안전 펜니들 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the safety pen needles market was valued at USD 0.77 billion in 2025 and expected to grow from USD 0.83 billion in 2026 to reach USD 1.22 billion by 2031, at a CAGR of 8.16% during the forecast period (2026-2031).

This report is Segmented by Safety Mechanism Type (Active, Passive), Needle Length (5mm, 6mm, 8mm, 10mm, Others), Therapy (Insulin, GLP-1, Growth Hormone, Osteoporosis, Others), End-User (Home-Care, Hospitals & Clinics, Ambulatory Surgery Centers, Others), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). Market Forecasts are Provided in Value (USD).

Global Safety Pen Needles Market Trends and Insights

Regulatory Mandates for Sharps-Injury Prevention

ISO 23908:2024 establishes global test protocols that demonstrate a pen needle can prevent needlestick exposure during injection and disposal, accelerating approvals for products that include auto-disable shields or retractable cannulas. U.S. OSHA rules require hospitals to purchase engineering controls, while the European Union Medical Device Regulation mandates strict post-market surveillance. Intermountain Healthcare documented a 51% drop in injuries after standardizing on a 6-millimeter safety syringe, confirming regulatory aims in practice. These frameworks shift purchasing away from standard needles and narrow the historic price gap.

Diabetes Prevalence Fueling Injection Volumes

NCD-RisC pegged the global diabetes population at 828 million adults in 2022, and China plus India account for 217 million of those cases. The U.S. CDC reported that 26.5% of American adults with diabetes were on GLP-1 injectables in 2024, showing momentum for once-weekly regimens. Eli Lilly logged USD 5.2 billion in Mounjaro sales in 2024, while Novo Nordisk crossed USD 20 billion in GLP-1 revenue, underscoring the upside from compatible pen needles.

Availability of Alternate Drug-Delivery (Pumps, Patch Pens)

Embecta secured FDA clearance in 2025 for a disposable patch pump that can run for three days per reservoir, removing nearly 1,500 needles per converted patient annually. Insulet and Tandem pumps are also gaining users, especially among tech-savvy cohorts. Yet pump penetration remains below 40% even in well-funded markets, and GLP-1 drugs do not have pump formulations today, limiting near-term erosion of the safety pen needles market.

Other drivers and restraints analyzed in the detailed report include:

1. Shift to Home-Based Self-Administration
2. Passive Auto-Disable Innovations Reduce Training Burden
3. Premium Pricing Versus Standard Pen Needles

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Active models accounted for 69.31% of revenue in 2025, reflecting established training protocols in hospitals. Passive models are growing at 10.12% CAGR through 2031, the fastest of any mechanism, because they protect users without extra steps. Payers link passive designs to lower injury claims, and ISO 23908:2024 clearly favors automatic activation. Manufacturers now market dual-shield cannulas that auto-deploy once the dose is delivered, meeting both clinician and home-user needs.

Passive uptake is strongest in home care, retail clinic, and ambulatory surgery settings, where staff turnover is high, and patient dexterity varies. The safety pen needle market continues to tilt toward these devices as regulators audit compliance logs and insurers tie reimbursements to safety outcomes. Active designs will remain relevant in high-volume hospital wards that value tactile confirmation, but their relative weight will fall as self-administration rises.

Five-millimeter needles held a 31.58% share in 2025, thanks to comfort and low pain scores. Six-millimeter models are expanding at 11.01% CAGR because they reach consistent subcutaneous depth in patients with higher BMI. Manufacturers refine thin-wall stainless tubes that sustain flow even at mid-lengths, and real-world evidence shows equal comfort scores compared with shorter cannulas.

Longer 8 and 10-millimeter needles serve niche cases but see limited consumer acceptance. Ultra-short 4 millimeter variants target pediatric users and sensitive adults, yet their contribution to overall volume remains small. Technological advances that enable smaller outer diameters without compromising rigidity will likely reinforce the mid-range trend and keep 5 to 6-millimeter products at the core of the safety pen needles market.

Geography Analysis

North America generated 43.83% of 2025 revenue, driven by OSHA rules, CMS reimbursement for safety devices, and the rapid uptake of GLP-1 prescriptions. Domestic capacity investments by BD and Sharps Technology validate the region's strong demand base and reflect policy moves to shorten supply chains.

Europe follows with solid value per unit, thanks to MDR enforcement and high safety expectations in public tenders. Germany, France, and the United Kingdom remain anchor markets even as budget constraints pressure prices. Central and Eastern Europe shows room for penetration as hospital groups modernize.

Asia-Pacific is on track for a 14.67% CAGR to 2031, the highest globally. The prevalence of diabetes in China and India, along with local manufacturing scale, makes the region crucial for volume. Regulators in both countries are aligning with ISO 23908, opening tenders to safety designs. Mature markets such as Japan and Australia maintain high adoption rates, while Southeast Asia is moving up the curve as urban incomes rise.

Latin America and the Middle East & Africa post modest but improving growth. Brazil and Mexico lead Latin America as private pay segments expand. In the Gulf Cooperation Council, investment in chronic-disease programs increases demand, though public-sector price caps slow the uptake of premium devices. Safety needle penetration should increase as injury data becomes more visible and local sterilization capacity improves.

1. AdvaCare
2. Allison Medical Inc.
3. Arkray
4. Artsana Group
5. B. Braun
6. Beckton Dickinson
7. Beipu Medical
8. Berpu Medical Technology
9. Embecta Corp.
10. GlucoRx Ltd.
11. Hindustan Syringes & Medical Devices
12. HTL-STREFA S.A.
13. Kangdelai
14. NIPRO Corporation
15. Novo Nordisk
16. Owen Mumford
17. PromiseMed Medical Devices
18. Terumo
19. Trividia Health
20. Ultimed
21. VOGT Medical Vertrieb GmbH
22. Ypsomed

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

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 Regulatory Mandates for Sharps-Injury Prevention
  • 4.2.2 Diabetes Prevalence Fueling Injection Volumes
  • 4.2.3 Shift to Home-Based Self-Administration
  • 4.2.4 Passive Auto-Disable Innovations Reduce Training Burden
  • 4.2.5 Trade-Driven Near-Shoring of Needle Production
  • 4.2.6 Shift Toward Safety Pen Needles to Curb Needlestick Injuries
• 4.3 Market Restraints
  • 4.3.1 Availability of Alternate Drug-Delivery (Pumps, Patch Pens)
  • 4.3.2 Premium Pricing Versus Standard Pen Needles
  • 4.3.3 Stringent ISO / FDA Biocompatibility Test Cycles
  • 4.3.4 Ethylene-Oxide Sterilization Capacity Bottlenecks
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Safety Mechanism Type
  • 5.1.1 Active Safety Pen Needles
  • 5.1.2 Passive Safety Pen Needles
• 5.2 By Needle Length
  • 5.2.1 5 mm
  • 5.2.2 6 mm
  • 5.2.3 8 mm
  • 5.2.4 10 mm
  • 5.2.5 Others
• 5.3 By Therapy
  • 5.3.1 Insulin Therapy
  • 5.3.2 GLP-1 Therapy
  • 5.3.3 Growth-Hormone Therapy
  • 5.3.4 Osteoporosis
  • 5.3.5 Other Therapies
• 5.4 By End-User
  • 5.4.1 Home-Care Settings
  • 5.4.2 Hospitals & Clinics
  • 5.4.3 Ambulatory Surgery Centers
  • 5.4.4 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 AdvaCare Pharma
  • 6.3.2 Allison Medical Inc.
  • 6.3.3 ARKRAY Inc.
  • 6.3.4 Artsana Group
  • 6.3.5 B. Braun SE
  • 6.3.6 Becton, Dickinson & Company
  • 6.3.7 Beipu Medical
  • 6.3.8 Berpu Medical Technology
  • 6.3.9 Embecta Corp.
  • 6.3.10 GlucoRx Ltd.
  • 6.3.11 Hindustan Syringes & Medical Devices
  • 6.3.12 HTL-STREFA S.A.
  • 6.3.13 Kangdelai
  • 6.3.14 NIPRO Corporation
  • 6.3.15 Novo Nordisk A/S
  • 6.3.16 Owen Mumford Ltd.
  • 6.3.17 PromiseMed Medical Devices
  • 6.3.18 Terumo Corporation
  • 6.3.19 Trividia Health Inc.
  • 6.3.20 UltiMed Inc.
  • 6.3.21 VOGT Medical Vertrieb GmbH
  • 6.3.22 Ypsomed AG

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment