Q: Why has patient self-administration of therapies become such an important driver in the healthcare and pharma sectors?

(MACIEJ FROLOW/GETTY IMAGES)

This trend has had a significant impact on the evolution of injectable drug delivery technologies. Many people are familiar with self-administered medications, such as inhalers for treating asthma, but few individuals, other than diabetics, have experience of injecting themselves using a syringe. As a result, drug delivery companies have had to develop devices that are both intuitive and safe. With the increasing number of approvals for new biologics in recent years, demand will also be quite strong for auto injectors and pen injectors. However, developing and producing an injection device that is safe, ergonomic, easy to use and accurate enough for a patient to self-administer involves meticulous designs, innovative technologies and consistent manufacturing. For example, the spring mechanism inside an auto injector controls the force and timing of the injection and is designed to accommodate the desired injection specifications, while the outer shell of the device may be affected in size and design by the primary container inside and human factor constraints. Once a proven mechanism is designed, ensuring consistent manufacturing then becomes vital because quality needs to be built into every device produced. At this time, there are only a few companies in the world that can design, develop, manufacture and assemble these pen-like devices, and these companies will need to work closely with biopharmaceutical partners to ensure that patients get the best drug delivery devices possible for their given therapeutic area.

Steven Kaufman

These biologics often have complex technical requirements for injection. For example, they have higher volume or are more viscous, so the technical specifications of these biologics is more challenging and requires complex delivery technology. This growing trend explains why self-administration has become so important. In this respective, device manufacturers must be proficient in patient-centric design and should consider the ergonomic and human factors.

Integrating those biologics with the right delivery system has become critical, not only from a technical specification standpoint, but also from a competitive perspective. The competitive dynamics for new drugs in different fields will require different considerations in the selection of an injection device. Patient consideration is also a factor; for example, a patient with rheumatoid arthritis may have dexterity issues, requiring certain design specifications to make the device intuitive and easy-to-use. In this respective, it's important for device manufacturers to be proficient in patient-centric design and to consider the ergonomic and human factors.

Integrating the primary container with the secondary device successfully is also critical. Companies offering self-administration technology need to have that expertise in order to improve performance of a drug device solution, reduce risk of failure and accelerate speed to market for customers.

Potter: Rising healthcare costs mean that treating patients is becoming more and more expensive. If a patient can self-administer their medication then this reduces the time they need to spend with a healthcare professional and, thus, reduces cost. Most medications can be taken orally, but many peptides and proteins have to be injected to ensure they are not damaged by the acidic environment in the gastrointestinal tract. If a patient is to be trained to self-inject, however, then the technology needs to be simple to ensure that it is operated correctly. In addition, medication compliance is a serious issue with many patients; the easier and more convenient the product is to use, then the more likely the patient is to take their medication. These needs for lower cost of goods, ease of use and convenience are also shaping the evolution in drug delivery technologies suitable for self-injection.

Sadowski: Self-administered products currently account for about half of the of therapeutic biologics market. The simple reason for this is that more biological agents requiring injection are being used in chronic conditions, such as rheumatoid arthritis, psoriasis and multiple sclerosis. Since it is both costly and inconvenient for patients to go to their healthcare provider to administer these biologics daily or weekly on a chronic basis, the burden falls upon the patient. Fortunately, technologies exist that make the self-medication process as comfortable and easy as taking a pill.