Self-Injection Device Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Self-Injection Device Market Report is Segmented by Product (Pen Injectors, Auto-Injectors, Wearable Injectors, and Needle-Free Injectors), Usage (Disposable and Re-Usable), Application (Diabetes & Other Hormonal Disorders, Auto-Immune Diseases, and More), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Self-injection Device Market Size and Share

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Self-injection Device Market Analysis by Mordor Intelligence

The global self-injection devices market stood at USD 25.22 billion in 2025 and, on the strength of a 10.67% compound annual growth rate (CAGR), is forecast to reach USD 41.87 billion by 2030 bd.com. Growth rests on three pillars: population aging that drives chronic disease prevalence, the biopharmaceutical shift toward patient-centric delivery formats, and payer pressure to keep treatment in lower-cost settings. Pharmaceutical producers, device specialists, and contract manufacturers are expanding capacity for glucagon-like peptide-1 (GLP-1) therapies, oncology drugs, and other biologics formulated for at-home administration, signalling durable demand for advanced injection platforms. Regulatory harmonisation—in particular the United States Food and Drug Administration’s streamlined pathways for combination products and the European Union’s evolving Medical Device Regulation (MDR)—shortens approval cycles and spurs device iteration. Meanwhile, biosimilar launches are widening access to molecules once confined to infusion centres, further shifting the point of care to the patient’s home. Novo Nordisk’s USD 4.1 billion factory programme in North Carolina and the FDA clearance of Hikma’s liraglutide biosimilar in December 2024 encapsulate the dual forces of large-scale capacity build-out and affordable alternatives that underpin the current expansion[1]CNBC News Desk, “Novo Nordisk to Invest $4.1 Billion in North Carolina Manufacturing Hub,” cnbc.com.

Key Report Takeaways

  • By product category, pen injectors retained 47.67% of self-injection devices market share in 2024; wearable injectors are projected to expand at a 12.56% CAGR to 2030.
  • By usage, disposable formats held 61.23% of the self-injection devices market size in 2024, while re-usable systems record the highest projected CAGR at 12.33% through 2030.
  • By application, diabetes and hormonal disorders led with 46.54% of self-injection devices market size in 2024, whereas oncology registers the fastest 13.56% CAGR to 2030.
  • By geography, North America commanded 38.54% revenue share in 2024; Asia-Pacific is the fastest-growing region, advancing at an 11.56% CAGR through 2030.

Segment Analysis

By Product: Wearable Injectors Accelerate Innovation Despite Pen Dominance

Pen injectors generated the highest revenue, holding 47.67% self-injection devices market share in 2024, supported by mature manufacturing infrastructure and clinician familiarity. The self-injection devices market size for pens is projected to reach USD 18.9 billion by 2030 at a steady 8.4% CAGR. Wearable injectors, however, outpace every other product class at a 12.56% rate as biologic concentrations and volumes rise. Stevanato Group’s Vertiva on-body system dispenses up to 10 mL over several minutes, lending itself to oncology and rare-disease regimens once limited to intravenous infusion. Auto-injectors remain a resilient sub-segment, buoyed by biosimilar filtration of adalimumab and etanercept into primary care. Needle-free devices, although technologically compelling, still confront price and regulatory hurdles that curb immediate impact.

A second wave of innovation focuses on device connectivity. Bluetooth modules in wearable pumps transmit dosing logs to cloud dashboards, giving physicians granular adherence visibility. Pharmaceutical firms now bundle apps with devices to differentiate therapy packages and gather real-world evidence for health-technology assessments. As data architecture becomes integral, device makers are forced to build cybersecurity competencies alongside mechanical engineering capabilities, raising entry barriers for new entrants and intensifying collaboration needs between software and hardware teams.

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Note: Segment shares of all individual segments available upon report purchase

By Usage: Sustainability Concerns Lift Re-Usable Formats

Disposable units retained 61.23% revenue in 2024 because infection-control guidelines and patient convenience favour single-use simplicity. Yet pressure from European regulators and hospital sustainability mandates is nudging buyers toward re-usables, which are expanding at 12.33% annually through 2030. The self-injection devices market size for re-usable formats is forecast to climb from USD 9.7 billion in 2025 to USD 17.5 billion by 2030. SHL Medical’s electromechanical Elexy platform, compatible with cartridges and prefilled syringes from 1–5 mL, addresses both environmental and cost objectives by spreading electronics across hundreds of injections.

Healthcare providers in France and Sweden have begun pilot tenders requiring carbon-footprint disclosures, accelerating adoption curves for re-usable hardware. Meanwhile, the economics of embedding radios, batteries, and displays favour re-usables because fixed electronics costs are amortised over greater dose counts. Manufacturers respond with modular designs where drug-contact components remain disposable while drive units are retained, balancing sterility with sustainability.

Self-Injection Device Market
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Note: Segment shares of all individual segments available upon report purchase

By Application: Oncology Leads Growth While Diabetes Maintains Scale

Diabetes and hormonal disorders accounted for 46.54% revenue in 2024, underpinned by the entrenched insulin-pen ecosystem and growing prevalence of GLP-1 obesity treatments. However, oncology indications register the fastest 13.56% CAGR through 2030 because immuno-oncology agents migrate from infusion chairs to subcutaneous auto-injectors. The FDA’s July 2024 approval of Tecentriq Hybreza, cutting administration time to 7 minutes, accelerates oncologist embrace of in-home dosing protocols. Together, oncology and supportive-care injectors are set to represent USD 6.8 billion self-injection devices market size by 2030.

Autoimmune-disease treatments continue to benefit from 1 mL autoinjectors, but pipeline analysis shows upcoming agents trending toward higher concentrations, which may shift volume to wearable devices. Pain management lags because opioid stewardship dampens injections, although neurology biologics for migraine and multiple sclerosis add incrementally. Niche growth appears in rare diseases where high-cost therapies demand precision delivery to justify payer reimbursement.

Geography Analysis

North America contributed 38.54% of global revenue in 2024 thanks to robust reimbursement, high biologic penetration, and early connected-device adoption. The region’s self-injection devices market size is on track to grow 9.2% per year through 2030, supported by BD’s expanded syringe-barrel capacity and the FDA’s clear guidance on digital-health add-ons. Canada’s health-technology assessments increasingly endorse connected autoinjectors for adherence improvement, while Mexico’s maquiladora site expansions create a cost-efficient production corridor for export into the United States.

Asia-Pacific, expanding at an 11.56% CAGR, is propelled by China’s National Medical Products Administration, which approved 12,213 devices in 2024, a gateway for local manufacturers scaling into global supply chains. India’s contract-development organisations are pairing with European pharma to build fill-finish lines dedicated to GLP-1 pens, compressing lead times and costs. Japan, South Korea, and Australia combine mature reimbursement systems with ageing populations, creating immediate demand for high-end connected devices.

Europe sustains mid-single-digit growth as MDR compliance costs restrain smaller players even while harmonised rules simplify multi-country launches. Germany’s sickness funds reimburse electromechanical pens when paired with outcomes-based contracts that cap payer risk. The UK’s National Institute for Health and Care Excellence (NICE) has invited real-world evidence generated by connected autoinjectors into cost-effectiveness files, a move expected to encourage broader digital uptake across the bloc. Eastern European markets remain cost-sensitive but are adopting disposable pens for biosimilar adalimumab at faster clips than Western peers.

South America and the Middle East & Africa are at earlier stages, yet rising chronic-disease incidence and public-sector procurement reforms point to higher volumes over the decade. Brazil’s national immunisation plan has already earmarked budget for 3 mL prefilled devices to support oncology biosimilars, while Saudi Arabia’s Vision 2030 healthcare push fast-tracks registration of patient-centric devices.

Self-Injection Device Market
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Competitive Landscape

BD, SHL Medical, and Insulet anchor a market that remains moderately consolidated; the top five firms jointly hold roughly 60% share. BD surpassed USD 1 billion in biologics-delivery sales and deepened its moat with a French plant that will lift prefillable syringe output sevenfold by 2030. SHL Medical safeguards its lead through a patent wall and, in March 2025, inaugurated a United States facility to shorten customer supply chains and capture rising biologic volumes. Insulet exemplifies therapeutic-area specialisation: with more than 500,000 active global users of the Omnipod system, it booked 22% revenue growth in 2024 and plans a product family extension into multi-hormone delivery.

Competitive strategy now centres on three vectors. First, capacity scalability—Gerresheimer’s USD 180 million Georgia expansion and Gerresheimer–Eli Lilly supply deals underscore the premium on secure, high-volume output. Second, technology platforms—BD–Ypsomed’s collaboration illustrates demand for flexible systems that can accept highly viscous formulations without altering patient technique. Third, therapeutic alignment—Aktiv Medical Systems’ partnership with a global pharma company on 4 mL autoinjectors positions it as a go-to platform for obesity agents with higher dose volumes.

Mergers and acquisitions remain an expedient route to pipeline access; Teleflex’s EUR 760 million acquisition of BIOTRONIK’s vascular-intervention unit broadens its drug-coated device portfolio, hinting at further convergence between interventional and subcutaneous delivery technologies. At the fringes, needle-free specialists and oral-delivery startups present disruption risks, although regulatory and clinical validation hurdles remain high. Overall, capital intensity, regulatory expertise, and integrated digital capabilities act as key competitive buffers.

Self-injection Device Industry Leaders

  1. Becton, Dickinson and Company

  2. Insulet Corporation

  3. Ypsomed AG

  4. Gerresheimer AG

  5. Halozyme (Antares Pharma Inc)

  6. *Disclaimer: Major Players sorted in no particular order
Self-injection Device Market
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Recent Industry Developments

  • March 2025: SHL Medical opened a new autoinjector manufacturing site in the United States, adding regional capacity for high-volume biologics delivery.
  • February 2025: Teleflex acquired BIOTRONIK’s Vascular Intervention business for EUR 760 million (USD 820 million) to enhance its drug-coated delivery portfolio.
  • February 2025: The FDA approved Merilog (insulin-aspart-szjj), the first rapid-acting insulin biosimilar in a 3 mL prefilled pen, broadening access for 8.4 million Americans with insulin needs.
  • January 2025: Aktiv Medical Systems partnered with a global pharmaceutical company to co-develop high-concentration autoinjectors up to 4 mL.
  • December 2024: The FDA cleared Hikma’s generic liraglutide, the first GLP-1 biosimilar, reducing diabetes-therapy cost barriers.

Table of Contents for Self-injection Device Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Prevalence of Chronic Diseases
    • 4.2.2 Increasing Patient Preference For Home Healthcare
    • 4.2.3 Expansion of Biologic And Biosimilar Therapeutics
    • 4.2.4 Advancements In Drug-Device Combination Technologies
    • 4.2.5 Supportive Reimbursement and Cost-Containment Policies
    • 4.2.6 Growing Investments From Pharma and Medtech Partnerships
  • 4.3 Market Restraints
    • 4.3.1 Stringent Regulatory and Quality Compliance Requirements
    • 4.3.2 Availability of Alternative Drug Delivery Modalities
    • 4.3.3 High Upfront Device Development And Manufacturing Costs
    • 4.3.4 Concerns Over Safety, Needle Anxiety, And User Errors
  • 4.4 Regulatory Landscape
  • 4.5 Porter's Five Forces Analysis
    • 4.5.1 Threat of New Entrants
    • 4.5.2 Bargaining Power of Buyers
    • 4.5.3 Bargaining Power of Suppliers
    • 4.5.4 Threat of Substitutes
    • 4.5.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Product
    • 5.1.1 Pen Injectors
    • 5.1.1.1 Disposable Pens
    • 5.1.1.2 Re-usable Pens
    • 5.1.2 Auto-injectors
    • 5.1.2.1 Prefilled Disposable
    • 5.1.2.2 Prefilled Re-usable
    • 5.1.3 Wearable Injectors
    • 5.1.3.1 Large-volume Patch Pumps
    • 5.1.3.2 Bolus-on-demand Devices
    • 5.1.4 Needle-Free Injectors
    • 5.1.4.1 Spring-powered Jet
    • 5.1.4.2 Gas-powered Jet
  • 5.2 By Usage
    • 5.2.1 Disposable
    • 5.2.2 Re-usable
  • 5.3 By Application
    • 5.3.1 Diabetes & Other Hormonal Disorders
    • 5.3.2 Auto-immune Diseases
    • 5.3.3 Oncology
    • 5.3.4 Pain Management
    • 5.3.5 Other Applications
  • 5.4 Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
    • 6.3.1 Becton, Dickinson & Co.
    • 6.3.2 Gerresheimer AG
    • 6.3.3 Insulet Corp.
    • 6.3.4 Ypsomed AG
    • 6.3.5 West Pharmaceutical Services
    • 6.3.6 SHL Medical
    • 6.3.7 Owen Mumford Ltd.
    • 6.3.8 Recipharm AB
    • 6.3.9 Halozyme (Antares Pharma Inc)
    • 6.3.10 Novo Nordisk A/S
    • 6.3.11 Eli Lilly & Co.
    • 6.3.12 Sanofi
    • 6.3.13 Roche Diabetes Care
    • 6.3.14 Amgen Inc.
    • 6.3.15 Teva Pharmaceutical Industries
    • 6.3.16 Bespak by Recipharm
    • 6.3.17 Nemera
    • 6.3.18 Phillips-Medisize (Molex)
    • 6.3.19 Haselmeier GmbH
    • 6.3.20 Medtronic plc

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Self-injection Device Market Report Scope

As per the scope of the report, self-injection devices are injections or wearable devices that can be used by the patient in a home setting to administer the medication himself. The Self-injection Device market is segmented by Product (Pen Injectors, Autoinjectors, Wearable Injectors, Needle-Free Injectors), Usage (Disposable and Reusable), Application (Cancer, Auto Immune Diseases, Hormonal Disorders, Pain Management, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Market report also covers the estimated market sizes and trends of 17 countries across major regions globally. The report offers the value in USD (US Dollar) million for the above segments.

By Product Pen Injectors Disposable Pens
Re-usable Pens
Auto-injectors Prefilled Disposable
Prefilled Re-usable
Wearable Injectors Large-volume Patch Pumps
Bolus-on-demand Devices
Needle-Free Injectors Spring-powered Jet
Gas-powered Jet
By Usage Disposable
Re-usable
By Application Diabetes & Other Hormonal Disorders
Auto-immune Diseases
Oncology
Pain Management
Other Applications
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Product
Pen Injectors Disposable Pens
Re-usable Pens
Auto-injectors Prefilled Disposable
Prefilled Re-usable
Wearable Injectors Large-volume Patch Pumps
Bolus-on-demand Devices
Needle-Free Injectors Spring-powered Jet
Gas-powered Jet
By Usage
Disposable
Re-usable
By Application
Diabetes & Other Hormonal Disorders
Auto-immune Diseases
Oncology
Pain Management
Other Applications
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the current size of the self-injection devices market?

The self-injection devices market is valued at USD 25.22 billion in 2025 and is projected to reach USD 41.87 billion by 2030.

Which product type is growing fastest within self-injection devices?

Wearable injectors are advancing at a 12.56% CAGR, outpacing pen and auto-injectors thanks to their ability to deliver large-volume biologics.

Why is Asia-Pacific the fastest-growing region for self-injection devices?

Regulatory streamlining, domestic manufacturing build-out, and rising chronic-disease prevalence are pushing Asia-Pacific market revenue at an 11.56% CAGR through 2030.

How are sustainability goals shaping device design?

Regulators and hospital systems, especially in Europe, favour re-usable or hybrid platforms that cut single-use plastics, driving 12.33% annual growth in re-usable formats.

Which therapeutic area will contribute most to future market acceleration?

Oncology is forecast to expand at 13.56% through 2030 as immuno-oncology agents transition from infusion to subcutaneous autoinjector delivery.

What major hurdle could slow market growth?

Stringent regulatory and quality-system requirements, particularly under the EU MDR and FDA combination-product rules, can extend development timelines and inflate compliance costs.

Self-injection Device Market Report Snapshots