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市場調査レポート
商品コード
1776202
デジタル生検の世界市場 - 市場考察、競合情勢、市場予測(2032年)Digital Biopsy - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
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デジタル生検の世界市場 - 市場考察、競合情勢、市場予測(2032年) |
出版日: 2025年07月01日
発行: DelveInsight
ページ情報: 英文 150 Pages
納期: 2~10営業日
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世界のデジタル生検の市場規模は、2025年~2032年の予測期間にCAGRで16.87%の成長が見込まれます。乳がん、脳腫瘍、メラノーマ、扁平上皮がん、基底細胞がんなど、がんの罹患率の増加により、世界中でデジタル生検の需要が高まっています。非侵襲的診断法への選好の高まりと、デジタル生検システムの技術的進歩が、この動向をさらに後押ししています。これらの要因は、持続的な市場成長の強力な基礎となっており、デジタル生検市場は2025年~2032年に安定して健全に拡大するものとみられます。
デジタル生検の市場力学
GLOBOCAN(2023)のデータによると、2022年に世界で約2,000万件の新規がん症例が報告され、2045年までに3,260万件に増加すると予測されています。この急激な増加は、デジタル生検ソリューションのような、より効率的で正確かつ拡張性のある診断技術の緊急の必要性を強調しています。
皮膚がんは、世界中でもっとも急速に増加しているがんの1つです。International Agency for Research on Cancer(IARC)(2022)の報告によると、2022年に世界で新たに33万人のメラノーマ患者が診断され、6万人近くが死亡しています。同様に、National Institutes of Health(2025)は、2024年に世界で約33万1,722人がメラノーマと診断されたと報告しています。皮膚がんの罹患率の増加は、デジタル生検技術の需要に大きく寄与しています。デジタル生検技術は、スクリーニングと早期発見に利用する、非侵襲的で再現性の高いリアルタイムな方法を提供し、特にメラノーマやその他の皮膚がんにとって重要です。
乳がんもまた、依然として世界の健康上の大きな課題です。世界保健機関(WHO)(2024)によると、2022年に230万人の女性が乳がんと診断され、世界全体で67万人が死亡しました。デジタル生検ソリューションは、臨床医が良性病変と悪性病変を非侵襲的に鑑別し、不必要な外科的生検を減らし、診断の意思決定を迅速化し、結果として患者の転帰を向上させることで、この課題への対処に寄与します。
さらに、脳腫瘍の罹患率の増加は、先進の診断法の必要性をさらに強調しています。Brain Tumour Research UK(2024)のデータによると、英国では年間1万6,000人以上が脳腫瘍と診断され、オーストラリア政府(2024年)は毎年約2,000人が新たに脳腫瘍に罹患していると報告しています。デジタル生検技術はこのような症例において、物理的に組織を摘出することなく腫瘍のタイプと悪性度(例えば、膠芽腫と低悪性度神経膠腫)を特定し、患者のリスクを最小化し、よりタイムリーな介入を支援することで、革新的なアプローチを提供します。
疾病負担の増大に加え、技術革新と製品承認も市場成長を加速させています。例えば2023年11月、BrainSpecは脳腫瘍の検出用に設計された最先端の非侵襲性デジタル生検装置であるBrainSpec Core(TM)をFDAが承認したと発表しました。BrainSpec Core(TM)は、先進のイメージング技術を活用し、脳内の化学品の濃度を分析し、標準的なMRIスキャナーを使用してバーチャル生検を生成します。この革新的なアプローチにより、侵襲的な組織切除を必要とせずに正確な腫瘍診断が可能となります。このことは脳腫瘍診断における重要な進歩を示しています。
しかし、デジタル生検機器に伴う技術的限界や代替製品の入手可能性などが、デジタル生検市場の成長を制限しうる重要な抑制要因となっています。
北米がデジタル生検市場全体を独占すると予測される
複数の要因により、北米が2024年にデジタル生検市場で最大のシェアを占めると予測されます。この地域の優位性は主に、がん罹患率の上昇、非侵襲的診断法の採用の拡大、技術革新への強い注目によるものです。この地域は、定評のある医療インフラ、有利な償還政策、臨床医の高い認知度などの恩恵を受けています。さらに、主要な市場参入企業によるさまざまな製品の承認や進歩が採用を加速させ、北米の市場での優位を確立しています。
当レポートでは、世界のデジタル生検市場について調査分析し、市場規模と予測、過去3年の製品/技術開発、市場の主要企業、利用可能な機会などの情報を提供しています。
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: