Lung Cancer Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Small Cell Lung Cancer, Non-small Cell Lung Cancer), By Test (Imaging Test, Biopsy, Sputum Cytology, Molecular Test, Others) By Region and Competition, 2020-2030F

Market Overview

The Global Lung Cancer Diagnostics Market, valued at USD 1.54 Billion in 2024, is projected to experience a CAGR of 6.99% to reach USD 2.31 Billion by 2030. The Global Lung Cancer Diagnostics Market encompasses a diverse range of technologies and procedures utilized for the early detection and precise characterization of lung cancer. Market growth is primarily driven by the escalating global incidence of lung cancer and heightened awareness surrounding the benefits of early screening. Further support comes from the ongoing advancements in precision medicine, which necessitate comprehensive molecular profiling for targeted therapies, alongside continuous technological innovations in diagnostic modalities. According to the American Lung Association, in 2022, only 16.0% of eligible individuals in the U. S. received lung cancer screening.

A notable challenge potentially impeding market expansion is the substantial capital investment required for advanced diagnostic technologies. This high cost can restrict widespread accessibility and adoption, particularly within emerging economies with limited healthcare budgets and infrastructure, thus affecting the global reach of innovative diagnostic solutions.

Key Market Drivers

The increasing global incidence of lung cancer represents a fundamental driver for the diagnostics market. This rising number of new cases directly necessitates expanded diagnostic capabilities for early detection and precise staging, which are vital for effective treatment planning and improved patient outcomes. The escalating incidence creates continuous demand on healthcare systems for accessible diagnostic tools, encompassing advanced imaging modalities and comprehensive molecular profiling. According to the American Cancer Society and the International Agency for Research on Cancer, in April 2024, "Global Cancer Statistics, 2024" reported an estimated 2.5 million cases of lung cancer were newly diagnosed worldwide in 2022. This substantial global burden underscores the urgent need for robust diagnostic solutions.

Concurrently, advancements in diagnostic technologies significantly influence the market. Innovations like liquid biopsies, AI enhanced imaging, and comprehensive genomic profiling enable more precise and less invasive detection methods. These technological developments enhance diagnostic accuracy and facilitate personalized medicine, driving demand for sophisticated diagnostic platforms. For instance, according to the National Cancer Institute, a Notice of Funding Opportunity published in June 2024 outlined an initiative expected to provide up to $2.4 million in funding for fiscal year 2025 to test strategies for scaling up and sustaining high-quality lung cancer screening. This investment highlights the commitment to enhancing diagnostic reach. Moreover, the imperative for companion diagnostics grows with novel therapeutic approvals, exemplified by the US Food and Drug Administration's approval on September 25, 2024, of osimertinib for unresectable stage III non-small cell lung cancer with specific EGFR mutations, requiring confirmation via an FDA-approved test. This interdependence of therapeutics and diagnostics drives dynamic market expansion.

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Key Market Challenges

The substantial capital investment required for advanced diagnostic technologies poses a notable challenge to the expansion of the Global Lung Cancer Diagnostics Market. The high acquisition, installation, and ongoing maintenance costs associated with state-of-the-art imaging equipment, advanced molecular profiling platforms, and specialized laboratory infrastructure significantly limit their widespread accessibility and adoption. This financial barrier is particularly impactful in emerging economies, where healthcare budgets are often constrained and robust medical infrastructure is less developed.

Consequently, the global reach of innovative diagnostic solutions is hampered, restricting access for a large segment of the population. According to the World Health Organization, in February 2024, lung cancer-related services were reportedly four to seven times more likely to be included in a health benefit package in a high-income country than in a lower-income country, illustrating a significant disparity in resource allocation. This directly impedes market growth by creating an uneven landscape for diagnostic implementation and utilization worldwide.

Key Market Trends

The expansion of global lung cancer screening programs represents a significant trend driving the diagnostics market by systematically increasing the early detection of the disease. These initiatives, increasingly backed by updated guidelines, broaden the eligible population for low-dose computed tomography (LDCT) screening, leading to a greater demand for imaging equipment, skilled radiologists, and subsequent diagnostic procedures. For instance, according to the American Cancer Society, in June 2024, a study found that the up-to-date lung cancer screening prevalence in the United States was 18.1% in 2022, highlighting ongoing efforts to improve screening rates. This programmatic expansion ensures that more individuals at high risk are undergoing regular examinations, facilitating earlier diagnosis and intervention. In the United Kingdom, a national lung cancer screening program, which commenced as a pilot study in 2011, had expanded throughout the country by December 2024, leading to the detection of 5,000 cancers with 76% identified at an early stage. Such widespread implementation underscores the growing emphasis on population-level screening, directly influencing the market for foundational and advanced diagnostic tools.

The development of novel and specific lung cancer biomarkers is a critical trend influencing the diagnostics market through enhanced precision medicine and targeted therapeutic selection. These advanced biomarkers enable the detailed molecular profiling of tumors, facilitating the identification of unique genetic mutations, protein expressions, and epigenetic alterations. This capability allows for more accurate disease subclassification, predicting treatment response and monitoring recurrence. According to the International Association for the Study of Lung Cancer, a global survey released in July 2025 indicated that 67% of respondents estimated more than half of individuals with lung cancer in their respective countries undergo biomarker testing, an increase from 39% in a 2018 survey. This rising adoption of biomarker testing directly supports the market for next-generation sequencing, liquid biopsy platforms, and specialized assays. GRAIL, in April 2024, announced that a novel risk-classification test utilizing its proprietary methylation platform was being employed in an AstraZeneca lung cancer study in Japan, validated for recurrence risk classification in newly diagnosed Stage I non-small cell adenocarcinoma, exemplifying the integration of specific biomarkers into clinical research for enhanced patient management.

Segmental Insights

The Molecular Test segment is experiencing rapid expansion within the Global Lung Cancer Diagnostics Market due to its pivotal role in advancing personalized medicine. This growth is primarily driven by the ability of molecular tests to accurately identify specific genetic mutations, known as oncogenic drivers, in tumor cells. These findings enable the selection of highly effective targeted therapies, significantly improving patient outcomes compared to conventional treatments. Furthermore, regulatory developments, including drug approvals by bodies such as the US Food and Drug Administration, have led to clinical guidelines increasingly recommending molecular profiling to guide treatment decisions for eligible patients. Advancements in genomic technologies, such as Next-Generation Sequencing, further facilitate comprehensive and efficient detection of these actionable biomarkers, solidifying molecular testing as a critical diagnostic approach.

Regional Insights

North America leads the Global Lung Cancer Diagnostics Market owing to its robust and advanced healthcare infrastructure, complemented by significant healthcare expenditure. The region benefits from strong reimbursement regulations, including favorable policies such as Medicare coverage for annual low-dose CT screening for high-risk individuals. Furthermore, the early and widespread adoption of advanced diagnostic technologies, including molecular testing and liquid biopsies, alongside government-backed screening initiatives and a highly skilled medical workforce, significantly contribute to market dominance. This comprehensive approach facilitates early detection and precise classification of lung cancer, reinforcing the region's prominent position.

Recent Developments

• In October 2025, Intuitive, a leader in robotic-assisted surgery, obtained FDA clearance for software advancements in its Ion endoluminal system. These enhancements integrate artificial intelligence (AI) across the system's navigational workflow and include new advanced imaging capabilities. The updated technology is designed to improve the precision and efficiency of lung biopsies by addressing challenges like CT-to-body divergence, aiming to support earlier lung cancer diagnosis and better patient outcomes.

• In July 2025, Thermo Fisher Scientific announced that its Oncomine Dx Express Test received FDA approval as a companion diagnostic for a new non-small cell lung cancer (NSCLC) treatment. This rapid next-generation sequencing (NGS) test, which runs on the Ion Torrent Genexus Dx Integrated Sequencer, is capable of delivering results in as little as 24 hours. The approval targets patients with EGFR exon 20 insertion mutations, making them eligible for treatment with Dizal Pharmaceutical's Zegfrovy (sunvozertinib), and also supports broader tumor profiling.

• In August 2024, Illumina, a global leader in DNA sequencing, received U.S. Food and Drug Administration (FDA) approval for its TruSight™ Oncology (TSO) Comprehensive test. This in vitro diagnostic (IVD) kit is designed for comprehensive genomic profiling, interrogating over 500 genes in solid tumors. It functions as a companion diagnostic to identify patients with RET fusion-positive non-small-cell lung cancer (NSCLC) who may benefit from specific targeted therapies, advancing precision oncology in lung cancer diagnostics.

• In January 2024, researchers at MIT developed a breakthrough non-invasive diagnostic method for early lung cancer detection. This new technology involves inhaling nanoparticle sensors, which, upon encountering cancer-linked proteins in the lungs, produce a signal detectable through a simple urine test. This innovative approach aims to potentially replace or supplement traditional low-dose computed tomography (CT) scans, offering a more accessible and less invasive screening option, particularly valuable in regions with limited access to advanced imaging.

Key Market Players

• Sanofi S.A.
• Roche Diagnostics Corporation
• BioMérieux SA
• Qiagen N.V.
• Agilent Technologies, Inc.
• Thermo Fisher Scientific Inc.
• AstraZeneca plc
• Illumina Inc.
• Johnson & Johnson
• Abbott Laboratories Inc.

Report Scope:

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

• Lung Cancer Diagnostics Market, By Type:

o   Small Cell Lung Cancer

o   Non-small Cell Lung Cancer

• Lung Cancer Diagnostics Market, By Test:

o   Imaging Test

o   Biopsy

o   Sputum Cytology

o   Molecular Test

o   Others

• Lung Cancer Diagnostics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Lung Cancer Diagnostics Market.

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Company Information

• Detailed analysis and profiling of additional market players (up to five).

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