Prefilled Syringes Market

Prefilled Syringes Market Size, Share and Growth Forecast by Material, by Application, by Distribution Channel, and by region for 2024-2031

Report ID: PMRREP34583

Report Type: Ongoing

Format: PPT*, PDF, EXCEL

Industry: Healthcare

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Prefilled Syringes Market Size, Share, & Growth Analysis

The global market for prefilled syringes is estimated to value at US$13.6 Bn by the end of 2031 from US$ 7.5 Bn recorded in 2024. the market is expected to secure a CAGR of 8.9% in the forthcoming years from 2024 to 2031.

Key Highlights of the Market

  • The role of advanced technologies like automated segregation systems for efficient production, smart labelling, and RFID is growing substantial in the market build-up.
  • Integration of advanced safety mechanisms is growing, eying minimum needlestick injuries, and cross-contamination risks.
  • Early incorporation of prefilled syringes into the drug lifecycle, which is often considered as early as Phase II in clinical trials.
  • Cyclic olefin copolymer (COC) syringes are gaining traction for their break-resistant, lightweight properties.

Market Attributes

Key Insights

Market Size (2024E)

US$7.5 Bn

Projected Market Value (2031F)

US$13.6 Bn

Global Market Growth Rate (CAGR 2024 to 2031)

8.9%

Historical Market Growth Rate (CAGR 2018 to 2023)

7.6%

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Prefilled Syringes Market Introduction and Trend Analysis

The prefilled syringes industry is undergoing significant transformation with the introduction of advanced technologies, and innovative practices aimed at improving safety, efficiency, and environmental sustainability.

Prefilled syringes represent a significant advancement in the pharmaceutical and healthcare industries, combining convenience, accuracy, and safety in medication administration.

Initially developed to enhance the precision and efficiency of drug delivery, prefilled syringes have evolved into a preferred choice for a wide range of injectable therapies, including vaccines, biologics, and anticoagulants.

Their rise in popularity is driven by several factors, including the growing prevalence of chronic diseases, the increasing need for home healthcare solutions, and stringent regulatory requirements for drug administration safety.

Prefilled syringes reduce the risk of dosage errors and contamination, streamline the medication preparation process, and improve patient compliance with self-administration, making them particularly valuable in managing conditions such as diabetes and rheumatoid arthritis.

Furthermore, the integration of safety features, such as retractable needles and needle guards, addresses the critical issue of needlestick injuries, thereby enhancing their appeal to healthcare providers.

As the global healthcare landscape continues to evolve, the demand for prefilled syringes is expected to expand, supported by technological advancements, innovative drug formulations, and the rising emphasis on patient-centric care.

Historical Growth and Course Ahead

The market for prefilled syringes has witnessed substantial growth over the past few decades. Initially, the adoption of prefilled syringes was driven by the need for improved accuracy and safety in drug delivery.

The pharmaceutical industry's shift towards biologics and injectable therapies further fueled this growth. The early 2000s saw significant advancements in syringe technology, including the development of materials like high-quality glass and advanced polymers, which enhanced the safety and usability of prefilled syringes.

Regulatory bodies such as the US FDA and the EMA also played a pivotal role by implementing stringent guidelines that emphasized the importance of minimizing medication errors and ensuring patient safety.

The increasing prevalence of chronic diseases such as diabetes, cancer, and autoimmune disorders necessitates efficient and reliable drug delivery systems, positioning prefilled syringes as an essential component of modern healthcare.

Additionally, the global emphasis on vaccination programs, highlighted by the COVID-19 pandemic, underscores the critical role of prefilled syringes in ensuring safe and effective vaccine administration.

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Market Growth Drivers

The Growing Role of Prefilled Syringes in Meeting Vaccine Demand

In 2021, approximately 16 billion vaccine doses worth US$ 141 billion were supplied, a substantial increase from the 2019 figures, largely driven by the demand for COVID-19 vaccines.

This surge underscores the importance of efficient vaccine delivery systems. Prefilled syringes, with their ease of use, accuracy in dosing, and enhanced safety, are ideally suited to support large-scale immunization efforts.

Additionally, the ongoing struggle of lower-income countries to access vital vaccines like those for COVID-19, and cervical cancer highlights the need for equitable distribution solutions.

Prefilled syringes can play a crucial role in addressing these disparities by ensuring that vaccines are readily available and easily administered in diverse settings.

Moreover, the concentration of vaccine manufacturing among a few suppliers and regions underscores the risk of shortages and the necessity for reliable and efficient vaccine delivery methods.

As global health organizations call for ambitious action to guarantee equitable access to vaccines and improve responses to future pandemics, the demand for prefilled syringes is poised to grow, driven by their ability to facilitate efficient, safe, and widespread vaccine administration.

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Factors Impeding the Market

Quality, and Compliance

The supply chain for prefilled syringes has faced several significant challenges, particularly concerning the quality and performance of plastic syringes manufactured in China.

The FDA has issued warning letters to companies distributing these syringes in the US, highlighting concerns about their ability to deliver the correct dose of medication.

This issue has prompted an evaluation of the supply and manufacturing capacity of plastic syringes from other countries, including domestic production, which the FDA considers adequate to meet current healthcare demand.

However, ensuring compliance with serialization mandates and incorporating new digital technologies for enhanced manufacturing efficiency and safety remains a challenge for pharmaceutical companies.

Moreover, the selection of appropriate label materials for prefilled syringes is crucial, given that advanced medicines such as biologics require a complex supply chain and are often exposed to extreme temperatures and humidity during sterilization or low temperatures during storage and transport.

These issues underscore the importance of stringent quality control, regulatory compliance, and ongoing innovation in the prefilled syringe supply chain to ensure the safety and efficacy of drug delivery.

Cost Constraints

The manufacturing process involves advanced moulding techniques requiring precision engineering, which inherently increases production expenses.

Stringent quality control measures are essential to ensure the highest safety and efficacy standards for these medical devices, further elevating costs.

Complex manufacturing conditions necessitate precise control to maintain syringe integrity, particularly when dealing with biologics and biosimilars, which present unique challenges such as volume and viscosity management.

Aseptic processing, critical for maintaining product sterility through formulation, filtering, filling, and packaging phases, is both complex and costly.

Additionally, compliance with strict regulatory requirements and the need to manage interactions between syringe materials and drugs, especially biologics, contribute to higher operational costs.

Although pharmaceutical companies can achieve some cost savings by reducing labor expenses and minimizing waste through the elimination of manual filling and stoppering, the initial investment in technology and the complexities involved in maintaining high operational standards keep overall production costs elevated.

Future Opportunities for Prefilled Syringes Companies

The Rise of Self-Administration Trend

With the rise in chronic diseases such as diabetes, rheumatoid arthritis, and multiple sclerosis, patients are increasingly seeking convenient and reliable methods to manage their conditions at home.

Prefilled syringes offer a user-friendly solution that enhances patient compliance and independence, reducing the need for frequent visits to healthcare facilities.

These syringes are designed for ease of use, ensuring accurate dosing and minimizing the risk of medication errors, which is particularly beneficial for patients who may struggle with traditional syringes.

As healthcare systems and patients alike recognize the benefits of prefilled syringes in improving treatment adherence and outcomes, the market is poised to expand significantly, driven by this increasing preference for self-administered therapies.

Scope for Expansion Across Developing Markets

Technological advancements have significantly reshaped the prefilled syringes market, presenting abundant opportunities for growth and innovation.

These syringes, pre-filled with precise doses of medication, have become increasingly popular due to their convenience, safety, and ease of use in healthcare settings. One major technological advancement is the development of advanced materials for syringe components.

Innovations in plastics and biocompatible materials have improved the safety and reliability of prefilled syringes, ensuring that drugs remain stable and uncontaminated until administration. This not only enhances patient safety but also extends shelf life, reducing wastage and costs for pharmaceutical companies.

Additionally, advancements in syringe design and manufacturing processes have led to the creation of user-friendly features such as ergonomic grips, needle safety mechanisms, and precise dose indicators.

Such innovations cater to healthcare providers' preferences for efficient and error-free medication delivery, thereby improving overall patient care and compliance.

Category-wise Analysis

Category

Projected CAGR through 2031

Material Category - Glass

5.3%

Application - Vaccine

6.2%

Glass Syringes Continue to Account for the Significant Share

Glass prefilled syringes are preferred for their inert nature, which ensures compatibility with a wide range of drug formulations, including biologics and sensitive medications.

These attributes help with the maintenance of drug stability and integrity throughout storage and administration, crucial for maintaining therapeutic efficacy.

Glass syringes are widely recognized for their high transparency, allowing for clear visibility of the drug and any potential particulate matter, thereby enhancing safety during drug preparation and administration.

Additionally, glass syringes are considered environmentally friendly as they are recyclable and can be safely disposed of after use.

These attributes make glass prefilled syringes a preferred choice for pharmaceutical companies and healthcare providers seeking reliable, safe, and sustainable drug delivery solutions, thereby driving their significant share in the prefilled syringes market.

Vaccines to be the Significant Application Category

Vaccines are poised to experience notable growth as an application for prefilled syringes for several compelling reasons. The global emphasis on immunization programs, especially in the light of recent pandemics like COVID-19, underscores the critical role of vaccines in public health.

Prefilled syringes offer advantages such as precise dosing, reduced preparation time, and enhanced safety features like needlestick prevention mechanisms, making them ideal for mass vaccination campaigns, and routine immunization schedules.

The increasing prevalence of infectious diseases and the need for timely vaccination drives demand for efficient and reliable vaccine delivery systems.

Prefilled syringes not only streamline the administration process but also ensure accurate dosage, which is crucial for achieving optimal immune response and vaccine efficacy.

Moreover, regulatory bodies globally recognize the benefits of prefilled syringes in vaccine delivery due to their ability to minimize contamination risks and maintain sterility throughout the storage and administration process.

This regulatory support further encourages the adoption of prefilled syringes for vaccine applications.

Region-wise Analysis

Region

CAGR through 2034

North America

5.9%

Asia Pacific

6.1%

North America Represents the Lion’s Share of Global Prefilled Syringe Sales

North America is poised to dominate the prefilled syringes market, accounting for a significant share due to several key factors.

The region boasts a robust healthcare infrastructure with advanced pharmaceutical manufacturing capabilities and stringent regulatory standards, ensuring high-quality production and compliance.

The increasing adoption of biologics and vaccines, coupled with a rising prevalence of chronic diseases, drives demand for prefilled syringes that offer precise dosing and enhanced safety features.

Moreover, favorable reimbursement policies and strong market presence of leading pharmaceutical companies further propel market growth in North America.

Asia Pacific Gears up for Notable Growth

Asia Pacific is projected to exhibit a notable value CAGR throughout the period of projection. The region is experiencing rapid urbanization, and economic growth, leading to improved healthcare infrastructure and increased access to advanced medical technologies.

The estimated growth is accompanied by rising healthcare expenditures and a growing elderly population, driving demand for convenient and safe drug delivery systems like prefilled syringes.

The expanding pharmaceutical and biotechnology sectors in countries like China, India, and Japan are contributing to the market expansion, with a focus on developing and manufacturing biologics, and specialty drugs that require precise dosing and reliable delivery methods.

Furthermore, regulatory reforms aimed at improving healthcare standards and increasing patient safety are facilitating market growth by encouraging the adoption of innovative medical devices.

Competitive Landscape Analysis

Acquisitions and partnerships, along with the development of innovative products and the expansion of production capacities, are key growth strategies followed by major players in the prefilled syringes market.

Innovations in this sector include automated manufacturing processes for enhanced efficiency, smart technologies integrating RFID, and NFC for improved tracking and authentication, and advancements in biocompatible materials to ensure drug stability, and safety.

Additionally, there is a trend towards sustainable practices, such as eco-friendly packaging materials and energy-efficient manufacturing processes, aligning with global initiatives for environmental responsibility and resource conservation in healthcare.

Recent Industry Developments

June 2024

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Icatibant Injection used for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

June 2024

Moderna has received the Food and Drug Administration’s approval for RESVIA (mRNA-1345), an mRNA respiratory syncytial virus vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

Report Scope

Attributes

Details

Forecast Period

2024 to 2031

Historical Data Available for

2019 to 2023

Market Analysis

US$ Billion for Value

Key Regions Covered

  • North America
  • Europe
  • East Asia
  • South Asia & Pacific
  • Middle East and Africa
  • Latin America

Key Market Segments Covered

  • Material
  • Application
  • Distribution Channel
  • Region

Key Companies Profiled in the Report

  • Fresenius Kabi USA, LLC
  • SCHOTT Pharma
  • Catalent
  • Terumo Group
  • West Pharmaceuticals
  • Nipro
  • Bausch + Lomb
  • Roncadelle Operations
  • AptarGroup, Inc.
  • Platinum Pharma Services Srls
  • FOSAFE Medical Technology Co.,Ltd.
  • Jiangsu Micsafe Medical Technology Co., Ltd. 
  • MedXL Inc.
  • BD
  • B. Braun SE
  • Teleflex Incorporated
  • Baxter
  • STI Group
  • Fagron Sterile Services US

Report Coverage

  • Market Forecast and Trends
  • Company Share Analysis
  • Competitive Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

Customization & Pricing

Available upon request

Prefilled Syringes Market Segmentation

By Material

  • Glass
  • Plastic
  • Others

By Application

  • Vaccines
  • Monoclonal Antibodies
  • Blood Stimulators
  • Therapeutic Proteins
  • Others

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Institutional Sales
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Middle East and Africa
  • Latin America

For report customisation and delivery information contact our sales representative.

Companies Covered in This Report

Frequently Asked Questions

The demand for prefilled syringes is skyrocketing due to their role in safely administering complex biologics, and vaccines while reducing medication errors and contamination risks.

Innovations such as advanced materials for syringe components, smart technologies like RFID tags, and ergonomic designs with safety features such as needle guards.

Regulatory bodies such as the FDA in the United States, the EMA in Europe, and similar agencies worldwide set standards for design, materials, sterility, biocompatibility, and drug compatibility.

The estimated future trends include increased adoption for biologics and biosimilars, integration of smart technologies for enhanced tracking, emphasis on safety features and usability improvements, and focus on environmental sustainability.

North America is likely to account for a significant share of the market.

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