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市场调查报告书
商品编码
1776202
数位切片检查的全球市场 - 市场考察,竞争情形,市场预测(2032年)Digital Biopsy - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
预计 2025 年至 2032 年期间,全球数位活检市场将以 16.87% 的复合年增长率成长。乳癌、脑瘤、黑色素瘤、鳞状细胞癌和基底细胞癌等癌症的发生率不断上升,推动了全球对数位活检的需求。而人们对非侵入性诊断方法的日益青睐以及数位活检系统的技术进步,进一步推动了这一趋势。这些因素为持续的市场成长奠定了坚实的基础,预计数位活检市场将在2025年至2032年期间稳步健康地扩张。
数位活检市场动态
根据GLOBOCAN (2023) 的数据,2022年全球将通报约2,000万例新发癌症病例,预计到2045年将增至3,260万例。这种快速成长凸显了对更有效率、更准确、更可扩展的诊断技术(例如数位活检解决方案)的迫切需求。
皮肤癌是全球成长最快的癌症之一。根据国际癌症研究机构 (IARC) (2022) 的报告,2022年全球将诊断出33万例黑色素瘤新病例,导致近6万人死亡。同样,美国国立卫生研究院 (National Institutes of Health, NIH) (2025) 报告称,2024 年全球将诊断出约 331,722 例黑色素瘤。皮肤癌盛行率的上升是推动数位活检技术需求的主要驱动力。数位活检技术提供了一种非侵入性、高度可重复、即时的筛检和早期检测方法,这对黑色素瘤和其他皮肤癌尤其重要。
乳癌仍是全球面临的重大健康挑战。根据世界卫生组织 (WHO) (2024) 的数据,2022 年全球将有 230 万名女性被诊断出罹患乳癌,导致 67 万人死亡。数位活检解决方案有助于应对这项挑战,使临床医生能够非侵入性地区分良性和恶性病变,减少不必要的手术活检,加快诊断决策,并最终改善患者预后。
此外,脑肿瘤发生率的上升进一步凸显了对先进诊断方法的需求。根据英国脑肿瘤研究中心 (2024) 的数据,英国每年有超过 16,000 人被诊断出患有脑肿瘤,而澳洲政府 (2024) 报告每年约有 2,000 例脑肿瘤新发病例。数位活检技术为此类病例提供了一种创新方法,它无需物理切除组织即可识别肿瘤类型和等级(例如,胶质母细胞瘤与低级别胶质瘤),最大限度地降低患者风险,并支持更及时的干预。
除了日益加重的疾病负担外,技术创新和产品审批也在推动市场成长。例如,2023 年 11 月,BrainSpec 宣布 FDA 批准 BrainSpec Core™,这是一款用于检测脑肿瘤的尖端非侵入式数位活检设备。 BrainSpec Core™ 利用先进的影像技术分析脑内化学浓度,并使用标准 MRI 扫描仪产生虚拟活检样本。这种创新方法无需侵入性组织切除即可实现精准的肿瘤诊断,代表脑肿瘤诊断领域的重大进步。
然而,数位活检设备的技术限制以及替代产品的供应不足是限制数位活检市场成长的重要因素。
预计北美将主导整个数位活检市场。
受多种因素影响,预计北美将在 2024 年占据数位活检市场的最大占有率。该地区的主导地位主要归功于癌症发病率的上升、非侵入性诊断方法的日益普及以及对技术创新的高度重视。该地区拥有完善的医疗基础设施、优惠的报销政策以及临床医生的高度认知。此外,主要市场参与者对各种产品的认可和推进正在加速其采用,并巩固北美在市场上的主导地位。
本报告研究并分析了全球数位活检市场,提供了市场规模和预测、过去三年产品/技术发展、主要市场参与者以及可用机会的资讯。
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: