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市场调查报告书
商品编码
1832004

移植诊断市场报告:2025 年至 2033 年按组件、技术、器官类型、应用、最终用户和地区分類的规模、份额、趋势和预测

Transplant Diagnostics Market Report Size, Share, Trends and Forecast by Component, Technology, Organ Type, Application, End User, and Region, 2025-2033

出版日期: | 出版商: IMARC | 英文 148 Pages | 商品交期: 2-3个工作天内

价格

2024 年全球移植诊断市场规模为 9.3928 亿美元。展望未来, IMARC Group估计,到 2033 年,市场规模将达到 18.02 亿美元,2025-2033 年期间的复合年增长率为 7.13%。北美目前占据市场主导地位,2024 年市占率约 34.6%。器官移植发生率的增加以及对精确、快速和非侵入性诊断系统的需求不断增长,以验证移植相容性并追踪移植后状态,推动了市场的发展。此外,分子诊断、次世代定序和生物资讯学的进步有助于增强对捐赠者-接受者相容性、排斥风险和感染追踪的检测。此外,不断增长的医疗支出和政府的支持性计划进一步扩大了移植诊断市场份额。

非侵入性检测方法的进步、个人化医疗的普及以及医疗基础设施投资的增加推动了市场的发展。此外,许多国家政府在医疗保健方面的支出不断增加,这也推动了市场扩张。根据一份产业报告,2021 年全球医疗保健支出达到 9.8 兆美元的历史新高,占全球 GDP 的 10.3%。此外,人们对器官捐赠的认识不断提高,加上国际卫生组织的支持政策,正在促进器官移植手术的普及。此外,人工智慧与诊断工作流程的整合提高了对排斥风险的预测准确性。此外,诊断公司和医疗保健提供者之间的策略合作正在进一步加速创新,确保为全球移植专案提供精确、经济高效且可扩展的检测解决方案。

在美国,市场受到强有力的监管框架、高昂的医疗支出以及尖端诊断技术的广泛应用的驱动。此外,拥有先进实验室的专业移植中心的存在有助于快速可靠地进行相容性测试。新兴的移植诊断市场趋势之一是扩大优惠的保险覆盖范围和报销政策,这鼓励使用高价值的分子和基因组检测。此外,促进器官捐赠的支持性措施和模式也正在支持市场发展。例如,2024年11月,医疗保险和医疗补助服务中心 (CMS) 最终确定了为期六年的强制性「增加器官移植可及性」(IOTA) 模型,旨在改善肾移植的可及性,提高护理质量,优化护理协调,减少差异,并降低医疗保险成本。该模式计划于 2025 年 7 月 1 日开始实施,涉及 103 家肾臟移植医院,并将采用基于绩效的财务激励和惩罚措施,以鼓励增加移植量、更快、更有效地接受器官捐赠,并提高移植物存活率。

移植诊断市场趋势:

老年人口不断扩大

全球老年人口的成长为市场创造了巨大的成长机会。老年患者罹患退化性老年疾病以及心血管疾病、肾衰竭和肝病等慢性疾病的风险更高,这些疾病通常需要器官移植。一份行业报告显示,约93%的65岁及以上成年人至少患有一种慢性疾病,约79%患有两种或两种以上慢性疾病。此外,手术方法和术后护理的改进使老年患者接受器官移植的可能性越来越大,从而扩大了潜在候选人的数量。老年人的免疫系统带来了特殊的挑战,需要精准而复杂的诊断方法来确定器官相容性并有效控制排斥风险。此外,移植前后的分子检测和生物标记导向监测对于这一人群获得最佳治疗方案尤其重要。随着全球人口寿命的延长,医疗保健系统对老年人器官移植的需求不断增长,这直接推动了对精准、有效、快速的移植诊断解决方案的需求,这些解决方案必须能够与复杂的老年患者管理相容。

慢性病发生率上升

由于加工食品消费量不断增加以及吸烟和饮酒人数不断增加,急性和慢性疾病的盛行率不断上升,导致器官衰竭病例数量显着上升。这反过来又对移植诊断市场前景产生了正面影响。据报道,到2030年,慢性病的负担预计将达到约47兆美元。此外,慢性肾臟病、肝硬化和心臟衰竭等疾病往往会发展为末期器官衰竭,而移植是最可行的治疗选择。慢性病盛行率的上升与生活方式选择有关,例如营养不良、缺乏运动、超重/肥胖,以及糖尿病和高血压的增加。每个移植过程都需要广泛的移植前和移植后诊断评估,例如HLA分型、交叉配对和免疫监测,以便为患者提供最佳结果。日益加重的慢性病负担不仅增加了移植候选人的数量,而且还导致实施复杂的分子和血清学检测技术,以加强相容性测试,最大限度地减少器官排斥的机会,并最大限度地提高不同类型器官的长期移植物存活率。

严重道路交通事故数量不断增加

严重道路交通事故发生率的上升,间接促进了移植诊断市场的成长,因为它增加了已故捐赠者器官的可用性。根据业界报告,全球每年约有119万人死于道路交通事故。创伤性脑损伤和致命事故往往能带来可行的器官捐赠,这对于满足日益增长的移植需求至关重要。在此类情况下,捐赠器官的可用性促使人们迫切需要快速可靠的诊断检测,以便在紧迫的时间内确定捐赠者与受体的相容性。此外,即时PCR、新一代定序和先进的交叉配型分析等技术在确保准确配型和降低排斥风险方面发挥着至关重要的作用。此外,事故高发生地区通常拥有完善的器官采购系统,这进一步加速了移植诊断的应用。由于器官短缺仍然是一项全球性挑战,致命事故的不幸增加无意中维持了移植医学对快速、高精确度诊断工具的需求。

目录

第一章:前言

第二章:范围与方法

  • 研究目标
  • 利害关係人
  • 资料来源
    • 主要来源
    • 二手资料
  • 市场评估
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第三章:执行摘要

第四章:简介

第五章:全球移植诊断市场

  • 市场概况
  • 市场表现
  • COVID-19的影响
  • 市场预测

第六章:市场细分:按组成部分

  • 仪器设备
  • 试剂和耗材
  • 软体和服务

第七章:市场区隔:依技术

  • 非分子检测
    • 关键部分
      • 血清学检测
      • 混合淋巴球培养
  • 分子检测
    • 关键部分
      • 基于PC
      • 基于定序

第八章:市场细分:依器官类型

  • 胰臟
  • 其他的

第九章:市场区隔:依应用

  • 移植前诊断
  • 移植后诊断

第 10 章:市场区隔:依最终用户

  • 医院及移植中心
  • 研究实验室和学术机构
  • 商业服务提供者

第 11 章:市场区隔:按地区

  • 北美洲
    • 美国
    • 加拿大
  • 亚太
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 印尼
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙
    • 俄罗斯
    • 其他的
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他的
  • 中东和非洲

第 12 章:SWOT 分析

第 13 章:价值链分析

第 14 章:波特五力分析

第 15 章:价格分析

第 16 章:竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • Abbott Laboratories
    • Becton Dickinson and Company
    • bioMerieux SA
    • Bio-Rad Laboratories Inc.
    • F. Hoffmann-La Roche AG
    • Hologic Inc
    • Illumina Inc.
    • Immucor Inc. (IVD Holdings Inc.)
    • Merck KGaA
    • Qiagen NV
    • Thermo Fisher Scientific Inc.
Product Code: SR112025A4436

The global transplant diagnostics market size was valued at USD 939.28 Million in 2024. Looking forward, IMARC Group estimates the market to reach USD 1,802.00 Million by 2033, exhibiting a CAGR of 7.13% during 2025-2033. North America currently dominates the market, holding a significant market share of around 34.6% in 2024. The market is fueled by the increasing incidences of organ transplants and increasing demand for precise, fast, and non-invasive diagnostic systems to verify transplant compatibility and track post-transplant status. Furthermore, advances in molecular diagnostics, next-generation sequencing, and bioinformatics are facilitating enhanced detection of donor-recipient compatibility, risk of rejection, and infection tracking. Besides that, rising healthcare spending and supportive government programs are further augmenting the transplant diagnostics market share.

The market is propelled by advancements in non-invasive testing methods, increasing adoption of personalized medicine, and growing investments in healthcare infrastructure. Furthermore, the rising government spending on healthcare across numerous nations is driving market expansion. According to an industry report, global healthcare spending hit an all-time high of USD 9.8 Trillion in 2021, representing 10.3% of the global GDP. Besides this, rising awareness about organ donation, coupled with supportive policies from international health organizations, is fostering broader access to transplantation procedures. Additionally, the integration of artificial intelligence in diagnostic workflows is enhancing predictive accuracy for rejection risks. Also, strategic collaborations between diagnostic companies and healthcare providers are further accelerating innovation, ensuring the availability of precise, cost-efficient, and scalable testing solutions for global transplant programs.

In the United States, the market is driven by a strong regulatory framework, high healthcare spending, and extensive adoption of cutting-edge diagnostic technologies. Moreover, the presence of specialized transplant centers with advanced laboratory capabilities facilitates rapid and reliable compatibility testing. One of the emerging transplant diagnostics market trends is the expansion of favorable insurance coverage and reimbursement policies, which encourage the use of high-value molecular and genomic assays. Apart from this, supportive initiatives and models promoting organ donation are supporting market development. For instance, in November 2024, the Centers for Medicare & Medicaid Services (CMS) finalized the six-year mandatory Increasing Organ Transplant Access (IOTA) Model, aimed at improving access to kidney transplants, enhancing quality of care, optimizing care coordination, reducing disparities, and lowering Medicare costs. Scheduled to begin on July 1, 2025, the model will involve 103 kidney transplant hospitals and will employ performance-based financial incentives and penalties to encourage increased transplant volumes, faster and more efficient organ offer acceptance, and improved graft survival rates.

Transplant Diagnostics Market Trends:

Expanding Geriatric Population

The global rise in the geriatric population is creating substantial growth opportunities for the market. Older patients are at higher risk of degenerative age-related conditions and chronic diseases like cardiovascular disease, renal failure, and liver disease, which often require transplantation of organs. According to an industry report, approximately 93% of adults aged 65 years and over suffer from at least one chronic illness. Approximately 79% suffer from two or more. Moreover, improved surgical methods and care after surgery have made transplantation increasingly possible for older patients, increasing the pool of potential candidates. The older immune system poses special challenges, with accurate and sophisticated diagnostics needed to determine compatibility and effectively control rejection risks. Additionally, pre- and post-transplant molecular testing and biomarker-directed monitoring are especially important in this population to achieve optimal therapy. With the increasing longevity of people worldwide, healthcare systems have been experiencing increased demand for organ transplantation among the elderly population, directly driving up the demand for accurate, effective, and speedy transplant diagnostic solutions compatible with the intricacies of geriatric patient management.

Rising Chronic Diseases

The growing prevalence of acute and chronic diseases on account of the increasing consumption of processed food products and the escalating number of individuals who smoke tobacco products and consume alcohol is causing a significant rise in the number of organ failure cases. This, in turn, is positively impacting the transplant diagnostics market outlook. According to reports, the burden of chronic diseases is projected to reach approximately USD 47 Trillion by 2030. Moreover, diseases like chronic kidney disease, cirrhosis, and heart failure tend to advance to end-stage organ failure, where transplantation is the most viable treatment option. This increased prevalence of chronic diseases correlates with lifestyle choices, such as poor nutrition, lack of activity, and overweight/obesity, and the increase in diabetes and hypertension. Every transplant process entails extensive pre- and post-transplant diagnostic evaluation, such as HLA typing, crossmatching, and immune monitoring, to provide the best possible outcomes for patients. The escalating chronic disease burden is not only increasing the number of transplant candidates but also leading to the implementation of sophisticated molecular and serological testing technologies in order to enhance compatibility testing, minimize chances of organ rejection, and maximize long-term graft survival rates for different types of organs.

Escalating Number of Severe Road Accidents

The rising incidence of severe road accidents is indirectly contributing to the transplant diagnostics market growth by increasing the availability of organs from deceased donors. As per industry reports, around 1.19 Million people lose their lives each year worldwide as a result of road accidents. Traumatic brain injuries and fatal accidents often result in viable organ donations, which are vital to meeting the growing demand for transplants. The availability of donor organs from such cases triggers the immediate need for fast and reliable diagnostic testing to determine donor-recipient compatibility within tight timeframes. Furthermore, technologies like real-time PCR, next-generation sequencing, and advanced crossmatching assays play a crucial role in ensuring accurate matching and reducing rejection risks. Besides this, regions with high accident rates often have robust organ procurement systems in place, further accelerating the use of transplant diagnostics. As organ shortages remain a global challenge, the unfortunate rise in fatal accidents is inadvertently sustaining the demand for rapid, high-precision diagnostic tools in transplant medicine.

Transplant Diagnostics Industry Segmentation:

Analysis by Component:

  • Instrument and Equipment
  • Reagent and Consumables
  • Software and Services

Reagent and consumables lead the market in 2024. The segment constitutes the foundation of laboratory testing protocols. They are test kits, assay reagents, buffers, and disposable lab supplies utilized for HLA typing, crossmatching, and detection of antibodies. Their continual demand arises from the fact that every diagnostic test demands fresh and accurate materials for guaranteed accurate and reliable results, which have a direct bearing on transplant compatibility tests. As organ transplant success is highly dependent on reducing the risks of rejection, the quality and availability of such consumables are critical. Moreover, the increasing rate of transplant procedures being performed globally, along with the development of molecular and serological testing technology, fuels consistent market growth for these products. Suppliers are aided by a repeat business model, as the labs need to constantly restock, and the reagents and consumables are not only critical to clinical pathways but also a big revenue division in the market.

Analysis by Technology:

  • Non-Molecular Assay
    • Serological Assay
    • Mixed Lymphocyte Culture
  • Molecular Assay
    • PC-based
    • Sequencing-based

Molecular assay leads the market with around 42.6% of market share in 2024. They are precise, fast, and can identify genetic differences at a detailed level. Such tests, involving PCR-based techniques and next-generation sequencing (NGS), are extensively applied to HLA typing, donor-specific antibody detection, and monitoring post-transplant immune status. By confirming gene compatibility among donors and recipients with precise accuracy, molecular tests decrease organ rejection risk and enhance long-term graft survival. Their use is increasing as healthcare systems move toward more individualized and streamlined transplant evaluation processes. The technology's capability to rapidly handle complex genetic information aids in making timely decisions, important in transplant situations in which time sensitivity can determine patient outcomes. With ongoing developments, molecular assays are transforming the future of transplant diagnostics, rendering them invaluable in pre-transplant screening and post-transplant monitoring.

Analysis by Organ Type:

  • Kidney
  • Liver
  • Heart
  • Lung
  • Pancreas
  • Others

Kidney leads the market in 2024 due to the large prevalence of end-stage renal failure and chronic kidney disease globally. Timely and accurate diagnostics in this segment are critical to avoid incompatibility between the donor and recipient, minimize rejection risk, and maximize graft survival rates. These include tests like HLA typing, crossmatching, and detection of donor-specific antibodies, which are applied on a routine basis prior to and after kidney transplants, making diagnosis a part of the treatment process. Transplant diagnostics in kidney transplants are also bolstered by increased numbers of live and cadaveric donor transplants, as well as technology developed in molecular diagnostics that can furnish quicker and more accurate results. Since kidney transplants continue to be the most prevalent solid organ transplant, they are still a driving force for revenue and innovation in the market.

Analysis by Application:

  • Pre-Transplant Diagnostics
  • Post-Transplant Diagnostics

Pre-transplant diagnostics are critical to assess donor-recipient compatibility and reduce the threat of graft rejection. Such tests comprise HLA typing, crossmatch, and donor-specific antibody screening, all of which identify the optimal match prior to surgery. Precise pre-transplant evaluation increases the success rate of transplants, minimizes complications, and facilitates improved long-term outcomes. Infectious disease workup is also done in addition to compatibility testing to avoid transmission of infection during transplantation. The increase in organ transplant demand and organ unavailability renders accurate and efficient pre-transplant diagnostics essential for making timely decisions. Advances in molecular tests and automation further increase test accuracy and efficiency, reinforcing their role as a cornerstone step in the process of transplantation.

Post-transplant diagnostics target the surveillance of the recipient's immune reaction to identify early indicators of rejection or infection. The tests involved are donor-specific antibody measurement, biomarker determination, and molecular testing to determine the function of the graft and immune activity. Continuous post-transplant monitoring enables clinicians to modulate immunosuppressive therapy early in the course of disease, averting irreversible transplanted organ damage. The increased uptake of non-invasive and quick testing technologies enhanced the comfort of patients and facilitated more regular monitoring, resulting in improved long-term graft survival rates. Since organ rejection may take months or years to be observed following surgery, demand for trusted post-transplant diagnosis continues to be robust. Ongoing innovation in this space is broadening the capacity for earlier detection of complications and is an essential part of integrated transplant medicine.

Analysis by End User:

  • Hospitals and Transplant Centers
  • Research Laboratories and Academic Institutes
  • Commercial Service Providers

Hospitals and transplant centers are one of the key end users as they have direct responsibility for patient evaluation, surgery, and post-operative care. Transplant centers depend on sophisticated diagnostic instrumentation to do HLA typing, crossmatching, and immune monitoring, maximizing donor-recipient compatibility and minimizing rejection. With the increasing number of transplant procedures globally, hospitals are increasingly implementing fast and precise molecular and serological diagnostic testing methodologies to enhance patient outcomes. Most transplant centers also have specialized laboratories within their premises, allowing for quicker turnaround times for urgent diagnostic results. Their place is not just pivotal in clinical decision-making but also in managing multidisciplinary teams, thereby a prime driver for demand in the transplant diagnostics market.

Research institutes and academic institutions are involved in the market by adding innovation, method development, and validation of novel testing methods. They are engaged in developing molecular assays, discovery of biomarkers, and genomic technology to make transplants more successful and minimize complications. They are also significantly involved in clinical trials to evaluate new diagnostic tools before using them in hospitals and commercial applications. Cooperation among scientific centers and industry players serves to convert the results of research into applicable diagnostic solutions. Besides, these companies equip medical specialists and scientists with training, thereby providing the transplant community with a qualified workforce. Their efforts lead to ongoing improvement in diagnostic precision, sensitivity, and economic efficiency, which further consolidates their place in the overall transplant diagnostics system.

Commercial service providers provide specialized transplant diagnostic tests on behalf of hospitals, transplant programs, and research institutions. These firms tend to have centralized labs with high-end technologies, allowing them to provide high-throughput and accurate testing services. With outsourcing to commercial vendors, healthcare facilities can obtain specialized knowledge and complex molecular tests without huge investments in infrastructure. This is highly beneficial for small centers with limited internal capabilities. Commercial vendors also help with quality assurance, compliance with regulations, and implementation of state-of-the-art technologies, including next-generation sequencing. Their efficiency, scalability, and capacity to work with numerous clients across regions make them a fundamental piece in bridging access to timely and reliable transplant diagnostics globally.

Regional Analysis:

  • North America
    • United States
    • Canada
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

In 2024, North America accounted for the largest market share of over 34.6% driven by the region's robust healthcare infrastructure, intensive use of sophisticated diagnostic technologies, and significant presence of top industry players. Moreover, the high rate of organ transplant surgeries, fueled by increasing numbers of chronic illnesses like kidney and liver failure, provides a boost to the market. Transplant centers and hospitals in the US and Canada employ cutting-edge molecular assays, next-generation sequencing, and serological testing to provide precise donor-recipient matching as well as efficient post-transplant monitoring. Supportive reimbursement policies, government programs to encourage organ donation, and research collaborations continue to enhance the market. Furthermore, North America's emphasis on innovation and high clinical trial activity rate continues to fuel advances in transplant diagnostic techniques.

Key Regional Takeaways:

United States Transplant Diagnostics Market Analysis

In 2024, the United States holds a substantial share of around 88.70% of the transplant diagnostics share in North America. The market driven by a sharp rise in chronic diseases, particularly kidney failure, diabetes, heart conditions, and liver diseases, which is increasing the demand for organ transplants in top-tier medical centers nationwide. According to an industry report published in 2024, in the United States, an estimated 129 million individuals are affected by at least one major chronic illness, such as heart disease. Moreover, 42% suffer from two or more, while 12% suffer from as many as 5. Additionally, advancements in molecular diagnostics, particularly in the areas of human leukocyte antigen (HLA) typing and next-generation sequencing, have significantly improved donor-recipient matching and transplant outcomes, increasing the adoption of sophisticated diagnostic tools. Furthermore, growing awareness among healthcare professionals and patients about the importance of early and accurate diagnostic testing in transplantation is fueling market growth. The expansion of organ transplant programs and supportive government initiatives to improve transplant infrastructure have further heightened the need for reliable diagnostic systems. The presence of technologically advanced healthcare facilities and a favorable reimbursement environment are also contributing to increased diagnostic testing. Other than this, increased investments in research and development (R&D) by key market players are resulting in more accurate, faster, and cost-effective diagnostic tools.

Asia-Pacific Transplant Diagnostics Market Analysis

In Asia Pacific, the market is expanding due to the rapid expansion of healthcare infrastructure and transplant programs across the region, which is increasing access to crucial diagnostic testing. For instance, in March 2023, India's healthcare infrastructure comprises a total of 1,69,615 Sub-Centres (SCs), 31,882 Primary Health Centres (PHCs), 6,359 Community Health Centres (CHCs), 1,340 Sub-Divisional/District Hospitals (SDHs), 714 District Hospitals (DHs), and 362 Medical Colleges (MCs), spanning both urban and rural regions. Moreover, the increasing adoption of digital health technologies and laboratory automation, which enhance the efficiency and accuracy of diagnostic workflows, is also supporting industry expansion. The integration of artificial intelligence (AI) and machine learning (ML) in diagnostic platforms is also contributing to improved interpretation of complex genetic data, supporting more informed clinical decisions. Besides this, government support for transplant initiatives and favorable reimbursement policies in key nations are also encouraging the adoption of sophisticated testing systems.

Europe Transplant Diagnostics Market Analysis

The growth of the market in Europe is largely propelled by technological innovations and evolving healthcare policies. An increasing geriatric population and rising incidence of chronic conditions such as kidney disease, liver failure, and cardiometabolic disorders have heightened the demand for organ transplantation and associated diagnostics. According to reports, the number of individuals aged 65 years and older in the European Union accounted for 21.6% of the population of the region in January 2024. In parallel, breakthroughs in immunogenetics, advanced tissue typing platforms, and non-invasive biomarker assays are enabling more precise donor matching, early rejection detection, and optimal long term graft health. Increased awareness among clinicians and patients about the critical role of timely and accurate diagnostics in transplantation processes is also fueling uptake. Moreover, cross border healthcare initiatives and funding under pan European health programs are strengthening transplant networks, harmonizing diagnostic standards, and improving access across countries. A supportive reimbursement environment and alignment with personalized medicine strategies are also encouraging hospitals and laboratories to invest in sophisticated testing systems. Additionally, collaborative research efforts among academic institutions, biotech firms, and diagnostic companies are accelerating the commercialization of next generation assays tailored to European regulatory frameworks. The growing emphasis on quality metrics, audit compliance, and real world patient outcomes is further driving the adoption of standardized, high sensitivity diagnostic solutions.

Latin America Transplant Diagnostics Market Analysis

In Latin America, the market is significantly influenced by a growing focus on improving transplant success rates through personalized medicine and precision diagnostics. As healthcare systems strive to reduce post-transplant complications and improve long-term patient outcomes, there is an increasing demand for advanced immunological monitoring and molecular diagnostic tools. The gradual adoption of digital health and data integration technologies is also enhancing clinical decision-making and streamlining diagnostic processes. For instance, the digital health market in Brazil reached USD 10.66 Billion in 2024 and is projected to reach USD 40.85 Billion by 2033, growing at a CAGR of 16.10% during 2025-2033. Besides this, gradual enhancements in healthcare financing, insurance coverage, and reimbursement policies are making sophisticated transplantation diagnostics more accessible, supporting market growth.

Middle East and Africa Transplant Diagnostics Market Analysis

The market in the Middle East and Africa is experiencing robust growth due to the expansion of specialty healthcare facilities and the establishment of regional transplant centers catering to growing patient demand. Increasing investment in modern clinical laboratories is enabling access to advanced diagnostic methods such as immunogenetic profiling and multiplex biomarker assays. Governments in the region are also progressively prioritizing organ transplantation as part of national healthcare strategies, leading to improved funding and support for transplant-related services, including diagnostics. Additionally, the rising burden of non-communicable diseases, such as diabetes and hypertension, is leading to increased cases of organ failure and transplant need. An industry report indicates that the Middle East and North Africa region currently has 85 Million people living with diabetes, which is projected to rise to 163 million by 2050.

Competitive Landscape:

The market is characterized by intense innovations, led by the growing need for effective, timely, and non-invasive diagnostic products that can enhance patient outcomes in organ transplantation. Market players compete based on advancements in molecular diagnostics, next-generation sequencing (NGS), and polymerase chain reaction (PCR) technologies to deliver improvements in donor-recipient matching and post-transplant monitoring. Moreover, strategic partnerships with healthcare centers and research institutions are not uncommon, facilitating access to cutting-edge technology and increased global presence. In addition, regulatory compliance, quality control, and the capacity to deliver cost-efficient test solutions are foremost determinants of competitiveness. According to the transplant diagnostics market forecast, increasing transplant volumes, increasing knowledge of graft rejection detection in the early stage, and the incorporation of AI-powered data analytics are expected to sharpen competition between market players. Besides this, the emphasis on creating multiplex assays and custom testing solutions is opening new paths for differentiation, while regional growth strategies are being pursued to leverage emerging healthcare markets.

The report provides a comprehensive analysis of the competitive landscape in the transplant diagnostics market with detailed profiles of all major companies, including:

  • Abbott Laboratories
  • Becton Dickinson and Company
  • bioMerieux SA
  • Bio-Rad Laboratories Inc.
  • F. Hoffmann-La Roche AG
  • Hologic Inc.
  • Illumina Inc.
  • Immucor Inc. (IVD Holdings Inc.)
  • Merck KGaA
  • Qiagen N.V.
  • Thermo Fisher Scientific Inc.

Key Questions Answered in This Report

  • 1.How big is the transplant diagnostics market?
  • 2.What is the future outlook of the transplant diagnostics market?
  • 3.What are the key factors driving the transplant diagnostics market?
  • 4.Which region accounts for the largest transplant diagnostics market?
  • 5.Which are the leading companies in the global transplant diagnostics market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Transplant Diagnostics Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Component

  • 6.1 Instrument and Equipment
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Reagent and Consumables
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Software and Services
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast

7 Market Breakup by Technology

  • 7.1 Non-Molecular Assay
    • 7.1.1 Market Trends
    • 7.1.2 Key Segments
      • 7.1.2.1 Serological Assay
      • 7.1.2.2 Mixed Lymphocyte Culture
    • 7.1.3 Market Forecast
  • 7.2 Molecular Assay
    • 7.2.1 Market Trends
    • 7.2.2 Key Segments
      • 7.2.2.1 PC-based
      • 7.2.2.2 Sequencing-based
    • 7.2.3 Market Forecast

8 Market Breakup by Organ Type

  • 8.1 Kidney
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Liver
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Heart
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Lung
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Pancreas
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast
  • 8.6 Others
    • 8.6.1 Market Trends
    • 8.6.2 Market Forecast

9 Market Breakup by Application

  • 9.1 Pre-Transplant Diagnostics
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Post-Transplant Diagnostics
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast

10 Market Breakup by End User

  • 10.1 Hospitals and Transplant Centers
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Research Laboratories and Academic Institutes
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 Commercial Service Providers
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast

11 Market Breakup by Region

  • 11.1 North America
    • 11.1.1 United States
      • 11.1.1.1 Market Trends
      • 11.1.1.2 Market Forecast
    • 11.1.2 Canada
      • 11.1.2.1 Market Trends
      • 11.1.2.2 Market Forecast
  • 11.2 Asia-Pacific
    • 11.2.1 China
      • 11.2.1.1 Market Trends
      • 11.2.1.2 Market Forecast
    • 11.2.2 Japan
      • 11.2.2.1 Market Trends
      • 11.2.2.2 Market Forecast
    • 11.2.3 India
      • 11.2.3.1 Market Trends
      • 11.2.3.2 Market Forecast
    • 11.2.4 South Korea
      • 11.2.4.1 Market Trends
      • 11.2.4.2 Market Forecast
    • 11.2.5 Australia
      • 11.2.5.1 Market Trends
      • 11.2.5.2 Market Forecast
    • 11.2.6 Indonesia
      • 11.2.6.1 Market Trends
      • 11.2.6.2 Market Forecast
    • 11.2.7 Others
      • 11.2.7.1 Market Trends
      • 11.2.7.2 Market Forecast
  • 11.3 Europe
    • 11.3.1 Germany
      • 11.3.1.1 Market Trends
      • 11.3.1.2 Market Forecast
    • 11.3.2 France
      • 11.3.2.1 Market Trends
      • 11.3.2.2 Market Forecast
    • 11.3.3 United Kingdom
      • 11.3.3.1 Market Trends
      • 11.3.3.2 Market Forecast
    • 11.3.4 Italy
      • 11.3.4.1 Market Trends
      • 11.3.4.2 Market Forecast
    • 11.3.5 Spain
      • 11.3.5.1 Market Trends
      • 11.3.5.2 Market Forecast
    • 11.3.6 Russia
      • 11.3.6.1 Market Trends
      • 11.3.6.2 Market Forecast
    • 11.3.7 Others
      • 11.3.7.1 Market Trends
      • 11.3.7.2 Market Forecast
  • 11.4 Latin America
    • 11.4.1 Brazil
      • 11.4.1.1 Market Trends
      • 11.4.1.2 Market Forecast
    • 11.4.2 Mexico
      • 11.4.2.1 Market Trends
      • 11.4.2.2 Market Forecast
    • 11.4.3 Others
      • 11.4.3.1 Market Trends
      • 11.4.3.2 Market Forecast
  • 11.5 Middle East and Africa
    • 11.5.1 Market Trends
    • 11.5.2 Market Breakup by Country
    • 11.5.3 Market Forecast

12 SWOT Analysis

  • 12.1 Overview
  • 12.2 Strengths
  • 12.3 Weaknesses
  • 12.4 Opportunities
  • 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

  • 14.1 Overview
  • 14.2 Bargaining Power of Buyers
  • 14.3 Bargaining Power of Suppliers
  • 14.4 Degree of Competition
  • 14.5 Threat of New Entrants
  • 14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

  • 16.1 Market Structure
  • 16.2 Key Players
  • 16.3 Profiles of Key Players
    • 16.3.1 Abbott Laboratories
      • 16.3.1.1 Company Overview
      • 16.3.1.2 Product Portfolio
      • 16.3.1.3 Financials
      • 16.3.1.4 SWOT Analysis
    • 16.3.2 Becton Dickinson and Company
      • 16.3.2.1 Company Overview
      • 16.3.2.2 Product Portfolio
      • 16.3.2.3 Financials
      • 16.3.2.4 SWOT Analysis
    • 16.3.3 bioMerieux SA
      • 16.3.3.1 Company Overview
      • 16.3.3.2 Product Portfolio
      • 16.3.3.3 Financials
      • 16.3.3.4 SWOT Analysis
    • 16.3.4 Bio-Rad Laboratories Inc.
      • 16.3.4.1 Company Overview
      • 16.3.4.2 Product Portfolio
      • 16.3.4.3 Financials
      • 16.3.4.4 SWOT Analysis
    • 16.3.5 F. Hoffmann-La Roche AG
      • 16.3.5.1 Company Overview
      • 16.3.5.2 Product Portfolio
      • 16.3.5.3 SWOT Analysis
    • 16.3.6 Hologic Inc
      • 16.3.6.1 Company Overview
      • 16.3.6.2 Product Portfolio
      • 16.3.6.3 Financials
      • 16.3.6.4 SWOT Analysis
    • 16.3.7 Illumina Inc.
      • 16.3.7.1 Company Overview
      • 16.3.7.2 Product Portfolio
      • 16.3.7.3 Financials
      • 16.3.7.4 SWOT Analysis
    • 16.3.8 Immucor Inc. (IVD Holdings Inc.)
      • 16.3.8.1 Company Overview
      • 16.3.8.2 Product Portfolio
      • 16.3.8.3 SWOT Analysis
    • 16.3.9 Merck KGaA
      • 16.3.9.1 Company Overview
      • 16.3.9.2 Product Portfolio
      • 16.3.9.3 Financials
      • 16.3.9.4 SWOT Analysis
    • 16.3.10 Qiagen N.V.
      • 16.3.10.1 Company Overview
      • 16.3.10.2 Product Portfolio
      • 16.3.10.3 Financials
      • 16.3.10.4 SWOT Analysis
    • 16.3.11 Thermo Fisher Scientific Inc.
      • 16.3.11.1 Company Overview
      • 16.3.11.2 Product Portfolio
      • 16.3.11.3 Financials
      • 16.3.11.4 SWOT Analysis

List of Figures

  • Figure 1: Global: Transplant Diagnostics Market: Major Drivers and Challenges
  • Figure 2: Global: Transplant Diagnostics Market: Sales Value (in Million USD), 2019-2024
  • Figure 3: Global: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 4: Global: Transplant Diagnostics Market: Breakup by Component (in %), 2024
  • Figure 5: Global: Transplant Diagnostics Market: Breakup by Technology (in %), 2024
  • Figure 6: Global: Transplant Diagnostics Market: Breakup by Organ Type (in %), 2024
  • Figure 7: Global: Transplant Diagnostics Market: Breakup by Application (in %), 2024
  • Figure 8: Global: Transplant Diagnostics Market: Breakup by End User (in %), 2024
  • Figure 9: Global: Transplant Diagnostics Market: Breakup by Region (in %), 2024
  • Figure 10: Global: Transplant Diagnostics (Instrument and Equipment) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 11: Global: Transplant Diagnostics (Instrument and Equipment) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 12: Global: Transplant Diagnostics (Reagent and Consumables) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 13: Global: Transplant Diagnostics (Reagent and Consumables) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 14: Global: Transplant Diagnostics (Software and Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 15: Global: Transplant Diagnostics (Software and Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 16: Global: Transplant Diagnostics (Non-Molecular Assay) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 17: Global: Transplant Diagnostics (Non-Molecular Assay) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 18: Global: Transplant Diagnostics (Molecular Assay) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 19: Global: Transplant Diagnostics (Molecular Assay) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 20: Global: Transplant Diagnostics (Kidney) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 21: Global: Transplant Diagnostics (Kidney) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 22: Global: Transplant Diagnostics (Liver) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 23: Global: Transplant Diagnostics (Liver) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 24: Global: Transplant Diagnostics (Heart) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 25: Global: Transplant Diagnostics (Heart) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 26: Global: Transplant Diagnostics (Lung) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 27: Global: Transplant Diagnostics (Lung) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 28: Global: Transplant Diagnostics (Pancreas) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 29: Global: Transplant Diagnostics (Pancreas) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 30: Global: Transplant Diagnostics (Other Organ Types) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 31: Global: Transplant Diagnostics (Other Organ Types) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 32: Global: Transplant Diagnostics (Pre-Transplant Diagnostics) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 33: Global: Transplant Diagnostics (Pre-Transplant Diagnostics) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 34: Global: Transplant Diagnostics (Post-Transplant Diagnostics) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 35: Global: Transplant Diagnostics (Post-Transplant Diagnostics) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 36: Global: Transplant Diagnostics (Hospitals and Transplant Centers) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 37: Global: Transplant Diagnostics (Hospitals and Transplant Centers) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 38: Global: Transplant Diagnostics (Research Laboratories and Academic Institutes) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 39: Global: Transplant Diagnostics (Research Laboratories and Academic Institutes) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 40: Global: Transplant Diagnostics (Commercial Service Providers) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 41: Global: Transplant Diagnostics (Commercial Service Providers) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 42: North America: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 43: North America: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 44: United States: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 45: United States: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 46: Canada: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 47: Canada: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 48: Asia-Pacific: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 49: Asia-Pacific: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 50: China: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 51: China: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 52: Japan: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 53: Japan: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 54: India: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 55: India: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 56: South Korea: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 57: South Korea: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 58: Australia: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 59: Australia: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 60: Indonesia: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 61: Indonesia: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 62: Others: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 63: Others: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 64: Europe: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 65: Europe: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 66: Germany: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 67: Germany: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 68: France: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 69: France: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 70: United Kingdom: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 71: United Kingdom: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 72: Italy: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 73: Italy: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 74: Spain: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 75: Spain: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 76: Russia: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 77: Russia: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 78: Others: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 79: Others: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 80: Latin America: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 81: Latin America: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 82: Brazil: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 83: Brazil: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 84: Mexico: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 85: Mexico: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 86: Others: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 87: Others: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 88: Middle East and Africa: Transplant Diagnostics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 89: Middle East and Africa: Transplant Diagnostics Market: Breakup by Country (in %), 2024
  • Figure 90: Middle East and Africa: Transplant Diagnostics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 91: Global: Transplant Diagnostics Industry: SWOT Analysis
  • Figure 92: Global: Transplant Diagnostics Industry: Value Chain Analysis
  • Figure 93: Global: Transplant Diagnostics Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Transplant Diagnostics Market: Key Industry Highlights, 2024 and 2033
  • Table 2: Global: Transplant Diagnostics Market Forecast: Breakup by Component (in Million USD), 2025-2033
  • Table 3: Global: Transplant Diagnostics Market Forecast: Breakup by Technology (in Million USD), 2025-2033
  • Table 4: Global: Transplant Diagnostics Market Forecast: Breakup by Organ Type (in Million USD), 2025-2033
  • Table 5: Global: Transplant Diagnostics Market Forecast: Breakup by Application (in Million USD), 2025-2033
  • Table 6: Global: Transplant Diagnostics Market Forecast: Breakup by End User (in Million USD), 2025-2033
  • Table 7: Global: Transplant Diagnostics Market Forecast: Breakup by Region (in Million USD), 2025-2033
  • Table 8: Global: Transplant Diagnostics Market: Competitive Structure
  • Table 9: Global: Transplant Diagnostics Market: Key Players