Drug delivery systems have evolved over the last six decades; pills were the initial area of focus, but in the last 12 years, drugs have been delivered using self-regulated and nano-technology systems. With the markets for biosimilars and biologics surfacing, manufacturers have the opportunity to innovate and design more complex delivery methods. As competition becomes increasingly tense in both the pharmaceutical and medical device industries, companies have turned toward developing drug delivery devices as an opportunity to differentiate themselves and to diversify their portfolio. These industry trends beg various questions that I hope to provide some answers to, including: What is driving growth in the drug delivery device market? What challenges do manufacturers face? And how can these challenges be successfully overcome in order to fully reap substantial returns in this lucrative market?
What is driving the drug delivery market?
One of the key advantages of drug delivery systems is that they allow the drug to target a specific site of action. This enables the drug’s effect to be more localized and for sites to be targeted that would otherwise be difficult to reach. Drugs that are more site-specific can also help minimize undesired side effects. For example, UroGen Pharma, an Israel-based drug manufacturer, has partnered with Allergan, the manufacturer of Botox, to develop a drug delivery system that allows botulinum toxin to be delivered to the bladder through intravesical instillation to treat urinary incontinence. UroGen’s delivery system mixes Botox with its RTGel, which has thermosensitive properties, converting from a liquid state when chilled to a gel at body temperature. Upon contact with the urinary bladder, the gel’s mucoadhesive properties allow it adhere to the bladder wall, and as it gradually dissolves because of its biocompatibility and water solubility, it provides a sustained release of Botox. This delayed excretion of the drug produces a longer-lasting effect, potentially improving treatment efficacy.
Another area of focus is increasing patient compliance—a big concern among physicians and manufacturers alike. For example, manufacturers are working on self-injection systems that are user-friendly, are intuitive to use, and also increase patient comfort. For example, Novo Nordisk’s FlexTouch insulin pen is created with a non-extending dose button that requires minimum force to inject, an end-of-dose click to confirm administration, as well as a thin needle to reduce pain when injecting. Similarly, Bayer’s Mirena device, a hormonal intrauterine device (IUD), has gained popularity as a method of long-term contraception. The IUD requires replacement only once every 5 years, in comparison to a hormonal pill, which needs to be taken daily and requires a doctor’s visits for each prescription. Companies are also increasing convenience for patients by enabling them to use the same device they have become comfortable and familiar with to treat new indications. For example, GlaxoSmithKline’s Breo Ellipta inhaler can now be used for the treatment of asthma, in addition to its initial indication as a once-a-day respiratory inhaler. Going forward, manufacturers are developing devices that would enable the transfer of more viscous drug products; larger molecules and higher dose concentrations are often more difficult and painful to inject through manual delivery methods.
In addition to benefiting the patient, drug delivery systems can also be beneficial to manufacturers. The development of a drug delivery device can help extend the patent protection on a drug. For example, GlaxoSmithKline’s patent on Advair—a drug used for the treatment of asthma attacks and chronic obstructive pulmonary disease—expired in 2010 in the US. However, the company gained an extra six years of protection through a separate patent on its Diskus inhaler used to deliver Advair into the lungs. Not only does the delivery device extend the drug’s patent protection by delaying when a generic can be launched, but it also makes it more difficult for manufacturers to develop a generic with an equivalent function.
What challenges do manufacturers face?
Because quality control, regulatory guidelines, and reimbursement work very differently across the pharmaceutical and medical device industries, companies that are considering developing a drug delivery device need to recognize and incorporate necessary research and development early in the planning process to help mitigate problems that could arise later in the production process. Considerations that a pharmaceutical company may have, such as whether to run production in-house or by partnering with a medical device manufacturer, or where and how to perform quality control, need to be fully understood prior to production. Similarly, medical device manufacturers need to consider clinical guidelines such as the timeliness and likelihood of success of drug clinical trials as well as ensuring their device is designed to meet the needs of the intended use of the drug.
Moreover, regulatory requirements governing combination products also differ from both pharmaceuticals and medical devices. The available FDA guidelines for combination products are not well established because of the relative novelty of these device types; this will pose a challenge for competitors in this space as they attempt to deliver their products while complying with standards that currently lack clarity.
Traditionally, the drug delivery device market has been largely dominated by pharmaceutical companies that collaborate with medical device companies late in the production process; device manufacturers that sell their devices to pharmaceutical companies; or more recently, large pharmaceutical companies such as Pfizer, Eli Lilly, and AstraZeneca, that run production in-house. Setting up in-house production for a device, however, is a costly investment, particularly for smaller companies. Thus, it is likely that the future of the market will see a convergence between the pharmaceutical and medical device sectors, be that through acquisitions or the formation of partnerships.
How can manufacturers fully reap substantial returns in this lucrative market?
It is evident that, with the advent of biosimilars that are driving the need for more complex drug delivery systems, as well as a growing demand for more efficient drug delivery methods, the market for drug delivery devices will continue to develop and represent a lucrative opportunity for drug and device manufacturers alike. In a market strongly driven by innovation, manufacturers need to ensure their devices are customizable and user-friendly for patients in order to drive compliance. Moreover, the consideration of regulatory implications and device reimbursement should be deliberated early in the production process to ensure cost effectiveness and regulatory success. What the future holds for this market is the emergence of increased collaboration between the currently disconnected medtech and pharma industries through increased acquisitions, communication and integration.
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