For decades, intravenous (IV) infusions in clinical settings were the standard for therapies such as monoclonal antibodies. Today, advances in drug formulation and device design have enabled subcutaneous (SC) delivery via auto-injectors or on-body delivery systems (OBDS) at home.
Smart devices and patient-centric care
Technology has come a long way from early emergency-use auto-injectors, now accommodating biologics by delivering with controlled force and speed. Ultra-thin-wall needles support comfortable delivery of viscous formulations, while automatic retraction eliminates accidental needle-stick injuries. New models also now deliver up to 5 mL (from early limits of 1 mL) in a single injection, enabling many antibody therapies to be packaged in patient-friendly device formats.
Wearable injectors attach to the skin and infuse large volumes slowly and comfortably, often using reusable cores with disposable drug cartridges for greater sustainability. The miniaturisation of motors, pumps, and electronics has made such wearable injectors viable, while advances in adhesives ensure devices remain secure yet gentle on the skin.
On the drug formulation side, technological innovations include Halozyme’s ENHANZE® platform, which uses recombinant human hyaluronidase to temporarily expand the space in subcutaneous tissue, allowing injection of volumes that were previously unthinkable. In addition, Elektrofi’s Hypercon® technology creates highly concentrated biologics that can be delivered in smaller, stable volumes.
Meanwhile, innovations in closure components are just as critical as the injectors and formulations themselves. Datwyler’s NeoFlex™ plungers use a fluoropolymer coating to create a robust barrier between drug and elastomer, preventing leachables or particulates that could compromise biologic stability. These coated plungers ensure smooth gliding in all siliconised barrels available on the market without the need for siliconisation of the plungers themselves, reducing the risk of protein aggregation and immunogenic reactions.
Available in formats up to 10 mL, NeoFlex plungers are compatible with both glass and polymer syringes, which is increasingly important as devices shift towards lightweight, break-resistant polymer systems. With production facilities across Europe, Asia, and the US, Datwyler is positioned to supply the volumes needed as biologics continue to scale.
For patients, the differences that these innovations bring can be profound. Where an infusion of the cancer therapy daratumumab once required three to seven hours, the reformulated SC version can be administered in as little as five minutes. Today, more than 90% of US patients receive this convenient form.
No longer required to spend hours in a clinical setting, patients can integrate treatment seamlessly into daily routines. For healthcare systems under pressure, these devices also free up clinical resources and cut costs.
Beyond convenience, patient-centric benefits include ergonomic design and simple operation that make these devices accessible to patients with dexterity issues, arthritis, or needle anxiety. Automation also reduces the risk of user error, with pre-measured doses, automatic insertion and retraction, and a concealed needle.
Market dynamics and regulatory shifts
In the pharmaceutical pipeline, 15% of all biopharmaceuticals in development or on the market could be classified as large-volume SC candidates (doses over 2 mL). This includes at least 182 products, predominantly monoclonal antibodies and other complex biologics, targeting diseases from cancer to autoimmune and cardiovascular conditions.
Regulators are responding, too. The US FDA and EMA have approved several on-body injector systems, creating clear precedents for combination products. Agencies in Japan, China, and India are also beginning to establish frameworks for drug–device approvals.
Consequently, established device manufacturers and startups alike are investing in new facilities and forging partnerships with pharma companies to develop tailored solutions. Contract manufacturers are expanding capabilities to meet the demand for fill/finish of the barrel sizes and device assembly at scale.
A patient-centric future
By reducing treatment burden, empowering self-administration, and ensuring drug stability, these devices are redefining the patient experience. Looking ahead, as biologic therapies proliferate, demand for patient-friendly injectors will continue to grow.
Download the full report, The Rise of Large-Volume Injectors in a Patient-Centric Era, to explore the technologies, market dynamics, and material innovations shaping the next generation of drug delivery.
