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Transplant Diagnostics Global Market Report 2022

Transplant Diagnostics Global Market Report 2022

  • May 2022
  • 200 pages
  • ID: 6280838
  • Format: PDF
  • The Business Research Company


Table of Contents

Major players in the transplant diagnostics market are Thermo Fisher ScientificInc., Illumina Inc., F. Hoffmann La-Roche AG., Abbott LaboratoriesInc., Qiagen N.V., Immucor Transplant Diagnostics Inc., Bio-rad Laboratories Inc., Omixon Ltd., CareDx, Affymetrix Inc., and GenDx.

The global transplant diagnostics market is expected to grow from $1.53 billion in 2021 to $1.66 billion in 2022 at a compound annual growth rate (CAGR) of 8.5%. The market is expected to grow to $2.25 billion in 2026 at a compound annual growth rate (CAGR) of 7.9%.

The transplant diagnostics market consists of sales of transplant diagnostics test products and related services.Transplant diagnostics are the tests conducted before relocation/ transplantation of the donor organ to the recipient patient.

The related services include only installation and maintenance services offered by equipment manufacturers. Transplant diagnostics tests include Human leukocyte antigen (HLA) diagnostic testing, PCR-based assay, serological assay, and mixed lymphocyte culture (MLC) assay among others.

The main types of transplant diagnostics are reagents and consumables, instruments, and software and services.The transplant diagnostics instruments are products that are designed to speed up and improve the quality of transplant diagnostics.

The technologies used in transplant diagnostics are non-molecular assay, and molecular assay to transplant various organs such as kidney, liver, heart, lung, and pancreas. The transplant types included are solid organ and stem cells that are used by end-users such as hospitals and transplant centers, research laboratories and transplant centers, and commercial service providers.

Rising incidents of acute diseases are leading to an increase in organ failure rates, thus increasing the demand for transplant procedures driving the transplant diagnostics market.Organ transplant is a complex process and the success of the procedure depends on the acceptance of the donor’s organ by the recipient’s body system.

To check whether the organ transplant can be successful, transplant diagnostic tests are performed.According to US department of health and human service in the year 2019, 39,718 transplants were performed.

Moreover, according to HRSA, more than 113,000 people are on the waiting list for the organ transplant in 2019.According to Health Resources and Services Administration, as of 2019, every 10 minutes a person is being added to this waiting list for organ transplants.

This high demand for diagnostic tests is driving the transplant diagnostics market.

A huge gap between organ donation and demand for organ transplantation is restraining the growth of the transplant diagnostics market.The number of organ donors is increasingly falling short of the number of people requiring organ transplantation.

According to Health Resources and Services Administration in 2019, the number of people requiring organ transplantation in the US was 112,568, while the number of organ donors was as low as 19,267.This is creating a huge deficit between the supply and demand of organ donors, with the number of people on the waiting list for organ transplants growing increasing with each passing year.

This low number of organ donors is limiting the need for transplant diagnostic tests and devices, thus restraining the market growth.

Companies in the transplant diagnostics market 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 the match, a 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 the Decision Dx-CMSeq Test that used NGS (Next Generation Sequencing) to identify somatic mutations in genes.

The transplant diagnostics market is regulated by authorities such as the US Food and Drug Administration (FDA).For instance, companies in the transplant diagnostics market must comply with the Good Laboratories Practices (GLP) Part 58 directed by the FDA Title 21.

According to this regulation, all the clinical instruments used to diagnose specimens must be maintained under specified conditions and should be properly calibrated, so that there should be minimal distortion in the result. The testing facility must be equipped with a quality assurance unit to monitor each piece of equipment, personnel, methods, practices, record, and controls.

In June 2019, Eurofins, a France-based testing laboratories company acquired Transplant Genomics, Inc. for an undisclosed amount. This acquisition significantly reinforces the large existing range of innovative tests of Eurofins to transplant hospitals and practitioners in the United States and strengthens Eurofins leadership position in the transplant testing market and ability to deploy the latest scientific advances to benefit patients. Transplant Genomics, Inc., a molecular diagnostics company committed to improving organ transplant outcomes, with an initial focus on kidney transplant recipients.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

The countries covered in the transplant diagnostics market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA.

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