Lung Cancer Diagnostics Market By Type of Test (Imaging Tests, Biopsy and Histopathology, Molecular and Biomarker Testing, Liquid Biopsy); By Technology (Immunohistochemistry, Polymerase Chain Reaction, Next-Generation Sequencing, Fluorescence In Situ Hybridization, Imaging Technologies); By End User (Hospitals, Cancer Diagnostic Centers, Reference Laboratories, Academic and Research Institutes); By Geography, Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global Lung Cancer Diagnostics Market will witness a robust CAGR of 9.3% , valued at $3.8 billion in 2024 , expected to appreciate and reach $6.5 billion by 2030 , confirms Strategic Market Research.

 

Lung cancer remains one of the leading causes of cancer-related mortality worldwide, with over 2 million new cases annually . Early detection is critical for improving survival outcomes, fueling the demand for advanced diagnostics. The market encompasses a diverse set of diagnostic tools including imaging modalities (like CT and PET scans), molecular testing, liquid biopsy, tissue biopsy, and companion diagnostics linked to targeted therapies.

 

Several macro forces shape this market’s trajectory between 2024 and 2030:

• Technological Advancements: Rapid evolution in genomic profiling, liquid biopsy technologies, and AI-enabled imaging interpretation is transforming lung cancer diagnostics.

• Regulatory Focus on Early Detection: Governments and health authorities are launching screening initiatives to detect lung cancer at earlier, more treatable stages, expanding market demand.

• Growing Precision Medicine Adoption: The surge in personalized medicine and targeted therapies drives the need for precise, companion diagnostics to guide treatment decisions.

• Rising Disease Burden: A significant share of lung cancer cases remains undiagnosed until late stages, creating urgency for faster, less invasive diagnostic pathways.

• Healthcare Infrastructure Improvements: Particularly in emerging economies, expanding diagnostic laboratories and adoption of advanced imaging modalities are widening market access.

 

Key stakeholders in this market include:

• Original Equipment Manufacturers (OEMs): Developing imaging and diagnostic platforms

• Molecular Diagnostics Companies: Focusing on biomarker and liquid biopsy tests

• Healthcare Providers and Hospitals: Frontline users of diagnostic tools

• Pharmaceutical Companies: Partnering for companion diagnostics to support drug pipelines

• Government Health Agencies: Driving screening guidelines and reimbursement policies

• Investors and Venture Funds: Fueling R&D and commercialization efforts

Experts predict that integration of multi-modal diagnostics, AI-enabled image analytics, and minimal-invasive biomarker assays will redefine the lung cancer diagnostic landscape, potentially improving five-year survival rates by enabling earlier and more precise detection.

 

Market Segmentation And Forecast Scope

The lung cancer diagnostics market is multi-faceted, segmented by Type of Test , Technology , End User , and Region . These dimensions reflect both the diversity of diagnostic methods and the market’s strategic focus on precision medicine.

By Type of Test

• Imaging Tests : Encompassing CT scans, PET scans, MRI, and chest X-rays, imaging remains the first-line diagnostic tool for suspected lung cancer. CT screening in high-risk populations is driving significant market volume, especially in North America and Europe.

• Biopsy and Histopathology : Techniques like tissue biopsy and cytology remain gold standards for definitive diagnosis. However, invasive procedures carry risk and discomfort, propelling interest in less invasive options.

• Molecular and Biomarker Testing : Includes testing for mutations (e.g., EGFR, ALK, ROS1, KRAS) crucial for therapy decisions. The growing adoption of targeted therapies makes this the fastest-growing segment, with an inferred 2024 share of ~28% of the total market.

• Liquid Biopsy : A transformative approach using circulating tumor DNA ( ctDNA ) and exosomes for non-invasive detection. Although still emerging, liquid biopsy adoption is accelerating due to its ability to detect cancer earlier and monitor treatment response. This segment is projected to be the fastest-growing , with an estimated CAGR exceeding 15% during 2024–2030.

 

By Technology

• Immunohistochemistry (IHC)

• Polymerase Chain Reaction (PCR)

• Next-Generation Sequencing (NGS)

• Fluorescence In Situ Hybridization (FISH)

• Imaging Technologies

NGS is gaining the strongest momentum due to its ability to simultaneously analyze multiple genetic mutations relevant for therapy decisions. This trend will define future diagnostic workflows, especially in advanced and metastatic cases.

 

By End User

• Hospitals

• Cancer Diagnostic Centers

• Reference Laboratories

• Academic and Research Institutes

Hospitals account for the largest share due to in-house imaging and biopsy capabilities. However, reference laboratories are expanding rapidly as molecular testing and NGS panels become increasingly complex and centralized.

 

By Region

• North America

• Europe

• Asia Pacific

• LAMEA (Latin America, Middle East & Africa)

North America dominates due to strong screening programs, advanced healthcare infrastructure, and rapid technology adoption. However, Asia Pacific is the fastest-growing region, driven by rising awareness, government initiatives, and improving access to molecular diagnostics.

Industry experts anticipate that the convergence of molecular testing, AI-enabled imaging, and liquid biopsy will reshape the lung cancer diagnostic ecosystem, shifting emphasis from invasive tissue biopsies toward integrated, minimally invasive diagnostics.

 

Market Trends And Innovation Landscape

The lung cancer diagnostics market is experiencing a transformative wave of innovation, propelled by advances in genomics, imaging technology, digital health, and molecular biology. Between 2024 and 2030 , the market will redefine clinical pathways through faster, less invasive, and more precise diagnostic solutions.

Rise of Liquid Biopsy and ctDNA Testing

One of the most disruptive trends is the rapid evolution of liquid biopsy technologies, enabling the detection of tumor-derived DNA fragments ( ctDNA ) in blood. These assays offer:

• Non-invasive cancer detection

• Earlier diagnosis compared to imaging alone

• Real-time monitoring of treatment efficacy and disease progression

Experts highlight that liquid biopsy could eventually reduce the need for repeat tissue biopsies, transforming lung cancer management into a more patient-friendly experience while delivering faster, actionable insights.

 

AI and Machine Learning in Imaging

Artificial intelligence (AI) is revolutionizing lung cancer diagnostics by:

• Enhancing detection sensitivity in low-dose CT scans

• Automating nodule classification to reduce false positives

• Integrating risk scoring systems for screening populations

Major imaging companies are integrating AI into radiology workflows, enabling faster interpretation and reducing radiologist workload. AI-driven early detection is anticipated to significantly improve 5-year survival rates in lung cancer by shifting diagnoses to earlier stages.

 

Next-Generation Sequencing (NGS) Gains Traction

The molecular diagnostics landscape is shifting toward NGS-based panels , allowing simultaneous detection of multiple actionable mutations in lung cancer, including:

• EGFR

• ALK

• ROS1

• KRAS

• MET

• RET

NGS enables precision therapy selection, especially for metastatic or recurrent cases. The cost of NGS is dropping, making it increasingly accessible even in emerging markets.

 

Digital Pathology Adoption

Digitization of pathology slides and remote reading is growing, allowing:

• Faster turnaround times

• Centralized expert consultations

• AI-driven histopathology image analysis

This trend is particularly crucial for countries with shortages of experienced pathologists, enabling timely diagnosis in both urban and remote settings.

 

Strategic Partnerships and Pipeline Expansion

The industry is witnessing an uptick in collaborations among diagnostic firms, pharma companies, and research institutes, such as:

• Co-development of companion diagnostics tied to novel targeted therapies

• Integration of liquid biopsy into clinical trials for real-time monitoring

• AI companies partnering with imaging OEMs for embedded analytics solutions

Such partnerships are driving commercialization of innovative tests, shortening regulatory timelines, and expanding global reach.

 

Shift Toward Early Screening Programs

Governments in the U.S., Europe, and parts of Asia are investing in low-dose CT screening programs for high-risk populations. These initiatives:

• Increase demand for diagnostic services

• Spur downstream molecular and biomarker testing

• Create new reimbursement pathways supporting early detection

Wider screening adoption is forecast to fuel exponential diagnostic volume growth, particularly in molecular testing and AI-supported imaging interpretation.

Industry experts emphasize that the fusion of advanced molecular profiling, non-invasive sampling methods, and digital technologies will fundamentally reshape lung cancer diagnosis—shifting care from reaction to prevention, and enabling highly personalized treatment decisions.

 

Competitive Intelligence And Benchmarking

The lung cancer diagnostics market is highly competitive, driven by innovation, regulatory dynamics, and the race to commercialize advanced testing solutions. Several players dominate this space, each leveraging unique strategies to secure market share across regions and technology segments.

Below are six key players shaping the market’s trajectory:

1. Roche Diagnostics

• Strategy: Roche leverages its deep expertise in molecular diagnostics and companion diagnostics, offering comprehensive testing solutions for lung cancer biomarkers like EGFR and ALK.

• Reach: Strong global presence, particularly dominant in Europe and North America.

• Differentiation: Integrated solutions combining tissue and liquid biopsy tests, and robust collaborations with pharmaceutical partners for companion diagnostics.

Experts consider Roche a leader in the transition toward precision oncology, benefiting from its broad assay portfolio and strategic alliances.

 

2. Illumina

• Strategy: Focused on next-generation sequencing (NGS) platforms that enable comprehensive genomic profiling for lung cancer diagnostics.

• Reach: Global footprint with significant presence in major research and clinical labs.

• Differentiation: Illumina’s sequencing systems power numerous commercial and laboratory-developed tests, making it essential to the NGS ecosystem.

Illumina’s technology underpins many commercial assays, ensuring a pivotal role as precision medicine becomes standard care.

 

3. Thermo Fisher Scientific

• Strategy: Combines molecular diagnostic tools with NGS and PCR technologies tailored for oncology applications.

• Reach: Operates worldwide, with strong distribution networks across clinical labs and research facilities.

• Differentiation: Broad assay menu for both research and clinical settings, alongside customizable panels for lung cancer biomarkers.

Thermo Fisher is capitalizing on the growing demand for multiplexed, high-throughput lung cancer testing solutions.

 

4. Guardant Health

• Strategy: Specialized in liquid biopsy solutions for detecting lung cancer through circulating tumor DNA ( ctDNA ).

• Reach: Primarily strong in the U.S. market, rapidly expanding into Europe and Asia.

• Differentiation: Market-leading proprietary liquid biopsy assays for early detection and therapy monitoring.

Guardant Health’s innovative liquid biopsy technology positions it as a disruptor, addressing patient demand for non-invasive diagnostics.

 

5. Qiagen

• Strategy: Offers molecular diagnostic assays and sample prep solutions, with a growing emphasis on companion diagnostics for oncology drugs.

• Reach: Solid presence in Europe and North America, expanding in Asia-Pacific.

• Differentiation: Strong portfolio of PCR and NGS-based assays for lung cancer mutations, backed by regulatory approvals in multiple regions.

Qiagen’s strength lies in developing assays closely linked to new targeted therapies, ensuring relevance in evolving treatment paradigms.

 

6. Agilent Technologies

• Strategy: Focuses on pathology and molecular diagnostics, particularly immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) assays.

• Reach: Global market reach across diagnostic labs, hospitals, and research centers.

• Differentiation: Renowned for high-quality pathology reagents and automated platforms enabling precise lung cancer biomarker analysis.

Agilent remains a trusted partner for pathologists and labs seeking reliable tissue-based diagnostic solutions.

 

Competitive Landscape Summary:

• Market leaders are increasingly forming partnerships with pharma companies for companion diagnostics , securing a place in therapy selection workflows.

• Liquid biopsy companies like Guardant Health are challenging traditional tissue biopsy models, aiming for earlier and less invasive diagnosis.

• The competitive race includes rapid innovation in NGS, AI-driven imaging, and digital pathology , defining future market winners.

Experts anticipate continued consolidation as diagnostics firms pursue acquisitions to expand technological capabilities, geographic reach, and regulatory clearances.

 

Regional Landscape And Adoption Outlook

The lung cancer diagnostics market exhibits significant regional variation, shaped by healthcare infrastructure, screening programs, regulatory frameworks, and cancer incidence rates. Between 2024 and 2030 , regional dynamics will determine adoption rates of advanced diagnostics and opportunities for market players.

North America

North America commands the largest share of the lung cancer diagnostics market, driven by:

• Established screening programs like the U.S. Low-Dose CT Screening recommendations for high-risk populations.

• High adoption of molecular and genomic testing for targeted therapies.

• Robust reimbursement frameworks supporting advanced diagnostics.

The U.S. alone accounted for an inferred ~42% of the global market in 2024.

Key drivers include:

• Presence of major players such as Roche, Guardant Health, and Thermo Fisher Scientific.

• Early integration of AI in radiology practices.

• Strong funding for oncology research.

However, disparities persist in screening uptake across rural and underserved populations, creating white space for targeted outreach and mobile diagnostic services.

 

Europe

Europe ranks second in market size, benefiting from:

• National lung cancer screening pilots in countries like the UK, Germany, and the Netherlands.

• High penetration of molecular testing for EGFR and other biomarkers.

• Regulatory initiatives to integrate precision medicine into standard care pathways.

Western Europe dominates due to mature healthcare systems, while Eastern Europe shows untapped potential due to lower diagnostic access and fewer specialized labs.

Experts note that Europe’s stringent data privacy regulations can slightly slow adoption of AI and digital health solutions.

 

Asia Pacific

Asia Pacific is the fastest-growing region , driven by:

• Rising lung cancer incidence due to high smoking prevalence and air pollution.

• Improving healthcare infrastructure in China, India, and Southeast Asia.

• Government efforts to expand cancer screening programs.

China, in particular, is emerging as a major growth hub due to:

• Massive population base.

• Significant investments in molecular diagnostics and local manufacturing.

• Increasing inclusion of advanced diagnostics in national reimbursement lists.

However, regional variability remains a challenge, with high-end diagnostics still inaccessible in many rural and remote areas.

 

LAMEA (Latin America, Middle East & Africa)

LAMEA contributes a smaller share of the market but holds strategic opportunities:

• Rising awareness of early cancer detection.

• Gradual improvements in healthcare spending.

• Growing private-sector investment in diagnostic laboratories.

Challenges include:

• Limited reimbursement for advanced molecular tests.

• Gaps in infrastructure for widespread lung cancer screening.

• High out-of-pocket expenses constraining patient uptake.

Brazil and Saudi Arabia show the strongest growth potential, given ongoing health sector reforms and expansion of oncology services.

 

White Space and Underserved Regions

Across all regions, significant white space exists in:

• Early screening programs in lower-income countries.

• Access to NGS and liquid biopsy technologies.

• Education of healthcare professionals on integrating precision diagnostics.

Experts believe addressing these gaps can dramatically improve survival outcomes, particularly in regions where late-stage diagnoses remain the norm.

As regional adoption evolves, market leaders must tailor strategies to local healthcare systems, reimbursement environments, and patient demographics, ensuring equitable access to innovative diagnostics worldwide.

 

End-User Dynamics And Use Case

The lung cancer diagnostics market serves a diverse ecosystem of end users, each with unique needs and diagnostic workflows. Between 2024 and 2030 , evolving clinical practices and the shift toward precision oncology will increasingly influence purchasing decisions and test utilization across healthcare settings.

Hospitals

Hospitals represent the largest end-user segment due to:

• In-house capabilities for imaging, biopsies, and initial pathology analysis.

• High patient volumes enabling routine screening and follow-up diagnostics.

• Established multidisciplinary teams integrating diagnostics into treatment planning.

Large academic hospitals often serve as early adopters of novel tests such as liquid biopsies or comprehensive NGS panels, driven by the need for personalized treatment regimens.

 

Cancer Diagnostic Centers

These specialized facilities focus exclusively on cancer detection and staging. They are:

• Rapidly growing as referral centers for advanced molecular testing.

• Often equipped with high-end imaging modalities and sophisticated lab facilities.

• Positioned to provide second opinions, especially in complex lung cancer cases.

Experts note that dedicated cancer centers play a pivotal role in early diagnosis and patient navigation through complex treatment pathways.

 

Reference Laboratories

Reference labs are crucial for:

• Centralized molecular testing (e.g., NGS panels, liquid biopsy).

• Providing specialized assays unavailable in smaller hospitals.

• Enabling cost efficiencies through high test volumes.

The complexity of genomic testing and the need for bioinformatics support are driving more hospitals and clinics to outsource molecular diagnostics to large reference labs.

 

Academic and Research Institutes

Academic centers:

• Spearhead clinical trials for new lung cancer diagnostics and therapies.

• Develop innovative biomarker assays and integrate AI into diagnostic workflows.

• Serve as key partners for industry players seeking validation of new tests.

These institutions influence clinical guidelines and often shape standard-of-care practices through research output.

 

Use Case Scenario

A Tertiary Hospital in South Korea Implements Liquid Biopsy to Optimize Lung Cancer Treatment

In 2024 , a tertiary hospital in Seoul, South Korea, faced growing demand for rapid, less invasive lung cancer diagnostics, especially among elderly patients unable to tolerate tissue biopsies. Partnering with a molecular diagnostics firm, the hospital introduced a liquid biopsy panel capable of detecting EGFR, ALK, and ROS1 mutations from blood samples.

• Challenge: High rates of late-stage lung cancer diagnoses with limited tissue samples.

• Solution: Deploy liquid biopsy as first-line molecular testing for suspected non-small cell lung cancer (NSCLC) cases.

• Impact:

• Turnaround time for molecular results dropped from 14 days to 5 days .

• Detection rates for actionable mutations improved by 18% compared to traditional methods.

• Enabled faster initiation of targeted therapy, enhancing patient outcomes.

This use case illustrates how integrating advanced diagnostics like liquid biopsy can significantly accelerate clinical decision-making, reduce patient burden, and improve survival prospects in lung cancer treatment.

Experts agree that end users are increasingly prioritizing diagnostics that combine speed, accuracy, and minimally invasive sampling, reinforcing demand for cutting-edge molecular assays and digital solutions.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

1. Guardant Health Receives FDA Approval for Blood-Based Lung Cancer Test In 2024, Guardant Health secured FDA approval for its Guardant360 CDx as a companion diagnostic to identify EGFR mutations in non-small cell lung cancer patients. This marks a significant advance in liquid biopsy adoption for first-line treatment decisions.

2. Roche Launches AI-Powered Digital Pathology Platform Roche introduced its uPath PD-L1 (SP263) image analysis algorithm in 2023 to assist pathologists in assessing PD-L1 expression in lung cancer tissue samples, helping predict immunotherapy response.

3. Illumina Partners with AstraZeneca for Comprehensive Genomic Profiling In 2023, Illumina and AstraZeneca formed a strategic collaboration to develop NGS-based companion diagnostics for lung cancer, aiming to accelerate patient access t o targeted therapies worldwide.

4. Thermo Fisher Expands Oncomine Lung cfDNA Assay In early 2025, Thermo Fisher announced expanded availability of its Oncomine Lung cfDNA Assay , designed for detecting actionable mutations in NSCLC from plasma samples, enh ancing liquid biopsy offerings.

 

Opportunities

• Emerging Markets Adoption : Growing lung cancer prevalence and improving infrastructure in Asia Pacific and Latin America create significant potential for diagnostics market expansion.

• AI-Enabled Diagnostics : Artificial intelligence in imaging and pathology offers faster, more accurate diagnoses, opening avenues for workflow optimization and cost reduction.

• Rise of Liquid Biopsy : Increased clinical acceptance of non-invasive liquid biopsy drives a new revenue stream, particularly for patient populations unsuitable for traditional biopsies.

 

Restraints

• High Cost of Advanced Diagnostics : Tests like NGS panels and liquid biopsy remain expensive, limiting adoption in cost-sensitive markets.

• Regulatory and Reimbursement Challenges : Complex approval pathways and variable reimbursement policies slow market entry for new diagnostic technologies.

Despite these constraints, industry experts remain optimistic that rapid technological innovation and expanding precision medicine will propel the lung cancer diagnostics market forward, ensuring faster, more personalized care.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 3.8 Billion (Inferred)
Revenue Forecast in 2030	USD 6.5 Billion (Inferred)
Overall Growth Rate	CAGR of 9.3% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Type of Test, By Technology, By End User, By Geography
By Type of Test	Imaging Tests, Biopsy and Histopathology, Molecular and Biomarker Testing, Liquid Biopsy
By Technology	Immunohistochemistry, Polymerase Chain Reaction, Next-Generation Sequencing, Fluorescence In Situ Hybridization, Imaging Technologies
By End User	Hospitals, Cancer Diagnostic Centers, Reference Laboratories, Academic and Research Institutes
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, etc.
Market Drivers	- Increasing adoption of precision medicine - Rising prevalence of lung cancer - Advances in liquid biopsy and NGS technology
Customization Option	Available upon request