Lung Cancer Genomic Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Component (Products v/s Services), By Technology (Next Generation Sequencing, Polymerase Chain Reactions, Fluorescence In Situ Hybridization (FISH)/In Situ Hybridization (ISH), Others), By Panel Type (Single Panel v/s Multi-Gene Panel), By Sample Type (Tissue Biopsy v/s Liquid Biopsy), By End User (Academic & Research Institutions, Hospitals & Clinics, Diagnostic Laboratories, Others), and By Region 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.17 Billion
CAGR (2026-2031)	9.59%
Fastest Growing Segment	Polymerase Chain Reaction
Largest Market	North America
Market Size (2031)	USD 3.76 Billion

Market Overview

The Global Lung Cancer Genomic Testing Market will grow from USD 2.17 Billion in 2025 to USD 3.76 Billion by 2031 at a 9.59% CAGR. Lung cancer genomic testing involves the molecular analysis of tumor tissue or liquid biopsies to identify specific genetic alterations such as EGFR mutations or ALK rearrangements that dictate the selection of targeted therapies. The market is primarily propelled by the clinical transition toward personalized medicine and the stringent regulatory requirement for companion diagnostics to authorize the use of novel oncology drugs. This growth is further reinforced by updated global treatment guidelines that prioritize comprehensive profiling to improve therapeutic outcomes. According to the International Association for the Study of Lung Cancer, in 2024, 67% of surveyed global experts reported that more than half of the patients in their region received biomarker testing, illustrating a marked increase in clinical adoption.

Despite the robust growth trajectory driven by these clinical mandates, the market faces a notable impediment regarding the financial accessibility of complex diagnostic tools across different healthcare systems. A significant challenge restricting broader market expansion is the inconsistent reimbursement landscape for next-generation sequencing, which creates economic barriers that delay or prevent patient access to essential genomic information in many regions.

Key Market Drivers

The Rising Global Incidence and Prevalence of Lung Cancer serves as the foundational catalyst for the genomic testing market, creating an expanding patient pool that necessitates precise molecular diagnosis. As the burden of lung malignancy remains high globally, healthcare systems are increasingly mandating comprehensive biomarker testing for all newly diagnosed patients to determine the most effective management strategies. This volume-driven demand is evidenced by the sheer scale of diagnoses in major markets. According to the American Cancer Society, January 2025, in the 'Cancer Facts & Figures 2025' report, it was estimated that 226,650 new cases of lung cancer would be diagnosed in the United States alone, underscoring the critical need for scalable diagnostic solutions to stratify this vast population for appropriate care.

Simultaneously, the Expansion of Approved Targeted Therapies for Non-Small Cell Lung Cancer is rapidly transforming testing from a niche requirement into a clinical standard of care. As regulatory bodies continue to authorize novel drugs that target specific genetic alterations, the commercial value and clinical utility of genomic tests increase proportionately. This trend is accelerating, as noted by the Lung Cancer Research Foundation, October 2025, in the 'History of Lung Cancer Treatment Advances' update, which highlighted that four novel therapies for lung cancer were approved by the FDA in the first half of 2025 alone. This proliferation of treatment options has directly surged the utilization of diagnostic tools; for instance, according to Guardant Health, October 2025, in the 'Third Quarter 2025 Financial Results', the company reported a 40% year-over-year increase in clinical test volume, reaching approximately 74,000 tests, as providers increasingly rely on genomic profiling to guide therapeutic selection.

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Key Market Challenges

The inconsistent reimbursement landscape for next-generation sequencing constitutes a substantial barrier hampering the growth of the Global Lung Cancer Genomic Testing Market. While clinical guidelines increasingly recommend comprehensive profiling, the lack of uniform payer coverage creates severe economic friction that disconnects clinical availability from patient accessibility. Diagnostic developers face restricted revenue potential as healthcare providers often hesitate to order advanced genomic profiling due to uncertainty regarding payment authorization. This financial instability forces companies to navigate complex, fragmented payer negotiations rather than scaling operations efficiently, directly reducing the volume of tests performed and stalling the adoption of precision oncology.

This regulatory disparity limits market expansion by shifting the financial burden onto patients or institutions, thereby stifling broader utilization. The magnitude of this reimbursement gap is evident in major markets that typically drive global trends. According to the American Lung Association, in 2024, only 15 states in the U.S. required insurance coverage for comprehensive biomarker testing, whereas 30 states had no such requirements. This lack of standardized funding mechanisms creates a volatile environment where economic barriers delay the integration of essential genomic information into standard care, ultimately depressing market value and slowing the overall growth trajectory.

Key Market Trends

The transition from single-gene assays to comprehensive next-generation sequencing (NGS) panels is reshaping the diagnostic standard for lung malignancy, driven by the need to efficiently identify multiple actionable alterations from limited tissue samples. Clinicians are increasingly abandoning iterative single-biomarker testing, which risks tissue exhaustion, in favor of broad genomic profiling that captures co-occurring mutations and complex signatures like tumor mutational burden in a single workflow. This consolidation is critical for matching patients to the growing array of targeted therapies without the latency of sequential testing. According to Tempus AI, November 2025, in the 'Third Quarter 2025 Results' report, the company experienced an acceleration in oncology testing volume to 27% year-over-year, delivering 217,000 clinical tests, which underscores the rapid clinical migration toward data-driven, comprehensive genomic profiling solutions.

Accelerated adoption of liquid biopsy for non-invasive longitudinal monitoring represents a parallel shift, allowing oncologists to bypass the risks of repeat invasive procedures while gaining real-time insights into tumor evolution. This technology is moving beyond initial diagnosis into recurrence monitoring and the detection of resistance mechanisms, such as EGFR T790M, which emerge during treatment. The scalability of blood-based testing is driving significant volume growth as it becomes a routine component of patient management rather than just a salvage tool. According to Guardant Health, April 2025, in the 'First Quarter 2025 Financial Results' report, the company witnessed a 25% year-over-year increase in clinical oncology test volume, reaching approximately 59,000 tests, highlighting the robust demand for high-sensitivity liquid biopsy assays in routine care.

Segmental Insights

The Polymerase Chain Reaction segment represents the fastest-growing category within the Global Lung Cancer Genomic Testing Market due to its proven efficacy in detecting specific genetic mutations rapidly. Healthcare providers increasingly prioritize this technology for its cost-efficiency and quick turnaround times, which are critical for timely treatment planning. This expansion is further supported by the U.S. Food and Drug Administration approving numerous PCR-based companion diagnostics essential for identifying candidates for targeted therapies. Consequently, the technology remains a preferred option for clinical laboratories seeking reliable and accessible testing solutions for non-small cell lung cancer.

Regional Insights

North America maintains a leading position in the lung cancer genomic testing market, driven by the widespread adoption of precision oncology and established healthcare infrastructure. The region benefits significantly from favorable reimbursement coverage and the presence of major diagnostic developers. Additionally, the U.S. Food and Drug Administration actively supports market expansion through frequent approvals of companion diagnostics for targeted therapies. This regulatory support, combined with high awareness among medical professionals regarding biomarker-driven treatment protocols, ensures that the United States and Canada continue to command the primary share of the global industry.

Recent Developments

• In November 2025, Thermo Fisher Scientific received approval from the U.S. Food and Drug Administration for its Oncomine Dx Target Test to serve as a companion diagnostic for a new lung cancer therapy. The regulatory clearance allowed the next-generation sequencing-based assay to identify patients with non-small cell lung cancer harboring HER2 mutations who might be eligible for treatment with Bayer’s targeted therapy, Hyrnuo. This development addressed a critical need for precision medicine tools that could accurately detect specific genetic alterations, ensuring that clinicians could select the most appropriate therapeutic regimens for individuals facing this difficult-to-treat form of the disease.
• In December 2024, Guardant Health announced a strategic collaboration with Boehringer Ingelheim to develop a blood-based companion diagnostic for advanced lung cancer. The partnership focused on pursuing regulatory approval for the Guardant360 CDx liquid biopsy test to identify patients with non-small cell lung cancer carrying specific HER2 mutations. The companies aimed to use the test to select eligible candidates for treatment with zongertinib, an investigational tyrosine kinase inhibitor. This agreement underscored the increasing reliance on comprehensive genomic profiling of blood samples to guide the administration of targeted therapies in the global oncology market.
• In November 2024, Foundation Medicine obtained approval from the U.S. Food and Drug Administration for its liquid biopsy test, FoundationOne Liquid CDx, to be used as a companion diagnostic. The comprehensive genomic profiling assay was authorized to identify patients with metastatic non-small cell lung cancer harboring MET exon 14 skipping alterations who might be eligible for treatment with Merck KGaA’s therapy, Tepmetko. This regulatory milestone marked the first approval of a blood-based diagnostic for this specific indication, offering a less invasive testing option for patients and supporting the broader adoption of precision oncology in treating advanced lung malignancies.
• In August 2024, Illumina received approval from the U.S. Food and Drug Administration for its TruSight Oncology Comprehensive test, a distributable in vitro diagnostic kit. The approval included its designation as a companion diagnostic to identify adult patients with locally advanced or metastatic non-small cell lung cancer positive for RET fusions who might benefit from Eli Lilly’s Retevmo. This comprehensive genomic profiling assay interrogates over 500 genes, enabling laboratories to perform sophisticated testing in-house. The launch aimed to expand access to precision cancer care by allowing improved detection of actionable biomarkers directly within local pathology departments.

Key Market Players

• QIAGEN NV
• Agilent Technologies Inc.
• Thermo Fisher Scientific Inc.
• Quest Diagnostics Incorporated
• Laboratory Corporation of America Holdings
• CENTOGENE N.V.
• BGI Genomics Co. Ltd.
• CeGaT GmbH
• Illumina Inc.
• F. Hoffmann-La Roche Ltd

By Component	By Technology	By Panel Type	By Sample Type	By End User	By Region
Products v/s Services	Next Generation Sequencing Polymerase Chain Reactions Fluorescence In Situ Hybridization (FISH)/In Situ Hybridization (ISH) Others	Single Panel v/s Multi-Gene Panel	Tissue Biopsy v/s Liquid Biopsy	Academic & Research Institutions Hospitals & Clinics Diagnostic Laboratories Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Lung Cancer Genomic Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Lung Cancer Genomic Testing Market, By Component:

• Products v/s Services

• Lung Cancer Genomic Testing Market, By Technology:

• Next Generation Sequencing
• Polymerase Chain Reactions
• Fluorescence In Situ Hybridization (FISH)/In Situ Hybridization (ISH)
• Others

• Lung Cancer Genomic Testing Market, By Panel Type:

• Single Panel v/s Multi-Gene Panel

• Lung Cancer Genomic Testing Market, By Sample Type:

• Tissue Biopsy v/s Liquid Biopsy

• Lung Cancer Genomic Testing Market, By End User:

• Academic & Research Institutions
• Hospitals & Clinics
• Diagnostic Laboratories
• Others

• Lung Cancer Genomic Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE