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Manufacturing capacity for regenerative medicine therapies appears to be becoming a bigger factor of concern in the Asia-Pacific region, where clinical adoption is outpacing production capabilities. Therapies like cell therapies and tissue engineering treatments typically require tight controls in manufacturing and have been predominantly produced in relatively few sites across the region.
The issue is now gaining attention from both healthcare facilities, distributors and private investors interested in the regenerative medicine market. Production reliability is beginning to influence purchase decisions due to its effect on scheduling and patient eligibility windows.
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A number of APAC regions are still dependent on imported manufacturing supplies, specialist manufacturing equipment and external manufacturing support in producing their regenerative medicine therapies. Disruptions in transportation, customs inspections and document clearance can disrupt the availability of treatments, regardless of the clinical need for them in an area. Sourcing stability has become an important consideration for buyers, following several interruptions in the APAC supply chain that disrupted treatment access in certain areas.
Ramping up manufacturing capacity can prove complicated due to the nature of the regenerative medicine industry. Manufacturing regenerative medicine therapies requires controlled environments, specially-trained personnel and rigorous quality verification processes. Ramping up capacity too fast can result in inconsistencies, which is why some companies prefer to take their time ramping up manufacturing capacity rather than focus on scaling.
Manufacturing regenerative medicine locally has proven more common in some APAC markets. However, fragmentation can still be a problem. Biotech firms that have the research capabilities required by a regenerative medicine manufacturer may lack the funding required to establish commercial production capacity. Contract manufacturing partnerships between hospitals, research facilities and manufacturing facilities are appearing in markets where governments want to limit their dependence on imported therapies.
These partnerships raise new quality control concerns for buyers. It can be tricky to identify where the responsibility lies when it comes to quality control, as there will be several entities involved in producing, storing and distributing the finished therapy. Evaluating the ability to comply with audits, the process documentation and the shipment tracking becomes part of the process for buyers selecting regenerative medicine manufacturers.
Shipping logistics have also emerged as a potential source of disruption in the supply chain. Certain regenerative medicine therapies require very strict transportation protocols for long-distance shipments. The slightest delay that would not affect pharmaceuticals could potentially ruin the biological samples used. Providers in the industry are witnessing increased interest in specialized transport options and contingency plans from logistics buyers.
Estimating costs in APAC regenerative medicine manufacturing is also difficult. Production economics for regenerative medicine treatments are different from those involved in pharmaceutical manufacturing. Treatment volume in regenerative medicine therapies may vary, and individualized treatments can make cost predictions unreliable, complicating forecasts from health care facilities.
The APAC government continues to provide support for biotech industry development through research grants and other measures, but there are significant disparities in manufacturing maturity. Some APAC markets are developing rapidly in terms of clinical capabilities, but continue to rely on imported products for manufacturing or laboratory support.
Supply chain reliability, manufacturing consistency and scalability are becoming equally important topics as the regenerative medicine conversation expands across APAC. There is plenty of willingness on the part of hospitals to adopt new technology, but there is increasing caution when it comes to unstable supply chains.
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