US and Europe Injectable Drug Delivery Market Size and Forecast (2021 - 2031), Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Devices Type (Conventional Drug Delivery Devices and Advanced Drug Delivery Devices), Formulation (Co

The US and Europe injectable drug delivery market size is expected to grow from US$ 27.17 billion in 2024 to US$ 46.74 billion by 2031; it is projected to register a CAGR of 8.2% during 2025-2031. The rising prevalence of diabetes and demand for self-administered biologics, advancements in oncology and biologics requiring precision delivery, and expansion in autoimmune and cardiovascular disease management are noteworthy factors contributing to the expansion of the US and Europe injectable drug delivery market size. Additionally, the rising focus on biologics and personalized medicine is projected to bring new US and Europe injectable drug delivery market trends in the near future.

The US and Europe are putting more and more weight on biologics and personalized medicine, things that have a great impact on the injectable drug delivery market. Biologic therapies, which include monoclonal antibodies and gene therapies among others, although not cheap, are gaining acceptance due to their potency in dealing with extremely difficult diseases such as cancer and autoimmune disorders. To be precise, in the year 2023, the US FDA gave the green light to more than 50 biologic drugs, and the majority of them had already been utilizing specialized delivery systems that allow for multidose pens and connected injectors. On the other hand, according to the EMA, the European market experienced a 12% rise in biologic approvals from 2022 to 2023. Meanwhile, one important aspect of the drug delivery technology is the smart injectors, which come with digital connectivity and are able to monitor dosage and adherence, thus improving patient outcomes. Among the recent developments that have taken place in this field is the launching of smart auto-injectors by companies such as Amgen and Novo Nordisk in 2024, where the technology has IoT capabilities for real-time monitoring. In an effort to keep being innovative, the governments have provided financial support and set up regulatory pathways that simplify the approval processes for advanced delivery devices. The growth of personalized medicine has led to the need for injection systems that are flexible, efficient, and patient-friendly, which in turn forces the companies to continue their R&D investments. This drift signifies a move towards more customized, technology-driven injectable solutions in both markets, thereby emerging as a significant trend in the US and Europe injectable drug delivery market.

End User-Based Insights

Based on end user, the US and Europe injectable drug delivery market is segmented into pharmaceutical and biopharma companies and CMOs and CDMOs. The pharmaceutical and biopharma companies segment held a larger US and Europe injectable drug delivery market share in 2024. The injectable drug delivery market of the US and Europe has mainly the pharmaceutical and biopharmaceutical companies as the end-users who support innovation and volume. Large multi-nationals and biotech firms are increasingly defining combination products, pre-filled syringes, autoinjectors, on-body injectors, and cartridge-based pens to secure lifecycle differentiation and favorable formulary positioning during clinical development. In the US, partnerships with device manufacturers start at Phase II so as to satisfy the FDA combination product requirements and to have the Design History Files support both drug and device approvals. European drug sponsors utilize the EU MDR Article 117 to incorporate Notified Body Opinions at the very beginning, thus speeding up the subcutaneous oncology and immunology programs. Both regions have the same focus on platform technologies (for instance, 2.25 mL autoinjectors, and 3 mL cartridges), which allow quick line extensions and new products from biosimilars. The gradual increase in the number of high-concentration biologics is directly responsible for the investment in advanced primary containers (COC/COP barrels and silicone-free systems) and filling lines with 100% in-process control capability that is fully monitored. Also, biopharma companies support the digital health integrations—Bluetooth dose logging, adherence apps, and recycling programs—with the purpose of producing real-world evidence and meeting the expectations of payers in both the US and Europe, thereby fueling the US and Europe injectable drug delivery market growth.

The Centers for Disease Control and Prevention and National Institutes of Health are among the primary and secondary sources referred to while preparing the US and Europe injectable drug delivery market report.

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