Global PCR Based Transplant Diagnostics Market Size To Exceed USD 1285.0 Million By 2035 | CAGR of 6.40%

Global PCR Based Transplant Diagnostics Market Size To Exceed USD 1285.0 Million By 2035

According to a research report published by Spherical Insights & Consulting, The Global PCR Based Transplant Diagnostics Market Size is expected to Grow from USD 649.5 Million in 2024 to USD 1285.0 Million by 2035, at a CAGR of 6.40% during the forecast period 2025-2035.

Browse 210 Market Data Tables And 45 Figures Spread Through 190 Pages and In-Depth TOC On the" Global PCR Based Transplant Diagnostics Market Size, Share, and COVID-19 Impact Analysis, By Test Type (CMV PCR Test, EBV PCR Test, BKV PCR Test, VZV PCR Test, and Others), By Transplant Type (Kidney Transplantation, Liver Transplantation, Heart Transplantation, Lung Transplantation, and Other Transplantations), By Application (Diagnostic Applications and Research Applications), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 – 2035." Get Detailed Report Description Here:https://www.sphericalinsights.com/reports/pcr-based-transplant-diagnostics-market

The PCR-based Transplant Diagnostics Market Size is an industry focusing on utilizing the polymerase chain reaction (PCR) to enhance organ transplant success by ensuring donor-recipient compatibility and monitoring for post-transplant complications like rejection or infection. Digital PCR provide quantification of donor-derived cfDNA (dd-cfDNA) in the monitoring of solid organ transplants, offering faster turnaround times, lower costs, and better sample control than sequencing. The emergence of non-invasive biomarkers and molecular imaging techniques for early and accurate detection of transplant rejection is driving a huge surge in the global market. Incorporation of PCR into digital health platforms, along with surging advancements in molecular diagnostics, is bolstering the market growth opportunity. The PCR based transplant diagnostics market is primarily driven by an increasing number of organ transplant. Further, advancements in molecular diagnostics contribute to propelling the market growth. However, the limited availability of donor organs against the increasing demand for transplantation procedures, as well as strict regulations and reimbursement policies, are restraining the market growth.  

The CMV PCR test segment dominated the market with the largest revenue share of about 28.7% in 2024 and is projected to grow at a substantial CAGR during the forecast period.

Based on the test type, the PCR based transplant diagnostics market is divided into CMV PCR test, EBV PCR test, BKV PCR test, VZV PCR test, and others. Among these, the CMV PCR test segment dominated the market with the largest revenue share of about 28.7% in 2024 and is projected to grow at a substantial CAGR during the forecast period. CMV PCR testing aids in providing accurate information on viral load kinetics during post-transplant monitoring of CMV infection, particularly in patients receiving LMV. The surging demand for CMV monitoring in solid organ and hematopoietic stem cell transplant recipients is propelling the segmental market.

The kidney transplantation segment accounted for the largest share of about 39.5% in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period.

Based on the transplant type, the PCR based transplant diagnostics market is divided into kidney transplantation, liver transplantation, heart transplantation, lung transplantation, and other transplantations. Among these, the kidney transplantation segment accounted for the largest share of about 39.5% in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period. The increased volume of kidney transplants, driven by the routine use of PCR diagnostics for post-operative monitoring, leads to segmental market growth. Use of stool multiplex PCR aids in determining the etiological spectrum of diarrhoea in kidney transplant recipients.

The diagnostic applications segment held the largest market share of about 72.4% in 2024 and is anticipated to grow at a substantial CAGR during the projected period.

 Based on the application, the PCR based transplant diagnostics market is divided into diagnostic applications and research applications. Among these, the diagnostic applications segment held the largest market share of about 72.4% in 2024 and is anticipated to grow at a substantial CAGR during the projected period. The widespread application of PCR testing in routine transplant patient management and monitoring contributes to driving market expansion. Increased sensitivity of PCR as a molecular diagnostic technique is responsible for earlier detection of viral replication in the post-transplant period, before the onset of symptoms.

North America is expected to hold the majority share of the global PCR Based Transplant Diagnostics market during the forecast period.

North America is expected to hold the majority share of about 41.5% in the global PCR Based Transplant Diagnostics market during the forecast period. The U.S. is dominating the North America PCR based transplant diagnostics market, accounting for significant growth, driven by the launch of an AI-driven diagnostic platform, along with an increasing strategic collaborations between diagnostic companies, research institutes, and transplant centres. Due to their innovative PCR based transplant diagnostics products and partnerships with other industry players, well-known North American businesses like Thermo Fisher Scientific, Bio-Rad Laboratories, Inc., QIAGEN, and others have played a significant role in propelling the market's expansion. The region's increasing strategic collaborations between healthcare professionals and laboratory experts are further responsible for driving the PCR based transplant diagnostics market.

Asia Pacific is anticipated to grow at the fastest pace in the global PCR based transplant diagnostics market during the forecast period. China is dominating the Asia Pacific PCR-based transplant diagnostics market, owing to the improvement in healthcare infrastructure, increasing public awareness, and government-led measures for upgrading hospitals, providing access to new diagnostic technology. The Asia Pacific area has a thriving market for PCR based transplant diagnostics due to the high prevalence of chronic illness and use of stem cell therapy & personalized medications. Due to their governments' active support towards providing quality medical care by the adoption of NAT screening for transfusion-transmitted infections, this significantly contributes to the market growth.

Major vendors in the global PCR based transplant diagnostics market are Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings (Labcorp), Eurofins Viracor, LLC, Sonic Healthcare USA, ARUP Laboratories, Ambar Lab, Dr. Lal PathLabs, and Others.

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Key Market Development 

• In November 2025, CareDx, Inc., the Transplant Company, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, announced new data presentations featuring CareDx technologies at American Society of Nephrology (ASN) Kidney Week 2025, underscoring the power of molecular biomarkers to advance transplant care.

• In October 2024, Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, announced the finalization of a partnership agreement with Werfen, a worldwide leader in specialized diagnostics, on the technology-sharing initiative. This partnership builds on the momentum of the technology-sharing initiative, which includes the first NewCo partnership in March 2023 with Hylabs, a leading diagnostic company in Israel.  

• In April 2024, Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics products, announced a collaboration agreement with Oncocyte Corporation, a precision diagnostics company, to develop and commercialize transplant monitoring products using Bio-Rad’s Droplet Digital PCR (ddPCR) instruments and reagents.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the PCR based transplant diagnostics market based on the below-mentioned segments:

Global PCR Based Transplant Diagnostics Market, By Test Type  

• CMV PCR Test
• EBV PCR Test
• BKV PCR Test
• VZV PCR Test
• Others

Global PCR Based Transplant Diagnostics Market, By Transplant Type

• Kidney Transplantation
• Liver Transplantation
• Heart Transplantation
• Lung Transplantation
• Other Transplantations

Global PCR Based Transplant Diagnostics Market, By Application

• Diagnostic Applications
• Research Applications

 Global PCR Based Transplant Diagnostics Market, By Regional Analysis

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

About the Spherical Insights & Consulting

Spherical Insights & Consulting is a market research and consulting firm which provides actionable market research study, quantitative forecasting and trends analysis provides forward-looking insight especially designed for decision makers and aids ROI.

Which is catering to different industry such as financial sectors, industrial sectors, government organizations, universities, non-profits and corporations. The company's mission is to work with businesses to achieve business objectives and maintain strategic improvements. 

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