2.4% and 5.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 3.2% CAGR.

Global Tissue-Based Genomic Profiling Market - Key Trends & Drivers Summarized

Is Tissue-Based Genomic Profiling Ushering in a New Era of Precision Oncology?

Tissue-based genomic profiling (TGP) has emerged as a transformative tool in personalized medicine, enabling the identification of genetic alterations in solid tumors through the analysis of formalin-fixed paraffin-embedded (FFPE) or fresh tissue samples. It allows oncologists to match patients with targeted therapies and immunotherapies based on tumor-specific genomic alterations, improving outcomes and minimizing unnecessary treatments. TGP is now central to precision oncology, aiding not only in diagnosis and therapy selection but also in prognostic evaluation and monitoring resistance mechanisms.

This method is being widely adopted in clinical oncology practices and cancer research, especially for lung, breast, colorectal, and prostate cancers. It supports both single-gene assays and comprehensive panels using next-generation sequencing (NGS), which simultaneously analyzes hundreds of mutations, amplifications, and fusions across cancer-related genes. As clinical guidelines increasingly endorse biomarker-driven treatment decisions, tissue-based genomic profiling is evolving from a niche diagnostic option to a frontline tool for therapy selection and trial enrollment.

How Are Advancements in NGS and Bioinformatics Enhancing Clinical Utility?

Technological advancements are significantly expanding the capabilities and accuracy of TGP. High-throughput NGS platforms now allow for ultra-deep sequencing with high sensitivity and specificity, even from low-quality or limited tissue samples. Improvements in library preparation kits, hybrid capture techniques, and PCR-based enrichment are enhancing coverage of clinically relevant mutations, including rare and complex variants that were previously undetectable. Turnaround times are also improving, making the technology more viable for routine clinical use.

Parallel progress in bioinformatics is revolutionizing data interpretation. Cloud-based pipelines, AI-powered variant classification, and integrated clinical databases enable rapid analysis of vast genomic data and annotation of pathogenicity and drug response. These tools also support the integration of genomic, transcriptomic, and epigenetic data into unified clinical reports, enhancing diagnostic precision. Importantly, laboratories are developing protocols to preserve DNA/RNA integrity from FFPE samples—critical for retrospective and real-world analyses. Together, these advancements are making TGP a reliable and indispensable asset in precision oncology.

Can Clinical Adoption, Companion Diagnostics, and Reimbursement Policies Expand Access?

One of the strongest tailwinds for the TGP market is the rising integration of genomic data into therapeutic decision-making pathways. Companion diagnostics approved alongside targeted drugs—such as EGFR, ALK, ROS1, and BRAF inhibitors—now often require tissue-based genomic confirmation for eligibility. As more cancer drugs become biomarker-dependent, the demand for validated, high-throughput genomic profiling platforms is increasing. In parallel, academic medical centers and leading oncology hospitals are adopting TGP as a routine part of tumor boards and treatment planning.

Reimbursement policies are also evolving. In many countries, public and private payers are beginning to cover comprehensive genomic profiling for select cancer types, particularly when linked to a guideline-recommended targeted therapy. Regulatory bodies are increasingly recognizing the clinical utility of multiplex panels over sequential single-gene tests, which are more time-consuming and less cost-effective. Training and infrastructure investments in pathology labs, as well as partnerships between diagnostic companies and healthcare providers, are expanding the availability of TGP even in mid-tier hospitals and research institutions. These efforts are democratizing access and reducing diagnostic inequities in cancer care.

What Is Driving the Global Growth of the Tissue-Based Genomic Profiling Market?

The growth in the tissue-based genomic profiling market is driven by several interrelated forces stemming from technological innovation, oncology practice transformation, and regulatory evolution. First, the widespread adoption of NGS platforms with high accuracy and throughput is enabling robust, scalable genomic analysis from routine biopsy samples. Second, increasing clinical reliance on biomarker-driven treatment selection is driving demand for actionable genomic data derived directly from tumor tissue.

Third, the expanding list of FDA- and EMA-approved companion diagnostics and targeted therapies is linking therapeutic access directly to tissue-based genomic insights. Fourth, rising reimbursement support and national precision medicine initiatives are improving affordability and integration into standard care protocols. Fifth, improved tissue processing, sequencing chemistry, and data interpretation tools are reducing failure rates and making profiling viable even in challenging sample conditions. Lastly, global investment in oncology infrastructure and clinical research is fostering partnerships between biopharma, diagnostics firms, and healthcare institutions, accelerating the adoption of TGP in both developed and emerging markets. Together, these drivers are firmly positioning tissue-based genomic profiling at the heart of next-generation cancer diagnostics and therapeutics.

SCOPE OF STUDY:

The report analyzes the Tissue-based Genomic Profiling market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Technology (Sequencing Techniques, Immunohistochemistry, Other Technologies); Application (Personalized Medicine Application, Oncological Diagnostics Application, Research Application); End-Use (Research Institutes End-Use, Clinical Research Organizations End-Use, Hospitals & Clinics End-Use, Diagnostic Laboratories End-Use, Pharma & Biotech Companies End-Use, Other End-Uses)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 44 Featured) -

• Agilent Technologies
• Bio-Rad Laboratories
• Biocartis
• Caris Life Sciences
• F. Hoffmann-La Roche AG
• Foundation Medicine (Roche)
• Guardant Health
• Illumina, Inc.
• Invitae Corporation
• LabCorp (Covance)
• MDxHealth
• NanoString Technologies
• Novogene
• Personalis, Inc.
• QIAGEN N.V.
• Roche Diagnostics
• SOPHiA GENETICS
• Thermo Fisher Scientific
• Veracyte, Inc.
• WuXi NextCODE

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