Tissue-based Genomic Profiling - Global Strategic Business Report

The global market for Tissue-based Genomic Profiling was estimated at US$1.4 Billion in 2024 and is projected to reach US$1.9 Billion by 2030, growing at a CAGR of 5.0% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Tissue-based Genomic Profiling market.

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.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the Sequencing Techniques segment, which is expected to reach US$1.2 Billion by 2030 with a CAGR of a 5.4%. The Immunohistochemistry segment is also set to grow at 3.9% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, estimated at $386.4 Million in 2024, and China, forecasted to grow at an impressive 7.9% CAGR to reach $376.9 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

• Detailed Market Analysis: Access a thorough analysis of the Global Tissue-based Genomic Profiling Market, covering all major geographic regions and market segments.
• Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
• Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Tissue-based Genomic Profiling Market.
• Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

• How is the Global Tissue-based Genomic Profiling Market expected to evolve by 2030?
• What are the main drivers and restraints affecting the market?
• Which market segments will grow the most over the forecast period?
• How will market shares for different regions and segments change by 2030?
• Who are the leading players in the market, and what are their prospects?

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Agilent Technologies, Bio-Rad Laboratories, Biocartis, Caris Life Sciences, F. Hoffmann-La Roche AG and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 44 companies featured in this Tissue-based Genomic Profiling market report include:

• 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

This edition integrates the latest global trade and economic shifts as of June 2025 into comprehensive market analysis. Key updates include:

• Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
• Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes segmentation by product, technology, type, material, distribution channel, application, and end-use, with historical analysis since 2015.
• Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
• Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
• Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
• Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.
• Complimentary Update: Buyers receive a free July 2025 update with finalized tariff impacts, new trade agreement effects, revised projections, and expanded country-level coverage.