Fusion Biopsy Market Size, Share & Trends Analysis Report By Biopsy Route (Transrectal, Transperineal), By End-use (Hospitals, Diagnostic Centers, Ambulatory Care Centers), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global fusion biopsy market size was valued at USD 569.8 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.6% from 2023 to 2030. The increasing prevalence of prostate cancer, growing awareness about the importance of regular clinical interventions, and developing reimbursement policies are factors likely to boost the demand for targeted fusion biopsy systems over the forecast period. Targeted MR/Ultrasound fusion biopsy systems are being used more frequently as a result of more radiologists becoming skilled with interpreting prostate MRI and the adoption of industry-standard image grading systems such as PI-RADS and Gleason score.

A study published using GLOBOCAN 2020 estimates regarding cancer incidence and mortality, produced by the International Agency for Research on Cancer (IARC), stated that there were approximately 10.0 million cancer-related deaths and 19.3 million new cases worldwide in 2020. In 2040, 28.4 million new cases of cancer are anticipated worldwide, a 47% increase from 2020.

Additionally, the World Health Organization (WHO) predicts that by 2025, there will be over 167 million obese people worldwide, including both adults and children. The rising prevalence of these chronic conditions is anticipated to increase demand for fusion biopsy methods for early diagnosis and treatment, which will likely drive market growth. Market limitations include the risk of infection or bleeding during the process, which could possibly prove to be fatal in certain cases, as well as the cost of the procedure, which patients may not always be able to afford.

The primary diagnostic test of prostate cancer includes prostate-specific antigen and digital rectal examination. If this preliminary test shows abnormal results, then further ultrasound imaging is recommended. However, these ultrasound scans have a high possibility to miss significant tumors, especially those which are smaller in size and may cause clinical complications in the future. Therefore, urologists refrain from taking risks and try to make a diagnosis as promptly and accurately as possible. This has led to the growing demand for prostate biopsy procedures, highlighting its safety, reliability, and sensitivity in prostate cancer diagnosis.

Governments and private bodies are committed to improving the health outcomes for men with prostate cancer by making significant investments in R&D for early and accurate diagnostic tools. For instance, since 2013, the government of Australia has spent over USD 84 million on prostate cancer treatment and diagnostic research through Cancer Australia, Prostate Cancer Research Foundation Australia, and National Health Medical Research Council Australia. Also, in December 2022, Novartis announced that the European Commission (EC) had granted approval for the targeted radioligand therapy Pluvicto. For those with advanced prostate cancer, Pluvicto is now the first targeted radioligand therapy that is commercially accessible, fulfilling an unmet need for a new therapeutic alternative.

Biopsy Route Insights

The transrectal segment accounted for the largest revenue share of 85.81% in 2022 since it has been considered the gold standard in performing prostate biopsies globally for many years. Most of the commercially available fusion biopsy techniques are limited to the transrectal approach, contributing to its dominant market share. However, reports of patients with fever, sepsis, hematuria, and rectal bleeding after transrectal fusion biopsy have resulted in the sluggish growth of this segment in the market. Based on the biopsy route, the market for fusion biopsy is segmented into transperineal and transrectal biopsy routes.

Transperineal fusion biopsy is an emerging trend and is expected to experience the fastest CAGR of 11.4% during the forecast period. A lower sepsis rate and lower risk of rectal bleeding in comparison to the traditional approach is expected to contribute towards the segment growth. Moreover, the transperineal approach is efficient in assessing the ventral prostate areas that are typically omitted during transrectal fusion biopsy. Market players such as Koelis and BiopSee are offering both transrectal and transperineal accessories with their fusion biopsy systems, giving urologists the flexibility of providing personalized patient care.

End-use Insights

The hospitals segment held the largest market share of approximately 60.86%, owing to their high purchasing power. The average unit price of a fusion biopsy system is high, making it unaffordable for private diagnostic centers. However, the adoption of these systems in ambulatory care centers is reported to be increasing with the growing demand for prostate cancer care in rural areas.

The availability of skilled personnel & resources in hospitals, such as MRI scanners, anesthesiologists, radiologists, and urologists, allows them to perform fusion biopsies on demand. There is an increase in participation by private sector players in the hospital industry, making patient comfort a primary outcome. Thereby, a transperineal fusion biopsy system is adopted to gain greater acceptance in hospitals, boosting the market. Based on end-use, the fusion biopsy market is segmented into hospitals, diagnostic centers, and ambulatory care centers.

Diagnostic centers are expected to grow at a significant rate over the forecast period. Shorter wait times, cost efficiency, and a developing reimbursement paradigm are the factors expected to drive the growth of this segment. As targeted MR/Ultrasound biopsy system is an emerging technology, the high cost is a major barrier to its implementation in diagnostic centers. However, the practice of two diagnostic centers partnering to purchase an MR/Ultrasound fusion biopsy system has been observed, contemplating its quick ROI and surging demand for fusion biopsy. 

Ambulatory care centers are expected to grow at the fastest rate of 9.4% during the forecast period. The rising prevalence of prostate cancer in rural areas that have very limited access to healthcare services is a major factor expected to drive the growth of the segment. Moreover, the introduction of highly portable and low-cost MRI is expected to enhance the adoption rate of targeted MR/Ultrasound biopsy in ambulatory care centers, thus boosting the overall market growth.

Regional Insights

North America accounted for the largest revenue share of 41.90% in the market for fusion biopsy in 2022 and is expected to continue its dominance over the forecast period. Asia Pacific is anticipated to register the fastest growth in the market. The presence of key players, the increase in the incidence of prostate cancer, and the development of healthcare infrastructure are factors likely to propel market growth in the region.

Europe held the second-largest share in the global market for fusion biopsy in 2022. Developed economies and favorable regulatory procedures are some factors creating huge opportunities for major market players in this region. Thus, the market is expected to exhibit lucrative growth during the forecast period. Some key markets in the region are the UK, Germany, France, Italy, and Spain.

The Asia Pacific region is anticipated to advance at a CAGR of 9.9% during the forecast period. Asia Pacific exhibits a lucrative growth opportunity, with emerging economies at the forefront of development. Major factors driving market growth include rising awareness of prostate cancer, increasing population base, and rising disposable income levels, as well as high unmet needs of patients in emerging countries such as India, Japan, and China. Growing unhealthy lifestyles in the region along with the aging population have led to a rising occurrence of various diseases, including cancer. Thus, the growing demand for diagnosis in the region is expected to propel market growth.

Key Companies & Market Share Insights

The market for fusion biopsy is fragmented, with the top few players holding a significant market share. However, increasing demand for efficient diagnostic tools in prostate cancer management is creating growth opportunities for new players to enter the market. The market players are adopting various strategies such as mergers and acquisitions, product launches, collaborations, reinforcing distribution networks, and entering untapped markets, especially in developing economies, to strengthen their market presence.

For instance, in August 2022, Promaxo, Inc., a supplier of medical imaging, robotics, and AI technology, announced that it had signed research partnerships for developing regulatory pathways as well as for MR-guided prostate interventions with Imperial College London and University Hospital Tuebingen Germany, two of the top university hospitals in Europe. Some of the prominent players in the global fusion biopsy market include:

• Eigen Health

• Koninklijke Philips N.V.

• Hitachi Ltd.

• MedCom

• ESAOTE SpA

• KOELIS

• Focal Healthcare

• UC-Care Medical Systems Ltd.

• GeoScan Medical

Fusion Biopsy Market Report Scope 

Global Fusion Biopsy Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global fusion biopsy market report on the basis of biopsy route, end-use, and region:

• Biopsy Route Outlook (Revenue, USD Million, 2018 - 2030)

  • Transrectal

  • Transperineal

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Diagnostic Centers

  • Ambulatory Care Centers

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • Thailand

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait