• lung cancer diagnostics market was valued at approximately USD 5.02 billion in 2024 and is projected to reach around USD 9.45 billion by 2034, growing at a compound annual growth rate (CAGR) of 6.53 during the forecast period.

• Non-small cell lung cancer (NSCLC) remains the dominant cancer type, accounting for approximately 67.2 of the market share in 2024, with EGFR mutation tests leading the diagnostic test segment at a share of 38.9.

• North America led the market with a share of 47 in 2024, attributed to advanced healthcare infrastructure, high awareness about early cancer detection, and strong government support for cancer screening initiatives.

• The hospitals and clinics segment held the largest end-user share at 49 in 2024, while diagnostic laboratories are anticipated to register the fastest growth over the projected period, driven by expansion in specialized molecular testing and strategic partnerships.

• Technological advancements, such as the development of liquid biopsies, which analyze circulating tumor DNA for non-invasive detection, are enhancing early detection capabilities and driving market growth.

• Key players in the market include Roche, Thermo Fisher Scientific, Illumina, Agilent Technologies, Qiagen, Abbott, Bio-Rad, Neogenomics Laboratories, bioMérieux, and Myriad Genetics, focusing on innovation and expanding their product offerings to meet growing consumer needs.

• Challenges such as high treatment costs, development of resistance to existing therapies, and limited access to advanced care in emerging markets are influencing market dynamics and prompting innovation in treatment approaches.

In this report, Lung Cancer Diagnostics Market has been segmented by Cancer, Diagnostic Test, End-User, and Geography.

Lung Cancer Diagnostics Market, Segmentation by Cancer

lung cancer diagnostics market is classified based on the type of cancer, primarily into Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). The growing incidence of NSCLC, which accounts for nearly 85% of all lung cancer cases, drives significant demand for precise diagnostic techniques. Continuous advancements in molecular diagnostics and the adoption of targeted therapies further boost the need for accurate cancer typing and biomarker detection.

Non-Small Cell Lung Cancer (NSCLC)

NSCLC dominates the global market due to its higher prevalence and the growing adoption of genetic and molecular testing methods. The use of EGFR, ALK, and KRAS mutation tests helps clinicians tailor personalized treatment strategies, improving patient survival outcomes. Increased investments in biomarker discovery and the approval of novel diagnostic kits contribute to sustained growth in this segment.

Small Cell Lung Cancer (SCLC)

The SCLC segment, though less prevalent, remains critical owing to its aggressive progression and limited treatment options. Early detection through sensitive diagnostic methods like immunohistochemistry and molecular profiling is essential for improving prognosis. The segment’s expansion is supported by emerging research initiatives focusing on predictive biomarkers and improved screening tools for high-risk populations.

Lung Cancer Diagnostics Market, Segmentation by Diagnostic Test

The market is further segmented based on the type of diagnostic tests, encompassing CA Test, HER2 Test, ALK Test, Angiogenesis Inhibitors, EGFR Mutation Test, and KRAS Mutation Test. The growing use of companion diagnostics and liquid biopsy technologies is accelerating test adoption globally. Advances in next-generation sequencing (NGS) and precision oncology are enabling faster, more accurate identification of genetic abnormalities that guide targeted therapy selection.

CA Test

The CA test plays a vital role in detecting tumor-associated antigens and monitoring disease progression. Increased demand for tumor marker assays and their integration into screening programs supports this segment’s steady growth. Technological advances in immunoassay platforms enhance test accuracy and clinical utility.

HER2 Test

HER2 testing enables detection of gene overexpression and guides the use of targeted therapies. Its expanding role in lung cancer, alongside breast cancer diagnostics, reflects broader adoption of precision medicine approaches. Rising awareness and the availability of FDA-approved HER2 diagnostic kits contribute to growth.

ALK Test

ALK tests are crucial for identifying gene rearrangements in NSCLC patients. Increased approval of ALK inhibitors has significantly driven the need for companion testing. Laboratories and hospitals are increasingly deploying FISH and NGS-based assays for enhanced diagnostic accuracy.

Angiogenesis Inhibitors

This segment refers to tests used to assess the efficacy of angiogenesis inhibitor therapies. As the development of anti-VEGF agents expands, the need for diagnostic validation grows. Clinical research and pharma collaborations are fostering advanced biomarker testing in this category.

EGFR Mutation Test

The EGFR mutation test is one of the most widely used diagnostics in NSCLC. It aids in identifying patients suitable for targeted therapies such as erlotinib and osimertinib. With the adoption rate exceeding 70% in developed markets, this test remains a cornerstone of personalized lung cancer management.

KRAS Mutation Test

KRAS mutation testing helps in excluding patients unlikely to benefit from certain targeted treatments. The increasing development of KRAS G12C inhibitors is stimulating demand for accurate diagnostic tools. Its role in clinical decision-making continues to expand with advancements in molecular pathology.

Lung Cancer Diagnostics Market, Segmentation by End-User

Based on end-users, the market is categorized into Hospitals, Laboratories, and Others. Hospitals remain the dominant segment, supported by robust diagnostic infrastructure and multidisciplinary oncology care. Laboratories, particularly those offering specialized molecular and genomic testing, are experiencing notable growth due to increased outsourcing of complex analyses and rising demand for precision medicine solutions.

Hospitals

Hospitals account for the largest revenue share owing to their role in integrated cancer management. They provide immediate access to diagnostic imaging, biopsy analysis, and oncologic consultations under one roof. Expanding hospital-based diagnostic centers and adoption of digital pathology platforms are enhancing efficiency and accuracy in lung cancer detection.

Laboratories

Laboratories play a pivotal role in performing advanced biomarker assays and molecular profiling. Independent diagnostic labs are investing in automation and AI-powered data interpretation to handle large sample volumes efficiently. Their strategic collaborations with pharmaceutical companies for clinical trials continue to strengthen the global diagnostic ecosystem.

Others

The Others category includes research institutes, academic centers, and point-of-care facilities. Growth in this segment is driven by R&D activities, government funding, and early adoption of experimental diagnostic technologies. These institutions play a vital role in validating novel biomarkers and facilitating translational research in oncology.

Lung Cancer Diagnostics Market, Segmentation by Geography

In this report, Lung Cancer Diagnostics Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

North America

North America leads the global market due to high awareness, widespread access to advanced diagnostic technologies, and supportive reimbursement frameworks. The U.S. dominates regional revenue with a well-established healthcare infrastructure and strong presence of diagnostic giants like Thermo Fisher Scientific and Roche Diagnostics. Rising adoption of liquid biopsy and NGS panels is further accelerating market penetration.

Europe

Europe demonstrates steady growth fueled by national screening programs and robust R&D investments. Countries like Germany, France, and the U.K. are expanding molecular testing capabilities, driven by favorable government initiatives and partnerships with biotechnology firms. Increased emphasis on early detection and personalized medicine supports a positive market trajectory.

Asia Pacific

Asia Pacific is emerging as the fastest-growing region, driven by the rising prevalence of lung cancer and improving diagnostic infrastructure. Nations such as China, Japan, and India are witnessing substantial adoption of genetic testing and AI-based diagnostic systems. Government health reforms and local manufacturing incentives are boosting market expansion across the region.

Middle East and Africa

The Middle East and Africa region is experiencing moderate growth, with increasing government investments in cancer care infrastructure. The introduction of specialized oncology centers and partnerships with global diagnostic providers are improving access to testing. However, limited reimbursement policies and uneven healthcare access remain key challenges in rural zones.

Latin America

Latin America shows gradual adoption of modern lung cancer diagnostics, supported by expanding healthcare coverage and collaborations with international healthcare firms. Countries like Brazil and Mexico are focusing on enhancing laboratory capabilities and integrating biomarker-based testing into routine care. Continued awareness initiatives and training programs are expected to propel long-term growth in this region.

This report provides an in depth analysis of various factors that impact the dynamics of Lung Cancer Diagnostics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Advanced screening technologies
• Rising incidence of lung cancer
• Growing awareness and early detection

• Technological advancements in diagnostics - lung cancer diagnostics market is driven by rapid technological innovations that greatly enhance early detection and diagnostic accuracy. Advanced tools such as high-resolution imaging, next-generation sequencing, and molecular assays have transformed how lung cancer is identified and classified, enabling clinicians to detect the disease at earlier, more treatable stages and thereby improving patient outcomes.

  Non-invasive diagnostic methods, including liquid biopsies, have increased patient comfort and accessibility while allowing ongoing monitoring of disease progression and treatment effectiveness. The integration of artificial intelligence (AI) and machine learning algorithms into imaging and pathology further reduces errors and supports personalized treatment planning by efficiently analyzing large datasets with enhanced precision.

  Improvements in diagnostic platforms have also shortened turnaround times for results, facilitating quicker clinical decisions and more effective patient management. This is especially critical for lung cancer, where early intervention can dramatically alter treatment success.

  These ongoing technological advancements make lung cancer diagnostics more reliable, accessible, and patient-centric, fueling market growth. Continued innovation is expected to further refine diagnostic capabilities and expand their clinical applications worldwide.

Restraints

• High costs of diagnostic procedures
• Limited accessibility in rural areas
• Regulatory hurdles for new technologies

• Lack of skilled healthcare professionals - A significant obstacle in lung cancer diagnostics market is the shortage of skilled healthcare professionals. Accurate diagnosis requires expertise in fields such as radiology, pathology, and molecular biology, which are unevenly distributed, especially in developing countries. This skills gap can cause delays, reduce diagnostic quality, and limit the uptake of advanced technologies.

  Overworked healthcare workers often face high patient loads, which can increase the risk of diagnostic inaccuracies. Furthermore, the complexity of modern diagnostic tools demands ongoing training and education, which is frequently insufficient, intensifying the shortage of qualified personnel.

  The lack of expertise not only affects diagnostic accuracy but also hampers healthcare efficiency. Facilities without trained professionals may hesitate to adopt cutting-edge diagnostics, restricting patient access to early and precise lung cancer detection.

  Addressing this challenge requires investment in education, professional training, and workforce development. Until these measures are widely implemented, the shortage of skilled professionals will continue to constrain the growth and effectiveness of lung cancer diagnostics worldwide.

Opportunities

• Expansion of imaging technologies
• Personalized medicine and targeted therapies
• Integration of AI in diagnostics

• Collaborative research and development efforts - Collaborative research and development (R&D) initiatives offer valuable opportunities in lung cancer diagnostics market. Partnerships among academic institutions, biotech companies, pharmaceutical firms, and healthcare providers combine resources and expertise, accelerating the creation of innovative diagnostic technologies and personalized medicine approaches.

  These collaborations overcome individual limitations in technology and funding, enabling comprehensive clinical trials and studies. Such teamwork fosters breakthroughs including advanced biomarker discovery, improved imaging agents, and integrated diagnostic platforms that analyze genetic, molecular, and morphological information simultaneously.

  Joint efforts also promote standardization of diagnostic procedures and facilitate regulatory approvals, making it easier to introduce new tests to the market and gain clinical acceptance. Sharing data and insights improves the accuracy and cost-effectiveness of lung cancer diagnostics.

  These partnerships help extend innovative diagnostics to broader patient populations and speed up the translation of research into clinical use, representing a major growth opportunity for the market.

Key players in Lung Cancer Diagnostics Market include:

• F Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific
• Illumina Inc
• Agilent Technologies
• Qiagen
• Abbott Laboratories
• Bio-Rad
• Neogenomics Laboratories
• bioMérieux
• Myriad Genetics
• Guardant Health
• Siemens Healthineers
• GE Healthcare
• Hologic
• Philips

In this report, the profile of each market player provides following information:

• Market Share Analysis
• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis