![]() |
市場調查報告書
商品編碼
1914723
全球器官移植診斷市場-按產品、應用、移植類型、技術、最終用戶、地區和競爭格局分類的產業規模、佔有率、趨勢、機會和預測(2021-2031 年)Organ Transplant Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Offering, By Application, By Transplant Type, By Technology, By End User, By Region & Competition, 2021-2031F |
||||||
全球器官移植診斷市場預計將從 2025 年的 64.7 億美元成長到 2031 年的 98.7 億美元,複合年成長率為 7.29%。
該市場涵蓋了組織配型、病原體篩檢和移植過程中免疫監測所必需的各種檢測方法、試劑和儀器系統。推動這一成長的主要因素是全球慢性疾病導致器官衰竭的趨勢日益加劇,以及人口老化需要更先進的醫療干預,這些因素共同推動了對嚴格的相容性分析的需求。全球捐贈與移植觀察站的報告也印證了這個日益成長的臨床需求:到2024年12月,全球固態器官移植數量將達到172,397例,比上一個評估週期增加9.5%。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 64.7億美元 |
| 市場規模:2031年 | 98.7億美元 |
| 複合年成長率:2026-2031年 | 7.29% |
| 成長最快的細分市場 | 次世代定序(NGS) |
| 最大的市場 | 北美洲 |
儘管該領域呈現積極的成長趨勢,但由於全球捐贈器官長期短缺,仍面臨嚴峻的挑戰。龐大的患者等待名單與可用器官的供不應求之間的不平衡限制了手術數量,從而限制了術前交叉配對試驗配型和確診診斷的潛在市場規模。此外,分子檢測技術的高成本,以及新興經濟體報銷政策的不一致性,進一步阻礙了這些重要診斷方案的廣泛應用和推廣。
對非侵入性移植後監測日益成長的需求正在改變全球器官移植診斷市場,為病患監測和移植器官保護樹立了新的標準。醫療專業人員擴大採用液態切片解決方案,該方案可檢測供體來源的遊離DNA (dd-cfDNA)。與傳統的組織切片檢查相比,dd-cfDNA能夠更快、更靈敏地檢測出排斥反應的徵兆,從而減輕患者負擔並提高免疫監測的準確性。這種轉變正推動診斷服務提供者的檢測量顯著成長。例如,CareDx在其2025年11月發布的「2025年第三季財務業績」報告中指出,其提供的檢測服務數量達到50,300項,年成長13%,證實了這些先進方法在臨床應用中的快速普及。
同時,導致器官衰竭的慢性疾病日益增多,是推動移植前相容性檢測持續擴展的主要因素。由於末期腎功能衰竭和心血管衰竭等疾病導致等待移植的患者人數不斷增加,嚴格的組織相容性分析和HLA型檢測對於確保器官的合理分配至關重要。根據美國衛生資源與服務管理局 (HRSA) OrganDonor.gov 網站 2025 年 5 月更新的數據,全國器官移植等待名單上的患者人數已超過 10.3 萬人。如此強勁的臨床需求支撐著手術能力。器官捐贈和移植網路 (OPTN) 2025 年 1 月的報告顯示,2024 年美國器官移植數量達到創紀錄的 48,149 例,凸顯了該體系對健全診斷基礎設施的依賴。
供體器官持續短缺是限制全球器官移植診斷市場商業性成長的主要因素。由於診斷測試的使用與手術數量密切相關,器官供應有限實際上限制了市場的收入潛力。這種限制降低了術前相容性檢測的頻率,並限制了能夠進入移植後監測階段的患者數量。因此,該行業無法完全滿足臨床需求,而由於供體器官供應停滯不前,可供移植的患者數量也受到實際限制。
這種結構性瓶頸正在擴大潛在需求與實際檢測量之間的差距。根據器官取得和移植網路的數據,截至2024年,美國國家器官移植等待名單上已有超過10.3萬人。這一巨大缺口表明,捐贈者短缺如何阻礙了很大一部分患者獲得全面的診斷服務,從而妨礙了原本可以透過常規檢測獲得的永續收入來源的建立。
人工智慧 (AI) 和機器學習 (ML) 的應用正在革新預測性風險分層,旨在解決傳統方法無法應對的器官獲取效率低下問題。這些先進技術能夠解讀複雜的供體變量,最佳化從終止生命維持到器官摘取這一關鍵決策視窗。能夠準確預測捐贈者預後的 AI 工具可最大限度地減少可用器官的浪費,從而直接緩解持續存在的供不應求。例如,《衛報》在 2025 年 11 月報道稱,史丹佛大學研究人員開發的一種機器學習模型與標準預測相比,可將器官試驗的浪費減少 60%。
同時,隨著新型RNA生物標記的引入,市場正朝著個人化移植醫學的方向發展,這些生物標記能夠提供比標準液態生物檢體更深入的資訊。臨床醫生越來越依賴轉錄組分析來更特異性評估排斥風險,從而實現免疫抑制療法的個人化客製化,並降低長期移植毒性。這種向精準診斷的轉變也體現在下一代檢測技術的商業性成功上;Verisi Diex在其2025年7月發布的《企業趨勢報告》中宣布,其診斷測試Tutivia在2025年第二季度已獲得299份訂單,這表明人們越來越依賴先進的基因組特徵來進行個性化患者管理。
The Global Organ Transplant Diagnostics Market is projected to expand from USD 6.47 Billion in 2025 to USD 9.87 Billion by 2031, reflecting a compound annual growth rate of 7.29%. This market encompasses a broad range of assays, reagents, and instrument systems essential for histocompatibility testing, pathogen screening, and immune monitoring throughout the transplant continuum. The primary catalysts for this growth are the increasing global prevalence of chronic diseases causing organ failure and an aging population requiring advanced medical interventions, which collectively drive the demand for rigorous compatibility profiling. As evidence of this rising clinical need, the Global Observatory on Donation and Transplantation reported in December 2024 that global solid organ transplant volumes reached 172,397 procedures, marking a 9.5% increase over the prior assessment cycle.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 6.47 Billion |
| Market Size 2031 | USD 9.87 Billion |
| CAGR 2026-2031 | 7.29% |
| Fastest Growing Segment | Next-Generation Sequencing (NGS) |
| Largest Market | North America |
Despite the positive growth trajectory, the sector encounters significant hurdles stemming from the chronic global shortage of donor organs. This imbalance between the extensive waitlists of patients and the scarce supply of viable organs limits the number of surgeries performed, thereby placing a ceiling on the addressable market for pre-surgical cross-matching and confirmatory diagnostics. Additionally, the high costs associated with molecular testing technologies, combined with inconsistent reimbursement policies in emerging economies, pose further barriers that may hinder the widespread accessibility and expansion of these essential diagnostic solutions.
Market Driver
The escalating demand for non-invasive post-transplant monitoring is transforming the Global Organ Transplant Diagnostics Market by setting new benchmarks for patient surveillance and allograft protection. Medical professionals are increasingly utilizing liquid biopsy solutions that detect donor-derived cell-free DNA (dd-cfDNA) to spot potential rejection events with greater speed and sensitivity than traditional tissue biopsies, reducing patient burden while enhancing immune monitoring accuracy. This shift is driving significant volume growth for diagnostic providers; for instance, CareDx reported in its 'Third Quarter 2025 Financial Results' in November 2025 that testing services volume reached 50,300 tests, a 13% increase from the previous year, underscoring the rapid clinical adoption of these advanced modalities.
Concurrently, the increasing prevalence of chronic conditions leading to organ failure serves as a major driver for the continued expansion of pre-transplant compatibility testing. Diseases such as end-stage renal disease and cardiovascular failure are expanding patient waitlists, thereby necessitating rigorous histocompatibility profiling and HLA typing to facilitate successful organ allocation. Data from the Health Resources and Services Administration's OrganDonor.gov, updated in May 2025, indicates that over 103,000 individuals were listed on the national transplant waiting list. This intense clinical demand supports procedural throughput, as evidenced by the Organ Procurement and Transplantation Network's January 2025 report, which noted a record 48,149 organ transplants performed in the United States during 2024, highlighting the ecosystem's reliance on robust diagnostic infrastructure.
Market Challenge
The enduring scarcity of donor organs serves as a primary constraint on the commercial growth of the global organ transplant diagnostics market. Because the use of diagnostic assays is intrinsically linked to the volume of surgical procedures, the limited availability of organs effectively places a hard cap on market revenue potential. This restriction diminishes the frequency of pre-surgical compatibility testing and limits the number of patients who can transition into the post-transplantation monitoring phase. Consequently, the industry is unable to fully meet clinical demand, as the addressable patient population is physically constrained by the stagnant supply of donors.
This structural bottleneck results in a widening disparity between potential demand and actual testing volumes. According to data from the Organ Procurement and Transplantation Network, there were more than 103,000 candidates awaiting a transplant on the national waiting list in the United States in 2024. This significant gap illustrates how the shortage of donors precludes a large portion of the patient population from utilizing the full spectrum of diagnostic services, thereby impeding the generation of recurring revenue streams that would otherwise arise from routine profiling.
Market Trends
The incorporation of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing predictive risk stratification, targeting inefficiencies in organ procurement that conventional methods fail to address. These advanced technologies are being utilized to interpret complex donor variables, thereby optimizing the crucial decision-making period between the withdrawal of life support and organ retrieval. By offering accurate predictions of donor progression, AI tools help minimize the discard rate of viable organs, directly mitigating the ongoing supply shortage; for example, The Guardian reported in November 2025 that a machine learning model developed by Stanford University researchers achieved a 60% reduction in futile procurement attempts compared to standard predictions.
In parallel, the market is witnessing a transition toward personalized transplant medicine driven by the adoption of novel RNA-based biomarkers that provide deeper insights than standard liquid biopsies. Clinicians are increasingly relying on transcriptomic profiling to evaluate rejection risks with greater specificity, enabling the customization of immunosuppression regimens to reduce long-term graft toxicity. This shift toward precision diagnostics is reflected in the commercial success of next-generation assays; Verici Dx reported in a July 2025 corporate update that it received 299 orders for its Tutivia diagnostic test in the second quarter of 2025, demonstrating a growing reliance on advanced genomic signatures for individualized patient management.
Report Scope
In this report, the Global Organ Transplant Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Organ Transplant Diagnostics Market.
Global Organ Transplant Diagnostics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: