United States Self-injection Device Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Self-injection Device Market is forecast to reach at a high CAGR during the forecast period (2024-2031)

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Key Development:

United States: Recent Self‐Injection Device Developments

✅ In December 2025, the FDA approved the Leqembi IQLIK weekly subcutaneous autoinjector, enabling at‐home self‐injection for maintenance dosing in early Alzheimer's disease after initial IV therapy, enhancing convenience and patient independence.

✅ In May 2025, the U.S. FDA granted approval to Amneal's Brekiya® autoinjector a ready‐to‐use self‐administered device for acute migraine and cluster headache treatment that requires no assembly or refrigeration.

✅ In April 2025, the FDA cleared a prefilled syringe version of Argenx's Vyvgart Hytrulo for at‐home self‐administration in generalized myasthenia gravis and CIDP, improving accessibility for chronic immune disorders.

✅ In early 2025, the FDA selected new biologics/device approvals lists that include self‐injection options for additional therapies, reflecting continued regulatory emphasis on patient‐centric delivery solutions.

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Japan: Recent Self‐Injection Device Developments

✅ In December 2025, Japanese markets are seeing expansion in auto‐injectors for GLP‐1 receptor agonists, driven by rising diabetes and obesity co‐morbidities and demand for convenient at‐home dosing options with precise, user‐friendly devices.

✅ In June 2025, Pyzchiva® autoinjector technology (ustekinumab biosimilar) was noted internationally, and Japanese pharma stakeholders accelerated collaborations to integrate next‐gen digital self‐injection features tailored for home care.

✅ In May 2025, Eisai and Medac's "メトジェクト®皮下注ペン" pen‐type self‐injector for methotrexate became available in Japan, improving convenience and safety for rheumatoid arthritis self‐administration.

✅ In late 2025, domestic industry and regulatory focus has turned toward smart, connected self‐injection platforms combining digital adherence tracking and AI guidance to boost patient compliance, particularly in chronic disease management.

Key Players:

=> Becton, Dickinson and Company, Ypsomed AG, Fresenius Kabi, Gerresheimer AG, Pfizer, Inc., Antares Pharma, Inc., West Pharmaceutical Services, Insulet Corporation, Owen Mumford Ltd. and SHL Group Auto.

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Key Segments:

By Product

Pen Injectors dominate with 35% share, widely used for self-administration of biologics and insulin.
Wearable Injectors hold 25% share, enabling large-volume drug delivery with improved patient adherence.
Needle-Free Injectors account for 15%, preferred for pain-free delivery and enhanced patient compliance.
Autoinjectors represent 25%, offering convenience, accuracy, and safety for chronic disease management.

By Usage

Disposable Injectors lead with 60% share, favored for single-use safety and infection control.
Reusable Injectors hold 40%, suitable for long-term therapies with cost-effectiveness considerations.

By Application

Autoimmune Disorders account for 30%, driven by increasing prevalence of conditions like rheumatoid arthritis and multiple sclerosis.
Allergic Disorders hold 20%, supported by rising allergy cases and immunotherapy adoption.
Hormonal Diseases represent 15%, primarily diabetes and endocrine therapies.
Infectious Diseases contribute 25%, including vaccines and biologic treatments.
Other Applications account for 10%, including rare diseases and specialized therapies.

By Distribution Channels

Hospital Pharmacies lead with 40% share, preferred for inpatient and specialized therapies.
Retail Pharmacies account for 35%, serving outpatient prescriptions and chronic care patients.
Online Pharmacies hold 25%, rapidly growing due to convenience, home delivery, and telehealth adoption.

By Region

North America - 35% Share
Driven by advanced healthcare infrastructure, high adoption of self-injection devices, and presence of leading manufacturers.

Europe - 25% Share
Growth supported by aging population, increasing chronic disease prevalence, and reimbursement policies.

Asia Pacific - 20% Share
Emerging adoption fueled by rising healthcare awareness, diabetes incidence, and growing pharma market.

South America - 10% Share
Adoption primarily in urban healthcare centers, with opportunities in expanding retail pharmacy networks.

Middle East & Africa - 10% Share
Opportunities in government healthcare initiatives, infectious disease management, and increasing awareness of self-injection therapies.

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