Identifying Key Regenerative Medicine Manufacturing Challenges

February 6, 2020

Regenerative medicines are currently the hive of innovation in modern science with far-reaching benefits for big pharma, healthcare systems, and patient outcomes. We can expect a rapid pace of development in the US regenerative medicine market over the next decade. Some of the key factors fueling demand include the increasing investments in R&D activities and the rising incidence of chronic diseases in the country. Leading vendors have enhanced their R&D investments to develop innovative medical therapies, which is driving the overall growth of the market.

Furthermore, M&A and strategic alliances among vendors will have a significant impact on the overall market growth and innovation. Nevertheless, the actual delivery of regenerative medicines has proven to be rather challenging with several roadblocks to commercially viable therapies that are capable of catering to unmet clinical needs. In this article, based on a series of discussions with industry analysts at Infiniti Research, we highlight some of the most relevant and pressing manufacturing challenges in regenerative medicine products.

Regenerative medicines

The promise of regenerative medicines requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network. Planning to venture into this space? Request a free proposal for comprehensive insights into the market.

Regenerative medicines – Manufacturing challenges

Manufacturing expense

Cell therapy manufacturing processes are generally highly expensive. Scaling up from limited laboratory facilities to automated systems for bulk production will largely be based on cost, therefore impeccable financial and time planning become vital. As a first-generation technology, stakeholders can expect greater stakeholder tolerance for higher pricing, but this will only be for a limited time period. 

Design quality

After collecting sufficient evidence of the clinical effectiveness of regenerative medicines, bioreactor technologies are considered for the manufacture of regenerative medicine products. But even minor process changes at this stage will require new validation of the product performance. So, in the case of automation, robots manually reproduce the existing inefficient manual processes due to which the products are often based on obsolete technologies. As a result, the manufacture of regenerative medicines sometimes misses the opportunity to improve their quality by innovating process design.

The personalization and unique requirements of regenerative medicines require manufacturers to provide increased focus on the precision and accuracy of processes.

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