Major players in the transplant diagnostics market are Thermo Fisher Scientific, Inc., Illumina, Inc., F. Hoffmann La-Roche AG., Abbott Laboratories, Inc. and Qiagen N.V.
The global transplant diagnostics market is expected to grow from $0.73 billion in 2020 to $0.8 billion in 2021 at a compound annual growth rate (CAGR) of 9.6%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $1.06 billion in 2025 at a CAGR of 7.3%.
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 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 transplant diagnostics market covered in this report is segmented by type into reagent & consumables, instrument, software & services. It is also segmented by transplant type into solid organ, stem cell; by end user into hospitals and transplant centers, research laboratories & transplant centers, commercial service providers; by technology into non molecular assay, molecular assay and by organ into kidney, liver, heart, lung, pancreas.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
Huge gap between organ donation and demand for organ transplantation is restraining the growth of the transplant diagnostics market.The number of organ donor 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 supply and demand of organ donors, with the number of people in waiting list for organ transplant growing increasing with each passing year.
This low number of organ donors is limiting the need of transplant diagnostic tests and devices, thus restraining the market growth.
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 end result. The testing facility must be equipped with quality assurance unit so as to monitor each 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.
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.
In order 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 in the waiting list for organ transplant in 2019.According to Health Resources and Services Administration, as of 2019, every 10 minute a person is being added to this waiting list for organ transplants.
This high demand for diagnostic tests is driving the transplant diagnostics market.
Companies in the 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 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.
The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
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