On-body Drug Delivery Devices Market By Product Type (Prefilled On-Body Injectors, Fillable/Customizable On-Body Systems); By Therapy Area (Autoimmune Disorders, Oncology, Diabetes, Cardiovascular & Metabolic Diseases, Others); By End User (Home Care Settings, Hospitals & Infusion Centers, Specialty Clinics, Retail Pharmacies); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global On-Body Drug Delivery Devices Market will witness a steady CAGR of 7.8 %, valued at USD 5.2 billion in 2024, and expected to reach USD 8.16 billion by 2030, confirms Strategic Market Research.

 

On-body drug delivery devices aren’t just about convenience — they’re redefining how chronic conditions are managed outside the hospital. These wearable injectors allow patients to self-administer large-volume biologics, chemotherapy agents, or insulin over extended durations — often in their own homes. That shift has enormous implications for care models, cost structures, and patient adherence.

 

Biopharma innovation is a major tailwind. Many next-gen biologics can’t be delivered via traditional syringes or auto-injectors because of their viscosity or volume. Enter the on-body injector — designed to deliver doses as high as 5–15 mL over hours, not seconds. These devices are increasingly being co-developed with the drug itself, turning delivery into part of the product value proposition.

 

From a systems perspective, the trend is unmistakable: decentralization of care. Payers are actively pushing to reduce infusion center visits. Hospitals want to clear outpatient backlogs. And patients — especially those with autoimmune, oncology, or metabolic conditions — are demanding more autonomy. That creates a perfect storm of adoption.

 

Key stakeholders span across biopharmaceutical firms, wearable device manufacturers, CDMOs (contract development and manufacturing organizations), home healthcare providers, payers, and regulators. Pharmaceutical companies are especially invested — on-body devices extend patent lifespans, support premium pricing, and open doors to real-world evidence through connected features.

 

Regulatory bodies have also adapted. The U.S. FDA, EMA, and Japan’s PMDA have all cleared multiple device-drug combinations for at-home use. Guidance is now available around human factors engineering and connectivity — an important shift that’s encouraging more OEM–pharma partnerships.

 

To be honest, this isn’t just a hardware market. It’s a convergence play between biologics, digital therapeutics, and home care infrastructure. And from 2024 to 2030, that convergence is likely to accelerate.

 

Market Segmentation And Forecast Scope

The on-body drug delivery devices market is typically segmented by product type, therapy area, end user, and geography. Each of these dimensions reflects how healthcare systems, biopharma companies, and patients engage with these wearables — not just as devices, but as delivery solutions tied directly to treatment protocols.

By Product Type

• Prefilled On-Body Injectors

• Fillable/Customizable On-Body Systems

Prefilled on-body injectors currently dominate market share — accounting for roughly 68% of revenue in 2024 — largely because they simplify compliance and manufacturing for pharmaceutical partners. They’re typically shipped with the drug already loaded, sterile-sealed, and ready for patient use. Devices like Amgen’s Neulasta® Onpro ® have set the precedent here.

In contrast, fillable/customizable systems are gaining traction among smaller biotechs and CDMOs. These offer flexibility, especially in clinical trials or personalized medicine applications where prefilled solutions aren’t always viable. Some devices are designed with modular cartridges or digital interfaces for user customization, especially in insulin or hormone delivery.

 

By Therapy Area

• Oncology

• Autoimmune Disorders (e.g., RA, IBD)

• Diabetes

• Cardiovascular & Metabolic Diseases

• Others (e.g., Pain Management, Hormonal Disorders)

Autoimmune therapies are the largest and fastest-growing segment. Biologics like adalimumab or ustekinumab — which require regular, high-volume dosing — are increasingly being reformulated for on-body delivery. Patients with rheumatoid arthritis, Crohn’s disease, or psoriasis now expect wearable options that reduce clinic visits.

Oncology is a close second, particularly for drugs requiring long-duration infusion but manageable side effects. Several biosimilars and immunotherapies are now being trialed with on-body injectors for outpatient use.

 

By End User

• Home Care Settings

• Hospitals & Infusion Centers

• Specialty Clinics

• Retail Pharmacies

The home care segment leads usage — representing over 55% of all deployments in 2024. Patients are increasingly being discharged with on-body devices pre-attached or trained at point-of-care. This shift reduces costs and enhances patient satisfaction, especially for therapies with minimal monitoring requirements.

Hospitals and specialty clinics still play a critical role in device initiation and first-dose monitoring. Many institutions are developing nurse-led “self-injection training” programs as part of outpatient transition protocols.

 

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa (MEA)

North America currently dominates, due to payer-backed at-home care models, strong regulatory support, and widespread biologic drug adoption. But Asia Pacific is the fastest-growing — driven by rising chronic disease rates, improved digital health infrastructure, and localized device manufacturing in markets like China and South Korea.

Scope Note: While the segmentation appears device-centric, the reality is pharmaceutical-driven. Success in this market depends less on hardware innovation and more on drug-device compatibility, regulatory alignment, and patient behavior models.

 

Market Trends And Innovation Landscape

Innovation in the on-body drug delivery devices market isn’t happening in isolation — it’s being shaped by how fast biologics are evolving, how healthcare systems are decentralizing, and how patients are demanding more autonomy. Over the last two years, we’ve seen rapid shifts in how these devices are built, approved, and integrated into real-world care.

Smart Devices Are Becoming the Norm

Today’s devices aren’t just mechanical pumps — they’re connected platforms. Manufacturers are embedding Bluetooth, NFC, and low-power Wi-Fi chips into injectors to capture dose history, monitor adherence, and sync with patient mobile apps. This connectivity layer opens up new value for both pharma companies and clinicians.

One leading developer called this “pharmacovigilance built into the device.”

We’re also seeing a wave of companion apps that offer training simulations, adherence reminders, and even real-time nurse support via chat — features that reduce patient anxiety and lower abandonment rates.

 

Device + Drug Co-Development Is Now Industry Standard

Previously, a biologic was developed first, and a delivery system came later. Not anymore. Pharma firms now treat drug-device combination as a single product, with joint submissions to regulatory bodies.

That means device engineering now begins during Phase II of clinical trials — long before commercial launch. The design must meet drug viscosity, delivery duration, and storage condition specs from day one.

This early integration is why you’ll increasingly see co-branded products where the drug name and device are inseparable.

 

Human Factors Engineering Is Front and Center

Regulators now require robust human factors testing, especially for home-use medical devices. This includes usability studies in elderly, low-literacy, or dexterity-challenged patient populations. As a result, UI/UX is getting more attention than ever.

Expect to see more:

• Haptic feedback for device status

• One-button activation systems

• Adhesive sensors that alert patients if the patch is coming loose

To be blunt, if a patient can’t figure it out in two minutes, it won’t make it past FDA.

 

Sustainability and Reusability Are Entering the Conversation

As volumes grow, so do environmental concerns. A single on-body injector can generate significant plastic and lithium waste. In response, OEMs are prototyping reusable bases with disposable drug cartridges — or “hybrid” models that combine digital brains with recyclable disposables.

One European firm is piloting a biodegradable housing unit for short-term injectors, aimed at reducing landfill burden by over 60%.

 

3D Printing and Rapid Prototyping Are Speeding Time-to-Market

In the race to align device form factors with biologic pipelines, 3D printing and modular prototyping have become critical. Developers can now test multiple form factors — oval vs rectangular, top-mounted vs side-mounted ports — with real-world patient feedback in weeks, not quarters.

This iterative design cycle means even small biotech firms can launch highly customized devices without building massive internal hardware teams.

 

Industry Partnerships Are Getting Deeper

It’s no longer just OEMs licensing tech to pharma. We’re seeing:

• Joint ventures between drug makers and wearable tech startups

• CDMOs investing in device production lines

• Payviders (payer + provider hybrids) pushing for bundled pricing models

The result is faster deployment and tighter integration into therapy pathways.

Bottom line? This market is evolving at the intersection of form, function, and data. The best devices don’t just deliver drugs — they deliver confidence, for both the patient and the health system backing them.

 

Competitive Intelligence And Benchmarking

The on-body drug delivery devices market is relatively concentrated but fiercely innovative. Unlike traditional medtech segments, success here depends on mastering both device engineering and biologic compatibility — not to mention regulatory nuance, supply chain agility, and digital connectivity. The leaders in this space aren’t just device manufacturers; they’re strategic partners to pharma.

Let’s break down how key players are competing — and what makes them stand out.

BD (Becton, Dickinson and Company)

BD is a dominant force in injection systems, and their Libertas™ wearable injector platform has become a go- to choice for high-volume biologics. What sets BD apart is its early collaboration model — they work directly with biopharma clients during clinical phases to adapt device design to molecule behavior.

They’ve also made notable investments in platform versatility — supporting subcutaneous delivery of drugs up to 10 mL+, even at higher viscosities. That’s a major win in oncology and autoimmune applications.

BD’s edge? Deep integration with biopharma R&D timelines — not just post-approval device customization.

 

West Pharmaceutical Services

West is focused on combination product delivery and is often the first call for injectable biologics needing customization. Their SmartDose ® platform is well known for its patient-centric ergonomics and has seen widespread adoption across autoimmune and oncology segments.

They’re also leading the charge on connectivity — integrating sensor-enabled platforms that capture adherence data in real time. West’s tight regulatory documentation and manufacturing standards give it a strong foothold among top-tier pharma.

 

Ypsomed

This Swiss-based manufacturer offers flexible on-body solutions like YpsoDose, designed for fixed-dose, high-volume delivery. Ypsomed’s key strength lies in device design simplicity — intuitive interfaces, minimal user steps, and high customization for branding.

The company also supports full device lifecycle services, including packaging, labeling, and training kits. This all-in-one approach makes it attractive for mid-sized pharma launching their first wearable-based biologic.

Their partnerships in Europe and Asia are accelerating — particularly with biosimilar developers looking to differentiate through delivery.

 

Enable Injections

A true innovator, Enable focuses on high-volume wearable injectors that rival infusion pumps — their enFuse ® system delivers doses up to 50 mL. That opens the door to subcutaneous delivery of drugs previously limited to IV.

They’ve signed major co-development deals with global pharma for rare disease biologics and enzyme replacement therapies. With ongoing clinical trials and a growing pipeline, Enable is positioned more as a disruptor than a vendor.

Their model: eliminate the infusion center entirely for certain classes of therapy.

 

Stevanato Group

Originally a precision glass and packaging company, Stevanato has pivoted into integrated delivery systems — and is now pushing aggressively into on-body device platforms through its Vertiva ™ system.

Their big differentiator? In-house component manufacturing. They control the supply chain for everything from prefilled cartridges to microfluidic modules. This vertical integration gives them speed and pricing leverage — especially for pharma clients seeking a single-source solution.

 

Other Emerging Players

Companies like Subcuject, Debiotech, and CeQur are carving niches in ultra-simple, low-cost devices. While they aren’t competing head-to-head with BD or West yet, their minimalist designs are attracting interest from biosimilar developers, clinical trial sponsors, and home infusion service providers looking to scale without complex infrastructure.

 

Competitive Landscape: A Few Patterns to Note

• BD and West dominate partnerships with Big Pharma

• Enable Injections and Ypsomed are favored by mid-size innovators

• Digital connectivity is fast becoming a dealbreaker

• Manufacturing scalability is critical — biopharma doesn’t want to bet on a device that can’t hit volume by launch

This isn’t a typical medical device war. It’s a tight race where trust, regulatory reliability, and ease of pharma integration matter just as much as innovation.

 

Regional Landscape And Adoption Outlook

Geographically, the on-body drug delivery devices market is developing in waves — with North America leading the current surge, Europe following with a measured, reimbursement-driven rollout, and Asia Pacific quickly catching up thanks to chronic disease burden and biopharma localization. Let’s break it down region by region.

North America

Unsurprisingly, North America, led by the United States, owns the lion’s share of the market — close to 45% in 2024. The U.S. healthcare ecosystem favors home-based care, self-administration, and biologic therapies — all of which play into the hands of on-body injectors.

The FDA has been proactive in approving drug-device combination products, and payers are increasingly reimbursing for home-administered biologics, especially in oncology and autoimmune disease management. The shift is driven by economics: avoiding infusion center visits saves money, time, and capacity.

Canada is also advancing in adoption, but more conservatively, often requiring provincial-level approval and integration into hospital-led programs. Still, major cancer centers and rheumatology networks are experimenting with wearable injectors for reducing patient traffic.

 

Europe

Europe is less aggressive but more structured. Countries like Germany, the Netherlands, and the UK are steadily integrating on-body devices into chronic care pathways, especially for rheumatology and diabetes. But adoption is heavily influenced by national reimbursement schemes and comparative cost-effectiveness reviews.

What’s helping? The region’s growing biosimilar market. On-body devices allow biosimilar players to differentiate beyond price — something regulators like NICE and IQWiG are now actively evaluating as part of value-based care decisions.

France and Italy are slower movers, as their outpatient biologic care models are still hospital-centric. That said, clinical pilot programs are underway in cancer care and post-surgical pain management, testing long-duration delivery at home using disposable wearable pumps.

In short, Europe is evolving — but it’s policy-first, technology-second.

 

Asia Pacific

Asia Pacific is emerging as the fastest-growing region, driven by rising chronic disease incidence and a push toward decentralized care infrastructure. China, Japan, South Korea, and India are the biggest contributors.

Japan leads in patient-friendly device adoption — wearable injectors are already common in insulin delivery, and pharma partnerships with Japanese OEMs are growing. China is investing in local manufacturing, and its biologics market is expanding rapidly. The government is encouraging at-home care to reduce hospital congestion, creating real opportunity for on-body injectors. India is earlier-stage, but private hospitals are piloting wearables for oncology and autoimmune care, especially in Tier 1 cities.

Also worth noting: Asia-based CDMOs are becoming viable partners for Western pharma firms needing cost-effective, scalable manufacturing of device components.

 

Latin America, Middle East & Africa

Adoption in Latin America, Middle East & Africa (LAMEA) is limited — but not insignificant. In Brazil, a few private insurance providers are covering wearable injectors for select biologics. In South Africa, donor-backed HIV programs are exploring on-body devices for long-acting antiretrovirals.

Still, market penetration is constrained by: High device costs, Limited patient training infrastructure, Weak last-mile logistics

That said, global manufacturers are eyeing pilot projects and access programs in these regions, particularly for cancer and rare disease treatments. These initiatives may pave the way for broader adoption post-2030.

 

Summary

• North America: Strong payer support + mature biologics ecosystem = dominant market share

• Europe: Reimbursement-driven adoption with focus on biosimilar value

• Asia Pacific: High-growth region with expanding local pharma and infrastructure

• LAMEA: White space, but opportunities through pilot programs and access schemes

If you're a device OEM or pharma innovator, your growth playbook needs to shift region by region — what works in San Francisco won’t scale the same in Seoul, Frankfurt, or São Paulo.

 

End-User Dynamics And Use Case

The adoption of on-body drug delivery devices is being driven not just by clinical efficacy or device innovation — but by how different stakeholders in the healthcare ecosystem actually use and value them. End users in this market aren’t limited to patients; they include physicians, home care teams, infusion centers, specialty clinics, and even retail pharmacists.

Let’s unpack how usage patterns vary — and where the real-world value lies.

Home Care Settings: The Epicenter of Growth

This is where the bulk of adoption is happening. Home care providers are increasingly relying on pre-attached or patient-administered wearable injectors to reduce readmissions, extend treatment cycles, and cut infusion center reliance.

Patients with Crohn’s disease, rheumatoid arthritis, and HER2+ breast cancer, for instance, are now routinely sent home with wearable injectors following initial dose monitoring in-clinic. Once trained, these patients no longer require IV lines or infusion chairs.

The appeal? Comfort, convenience, and the ability to maintain therapy adherence without disrupting daily life.

In one scenario, a rheumatoid arthritis patient in Toronto received her monthly biologic injection via a wearable device at home — eliminating four hours of clinic travel and waiting time per treatment cycle.

 

Hospitals and Infusion Centers : Shift from Centralized to Transitional Role

While hospitals are no longer the endpoint for most biologic therapies, they play a vital role in initiating therapy, educating patients, and managing first-dose responses. Nurse educators and pharmacists often lead onboarding programs that include wearable demo units, mock injections, and mobile app tutorials.

Infusion centers, especially in North America and Europe, are reconfiguring themselves as training hubs rather than long-term administration sites. Some centers now dedicate space to “device literacy sessions” to onboard patients transitioning to self-care models.

This shift also benefits hospitals operationally — freeing up infusion chairs and allowing staff to prioritize high-acuity therapies that must remain in-clinic.

 

Specialty Clinics: Disease-Specific Integration

Specialty clinics in dermatology, endocrinology, and oncology are integrating on-body devices into longitudinal care plans. For diseases like psoriasis or thyroid disorders, where monthly or quarterly administration is needed, wearable injectors offer a low-friction solution that avoids recurring appointment bottlenecks.

These clinics are particularly fond of prefilled, pre-programmed devices, since they minimize training time and reduce human error risk. Many also collaborate with pharma reps to ensure up-to-date training materials and device supply.

 

Retail Pharmacies: A New Frontier for Access and Counseling

In some markets — particularly in the United States and Germany — retail pharmacies are starting to serve as distribution and support points for on-body devices. Patients can pick up prefilled devices (with prescriptions) and receive basic counseling or device demonstrations on-site.

This expands access significantly, especially in rural areas where hospital visits are infrequent or burdensome. It also opens the door for pharmacies to offer value-added services like refill reminders and app onboarding.

 

Summary of End-User Behavior

• Home care is driving device volume, especially in chronic disease management.

• Hospitals act as transitional educators and safety net for early-stage therapy.

• Specialty clinics enable condition-specific integration and device standardization.

• Pharmacies are the emerging access point, particularly for maintenance therapies.

 

Use Case Highlight

A tertiary hospital in South Korea recently piloted an at-home chemotherapy program using on-body injectors for breast cancer patients receiving trastuzumab. After two in-clinic supervised cycles, patients transitioned to home-based self-injection using a connected wearable device. Results showed a 40% reduction in hospital resource utilization, with no compromise in treatment adherence or outcomes.

When done right, on-body devices don’t just deliver medicine — they deliver agency. That’s what makes them so compelling across end-user environments.

 

Recent Developments + Opportunities & Restraints

The last two years have seen a sharp uptick in strategic moves across the on-body drug delivery devices market — from regulatory approvals and pharma partnerships to sustainability pilots and digital ecosystem expansion. These developments are setting the stage for wider adoption and more integrated device-drug ecosystems.

Recent Developments (2022–2024)

• Amgen expanded access to its Neulasta® Onpro ® device across Asia Pacific, launching in new markets like Singapore and South Korea after receiving updated regulatory clearances.

• West Pharmaceutical Services launched its next-gen SmartDose 3.0, designed for improved skin adhesion, higher drug viscosity compatibility, and Bluetooth-enabled patient monitoring.

• Enable Injections secured Series C funding worth $215 million to scale commercial production of its enFuse ® system and expand co-development partnerships with biopharma companies.

• Stevanato Group entered a strategic collaboration with Bexson Biomedical to develop a wearable ketamine delivery system for mental health and chronic pain — marking expansion beyond traditional biologics.

• FDA approved a drug-device combination for subcutaneous cancer therapy using an on-body wearable platform, reinforcing regulatory support for home-based oncology treatment.

 

Opportunities

• Integration with Digital Health Ecosystems: On-body devices with embedded sensors and app connectivity can enable real-time adherence tracking, dose validation, and remote care coordination — especially valuable for high-risk therapies.

• Expansion in Emerging Markets: Countries like India, China, and Brazil are ramping up domestic biologics production. On-body devices that align with these therapies could see accelerated adoption through local manufacturing and value-based pricing.

• Drug Reformulation Tailored to On-body Use: Biopharma firms are increasingly optimizing biologics specifically for on-body delivery — adjusting pH, viscosity, and delivery time to align with wearable design specs.

 

Restraints

• High Initial Development and Customization Costs: Device customization for each biologic requires extensive testing, regulatory alignment, and human factors validation — increasing time-to-market and cost for smaller pharma players.

• Limited Patient Education and Support Infrastructure: Successful adoption depends on effective training — a gap that remains especially acute in low-resource settings and among elderly populations.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 5.2 Billion
Revenue Forecast in 2030	USD 8.16 billion
Overall Growth Rate	CAGR of 7.8% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Therapy Area, By End User, By Geography
By Product Type	Prefilled On-Body Injectors, Fillable/Customizable On-Body Systems
By Therapy Area	Autoimmune Disorders, Oncology, Diabetes, Cardiovascular & Metabolic Diseases, Others
By End User	Home Care Settings, Hospitals & Infusion Centers, Specialty Clinics, Retail Pharmacies
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Canada, Germany, U.K., France, China, India, Japan, South Korea, Brazil, etc.
Market Drivers	- Rapid growth in biologic therapies requiring at-home administration - Increasing pressure on healthcare systems to reduce infusion center costs - Patient preference for convenient, needle-free or long-acting drug delivery
Customization Option	Available upon request