The global breath biopsy testing market is experiencing rapid transformation, fuelled by growing demand for non-invasive diagnostic solutions, according to a new report from Persistence Market Research.
Announced on Thursday, the project is valued at USD$1.3 billion in 2025. Furthermore, the market is projected to reach USD$3.6 billion by 2032, reflecting an impressive compound annual growth rate (CAGR) of 15.7 per cent during the forecast period.
Clinicians, researchers, and healthcare systems increasingly rely on breath biopsy to detect chronic diseases early, offering accurate and minimally invasive diagnostics.
Chronic diseases such as cancer, respiratory infections, and gastrointestinal disorders continue to rise worldwide. Consequently, healthcare providers are prioritizing technologies that reduce patient discomfort while delivering reliable results.
Breath biopsy has emerged as a critical tool in this effort.
It allows clinicians to detect disease specific biomarkers rapidly, avoiding the risks and costs associated with traditional tissue biopsies. Furthermore, patients benefit from a non-intrusive diagnostic experience, which encourages adherence to regular screenings.
The reported said that advancements in volatile organic compounds (VOC) analysis and mass spectrometry have significantly accelerated market growth.
In addition, governments are increasingly funding early disease detection programs, particularly for cancers. Expanding healthcare infrastructure in emerging economies has further strengthened the market’s reach.
North America leads globally with a 45 per cent share in 2025, driven by advanced diagnostic facilities, substantial R&D investment, and strong disease surveillance programs. Meanwhile, lung cancer detection represents the largest application segment, commanding 38 per cent of the market.
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Breath biopsy spans lung cancer detection
VOC analysis dominates the market with a 35.5 per cent share, owing to its sensitivity and non-invasive profiling capabilities.
Companies such as Owlstone Medical have set industry standards with VOC analyzers that detect early stage disease with remarkable precision. Additionally, mass spectrometry is gaining traction due to its high sensitivity and utility in research and high throughput diagnostics. These technological innovations allow healthcare providers to implement more accurate and timely diagnostic procedures, improving patient outcomes.
By application, breath biopsy spans lung cancer detection, respiratory disease monitoring, gastrointestinal disorder diagnosis, and infectious disease detection.
Lung cancer leads with a 38 per cent share, reflecting rising awareness of early detection programs. Conversely, infectious disease detection has become the fastest growing segment post COVID-19. The pandemic emphasized the need for rapid, real time diagnostics, particularly in outbreak prone regions, making breath based pathogen detection increasingly valuable.
North America, especially the United States, maintains its dominance in the breath biopsy testing market. Advanced diagnostic infrastructure, high healthcare penetration, and robust investments in R&D contribute to its 45 per cent market share in 2025.
Additionally, leading manufacturers such as Owlstone Medical continues to develop state-of-the-art VOC based diagnostic tools. Favourable reimbursement policies further drive adoption, while early regulatory approvals allow faster commercialization of innovative devices.
Europe also exhibits steady market growth. Germany, the U.K., and France constitute the key markets. Germany leads due to its strong industrial base and focus on medical innovation. In addition, the U.K., through institutions like the National Health Service (NHS), actively implements non invasive cancer diagnostics programs.
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Government initiatives have fuelled market expansion
Regulatory frameworks, including the Medical Device Regulation (MDR), support innovation and facilitate commercialization, benefiting companies such as IONICON and Ambetronics Engineers Pvt. Ltd. European healthcare systems increasingly integrate breath biopsy diagnostics to enhance early detection and patient care.
The market faces several strong drivers. The surge in chronic diseases, particularly cancer, continues to stimulate demand. The World Health Organization reports over 2.5 million new lung cancer cases annually, making early detection critical.
Consequently, clinicians increasingly adopt breath biopsy due to its low cost, non invasiveness, and accuracy. Furthermore, technological advancements such as the ReCIVA Breath Sampler and AI integrated electronic nose tools enable real time biomarker analysis.
These devices work even in low resource settings, reducing diagnostic turnaround times and improving patient outcomes.
Government initiatives have also fuelled market expansion.
Programs such as Horizon Europe, Healthy China, and the U.S. National Cancer Institute’s biomarker research funding have increased investments in breath biopsy. In addition, these initiatives encourage healthcare providers to integrate non invasive diagnostics into routine clinical practice. Consequently, patients benefit from earlier interventions and better survival rates, particularly in oncology.
Despite these advantages, the market faces notable restraints. Advanced testing platforms, especially those relying on mass spectrometry, remain expensive. Maintenance costs, sensor calibration, and infrastructure requirements create barriers, particularly in low income regions.
Furthermore, trained personnel are often limited. Breath biopsy systems require expertise in breathomics and analytical chemistry, disciplines still emerging in many countries. As a result, developing regions experience slower adoption, restricting the global reach of these promising diagnostic tools.
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Multiple companies invest heavily in breath biopsy devices
Opportunities, however, remain abundant.
The development of portable and point-of-care (POC) breath biopsy devices addresses many limitations. These mobile platforms enable real time testing in remote or underserved areas.
Companies such as Owlstone Medical and Aeroqual invest heavily in miniaturized devices to meet rising demand. In addition, integrating Internet of Things (IoT) connectivity and AI analytics allows remote monitoring and diagnostics, opening new avenues for telemedicine and digital healthcare.
Asia Pacific represents a particularly lucrative growth opportunity. Rapidly expanding healthcare infrastructure, coupled with large populations, drives demand for decentralized diagnostics.
Governments in India and China promote adoption through national health missions and digital health initiatives. Consequently, companies can expand their footprint while supporting public health objectives.
Meanwhile, investments in healthcare technology continue to grow, further encouraging the use of breath biopsy systems for chronic disease detection and monitoring.
The market’s transformation also benefits private companies. Owlstone Medical, for instance, secured USD$27 million in 2025 to accelerate commercialization of its breath biopsy diagnostics.
Additionally, other players focus on expanding their VOC analyzer capabilities and developing AI powered analytical tools. Kentucky-based Breath Diagnostics Inc develops advanced VOC analyzers capable of detecting minute concentrations of disease specific biomarkers in exhaled breath. Their AI powered platform integrates machine learning algorithms to interpret complex VOC patterns, enabling early detection of conditions such as lung cancer, respiratory infections, and gastrointestinal disorders.
Furthermore, the system continuously refines its predictive models as more patient data is analyzed, improving diagnostic accuracy over time. In addition, Breath Diagnostics offers cloud based reporting tools that allow clinicians to access results remotely, facilitating faster clinical decision making and streamlined patient care workflows.
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