U.S. Fusion Biopsy Market (2024 - 2030)

U.S. Fusion Biopsy Market Size & Trends

The U.S. fusion biopsy market size was estimated at USD 217.5 million in 2023 and is estimated to grow at a CAGR of 7.1% from 2024 to 2030. The market growth of is primarily driven by factors such as the high prevalence of prostate cancer in the population, the increasing importance of regular clinical interventions, and favorable government reimbursement programs.

In 2023, The U.S. accounted for over 30% in the global fusion biopsy market. Prostate cancer is one of the most prevalent and deadly cancers affecting men. According to the American Cancer Society, about 1 out of every 8 men will be diagnosed with prostate cancer during their lifetime. Nearly 280,000 prostate cancers are diagnosed annually in the U.S, and 69% of these cases are determined to be localized cancers that require either active surveillance or treatment decision. There are approximately 3 million prostate cancer screenings conducted in the U.S. which show elevated PSA results. Approximately 500,000 men undergo biopsies annually, but 60% of biopsies do not reveal cancer and may lead to increased complications and hospitalization. Moreover, approximately 30% of cancer-negative biopsies are false negatives, meaning these patients have cancer.

Technological advancements in fusion biopsy systems are propelling market growth. These advancements focus on improving portability, effectiveness, and safety. Additionally, software enhancements include advanced image measurement, multiplanar image reconstruction, patient data management, and image registration tools. These features optimize the operational workflow of prostate biopsies, leading to increased precision and efficiency. The progress in cancer detection through these innovations is expected to drive market growth in the near future.

The anticipated market growth for fusion biopsy is driven by streamlined reimbursement policies from Medicare, Medicaid, and private organizations, which cover the costs of fusion biopsy and MRIs, fostering market expansion over the forecast period. For instance, Cigna broadens its commercial and Medicare Advantage coverage to encompass Mdxhealth's Select mdx for Prostate Cancer Test. Under this scheme, Cigna expands its insurance coverage to include Mdxhealth's full range of precision diagnostic cancer tests, incorporating Confirm mdx and Genomic Prostate Score (GPS) tests.

Market Concentration & Characteristics

The U.S. fusion biopsy market is moderately fragmented due to the presence of many companies that hold significant industry shares. The industry is characterized by intense competition, with major companies focusing on innovation and technology advancements to strengthen their market presence. For instance, in July 2022, miR Scientific announced the miR Sentinel^™ Prostate Cancer Test in the United States. This test assesses the risk of chronic prostate cancer and helps in the clinical management of men who are at risk of prostate cancer.

Acquiring other companies or part of the companies in the industry is a strategic move that allows companies to enhance their market position by boosting their capabilities, expanding product offerings, and strengthening competencies. For instance, in August 2022, MDxHealth announced the acquisition of the Oncotype DX GPS test of Exact Sciences, providing prediction of prostate cancer chronicity. The acquisition deal closed at USD 30 million.

Regulatory bodies such as the US FDA impact the approvals of biopsies and further support the innovation and product expansion strategies undertaken by key industries of the market. For instance, in April 2023, Lantheus Holdings, Inc. announced the U.S. FDA approval for ¹⁷⁷Lu-PNT2002 which treats metastatic castration-resistant prostate cancer (mCRPC).

Several key companies focusing on product as well as regional expansion initiatives to expand their product portfolio, and geographic exposure to fulfill the needs of consumers in that region. For instance, In January 2024, PanGIA Biotech announced an expansion of multi-cancer early-detection liquid biopsy. Through this expansion, the company would substantially broaden its platform by initiating follow-up studies in ten more cancer types.

Biopsy Route Insights

Based on product, the transrectal biopsy route dominated the market with the largest share of 83% in 2023. This growth can be attributed to the high preference for transrectal biopsies to detect prostate cancer in the U.S. The transrectal approach is commonly used for fusion biopsy due to its proximity to the prostate and the familiarity among urologists. It is known as a provider-centric method for prostate biopsy, being quick and convenient to perform. These applications of transrectal biopsies further fuel the market growth.

The transperineal biopsy segment is expected to grow at the fastest rate at 10.1% CAGR from 2024 to 2030. This biopsy is patient-centric and often considered a clean procedure, with minimal risk of sepsis. It eliminates the necessity for prophylactic antibiotics required in the transrectal approach. These benefits of this biopsy will likely escalate the growth opportunities in the market over the forecast years.

End-use Insights

Based on end-use, hospitals held the largest share of 59% in 2023 owing to the high installation of fusion biopsy settings in the hospitals. These installations help in providing hands-on training experience with advanced technology to young urologists. Moreover, hospitals are comprised of skilled personnel and relevant resources such as MRI scanners, radiology wards, and medical equipment, contributing to the accelerating growth of the market. Moreover, growing awareness about preclinical tests among individuals is likely to boost the segment’s growth.

The ambulatory care centers segment is projected to expand at the fastest CAGR from 2024 to 2030 owing to cost-effectiveness and better patient accessibility. The rise in patient preference for undergoing examinations in cost-effective medical settings has been the primary driver behind the development of ambulatory surgical centers (ASCs). Moreover, the launch of specialized ambulatory care centers for treating urological disorders is expected to accelerate the growth opportunity in the market over the forecast period. For instance, in April 2023, The University of Arkansas for Medical Sciences (UAMS) announced the launch of a new Urology Center in West Little Rock. This center offers specialized treatment for complex kidney stones, urinary system reconstruction, erectile dysfunction, and high-quality routine urology services.

Key U.S. Fusion Biopsy Company Insights

Key U.S. fusion biopsy companies include Artemis, Koelis, Eigen Health, and Focal Healthcare among others.

There is intense competition in the U.S. fusion biopsy market. The adoption of competitive strategies such as mergers & acquisitions, strategic alliances, collaborative agreements, and partnerships helps to sustain the competition.

Recent Developments

• In January 2024, Cleveland Diagnostics received USD75 million from Novo Holdings to Advance its early-detection oncology testing platform. The funding will speed up the commercial strategy for its IsoPSA prostate cancer test and broaden its range of non-invasive tests.

• In July 2023, Quest Diagnostics launched a novel prostate cancer test that aims to meet the urgent clinical demand for tests that can assist in identifying and distinguishing potentially aggressive cases of prostate cancer in men.

U.S. Fusion Biopsy Market