미국의 약물전달 디바이스 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the United States drug delivery devices market size is expected to increase from USD 51.24 billion in 2025 to USD 54.41 billion in 2026 and reach USD 75.57 billion by 2031, growing at a CAGR of 6.79% over 2026-2031.

This report is Segmented by Device Type (Injectable, Inhalation, Transdermal, Ocular, Oral Controlled-Release, Other), Route of Administration (Intravenous, Subcutaneous, Intradermal, Oral, Others), Application (Oncology, Diabetes, Respiratory, and More), End User (Hospitals, Ascs, Home-Healthcare, Specialty Clinics), and Geography. The Market Forecasts are in Value (USD).

United States Drug Delivery Devices Market Trends and Insights

Rising Prevalence of Chronic Diseases

Nearly 38.4 million Americans lived with diagnosed diabetes in 2024, and the CDC projects one in three adults will carry the diagnosis by 2050, intensifying long-term demand for continuous glucose monitors, insulin pumps, and GLP-1 autoinjectors. Cancer incidence surpassed 2 million new cases in 2024, sustaining high utilisation of port-a-cath systems and ambulatory infusion pumps for chemotherapy. Cardiovascular disease affects 127 million adults, prompting increased use of anticoagulant pens and drug-eluting stents that mitigate hospital readmissions. Chronic respiratory conditions and a growing autoimmune population are driving the United States drug delivery devices market toward durable, patient-managed formats. The cumulative effect is a multiyear lift in baseline procedure volumes, supporting predictable unit shipments well beyond the forecast horizon.

Growing Preference for Self-Administration & Home Healthcare

CMS introduced stand-alone reimbursement codes for home infusion therapy in 2025, neutralising historical payment penalties and giving providers an economic incentive to discharge stable patients with wearable injectors and connected pumps. Medicare Advantage enrollment crossed 33 million members the same year, and plans rapidly bundled device supplies with telehealth monitoring to cut emergency-department visits. The American Nurses Association forecasts 78,000 unfilled RN positions by 2026, further encouraging technologies that shift dosing responsibility to patients. Device makers answered with user-centred autoinjectors featuring needle-retraction windows and audible cues that reduce error rates among seniors. Collectively, these trends pivot the United States drug delivery devices market toward home-centric care pathways that reward simplicity and remote visibility.

Stringent FDA Regulatory Requirements

Cybersecurity guidance released in 2024 makes an SBOM and threat-modeling dossier a condition of clearance for any wireless device, extending development cycles 6-12 months and adding USD 2-5 million per platform. Combination product reviews now require human factors validation even when predicate devices exist, and post-market surveillance reporting is mandatory within 30 days of serious incidents. Smaller innovators struggle with the staffing and documentation load, slowing pipeline velocity and nudging the United States drug delivery devices industry toward consolidation. Real-world evidence is also becoming increasingly important; products must demonstrate performance in routine practice within 24 months, which escalates launch costs.

Other drivers and restraints analyzed in the detailed report include:

1. Connected Smart Devices Improve Adherence & Outcomes
2. Biologics Capacity Boom Drives Demand for Advanced Containers
3. Recalls & Device Malfunctions Undermine Confidence

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

Segment Analysis

Injectable platforms generated 43.27% revenue in 2025, anchoring the United States drug delivery devices market share with 8.2 billion units shipped. Wearable injectors such as BD Libertas and Enable enFuse now handle 5-50 mL biologics, opening subcutaneous routes for therapies once limited to infusion chairs. Oral controlled-release systems, although only 18% of 2025 revenue, will outpace all categories at 7.32% CAGR to 2031 because Rybelsus proved peptides can survive GI transit when paired with absorption enhancers.

The historical CAGR for injectables averaged 5.8% during 2019-2025, but steps up slightly over 2026-2031 as biosimilar launches and GLP-1 demand intensify. Smart sensors improved adherence, but adoption lags pending uniform payer coverage. Transdermal and ocular devices together remain below 10% share but win premium pricing where they reduce clinic visits, exemplified by Genentech's twice-yearly Susvimo refills for AMD.

Intravenous delivery captured 36.83% of the 2025 value, primarily through hospital chemotherapy and TPN volumes, yet its forecast CAGR tails at 5.2% as payers reroute suitable biologics to the home. Subcutaneous delivery will grow 7.69% annually, driven by the scaling of large-volume patch pumps reimbursed under new home-infusion codes. Intradermal remains niche, though microneedle vaccine patches secured Breakthrough Device status in 2024. Oral routes hold a stable base, while pulmonary and transdermal routes serve targeted populations like COPD and chronic pain, sustaining mid-single-digit growth.

Complete Report Scope:

• Device Type
  • Injectable Delivery Devices
  • Inhalation Delivery Devices
  • Transdermal Delivery Devices
  • Ocular Delivery Devices
  • Oral Controlled-Release Systems
  • Other Device Types (Implantable Drug Delivery Devices, Nasal Delivery Devices, etc.)
• Route of Administration
  • Intravenous
  • Subcutaneous
  • Intradermal
  • Oral
  • Others (Pulmonary, Transdermal, etc.)
• Application / Therapeutic Area
  • Oncology
  • Diabetes
  • Respiratory Diseases
  • Cardiovascular Diseases
  • Auto-immune Diseases
  • Other Applications (Infectious Diseases, CNS Disorders, etc.)
• End User
  • Hospitals
  • Ambulatory Surgical Centers
  • Home-Healthcare Settings
  • Specialty Clinics

List of Companies Covered in this Report:

1. 3M
2. Abbvie
3. Amgen
4. AstraZeneca
5. Beckton Dickinson
6. Boston Scientific
7. Eli Lilly and Company
8. Gerresheimer
9. Insulet
10. Johnson & Johnson
11. Medtronic
12. Novartis
13. Pfizer
14. Sanofi
15. Tandem Diabetes Care
16. Teva Pharmaceutical Industries
17. West Pharmaceutical Services

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 Rising Prevalence of Chronic Diseases
  • 4.2.2 Growing Preference for Self-Administration & Home Healthcare
  • 4.2.3 Connected Smart Devices Improve Adherence & Outcomes
  • 4.2.4 Biologics Capacity Boom Drives Demand for Advanced Containers
  • 4.2.5 Value-Based Care Models Favor Long-Acting Implants
  • 4.2.6 Expanding Biologics Pipeline Necessitating Advanced Parenteral Delivery Platforms
• 4.3 Market Restraints
  • 4.3.1 Stringent FDA Regulatory Requirements
  • 4.3.2 Recalls & Device Malfunctions Undermine Confidence
  • 4.3.3 Raw-Material Bottlenecks in Medical-Grade Polymers
  • 4.3.4 Rising Needlestick Injury Litigation Elevating Liability Insurance Premiums
• 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 Substitute Products
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 Device Type
  • 5.1.1 Injectable Delivery Devices
  • 5.1.2 Inhalation Delivery Devices
  • 5.1.3 Transdermal Delivery Devices
  • 5.1.4 Ocular Delivery Devices
  • 5.1.5 Oral Controlled-Release Systems
  • 5.1.6 Other Device Types (Implantable Drug Delivery Devices, Nasal Delivery Devices, etc.)
• 5.2 Route of Administration
  • 5.2.1 Intravenous
  • 5.2.2 Subcutaneous
  • 5.2.3 Intradermal
  • 5.2.4 Oral
  • 5.2.5 Others (Pulmonary, Transdermal, etc.)
• 5.3 Application / Therapeutic Area
  • 5.3.1 Oncology
  • 5.3.2 Diabetes
  • 5.3.3 Respiratory Diseases
  • 5.3.4 Cardiovascular Diseases
  • 5.3.5 Auto-immune Diseases
  • 5.3.6 Other Applications (Infectious Diseases, CNS Disorders, etc.)
• 5.4 End User
  • 5.4.1 Hospitals
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Home-Healthcare Settings
  • 5.4.4 Specialty Clinics

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 as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)
  • 6.3.1 3M
  • 6.3.2 AbbVie Inc.
  • 6.3.3 Amgen Inc.
  • 6.3.4 AstraZeneca plc
  • 6.3.5 Becton, Dickinson and Company
  • 6.3.6 Boston Scientific Corporation
  • 6.3.7 Eli Lilly and Company
  • 6.3.8 Gerresheimer AG
  • 6.3.9 Insulet Corporation
  • 6.3.10 Johnson & Johnson
  • 6.3.11 Medtronic plc
  • 6.3.12 Novartis AG
  • 6.3.13 Pfizer Inc.
  • 6.3.14 Sanofi S.A.
  • 6.3.15 Tandem Diabetes Care Inc.
  • 6.3.16 Teva Pharmaceutical Industries Ltd.
  • 6.3.17 West Pharmaceutical Services Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment