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市場調查報告書
商品編碼
1776202
數位切片檢查的全球市場 - 市場考察,競爭情形,市場預測(2032年)Digital Biopsy - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
預計 2025 年至 2032 年期間,全球數位活檢市場將以 16.87% 的複合年增長率成長。乳癌、腦瘤、黑色素瘤、鱗狀細胞癌和基底細胞癌等癌症的發生率不斷上升,推動了全球對數位活檢的需求。而人們對非侵入性診斷方法的日益青睞以及數位活檢系統的技術進步,進一步推動了這一趨勢。這些因素為持續的市場成長奠定了堅實的基礎,預計數位活檢市場將在2025年至2032年期間穩步健康地擴張。
數位活檢市場動態
根據GLOBOCAN (2023) 的數據,2022年全球將通報約2,000萬例新發癌症病例,預計到2045年將增至3,260萬例。這種快速成長凸顯了對更有效率、更準確、更可擴展的診斷技術(例如數位活檢解決方案)的迫切需求。
皮膚癌是全球成長最快的癌症之一。根據國際癌症研究機構 (IARC) (2022) 的報告,2022年全球將診斷出33萬例黑色素瘤新病例,導致近6萬人死亡。同樣,美國國立衛生研究院 (National Institutes of Health, NIH) (2025) 報告稱,2024 年全球將診斷出約 331,722 例黑色素瘤。皮膚癌盛行率的上升是推動數位活檢技術需求的主要驅動力。數位活檢技術提供了一種非侵入性、高度可重複、即時的篩檢和早期檢測方法,這對黑色素瘤和其他皮膚癌尤其重要。
乳癌仍是全球面臨的重大健康挑戰。根據世界衛生組織 (WHO) (2024) 的數據,2022 年全球將有 230 萬名女性被診斷出罹患乳癌,導致 67 萬人死亡。數位活檢解決方案有助於應對這項挑戰,使臨床醫生能夠非侵入性地區分良性和惡性病變,減少不必要的手術活檢,加快診斷決策,並最終改善患者預後。
此外,腦腫瘤發生率的上升進一步凸顯了對先進診斷方法的需求。根據英國腦腫瘤研究中心 (2024) 的數據,英國每年有超過 16,000 人被診斷出患有腦腫瘤,而澳洲政府 (2024) 報告每年約有 2,000 例腦腫瘤新發病例。數位活檢技術為此類病例提供了一種創新方法,它無需物理切除組織即可識別腫瘤類型和等級(例如,膠質母細胞瘤與低級別膠質瘤),最大限度地降低患者風險,並支持更及時的干預。
除了日益加重的疾病負擔外,技術創新和產品審批也在推動市場成長。例如,2023 年 11 月,BrainSpec 宣布 FDA 批准 BrainSpec Core™,這是一款用於檢測腦腫瘤的尖端非侵入式數位活檢設備。 BrainSpec Core™ 利用先進的影像技術分析腦內化學濃度,並使用標準 MRI 掃描儀產生虛擬活檢樣本。這種創新方法無需侵入性組織切除即可實現精準的腫瘤診斷,代表腦腫瘤診斷領域的重大進步。
然而,數位活檢設備的技術限制以及替代產品的供應不足是限制數位活檢市場成長的重要因素。
預計北美將主導整個數位活檢市場。
受多種因素影響,預計北美將在 2024 年佔據數位活檢市場的最大佔有率。該地區的主導地位主要歸功於癌症發病率的上升、非侵入性診斷方法的日益普及以及對技術創新的高度重視。該地區擁有完善的醫療基礎設施、優惠的報銷政策以及臨床醫生的高度認知。此外,主要市場參與者對各種產品的認可和推進正在加速其採用,並鞏固北美在市場上的主導地位。
本報告研究並分析了全球數位活檢市場,提供了市場規模和預測、過去三年產品/技術發展、主要市場參與者以及可用機會的資訊。
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: