Transplant Diagnostics Market By Technology (Molecular Assays, Non-molecular Assays), By Transplant Type (Solid Organ Transplantation, Stem Cell Transplantation), By Application (Pre-transplantation Diagnostics, Post-Transplantation Diagnostics, Research), By Product (Instruments, Reagents And Consumables, Software), By Usage Area (Hospitals And Transplant Centers, Research And Academia, Pathophysiology Laboratories) - Growth, Share, Opportunities & Competitive Analysis, 2018 – 2026

Industry Outlook

Transplant diagnostics are an integral step in organ transplant procedures. Transplant diagnostics are performed to study organ donor and recipient compatibility, and these methods also play a critical role after the transplantation procedure. Performing diagnosis methods at every stage of the transplant procedure assists physicians and surgeons in safeguarding patients by controlling the risk of organ failure or transplant rejection. As the global incidence of chronic diseases is increasing, the number of cases of organ failure is also on the rise. This has consequently resulted in increased growth in the transplant diagnostics market. The growing number of organ donations has further led to additional growth in the global transplant diagnostics market.

A precise diagnosis is a prerequisite for deciding on medication in transplantation. It was only recently that the precision in defining the mechanism of transplant rejection increased. Such development was mainly driven by the introduction of new diagnostic tools such as solid-phase HLA antibody testing and C4d staining. However, the current empirically derived diagnostic criteria for biopsy assessment are prone to varied interpretations and therefore have limited accuracy. Furthermore, the previously employed platforms and approaches for the assessment and monitoring of alloantibodies were also subject to institutional variation. Such a previous lack of precision in diagnostic and interpretation methods has had an impact on patient management.

Additionally, the identification of allograft injury is also vital for increasing the longevity of the transplant. Cases of acute rejection that result from a variety of immune and non-immune reasons pose a major risk to organ acceptance. The last two decades have marked a growth in the discovery of new transcriptomic, proteomic, and genomic biomarkers in molecular diagnostics, offering evolved potential for personalized patient management. The field of transplant diagnostics is seeking new methodologies that will allow multiplexing to simultaneously identify multiple targets, therefore providing more precise biomarkers and a better understanding of transplant mechanisms.

Market Synopsis

Higher Preference for Molecular Assays Observed as a Global Trend

Non-molecular assays are currently the dominant technology segment in the global transplant diagnostics market in terms of revenue. An increasing preference for non-invasive molecular assays is observed, surpassing the demand for serological assays. Benefits such as greater accuracy and less risk of deviant test results contribute to this trend. Non-molecular assays represent conventional methods for transplant diagnostics and are employed worldwide for the detection of transplant rejection. Furthermore, these methods allow the practice of antibody-based histocompatibility, offering low-resolution typing. Non-molecular assays address challenges faced during molecule identification that are involved in the immune rejection of mismatched grafts. In the molecular assays segment, PCR-based molecular assays hold a prominent market share globally. Sequencing-based molecular assays, comprising Sanger sequencing and next-generation sequencing, are anticipated to progress at a considerable pace during the forecast period.

Large procedure rates contribute to the dominance of solid organ transplant diagnostics.

Based on the type of transplant, the global transplant diagnostics market is categorized into solid organ transplantation and stem cell transplantation. Between these, the solid organ transplantation segment is expected to contribute to the leading share in the global market. Factors facilitating the dominance of this segment include higher procedure rates for kidney, liver, and heart transplants; growing incidence of end-stage renal diseases and cardiac conditions; and rising demand for new organs for cancer treatment. Supportive reimbursements in developed countries for the treatment of end-stage diseases have also led to high market demand for solid organ transplantations. On the other hand, technological developments in the field of stem cell transplantation and increased application areas of the same will allow rapid growth of this segment.

Pre- and Post-Transplant Diagnosis spearhead the global market

Due to the higher rates of solid organ transplantation, the market share of pre- and post-transplant diagnosis is significantly high in the global market. The greater incidence of renal, liver and cardiac diseases has urged more and more patients to opt for transplants. Therefore, verification of histocompatibility before transplantation procedures and follow-up tests for reducing the risk of transplant rejection up to several years following transplantation have contributed to a higher share of these segments. Additionally, technological evolution in HLA typing has further increased the uptake of pre-transplant diagnostics globally. On the other hand, growing drug discovery initiatives and evolution in the field of stem cell transplantation have urged increasing demand for both molecular and non-molecular diagnostic methods in research applications.

Reagents and Consumables, Hospitals and Transplant Centers Have a Major Influence on Market Size

Based on the product types, the global transplant diagnostics market is segmented into instruments, reagents and consumables, and software. Among these, the reagents and consumables segment contributes to a larger revenue share globally. A higher consumption rate of these products across all applications and end-uses, along with greater replacement rates despite the lower cost, is the key attribute of this segment. Additionally, hospitals and transplant centers, research and academia, and pathophysiology laboratories are the prime usage areas cumulatively contributing to this market. Hospitals and transplant centers are anticipated to take a major revenue share in the global market. Higher patient footfall and greater post-transplant diagnosis processes being performed at these locations are attributed to the leading position of this segment. The pathophysiology laboratories segment will progress at an above-benchmark rate during the forecast period due to the increasing trend of outsourcing test procedures.

The United States leads the global transplant diagnostics market due to greater awareness and a supportive business environment.

North America dominated the global transplant diagnostics market in 2018. The dominance of North America is mainly driven by the increasing geriatric population, the growing incidence of chronic diseases leading to organ failure, and the high adoption of transplantation techniques. Furthermore, the reduction in the cost of gene sequencing and growing private and public funding for the evolution of diagnostic techniques are other key drivers defining the North American market. Additionally, increasing awareness programs for the patient population, rapidly evolving skills of healthcare professionals, and increasing incomes are facilitating the fast market growth of the Asia Pacific region. In this region, China and Japan shall be the key revenue holders through the forecast period.

Historical and Forecast Period

2016: Historical Year

2017: Base Year

2018-2026: Forecast Period

This research report presents the analysis of each considered segment for the period from 2016 to 2026, using 2017 as the base year for estimations. Compounded annual growth rates (CAGRs) for each segment are calculated for the forecast period from 2018 to 2026.

Report Scope by Segments

This report includes qualitative and quantitative information on the transplant diagnostics industry, mapped for the period from 2016 to 2026. Qualitative information about this market is presented in the form of an analysis of each market segment, including drivers, challenges, opportunities, and the competitive landscape. The global transplant diagnostics market is segmented in terms of technology, transplant type, application, usage area, and geography.

By Technology (2016–2026; US$ Mn)

• Molecular Assays
• PCR-based molecular assays
• Sequencing-Based Molecular Assays
• Sanger Sequencing
• Next-Generation Sequencing
• Non-molecular Assays
• Serological Assays
• Mixed Lymphocyte Culture (MLC) Testing

By Transplant Type (2016–2026; US$ Mn)

• solid organ transplantation
• Stem Cell Transplantation

By Application (2016–2026; US$ Mn)

• Pre-transplantation Diagnostics
• Post-transplantation Diagnostics
• Research

By Products (2016–2026; US$ Mn)

• Instruments
• Reagents and consumables
• Software

By usage area (2016–2026; US$ Mn),

• Hospitals and Transplant Centers
• Research and academia
• Pathophysiology Laboratories

Geography Segment (2016–2026; US$ Mn)

• North America
• U.S.
• Canada
• Europe
• U.K.
• Germany
• Rest of Europe
• Asia-Pacific (APAC)
• China
• Japan
• Rest of APAC
• Latin America (LATAM)
• Brazil
• Mexico
• rest of Latin America
• Middle East and Africa (MEA)
• GCC
• Rest of the Middle East and Africa

The research study also includes a profile of the major market players engaged in this industry. Such profiling is performed on the following companies based on parameters such as business overview, financial information, product portfolio, and key developments: Thermo Fisher Scientific, Inc., Abbott Laboratories, Inc., Bio-Rad Laboratories, Bio-Reference Laboratories, F. Hoffmann-La Roche Ltd., Immucor, Inc., Illumina, Inc., Qiagen N.V., Luminex Corporation, and Genome Diagnostics B.V.

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