By Doug Roe, Chief Editor
This Q&A is the first in a five-part series that will examine industry opportunities in the drug delivery device space. Subsequent installments will look at regulatory compliance, quality systems, mHealth and the Internet of Things (IoT), and vertical integration of product development.
As challenges continue to mount in the med device industry, many companies are looking to diversify. One area to look may be right in our life science backyard. Whether you are an original device manufacturer, an outsourced service provider, or a component/material supplier, the opportunity for growth over the next ten years in drug delivery devices is enticing.
EvaluatePharma projects that biologics will represent 50 percent of the world’s top-selling drugs by 2020. That translates to a 200 percent increase in just five years. Why is that significant? Unlike typical oral dose drugs, biologics require a device to deliver them past the body’s natural defense systems.
Again, why is that significant? Drug manufacturers have decades of experience with the research, development, and formulation of drugs, but only a few have the necessary expertise in device development. As healthcare reimbursement eligibility becomes more stringent, drug companies must outperform the “me too” status quo. Also, serving the adherence and compliance needs of the modern, tech-savvy patient requires meeting demand for improved device usability. These combined drivers will force the advancement of additional technological features and benefits for delivery devices.
The huge growth in biologics will lead to a large demand for new and more complex devices in a drug industry that lacks the needed expertise. Opportunity is knocking.
I recently sat down with a group of drug delivery device experts on behalf of our sister publication, Life Science Leader magazine. The resulting article discussed this convergence of drug and device, as well as the drug delivery market outlook for 2016 and beyond.
One of those participants was Neil Cammish, Technical Director, International Device Solutions. Neil has his roots in design engineering and manufacturing management. He has spent the last ten years sharing that expertise with pharma/bio companies like Teva, Sanofi, and Roche to develop drug delivery device solutions.
What therapeutic areas — related to drugs administered via a delivery device — will represent the biggest opportunity in 2016?
Neil Cammish: Areas related to drugs that are difficult to deliver manually. They fall into two general categories: Long-acting release therapies (e.g., Bydureon), which involve complex user setups, and viscous drug products, which include long chain molecules, oily suspensions, or micro spheres. This latter category contains larger molecules with higher dosage concentrations, which cause discomfort or pain during injection.
For these reasons, rheumatoid arthritis and type 2 diabetes have the biggest opportunities in the short to mid-term. Of course, this will be exacerbated by any related patent expiry.
For example, many generic and biosimilar companies have their eye on AbbVie’s Humira, as part of the original drug developer’s intellectual property protection will expire in the U.S. in December.
Which drug delivery device platforms do you expect to have the most growth in 2016?
Cammish: Conventional auto-injectors will have the most growth, driven by the continued transition from the traditional prefilled syringe to automated delivery devices. There will also be large, mostly hidden, growth in device development for bolus and high-volume delivery mechanisms. This is mainly due to latency in the market and the start of second-generation devices, which will add additional patient benefit and market advantage. Think of the smartphone leap from the functional entry-level Windows CE phone (in 2001) to the dynamic iPhone (first generation was launched in 2007) we know today.
What will be some of the key challenges facing companies that are expanding competencies into these delivery device platforms?
Cammish: There are challenges at all levels of the company: R&D must find an unmet need related to the combination of drug and device. Legal must not losing sight of intellectual property considerations. Human resources must source experienced staff and support personnel that have both technical and device industry experience. Finally, it will be up to C-suite leadership to trust the experts that they hire.
How can drug companies drive delivery device design innovation in 2016 and beyond?
Cammish: Install user-led design. Focus solely on delivery mechanisms and devices, without waiting for a molecule. Funding is typically top-down therapy-led, with a direct market need and an aggressive timeline. There is a definite innovative benefit to stepping back and funding development outside of standard-project constraints. Determine what patient populations require and work from the bottom up. The allocation of time and space for existing device-development teams, working only on innovation, is what would be required.
What are your market growth expectations for drugs delivered by device?
Cammish: There will be little growth in pen devices as therapies shift to longer-acting, modified-release drugs. It is not that the usability or utility of the pen injector will decline, but simply a reduction in its frequency of use.
Expect double-digit growth in auto-injectors and other devices capable of high volume and/or viscous drug delivery. The majority of this growth will be linked to biologics. The core need is for patient convenience, coupled with the reduction of clinical care costs by facilitating home use.