Bioprinting: The key development hurdles to scalability

Pascale Diesel and Lev Gerlovin, both vice presidents at Charles River Associates (CRA), describe the current capabilities and future potential of bioprinting alongside Andrew Thomson, an analyst in the life sciences practice at CRA.

Bioprinting has advanced rapidly over recent years through engineering step-changes in the use of 3D printing devices. With these developments, living cells can now be positioned layer-by-layer to produce functional tissue structures. Key attributes of this emerging technology are that it is scalable and highly customisable, which facilitates the manufacturing of a large variety of tissues in an automated and repeatable way. These capabilities equip developers with tools to advance 3D-tissues for broad applications, from in vitro drug testing models, to therapeutic tissue implants to whole organ transplants.

The bioprinting market is young, but it is close to producing engineered tissue products with high commercial potential. Several companies (e.g. Organovo, Regenovo, BioDan, etc.) have had success developing and marketing 3D bioprinted tissue products used for drug testing and pharmaceutical studies. The use of 3D tissue models in drug development, paired with the potential to create living tissue replacements and a rapidly advancing technological platform, have led the bioprinting sector to be valued at a forecasted $4.7B by 2025.

Inspired by recent developments, we are seeing early-stage investors engaging the bioprinting market. Large pharmaceutical entities are moving bioprinting companies in-house, dozens of new players are entering the field, and stakeholders are collaborating at every level of development. Government bodies such as the U.S. Department of Defense, the European Commission, and NASA are committing extensive resources to advance bioprinting and the Food and Drug Administration (FDA) is working to address and prepare for the imminent impact of bioprinted products.

The bioprinting field is gaining traction at the commercial and technological level, but three key development hurdles are holding back bioprinting players attempting to evolve basic-demonstrative technologies through higher levels of proof and technical readiness.

First, regulators must establish clear regulatory guidelines for bioprinted products. The FDA is leading the charge amongst federal agencies by establishing close collaborations with bioprinting manufacturers and requesting specific proof-of-effectiveness data, but has yet to define clear safety guidelines for these products. Investors and manufacturers need navigable regulatory pathways to support their confidence in the real-world applicability of bioprinted products.

Second, a target consumer population has not been clarified, given the wide variety of potential applications of bioprinted products and the many possible end-users of these technologies. This makes investors hesitant to commit to the field and does not allow developers to effectively direct their research and development efforts. It is clear that a market for bioprinted products must be explicitly defined.

Third, developers are challenged by a lack of established commercial revenue. The bioprinting field must reach a critical mass of industry players equipped with a profitable revenue stream to support the creation of an established research and development infrastructure and drive engineering innovations towards delivering commercially viable products.

All three of these hurdles must be overcome before the ambitious goal of developing and commercialising scalable, safe, and therapeutic bioprinting offerings can be broadly realised.

The views expressed herein are the authors’ and not those of CRA or any of the organisations with which the authors are affiliated.