Report

Global lung biopsy market is projected to witness a CAGR of 11.27% during the forecast period 2024-2031, growing from USD 3.01 billion in 2023 to USD 7.07 billion in 2031F. The lung biopsy market is expected to thrive under the impact of drivers such as the rising prevalence of lung cancer and other respiratory diseases, the growing demand for early identification and detection of lung cancer, and the increasing popularity of minimally invasive surgeries. Deteriorating AQI levels, increasing consumption of tobacco, and the presence of carcinogens in the air are major factors contributing to the increasing prevalence of lung cancer. Followed by the preliminary imaging analysis of the lungs, the biopsy and endoscopy procedures are performed for confirmation of cancer cells. With rising cases of lung cancer, the demand for lung biopsy solutions is anticipated to increase significantly. Additionally, the government initiatives addressing the concerns associated with cancer cases and awareness campaigns being run by various authorities significantly promoted the diagnosis procedures including biopsies.
However, the high cost of biopsy procedures and equipment associated with lung cancer is a major challenge for market expansion in middle and low-income regions. The availability of alternate diagnostic methods like imaging analysis, rapid testing facilities, and others poses a significant pushback to the adoption of biopsy methods. Alongside, stringent regulatory guidelines for the manufacturing of biopsy instruments and carrying out biopsy procedures are major challenges for key players to expand the market growth. Despite these challenges, the market is witnessing promising growth.
For instance, in October 2023, Delfi Diagnostics launched a new product called FirstLook Lung. The product aims to identify individuals who could benefit the most from lung cancer screening. It uses a novel approach to liquid biopsy, which involves the detection of DNA fragments in the blood to identify the tumors. Delfi focuses primarily on lung cancer, which is the leading cause of cancer-related deaths.
Increasing Adoption of Robotics in Lung Biopsy
Robotic technology aids healthcare professionals to perform minimally invasive procedures with high accuracy. The use of artificial intelligence, machine learning algorithms, and other similar technologies to enhance the efficacy of biopsy devices is a major key trend in the market. Robotic lung biopsies use robotic-assisted technology to perform cancer diagnostic procedures and help guide the course of treatment.
With the rising demand for minimally invasive procedures, lung biopsies are being performed through robots along with the integration of artificial intelligence and other tools for better clinical outcomes. It increases the speed and accuracy of diagnosis, further contributing to the advancements in the market.
In March 2023, Noah Medical announced its clinical trial at Macquarie University Hospital in Sydney, Australia. The trial, called FRONTIER, is the first-in-human study that aims to evaluate the safety and feasibility of the Galaxy System. The system is designed to enhance the accuracy of locating and diagnosing lung nodules using its TiLT+ technology. The Galaxy System features integrated tomosynthesis and augmented fluoroscopy in its TiLT+ technology, a single-use disposable bronchoscope, and a small, compact design that improves procedural workflow.
Increasing Prevalence of Lung Cancer
The prevalence of lung cancer is growing, particularly in developing nations where tobacco smoking and industrialization are increasing. Lung cancer is the leading cause of global cancer incidence and mortality. Major reasons for lung cancer in the present scenario include increasing air pollution and the presence of carcinogens and PM 2.5 particles in the air. A significant decrease in lung cancer cases has been observed in developed nations but the condition is still at an alarming rate in states belonging to emerging countries. The shift towards smoking cessation and initiatives for reducing CO2 emissions seem promising in reducing lung cancer cases in the long run. The increasing prevalence of lung cancer is increasing the demand for lung biopsy solutions to ensure early diagnosis and effective treatment methodologies. As per WHO, lung cancer is considered the most commonly occurring cancer worldwide with 2.5 million new cases accounting for 12.4% of the total new cases. Lung cancer is the leading cause of cancer deaths accounting for about 1.8 million deaths, which is 18.7% of the total cancer deaths.
Needle Biopsy Dominates Global Lung Biopsy Market in Terms of Procedure
Needle biopsies have gained significant popularity in lung cancer diagnosis due to their non-invasive nature, speed, convenience, and safety. Compared to open lung biopsy, needle biopsies like fine needle aspiration (FNA) and core needle biopsy (CNB) are less invasive, quicker, and often allow patients to return home the same day. These procedures provide accurate diagnoses and are cost-effective, making them more accessible for patients and healthcare systems. However, needle biopsies have limitations, as they remove a very small amount of tissue, which may not be sufficient for certain tests or diagnosis.
For instance, in November 2023, Broncus Medical Inc. announced the launch of BioStar Transbronchial Aspiration Needle (TBNA) which aims to transform the landscape of minimally invasive diagnostics. The innovative needle sets a new standard in accuracy, ease of use, and patient comfort. It offers medical professionals an unprecedented tool for precise tissue sampling, providing high-quality specimens needed for establishing a reliable tool for diagnosing the stage of lung cancer. The needle is available in 21G, 22G, and 25G configurations.
Hospitals to be the Dominant End-user of Lung Biopsy
Hospitals are the major end-users of lung biopsy products as they provide round-the-clock services to patients and are equipped with advanced medical equipment. Medical professionals who have expertise in lung biopsy systems are easily available in the hospital premises. Besides, hospitals offer patients better access to healthcare services which can result in a huge number of lung biopsies being performed. Hospitals are expanding their service offerings through the adoption of robotics and other technologies. In August 2023, the first robotic-assisted lung biopsy was performed at Royal Brompton Hospital and St Bartholomew's Hospital, the United Kingdom to aid in early diagnosis. The robotic-assisted lung biopsy surgery was performed by the Ion Endoluminal robotic system.
North America is the Leading Region with Highest Market Share
North America is anticipated to be the leading region in the lung biopsy market. Many lung cancer biopsies in North America are performed due to several factors, including the high prevalence of lung cancer, the need for accurate diagnosis, and lack of effective routine screening methods. Lung cancer is the leading cause of cancer-related deaths in the United States, and its rapid growth and tendency to spread make early detection and diagnosis critical for successful treatment. Additionally, the availability of specialized techniques and the presence of a large number of healthcare providers and facilities in the United States contribute to the high frequency of biopsies. Furthermore, grants for developing innovative biopsy solutions strengthen the dominance of North America.
For instance, in October 2023, radiology experts from The University of California, Los Angeles scored a USD 4.6 million grant from the National Institutes of Health for the development of liquid biopsy technology for the early detection of lung cancer. Liquid biopsy is a non-invasive alternative, allowing physicians to determine the molecular composition of a tumor without extracting tissue or performing any surgery.
Future Market Scenario (2024 - 2031F)
Liquid biopsy has seen significant advancements in the diagnosis and management of lung cancer. It is a minimally invasive approach that involves the detection of molecular alterations, tumor cells, and metabolites in body fluids such as blood, urine, sputum, and saliva. In recent times, several market products have been initiated to cater to the demand for liquid biopsy for lung cancer. Additionally, products based on virtual biopsy and image-guided biopsy methods are in the pipeline promising growth for the market.
For instance, in May 2023, Guardant Health, Inc. shared that Singapore's Health Sciences Authority (HSA) has given regulatory approval to Guardant360 CDx. It is a liquid biopsy test that detects tumor mutation profiling, known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers. The Guardant360 CDx test has been approved as a companion diagnostic tool for identifying patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with TAGRISSO (osimertinib).
Key Players Landscape and Outlook
Key players in lung biopsy market include key players from various levels including big players as well as emerging startups. Industry collaboration between medical device manufacturers and technology providers is crucial for the integration of technologies in biopsy devices. Significant mergers and acquisitions have been witnessed in recent times as well. Grants from several authorities for developing suitable solutions will further expand the market.
In February 2024, Renovaro Biosciences announced that its newly acquired subsidiary, GediCube, secured a binding letter of intent (LOI) for the acquisition of 75% of Dutch liquid biopsy firm Cyclomics, which developed a circulating tumor DNA detection technology using Oxford Nanopore sequencing. Cyclomics aims to use the technique for the development of multi-omic tests that can be run using a single vial of blood for early detection of cancer, recurrence monitoring, and precision oncology treatment.