Global Prefilled Syringes Market Size, Share, Opportunities, And Trends By Material, Applications, End-User, and Geography - Forecasts From 2025 To 2030

Description

Prefilled Syringes Market Size:

The global prefilled syringes market is projected to grow at a CAGR of 9.76% between 2025 to 2030.

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Prefilled syringes refer to the disposable syringe that is already loaded with the unit dose of the substance to be injected, to which a needle has already been fixed by the manufacturer. The syringes are designed in such a way that it administers the accurate amount of dosage, thus reducing the wastage of the medication. The rising preference for prefilled syringes over the conventional syringe-vial combination, because of the advantages offered by prefilled syringes such as increased patient safety and convenience, accuracy, etc., is the key factor driving the growth of the industry. In addition, the growth is attributed to the increasing prevalence of chronic diseases, reduced medication errors, and better use of controlled drugs such as narcotics using prefilled syringes.

The rapidly increasing number of patients suffering from chronic conditions, such as heart diseases, diabetes, and autoimmune diseases, which require patients to self-administer medications, will bolster the demand for prefilled syringes in the market. According to the National Institute of Environmental Health Science, in 2017, 24 million people had a condition of autoimmune disease in the United States. To help the patients self-administer medications for these chronic conditions, the requirement for prefilled syringes has expanded in the market, which will drive the growth of the prefilled syringes market.

Furthermore, the supportive government regulations (especially needlestick legislation) will further boost market growth. According to a report published by the Geneva Association, in the last two decades, the total aggregate global expenditure on healthcare as a percentage of GDP has increased from 8% to almost 10%, which is driven by the exorbitant cost of medical treatment, growing treatment options, and increasing customer demands. The increasing spending on medical expenditure by both developed and developing countries will augment the market growth of the global prefilled syringes market. Also, prefilled syringes are largely used for vaccination of the population against diseases such as polio, coronavirus, hepatitis, etc., which will contribute to the market growth during the forecast period.

Prefilled Syringes Market Analysis:

Growth Drivers

• The persistent global increase in the prevalence of chronic diseases like diabetes, rheumatoid arthritis, and oncology is the primary catalyst for demand.

These conditions necessitate long-term, routine, and often self-administered subcutaneous injections. PFS directly addresses this by offering a unit-dose system that is inherently simpler and safer for patients to use at home, thereby increasing patient adherence and reducing the burden on clinical settings. Furthermore, the burgeoning pipeline of biologic therapies, monoclonal antibodies, and recombinant proteins drives the demand for PFS with superior material compatibility and stability. These sensitive, high-value drugs require the inertness of Type I borosilicate glass or high-performance polymers to ensure drug purity and efficacy over the product's shelf life, thereby dictating the specifications and consequently the demand for advanced PFS systems.

• Availability of cheap alternatives

The availability of cheaper alternatives to the prefilled syringes and focus on the development of alternative drug delivery methods might restrain the market during the given time frame. The prefilled syringes are expensive as they have a challenging manufacturing procedure, due to which the patients might often resort to cheaper alternatives for drug delivery, such as needle-free injectors, etc., which hamper the market growth. Also, a large number of needle stick injuries are associated with the use of bare prefilled syringes, as patients are not aware of using the prefilled syringes on their own without any medical assistance, which may result in injury to them.

• Challenges and Opportunities

The primary challenge constraining market growth is the heightened regulatory burden for PFS, which are classified as combination products in key jurisdictions. This dual oversight requires compliance with both drug and device regulations, notably extending approval timelines and increasing manufacturing costs, creating a high barrier to entry that can suppress supply from smaller, innovative firms. Conversely, a significant opportunity lies in the accelerating need for deep-cold storage solutions to support novel therapies such as mRNA vaccines and gene therapies.

• Raw Material and Pricing Analysis

The prefilled syringes market is a physical product market predominantly reliant on two key raw materials: Type I borosilicate glass tubing and cyclic olefin copolymer (COC)/cyclic olefin polymer (COP). Glass pricing is subject to energy and commodity costs, given the high-temperature conversion process, which introduces price volatility in the supply chain. COC/COP pricing is less volatile but is dictated by specialized petrochemical production capacity. A critical pricing dynamic stems from the shift toward Ready-to-Fill (RTF) syringes. While the unit cost of an RTF syringe is higher than that of a bulk syringe, it commands a price premium because it streamlines the pharmaceutical manufacturer's fill-and-finish operations, reduces in-house preparation, and minimizes the risk of component contamination, thus lowering the total cost of ownership for drug companies.

Prefilled Syringes Market Segment Analysis:

• Segment by Application: Vaccines and Immunizations

The Vaccines and Immunizations segment is a historically dominant consumer of prefilled syringes, driven by the global imperative for mass vaccination programs and public health campaigns. The core demand driver is the operational efficiency and contamination mitigation inherent to the PFS format. In high-volume settings, PFS eliminates the multi-step process of drawing a dose from a vial, which saves critical time for healthcare workers and virtually eliminates the risk of needlestick injuries and microbial contamination during preparation. Furthermore, PFS supports crucial dose-sparing strategies in vaccine distribution by ensuring highly accurate dosing and minimizing drug residual volume (dead space), which is particularly vital for expensive or supply-constrained vaccines. The recent global focus on novel vaccines, including those utilizing mRNA technology, also drives specific demand for PFS that are stable in deep-cold or ultra-cold storage environments, mandating a technical evolution in container material and closure integrity.

• Segment by End-User: Home Care Settings

The demand from the Home Care Settings segment is experiencing the most dynamic growth, fueled by the societal trend toward decentralizing healthcare for chronic disease management. For patients managing long-term conditions such as diabetes, multiple sclerosis, or rheumatoid arthritis, PFS are an essential enabler of self-injection. The demand is intrinsically linked to the need for simplicity and error reduction, as PFS arrive pre-dosed and ready-to-administer, minimizing patient confusion and medication errors. This segment is particularly demanding of safety-engineered PFS (safety prefilled syringes) that incorporate automatic needle shielding mechanisms. These features enhance patient confidence, protect caregivers from accidental needlestick injuries, and comply with sharps disposal protocols outside of a clinical environment, creating a high-value demand pocket for advanced, user-centric delivery devices.

Prefilled Syringes Market Geographical Analysis:

• US Market Analysis (North America)

The US market exhibits robust demand, largely driven by the high uptake of expensive biologics and a strong regulatory push from the FDA for medical device safety. The sophisticated US healthcare infrastructure and high chronic disease burden (e.g., diabetes, autoimmune disorders) create a sustained demand imperative for advanced PFS, especially for autoinjector and pen injector compatibility. Local demand is heavily influenced by quality-of-care protocols and a high focus on patient adherence, which favors the adoption of ready-to-use, human-factor-engineered devices. Furthermore, the presence of major biopharmaceutical companies with extensive R&D pipelines ensures continuous investment in PFS as the preferred delivery system for novel drugs.

• Germany Market Analysis (Europe)

Germany's market demand is characterized by a strong compliance culture and high quality expectations, influenced by the European Medicines Agency (EMA) and the stringent MDR. The market is a key European manufacturing hub, driving internal demand for cutting-edge technologies like baked-on siliconization and ultra-low particle glass to support its large pharmaceutical and contract development and manufacturing organization (CDMO) base. The elderly demographic also drives demand for patient-centric designs, specifically PFS optimized for use with autoinjectors to support decentralized care and self-administration, requiring tight dimensional tolerances and consistent force performance.

Prefilled Syringes Market Competitive Environment and Analysis:

The global prefilled syringes market is consolidated, dominated by a few major players who are vertically integrated and possess the requisite high-precision manufacturing and regulatory expertise. The competition pivots on innovation in materials science, manufacturing quality, and digital traceability, rather than solely on price. Major companies are strategically positioning their portfolios to address the complex requirements of biologics, which include reducing drug-container interaction risks (e.g., tungsten or silicone oil residuals) and ensuring compatibility with advanced autoinjection platforms.

• Company Profile: Becton, Dickinson and Company (BD)

BD holds a dominant position in the global PFS market, leveraging its extensive manufacturing scale and a deep portfolio of both conventional and safety-engineered products. Its strategic positioning focuses on system integration and safety innovation. The launch of the BD Effivax™ Glass Prefillable Syringe specifically targets the vaccine market by featuring enhanced technology for reliability and efficiency during the fill/finish process, addressing pharmaceutical partners' need for reduced line stoppage and improved total cost of ownership. Furthermore, BD is actively advancing traceability through its collaboration on the BD iDFill™ Individual Prefillable Syringe Identification—an RFID-based solution aimed at enhancing fill-and-finish traceability and supply chain visibility, positioning the company as a leader in smart drug delivery.

• Company Profile: Schott Pharma (formerly SCHOTT AG)

Schott Pharma maintains a critical position as a leading supplier of pharmaceutical glass and polymer packaging, with a strategic focus on supporting highly sensitive drug formulations and demanding storage conditions. Their core strategy revolves around material innovation and customization. The company's product portfolio includes the syriQ BioPure® glass PFS, designed with low, uniform silicone levels for sensitive biologics, and the SCHOTT TOPPAC® polymer syringe line. The launch of SCHOTT TOPPAC® freeze polymer PFS specifically addresses the emerging deep-cold storage requirements of next-generation therapies like mRNA vaccines, demonstrating a proactive strategy to capture demand in high-growth, technically challenging segments.

Prefilled Syringes Market Developments:

• April 2025: Gerresheimer and Injecto launched complete silicone-oil- and PFAS-free syringe systems (glass/COP), meeting high-purity requirements for sensitive biologics and ophthalmology.
• May 2025: Zydus Lifesciences received USFDA approval for its Glatiramer Acetate Injection in single-dose prefilled syringes, expanding its complex generics portfolio.
• January 2025: SCHOTT Pharma launched TOPPAC infuse polymer syringes, aiming to boost safety and efficiency in drug delivery; compatible with existing filling lines.
• October 2024: BD (Becton, Dickinson and Company) announced a collaboration with CDMO ten23 health® to pilot an RFID-based solution for prefillable syringes, branded as BD iDFill™ Individual Prefillable Syringe Identification. 

Prefilled Syringes Market Scope:

Prefilled Syringes Market Segmentation:

• By Type
  • Conventional Prefilled Syringes
  • Safety Prefilled Syringes
  • Material
  • Glass
  • Plastic/Polymer
• By Design
  • Single-Chamber
  • Dual-Chamber
  • Customized/Multiple-Chamber
• By Closing System
  • Staked Needle System
  • Luer Cone System
  • Luer Lock System
• By Application
  • Vaccines and Immunizations
  • Diabetes
  • Rheumatoid Arthritis
  • Oncology/Cancer
  • Anaphylaxis
  • Thrombosis
  • Ophthalmology
  • Autoimmune Diseases
  • Others
• By End-Users
  • Hospitals and Clinics
  • Ambulatory Surgery Centers
  • Pharmaceutical & Biotechnology Companies
  • Mail Order Pharmacies
  • Home Care Settings
  • Others
• By Geography
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • UK
    • Germany
    • France
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • Israel
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • Indonesia
    • Taiwan
    • Thailand
    • Others

Table Of Contents

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

2.1. Market Overview

2.2. Market Definition

2.3. Scope of the Study

2.4. Market Segmentation

3. BUSINESS LANDSCAPE

3.1. Market Drivers

3.2. Market Restraints

3.3. Market Opportunities

3.4. Porter’s Five Forces Analysis

3.5. Industry Value Chain Analysis

3.6. Policies and Regulations

3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. Global prefilled syringes MARKET BY type

5.1. Introduction

5.2. Conventional Prefilled Syringes

5.3. Safety Prefilled Syringes

6. Global prefilled syringes MARKET BY material

6.1. Introduction

6.2. Glass

6.3. Plastic/Polymer

7. Global prefilled syringes MARKET BY design

7.1. Introduction

7.2. Single-Chamber

7.3. Dual-Chamber

7.4. Customized/Multiple-Chamber

8. Global prefilled syringes MARKET BY closing system

8.1. Introduction

8.2. Staked Needle System

8.3. Luer Cone System

8.4. Luer Lock System

9. Global prefilled syringes MARKET BY application

9.1. Introduction

9.2. Vaccines and Immunizations

9.3. Diabetes

9.4. Rheumatoid Arthritis

9.5. Oncology/Cancer

9.6. Anaphylaxis

9.7. Thrombosis

9.8. Ophthalmology

9.9. Autoimmune Diseases

9.10. Others

10. Global prefilled syringes MARKET BY END-USERs

10.1. Introduction

10.2. Hospitals and Clinics

10.3. Ambulatory Surgery Centers

10.4. Pharmaceutical & Biotechnology Companies

10.5. Mail Order Pharmacies

10.6. Home Care Settings Others

11. Global prefilled MARKET BY GEOGRAPHY

11.1. Introduction

11.2. North America

11.2.1. United States

11.2.2. Canada

11.2.3. Mexico

11.3. South America

11.3.1. Brazil

11.3.2. Argentina

11.3.3. Others

11.4. Europe

11.4.1. Germany

11.4.2. France

11.4.3. United Kingdom

11.4.4. Spain

11.4.5. Others

11.5. Middle East and Africa

11.5.1. Saudi Arabia

11.5.2. UAE

11.5.3. Others

11.6. Asia Pacific

11.6.1. China

11.6.2. India

11.6.3. Japan

11.6.4. South Korea

11.6.5. Indonesia

11.6.6. Thailand

11.6.7. Others

12. COMPETITIVE ENVIRONMENT AND ANALYSIS

12.1. Major Players and Strategy Analysis

12.2. Market Share Analysis

12.3. Mergers, Acquisitions, Agreements, and Collaborations

12.4. Competitive Dashboard

13. COMPANY PROFILES

13.1. Chemi S.p.A.

13.2. Catalent, Inc.

13.3. Becton, Dickinson and Company

13.4. Nipro Corporation

13.5. Taisei Kako Co. Ltd.

13.6. MEDEFIL, INC.

13.7. Alfasigma S.p.A

13.8. Aquabiliti

13.9. Schott Pharma (formerly SCHOTT AG)

13.10. Vetter Pharma International GmbH

13.11. Gerresheimer AG

13.12. West Pharmaceutical, Inc.

14. APPENDIX

14.1. Currency

14.2. Assumptions

14.3. Base and Forecast Years Timeline

14.4. Key benefits for the stakeholders

14.5. Research Methodology

14.6. Abbreviations

LIST OF FIGURES

LIST OF TABLES

Companies Profiled

Chemi S.p.A.

Catalent, Inc.

Becton, Dickinson and Company

Nipro Corporation

Taisei Kako Co. Ltd.

MEDEFIL, INC.

Alfasigma S.p.A

Aquabiliti

Schott Pharma (formerly SCHOTT AG)

Vetter Pharma International GmbH

Gerresheimer AG

West Pharmaceutical, Inc.

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