San Francisco, USA, Jan. 16, 2026 (GLOBE NEWSWIRE) -- The Pan-Genomic and Multi-Gene Panel Testing Market reached a valuation of US$ 8,907.34 million in 2024 and is projected to grow steadily over the coming years. The market is expected to register a compound annual growth rate (CAGR) of 12.04% between 2025 and 2032, supported by the rising adoption of precision diagnostics and expanding clinical applications of genomic technologies. The market revenue is anticipated to surpass US$ 25,906.10 Million by the end of 2032.
The global healthcare landscape is undergoing a profound transformation, driven by the growing influence of genomics in clinical decision-making. At the center of this shift lies pan-genomic and multi-gene panel testing, which is redefining how diseases are detected, classified, and treated across oncology, rare diseases, and personalized drug therapy. For instance, in precision oncology, the U.S. FDA has approved comprehensive genomic profiling tests such as FoundationOne® CDx (324-gene test) to detect biomarkers like MSI-H, enabling clinicians to identify patients who may benefit from KEYTRUDA (pembrolizumab) as a companion diagnostic use-case. Similarly, the FDA approved Illumina’s TruSight Oncology Comprehensive (517+ genes) as a distributable IVD genomic profiling kit with companion diagnostic claims—supporting wider hospital-level adoption of multi-gene testing.
Over the past decade, advances in sequencing technology, data analytics, and molecular biology have converged to make large-scale genomic testing more accessible and clinically relevant. What was once limited to academic research laboratories has now entered hospitals, diagnostic centers, and even routine outpatient care. This shift has created strong momentum for the pan-genomic and multi-gene panel testing market, positioning it as one of the most dynamic areas within the global diagnostics industry.
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From Single-Gene Testing to Comprehensive Genomic Insight
Traditional genetic tests typically focused on identifying mutations in a single gene associated with a specific condition. While effective in certain scenarios, this approach often failed to capture the complexity of many diseases, particularly cancers and inherited disorders with overlapping genetic drivers. Pan-genomic and multi-gene panel testing emerged as a response to these limitations.
Multi-gene panels analyze dozens or even hundreds of genes simultaneously, allowing clinicians to detect multiple disease-related variants in a single test. Pan-genomic testing goes a step further, examining broad sections of the genome to uncover rare mutations, structural changes, and novel genetic patterns. Together, these approaches provide a far more complete picture of an individual’s genetic makeup, enabling more accurate diagnoses and better-informed treatment decisions.
The growing preference for comprehensive testing reflects a broader trend toward data-driven medicine. Physicians increasingly rely on genetic insights not only to confirm diagnoses but also to predict disease progression, assess risk, and select therapies tailored to each patient’s unique biology.
Global Pan-Genomic And Multi-Gene Panel Testing Market Key Players
- Invitae Corporation
- Myriad Genetics
- Guardant Health
- Tempus Labs
- Ambry Genetics
- Foundation Medicine
- Caris Life Sciences
- GeneDx
- Natera
- Fulgent Genetics
- PathAI
- NeoGenomics
- Counsyl
- BioReference Laboratories
- ArcherDX
Market Growth Reflects Expanding Clinical Adoption
The pan-genomic and multi-gene panel testing market is expanding steadily, supported by rising clinical adoption across multiple specialties. Oncology remains the largest contributor, as cancer care increasingly shifts from organ-based diagnosis to molecular classification. Concrete example: The U.S. FDA has approved broad genomic profiling tests such as FoundationOne®CDx to identify MSI-H tumors, helping doctors determine patient eligibility for KEYTRUDA (pembrolizumab)—a real companion diagnostic pathway where multi-gene/pan-genomic testing directly impacts treatment selection.
Beyond cancer, genetic testing is growing in cardiology, neurology, pediatrics, and reproductive health due to improved clinical access and standardized test commissioning. Concrete example: Under the NHS Genomic Medicine Service (England), the National Genomic Test Directory defines which genomic tests are commissioned, eligible patient criteria, and technology type (single gene, panels, and whole genome sequencing), enabling large-scale routine adoption—especially for rare and inherited diseases where years of inconclusive testing can be resolved using genomic approaches.
Another key growth driver is the integration of genomics into preventive and population health programs. Concrete example: The CDC Tier 1 Genomics program highlights evidence-based genomic applications such as Hereditary Breast and Ovarian Cancer (BRCA1/BRCA2), Lynch syndrome, and Familial Hypercholesterolemia, supporting wider screening and risk assessment—accelerating genomics adoption beyond reactive diagnosis into proactive prevention.
Technological Innovation Fuels Market Momentum
At the core of this market’s expansion is rapid technological innovation. Advances in next-generation sequencing (NGS) have improved accuracy, speed, and scalability, enabling laboratories to process large volumes of samples efficiently and generate complex genomic data within hours—reshaping diagnostic workflows.
A major breakthrough is also coming from bioinformatics and AI-driven interpretation, which helps filter variants, prioritize clinically relevant mutations, and convert raw sequencing output into actionable clinical insights, reducing uncertainty linked to variants of unknown significance (VUS). In 2024, Illumina received FDA approval for TruSight Oncology Comprehensive, a distributable multi-gene oncology assay supporting broad tumor profiling—showing how innovation is moving multi-gene testing beyond specialized centers toward wider clinical access.
In parallel, automation across sample prep to reporting is lowering costs, minimizing manual errors, and helping labs scale with consistent quality—making comprehensive genomic testing increasingly feasible in routine clinical care.
Regional Market Dynamics Highlight Global Opportunity
Geographically, the pan-genomic and multi-gene panel testing market is performing strongly in developed regions, while emerging economies are rapidly catching up. North America remains the leading market, supported by mature healthcare infrastructure, strong genomics research networks, and early adoption of precision medicine. The region also benefits from a dense ecosystem of CLIA-certified labs, academic medical centers, and technology innovators continuously advancing genomic diagnostics and clinical implementation.
Meanwhile, Asia-Pacific is the fastest-growing region, fueled by rising healthcare expenditure, expanding diagnostic infrastructure, and a large, underserved patient base. Several countries are actively integrating genomic medicine into national healthcare modernization programs, which is improving test availability and clinician uptake. As affordability, awareness, and access continue to improve, demand for pan-genomic and multi-gene panel testing across Asia-Pacific is expected to accelerate further.
MARKET, BY TEST
- Oncology Multi-Gene Panels
- Pan-Genomic / Whole Exome Based Panels
- Pharmacogenomics (PGx) Panels
- Comprehensive Hereditary Disease Panels
MARKET, BY APPLICATION
- Neurology and Neurogenetics
- Oncology
- Reproductive Carrier Screening
- Cardiology & Cardiomyopathy
- Newborn & Pediatric Genomics
- Rare & Undiagnosed Genetic Diseases
MARKET, BY END-USE
- Specialty Genomic Centers
- Independent Diagnostic Labs
- Hospital-based Genetic Labs
- Others
Competitive Landscape and Industry Strategy
The pan-genomic and multi-gene panel testing market is highly competitive and innovation-driven, with global diagnostics leaders, specialized genomic laboratories, and AI-enabled startups competing on panel breadth, clinical validity, turnaround time, and companion diagnostic (CDx) integration. Key players are expanding their test portfolios, strengthening bioinformatics and interpretation capabilities, and building partnerships with hospitals and pharmaceutical companies to accelerate clinical adoption.
Top 3 Dominant Players in Pan-genomic And Multi-gene Panel Testing Market
1.Illumina:-
Illumina is expanding beyond sequencing platforms into FDA-approved, distributable clinical assays. Example: In 2024, the U.S. FDA approved Illumina TruSight Oncology Comprehensive (TSO Comprehensive), a 500+ gene assay and the first FDA-approved distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, supporting wider hospital-level implementation.
2. Thermo Fisher Scientific:-
Thermo Fisher remains a leading competitor through its strong oncology panel portfolio and established CDx ecosystem. Example: Oncomine Dx assays have FDA clearance/approval as companion diagnostics for targeted cancer therapies, enabling faster and more informed treatment selection, particularly in biomarker-driven cancers such as NSCLC.
3. Foundation Medicine (Roche):-
Foundation Medicine is a major name in comprehensive genomic profiling, supported by deep oncology expertise and strong biopharma collaboration. Its tests are widely used to guide therapy decisions and support clinical trial matching, strengthening its leadership in pan-genomic testing adoption.
Future Outlook: Toward Integrated Genomic Healthcare
Looking ahead, the pan-genomic and multi-gene panel testing market is poised for continued expansion. Integration with electronic health records, real-time clinical decision support, and population-level screening programs will further embed genomics into everyday healthcare. Advances in artificial intelligence and cloud computing are expected to enhance scalability and reduce interpretation challenges, making comprehensive testing more efficient and accessible.
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