Organ Transplant Diagnostics Market Size to Surpass USD 12.57 Billion by 2033 | Straits Research

The global organ transplant diagnostics market size was valued at USD 4.95 billion in 2024 and is projected to reach from USD 5.49 billion in 2025 to USD 12.57 billion by 2033, growing at a CAGR of 10.92% during the forecast period (2025-2033).

/EIN News/ -- New York, United States, Jan. 29, 2025 (GLOBE NEWSWIRE) -- An organ transplant is a surgical procedure replacing a damaged organ with a healthy one. Diagnostics for organ transplants are clinical diagnostic methods that improve the efficacy of transplantation procedures. Constantly, transplant diagnostics are conducted both before and after transplants. It aids in analyzing the medical situation of the patient. In applications involving organ and blood stem cell transplantation, HLA typing is of the utmost importance. Organs transplanted successfully include the kidneys, heart, liver, lungs, pancreas, and bone marrow.

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Market Dynamics

Rising Number of Organ Transplants Procedures Drives the Global Market

In the past decade, organ transplantation has expanded globally due to the rising prevalence of essential organ failure, the rising success of transplants, and the dramatic enhancement of post-transplant outcomes. According to a United Network for Organ Sharing (UNOS) 2020 research, clinicians in the United States performed 39,718 transplants involving organs from deceased and living donors. The number of organ transplant surgeries is increasing due to the rising prevalence of chronic diseases. The market for organ transplant diagnostics is likely to have enormous expansion over the coming decade, owing to the continuing and anticipated trend of an increasing number of transplant surgeries in significant countries across numerous geographies.

Increasing Awareness Regarding Transplants in High Potential Market Creates Tremendous Opportunities

Increasing donor and recipient awareness of transplant procedures in high-potential regions is projected to provide opportunities for the organ transplant diagnostics industry. The government arranges annual donation awareness events in emerging economies on a specific date to increase public awareness. According to the U.S. Department of Health & Human Services, 2020 Health Resources & Services Administration (HRSA), the nation celebrates a national event on January 1 known as "Donate Life Float is a part of the Rose Parade," honoring the millions of people touched by organ donation, including donors, donor families, transplant awaiting candidates, and transplant recipients. In addition, the Donation and Transplant Institute Foundation collaborates with numerous diagnostic firms to enhance awareness of donation and transplantation.

Regional Analysis

North America is the most significant global organ transplant diagnostics market shareholder and is expected to grow at a CAGR of 10.29% over the forecast period. The market for organ transplant diagnostics in North America is projected to be driven by technological breakthroughs that expand and broaden the scope of precision diagnostics. Many advanced research and development efforts, mostly centered on improving the practical applicability of organ transplant diagnostics for donor screening and post-transplant care, have contributed to exploring new paths to better meet the needs of human health. Several legacy organ transplant diagnostics companies are also modernizing their portfolios to offer innovative products and services in North America. One Lamba, Inc. (a Thermo Fisher Scientific, Inc. subsidiary), CareDx, Inc., Abbott Laboratories, Eurofins Scientific, Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, and ARUP Laboratories, Inc. are the legacy companies operating in the North American organ transplant diagnostics market. In addition, the increasing usage of molecular test technologies, such as polymerase chain reaction (PCR) and next-generation sequencing (NGS)-based organ transplant diagnostics products and services, is a significant factor in the region's market expansion.

Europe is anticipated to exhibit a CAGR of 11.19% over the forecast period. Numerous European nations, including Germany, France, the United Kingdom, Italy, Spain, and Switzerland, consistently try to improve research initiatives in Europe's organ transplant diagnostics market. Due to substantial funding infusions, the region has long been at the forefront of research to develop high-fidelity transplant diagnoses worldwide. In addition, the region serves as the headquarters for most market leaders, including bioMérieux S.A., F. Hoffmann-La Roche Ltd., Novacyt Group, QIAGEN N.V., and JETA Molecular B.V. In addition, regional standardization and harmonization of clinical review protocols for a streamlined approval process by regulatory authorities contribute to the expansion of the industry. Increasing approvals of diagnostic products for organ transplantation in European nations also creates chances for regional market expansion.

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Key Highlights

• The global organ transplant diagnostics market size was valued at USD 4.95 billion in 2024 and is projected to reach from USD 5.49 billion in 2025 to USD 12.57 billion by 2033, growing at a CAGR of 10.92% during the forecast period (2025-2033).
• Based on the offering, the global organ transplant diagnostics market is bifurcated into products and services. The services segment dominates the global market and is projected to grow at a CAGR of 10.27% over the forecast period.
• Based on transplant, the global organ transplant diagnostics market is divided into solid organ transplant and stem cell transplant. The solid organ transplant segment is the highest contributor to the market and is estimated to exhibit a CAGR of 10.96% over the forecast period.
• Based on technology, the global organ transplant diagnostics market is divided into molecular technologies, serology, flow cytometry, and others. The molecular technologies segment dominates the global market and is anticipated to exhibit a CAGR of 10.89% over the forecast period.
• Based on application, the global organ transplant diagnostics market is bifurcated into diagnostics and translational research. The diagnostics segment owns the highest market share and is predicted to grow at a CAGR of 10.81% over the forecast period.
• Based on the end-user, the global organ transplant diagnostics market is bifurcated into hospitals and transplant centers, reference laboratories, academic and research institutions, and others. The hospitals and transplant centers segment dominates the global market and is projected to exhibit a CAGR of 10.84% during the forecast period.
• North America is the most significant global organ transplant diagnostics market shareholder and is expected to grow at a CAGR of 10.29% over the forecast period.

Competitive Players

1. Thermo Fisher Scientific Inc.
2. Bio-Rad Laboratories, Inc.
3. QIAGEN N.V.
4. Hoffmann-La Roche Ltd.
5. Illumina, Inc.
6. Abbott Laboratories
7. bioMérieux SA
8. Immucor, Inc.
9. CareDx, Inc.
10. Hologic, Inc.
11. GenDx
12. Omixon Biocomputing
13. Diasorin S.p.A.
14. Beckman Coulter, Inc.
15. Becton, Dickinson and Company (BD)

Recent Developments

• February 2023- Merck announced that the U.S. Food and Drug Administration (FDA) accepted two supplementary new drug applications (SNDA) for PREVYMIS for review (letermovir). Priority review was approved for the SNDA for PREVYMIS to prevent sytomegalovirus (CMV) illness in high-risk adult kidney transplant recipients.
• October 2022- The biotechnology company Plexision began international operations by establishing a reference laboratory in Hyderabad, India. This laboratory would provide a complete array of transplant patient diagnostics. In addition to drug-level monitoring, pharmacogenomics, and genetic testing, these tests include the company's tailored transplant diagnostic tests to detect rejection and viral infections.

Segmentation

By Offering

• Products
• Services

By Transplant

• Solid Organ Transplant
• Stem Cell Transplant

By Technology

• Molecular Technologies
• Serology
• Flow Cytometry
• Others

By Applications

• Diagnostics
• Translational Research

By End-User

• Hospitals and Transplant Centers
• Reference Laboratories
• Diagnostic Laboratories
• Academic and Research Institutions
• Others

By Product

• Instruments
• Reagents and Consumables
• Software & Services

By Organ Type

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

By Region

• North America
• Europe
• Asia Pacific
• Middle East And Africa
• Latin America

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