Since 2015, the global injectable/parenteral drug delivery market is growing at a compounded rate of 11.8% and is forecasted to reach $640 million by 2021. It has the potential to soon eclipse oral delivery as the primary route of administration of pharmaceuticals, driven by the increased use of biological drugs.1 In 2017, Nine out of the top 10 products were biopharmaceutics while this number was just one, back in 2003.2
The biologics drug development has stimulated innovations in novel injectable drug delivery systems. The conventional intravenous (I.V.) formulation is not suitable for biologics delivery due to its high viscosity, higher dosage volume, higher molecule size, protein stability issues and the need for targeted delivery (e.g. ocular delivery). The subcutaneous (SC) formulation has several advantages over IV and other formulations
SC formulation is well established and accepted by patients of metabolic diseases e.g. growth hormone deficiency, diabetes etc. The SC injection technology is rapidly finding its utility in other therapy areas such as oncology and autoimmune disorders, in which traditionally IV was the standard of drug delivery. In 2017, 95 biologic therapies for SC administration approved by the US FDA. Approx. 240 SC biologics are either in development or have been submitted for FDA approval.3 Let us quickly look at some of the innovations in injectable drug delivery systems around SC formulation in recent times
The first EpiPen was invented in the mid-1970s and was commercially launched in the 1980s. It took more than two decades to have a generic EpiPen approved in 2016 (Mylan). The biggest value generated by self-injectors has been the patient control over her treatment and making them independent of caregiving. The high-speed injections have reduced the in-clinic time for patients. Increased use of this technology has shifted a significant portion of the disease management from hospitals / clinics into patient’s home. Self-injected pharmaceutical is the fastest growing injectable drug sub segment, driven by the extended treatment duration involving repeat dosing. The self-injected pharmaceutical market is growing at an annual rate of 22% to reach $80 billion by 2022 at 22%.1
The latest environment friendly idea in the field is the reusable modular auto-injector with remote connectivity, (de)centralized monitoring and dynamic dose delivery options.
Wearable Drug Delivery Technology
The SC technology comes with its own set of issues beyond the psychological barriers of being pricked! Physiologically the subcutaneous tissue has a limited physical and absorptive capacity for a rapid influx of large volumes (e.g. >10mL), and associated injection pressure may lead to drug leakage and injection pain. Wearable injectors effectively address the volume, viscosity and speed challenges of prefilled syringes and autoinjectors. For example, the Onpro® on-body injector allows the neutropenia drug Neulasta® to be diluted and administered over a long period without inhibiting the patient´s daily activities. Slower flowrates also mean reduced site reactions and pain.
Wearables definitely promise to positively impact patient compliance and adherence. Precedents have been set by Amgen with its Onpro® and Pushtronex® (a single-use on-body infuser containing evolocumab for hyperlipidaemia). These products have admirably eased patient lives by enabling them to administer their treatment in their homes safely and effectively.
The fear of needles can adversely affect patient compliance. According to a survey conducted in 2012, 20% of RA sufferers report that they would not consider using a medication that required self-injection. Needle-free technology has the potential to solve this need. These injectors work by generating a sudden burst of energy (and often an accompanying loud bang) that breaks the skin barrier and then drives the drug product through that breach of skin. Few problems with this approach are
a) unregulated injection depth,
b) inability to handle larger volumes, and
c) uncontrollable action.
Recently, Portal Instruments have designed a needle-free injector with a feedback system that enables the personalization of force generation and drug delivery. The velocity profile of Portal’s device is much more controlled, with an initial fast penetration phase followed by a consistent, slower delivery of the drug. The device can be connected and therefore presents the future possibility of remote delivery management.
Parenteral drug delivery has come a long way from being limited to use in specialist centers to being commonplace in managing chronic diseases at home. Patients are becoming informed ‘consumers’ and are demanding auto-injectors for greater control over disease management. The market for innovations in parenteral drug delivery is growing rapidly with the growth in the prevalence of chronic diseases: 50% of the world population will have a chronic disease by 2030.1
Drug delivery systems are a vital part of the patient therapeutic experience. Along with chemistry (molecule) engineering (delivery devices) innovations, the digital platforms are creating an opportunity for the Pharmaceutical industry to transition from disease management to outcomes management. A company´s ability to integrate the three technological frontiers to understand and improve patient experience and outcomes, will be critical to its commercial success.
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