Fusion Biopsy Market

Market Overview

The global fusion biopsy market size was valued at USD 606.97 million in 2022. It is estimated to reach USD 1,603.81 million by 2031, growing at a CAGR of 11.4% during the forecast period (2023–2031).

Fusion biopsy combines images from an MRI scan and an ultrasound to generate a 3-D image of the prostate gland. This procedure simplifies visualizing an abnormal tissue area to guide the biopsy needle into the abnormal tissue. Before fusion biopsy, medical professionals would randomly sample various prostate regions. A prostate MRI carried out in a 3T MRI is the first step in the MRI/ultrasound fusion biopsy. A radiologist will read this initial exam and look for any abnormal spots for cancer.

The biopsy can be arranged separately from the diagnostic MRI. Additional procedures include a diagnostic MRI and a potential biopsy on the same day. If the diagnostic MRI shows no target, the biopsy can be canceled. A fusion biopsy may detect prostate cancer cells that other biopsies would otherwise miss. It may aid in early detection and treatment planning for cancer. It is also referred to as MRI ultrasound fusion-guided biopsy.

Highlights

• Transrectal dominates the biopsy route segment
• Hospital dominates the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Increasing Prevalence of Prostate Cancer

Prostate cancer is the second most prominent occurring cancer in men. According to the American Institute for Cancer Research, 1.3 million new prostate cancer cases were reported in 2018. This is approximately 7% of the total cases of cancer diagnosed in 2018. However, the mortality rate of prostate cancer is comparatively lower than its incidence rate. It is estimated that over 3.7 million biopsy procedures are performed annually worldwide, and approximately 30% are done through MR/ultrasound fusion technique.

Additionally, the percentage is reported to continuously increase, considering the target biopsy system's ability to consistently deliver accurate results. Therefore, the demand for MR/ultrasound biopsy will grow simultaneously with the increasing prevalence of prostate cancer. According to the data published in the Translational Andrology and Urology article by researchers at the University of Melbourne, 2019, an estimated 2 million men yearly undergo prostate biopsy. The high prevalence rate of prostate cancer enhances the demand for diagnostic tests and active clinical monitoring, favoring market growth.

Increasing Funds and Investments by Public and Private Sector

The public and private sectors are committed to enhancing the prognosis for men with prostate cancer by funding R&D for timely and precise diagnostic equipment. For instance, the UK government announced in October 2018 that it had set aside USD 19 million to purchase cutting-edge diagnostic scanners and train radiologists to deliver medical services for prostate cancer. Under this program, several radiologists will be recruited and trained to read multiparametric MRI images and prebiopsy procedures in fusion biopsy. Such initiatives are expected to boost the installation rate of fusion biopsy systems worldwide, as targeted biopsy techniques can eliminate the cost of treatment and biopsy of insignificant tumors. Private organizations such as Prostate Cancer Foundation and CaP Cure extend their support to improving the quality of medical services in prostate cancer care, thereby driving the global market growth.

Market Restraint

High Cost of Fusion Biopsy System

Two issues are commonly reported with implementing a fusion biopsy system in healthcare centers. First, technical issues arise when merging 2D MRI into a 3D real-time ultrasound image, which may produce a fuzzy prostate image. Second, the high cost of a fusion biopsy machine. The average cost of a fusion biopsy machine is USD 200,000, making it unaffordable for urology centers with small capital. The cost of MRI further adds to the patient's final bill. Therefore, the high cost is expected to hinder the installation rate of the fusion biopsy system.

Market Opportunities

Technological Advancements in Fusion Imaging Modalities

Frequent technological advancements are made to the hardware and software aspects of the fusion biopsy system to make them portable, effective, and safer. The software advancements include advanced image measurement, multiplanar image reconstruction, patient data management, and image registration tolls. All these features help streamline the operational workflow of prostate biopsies and enable them to be performed with increased precision. For instance, the MRI–ultrasound fusion biopsy system by Koelis has a patented image registration software called Organ-Based Tracking Fusion that works in tandem with elastic fusion technology. The unique feature of this solution is that it compensates for the continuous motion of the prostate and delivers accurate 3D images of the prostate.

Similarly, an example of improving the mechanical aspect of the machine can be the launch of UroNav version 3.0 by Philips. The latest version of the fusion biopsy system had small mechanical enclosures compared to the earlier version, which enhanced the portability of this device. Thus, such technological advancements are likely to create market growth opportunities.

Regional Analysis

North America Dominates the Global Market

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global fusion biopsy market shareholder and is anticipated to exhibit a CAGR of 11.4% during the forecast period. The increasing target population and the presence of advanced healthcare infrastructure are major factors that have contributed to the segment's leading revenue. North American countries have some of the highest healthcare expenditures in the world and can rapidly adopt advanced technologies. Streamlined reimbursement policies offered by Medicare, Medicaid, and private organizations for expenditures on fusion biopsy, which can also cover the cost of MRIs, are the factors expected to expedite the market over the forecast period. The presence of efficient health coverage policies, low wait times for MRI scans, and growing awareness about targeted biopsy techniques are expected to drive the market during the forecast period.

Additionally, prostate cancer is very common in Canada, with 58 men diagnosed with the disease and 11 related deaths each day. The prevalence of prostate cancer is expected to increase further, owing to the rapidly growing geriatric population. Increasing awareness among the Canadian population regarding a higher survival rate linked to early diagnosis has also contributed to the growth in demand for diagnostic services related to prostate cancer. This can create greater opportunities for new companies looking to enter the market.

Europe is predicted to exhibit a CAGR of 11.2% over the forecast period. Developed economies and favorable regulatory procedures create huge opportunities for major regional market players. Therefore, the market is expected to exhibit lucrative growth over the forecast period. Some primary markets in the region are the UK, Germany, France, Italy, and Spain. Germany captured the largest market share owing to the presence of developed economies and the high adoption rate of advanced diagnosis systems. There is a growing demand for targeted MRI/fusion biopsy in negative biopsy and active surveillance in Germany.

A nationwide survey was conducted in 2019 to collect information about urologists' routine use, attitude, and knowledge of targeted biopsy techniques. The survey revealed that targeted biopsy was recommended by over 80% of urologists, owing to its significant advantages over traditional techniques. In addition, MRI/ultrasound fusion biopsy is favored by most urologists over cognitive fusion or in-bore MRI-guided biopsies. The growing clinical acceptance and usage of fusion biopsies and the growing incidence of prostate cancer are expected to propel the market in Germany.

Asia-Pacific exhibits a lucrative growth opportunity, with emerging economies at the forefront of development. The prominent aspects driving the market's growth include growing awareness of prostate cancer, increasing population base, rising disposable income levels, and high unmet needs of patients in emerging countries such as India, Japan, and China. Numerous illnesses and cancers are becoming more common in the area due to the aging population and the region's expanding unhealthy lifestyles. As a result, the region's rising need for diagnosis is anticipated to fuel market expansion. In addition, Japan dominated the regional market growth. More than 25% of the population in Japan is over the age of 65 years and faces an increased healthcare expenditure. With the high health expenditure, Japan's healthcare system is witnessing a transition, with more players expanding their service portfolio to include preventive and nursing care in disease management. The modern social security scheme is expected to create more opportunities for market growth.

The Latin American fusion biopsy market is anticipated to develop significantly throughout the forecast period because of this region's rapidly developing economies and improving healthcare infrastructure. Due to huge market potential, several key companies focus on geographic expansion in Latin America. Therefore, the abovementioned factor is expected to boost the demand for fusion biopsy during the forecast period.

In the Middle East and Africa, key fusion biopsy market countries are South Africa, Saudi Arabia, UAE, and others. The large disease burden, increasing privatization of healthcare, and growing penetration of health insurance are propelling regional market growth. The growing incidence of prostate cancer and the surging geriatric population are expected to drive the market over the forecast period. According to the Cancer Association of South Africa, prostate cancer is the second most significant cause of cancer-related death in South Africa, with a 1:19 risk for individuals being diagnosed. In addition, a rise in government initiatives being undertaken to improve healthcare infrastructure in South Africa and other African countries is expected to boost the demand for the market.

Segmental Analysis

The global market is segmented by biopsy route and end-user.

Based on the biopsy route, the global market is segmented into transperineal and transrectal approaches. 

The transrectal segment is the largest revenue contributor to the market and is projected to exhibit a CAGR of 10.7% over the forecast period. The transrectal approach is the most commonly used fusion biopsy technique, owing to the anatomical proximity of the prostate and the familiarity of this technique among urologists. Transrectal is referred to as a provider-centric approach to prostate biopsy as it is quick and convenient to perform. Moreover, the transrectal approach is based on the most commercially available MR/ultrasound fusion biopsy systems, such as Artemis, UroNav, Virtual Navigator, and Koelis Urostation. The approach involves prophylactic antibodies, such as fluoroquinolones, which can adversely affect muscles, tendons, nervous systems, and joints.

Similarly, in 2016, the U.S. FDA announced that fluoroquinolone should not be used unless there is no other alternative. It was also reported that fluoroquinolone is losing efficacy due to the increasing drug resistance rate at the rectal site. Therefore, the transrectal approach is expected to face a downturn in share in the global market.

The transperineal approach of prostate biopsy is more patient-centric and often called the clean procedure, with a minimum risk of sepsis. It eliminates the need for prophylactic antibiotics as required in the transrectal approach. Considering the increasing multidrug resistance of rectal flora, the demand for the transperineal approach is also anticipated to increase. However, factors such as lack of awareness, low accessibility to required equipment, and a high urinary retention rate limit its adoption rate.

Based on end-user, the global market is segmented into hospitals, diagnostic centers, and ambulatory care centers. 

The hospital segment owns the highest market share and is estimated to exhibit a CAGR of 11.1% during the forecast period. Fusion biopsy is increasingly used in teaching hospitals and universities as the new gold standard for prostate biopsy. This is to ensure that all graduating urologists get hands-on experience with advanced technology. For instance, until 2018, around 3,500 MR/ultrasound fusion biopsies were performed at the University of California (UCLA), U.S. Hospitals are also able to perform fusion biopsies on demand thanks to the availability of trained staff and resources like MRI scanners, anesthesiologists, radiologists, and urologists. Private sector players are becoming more active in the hospital sector, elevating patient comfort to a top priority. A transperineal fusion biopsy system is adopted to gain greater hospital acceptance, boosting the market.

The fusion biopsy system is 30% more accurate in diagnosing significant and aggressive tumors than the traditional TRUS prostate biopsy technique. Therefore, the installation rate of fusion biopsy systems has recently increased in diagnostic centers. Shorter wait time, cost-efficiency, adoption of digital technologies, and easy accessibility are the key factors contributing to the increasing volume of fusion biopsy procedures in diagnostic centers. More payers are beginning to provide reimbursements on fusion biopsies performed in diagnostic centers in countries such as the U.S., the U.K., and Australia, which is expected to boost the segment.

In addition, key restraining factors include the high cost and lack of expertise in anesthesia handling. The transperineal approach of prostate biopsy requires the application of general anesthesia, which can only be performed with proper professional skills. This has contributed to the low number of transperineal prostate biopsies performed in diagnostic centers.

Recent Developments

• January 2023- In an effort to revolutionize prostate cancer detection and treatment, Apollo Hospital Seshadripuram introduced a new technology, MRI Fusion TRUS guided Trans-Perineal Targeted Biopsy, which improves cancer detection accuracy by 95 to 97%.
• April 2023- UC San Diego Health announced to provide a new minimally invasive prostate cancer biopsy procedure. The procedure, known as a transperineal biopsy, combines 3D MRI fusion-guided technology to identify prostate cancer. It is the most recent urological cancer diagnostic instrument to be added to UC San Diego Health's extensive list of innovative cancer diagnostic resources.