May 6, 2020   SOURCE: BusinessWire

Infiniti’s Industry Experts Examine Regenerative Medicine Manufacturing Challenges

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Regenerative medicine is 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.

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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.

  • 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 we 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 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.

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About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. To know more, visit:https://www.infinitiresearch.com/about-us