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디지털 생검 시장 : 시장 인사이트, 경쟁 구도, 시장 예측(2032년)Digital Biopsy - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
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세계 디지털 생검 시장 규모는 2025-2032년 예측 기간 동안 CAGR 16.87%로 성장할 것으로 예상됩니다. 유방암, 뇌종양, 흑색종, 편평상피암, 기저세포암 등 암 발병률 증가로 인해 전 세계적으로 디지털 생검에 대한 수요가 증가하고 있습니다. 비침습적 진단법에 대한 선호도가 높아지고 디지털 생검 시스템의 기술적 진보가 이러한 추세를 더욱 촉진하고 있습니다. 이러한 요인들은 지속적인 시장 성장의 강력한 기반이 되고 있으며, 디지털 생검 시장은 2025-2032년 동안 안정적이고 건전한 성장세를 보일 것으로 예상됩니다.
디지털 생검의 시장 역학
GLOBOCAN(2023) 데이터에 따르면, 2022년에 전 세계적으로 약 2,000만 건의 신규 암 사례가 보고되었으며, 2045년까지 3,260만 건으로 증가할 것으로 예상됩니다. 이러한 급격한 증가는 디지털 생검 솔루션과 같은 보다 효율적이고 정확하며 확장 가능한 진단 기술의 시급한 필요성을 강조하고 있습니다.
피부암은 전 세계적으로 가장 빠르게 증가하고 있는 암 중 하나이며, 국제암연구소(IARC)의 보고에 따르면 2022년에는 전 세계적으로 33만 명의 흑색종 환자가 새로 진단받고 6만 명에 가까운 환자가 사망할 것으로 예상됩니다. 마찬가지로, National Institutes of Health(2025)는 2024년에 전 세계적으로 약 33만 1,722명이 흑색종 진단을 받았다고 보고했습니다. 피부암 발병률의 증가는 디지털 생검 기술에 대한 수요에 크게 기여하고 있습니다. 디지털 생검 기술은 스크리닝 및 조기 발견을 위한 비침습적이고 재현성이 높은 실시간 방법을 제공하며, 특히 흑색종 및 기타 피부암에 중요한 역할을 합니다.
유방암 또한 여전히 세계 보건의 큰 문제입니다. 세계보건기구(WHO)(2024)에 따르면, 2022년 230만 명의 여성이 유방암 진단을 받았고, 전 세계적으로 67만 명이 사망할 것으로 예상됩니다. 디지털 생검 솔루션은 임상의가 양성 병변과 악성 병변을 비침습적으로 구별하고, 불필요한 외과적 생검을 줄이며, 진단 의사결정을 신속히 내리고, 결과적으로 환자 예후를 개선함으로써 이 문제를 해결하는 데 기여할 수 있습니다.
Brain Tumour Research UK(2024)의 데이터에 따르면, 영국에서는 연간 16,000명 이상이 뇌종양 진단을 받고 있으며, 호주 정부(2024년)는 매년 약 2,000명이 새로이 뇌종양 진단을 받는다고 보고하고 있습니다. 매년 약 2,000명이 새롭게 뇌종양에 걸린다고 보고하고 있습니다. 디지털 생검 기술은 이러한 사례에서 물리적으로 조직을 제거하지 않고도 종양의 유형과 악성도(예: 교모세포종과 저악성 신경교종)를 식별하여 환자의 위험을 최소화하고 보다 적시에 개입할 수 있도록 도와주는 혁신적인 접근법을 제공합니다.
질병 부담의 증가와 더불어 기술 혁신과 제품 승인도 시장 성장을 가속화하고 있습니다. 예를 들어, 2023년 11월 BrainSpec은 FDA가 뇌종양 검출을 위해 설계된 최첨단 비침습적 디지털 생검 장치인 BrainSpec Core(TM)를 승인했다고 발표했습니다. 뇌 내 화학제품의 농도를 분석하고 표준 MRI 스캐너를 사용하여 가상 생검을 생성합니다. 이 혁신적인 접근법은 침습적인 조직 절제 없이도 정확한 종양 진단을 가능하게 합니다. 이는 뇌종양 진단에 있어 중요한 진전이라고 할 수 있습니다.
그러나 디지털 생검 장비에 따른 기술적 한계와 대체 제품의 가용성 등이 디지털 생검 시장의 성장을 제한할 수 있는 중요한 억제요인으로 작용하고 있습니다.
북미가 전체 디지털 생검 시장을 독식할 것으로 예상
여러 요인으로 인해 북미는 2024년 디지털 생검 시장에서 가장 큰 점유율을 차지할 것으로 예상됩니다. 이 지역의 우위는 주로 암 발병률 증가, 비침습적 진단 방법의 채택 확대, 기술 혁신에 대한 높은 관심에 기인합니다. 이 지역은 잘 구축된 의료 인프라, 유리한 상환 정책, 임상의들의 높은 인지도 등의 혜택을 누리고 있습니다. 또한, 주요 시장 진입자들의 다양한 제품 승인과 발전이 채택을 가속화하고 북미 시장에서 우위를 점하고 있습니다.
세계의 디지털 생검 시장에 대해 조사 분석했으며, 시장 규모와 예측, 최근 3년간의 제품/기술 개발, 주요 기업, 시장 기회 등의 정보를 전해드립니다.
Digital Biopsy Market by Technique (Radiofrequency Imaging, Ultrasound, Optical Imaging, X-ray, and Others), Indication (Skin Cancer, Brain Cancer, Breast Cancer, and Others), End-User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing incidence of cancer globally and rising shift towards non-invasive diagnostic procedures.
The digital biopsy market is estimated to grow at a CAGR of 16.87% during the forecast period from 2025 to 2032. The demand for digital biopsy is rising globally, driven by the increasing incidence of cancers such as breast cancer, brain cancer, melanoma, squamous cell carcinoma, basal cell carcinoma, and others. A growing preference for non-invasive diagnostic methods, along with ongoing technological advancements in digital biopsy systems, is further supporting this trend. These factors are creating a strong foundation for sustained market growth, positioning the digital biopsy market for steady and robust expansion from 2025 to 2032.
Digital Biopsy Market Dynamics:
According to data from GLOBOCAN (2023), approximately 20 million new cancer cases were reported globally in 2022, with projections indicating a rise to 32.6 million cases by 2045. This steep increase underscores the urgent need for more efficient, accurate, and scalable diagnostic technologies such as digital biopsy solutions.
Skin cancer is among the fastest-growing cancer types globally. As reported by the International Agency for Research on Cancer (IARC, 2022), an estimated 330,000 new melanoma cases were diagnosed worldwide in 2022, with nearly 60,000 deaths. Similarly, the National Institutes of Health (2025) reported that approximately 331,722 individuals were diagnosed with melanoma globally in 2024. The rising incidence of skin cancer is significantly contributing to the demand for digital biopsy technologies, which offer a non-invasive, repeatable, and real-time method for screening and early detection, especially critical for melanoma and other skin cancers.
Breast cancer also remains a major global health challenge. According to the World Health Organization (2024), 2.3 million women were diagnosed with breast cancer in 2022, with 670,000 deaths recorded globally. Digital biopsy solutions help address this challenge by enabling clinicians to non-invasively differentiate between benign and malignant lesions, reduce unnecessary surgical biopsies, and accelerate diagnostic decision-making, ultimately leading to improved patient outcomes.
Furthermore, the growing incidence of brain tumors further highlights the need for advanced diagnostic methods. Data from Brain Tumour Research UK (2024) revealed that over 16,000 people were diagnosed with brain tumors annually in the UK, while the Australian Government (2024) reported about 2,000 new brain cancer cases each year. Digital biopsy technologies provide a transformative approach in such cases by helping to identify tumor type and grade (e.g., glioblastoma versus low-grade gliomas) without the need for physically removing tissue, minimizing patient risk, and supporting more timely interventions.
In addition to rising disease burden, technological innovation and product approvals are also accelerating market growth. For instance, in November 2023, BrainSpec announced that the FDA approved BrainSpec Core(TM), a cutting-edge non-invasive digital biopsy device designed for the detection of brain tumors. Utilizing advanced imaging technology, BrainSpec Core(TM) analyzes the concentration of chemicals within the brain to generate a virtual biopsy, all through the use of standard MRI scanners. This innovative approach allows for accurate tumor diagnosis without the need for invasive tissue removal, marking a significant advancement in brain cancer diagnostics.
However, the technical limitations associated with digital biopsy devices and the availability of alternative products, among others, are some of the key constraints that may limit the growth of the digital biopsy market.
Digital Biopsy Market Segment Analysis:
Digital Biopsy Market by Technique (Radiofrequency Imaging, Ultrasound, Optical Imaging, X-ray, and Others), Indication (Skin Cancer, Brain Cancer, Breast Cancer, and Others), End-User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the technique segment of the digital biopsy market, the radiofrequency imaging category is estimated to account for the largest market share in 2024. The growth of this category is primarily driven by the rising global incidence of cancer and the increasing adoption of advanced, non-invasive diagnostic technologies such as radiofrequency imaging and digital biopsy devices.
According to the European Commission (2023), in 2022, approximately 2.74 million new cancer cases were reported in Europe, with around 3.7 million new cases diagnosed annually across the continent. Similarly, the World Health Organization (2023) reported that over 2.3 million people were diagnosed with cancer each year in the South-East Asia Region. This growing cancer burden has significantly increased demand for early detection and minimally invasive diagnostic solutions, fueling the demand for radiofrequency imaging digital biopsy solutions.
One of the most notable benefits of radiofrequency imaging digital biopsy devices is their non-invasive or minimally invasive nature, which significantly enhances their appeal in modern clinical settings. These advanced tools leverage imaging technologies and artificial intelligence (AI) to analyze tissues in real time, thereby reducing or eliminating the need for traditional surgical biopsies.
As a result, they enable faster diagnosis, allow for repeatable assessments for ongoing monitoring, and improve patient comfort by minimizing physical trauma. Additionally, by avoiding tissue excision, these devices help lower the risk of complications such as bleeding, infection, and scarring, making them particularly valuable in primary care and outpatient environments.
Moreover, the market is witnessing technological innovation and regulatory momentum. In January 2024, DermaSensor, Inc. received FDA clearance for DermaSensor, a digital biopsy device designed to detect all three common types of skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma. This marked a significant milestone in expanding access to non-invasive cancer diagnostics at the primary care level.
Thus, the factors mentioned above are likely to boost the market segment and thereby increase the overall market of digital biopsy across the globe.
North America is expected to dominate the overall digital biopsy market:
North America is projected to hold the largest share of the digital biopsy market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising incidence of cancer, growing adoption of non-invasive diagnostic methods, and a strong focus on technological innovation. The region benefits from a well-established healthcare infrastructure, favorable reimbursement policies, and high awareness among clinicians. Additionally, various product approvals and advancements by key market players are accelerating adoption and solidifying North America's dominant market position.
According to data from the International Agency for Research on Cancer (2025), the number of new cancer cases in the U.S. was 2,380,189 in 2022, with projections indicating a significant rise to 3,380,124 cases by 2045. Among these, leukemia had 63,100 new cases in 2022, expected to increase to 88,600 by 2045. Similarly, data from the Canadian Cancer Society (2024), over 11,300 people were diagnosed with melanoma skin cancer in Canada.
According to the American Cancer Society (2025), an estimated 104,960 new cases of melanoma were expected to be diagnosed in the U.S. in 2025, along with approximately 5.4 million cases of basal and squamous cell skin cancers annually. The same source also reported that 24,820 malignant tumors of the brain or spinal cord (14,040 in males and 10,780 in females) were projected to be diagnosed in 2025.
Additionally, in 2024, approximately 310,720 new cases of invasive breast cancer were reported. This increasing cancer burden is significantly driving demand for advanced digital biopsy solutions for early screening and accurate diagnosis.
Moreover, the market is being fueled by technological advancements and product approvals. For example, in October 2024, VPIX Medical Inc. announced that it had received FDA approval for its digital biopsy system, cCeLL-In vivo. This device works by converting laser scanning signals into digital tissue images through direct contact with the patient's body, enabling accurate, real-time diagnosis of brain cancer.
Collectively, the rising burden of cancer, the shift towards non-invasive diagnostics, and product approvals by key players are propelling the demand for digital biopsy in North America, reinforcing its position as a leading region in the global market.
Digital Biopsy Market Key Players:
Some of the key market players operating in the digital biopsy market include DermaSensor, Inc., SciBase, VITA IMAGING, Inc., MetaOptima Technology Inc., VPIX Medical Inc., Mauna Kea Technologies, Skin Analytics, Trafita Medical System, BRAINSPEC, Imaging Biometrics, LLC, Optovibronex, LLC, FUJIFILM Holdings Corporation, Canon Inc., VivaScope GmbH, and others.
Recent Developmental Activities in the Digital Biopsy Market:
Key takeaways from the digital biopsy market report study
Target audience who can benefit from this digital biopsy market report study
Frequently Asked Questions for the Digital Biopsy Market: