The global human platelet lysate market is expanding at a rapid rate owing to its expanding applications in cell therapy, regenerative medicine, and biopharmaceutical production. Human platelet lysate (HPL) is a xeno-free, serum-free substitute for fetal bovine serum (FBS). It is a safer and more ethical additive to in-vitro cell culture, particularly in the expansion of mesenchymal stem cells (MSC). This renders it a first choice for the production of clinical-grade cells and therapeutic research.
The growing need for advanced cell-based therapies and government funding support for regenerative medicine are the major drivers that are impacting the market. Additionally, the growing number of clinical trials for immune cell therapies and stem cells is also further driving the demand for reproducible, consistent, and GMP-grade cell culture media like HPL.
For instance, firms such as Macopharma and Compass Biomedical have expanded their GMP-qualified HPL product lines to address the quality and safety requirements needed in clinical studies. In addition, the shift toward personalized medicine and biologics has brought about the limelight on the need for long-term growth-capable animal-free culture systems. However, the industry is plagued by standardization and regulatory problems, which are being met by players in the industry through innovation and collaboration with healthcare facilities.
One of the strongest motivators to the human platelet lysate industry is the growing demand for stem cell therapy and regenerative medicine. HPL is full of growth factors and causes greater proliferation and differentiation of mesenchymal stem cells (MSCs) without the issues of animal-derived supplements and hence becomes the most appropriate one for clinical and commercial-scale cell growth.
For instance, application of HPL in the expansion of adipose-derived stem cells for autologous transplantation in orthopedic treatment is gaining momentum. Regenerative medicine clinics and hospitals in Europe and the U.S. are increasingly using HPL to provide FDA and EMA safety protocols in cell therapy.
In addition, HPL-based cell culture processes are being utilized by cell and gene therapy firms like Athersys and Pluristem to make them GMP-compatible as well as improve therapeutic effects. As clinical pipelines for regenerative products increase, the demand for cell culture systems like HPL, which is scalable, xeno-free, and reproducible, will greatly increase, thus fueling demand as well as industry growth.
The regulatory pressure toward serum-free and xeno-free media for clinical-grade cell production is the second major driver to the global human platelet lysate industry. The FDA, the EMA, and the PMDA have been concerned with the application of animal-derived ingredients like fetal bovine serum due to the risk of contamination (e.g., batch-to-batch variability, zoonoses, immunogenicity). The researchers and manufacturers have hence switched to the application of human platelet lysate as a safer alternative.
For instance, GMP-grade reagents such as Mill Creek Life Sciences' PLTMax are tailored to GMP standards and have been successfully employed in clinical trials for immunotherapy with immune cells. The ability of HPL to enhance reproducibility and reduce variability in batches of cell cultures also makes it increasingly desirable for clinical application and reproducibility in production.
In Japan, FBS was replaced with HPL by the Riken Center for Biosystems Dynamics Research for the cultivation of induced pluripotent stem cells (iPSC) in order to meet local regulatory requirements. Not only did the change enhance compliance, but it also maximized the growth condition for delicate cells. As regulatory bodies further tighten the reins on bioproduction inputs, HPL will increasingly supplant conventional supplements in an increasingly wider range of research and clinical applications.
North America is likely to lead the international human platelet lysate market as a consequence of a synergistic mix of factors that highlight the region's focus on biomedical and regenerative medicine research. The United States, for example, is well equipped with a highly advanced research infrastructure, with regenerative medicine, as well as the life sciences, being widely funded.
Institutions such as the NIH have long been investing significantly in stem cell research, such that it has driven research and development of HPL applications. The U.S. Food and Drug Administration has put in place standards of use of human-derived products assured to be safe and effective, hence facilitating the rapid integration of HPL in clinics.
Increase in the number of individuals living with chronic conditions such as Parkinson's disease and osteoarthritis in North America have stimulated demand for new treatments. HPL, as a regenerative medicine, is under development as a treatment for the above-named diseases
NA
NA
NA
Copyright © Transparency Market Research, Inc. All Rights reserved
Trust Online
Human Platelet Lysate Market
