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1685533

器官移植診斷市場 - 全球和區域分析，包括產品、應用、技術、移植類型、最終用戶、國家分析：2025 年至 2035 年

Organ Transplant Diagnostics Market - A Global and Regional Analysis: Focus on Offering, Application, Technology, Transplant Type, End User, and Country - Analysis and Forecast, 2025-2035

出版日期: 2025年03月25日 | 出版商:

BIS Research | 英文 140 Pages | 商品交期: 1-5個工作天內

價格

簡介目錄

全球器官移植診斷市場規模正在穩定成長，這得益於器官移植需求的增加、器官衰竭發生率的上升以及診斷技術的進步。

腎衰竭、肝硬化、心血管疾病和糖尿病等慢性病發病率的上升導致全球器官移植數量的增加。此外，免疫抑制治療的改進和移植後監測的改善提高了移植手術的成功率，進一步推動了對移植診斷的需求。

分子診斷、次世代定序(NGS)、聚合酵素鏈鎖反應(PCR) 和人類白血球抗原 (HLA) 分型的技術進步徹底改變了移植診斷。這些創新可以實現準確的兼容性測試、早期檢測移植排斥並改善患者的治療效果。非侵入性診斷方法和基於生物標記的測試也擴大被採用，從而降低了風險並提高了移植程序的準確性。

器官移植診斷市場對醫療保健領域產生了重大影響，主要企業包括雅培實驗室、碧迪公司和伯樂實驗室等。這些公司處於領先地位，為器官移植診斷提供尖端產品。

此外，策略聯盟、合併和研發投資進一步塑造了市場，使企業能夠擴大其全球影響力並推出創新解決方案。器官移植診斷市場的競爭格局不斷變化，人們越來越關注組織結構和疾病機制的理解，技術創新和以客戶為中心的方法推動差異化和成長。

本報告概述了全球器官移植診斷市場，包括按產品、應用、技術、移植類型、最終用戶、國家趨勢和公司概況分類的細分市場。

The global organ transplant diagnostics market is experiencing steady growth, driven by the increasing demand for organ transplants, rising incidences of organ failure, and advancements in diagnostic technologies. The increasing prevalence of chronic diseases such as kidney failure, liver cirrhosis, cardiovascular diseases, and diabetes has led to a growing number of organ transplants worldwide. Additionally, improvements in immunosuppressive therapies and better post-transplant monitoring have contributed to a higher success rate of transplant procedures, further boosting the demand for transplant diagnostics.

Technological advancements in molecular diagnostics, next-generation sequencing (NGS), polymerase chain reaction (PCR), and human leukocyte antigen (HLA) typing have revolutionized transplant diagnostics. These innovations enable accurate compatibility testing, early detection of transplant rejection, and improved patient outcomes. The adoption of non-invasive diagnostic methods and biomarker-based tests is also increasing, reducing the risk and improving the precision of transplant procedures.

Industrial Impact

The organ transplant diagnostics market has significantly influenced the healthcare landscape, driven by key players such as Abbott Laboratories, Becton, Dickinson, and Company, Bio-Rad Laboratories, Inc, and others. These companies have been at the forefront, providing cutting-edge products for organ transplant diagnostics.

Moreover, the market has been further shaped by strategic collaborations, mergers, and R&D investments, which enable companies to expand their global presence and introduce innovative solutions. With the increasing focus on understanding tissue architecture and disease mechanisms, the competitive landscape of the organ transplant diagnostics market is dynamic, with innovation and customer-centric approaches driving differentiation and growth.

Market Segmentation for Organ Transplant Diagnostics Market:

Segmentation 1: by Offering

Products
- Kits and Assays
- Consumables
Services

Services Segment to Dominate the Organ Transplant Diagnostics Market (by Offering)

The services segment is expected to dominate the organ transplant diagnostics market, driven by the increasing demand for high-quality diagnostic solutions, outsourced laboratory testing, and post-transplant monitoring. The growing complexity of organ transplant procedures necessitates continuous and precise testing to ensure compatibility, detect early signs of rejection, and monitor immune responses. Diagnostic service providers offer specialized expertise in HLA typing, cross-matching, donor-recipient compatibility testing, and post-transplant surveillance, making them an indispensable part of the transplantation process. Further, many hospitals and transplant centers prefer outsourcing diagnostic services to reference laboratories and specialized diagnostic providers rather than investing in in-house capabilities, further propelling the growth of this segment.

Segmentation 2: by Transplant Type

Solid Organ Transplant
- Kidney
- Liver
- Lung
- Pancreas
- Others
Stem Cell Transplant

Solid Organ Transplant Segment to Dominate the Organ Transplant Diagnostics Market (by Transplant Type)

The solid organ transplant segment is expected to dominate the organ transplant diagnostics market, primarily due to the high incidence of organ failure and the increasing number of kidney, liver, heart, and lung transplants worldwide. The growing burden of chronic diseases such as end-stage renal disease (ESRD), liver cirrhosis, heart failure, and chronic obstructive pulmonary disease (COPD) has significantly increased the demand for solid organ transplants. As a result, the need for precise and reliable transplant diagnostics has risen to ensure better donor-recipient compatibility, reduce rejection rates, and improve long-term patient outcomes. Furthermore, government initiatives, public awareness campaigns, and the expansion of transplant registries have significantly contributed to the rise in organ donations, further propelling the demand for organ transplant diagnostics.

Segmentation 3: by Application

Diagnostics
- Donor Testing
- Recipient Testing
Translational Research

Diagnostics Segment to Dominate the Organ Transplant Diagnostics Market (by Application)

The segmental growth is driven by the increasing demand for accurate and timely donor-recipient compatibility testing, pre-transplant screening, and post-transplant monitoring. As the number of organ transplants rises globally due to the increasing prevalence of chronic diseases, organ failure, and improved transplant success rates, the need for advanced diagnostic solutions has become critical to ensuring transplant viability and long-term patient outcomes. The dominance of the diagnostics segment is attributed to the growing adoption of molecular diagnostic techniques, such as next-generation sequencing (NGS), polymerase chain reaction (PCR), and human leukocyte antigen (HLA) typing, which play a crucial role in determining the compatibility between donors and recipients.

Segmentation 4: by Technology

Molecular Technologies
- PCR
- Sanger Sequencing
- NGS
- Other Molecular Technologies
Non-Molecular Technologies
- Serology
- Flow Cytometry
Other Technologies

Molecular Technologies Segment to Dominate the Organ Transplant Diagnostics Market (by Technology)

Molecular technologies are experiencing rapid growth in the organ transplant diagnostics market, driven by the need for high-precision, rapid, and non-invasive testing methods. As organ transplantation becomes more sophisticated, molecular diagnostic tools are playing a crucial role in pre-transplant compatibility testing, post-transplant monitoring, and early detection of transplant rejection. The shift towards molecular techniques is fuelled by advancements in genomics, proteomics, and personalized medicine, making these technologies indispensable in modern transplant procedures. Further, With ongoing research and technological innovations, the adoption of molecular technologies is expected to grow exponentially, transforming the future of organ transplantation.

Segmentation 5: by End User

Hospitals and Transplant Centers
Academic and Research Institutions
Reference Laboratories
Other End Users

Hospitals and Transplant Centers Segment to Dominate the Organ Transplant Diagnostics Market (by End User)

Hospitals and transplant centers are the primary end users in the organ transplant diagnostics market, as they serve as critical hubs for organ transplantation procedures, donor-recipient matching, and post-transplant care. With the rising incidence of organ failure due to chronic diseases such as kidney disease, liver cirrhosis, heart failure, and lung disorders, these healthcare institutions are increasingly adopting advanced diagnostic technologies to ensure successful transplants and long-term patient survival.

Segmentation 6: by Region

North America
- U.S.
- Canada
Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Switzerland
- Rest-of-Europe
Asia-Pacific
- Japan
- China
- India
- South Korea
- Australia
- Singapore
- Rest-of-Asia-Pacific
Latin America
- Brazil
- Mexico
- Rest-of-Latin America
Rest-of-the-World

In 2024, The North America region holds the largest share in the global organ transplant diagnostics market, driven by its well-established healthcare infrastructure, high transplant rates, and advanced diagnostic technologies. The region's dominance is attributed to the increasing prevalence of chronic diseases such as end-stage renal disease (ESRD), cardiovascular disorders, liver cirrhosis, and diabetes, which have led to a growing demand for organ transplants. Additionally, the presence of leading diagnostic companies, ongoing research initiatives, and government support for organ donation programs further strengthen the organ transplant diagnostics market in this region.

Recent Developments in the Organ Transplant Diagnostics Market

In May 2024, Thermo Fisher launched the CXCL10 testing service, specifically designed for kidney transplant patients. This new test enables faster detection of the CXCL10 chemokine compared to traditional methods, improving early identification of inflammation and potential transplant rejection. The innovation enhances post-transplant monitoring, allowing for timely interventions and better patient outcomes.
In April 2023, CareDx and Miromatrix formed an exclusive partnership to advance research on bioengineered organs for human transplantation. This collaboration aims to leverage CareDx's expertise in transplant diagnostics and Miromatrix's innovations in bioengineered organ technology to develop solutions that enhance organ availability and improve transplant outcomes. The partnership represents a significant step toward reducing organ shortages and advancing the field of regenerative medicine for transplantation.

Demand - Drivers, Challenges, and Opportunities

Market Drivers:

Rise in the Incidence of Chronic Diseases Leading to Organ Failure Increases the Use of Organ Transplant Diagnostics: The increasing prevalence of chronic diseases such as chronic kidney disease (CKD), liver cirrhosis, heart failure, diabetes, and chronic obstructive pulmonary disease (COPD) has led to a significant rise in organ failure cases worldwide. As a result, the demand for organ transplantation has surged, subsequently driving the need for advanced transplant diagnostics to ensure successful procedures and long-term graft survival.

Market Challenges:

Increased Gap in Organ Donation and Organ Transplant Demand: The organ shortage directly affects the demand for transplant diagnostics, as fewer transplants mean lower utilization of diagnostic tools for pre-transplant compatibility testing and post-transplant monitoring. Even though advancements in molecular diagnostics, biomarker testing, and non-invasive monitoring are improving transplant success rates, the fundamental issue of organ availability remains a key challenge limiting overall organ transplant diagnostics market growth.

Market Opportunities:

Advancements in Non-Invasive Diagnostics: One of the key opportunities in the organ transplant diagnostics market is the growing adoption of non-invasive diagnostic technologies. Traditional biopsy methods for detecting transplant rejection are invasive, painful, and carry potential risks. The development of biomarker-based assays, cell-free DNA (cfDNA) testing, and liquid biopsy techniques offers a less invasive, highly accurate, and real-time alternative for post-transplant monitoring. These innovations not only enhance early rejection detection but also improve patient compliance and long-term transplant success rates.

How can this report add value to an organization?

Product/Innovation Strategy: The global organ transplant diagnostics market has been extensively segmented based on various categories, such as offering, transplant type, application, technology, end user, and region.

Growth/Marketing Strategy: Mergers, acquisitions, and product launches accounted for the maximum number of key developments.

Competitive Strategy: The global organ transplant diagnostics market has numerous established players with product portfolios. Key players in the global organ transplant diagnostics market analyzed and profiled in the study involve established players offering products for organ transplant diagnostics.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

The base year considered for the calculation of the market size is 2024. The historical year analysis has been done from FY2021 to FY2023, and the market size has been calculated for FY2024 and projected for the period 2025-2035.
The geographical distribution of the market revenue is estimated to be the same as the company's net revenue distribution. All the numbers are adjusted to two digits after decimals for report presentation reasons. However, the real figures have been utilized for compound annual growth rate (CAGR) estimation. CAGR is calculated from 2025 to 2035.
The market has been mapped based on different types of products available in the market and based on several indications. All the key manufacturing companies that have a significant number of offerings to the organ transplant diagnostics market have been considered and profiled in the report.
In the study, the primary respondent's verification has been considered to finalize the estimated market for the organ transplant diagnostics market.
The latest annual reports of each market player have been taken into consideration for market revenue calculation.
Market strategies and developments of key players have been considered for the calculation of sub-segment split.
The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year. The currency conversion rate has been taken from the historical exchange rate of the Oanda website or from the annual reports of the respective company if stated.

Primary Research:

The primary sources involve industry experts in organ transplant diagnostics market, 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:

validation and triangulation of all the numbers and graphs
validation of the report's segmentation and key qualitative findings
understanding the competitive landscape and business model
current and proposed production values of a product by market players
validation of the numbers of the different segments of the market in focus
percentage split of individual markets for regional analysis

Secondary Research

Open Sources

Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
Annual reports, SEC filings, and investor presentations of the leading market players
Company websites and detailed study of their product portfolio
Gold standard magazines, journals, white papers, press releases, and news articles
Paid databases

The key data points taken from the secondary sources include:

segmentations and percentage shares
data for market value
key industry trends of the top players of the market
qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analysing company coverage, product portfolio, and market penetration.

Some of the manufacturers in organ transplant diagnostics market are:

Abbott Laboratories
Bio-Rad Laboratories, Inc.
F. Hoffmann-La Roche Ltd.
Illumina, Inc.
Immucor, Inc.
Omixon Inc.
QIAGEN N.V.
Thermo Fisher Scientific Inc.

Some of the service providers in organ transplant diagnostics market are:

ARUP Laboratories
CareDx, Inc.
Laboratory Corporation of America Holdings
Quest Diagnostics Incorporated

Companies that are not a part of the aforementioned pool have been well represented across different sections of the report (wherever applicable).

Executive Summary

Scope of the Study

Research Methodology

1. Global Organ Transplant Diagnostics Market Overview

1.1 Market Outlook
- 1.1.1 Definitions
- 1.1.2 Current Market Scenario
  - 1.1.2.1 Researchers
  - 1.1.2.2 Diagnostics
- 1.1.3 Inclusion and Exclusion Criteria
- 1.1.4 Market Size, 2024 - 2035 (US$)
- 1.1.5 Market Growth Scenario
  - 1.1.5.1 Realistic Scenario
  - 1.1.5.2 Optimistic Scenario
  - 1.1.5.3 Pessimistic Scenario
1.2 Industry Outlook
- 1.2.1 Introduction
- 1.2.2 Market Overview and Ecosystem
- 1.2.3 Key Trends
- 1.2.4 Opportunity Assessment
- 1.2.5 Patent Analysis
  - 1.2.5.1 By Country
  - 1.2.5.2 By Year
- 1.2.6 Regulatory Landscape / Compliances
  - 1.2.6.1 North America (U.S.)
  - 1.2.6.2 E.U.
  - 1.2.6.3 Asia-Pacific
  - 1.2.6.4 Other Key Countries
1.3 Market Dynamics
- 1.3.1 Market Opportunities and Trends
- 1.3.2 Market Drivers
  - 1.3.2.1 Impact Analysis
- 1.3.3 Market Restraints
  - 1.3.3.1 Impact Analysis

2. Global Organ Transplant Diagnostics Market (By Offering), $Million, 2024-2035

2.1 Overview
2.2 Products
- 2.2.1 Kits and Assays
- 2.2.2 Consumables
2.3 Services

3. Global Organ Transplant Diagnostics Market (By Transplant Type), $Million, 2024-2035

3.1 Overview
3.2 Solid Organ Transplant
- 3.2.1 Kidney
- 3.2.2 Liver
- 3.2.3 Lung
- 3.2.4 Pancreas
- 3.2.5 Others
3.3 Stem Cell Transplant

4. Global Organ Transplant Diagnostics Market (By Application), $Million, 2024-2035

4.1 Overview
4.2 Diagnostics
- 4.2.1 Donor Testing
  - 4.2.1.1 Pre-Transplantation Testing
    - 4.2.1.1.1 Histocompatibility Testing
    - 4.2.1.1.2 Blood Profiling Testing
    - 4.2.1.1.3 Other Testing
  - 4.2.1.2 Post-Transplantation Testing
    - 4.2.1.2.1 Post Infection Testing
    - 4.2.1.2.2 Risk of Disorder Testing
    - 4.2.1.2.3 Other Testing
- 4.2.2 Recipient Testing
  - 4.2.2.1 Pre-Transplantation Testing
    - 4.2.2.1.1 Histocompatibility Testing
    - 4.2.2.1.2 Blood Profiling Testing
    - 4.2.2.1.3 Other Testing
  - 4.2.2.2 Post-Transplantation Testing
    - 4.2.2.2.1 Post Infection Testing
    - 4.2.2.2.2 Risk of Disorder Testing
4.3 Translational Research

5. Global Organ Transplant Diagnostics Market (By Technology), $ Million, 2024-2035

5.1 Overview
5.2 Molecular Technologies
- 5.2.1 PCR
- 5.2.2 Sanger Sequencing
- 5.2.3 NGS
- 5.2.4 Other Molecular Technologies
5.3 Non-Molecular Technologies
- 5.3.1 Serology
- 5.3.2 Flow Cytometry
5.4 Other Technologies

6. Global Organ Transplant Diagnostics Market (By End User), $Million, 2024-2035

6.1 Overview
6.2 Hospitals and Transplant Centers
6.3 Academic and Research Institutions
6.4 Reference Laboratories
6.5 Other End Users

7. Global Organ Transplant Diagnostics Market (By Region), $Million, 2024-2035

7.1 Market Overview
- 7.1.1 North America
  - 7.1.1.1 North America Organ Transplant Test Volume, by Transplant Type
  - 7.1.1.2 Market Sizing and Forecast
    - 7.1.1.2.1 North America Organ Transplant Diagnostics Market (by Country)
      - 7.1.1.2.1.1 U.S.
      - 7.1.1.2.1.2 Canada
- 7.1.2 Europe
  - 7.1.2.1 Europe Organ Transplant Test Volume, by Transplant Type
  - 7.1.2.2 Market Sizing and Forecast
    - 7.1.2.2.1 Europe Organ Transplant Diagnostics Market (by Country)
      - 7.1.2.2.1.1 U.K.
      - 7.1.2.2.1.2 Germany
      - 7.1.2.2.1.3 France
      - 7.1.2.2.1.4 Italy
      - 7.1.2.2.1.5 Spain
      - 7.1.2.2.1.6 Switzerland
      - 7.1.2.2.1.7 Rest of Europe
- 7.1.3 Asia-Pacific
  - 7.1.3.1 Asia-Pacific Organ Transplant Test Volume, by Transplant Type
  - 7.1.3.2 Market Sizing and Forecast
    - 7.1.3.2.1 Asia-Pacific Organ Transplant Diagnostics Market (by Country)
      - 7.1.3.2.1.1 Japan
      - 7.1.3.2.1.2 China
      - 7.1.3.2.1.3 India
      - 7.1.3.2.1.4 Australia
      - 7.1.3.2.1.5 Singapore
      - 7.1.3.2.1.6 South Korea
      - 7.1.3.2.1.7 Rest of Asia Pacific
- 7.1.4 Latin America
  - 7.1.4.1 Latin America Organ Transplant Test Volume, by Transplant Type
  - 7.1.4.2 Market Sizing and Forecast
    - 7.1.4.2.1 Latin America Organ Transplant Diagnostics Market (by Country)
      - 7.1.4.2.1.1 Brazil
      - 7.1.4.2.1.2 Mexico
      - 7.1.4.2.1.3 Rest-of-Latin America
- 7.1.5 Rest-of-the-World
  - 7.1.5.1 Rest-of-the-World Organ Transplant Test Volume, by Transplant Type
  - 7.1.5.2 Market Sizing Forecast

8. Global Organ Transplant Diagnostics Market - Competitive Benchmarking and Company Profiles

8.1 Competitive Benchmarking
8.2 Growth Share Matrix (2024)
8.3 Market Share Analysis (2023 vs 2024)
8.4 Competitive Landscape
- 8.4.1 Key Strategies and Developments by Company
  - 8.4.1.1 Funding Activities
  - 8.4.1.2 Mergers and Acquisitions
  - 8.4.1.3 Regulatory Approvals
  - 8.4.1.4 Partnerships, Collaborations, and Business Expansions
- 8.4.2 Key Developments Analysis
8.5 Company Profiles
- 8.5.1 Manufacturers
  - 8.5.1.1 Abbott Laboratories
    - 8.5.1.1.1 Company Overview
    - 8.5.1.1.2 Product Portfolio
    - 8.5.1.1.3 Analyst Perception
  - 8.5.1.2 BAG Group GmbH
    - 8.5.1.2.1 Company Overview
    - 8.5.1.2.2 Product Portfolio
    - 8.5.1.2.3 Analyst Perception
  - 8.5.1.3 Bio-Rad Laboratories, Inc.
    - 8.5.1.3.1 Company Overview
    - 8.5.1.3.2 Product Portfolio
    - 8.5.1.3.3 Analyst Perception
  - 8.5.1.4 F. Hoffmann La. Roche. Ltd.
    - 8.5.1.4.1 Company Overview
    - 8.5.1.4.2 Product Portfolio
    - 8.5.1.4.3 Analyst Perception
  - 8.5.1.5 Illumina, Inc.
    - 8.5.1.5.1 Company Overview
    - 8.5.1.5.2 Product Portfolio
    - 8.5.1.5.3 Analyst Perception
  - 8.5.1.6 Immucor, Inc.
    - 8.5.1.6.1 Company Overview
    - 8.5.1.6.2 Product Portfolio
    - 8.5.1.6.3 Analyst Perception
  - 8.5.1.7 Omixon, Inc.
    - 8.5.1.7.1 Company Overview
    - 8.5.1.7.2 Product Portfolio
    - 8.5.1.7.3 Analyst Perception
  - 8.5.1.8 QIAGEN N.V.
    - 8.5.1.8.1 Company Overview
    - 8.5.1.8.2 Product Portfolio
    - 8.5.1.8.3 Analyst Perception
  - 8.5.1.9 Thermo Fisher Scientific, Inc.
    - 8.5.1.9.1 Company Overview
    - 8.5.1.9.2 Product Portfolio
    - 8.5.1.9.3 Analyst Perception
  - 8.5.1.10 Eurobio Scientific (Genome Diagnostics B.V.)
    - 8.5.1.10.1 Company Overview
    - 8.5.1.10.2 Product Portfolio
    - 8.5.1.10.3 Analyst Perception
- 8.5.2 Service Providers
  - 8.5.2.1 Arup Laboratories
    - 8.5.2.1.1 Company Overview
    - 8.5.2.1.2 Product Portfolio
    - 8.5.2.1.3 Analyst Perception
  - 8.5.2.2 Care Dx
    - 8.5.2.2.1 Company Overview
    - 8.5.2.2.2 Product Portfolio
    - 8.5.2.2.3 Analyst Perception
  - 8.5.2.3 LabCorp
    - 8.5.2.3.1 Company Overview
    - 8.5.2.3.2 Product Portfolio
    - 8.5.2.3.3 Analyst Perception
  - 8.5.2.4 Quest Diagnostics Incorporated
    - 8.5.2.4.1 Company Overview
    - 8.5.2.4.2 Product Portfolio
    - 8.5.2.4.3 Analyst Perception