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Subcutaneous Drug Delivery Devices Market

The market for Subcutaneous Drug Delivery Devices was estimated at $36.4 billion in 2025; it is anticipated to increase to $54.0 billion by 2030, with projections indicating growth to around $80.1 billion by 2035.

Report ID:DS1801090
Author:Debadatta Patel - Senior Consultant
Published Date:
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Subcutaneous Drug Delivery Devices
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Global Subcutaneous Drug Delivery Devices Market Outlook

Revenue, 2025

$36.4B

Forecast, 2035

$80.1B

CAGR, 2026 - 2035

8.2%

The Subcutaneous Drug Delivery Devices industry revenue is expected to be around $36.4 billion in 2026 and expected to showcase growth with 8.2% CAGR between 2026 and 2035. The rise in cases of chronic illnesses along with a rapidly ageing population and the move of patient care to out of hospital settings have caused subcutaneous drug delivery devices to be a key aspect of present injectable drug delivery systems. In a growing trend, users of injectable drugs are turning to self administration devices, which are becoming more common, including injectors that can be used by the patient alone and prefilled syringes. Increasing use of biologics and biosimilars in oncology, autoimmune diseases and rare conditions is seeing the subcutaneous method of administration become the preferred choice. Furthermore, developments in drug delivery and telemedicine are enhancing the benefits of these systems. By achieving these key objectives, subcutaneous drug delivery systems will be crucial in making treatments more patient centric, which will keep pharmaceutical companies, healthcare providers and insurance companies relevant in the long term.

Products for the delivery of drugs into the subcutaneous layer of the skin include auto injectors, insulin pens, wearable injectors and patch pumps. These self administered drug delivery devices have a high safety profile and are both easy to use and reliable. The majority of injectors are used in diabetes and autoimmune disease treatments, which together make up 67.9% of injector use, insulin pens being responsible for around $13 billion in 2025 revenue and setting a standard for insulin management that is easy to use. These days, the key characteristics of contemporary devices for injectable medicines comprise digital connectivity, ergonomic shape, needle protection mechanisms and precise dosing, as well as compact dimensions. The demand for subcutaneous drug delivery devices is anticipated to be driven by several emerging trends. These trends include a rise in the treatment of chronic diseases at home, a growth in the production of biologics and biosimilars, integration of smart drug delivery and the continued development of less invasive drug delivery systems.

Subcutaneous Drug Delivery Devices market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Subcutaneous Drug Delivery Devices Market Outlook

Market Key Insights

  • The Subcutaneous Drug Delivery Devices market is projected to grow from $36.4 billion in 2025 to $80.1 billion in 2035. This represents a CAGR of 8.2%, reflecting rising demand across Oncology, Auto‑Immune Disorders, and Fertility.

  • Among the dominant companies contributing to the competitive landscape of the market are Gerresheimer AG, BD and Medtronic.

  • The Subcutaneous drug delivery devices market will grow at a CAGR of 6 8.6% from 2025 to 2030 in the USA and Germany.

  • The highest growth rates with compound annual growth rates ranging from 7.9% to 10.3% , are anticipated for emerging markets such as Brazil, Mexico and India.

  • The trend towards home based care is expected to add a further $4 billion to the revenue of the subcutaneous drug delivery devices market by the year 2030.

  • The subcutaneous drug delivery systems market will be worth $43.7 billion more by 2035 compared to 2025. The producers are focusing on Oncology and Auto Immune Disorders application in this market region.

  • With

    rising prevalence of chronic diseases and growing demand for self-administered care solutions, and

    Integration of Smart, Connected Technologies to Enhance Treatment Outcomes, Subcutaneous Drug Delivery Devices market to expand 120% between 2025 and 2035.

subcutaneous drug delivery devices market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Subcutaneous Drug Delivery Devices - Country Share Analysis

Opportunities in the Subcutaneous Drug Delivery Devices

The rapid adoption of biological agents in cancer treatment in China and Japan is also spurring demand for subcutaneous drug delivery systems which reduce the time patients spend in a hospital chair. At present, portable and wearable injectors that enable cancer patients to safely administer thickened chemotherapy at home are only available in high end cancer treatment centres in major cities. The increasing trend to convert intravenous solutions for injection under the skin will heighten the need for pharmaceutical firms to collaborate with equipment producers. Over the forecast period to 2030, devices to administer insulin automatically are expected to grow the fastest globally, with a predicted 8.5% Compound Annual Growth Rate .

Growth Opportunities in North America and Asia Pacific

The North American subcutaneous drug delivery devices market is primarily driven by diabetes applications. The major products in this market are insulin pumps, wearable injectors and smart auto injectors. The strong reimbursement for self administration of drugs by patients at home and the advanced chronic disease management protocols for diabetes are the major factors behind this markets growth. Fields related to oncology and auto immune disorders are of significant relevance, driven by the popularity of subcutaneous drug delivery systems which provide remote monitoring and tracking capabilities. Device makers are having to compete with each other on several grounds such as data connectivity, patient centric products and comprehensive ecosystems in addition to the quality of the device itself. As a result, smaller firms with a specialisation in security, connectivity and design are finding opportunities in this market. The prime opportunities are in premium positioning for connected subcutaneous drug delivery systems for treatments requiring multiple medicines, forging partnerships with payers and health companies that offer digital services and the demonstration of the cost savings associated with the products. Additionally, in the public and private hospitals, expansion of educational services is possible in order to reduce the discontinuation of therapy and to give products a competitive edge in the market place.
In the Asia Pacific subcutaneous drug delivery system, the primary market force is found in diabetes treatments. The diabetes market in this region is driven by the high incidence and a rising diagnosis rate of diabetes. It is also affected by payers who pressure healthcare providers to deliver their treatments from hospitals to the patients homes using subcutaneous drug delivery systems. Growing demand in fertility and oncology medicine is being driven by the rising availability of biologic treatments, which are becoming increasingly appealing to middle class urban residents. These individuals prefer discreet self administration of drugs via prefilled devices. The market is made up of a mix of low cost producers aiming to sell large quantities and innovative global companies. As a result the market splits into two sectors, comprising high volume, low cost auto injectors and syringes and high end connected drug delivery devices. Opportunities exist for a tailored, modular subcutaneous drug delivery device to suit local regulatory and reimbursement conditions, through co development with pharmaceutical firms for their biosimilars and hormones products, or by using in house skills in human factors engineering, training and digital medicine to enhance patient compliance in the growing markets.

Market Dynamics and Supply Chain

01

Driver: Rising Prevalence of Chronic Diseases and Growing Demand for Self-Administered Care Solutions

A key driver for the drug delivery devices market is also the escalating prevalence of chronic diseases such as diabetes, cancer, cardiovascular, and respiratory disorders, which is also increasing the demand for precise and consistent medication delivery. Chronic disease management often requires frequent dosing and long-term treatment regimens, making advanced delivery systems like insulin pens, auto-injectors, inhalers, and wearable infusion pumps essential for maintaining therapeutic effectiveness and patient adherence. This rising disease burden not only fuels the volume of device usage but also pushes innovation toward patient-friendly formats and sustained release technologies. Parallelly, growing demand for self-administration and home healthcare is also reshaping how treatments are also delivered, with patients and caregivers seeking convenient, non-invasive, and cost-effective solutions that reduce reliance on hospital visits. Together these trends are also expanding the market while driving manufacturers to prioritize usability, safety, and connectivity in their devices.
The integration of smart and connected technologies into drug delivery devices is also another critical market driver, focusing on real-time monitoring, remote patient management, and data-driven treatment adjustments. Smart systems such as connected insulin pens, infusion pumps with digital interfaces, and IoT-enabled inhalers improve patient adherence and provide actionable insights for clinicians. These technologically advanced devices support personalized care by enabling dose tracking, condition monitoring, and feedback loops tied into broader healthcare ecosystems, enhancing treatment outcomes and facilitating value-based care models.
02

Restraint: High regulatory compliance requirements delay product approvals and increase costs

Stringent global regulatory standards from agencies like the FDA and EMA create lengthy approval timelines for innovative drug delivery devices, often requiring extensive clinical data and quality verification. These delays can postpone product launches, inflate development budgets, and restrict smaller players from bringing new technologies to market. Consequently, revenue growth suffers as firms grapple with higher compliance expenditures and slower commercialisation cycles.
03

Opportunity: Rising demand for home-based insulin Subcutaneous Drug Delivery Devices among elderly diabetic patients in North America and Connected Subcutaneous Drug Delivery Devices enabling chronic disease self-administration in digitally advanced Western European healthcare systems

There is increasing demand in the US for user friendly insulin injection devices for administration by injection under the skin due to diabetes prevalence and patient preference for home healthcare. The combined sales of prefilled syringes and insulin pens reached almost $24.4 billion by the year 2025. It is predicted that this figure will increase to more than $35.96 billion by the year 2030. However, there is still scope for development with these products among elderly patients suffering from multiple health issues. There is a need for products which simplify self administration, allow greater dose volumes, and provide clear visual cues. This product sector will be dominated by insulin pens in terms of revenue. In contrast, pumps which are patch based will be the fastest growing sector.
Healthcare providers in Western Europe have a growing interest in remote management and follow up of patients suffering from chronic conditions, which in turn means there is growing interest in devices for subcutaneous drug delivery that are connected. Patches are forecast to be the fastest growing category of insulin delivery devices. The insulin patch market, currently at approximately $3.46 billion in the year 2025, will grow to $5.4 billion by 2030. This CAGR will be 9.3%.Currently, integration with electronic health records, the provision of billing for continued use and app usage is still in its infancy. As the digital delivery system develops, pumps linked with the digital delivery system are expected to grow faster than prefilled syringes for patients receiving multiple shots over an extended period.
04

Challenge: High development and manufacturing costs limit affordability and adoption

Advanced drug delivery devices such as smart injectors, implantables, and connected wearables demand significant R&D, specialized materials, and precision engineering, driving up production costs. This price premium restricts adoption in cost-sensitive regions and strains healthcare budgets, reducing overall demand. Limited reimbursement coverage further inhibits patient access, slowing market expansion and dampening revenue growth for manufacturers.

Supply Chain Landscape

1

Raw Materials

BASF SEEvonik Industries AG
2

Subcutaneous Drug-Delivery Devices

Gerresheimer AGElcam Medical GroupYpsomed AG
3

Wearable Injectors

BDMedtronic Plc
4

End-use Applications

Hospitals & ClinicsHome HealthcareBiopharmaceutical Companies
Subcutaneous Drug Delivery Devices - Supply Chain

Use Cases of Subcutaneous Drug Delivery Devices in Oncology & Auto‑Immune Disorders

Oncology : In oncology applications, drug delivery devices play a pivotal role in administering chemotherapeutics and biologics with precision and minimized systemic toxicity, predominantly through infusion pumps, implantable ports, and targeted carriers that support controlled, site-specific drug release and improved patient comfort in hospital and outpatient settings. Nanoparticles and liposomal carriers are also widely used for targeted chemotherapy delivery. Leading players such as Roche, Johnson & Johnson, BD, and Medtronic lead with robust oncology-focused delivery portfolios and strong R&D pipelines that enhance treatment efficacy and patient adherence.
Auto‑Immune Disorders : In the Auto-Immune Disorders application of the drug delivery devices market, self-administrable injectables like auto-injectors and pre-filled syringes dominate due to their ease of use and precise dosing for chronic conditions such as rheumatoid arthritis and multiple sclerosis, especially in home healthcare settings. Auto-injectors enhance patient adherence and reduce clinical burden, while wearable and microneedle systems offer comfort and controlled delivery. Leading players such as BD, Amgen, Eli Lilly, Baxter, and West Pharma leverage strong biologics portfolios and innovation to strengthen market position and address expanding autoimmune therapy needs.
Fertility : In the fertility application of the drug delivery devices market, specialized delivery systems play a critical role in assisted reproductive technology (ART) and infertility treatments by enabling precise administration and handling of reproductive cells and hormones. Key devices include IVF instruments such as micromanipulators, incubators, sperm separation systems, and insemination catheters, predominantly used by fertility clinics and hospitals to improve conception outcomes. These technologies enhance embryo culture, sperm selection, and hormone delivery, boosting success rates and patient satisfaction. Leading market players like CooperSurgical, Vitrolife, Merck KGaA, and Cook Medical hold strong positions by offering comprehensive ART platforms, continuous innovation, and extensive global distribution, strengthening their competitive edge in fertility solutions.

Recent Developments

The drug delivery devices market has seen notable strategic developments recently, with companies integrating smart connected systems, telemedicine capabilities, and user-centric design to enhance patient adherence and real-time monitoring. Regulatory harmonization and strategic partnerships are accelerating approvals and combination product launches, while digital health and IoT integration drive personalization and remote dosing insights. A key trend is the shift toward minimally invasive and home-based delivery, such as wearable injectors and auto-injectors, improving treatment outcomes and expanding market reach across chronic and specialty care.

December 2024 : Gerresheimer expanded its production capacity at its Skopje, North Macedonia site by opening a new clean-room facility for syringes under GMP standards to support growing demand for injectable drug delivery components.
October 2024 : BD (Becton, Dickinson and Company) has entered a strategic collaboration with Ypsomed to integrate its BD Neopak XtraFlow glass prefillable syringes with Ypsomed’s YpsoMate 2.25 autoinjector platform, targeting the delivery of high-viscosity biologics.
June 2024 : Novo Nordisk announced a US $4.1 billion investment to build a new fill-and-finish manufacturing facility in Clayton, North Carolina, to expand global production capacity for injectable therapies and drug delivery devices.

Impact of Industry Transitions on the Subcutaneous Drug Delivery Devices Market

As a core segment of the Medical Device industry, the Subcutaneous Drug Delivery Devices market develops in line with broader industry shifts. Over recent years, transitions such as Shift Towards Home Healthcare and Integration of Smart and Connected Technologies have redefined priorities across the Medical Device sector, influencing how the Subcutaneous Drug Delivery Devices market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Shift Towards Home Healthcare

With growing demand for cost effective and patient focused care for elderly patients with chronic conditions, the move towards healthcare provided at home is driving the subcutaneous drug delivery systems industry. Systems of advanced subcutaneous injection that incorporate wearable injectors and connected devices allow for the secure, dependable self administration of biologics and other injectables outside of a clinic. This reduces hospital based treatment reliance and enables remote monitoring programmes. Not only is this shift behavioural but also it alters the size of the market that can be addressed. The addressable market will grow by an additional $4 billion by 2030 due to home based subcutaneous drug delivery, making it a significant business imperative for manufacturers to innovate in digital integration, usability and minimally invasive delivery systems if they wish to exploit this shift in demand.
02

Integration of Smart and Connected Technologies

Another major transition is the integration of digital and connected technologies into drug delivery devices. Smart injectors, connected inhalers, and digital infusion pumps now incorporate sensors, connectivity, and data analytics to monitor dosing accuracy, timing, and patient adherence. This transformation supports value-based healthcare models and real-world evidence generation, directly influencing pharmaceutical R&D, digital health, and data analytics sectors. Healthcare providers gain actionable insights, while payers benefit from improved treatment outcomes. Companies such as Medtronic, Insulet, and Phillips Medisize lead this transition by combining device engineering with software ecosystems, strengthening their competitive advantage and accelerating partnerships across the medtech and health IT industries.