Industry Outlook

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

Precise diagnosis is the prerequisite for deciding medication in transplantation. It was only recently that the precision in defining the mechanism of transplant rejection has 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, therefore are of limited accuracy. Furthermore, the previously employed platforms and approaches for assessment and monitoring of alloantobodies were also subject to institutional variation. Such previous lack of precision in diagnostic methods and interpretation methods has had an impact on patient management.

Additionally, identification of allograft injury is also vital for increasing the longevity of the transplant. Cases of acute rejection that cause from a variety of immune and non-immune reasons pose a major risk to organ acceptance. The last 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 provide more precise biomarkers and better understand transplant mechanism.

Higher Preference to 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. 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 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 immune rejection of mismatched grafts. In molecular assays segment, PCR based molecular assays hold prominent market share, globally. Sequencing based molecular assays comprising Sanger sequencing and next generation sequencing is anticipated to progress at considerable pace during the forecast period.

Large Procedure Rates Contribute to the Dominance of Solid Organ Transplant Diagnostics

Based on type of transplants, the global transplant diagnostics market is categorized into solid organ transplantation and stem cell transplantation. Between these, 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 of 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 in 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 higher rates of solid organ transplantation, the market share of pre- and post-transplant diagnosis is significantly high in the global market. Greater incidence of renal, liver and cardiac diseases has urged more and more patients to opt for transplants. Therefore for verification of histocompatibility before transplantation procedure and follow-up tests for reducing the risk of transplant rejection up to several years following transplantation has contributed to 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 has urged increasing demand for both molecular and non-molecular diagnostic methods in research application.

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, reagents and consumables segment contribute to larger revenues share globally. 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. Additionally, hospitals and transplant centers, research and academia, and pathophysiology laboratories are the prime usage areas cumulative 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. Pathophysiology laboratories segment will progress at above benchmark rate during the forecast period due to increasing trend of outsourcing of test procedures.

United States Leads the Global Transplant Diagnostics Market due to Greater Awareness and Supportive Business Environment

North America dominated the global transplant diagnostics market in 2021. The dominance of North America is mainly driven by increasing geriatric population, growing incidence of chronic diseases leading to organ failure, and high adoption of transplantation techniques. Furthermore, reduction in cost of gene sequencing, and growing private and public funding for evolution of diagnostic techniques are other key drivers characterizing North America market. Additionally, increasing awareness programmes for patient population, rapidly evolving skills of healthcare professionals, and increasing incomes are facilitating the fast market growth of Asia Pacific region. In this region, China and Japan shall be the key revenue holders through the forecast period.

Historical & Forecast Period

This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Transplant Diagnostics market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the Transplant Diagnostics market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of Transplant Diagnostics market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2032.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the Transplant Diagnostics market?
• Which is the largest regional market for Transplant Diagnostics market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving Transplant Diagnostics market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the Transplant Diagnostics market worldwide?