Smart Injections: Aptar and Enable Partner on Digital Drug Delivery
- Market Growth: The on-body drug delivery systems market is projected to grow from $40 billion in 2024 to over $82 billion by 2033. - Device Capacity: Enable’s enFuse® system delivers large volumes of medicine (2 mL to 10 mL) subcutaneously. - Regulatory Milestones: enFuse® received U.S. FDA approval in 2023 and EU’s CE Mark in March 2025.
Experts view this partnership as a strategic advancement in patient-centric care, leveraging digital health to improve adherence, treatment outcomes, and real-world data collection for biologic therapies.
Smart Injections: Aptar and Enable Partner on Digital Drug Delivery
CINCINNATI, OH – April 08, 2026 – In a significant move to merge advanced drug delivery with digital health, Aptar Digital Health and Enable Injections have announced a strategic partnership. The collaboration names Aptar Digital Health as the preferred partner to create a companion digital solution for Enable’s innovative enFuse® on-body drug delivery system, a technology designed for self-administering large-volume medications at home.
This alliance aims to create a more connected and supportive ecosystem for patients managing chronic conditions. By integrating a sophisticated digital application with the physical injection device, the two companies are poised to enhance patient confidence, improve adherence to complex treatment regimens, and provide invaluable real-world data to healthcare providers and pharmaceutical companies.
The Smart Injection Revolution
The partnership arrives at a pivotal moment in healthcare, marked by a decisive shift toward patient-centric, home-based treatment. The market for on-body drug delivery systems is expanding rapidly, with projections estimating its value will surge from approximately $40 billion in 2024 to over $82 billion by 2033. This growth is largely fueled by the proliferation of biologic drugs, which are increasingly formulated for subcutaneous (under-the-skin) delivery rather than time-consuming intravenous infusions in a clinical setting.
At the heart of this new collaboration is a digital solution designed to guide patients and their caregivers through every step of the treatment process. Key features will include comprehensive onboarding and training modules, real-time injection guidance, and automated treatment data recording. Furthermore, the application will empower patients to track symptoms and log patient-reported outcomes (PROs), giving them greater control over their health journey.
By wrapping a digital support layer around the physical device, the solution aims to demystify the process of self-injection, a common source of anxiety and a significant barrier to treatment adherence. This digital companion will not only support patients during administration but will also serve as an engagement tool before and after, fostering a continuous connection to their therapy.
Beyond the Needle: The Strategic Value of Data and Adherence
For pharmaceutical companies investing billions in developing life-changing biologic therapies, ensuring patients take their medication as prescribed is a critical challenge. Poor adherence can undermine treatment efficacy, lead to worse health outcomes, and skew data on a drug's real-world performance. This partnership directly addresses that challenge by transforming the drug delivery device into a source of actionable intelligence.
The companion solution will be built on a flexible, scalable architecture capable of capturing adherence data and patient insights remotely and securely. This information will be aggregated and presented via analytics dashboards, offering pharmaceutical partners a clear window into how their therapies are being used outside the controlled environment of a clinical trial. These insights can be leveraged across the entire drug lifecycle, from optimizing clinical development and informing launch strategies to demonstrating real-world value post-commercialization.
Aptar Digital Health, a division of the global drug delivery leader AptarGroup, brings a wealth of experience in creating regulated Software as a Medical Device (SaMD) and digital patient support programs. The company has a proven history of successful collaborations, including partnerships with SHL Medical for connected auto-injectors and AstraZeneca for AI-powered disease screening algorithms. This expertise ensures the digital solution for enFuse® will be robust, compliant, and designed to meet the specific needs of pharmaceutical clients.
“Large-volume biologic therapies are increasingly used to treat complex chronic conditions. They often require long-term adherence to achieve optimal outcomes,” said Damien McKeon, SVP Strategic Partnerships at Aptar Digital Health. “Digital solutions supporting treatment tracking and patient engagement can help address common adherence challenges associated with self-administration.”
Enable's enFuse®: A Platform Primed for Digital Integration
The enFuse® system by Enable Injections is not a newcomer to the market; it is an established platform already making an impact. The wearable, hands-free technology is designed to deliver large volumes of medicine (from 2 mL to 10 mL) subcutaneously, allowing patients to receive treatments that once required lengthy clinic visits in the comfort of their own homes.
The technology achieved a major milestone in 2023 with its first U.S. FDA approval as part of a combination product: the EMPAVELI Injector for pegcetacoplan, commercialized by Apellis Pharmaceuticals. Since then, the enFuse® has gained significant international traction, securing the EU's CE Mark under the new Medical Device Regulation (MDR) in March 2025, registration with the UK's MHRA in June 2025, and approvals from regulatory bodies in Brazil and Saudi Arabia.
Enable has also forged deep relationships with some of the world's largest pharmaceutical companies. In 2024, it expanded a partnership with Roche to apply the enFuse® technology to specific development programs. It also has collaborations with Sobi and received a $30 million investment from Sanofi in January 2026 to scale its manufacturing capabilities. These high-profile endorsements underscore the industry's confidence in the enFuse® platform, making its integration with a best-in-class digital solution a logical and powerful next step.
Empowering Patients in a Connected Future
Ultimately, the success of this partnership will be measured by its impact on patients. For individuals managing chronic illnesses like autoimmune disorders or cancer, the combination of the enFuse® system and its digital companion promises a new level of autonomy and support.
By providing clear instructions, tracking progress, and facilitating communication with healthcare teams, the technology aims to reduce the burden of self-management and improve quality of life. The regulatory pathway for such combination products is well-defined but rigorous, with bodies like the FDA and European Medicines Agency providing clear guidance on SaMD to ensure patient safety and data security.
The vision shared by both companies is one of a fully integrated treatment experience. “The enFuse® companion solution reflects our vision of a more connected treatment experience that supports patients beyond the moment of injection,” stated Michael D. Hooven, Chairman and CEO of Enable Injections. “Together with Aptar Digital Health, we aim to combine innovative drug delivery with digital support tools that can help patients remain engaged in their therapy and enable healthcare providers to better understand and support each patient’s journey.”
This collaboration is more than just a technology integration; it represents a fundamental step toward a future where the delivery of a drug and the digital support that ensures its effectiveness are one and the same.
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