The transplant diagnostics market Size was valued at USD 4.4 Billion in 2023 and is projected to grow from USD 4.72 Billion in 2024 to USD 8.3 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.3% during the forecast period (2024-2032).
The demand for transplant diagnostic products is expected to grow mainly due to factors such as the increasing public-private funding for target research activities, the growing burden of infectious diseases, the increasing number of transplant procedures, and technological advancements in the field of transplant diagnostics.
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
BioRad was given AQAC International and AFNOR approval for its iQ-Check kits in March 2023.
In February 2023, the FDA approved BD Onclarity HPV assay for BD in the serology testing segment.
In August 2022, QIAGEN published a validation study of its clinical decision support software, QIAGEN Clinical Insight Interpret One (QCI Interpret One), in the Journal of Molecular Pathology. Results from this study conducted independently by Genomics Quality Assessment (GenQA) and commissioned by QDI showed that QCI one achieved higher concordance with expert panels in the classification of variants in oncology patient samples than did human reviewers. This validation demonstrates how reliable and efficient this program can be when it comes to clinical settings so as to enhance the credibility of their research.
For example, NephroSant, which is a biotech company whose aim is to speed up the assessment of early kidney damage, enrolled its first patient for the Evaluation of QSant for Underlying Allograft Rejection (AQUA) trial in March 2022. For two years, up to 2000 individuals will be recruited and monitored using QSant assays along with standard-of-care diagnostics to look for signs of acute rejection.
In March 2022, Immucor Inc., a blood transfusion and transplantation diagnostic firm, announced two additions to its transplant diagnostics portfolio, illustrating its continued dedication towards new developments within the histocompatibility area.
In March 2022, Biocartis joined the Ophiomics consortium so as to focus on HepatoPredict commercialization, which is a gene expression signature test predicting patients who will benefit from liver transplantation.
Hoffmann-La Roche Ltd launched Cobas Infinity Edge in January 2022, which is a cloud-based point-of-care platform available worldwide. This novel platform provides healthcare practitioners with cutting-edge technology facilitating streamlined management of patient information, thereby boosting clinical workflows and fostering seamless interoperability across healthcare systems globally. The introduction of Cobas Infinity Edge reflects Roche’s commitment to diversifying its product line and meeting the evolving needs of healthcare providers in the digital era.
For instance, Natera Inc., a major stakeholder in genetic and cell-free DNA (cfDNA) testing for transforming patient care, introduced Prospera with Quantification, the cfDNA test for kidney rejection, in September 2021.
In April 2023, bioMérieux S.A. and Oxford Nanopore signed a strategic alliance to develop innovative diagnostic products for infectious diseases that would be used during transplantations of infected organs.
April 2023 saw CareDx and Miromatrix collaborate exclusively on moving ahead with research using bioengineered human transplantation organs.
On the other hand, Azure Biosystems, one of the leading providers of state-of-the-art bioanalytical solutions in protein and genomic research, partnered with GenDx in December 2022 to establish the compatibility of Azure Cielo 6 qPCR System with GenDx KMRtype and KMRtrack kits.
Bio-Rad Laboratories and NuProbe USA also entered into an agreement that allowed them to use digital PCR assay development by Bio-Rad. This technology will improve Bio-Rad’s collection of tools.
There was a deal worth $132.3 million between Eurobio Scientific and Genome Diagnostics BV (GenDx) in October 2022, leading to a finalization of the purchase of a 100% stake in the latter firm.
In September 2022, BioMAdvanced Diagnostics announced it had collected $1.3 million through fundraising. As such, BioMAdvanced Diagnostics intends to finish designing its first products and launch two clinical trials, including one on kidney transplant rejection and another one on lungs.
Biomadvanced diagnostics declared a design freeze on its IVD test for transplant kidney rejection in September 2022.
Oxford Nanopore Technologies (Oxford Nanopore), meanwhile, in September 2022, agreed on a non-exclusive service contract with GenDx to bring NGS-Turbo products to the transplantation market for high-resolution HLA typing.
Immucor Inc., which is specialized in transfusion as well as transplantation diagnoses, revealed two new additions to its transplant diagnostics portfolio in March 2022 as part of its ongoing commitment to advancing histocompatibility.
In March 2022, Biocartis and Ophiomics agreed to collaborate on the commercialization of HepatoPredict, a prognostic gene expression signature test to identify patients who will benefit from liver transplantation.
Globally, the rising prevalence of chronic diseases is subsequently increasing the incidence of organ failure, further surging the need for organ transplants. The Organ Donor states that over 1 million tissue transplants are performed every year. The geriatric population is highly susceptible to chronic diseases, which further increases the need for organ transplantation. As per the World Health Organization (WHO), by 2050, the world’s population aged 60 and older is expected to reach 2 billion, from 900 million in 2015.
Chronic kidney disease (CKD) is highly prevalent and the leading cause of kidney transplantation procedures. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) states that about 661,000 Americans have Kidney failure. About 468,000 people are on dialysis, and roughly 193,000 people live with a kidney transplant.
Moreover, one of the main factors further driving the expansion of the market under study is the increase in organ donation. In January 2021, more than 12,500 people donated one or more organs in 2020, up 6% from the year before, according to figures released by the Association of Organ Procurement Organizations (AOPO).
Increased transplant diagnostic testing will result from increased organ donation, propelling industry growth. Additionally, several significant players are releasing new products on the market, which is anticipated to further fuel market revenue. For instance, in September 2021, Thermo Fisher Scientific added two new products to its range of transplant diagnostics during the American Society for Histocompatibility and Immunogenetics (ASHI) annual meeting.
The market segments of transplant diagnostics, based on the product & service, includes instruments and reagents & consumables. The reagents & consumables segment dominated the global market in 2021. Higher consumption rate of these products across all applications and end-uses along with greater replacements rates despite less cost is the key attribute of this segment. Manufacturers of these type of diagnostic products are adopting strategies such as purchase contracts for reagents and consumables. In addition, the key factor accelerating the adoption of reagents and consumables is their repeat purchase.
The large share of this segment can be further attributed to the rapid modernization and automation of diagnostic laboratories, growing number of research & development activities outsourced by pharmaceutical & biotechnology companies to independent reference laboratories, and the growing number of organ transplantation procedures.
The transplant diagnostics market segmentation, based on the screening type, includes pre-transplant and post-transplant. The pre-transplant segment held the majority share in 2021, contributing to around ~60-64% of the market revenue of transplant diagnostics. These pre-transplantation analysis techniques are employed to ensure safe and effective procedures. Factors such as growing awareness among physicians and rapidly adopting technologically advanced tools are expected to drive growth in the coming years.
Further, growing geriatric population susceptible to the various chronic diseases due to weaker immunity are the key factors supporting the market growth of the pre-transplant diagnostics for diagnostic applications.
Transplant Diagnostics Screening Type 2021 and 2030
The market segmentation of transplant diagnostics, based on the organ type, includes kidney, liver, heart, lung, and pancreas. The kidney segment had the highest market revenue share in 2021. Increasing number of kidney transplantation procedures coupled with the supportive government regulations to augment organ donations across major healthcare markets supporting the segmental growth of the market. Kidney and liver transplants are more prevalent applications in the serological transplant diagnostic market fueled by the rise in incidences of kidney and liver failure in the geriatric population.
Especially, in those with chronic diseases. As per the reports published by the American Society of Nephrology titled- Chronic Kidney Disease in India, the range of CKD in India ranges from 1% to 13%.
January 2019: CORE Diagnostics, launched its division for advanced diagnostic services in nephrology called ‘nephroCORE’. These services will ensure best clinical intervention to improve outcomes in several chronic and generic kidney diseases including kidney transplants.
March 2020: CareDx Inc launched KIRA Immuno-Optimization to bring personalized care to pre-transplant.
By Region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. The North American Transplant Diagnostics market is expected to grow at a significant CAGR during the study period, accounting for USD 4.95 billion in 2021. North America is a well-established market for medical devices. The presence of a highly developed healthcare system, high adoption of innovative transplant diagnostic technologies among medical professionals, the large volume of organ transplantation procedures performed in the region, and technological advancements in the field of transplant diagnostics are the major factors driving the market in North America.
Further, the presence of many patients pool, who needs transplant treatment is helping to grow the market at a sustainable rate in this region.
Transplant Diagnostics market SHARE BY REGION 2021
Moreover, the major countries covered in the market report include the United States, Germany, Canada, France, the United Kingdom, Italy, Spain, India, Japan, Australia, China, South Korea, and Brazil.
The European Transplant Diagnostics market is the world's second-largest. Major drivers include the high adoption of advanced techniques and diagnostic tools, higher healthcare expenditure, and availability of skilled professionals. The U.K. holds the largest market share owing to factors such as highly developed healthcare infrastructure and the availability of skilled professionals. Moreover, the high adoption of personalized medicines, stem cell therapies, and soft tissue transplants are augmenting the regional market growth.
Increase in awareness among people related to the importance of organ transplantation has been an ongoing trend in the European countries. This has resulted in increasing number of organ donations especially from living donors. Further, the UK market of Transplant Diagnostics held the largest market share, and the German market of Transplant Diagnostics was the fastest-growing market in the European region.
The Asia Pacific Transplant Diagnostics market is expected to grow at the fastest CAGR during the forecast period. This is due to the rising number of organ transplants, donors, and the government's support in developing the transplant diagnosis market in the region. The Asia Pacific comprises a large pool of patient population and developing advanced healthcare infrastructure.
A vast rise in the prevalence of several chronic diseases and the resultant rise in transplant procedures, coupled with the availability of vast untapped growth opportunities in this region will attract many companies in the upcoming years. Moreover, China’s market of Transplant Diagnostics held the largest market share, and the Indian market of Transplant Diagnostics was the fastest-growing market in Asia-Pacific.
Transplant Diagnostics Key Market Players & Competitive Insights
The global market is highly competitive with very few players competing in the international market. The quality and accuracy constraints of transplant diagnostic techniques like serology-based and PCR-based HLA typing increase the overall cost of products. As a result, players are implementing strategies, such as long-term contracts with diagnostic clinics and laboratories and discount pricing for bulk purchases.
Companies in the in the market of Transplant Diagnostics are using the Next Generation Sequencing (NGS) for conducting tests to match organ donors and recipients. NGS technology allows the sequencing of an entire human genome, i.e., millions of DNA molecules within a single day. In Next-generation sequencing (NSG), genes are matched between the donor and recipient and depending on the extent of match, decision to perform organ transplantation is made. Nearly all transplant diagnostic tests and devices currently use this technology to decide on organ transplantation. For example, Castle Biosciences launched Decision Dx-CMSeq Test that used NGS (Next Generation Sequencing) to identify somatic mutations in genes.
Eurofins Scientific SE is a French group of laboratories headquartered in Luxembourg, providing testing and support services to the pharmaceutical, food, environmental, agriscience and consumer products industries and to governments. In June 2019, Eurofins Scientific acquired Transplant Genomics Inc to improve organ transplant outcomes with non-invasive serial monitoring guided by genomics.
Immucor Inc is a global in vitro diagnostics company specializing in the area of pre-transfusion diagnostics. The company offers a complete line of serology-based reagents and instruments used by hospitals, reference labs and donor centers to perform pre-transfusion typing and screening of blood and renders blood bank software solutions that are designed specifically to enhance the productivity of blood bank laboratories, providing transfusion test results in an efficient and productive way to the customers.
In March 2022, Immucor, Inc., a company focused on transfusion and transplantation diagnostics, announced two additions to its transplant diagnostics portfolio, demonstrating its ongoing commitment to new advancements in the field of histocompatibility.
Key Companies in the market of Transplant Diagnostics include
Transplant Diagnostics Industry Developments
August 2019: Care Dx (US) acquired XynManagement (US) to simplify transplant quality tracking and waitlist management.
March 2019: Hologic established a learning and experience center in Zaventem (Belgium) to create awareness among customers, healthcare professionals, and employees across Europe, the Middle East, and Africa about the benefits of diagnostic products, including transplant diagnostic products.
February 2019: Care Dx (US) launched the Allosure for lung transplants.
January 2018: F. Hoffman-LA Roche Limited (Switzerland) launched the Cobas Plasma Separation Card.
| Report Attribute/Metric | Details |
| Market Size 2023 | USD 4.4 billion |
| Market Size 2024 | USD 4.72 billion |
| Market Size 2032 | USD 8.3 billion |
| Compound Annual Growth Rate (CAGR) | 7.3% (2024-2032) |
| Base Year | 2021 |
| Market Forecast Period | 2024-2032 |
| Historical Data | 2018 & 2020 |
| Market Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Product & Service, Screening Type, Organ Type, and Region |
| Geographies Covered | North America, Europe, Asia Pacific, and the Rest of the World |
| Countries Covered | The U.S, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil |
| Key Companies Profiled | Becton Dickinson and Company (U.S.), Bio-Rad Laboratories Inc (U.S.), Illumina Inc (U.S.), Immucor Transplant Diagnostics Inc (U.S.), Thermo Fisher Scientific Inc (U.S.), CareDx (U.S.), Affymetrix Inc (U.S.), Linkage Biosciences (U.S.), Abbott Laboratories Inc (U.S.), BioMérieux S.A. (France), QIAGEN NV (Netherlands) |
| Key Market Opportunities | Increasing prevalence of chronic illnesses among the worldwide population |
| Key Market Dynamics | Growing incidence of organ failure to favor the market Rising adoption of stem cell therapy and customized drugs is gaining a reputation |
Frequently Asked Questions (FAQ) :
The transplant diagnostics market size was valued at USD 4.4 Billion in 2023.
The global market is projected to grow at a CAGR of 7.3% during the forecast period, 2024-2032.
North America had the largest share of the global market.
The key players in the market are Becton Dickinson and Company (U.S.), Bio-Rad Laboratories Inc (U.S.), Illumina Inc (U.S.), Immucor Transplant Diagnostics Inc (U.S.), Thermo Fisher Scientific Inc (U.S.), CareDx (U.S.), Affymetrix Inc (U.S.), Linkage Biosciences (U.S.), Abbott Laboratories Inc (U.S.), BioMérieux S.A. (France), and QIAGEN NV (Netherlands).
The reagents & consumables category dominated the market in 2021.
In 2021, pre-transplant had the largest share of the global market.
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Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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