Many pharmaceutical companies are prioritizing the clinical development and commercial use of injectable biologics that target the long-term treatment of chronic or rare diseases.
A series of converging market trends are driving the development of such molecules in patient-centric, subcutaneous formulations that strike the right balance between injection frequency, dose volume and drug viscosity. Limitations with conventional hand-held devices can necessitate formulation compromises that may lead to sub-optimal rates of therapy adherence, user acceptability and brand preference.
To help our customers enhance patient care, generate value-based healthcare outcomes and differentiate their therapeutic brands from the competition, we are committed to the development and supply of market-leading, high-quality products that meet their specific formulation, user and commercial requirements.
Converging Market Trends and Unmet Customer Needs
Our business strategy is centered upon addressing a series of converging market trends and unmet customer needs:
- Shift to patient self-administration
- Shift to injectable biologics
- Shift to subcutaneous administration
- Shift to the supply of therapies ready for injection
- Shift to the injection of larger dose volumes less frequently
- Shift to the selection of drugs based on value-driven healthcare outcomes
To reduce healthcare costs and enhance patient care, pharmaceutical companies are seeking to develop their therapies in formulations that are suitable for patient self-administration outside of healthcare facilities. Drug delivery systems such as wearable injectors can help to enable or enhance the delivery of therapies for intuitive, convenient and comfortable self-administration by patients whenever or wherever they are during a normal day. With many companies having multiple target molecules and indications, it can be beneficial to provide platform-based delivery systems that are easily customized to the specific needs of each patient population.
Global drug sales continue to shift from oral or small molecule drugs to biologics that must be administered by injection into the body. Injectable biologics are commonly approved for use as drug-device combination products, where the delivery system is integral to the administration of the therapy. Regulatory agencies are increasingly focusing on the approval of injectable biologics where there is strong human factors data supporting its safe and proper use by the target patient population. Long-term relationships between drug and device manufacturers can help to minimize risk and maximize success for the clinical development, approval and commercial use of combination products.
Helping to accelerate market trends for the self-injection of biologics is a shift in the route of administration from IV infusion to subcutaneous injection. Many therapies targeting the treatment of cancer or chronic diseases have traditionally required patients to either visit primary or specialty care centers, or to have healthcare professionals visit their home, to receive an infusion of medication over a few hours. The socio-economic costs of IV infusion can be significant, with patients, payers and prescribers typically preferring the use of therapies that are approved for subcutaneous injection.
Wearable injectors can be pre-configured to subcutaneously deliver a large dose volume of medication over a specific rate and duration. This can create opportunities for pharmaceutical companies seeking to improve or extend the commercial lifecycle of injectable therapies initially approved for IV infusion.
Traditionally, injectable drugs and vaccines have been supplied in vials, with healthcare professionals required to draw up a measured dose in a device such as a syringe prior to use. The complexity of some of these drugs may also require their delivery in a lyophilized or powder form for reconstitution, further increasing preparation time, cost and complexity. The supply of therapies in prefilled syringes, auto injectors or wearable injectors that can be pre-filled and fully integrated with a measured dose of liquid drug can help to reduce the number of parts required for purchase and storage, the time and cost of preparation, and the risk of human error or drug wastage.
While it is a common preference amongst patients and prescribers to administer therapies as infrequently as possible to minimize disruption to normal life, many biologics are traditionally approved for frequent administration cycles such as every week, two weeks or month.
A key gating factor restricting the administration of therapies on a less frequent basis is the limitation of hand-held devices such as prefilled syringes and disposable auto-injectors to the delivery of doses up to 1.2mL over a period of 20 seconds or less. Some companies have sought to overcome this constraint by supplying two or three prefilled devices to administer a single prescribed dose of medication. This may, however, affect rates of user preference, as well as increase the cost and time to administer a dose. Wearable injectors represent a significant opportunity to administer biologics a larger dose volume of drug less frequently, potentially increasing rates of therapy adherence and brand preference.
As healthcare providers shift from a price-based selection model to one based on the creation of value-based outcomes, it is becoming important for pharmaceutical companies to capture therapeutic data relating to rates of patient adherence and long-term drug performance. For many chronic diseases, poor rates of non-adherence due to factors such as not following a prescription regime due to forgetfulness, pain or discomfort, can adversely affect a patient’s health and create significant financial wastage.
Through the integration of modern technologies such as Bluetooth LE and apps with drug-device combination products, it becomes possible for pharmaceutical companies to create a therapeutic ecosystem that enables healthcare providers to make data-driven procurement decisions. Options created by smart drug delivery systems include reminders for patients to take their medication, automatic dose scanning to confirm prescription and expiration status, and the transmission of adherence-related information to data hubs for review by authorized parties. Such real-time or historic data can potentially be leveraged by pharmaceutical companies to build or protect market share against competitors with inferior access to such information. Unilife is the market leader for platform-based wearable injectors. To find out more about why a partnership with Unilife can enhance and differentiate your injectable therapies, click on one of the links below: