Development of Molecular Methods Contributing for Successful Transplantations

Transplantation is a surgical procedure involving replacement of a failed or damaged organ, tissue or cell in the human body with a new one from the same individual, a different individual of same species or different species. One of the main issues faced after an organ transplant is the development of immune response i.e. the recipient’s immune system starts recognizing the graft as a foreign body leading to graft rejection. Hence to avoid post-transplantation complications diagnostic tests are carried out to check donor and recipient organ compatibility and to monitor post-transplantation rejection. There is a remarkable advancement in the field of diagnostics over the past 60 years improving the long-term survival and quality of life of most transplant recipients. Increased incidences of diseases like cancer, diabetes, heart diseases etc. due to changing lifestyle and unhealthy habits are leading to damage the organs or tissues, necessitating transplantation procedures creating an opportunity for diagnostic firms to come up with advanced diagnostic procedures.

According to IQ4I analysis, Transplantation Diagnostics global market is expected to reach $2,059.2 million by 2022. Factors driving the market include increase in the rate of solid organ, tissue and stem cell transplantation, an increase in geriatric population coupled with chronic diseases, the technological shift from error-prone serological assays to more accurate gene-based HLA are contributing the growth of Transplantation Diagnostics market. Some of the opportunities which would further drive the market are increasing a number of early detection non-invasive procedures like cell-free DNA testing and growing awareness among people for organ donation and increase in healthcare expenditures.

According to United Network of Organ Sharing (UNOS) in 2015, transplantation has saved and enhanced the lives of more than 600,000 people in the United States. The transplantation market has been booming ever since solid organs like kidney, heart, liver, and pancreas have been successfully transplanted as it is the leading form of treatment for many forms of end-stage organ failure. According to WHO, more than 50,000 hematopoietic stem cell transplants are carried out annually worldwide and they are increasing each year. Stem cell transplantation remains as the last hope for patients with the advanced or refractory disease. The increasing transplantation procedure across the globe has led to the development of the new and advanced diagnostics tests and technologies in the market. Transplantation diagnostics by technology is categorized into Molecular and Non-molecular methods. The most commonly used technology currently in transplantation diagnostics market is non-molecular based methods which include Serological tests Mixed Lymphocyte Culture Assay and Flow Cytometry. Due to lack of appropriate antisera and not all Human Leukocyte Antigen (HLA) molecules can be resolved serologically there is a shift in technology from non-molecular to molecular methods. These nucleic acid based technologies are now considered as the standard for HLA typing. A variety of molecular methods is available, including Sequencing-based typing methods (NGS and Sanger Sequencing) and PCR-based typing methods (SSP-PCR, SSO-PCR, RFLP-PCR and SNP-PCR). When compared to Non-molecular methods, the molecular methods are expected to grow stronger due to the due their greater sensitivity, accuracy, and resolving power. PCR-based methods held the largest share and sequencing-based methods are expected to grow stronger since they generate unambiguous, ultra-high resolution typing for all loci on dozens of samples in the single assay on a single technology.

Transplantation diagnostic market has a huge untapped potential and sensing this opportunity many Biotechnology firms and diagnostic laboratories are acquiring other smaller companies or collaborating with them to develop new diagnostic tests. For instance, Thermo Fisher scientific, strengthened its dominant position in the transplantation market by acquiring Affymetrix, Inc (U.S.), a leading provider of products of cellular and genetic analysis in March 2016 for a deal of $1.3 billion. CareDx, Inc., a transplantation molecular diagnostics company which offers high-value diagnostic surveillance solutions acquired Allenex AB in April 2016 for the development of its new donor-derived cell-free DNA tests. In January 2016, Illumina, Inc. announced that it has completed its acquisition of Conexio Genomics (Fremantle, Australia), a world leader in the development of HLA typing solutions.

The transplantation diagnostics Products are categorized into Instruments, consumables and software & services. Consumables attracted the largest market revenue and are expected to grow strongly due to the huge growth potential with added opportunities from new avenues like non-invasive cell-free DNA tests which are likely to propel the market. Transplantation diagnostics are used in Diagnostic (Medical) and Research field. Many companies are coming up with innovative tests to detect organ rejection at an early stage which helps in continuous monitoring of appropriate dosage of the drug. Immucor, Inc., a leader in transplantation diagnostics launched a new product in May 2016 named kidney Solid Organ Response Test (kSORT), a molecular gene expression assay that measures kidney recipient’s immune response to predict organ rejection and graft injury. CareDx, Inc. is developing new donor-derived cell-free DNA tests for kidney and heart transplant patients. The turnaround time for most of the tests is too long and hence to address this issue Chronix Biomedical researchers recently applied Bio-Rad’s ddPCR technology to quantify graft-derived cell-free DNA (cfDNA) in liver transplant patients.

Geographically, North America holds the largest share of the Transplantation Diagnostics global market followed by Europe due to increasing number of organ and tissue transplantation, higher healthcare expenditure, the high adoption rate of advanced technology, reducing the cost of sequencing HLA genes are factors propelling market growth in this region.

Some of the prominent players in transplantation diagnostics market include Abbott Laboratories, Inc. (U.S), Bio-Rad Laboratories, Inc. (U.S), CareDx, Inc. (U.S), Illumina, Inc. (U.S), Immucor, Inc.(U.S), Linkage biosciences (U.S), Qiagen N.V. (Netherlands), Roche (Switzerland), Thermo Fisher Scientific, Inc. (U.S).

GenDx (Netherlands), BAG HealthCare GmbH (Germany), Chronix Biomedical (U.S.), ROSE GenTec Ltd (U.K.), Omixon (Hungary), Luminex Corporation (U.S.), Diagnomics (U.S.), Transplant Genomics, Inc. (U.S.), GMSbiotech (U.S.), BD Biosciences (U.S.), TBG Diagnostics Limited (Australia), TAI Diagnostics (U.S.) are some of the emerging players offering innovative services in transplantation diagnostics market.


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