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市場調查報告書
商品編碼
1841465
非癌症液態切片活體組織切片市場-全球和區域分析:按應用、技術、最終用戶和區域-分析和預測(2025-2035年)Non-Cancer Liquid Biopsy Testing Market - A Global and Regional Analysis: Focus on Application, Technology, End User, and Regional Analysis - Analysis and Forecast, 2025-2035 |
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2024 年全球非癌症液態切片切片市場規模為 42.761 億美元,預計到 2035 年將激增至 193.088 億美元,2025 年至 2035 年期間的複合年成長率將達到年複合成長率%。
| 主要市場統計數據 | |
|---|---|
| 預測期 | 2025-2035 |
| 2025年評估 | 50.751億美元 |
| 2035年的預測 | 193.88億美元 |
| 複合年成長率 | 14.3% |
全球非癌症液態切片活體組織切片市場的發展受到慢性疾病負擔日益加重的驅動,這些疾病涵蓋心血管和神經系統疾病、產前和移植護理等,對微創即時診斷的需求也日益成長。透過分析血液中的生物標記物,液態切片能夠早期發現並動態監測各種適應症,且無需承擔傳統採樣程序的風險。次世代定序和檢測靈敏度的進步,加上業界的巨大投入,使得液態切片成為一種適用於非侵入性產前檢測、移植排斥監測和感染疾病檢測等應用的方法。然而,由於高昂的資本成本、高昂的單位成本以及不同的報銷環境,其廣泛應用仍充滿挑戰。在服務欠缺地區進行工作流程的策略性本地化,例如在國內部署獲得CE認證的平台,將為縮短週轉時間、降低成本和擴大可及性提供強大的機會,為液態切片成為全球精準醫療和預防醫學的基石鋪平道路。
市場介紹
隨著生物製藥和診斷公司將微創、基於血液的分子檢測從腫瘤學擴展到產前篩檢、移植監測和感染疾病檢測等關鍵領域,全球非癌症液態切片活體組織切片市場正在快速成長。液態切片測試,例如 Illumina 的 Verifi、Natera 的 Panorama 和 Karius 的 Spectrum,利用遊離 DNA、 微型RNA和外泌體來提供以前需要有風險的組織採樣才能獲得的早期即時洞察,從而提高患者安全性和操作效率。持續的檢測創新和新生物標記的檢驗,加上戰略夥伴關係關係和有針對性的收購,正在本地化先進的工作流程並降低週轉時間、成本和物流障礙。隨著全球醫療保健系統擁抱精準醫療和預防保健,改進的性能、法規遵從性和數位健康整合的整合使非癌症液態切片成為下一代診斷的關鍵組成部分。
對產業的影響
非癌症液態切片活體組織切片市場正在經歷快速的產業化,主要企業利用策略聯盟、定向收購和大量資本,將先進的微創工作流程融入當地醫療生態系統。透過與數位醫療服務提供者和本地實驗室合作,該公司正在簡化端到端診斷路徑,縮短週轉時間,降低單次檢測成本,同時又不損害樣本完整性。同時,併購和地理擴張正在增強本土化能力,而產品組合的增強和新產品的發布則拓寬了其應用範圍,從產前和移植監測到感染疾病檢測。大量的資本流入加速了研發和商業化進程,實現了檢測的標準化和大規模合規性。這些產業動態的結合,正在將非癌症液態切片從利基創新轉變為一個強大的、全球可及的精準醫療和預防性醫療保健平台。
市場區隔
細分 1:按應用
產前檢測領域將主導非癌症液態切片檢測市場(按應用)
在全球非癌症液態切片活體組織切片市場(按應用分類)中,預計到2024年,產前檢測將佔據79.70%的市場佔有率,並在預測期內保持主導地位。這反映了產前檢測的微創特性、無風險的單次採血通訊協定、廣泛的報銷範圍以及通用的指南支援。這些因素共同支持了非癌症液態切片領域產前檢測的成長。
細分領域二:技術
NGS 主導非癌症液態切片檢測市場(按技術)
在全球非癌症液態切片檢測市場(按技術分類)中,NGS 在 2024 年佔據了 59.68% 的市場佔有率,並且由於其無與倫比的能力,可以在單次檢測中實現全面、高通量基因組分析,並且由於技術進步和規模效率的提高,每個樣本的成本穩步下降,預計在預測期內仍將保持主導地位。
細分 3:按最終用戶
非癌症液態切片檢測市場的臨床主導地位(按最終用戶)
在全球非癌症液態切片檢測市場(按最終用戶分類)中,預計臨床應用領域將在2024年佔據86.22%的市場佔有率,並有望在預測期內保持主導地位,這得益於液態切片在臨床實驗室的快速應用,以及製藥和生物技術公司在藥物開發和臨床試驗監測中的應用日益增多。這種主導地位反映了強大的報銷途徑、與常規患者照護的融合,以及臨床實踐和治療創新對微創診斷日益成長的需求。
細分4:按地區
預計預測期內亞太非癌症液態切片檢測市場將以 15.77% 的顯著速度成長。
近期動態
需求——促進因素、挑戰、機遇
市場促進因素:
疾病負擔日益加重,篩檢日益成長——由於慢性病負擔日益加重以及對非侵入性診斷工具的需求不斷成長,全球非癌症液態切片活體組織切片市場正在蓬勃發展。液態切片透過分析cfDNA和循環/外泌體miRNA等生物標記物,能夠早期發現和監測心血管和神經系統疾病等疾病。液態切片能夠即時洞察傳統組織切片檢查難以獲得的疾病訊息,並應用於其他領域。它們不僅支持心臟和大腦健康,還支持器官移植、產前檢測和感染疾病管理等應用。
市場挑戰:
不確定的報銷狀況和高昂的設置成本阻礙了其廣泛應用——非腫瘤科液態切片檢測的普及受到報銷狀況不明確和不一致的限制,尤其是在腫瘤科以外的領域。儘管液體活體組織切片具有臨床潛力,但付款方要求更有力的成本效益證據,而且技術的快速進步往往超過政策更新的速度。先進定序平台的高昂設定成本和每次檢測的高昂價格進一步限制了其普及,尤其是在缺乏保險覆蓋的情況下。這些挑戰阻礙了液體活體組織切片在臨床上的廣泛應用,尤其是在產前診斷、感染疾病和移植相關診斷方面。
市場機會:
擴大服務欠缺地區的可及性——非腫瘤液態切片公司正在服務欠缺地區本地化先進的診斷服務,以改善可及性並減少對海外實驗室的依賴。實施內部工作流程,例如 Yourgene Health 在摩洛哥和哥倫比亞的 NIPT 解決方案,可以縮短週轉時間、降低成本並減少檢測失敗率。此類努力能夠更快、更準確地進行診斷,同時增強臨床自主性。這種方法為產前、移植和感染疾病診斷領域的廣泛應用提供了可擴展的機會,從而促進了健康公平和市場滲透。
產品/創新策略:全球非癌症液態切片檢測市場已根據應用、技術、最終用戶、地區等不同類別進行廣泛細分。這有助於讀者清楚了解哪個細分市場佔有最大佔有率以及哪個細分市場在未來幾年可能會成長。
夥伴關係關係佔重大發展的最大數量,佔2022年1月至2025年5月期間全球非癌症液態切片檢測市場總發展的近40%。
全球非癌症液態切片檢測市場擁有眾多現有企業及其產品系列。本研究分析並概述了全球非癌症液態切片檢測市場中的主要企業概況,包括提供非癌症液態切片檢測系統產品的現有企業。
主要市場參與企業和競爭概況
公司簡介是根據對公司範圍、產品系列和市場滲透率的分析所收集的資訊而選擇的。
該市場的一些知名參與者包括:
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Introduction of Non-Cancer Liquid Biopsy Testing Market
The global non-cancer liquid biopsy testing market, initially valued at $4,276.1 million in 2024, is projected to witness substantial growth, surging to $19,308.8 million by 2035, marking a remarkable compound annual growth rate (CAGR) of 14.30% over the period from 2025 to 2035.
| KEY MARKET STATISTICS | |
|---|---|
| Forecast Period | 2025 - 2035 |
| 2025 Evaluation | $5,075.1 Million |
| 2035 Forecast | $19,308.8 Million |
| CAGR | 14.3% |
The global non-cancer liquid biopsy testing market is being propelled by the rising burden of chronic diseases, from cardiovascular and neurological disorders to prenatal and transplant care, and the growing demand for minimally invasive, real-time diagnostics. By analyzing blood-based biomarkers, liquid biopsy enables early detection and dynamic monitoring across a spectrum of indications without the risks of traditional sampling procedures. Advances in next-generation sequencing and assay sensitivity, coupled with significant industry investment, have positioned liquid biopsy as the preferred approach for applications such as non-invasive prenatal testing, graft-rejection surveillance and infectious-disease detection. However, high capital and per-test costs, along with an uneven reimbursement environment, continue to challenge widespread adoption. Strategic localization of workflows in underserved regions, exemplified by in-country deployments of CE-marked platforms, offers a powerful opportunity to reduce turnaround times, lower costs and broaden access, paving the way for liquid biopsy to become a cornerstone of precision and preventive medicine worldwide.
Market Introduction
The global non-cancer liquid biopsy testing market is rapidly growing as biopharma and diagnostics companies extend minimally invasive, blood-based molecular assays beyond oncology into critical areas such as prenatal screening, transplant surveillance and infectious-disease detection. By leveraging cell-free DNA, microRNAs and exosomes, liquid biopsy tests such as Illumina's Verifi, Natera's Panorama and Karius' Spectrum, deliver early, real-time insights that traditionally required risky tissue sampling, improving patient safety and operational efficiency. Ongoing assay innovations and novel biomarker validations, combined with strategic partnerships, and targeted acquisitions, are localizing advanced workflows and reducing turnaround times, costs and logistical hurdles. As healthcare systems worldwide embrace precision and preventive medicine, the convergence of enhanced performance, regulatory compliance and digital-health integration positions non-cancer liquid biopsy as a cornerstone of next-generation diagnostics.
Industrial Impact
The non-cancer liquid biopsy testing market is witnessing rapid industrialization as key players leverage strategic alliances, targeted acquisitions, and significant funding to embed advanced, minimally invasive workflows within regional healthcare ecosystems. By partnering with digital-health providers and local laboratories, companies are streamlining end-to-end diagnostic pathways, slashing turnaround times and reducing per-test costs without compromising sample integrity. Simultaneously, mergers and geographic expansions are strengthening in-country capacities, while portfolio enhancements and new product launches are broadening application scopes, from prenatal and transplant monitoring to infectious-disease detection. Substantial capital inflows have accelerated R&D and commercialization, enabling assay standardization and regulatory compliance at scale. Together, these industrial dynamics are transforming non-cancer liquid biopsy from a niche innovation into a robust, globally accessible platform for precision and preventive medicine.
Market Segmentation:
Segmentation 1: by Application
Prenatal Testing Segment to Dominate the Non-Cancer Liquid Biopsy Testing Market (by Application)
The global non-cancer liquid biopsy testing market (by application) has been dominated by prenatal testing, representing 79.70% of the market share in 2024, and is expected to maintain its dominance during the forecast period. This reflects prenatal testing's minimally invasive, single-blood-draw protocol with no risk, broad reimbursement coverage and universal guideline endorsements. These factors collectively support the growth of the prenatal testing in the non-cancer liquid biopsy space
Segmentation 2: Technology
NGS to Dominate the Non-Cancer Liquid Biopsy Testing Market (by Technology)
The global non-cancer liquid biopsy testing market (by technology) has been dominated by NGS, representing 59.68% of the market share in 2024, and is expected to maintain its dominance during the forecast period due to its unparalleled capacity for comprehensive, high-throughput genomic profiling in a single assay and its steadily declining per-sample costs enabled by technological advances and scale efficiencies.
Segmentation 3: by End User
Clinical to Dominate the Non-Cancer Liquid Biopsy Testing Market (by End User)
The global non-cancer liquid biopsy testing market (by end user) has been dominated by clinical segment, representing 86.22% of the market share in 2024, and is expected to maintain its dominance during the forecast period driven by rapid adoption of liquid biopsy in clinical laboratories and increasing utilization by pharmaceutical and biotech companies for drug development and clinical trial monitoring. This dominance reflects strong reimbursement pathways, integration into routine patient care and the escalating demand for minimally invasive diagnostics in both clinical practice and therapeutic innovation.
Segmentation 4: by Region
The non-cancer liquid biopsy testing market in the Asia-Pacific region is expected to witness a significant growth rate of 15.77% during the forecast period.
Recent Developments
Demand - Drivers, Challenges, and Opportunities
Market Drivers:
Growing Disease Burden and Screening: The global non-cancer liquid biopsy testing market is witnessing growth due to the rising burden of chronic diseases and the need for non-invasive diagnostic tools. Liquid biopsy enables early detection and monitoring of conditions like cardiovascular and neurological disorders by analyzing biomarkers such as cfDNA and circulating/exosomal miRNAs. It offers real-time disease insights, particularly where traditional tissue biopsies are difficult. Beyond heart and brain health, it also supports applications in organ transplantation, prenatal testing, and infectious disease management.
Market Challenges:
Uncertain Reimbursement Landscape and High Setup Costs Hindering Widespread Adoption: The adoption of non-cancer liquid biopsy tests is limited by an uncertain and inconsistent reimbursement landscape, especially outside oncology applications. Despite their clinical potential, payers demand stronger evidence of cost-effectiveness, and rapid technological advancements often outpace policy updates. High setup costs for advanced sequencing platforms and expensive per-test pricing further restrict access, especially without insurance coverage. These challenges hinder widespread clinical integration, particularly in prenatal, infectious disease, and transplant-related diagnostics.
Market Opportunities:
Expanding Access in Underserved Regions: Non-cancer liquid biopsy companies are localizing advanced diagnostic services in underserved regions to improve access and reduce reliance on overseas labs. By implementing in-house workflows, such as Yourgene Health's NIPT solutions in Morocco and Colombia, they've reduced turnaround times, costs, and test failures. These efforts enable faster, more accurate diagnoses while enhancing clinical autonomy. This approach presents a scalable opportunity for wider adoption across prenatal, transplant, and infectious disease diagnostics, promoting health equity and deeper market penetration.
How can this report add value to an organization?
Product/Innovation Strategy: The global non-cancer liquid biopsy testing market has been extensively segmented based on various categories, such as application, technology, end user, and region. This can help readers get a clear overview of which segments account for the largest share and which ones are well-positioned to grow in the coming years.
Growth/Marketing Strategy: Partnerships accounted for the maximum number of key developments, i.e., nearly 40% of the total developments in the global non-cancer liquid biopsy testing market were between January 2022 and May 2025.
Competitive Strategy: The global non-cancer liquid biopsy testing market has numerous established players with product portfolios. Key players in the global non-cancer liquid biopsy testing market analyzed and profiled in the study include established players offering products for non-cancer liquid biopsy testing systems.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
Primary Research:
The primary sources involve industry experts in non-cancer liquid biopsy testing, including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.
The key data points taken from the primary sources include:
Secondary Research
Open Sources
The key data points taken from the secondary sources include:
Key Market Players and Competition Synopsis
The companies profiled have been selected based on inputs gathered from an analysis of company coverage, product portfolio, and market penetration.
Some prominent names established in this market are:
Scope and Definition