Injection Devices

SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market

Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.

DRY-POWDER THERAPEUTICS - Respiration Inspiration: Local Treatment of Lung Cancer by Dry-Powder Inhaler

Philip Kuehl, PhD, and Kimberly B. Shepard, PhD, describe the formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. Two case studies are presented in which two approved drugs are successfully formulated for DPI administration to the lung.

Moderna & Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine & Clinical Portfolio

Moderna, Inc. and Catalent, Inc. recently announced the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other….

INHALATION DELIVERY - Inhaled Drug Development: Optimizing Delivery

Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.

BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices

Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.

What are Injection Devices?

Drug delivery devices are the physical agents that are included in the drug delivery system. There are a multitude of devices that people interact with every day which fall under this category. In modern pharmaceuticals, novel drug delivery devices and combination products are being designed for a number of reasons, including giving patients the ability to self-administer some medications at home, which can help them adhere to recommended regimens.

Evolution of Injection Devices

With modern technology and medicine, the combination product market is evolving. Any combination device, especially drug device combination devices, must follow strict guidelines. Thanks to advancements in engineering, an increasing number of drug delivery devices are being developed as electromechanical devices linked to apps in order to provide patients with more supervision when administering medications at home. Some of these medical apps may receive feedback from the device to track how much drug is being administered and how often, provide patients with dosing reminders and connect clinicians with this information so they can monitor patient compliance. The drug delivery devices that so many patients depend on must adhere to regulatory standards. There are strict guidelines for all methods of drug delivery, such as needle-based, aerosol, and needle-free injectors.

Smart devices, interconnectivity, and related technology provide real-time data to healthcare providers for analysis, but these device additions should not increase risks, including patient understanding of treatment delivery, or jeopardize compliance. Data collection needs to be “passive” to the patient. In other words, invisible to the patient’s use of the device so that the collected data provides a true benefit to the end user. If these design considerations can be implemented without impacting the patient or how they administer and receive treatment, then smart devices can provide advantages to the patient and the industry.

Injection Device Global Market Trends

The global injectable drug delivery devices market is expected to show significant growth in the coming years as manufacturers introduce technological advancements and product innovation meant to improve convenience, compliance, and ease of administration of parenterals. Additionally, the increasing preference for at-home self-injection is driving the market as patients prefer to continue to avoid healthcare settings post-COVID. With all of this taken into account, one market study predicts the global market to reach almost $26 billion by 2025, up from $15 billion in 2020. However, another report values the global market at $42.76 billion in 2021 and expects it to reach $50.9 billion in 2025.

How the numbers will play out is yet to be determined, but the studies do highlight the focus on single-use and reusable systems. Disposable-use prefilled syringes (PFS) are increasingly used due to the prevalence of chronic diseases and the growing number of biologics best delivered by syringes. Single-use autoinjectors are also poised to experience increased demand, particularly with the growing pervasiveness of anaphylaxis disorders. Autoinjectors also provide a convenient alternative to manual syringe injections for subcutaneous administration.

Reusable Injection Devices

Pen injectors with prefilled cartridges have also proven to be a viable  alternative to syringes. These injectors can perform hundreds of injections, with patients controlling the speed of delivery to minimize pain or discomfort during use.

Making injection devices partially reusable is a cost-saving strategy. Ideally, the device’s mechanism and/or electronics are the reusable parts of the system – as these are often the costliest – and the drug containers and needle are one-time use.

Another cost-saving strategy that several large pharmaceutical companies are deploying is to develop a device platform for multiple drug products in their portfolio. This allows them to spend resources on a single significant development program, for one optimal injection device, which then requires minimal customization for each sub-sequent product line.

Despite efforts to make better, safer, simpler injection devices, patient adherence is still a challenge associated with self-administration. This has resulted in the emergence of smart devices, such as wearable injectors, which share patient data with healthcare providers to ensure compliance. And while it is expected this sector will continue to grow, some industry insiders warn against making these devices too intrusive.