Transplant Diagnostics Market Assessment, By Product and Services [Reagents and Consumables, Instruments, Software and Services], By Technology [Molecular Assay, Non-Molecular Assay], By Transplant Type [Solid Organ, Stem Cell, Soft Tissue, Bone Marrow, O

Transplant Diagnostics Market Assessment, By Product and Services [Reagents and Consumables, Instruments, Software and Services], By Technology [Molecular Assay, Non-Molecular Assay], By Transplant Type [Solid Organ, Stem Cell, Soft Tissue, Bone Marrow, Others], By Application [Diagnostics, Research], By End-user [Hospitals and Transplant Centers, Research Laboratories and Academic Institutions, Independent Reference Laboratories], By Region, Opportunities and Forecast, 2017-2031F

Global transplant diagnostics market is projected to witness a CAGR of 8.05% during the forecast period 2024-2031, growing from USD 5075.22 million in 2023 to USD 9428.73 million in 2031. The market for transplant diagnostic products and services is thriving significantly with the rising number of transplant procedures. The transplant diagnostics market is anticipated to keep growing at a notable pace during the forecast period.

Transplant diagnostics involves various tests and procedures used to assess potential organ donors and organ recipients, match donors to recipients, and monitor transplanted organs for any signs of rejection. The market is gaining significant traction due to the rising demand for organ transplants. The rising disease burden and subsequent need for organ transplants, combined with rising awareness about organ transplants among people, drives the rising number of transplants. With an increase in transplant procedures, the demand for transplant diagnostics is also anticipated to increase due to regulatory constraints. The active participation of market players to enhance market growth through tactics like collaborations, mergers, and innovative product launches further strengthens the market for transplant diagnostics. For instance, in September 2023, Hungarian molecular diagnostics firm Omixon Inc. introduced a new single-locus human leukocyte antigen (HLA) typing kit called NanoType Mono, based on nanopore sequencing. Similarly, Dutch company Genome Diagnostics B.V., a division of Eurobio Scientific SA, launched another product called NGS-Turbo, an assay designed for high-resolution HLA typing using Oxford Nanopore Technologies platforms.

High Demand for Organ Transplants

The organ transplant procedures performed annually have significantly increased in recent years, reaching new record highs. This growth is driven by several key factors, including a rise in both deceased and living organ donors due to growing awareness about organ donations, advances in transplant medicine that have improved outcomes, the establishment of a national organ donation and transplant system, heightened public awareness and voluntary registration of potential donors. As a result of these developments, according to the Organ Procurement and Transplantation Network (OPTN) of the United States, over 46,000 organ transplants were performed in 2023, recording an 8.7% increase from the prior year 2022. The expanding pool of available organs has allowed more patients, including underrepresented groups, to receive the lifesaving transplants they need. As the number of transplant procedures increases, the demand for transplant-associated diagnostics is anticipated to increase too, as transplant diagnostics is a crucial part of transplant procedures.

Technological Advancements Drive Market Growth

Artificial intelligence (AI) and machine learning have revolutionized transplant diagnostics by enabling the development of AI-powered diagnostic models that can analyze digitized biopsy specimens, improve assessments of transplanted organs, and reduce variability among diagnoses. Advanced imaging techniques provide detailed information about organ function and structure, improving early diagnosis of complications. Innovations in organ preservation, ventricular assist devices, artificial hearts, gene editing, customized organs, and robotic technology have significantly improved transplant outcomes and reduced patient complications. Market players have come up with several AI-based solutions for transplant diagnostics. For instance, in May 2024, Thermo Fisher Scientific Inc. launched a new CXCL10 testing service to aid in the management of kidney transplant patients. The non-invasive urine test can detect the CXCL10 chemokine, which may provide valuable information faster than currently used tests and help identify early signs of kidney transplant rejection. The test is expected to make post-transplant care more convenient and less invasive for the nearly 250,000 Americans living with a kidney transplant. According to Thermo Fisher, this lower-cost, non-invasive testing option can expand access to care and improve patient adherence, as the sample can be collected at any local clinic.

Dominance of Solid Organ Transplant Segment in Transplant Diagnostics Market

Solid organ transplants are the most common type of transplant procedure performed over a long period of time; while other transplant methods like stem cell and soft tissue transplants evolved in the last few decades at the commercial level, the solid organ transplant segment is anticipated to hold the largest share in the market. The kidney, liver, and skin are the most common organs to be transplanted. For instance, according to the Organ Procurement and Transplantation Network (OPTN) of the United States, 10,000 liver transplants and 3,000 lung transplants have been performed in 2023, within the United States, while the total number of organ transplants is above 46,000, in the same place only around 23,000 Hematopoietic Stem Cell Transplantation (HSCT), i.e., stem cell type of transplant were performed in the United States.

North America Dominates Transplant Diagnostics Market

North America is anticipated to lead in the transplant diagnostics market during the forecasted period owing to a highly aware population who knows about organ donation and transplantation very well. The United States and Canada are two major North American countries with well-structured healthcare systems and government initiatives to promote organ transplants. The United States contributes a significant share of revenue in the global market due to the high cost of procedures. The United States reached the milestone of 1 million organ transplants in 2022, and the number is still rising. As per the International Registry on Organ Donation and Transplantation, the United States transplant system saves more lives than any other country. The United States leads with the highest rates of deceased donors and kidney and liver transplants from deceased donors.

Future Market Scenario (2024-2031F)

Immunogenetics and pharmacogenomics are revolutionizing transplant diagnostics by enabling more precise donor matching, personalized immunosuppression dosing based on genetic factors, non-invasive rejection monitoring techniques, and targeted cellular therapies, leading to improved outcomes and reduced complications for transplant recipients. These advancements are transforming the future of transplant care through personalized, data-driven approaches that leverage genetic insights. Key players in the market are also aligning themselves with this evolving technology through the launch of new products.

For instance, in June 2024, Omixon Inc., announced the launch of HolograFT One, a research-use-only kit and software designed for post-transplant monitoring using donor-derived cell-free DNA (dd-cfDNA). HolograFT One enables researchers to accurately quantify dd-cfDNA levels, which serve as a biomarker for detecting rejection in solid organ transplant recipients. This innovative solution combines a user-friendly sample preparation kit with advanced data analysis software, providing researchers with a comprehensive tool to monitor transplant health and potentially improve patient outcomes.

Key Players Landscape and Outlook

Becton Dickinson and Company, Bio-Rad Laboratories Inc., Illumina Inc., Immucor Transplant Diagnostics Inc., Thermo Fisher Scientific Inc., CareDx, Inc., F. Hoffmann-La Roche Ltd, Abbott Laboratories Inc., BioMérieux S.A., QIAGEN N.V. are some of the leading players in the transplant diagnostics market. The market witnessed some substantial market deals like mergers and collaborations to expand the market share of key players.

In May 2024, Werfen, S.A., announced the acquisition of Omixon Inc., a privately held company focused on Next Generation Sequencing (NGS) technologies for transplant diagnostics. The transaction, valued at approximately USD 25 million, is expected to be completed in 2024 and will allow Werfen to expand its portfolio of transplant diagnostics solutions. Omixon's expertise in bioinformatics, software engineering, and molecular biology will complement Werfen's strengths in transplant diagnostics, creating an opportunity to advance transplant diagnostics globally.

In April 2024, Eurofins, a global leader in bioanalytical testing, expanded its offerings in renal and transplant testing in the United States by acquiring Ascend Clinical LLC. This acquisition enhances Eurofins' capabilities in providing comprehensive testing solutions for kidney health and transplant patients.