이식 진단 시장 예측(-2032년) : 검사 유형별, 바이오마커 유형별, 이식 유형별, 용도별, 최종사용자별, 지역별

According to Stratistics MRC, the Global Transplant Diagnostics Market is accounted for $6.99 billion in 2025 and is expected to reach $13.11 billion by 2032 growing at a CAGR of 9.4% during the forecast period. Transplant diagnostics is a medical discipline focused on examining and monitoring the health and compatibility of transplanted organs or tissues. It encompasses testing to ensure donor-recipient matching, tracking organ functionality, and identifying potential rejection or infections at an early stage. Through precise and prompt assessments, this field assists healthcare providers in enhancing patient outcomes, prolonging graft longevity, and minimizing complications.

According to the Health Resources & Services Administration (HRSA), as of March 2024, more than 46,000 organ transplants were performed in the U.S.

Market Dynamics:

Driver:

Rising prevalence of chronic diseases

Healthcare providers are seeking precise testing methods to optimize donor-recipient matching and improve patient outcomes. Innovations in molecular and immunological assays are allowing earlier detection of transplant complications. Aging populations and rising comorbidity rates are expanding the need for diagnostic monitoring post-transplant. Hospitals and specialized clinics are adopting cutting-edge diagnostic platforms to reduce rejection risks. The growth of personalized medicine is encouraging the use of tailored diagnostic panels for each patient. Overall, the surge in chronic disease prevalence is accelerating the adoption of sophisticated transplant diagnostic solutions.

Restraint:

Organ shortage gap

Limited organ availability increases the pressure on diagnostic workflows to maximize graft success. Regulatory hurdles and strict ethical guidelines further complicate donor matching processes. Small laboratories and emerging market facilities often face resource constraints that restrict adoption of advanced tests. Prolonged approval timelines for new diagnostic kits delay clinical implementation. These limitations may hinder investment in innovative technologies despite clinical need. As a result, the organ supply-demand gap continues to restrain the expansion of the transplant diagnostics market.

Opportunity:

AI and machine learning

Predictive algorithms can enhance donor-recipient compatibility assessments and forecast graft survival. Automated data analysis reduces diagnostic errors and accelerates decision-making in transplant centers. Machine learning models are increasingly applied to interpret complex immunological and genomic datasets. Adoption of AI-driven platforms allows laboratories to improve efficiency while reducing operational costs. Cloud-based analytics facilitate real-time monitoring of transplant patients across multiple facilities. This trend is expected to transform transplant diagnostics by enabling precision medicine and predictive care solutions.

Threat:

Ethical & data privacy concerns

The handling of sensitive genomic and immunological information requires strict compliance with data protection regulations. Misuse or breaches of health data could erode trust in diagnostic services. Ethical debates around donor consent and organ allocation may affect market acceptance. Regulatory differences across regions create complexities for multinational diagnostic providers. Ensuring secure data storage and adherence to privacy standards increases operational costs. These concerns could slow the adoption of advanced transplant diagnostic technologies in some markets.

Covid-19 Impact:

Laboratory operations faced temporary closures and staffing shortages, affecting sample processing. Global supply chains for diagnostic reagents and kits experienced interruptions, limiting test availability. Telemedicine and remote monitoring were rapidly adopted to maintain patient follow-up and post-transplant care. Regulatory authorities introduced expedited approvals for critical diagnostic tools to support urgent cases. The crisis highlighted the need for resilient supply chains and decentralized laboratory networks. Post-pandemic, transplant diagnostics are focusing on automation, rapid testing, and operational flexibility to prevent future disruptions.

The molecular assays segment is expected to be the largest during the forecast period

The molecular assays segment is expected to account for the largest market share during the forecast period, due to their high sensitivity and specificity in detecting transplant-related complications. These assays are widely used for monitoring viral infections, graft rejection, and immune response. Technological advancements, such as multiplex PCR and next-generation sequencing, are expanding their clinical utility. Laboratories are increasingly implementing molecular platforms for faster turnaround times. Adoption is driven by growing awareness of early intervention benefits for transplant patients.

The reference labs segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the reference labs segment is predicted to witness the highest growth rate, due to their capacity for high-throughput and specialized testing. These facilities provide advanced diagnostic services that smaller hospitals may lack. Investments in automated platforms and AI-assisted interpretation improve efficiency and accuracy. Outsourcing diagnostic testing to reference labs reduces operational burdens for transplant centers. Rising demand for complex immunological and genomic testing is driving expansion. Reference labs are also expanding their global footprint to cater to emerging markets.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, due to its advanced healthcare infrastructure and strong adoption of innovative diagnostics. The U.S. and Canada have well-established transplant networks and specialized laboratories. High awareness of organ rejection risks is driving demand for sophisticated testing. Investment in R&D and regulatory support encourage development and commercialization of new assays. Strategic collaborations between academic centers and diagnostic companies are common. The region benefits from robust reimbursement frameworks that facilitate widespread diagnostic adoption.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by expanding healthcare infrastructure and increasing organ transplant programs. Countries like China, India, and Japan are investing heavily in modern laboratories and diagnostic technologies. Growing incidence of chronic diseases and rising awareness of transplant monitoring is boosting demand. Government initiatives are supporting local manufacturing and technology transfer. International collaborations are enabling access to advanced molecular and immunological assays. Rapid adoption of AI-enabled diagnostic platforms is enhancing testing accuracy.

Key players in the market

Some of the key players in Transplant Diagnostics Market include Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd., Abbott Laboratories, Illumina, Inc., QIAGEN N.V., Bio-Rad Laboratories, Inc., Becton, Dickinson and Company, Immucor, Inc., CareDx, Inc., Omixon Inc., Hologic, Inc., Adaptive Biotechnologies Corporation, NanoString Technologies, Inc., Eurofins Viracor, and GenDx.

Key Developments:

In January 2026, Thermo Fisher Scientific Inc. announced a strategic collaboration with NVIDIA to power AI-based solutions and laboratory automation at scale. The effort will leverage the NVIDIA Artificial Intelligence (AI) platform and Thermo Fisher Scientific solutions to progressively increase the automation, accuracy and speed of laboratories. The companies are working together to evolve the digital foundation that powers scientific instruments, laboratory infrastructure and data.

In January 2026, Abbott announced a collaboration with AtaCor Medical to advance a next-generation investigational extravascular implantable cardioverter defibrillator (EV-ICD) system designed to deliver defibrillation therapy to people with life-threatening heart rhythms. Through the collaboration, AtaCor's investigational parasternal EV-ICD lead (Atala(TM)) will be paired with Abbott's investigational ICD system.

Test Types Covered:

• Molecular Assays
• Non-Molecular Assays
• Sequencing-based Molecular Assays

Biomarker Types Covered:

• Instruments
• Genomic Biomarkers
• Proteomic Biomarkers
• Cellular Biomarkers
• Metabolomic Biomarkers

Transplant Types Covered:

• Kidney Transplant
• Liver Transplant
• Heart Transplant
• Lung Transplant
• Bone Marrow Transplant
• Other Organ Transplants

Applications Covered:

• Human Leukocyte Antigen (HLA) Testing
• Blood Profile Testing
• Pathogen Detection
• Crossmatching
• Other Applications

End Users Covered:

• Hospitals & Clinics
• Diagnostic Laboratories
• Research & Academic Institutes
• Reference Labs
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Transplant Diagnostics Market, By Test Type

• 5.1 Introduction
• 5.2 Molecular Assays
  • 5.2.1 PCR-based assays
  • 5.2.2 Real-time PCR
  • 5.2.3 Next-Generation Sequencing (NGS)
  • 5.2.4 Sanger Sequencing
• 5.3 Non-Molecular Assays
  • 5.3.1 Serological Assays
  • 5.3.2 Mixed Lymphocyte Culture
• 5.4 Sequencing-based Molecular Assays

6 Global Transplant Diagnostics Market, By Biomarker Type

• 6.1 Introduction
• 6.2 Instruments
• 6.3 Genomic Biomarkers
• 6.4 Proteomic Biomarkers
• 6.5 Cellular Biomarkers
• 6.6 Metabolomic Biomarkers

7 Global Transplant Diagnostics Market, By Transplant Type

• 7.1 Introduction
• 7.2 Kidney Transplant
• 7.3 Liver Transplant
• 7.4 Heart Transplant
• 7.5 Lung Transplant
• 7.6 Bone Marrow Transplant
• 7.7 Other Organ Transplants

8 Global Transplant Diagnostics Market, By Application

• 8.1 Introduction
• 8.2 Human Leukocyte Antigen (HLA) Testing
• 8.3 Blood Profile Testing
• 8.4 Pathogen Detection
• 8.5 Crossmatching
• 8.6 Other Applications

9 Global Transplant Diagnostics Market, By End User

• 9.1 Introduction
• 9.2 Hospitals & Clinics
• 9.3 Diagnostic Laboratories
• 9.4 Research & Academic Institutes
• 9.5 Reference Labs
• 9.6 Other End Users

10 Global Transplant Diagnostics Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 Thermo Fisher Scientific, Inc.
• 12.2 F. Hoffmann-La Roche Ltd.
• 12.3 Abbott Laboratories
• 12.4 Illumina, Inc.
• 12.5 QIAGEN N.V.
• 12.6 Bio-Rad Laboratories, Inc.
• 12.7 Becton, Dickinson and Company
• 12.8 Immucor, Inc.
• 12.9 CareDx, Inc.
• 12.10 Omixon Inc.
• 12.11 Hologic, Inc.
• 12.12 Adaptive Biotechnologies Corporation
• 12.13 NanoString Technologies, Inc.
• 12.14 Eurofins Viracor
• 12.15 GenDx