US Injectable Drug Delivery Market Set to Reach USD 465.15 Billion by 2031

The US injectable drug delivery market is entering a decisive growth phase as biologics, long-acting therapies, and patient-centric self-administration systems reshape how advanced medicines are developed, manufactured, and delivered. Valued at USD 285.81 billion in 2025 and USD 309.90 billion in 2026, the market is projected to reach USD 465.15 billion by 2031, expanding at a resilient CAGR of 8.5%.

Download PDF Brochure of US Injectable Drug Delivery Market

What is driving this expansion, and why does it matter now to pharmaceutical leaders, healthcare providers, and investors? Growth is being fueled by the accelerating adoption of biologics and specialty therapeutics, rising demand for self-injection and home-based care models, and the increasing need for advanced formulation science, device engineering, and scalable fill-finish manufacturing. The shift toward connected delivery technologies and integrated drug–device development is further amplifying investment across the value chain.

When and where is demand rising fastest? From 2026 to 2031, obesity therapies are projected to record the highest growth among therapeutic applications, reflecting the rapid uptake of injectable metabolic treatments. By product category, formulations are expected to post the strongest CAGR at 8.8%, underlining their central role in stabilizing complex biologics, peptides, and long-acting injectables. In packaging, ampoules continue to dominate, accounting for 46.3% market share in 2025 due to their sterility, regulatory acceptance, and cost efficiency in high-volume hospital use.

Who are the primary users and how are care settings evolving? Hospitals and clinics remain the largest end-user segment with a 56.4% share in 2025, supported by high patient throughput and complex biologic regimens. At the same time, dermal-based administration is the fastest-growing route, with a projected CAGR of 9.0%, as subcutaneous delivery, microneedle systems, and wearable injectors enable convenient self-care outside clinical environments. Curative care applications account for 66.1% of overall usage, reflecting the reliance on injectables in oncology, autoimmune diseases, metabolic disorders, and infectious disease management.

Why is the competitive landscape intensifying? Device leaders such as BD, West Pharmaceutical Services, Inc., and Cardinal Health are expanding their global reach with comprehensive portfolios spanning syringes, safety-engineered systems, and prefilled technologies. On the formulation side, Pfizer Inc., Johnson & Johnson, and Merck & Co., Inc. stand out for large-scale manufacturing capacity and international distribution networks. Pfizer is currently positioned as a “Star” player in the US market, supported by advanced fill-finish infrastructure and deep drug–device integration capabilities, while Novartis AG is emerging as a fast-rising innovator through injectable biologics and patient-centric delivery platforms.

How are technology and partnerships reshaping execution? The market is seeing rapid deployment of AI-enabled formulation design, automation in fill-finish operations, smart and connected injection devices, and on-body wearable infusion systems. Strategic collaborations between pharmaceutical companies, device manufacturers, and CDMOs are improving scalability, accelerating commercialization timelines, and raising delivery efficiency for next-generation injectable solutions.

Company and Market Insights:

The broader ecosystem now spans pharmaceutical and biologics manufacturers, device developers, CDMOs, healthcare providers, research institutions, and technology partners specializing in digital monitoring and automation. This interconnected structure is enabling faster development cycles, higher manufacturing reliability, and stronger patient adherence outcomes.

Market dynamics remain balanced between opportunity and constraint. Demand for self-injection devices continues to rise alongside chronic disease prevalence and home-based care adoption. However, needlestick-related infections and stringent regulatory frameworks remain key restraints, prompting higher investment in safety-engineered systems. At the same time, novel delivery platforms such as microneedle patches, long-acting injectables, and connected wearables present substantial growth opportunities, even as alternative routes of administration—including oral, transdermal, and inhalation—challenge traditional injectable dominance in select therapies.

Recent regulatory and partnership milestones highlight the market’s momentum. In March 2025, Johnson & Johnson Services, Inc. received US FDA approval for TREMFYA, the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for adult Crohn’s disease. In February 2025, Pfizer Inc. secured FDA approval for ADCETRIS in relapsed or refractory large B-cell lymphoma. Earlier, in October 2024, BD and Ypsomed collaborated to integrate the BD Neopak XtraFlow glass prefillable syringe with Ypsomed’s YpsoMate 2.25 autoinjector platform, enabling delivery of high-viscosity biologics exceeding 15 cP.