Transforming Patient Care with Dermal Drug Delivery Systems
Andrew Riso, Vice President, Dermal Delivery and Licensing, Kindeva Drug Delivery
As interest grows in drug delivery methods that can improve adherence, enhance patient experience and support new therapeutic formats, dermal delivery devices are receiving renewed attention. By enabling minimally invasive and user-friendly administration, these systems can support better adherence, particularly for patients with chronic conditions, needle aversion or limited access to clinical care. Both transdermal and microneedle array patches offer the possibility to deliver drugs through the skin, but each brings distinct formulation, device and manufacturing challenges. Their development and scale-up require a coordinated approach that considers more than just bioavailability or skin permeability.
We’re only just scratching the surface of skin-based drug delivery
A closer look at how integrated formulation, device design and manufacturing can support the rise of dermal platforms.
We are entering an exciting era for dermal drug delivery. Recent innovations in transdermal and intradermal technology promise a future where patients can administer drugs in a more effective and less invasive way, even at home.
These advances look set to herald the next step-change in the delivery of vaccines, as well as a range of other therapeutic treatments. However, several challenges must be overcome before this technology can be widely commercialized.
Patients and crucially, regulators must be confident that the platforms can administer the appropriate doses consistently, and that they can be manufactured at the scale required realizing their full potential across the world.
This requires an understanding of what is required for effective manufacturing, even at the earliest stages of formulation and development. Companies will need to consider the regulatory requirements of the final product, as well as how to adhere to good manufacturing practice (GMP) and de-risk the leap from lab to market.
The potential of these new dermal technologies is enticing. However, their development will require close cooperation and collaboration between experts at all stages of the process, from innovative biotech companies to experienced manufacturers.
The promise of dermal drug delivery
In recent years, we have seen increasing interest in dermal drug delivery platforms across the industry.
Patients are calling for treatments that can be used to treat a range of conditions, including existing and emerging chronic diseases. They also want treatments that can be administered at home rather than at a hospital, and without the discomfort of needles where possible.
The promise of at-home, personalized medicine has also attracted the attention of governments and funding organizations, who see an opportunity to reduce the strain on healthcare systems, improve patient take-up of medication, increase resilience against pandemics, and broaden access to drugs worldwide.
As a result, companies have launched several early-stage and pre-clinical studies aiming to advance transdermal and intradermal drug delivery technologies. In 2024 the market for transdermal drug delivery systems was already valued at 7.32 billion USD, with projections suggesting a rise to 9.87 billion USD by 2030 Innovative companies are considering the potential of this approach to treat conditions including diabetes, migraines and hypertension.
There is also considerable excitement about the possibilities of intradermal microneedle-array patches (MAPs), which feature an array of microscopic needles designed to deliver medication through the outermost layer of human skin. This technology is less invasive than traditional injections, making it more suitable for patients with needle-phobia. Applying a patch is also considerably simpler than the traditional intradermal injection process, which requires the precision of a trained healthcare professional.
Delivering directly into the dermis means a vaccine is in contact with more antigen-presenting cells, and could therefore generate the desired immune response, even with a smaller dose. This is an approach used in “dose sparing”, in which vaccine supplies are extended further by giving smaller amounts to each patient just under the top layer of skin.
MAPs can also potentially offer room temperature stability, which could allow them to be transported and stored worldwide without the need for rigorous cold-chain storage requirements. This could be vital in opening up products to markets without well-established healthcare infrastructure.
However, as of yet, no microneedle technology has been approved by the FDA for use in drugs or vaccine delivery.
Meeting the challenges
So, how do companies bring the potential of innovative dermal drug delivery platforms to market? The answer lies in collaboration. Biotech companies, academic institutions, and experienced contract development and manufacturing organizations (CDMOs) need to work together to develop a more holistic understanding of what is required at every step of the development process.
Companies and partnerships which consider the impact of formulation and design decisions on scaling and manufacturing from a very early stage have a far greater chance of bringing their products to market before the competition.
For example, choosing whether to deliver your drug using a transdermal or intradermal platform can come down to several factors. One of the main determinants is the desired pharmacokinetic profile for the drug – or how it is absorbed, distributed, metabolised and excreted in the body. Transdermal delivery is more suited to relatively low molecular weight drugs in which a slow, sustained release is beneficial to achieving the desired therapeutic outcome. Furthermore, the rate of diffusion of molecules through the skin will determine the size of the patch used, and the design will have to ensure that the drug is delivered over the required period, which is typically 1-7 days.
In the case of MAPs, the drug or vaccine will be delivered into the skin far more quickly, which is well suited for therapeutics and vaccines in which an immediate release profile is desired.
There are different types of MAPs currently in development, including solid needles coated with formulation, formulation moulded into dissolvable microneedles, and hollow microneedles through which liquid formulation is infused.
This means there are a number of complex considerations that developers and CDMO partners must consider, including:
• The microneedle material and how it releases the drug
• How the drug formulation is released, and its compatibility with the microneedle material
• How the drug is loaded
• How the patch is assembled
• How packaging maintains product stability
• The size and position of droplets on the microneedle
Ensuring that the required dosage of the drug is delivered in a sustained and consistent manner is integral to the process. There are a number of parameters that influence delivery from solid-coated MAPs:
• Needle height: Taller needles can carry more medication, but if taken to an extreme, can affect patient comfort
• Needle sharpness: A sharper needle can penetrate more easily, but may be more difficult to manufacture consistently.
• Microneedle density: Higher density can result in higher dose delivery, but can also reduce the effectiveness of penetration and result in greater local site reactions.
• Patch size: Larger patches can deliver more of the drug, but may cause inconvenience for the patient
Considering manufacturing from the outset
Developing any drug or combination product holds a certain degree of risk. However, considering manufacturing needs and challenges from the very start can help forward-thinking companies to anticipate and even avoid future challenges.
For example, it is vital that companies are able to produce dermal drug delivery products to scale and to a consistently high standard. These are drug-device products, which means that both the formulation and the device itself should be developed and optimized in sync to ensure that the final product is safe and performs to its potential.
An experienced CDMO can also work with a developer to ensure that the product can be scaled to the required level without sacrificing uniformity and quality. This comes with its own considerations, including the choice of materials for microneedles and how they are produced. By thinking ahead to manufacturing at the earliest possible stage, the right materials and approaches can be selected.
Companies must also consider issues such as quality control and adherence to regulatory standards. In the latter case, being able to maintain early and consistent contact with these bodies can be a strong advantage when it comes to maximising the chances of approval.
CDMOs with drug delivery expertise have the unique ability to address this demand. These partners have extensive knowledge of working with early-stage companies and calibrating manufacturing processes to specific patient needs, formulations, and market strategies. They ideally also have extensive knowledge of how to develop dermal products from concept to manufacturing, and how to work together to achieve optimal results.
A new era of collaboration
By working together effectively, drug developers and manufacturers will be able to achieve significant benefits.
They will potentially be able to deliver more effective treatments for a wider range of conditions and administer therapies in a less invasive and more personalized way. Governments and non-governmental organizations will be able to distribute essential care more widely, especially to places where transport and storage are an impediment.
However, to achieve this, we must make sure that these transformative products are given the best chance to succeed.
Complex combination products such as MAPs require a joined-up, holistic approach to development, where future challenges are anticipated and addressed. This means addressing manufacturing considerations from the very start, and working with experts who can smooth the path to regulatory approval and mass-market adoption.
We are already seeing collaborations and knowledge sharing across the industry, with developers integrating manufacturing insight into their processes from the outset. It is important that this trend continues.
By prioritizing manufacturing optimization, partners can ensure that these products provide optimal patient comfort and convenience and deliver much-needed treatments reliably and consistently.
Author Bio
Andrew Riso is a seasoned business development and licensing executive with over 15 years of experience across the pharmaceutical and financial services sectors. He currently serves as Vice President of Dermal Delivery and Licensing at Kindeva Drug Delivery, where he leads strategic initiatives in transdermal product innovation and partnership development.
Prior to his current role, Andy held multiple leadership positions within Kindeva and its predecessor, Meridian Medical Technologies, including Director of Business Development. He also provided strategic consulting services in business development and planning.
