IDTechEx recently released a research report on the impact of 3D printing in the medical industry and the pharmaceutical industry. The report forecast that the growing 3D printing industry could be worth $8.1bn (€7bn) by 2029.
3D printing technology, according to Bryony Core, technology analyst at IDTechEx, has been used since the 1980’s, when it originally printed with polymers. As the technology has improved, it has entered different markets including the pharmaceutical industry, where it has developed into the manufacturing of personalized medicine, creating preclinical and clinical research models, and shortening drug discovery lead times.
Personalized medicine, a growing area of treatment, relies on specific drug delivery and dosing. Due to the specificities, it can often require complex manufacturing. However, 3D printing technology has allowed for the manufacturing of oral solid dose personalized medicine in an efficient manner.
The technology can be used to manufacture patient-specific pills, with individualized dosages and custom drug combinations, which is significant for the growing use of personalized medicines that can be used to treat chronic conditions.
IDTechEx told us that 3D printing can take drug delivery profiles into account as it manufactures the medications, but this manufacturing technology is still at an early stage.
Last year, at AAPS PharmSci360, Joerg Ogorka, head of early stage development at Sandoz, gave a talk on the developments that have been made in the 3D printing process, and personalized medicines was one of his biggest talking points.
Ogorka said, “You can create layers of active pharmaceutical ingredients (APIs) with different binders and different powder compositions…we can create different profiles for the same tablet,” while talking about tablet optimization with 3D printing.
Despite the disruptability of 3D printing on the pharmaceutical manufacturing industry, IDTechEx stated that investment in research toward the technology is crucial. Moving forward with 3D printing does not just involve purchasing and implementing a 3D printer, but also necessitates progressing research behind the technology.
Scalability and regulatory impacts
In 2016, the US Food and Drug Administration (FDA) approved the first 3D printed prescription drug. The medicine was manufactured by Aprecia Pharmaceuticals and was printed through the company’s ZipDose Technology platform. The tablet, according to Jennifer Zieverink of Aprecia, was said to be able to disintegrate with just a sip of liquid.
Zieverink told us, “The key to unlocking the potential for 3D printing in pharmaceuticals was the proprietary technology needed for production at commercial scale.”
In 2018, FDA commissioner Scott Gottlieb wrote a blog post on how the agency will take steps to create a clearer regulatory pathway on manufacturing processes, like 3D printing. In the post, he wrote that drugmakers will not switch towards this systems until a clear path to the regulatory clarity for drugs created from these processes was established. He stated that $58m had been allocated to develop the regulatory and scientific architecture needed to encourage the adoption of the technology.
Gottlieb also stated that 3D printing and other advanced manufacturing processes could potentially save $60bn per year in the US should they be adopted.
3D printing technology can also be used to shorten lead times on drug discovery and create more efficient research, according to IDTechEx’s report.
The technology can enable a pharmaceutical company working on early-stage research and development to create small batch sizes, even just one pill, therefore not requiring the use of a high amount of APIs needed to test the medicine.
Additionally, 3D printing can create preclinical models. Another spokesperson for IDTechEx told us that that 3D printed cell cultures provide drug testing in a relative environment that can streamline results. The spokesperson went on to say that the technology may enable the industry to “replace Phase I clinical trials with these kinds of 3D structures.”