Industry Voices: How Will Macromolecular Drugs Change by 2030?
How Will Macromolecular Drugs Change by 2030?
We have already seen a great deal of development across macromolecular drugs over the last few years alone, revealing so much potential and many lessons still to learn.
How will the sector look in the next decade, and what shifts might we see throughout the biotech industry as a whole?
We reached out to three experts to find out their perspective
Ian Thompson, Vice President Business Development at Ypsomed Delivery Systems
The demand for subcutaneous self-injection delivery systems is growing significantly in line with the number of injectable drugs in development. Pen technologies are traditionally favoured for frequently injected peptide-based therapies. With longer-acting peptide formulations, iRNA/oligonucleotide therapies and the broad range of mAb therapies there is a huge increase in infrequently injected therapies requiring autoinjectors and in the future patch injectors for even larger injectable volumes. The use of convenient prefilled, preassembled devices dominates the space. Over the next 10 years we will see improved and connected versions of pen, autoinjector and patch injector technologies, that are safe and easy to use and at the same time sustainable.
Christopher A. Rhodes, Ph.D., President & CEO, Drug Delivery Experts
The holy grail of macromolecule delivery is still the search for an effective oral delivery system with the goal of systemic delivery. We have seen the recent clinical translation of the Rani Therapeutics intraluminal microneedle system with human data on octreotide and a bioavailability of 70%. By 2030, I would anticipate seeing more of these systems translated to humans and hopefully some in phase 2 and 3 development. Safety is the primary concern for these intraluminal injection systems.
Another area of developing interest is the topical delivery of peptides and proteins to receptors within the wall of the GI system. Much good work is going on in this space and I would anticipate more products get approved by 2030. Peptide products have been approved in this space and I would anticipate oral protein and antibody work will follow. Yet another developing field is the increased interest of macromolecule delivery to the brain. A number of systems are at the R&D stage and will hopefully be translated into the clinic by 2030.
Craig Duvall, Cornelius Vanderbilt Professor of Biomedical Engineering, Vanderbilt University
One of the biggest challenges is pursuing disease applications where there is significant value added by a macromolecular drug. Small molecule drug development pipelines / regulation are better established, and small molecules tend to be less expensive to manufacture and less complex to price and reimburse. Therefore, we need to continue to be thoughtful to prioritize pursuit of targets that are not “druggable” by conventional small molecule approaches or of scenarios where the macromolecular drug provides a large benefit over small molecule alternatives in terms of either safety or efficacy.
Continue to read more from Craig Duvall >>
RNA chemistries have made enormous strides over the past decade, with highly stable, carrier free, and cell-targeted molecular conjugates reaching the clinic. However, clinical success remains relegated to targets in the hepatocytes in the liver, and these technologies need to be extended to other cell and tissue applications.
Better developed non-viral delivery systems are still needed in particular for gene editing applications. Relative to viral formulations, non-viral systems may allow for potentially lower priced drugs and better compatibility with repeated treatment of patients who have or develop immunity against adeno associated viruses.
I think we’ll see continued growth and breakthroughs. I think we’ll see more and more prevalence of RNA drugs entering the market and continued growth of peptide drugs as well. I think that we will also see the clinical emergence of gene editing technologies. The first approvals will likely be delivery of ex vivo gene edited cells, but I anticipate we will see emergence of approved therapies for in vivo editing by the end of the next decade.
Created with Sketch.