Market Overview

Global Transplant Diagnostics Market size was valued at around 5.75 billion in 2023 and is expected to reach a value of USD 10.48 billion by 2032, at a CAGR of 6.9% over the forecast period (2024–2032).

The Global Transplant Diagnostics Market has also emerged as a highly critical component of contemporary healthcare, driven by the growing incidence of organ failure and ever-increasing demand for organ transplantation across the world. Transplant diagnostics offers varied testing solutions and methods to determine donor-recipient compatibility, monitor post-transplant health status, and prevent the risks of organ rejection. These diagnostics are leading the way in transplant procedure success through more accurate donor matching and post-operative monitoring, ultimately resulting in improved patient outcomes.

Advances in molecular diagnostics, immunogenetics, and NGS technology revolutionized transplant diagnostics significantly. These advanced methods allow for more detailed and precise evaluation of human leukocyte antigen compatibility, an important factor in a successful transplant. Advances in non-invasive testing methodologies and inclusion of AI and machine learning streamlined the diagnostic protocols to the briefest possible turnaround times while improving predictive capability. These advances have broadened the scope of transplant diagnostics beyond specialized transplant units to general hospitals, thus meeting the increased global demand.

The increase in the incidence of chronic diseases such as diabetes, cardiovascular disease, and end-stage renal disease has caused a sudden rise in cases of organ failure, which, in turn, has boosted the demand for organ transplantation. With advancements in medical science and surgical procedures, the success rate of transplant surgery and its viability have also risen, thus boosting the demand for accurate diagnostic techniques. Governments and healthcare institutions across the world are also emphasizing the importance of early diagnosis along with appropriate treatment modalities, thus contributing to the development of the transplant diagnostics market.

Market constraints continue to include the high costs of advanced diagnostic technology and HLA testing complexity. In addition, restricted accessibility and availability of such diagnostic tests in developing countries continue to act as major restraints on the expansion of markets. In the face of such barriers, concerted efforts by various stakeholders such as diagnostic manufacturers, healthcare professionals, and regulatory institutions focus on broadening the access and affordability of transplant diagnostics with the view of accelerating increased utilization and fair access to healthcare.

Market Drivers

Increasing number of transplant procedures.

• Transplants are becoming an increasingly viable alternative for an individual's life or rebirth due to increased application of different technologies, screening tests, genomic profiling, and cross-matching. The increasing CAGR of the transplant industry is the cause of an increase in transplant procedures in the countries of major influence. In 2021, for instance, there were 41,354 organ transplants conducted in the United States and 5,273 in France. Old individuals often develop diseases such as tuberculosis, end-stage renal disease, and cirrhosis of the liver, which require transplant surgery.

Key Findings:

The increasing demand for organ transplants

• There are far more people who can be helped by organ transplantation than there are organs available. Health Resources and Services Administration in 2020 reported that there were close to 184,000 transplant registrations in the US, while organ donors were as few as 18,316.

Market Opportunities

Growing public awareness about organ donation and transplantation.

• The American Transplant Foundation hosted the DLA Awards in 2022 as a fundraising event to benefit efforts that promote public awareness of organ donation and transplants. To enhance the readiness of the public to donate organs for transplant surgeries in India, the Organ Receiving and Giving Awareness Network (India) conducted an awareness campaign in 2021.Long three, five and ten km runs are conducted in the United States to create public awareness of organ transplantation and the need to save lives.

Market Restraining Factors

High procedural cost of NGS and PCR-based diagnostic assays

• Exorbitant procedural expense of polymerase chain reaction (PCR) and next-generation sequencing (NGS)-based diagnostic tests is the major constraint in the transplant diagnostics market. Though providing high precision with in-depth information on donor-recipient compatibility, these technologies are associated with high equipment procurement cost, reagent consumption, and operational maintenance fees. NGS platforms, for example, demand advanced infrastructure, software applications, and highly skilled scientists for analytics, thus increasing overall cost. Likewise, PCR tests, although used globally, are generally expensive in terms of reagents and require constant calibration and maintenance of sophisticated equipment.
• To medical professionals, especially in low- and middle-income nations, such expenses could be out of reach, limiting access to such advanced diagnostic equipment. Budgetary constraints by small hospitals and transplant centres add to the issue as they may not possess the ability to fund expensive diagnostic centres. The expense also gets transferred to patients, where it can create economic barriers towards receiving necessary transplant diagnostics, particularly in regions lacking universal healthcare coverage or insurance arrangements.

Segmentation Analysis

The market scope is segmented because of by Test, by Product, by Application.

By Test

Based on the Test of the market is segmented into Molecular Assays, Sequencing-based Molecular Assays, Non-molecular Assays.

The Molecular Assays segment led the transplant diagnostics market within the By Test segments because of its high usage, cost-effectiveness, and well-established position in clinical practice. Molecular assays, including polymerase chain reaction (PCR)-based tests, are used extensively to determine human leukocyte antigen (HLA) compatibility, track donor-specific antibodies, and identify post-transplant complications such as infections or early organ rejection. Their capability to provide correct and consistent results within a reasonable time frame has established them as a routine diagnostic tool in transplantation.

These tests have different advantages, including sensitivity, specificity, and flexibility, that have made them occupy a stronghold in the market. They also are less demanding of resources than sequence-based molecular tests, and thus a better option for most hospitals, particularly in resource-scarce settings. Moreover, constant innovations in PCR technology, for example, real-time PCR and digital PCR, have enhanced their diagnostic utility, which has facilitated greater use at transplant units all over the globe.

Though deeper in insights and more precise, sequencing-based molecular assays are prohibitively expensive and complicated to work with, restricting their use to specialized centres. Non-molecular assays, while inexpensive, are less sensitive and have been superseded by molecular methods to a large extent. Therefore, the molecular assays segment remains the market leader, filling the gap between cost-effectiveness and diagnostic quality, and serving its pivotal role in transplant diagnostics.

By Product

Based on the Product of the market is segmented into Reagents & Consumables, Instruments, Software and Services.

The growing demand for effective and early profiling in 2023 throughout organ transport pushed the reagents and consumables segment to become the market leader and command the largest revenue share.

Software and services industry is expected to increase at the highest rate over the period of projection on account of recent technological breakthroughs in the software industry as well as improved services offered by industry players. Further, new software technology developments and innovations with the inclusion of machine learning (ML) and artificial intelligence (AI) are delivering improved results.

Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. It had a major market share of 34.0% in 2023 due to the highly advanced health infrastructure of the region as well as the diverse usage of advanced medical technology. Further, the market is also being fuelled by a rise in spending on organ transplant research and development. Additionally, 46,000 organ transplants have been out in the United States as of March 2024, as reported by the Health Resource & Service Administration (HRSA).

Market Trends for Transplant Diagnostics in the US

Owing largely to enhanced medical technology and equipment, advanced healthcare infrastructure, and increased public knowledge regarding organ transplantation, the U.S. market for transplant diagnostics attained an impressive market share in 2023.

Market Trends for Transplant Diagnostics in Europe

In 2023, a significant percentage of the transplant diagnostics market was in Europe. This growth is attributed to the region's enhanced access to skilled surgeons, well-equipped advanced medical technology, and a rise in healthcare expenditure.

Due to its well-established healthcare infrastructure, rising healthcare expenditure, and prevalence of skilled surgeons, the UK transplant diagnostics market shared the largest market share in Europe.

Thanks to escalating healthcare expenditures and the implementation of advanced medical technology, the German transplant diagnostics market is forecasted to grow at the highest CAGR throughout the forecast period.

Market Trends for Transplant Diagnostics in Asia Pacific

Asia Pacific's market for transplant diagnostics is expected to increase at the highest rate during the forecast period with a projected CAGR of 9.87%. The growth is driven by the development in the healthcare system, rising healthcare expenditure, and rising disposable income. Moreover, the prevalence of chronic diseases among middle-aged and elderly individuals has risen considerably, especially in countries such as China, Japan, and India.

In 2023, China transplant diagnostics commanded the largest share of the market because of a better infrastructure as well as physicians and increased knowledge among the masses regarding the importance of organ transplanting.

List of Companies Profiled

• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• Hoffmann La-Roche Ltd
• Abbott
• QIAGEN
• Bruker
• BD (Becton, Dickinson and Company)
• Werfen (Immucor, Inc.)
• Bio-Rad Laboratories, Inc.
• Omixon Inc.

Key Industry Developments

In May 2024, Thermo Fisher launched a CXCL10 testing service for kidney transplant patients. This service allows for quick detection of the CXCL10 chemokine, providing an alternative to currently available tests that are quicker.

In February 2023, BD received FDA clearance for BD Onclarity HPV assay within the serology testing category.

In March 2023, BioRad gained AQAC International and AFNOR approval for its iQ-Check kits.

Report Coverage

The report will cover the qualitative and quantitative data on the Global Transplant Diagnostics Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Global Transplant Diagnostics Market Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Transplant Diagnostics market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Transplant Diagnostics. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Transplant Diagnostics companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Transplant Diagnostics Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Transplant Diagnostics Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions

• How much the global Transplant Diagnostics Market valued?
• Which region has the largest share in 2024 for the global Transplant Diagnostics Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of Transplant Diagnostics Market

• Historic year: 2019- 2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Billio

Transplant Diagnostics Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: