Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March 2023 print issue.
Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.
There are myriad factors influencing the drug delivery market, such as the rising prevalence of chronic conditions, an ageing population, and technological advancements in drug development, leading analysts to predict continued growth in the sector at a compound annual rate of 3.7% between 2022 and 2030 (1). A significant driver of growth within drug delivery has been highlighted as the advancement of the biopharmaceutical industry, which is giving rise to new and innovative drugs for previously untreatable or incurable diseases and, hence, the need for ways to deliver these novel therapies.
To learn more about influential drug delivery trends, market drivers, aspects of drug delivery that require greater research, and how partnering with an outsourcing company can help in this sector, BioPharm International® spoke with Torkel Gren, senior director, science and technology officer, and Uwe Hanenberg, head of product development, Oral Solid Dose, both at Recipharm.
BioPharm: Over the past decade, what, in your opinion, have been the most influential developments in alternative drug delivery formulation?
Gren (Recipharm): The most influential development in recent years has been the advance in solid lipid nanoparticles that allowed the development of mRNA [messenger RNA] vaccines to tackle COVID-19. [This advancement] opens up the opportunity to develop many new pharmaceutical products with increased efficacy in the future. There is plenty of potential to harness mRNA technology to create exciting new vaccines and other therapies to tackle previously untreatable conditions over the next decade.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March 2023 print issue.
BioPharm: What trends in alternative drug delivery formulation do you think may be seen during the next decade?
Hanenberg (Recipharm): There will be increasing investment in new delivery technology for targeted and or simplified drug delivery. The effect/side effect ratio of a large number of drug substances can be significantly improved when delivered directly to the site of action. Administration by injection will play a key part here, alongside other delivery routes—topical, pulmonary, and ophthalmic, for example.
Integration of dosing with smart devices will also be a major theme in the coming decade as a means of increasing patient adherence. By monitoring biodata, such as blood glucose, these systems can provide both patient and HCP [healthcare professional] with valuable information to ensure that medication is used optimally to meet the unique needs of individual patients.
It is expected that the next decade will see advances allowing oral delivery of a greater number of biologic formulations. Efforts are already being made to develop a platform technology to support absorption of orally administered biopharma treatments, with exciting potential to further improve patient convenience.
BioPharm: Could you elaborate on any of the market factors that are driving growth in the alternative drug delivery formulation sector?
Gren (Recipharm): Rising demand for new biologics has created the need for special formulations for these treatments. It is important to note that the term ‘biologics’ refers to a large number of different modalities, from monoclonal antibodies, nucleotides, CAR-T [chimeric antigen receptor T] cells, and microbiome products. These all have their specific scientific challenges, each requiring a different formulation approach.
Interest in improved treatment for small indications has also contributed to greater demand for alternative drug delivery, as these often call for some special drug delivery solutions.
BioPharm: How have these drivers changed over recent years?
Hanenberg (Recipharm): The trend toward more advanced biological treatments with a higher potential to cure the disease rather than just its symptoms has implications for drug delivery. Technologies that ensure an effective treatment by improving the stability of the active ingredient and that can be administered easily (e.g., orally) are drivers and will enhance patient compliance This could increase the demand for specialized drug delivery solutions in the coming years.
BioPharm: Are there any areas in alternative drug delivery formulation approaches that still require a significant amount of research?
Gren (Recipharm): [There have been] impressive developments in new biological medicines in recent years, with a number of new therapies entering the global market. However, the cost of these products has undermined their impact on public health and wellbeing. More work needs to be done to reduce development and manufacturing costs of these biopharma treatments while optimizing their efficacy.
New drug delivery technology may help solve this problem in the future. Better formulation approaches, for example, have the potential to improve stability, resulting in longer shelf life and reduced need for cold storage. This can cut distribution costs significantly, especially in countries with warm climates and limited infrastructure. Currently, biologics that have exceeded their shelf life or been transported outside their allowed temperature interval have to be disposed of—which is also very costly.
The fact that most biologics today need to be administered by injection is also contributing to their relatively high overall treatment cost, as this usually means they must be administered to patients by HCPs. There is some interesting work on alternative administration routes (orals, buccal, and pulmonary, for example), but it is likely that injection will continue to dominate in the future, due to the unique stability and absorption characteristics of biopharma. Injectable delivery systems, such as auto-injectors, which allow self-administration by the patient in the home, can help reduce costs by eliminating the need for a trip to a clinic to be treated by a HCP. Depot formulations allowing monthly dosing instead of daily injection can also reduce the burden on HCPs and clinics.
BioPharm: What is the role of an outsourcing partner in the alternative drug delivery formulation market?
Hanenberg (Recipharm): Many different types of drug delivery technologies will be needed for different modalities, administration routes, and markets. As such, it is almost impossible for pharmaceutical companies to fill all their needs in-house. Outsourcing drug development and manufacturing to contract development and manufacturing organization partners can address this issue. By working with partners that have experience in a particular alternative technology, companies can benefit from specialist expertise and infrastructure, helping to smooth their development journey.
1. Precedence Research. Pharmaceutical Drug Delivery Market (by Route of Administration: Oral, Pulmonary, Ocular, Nasal, Injectable, Topical, and Others; by Application: Cardiovascular, Diabetes, Cancer, Infectious Diseases, and Others; by End Users: Hospitals, Ambulatory Services, and Home Healthcare)—Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2021–2030. Market Report, January 2022.
Felicity Thomas is the European/senior editor for BioPharm International.
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