Prefilled Syringes Market

Prefilled Syringes Market Size:

The prefilled syringes market size reached US$ 7.6 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 15.2 Billion by 2032, exhibiting a growth rate (CAGR) of 7.9% during 2024-2032. Factors like the rising incidences of chronic illnesses, the need for patient safety, the advent of biologics and biosimilars, the convenience of drug administration, and the growing demand for self-injection devices are propelling the expansion of the prefilled syringes market.

Prefilled Syringes Market Analysis:

• Major Market Drivers: The rise in demand for self-injection equipment, escalating concerns about patient convenience and safety, and the increase in chronic illness are key drivers fueling the market growth.
• Key Market Trends: Continuous improvements in safety features, customization to meet varying therapeutic requirements, and a rising consciousness regarding sustainability, material choices, and package designs are important trends driving the market's expansion.
• Geographical Trends: Europe's geriatric population, strict regulations, and patient-centered care drive the market demand. Alongside, North America's thriving pharmaceutical industry as well as improved healthcare infrastructure and rising disposable income in emerging economies are aiding in market expansion.
• Competitive Landscape: Some of the major market players in the prefilled syringes industry include Abbott Laboratories, B. Braun Melsungen AG, Baxter International Inc., Bayer AG, Becton Dickinson and Company., Cardinal Health Inc., Catalent Inc., Fresenius SE & Co. KGa., Gerresheimer AG, and Nipro Corporation, among many others.
• Challenges and Opportunities: Stringent regulatory mandates and product compatibility issues are hampering market growth. Whereas, addressing unmet medical needs, leveraging technological advancements, and collaborating with healthcare stakeholders for research and development (R&D) investments are presenting lucrative opportunities.

Prefilled Syringes Market Drivers:

Enhanced Safety

In contrast to standard vials or ampoules, prefilled syringes offer improved safety features. Their design lowers the risk of infection and needlestick injuries, thereby improving patient and healthcare practitioners’ safety. Prefilled syringes have a closed system, with needle shields and tamper-evident closures that lessen the probability of contamination during storage and transit.

Preventable medication errors result in over a million hospital admissions annually, costing the US healthcare system between $2.7 and $5.1 billion in extra medical costs. Prefilled syringes' one-dose design reduces the possibility of dosage errors and cross-contamination, ensuring accurate medication delivery. Such enhanced safety features make prefilled syringes increasingly popular in healthcare settings, fueling their adoption across the world.

Compatibility with Autoinjectors

Prefilled syringes’ compatibility with autoinjectors improves patient convenience and simplicity of medication administration, particularly for individuals who need self-injection therapy. Prefilled syringe autoinjectors streamline the medicine distribution process by eliminating the need for manual syringe filling and reducing the possibility of dosage mistakes.

For instance, BD Medical-Pharma Systems launched a disposable autoinjector called Intevia 2.25 mL. The two-step push-on-skin device combines an autoinjector with a Neopak XtraFlow 2.25-mL glass pre-fillable syringe that can handle viscosities up to 40 cP and a variety of injection volumes.

Additionally, this compatibility also makes it possible for patients who struggle with movement or dexterity to efficiently self-administer drugs, thereby impelling the market growth. The tool has a wide viewing glass, a plunger rod, and visible and audio feedback indications for precise injections. As demand for self-administered medicines grows, the compatibility of prefilled syringes with autoinjectors becomes a key driver, boosting market growth.

Growing Demand in Biologics Market

Surging cases of frequencies of chronic maladies, combined with a higher acceptance rate of biologics, have propelled the demand for prefilled syringes in the biologics industry. Prefilled syringes offer precise dosage, with almost diminished risk of infection, and heightened stability during storage and transit. Their ready-to-use packaging makes the medication administration procedure a lot easier, thereby enhancing patient comfort and compliance.

For example, the FDA recently authorized a new autoinjector for Cyltezo, an interchangeable biosimilar of Humira®, called the Cyltezo® Pen from Boehringer Ingelheim. With just one button, three-step activation, complete medicine visibility, and a protected needle, it offers a patient-centered design.

With the extensive R&D and approval of biologic therapies for various indications, the demand for prefilled syringes is projected to grow, creating a positive outlook for market expansion.

Prefilled Syringes Market Opportunities:

Market Expansion in Emerging Economies

Emerging nations provide remunerative opportunities for prefilled syringes due to their improved healthcare infrastructure, inflating disposable income, and enhanced access to healthcare services. As these nations work to resolve healthcare concerns and improve patient outcomes, there is a growing need for prefilled syringes.

By customizing their products with budget-friendly fixes and localized packaging suitable for the distinct needs and preferences of burgeoning economies, manufacturers are contributing to the market expansion. For instance, Baxter International made a $100 million investment in their sterile fill/finish manufacturing facility in Halle/Westfalen, Germany. This expansion featured an extended manufacturing footprint, an additional lyophilized vial capacity, and a syringe filling line.

Enhanced Product Differentiation

Product differentiation is essential for manufacturers to gain a competitive edge in the prefilled syringes market. Ingenious features like ergonomic designs, safety systems for needles, and improved medication stability help cater to a wide range of patient and healthcare provider demands. Moreover, manufacturers tailor their solutions to specific therapeutic areas and drug formulations by giving customizable alternatives such as different syringe materials, fill volumes, and needle gauges, which further bolsters the market growth.

Companies like Gerresheimer are pioneering in prefilled syringe technologies by expanding the range of prefillable polymer syringes for sensitive biologics, biosimilars, and biobetters to include a Gx RTF ClearJect COP needle syringe, 1.0-mL luer lock. Apart from this, differentiation via branding, packaging, and value-added services can also bolster product appeal and customer loyalty.

Accurate Dosing

Accurate dosing is critical in healthcare to ensure patient safety and therapeutic efficacy, making it a key market opportunity for prefilled syringes. With advancements in technology and manufacturing processes, prefilled syringes can achieve highly accurate dose delivery, even for low-volume injections.

For instance, ApiJect Systems established a Technology Development Center in Orlando, FL, to support the development of pre-filled blow-fill-seal (BFS) syringes. This is a significant step towards improving dosing accuracy in prefilled syringes since the BFS method allows for high-volume, scalable production of single-dose injectors ​. 

Besides this, Nemera also introduced an addition to its Safe'n'Sound pre-filled syringe accessory lineup with a 2.25-mL size, designed to offer precise dosing as well as enhanced safety and convenience. The passive device prevents needlestick injuries, is compatible with low fill volumes and high viscosities, and features a large thumb pad.

Consequently, the growing demand for prefilled syringes with accurate dosing capabilities due to the increasing focus on patient safety and precision is impelling the market growth.

Key Technological Trends & Development:

Advance Features

The prefilled syringes market is experiencing continuous technological advancements like the inclusion of sophisticated features, such as needle safety mechanisms, dose indications, and tamper-evident seals. These dedicated offerings improve the safety, usage, and credibility of prefilled syringes by tackling issues like needlestick injuries, dosage precision, and product integrity.

For example, Ypsomed introduced YpsoMate On, an autoinjector made for prefilled syringes with integrated connectivity in 2021. This device combines the advantages of the YpsoMate autoinjector with digital therapy support, based on the YpsoMate platform. It records drug administration, transmits data wirelessly, and provides visual feedback.

Furthermore, continuous R&D efforts concentrated on integrating and improving advanced features to meet evolving customer demands and regulatory requirements are positively impacting the market expansion.

Customization and Innovation

Customization and innovation play a crucial role in the development of prefilled syringes to meet the diverse needs of pharmaceutical companies and healthcare providers. Manufacturers are increasingly offering customizable options such as various syringe materials, fill volumes, and needle gauges to accommodate different drug formulations and therapeutic applications.

Additionally, innovative designs and functionalities, such as dual-chamber syringes for reconstitution and combination therapies, contribute to product differentiation and market growth. Credence MedSystems, for example, developed a Dual Chamber Reconstitution Syringe. The Credence Dual Chamber Syringe is unique due to its simplicity, flexibility, ergonomic design, and safety features. The system can be used with a pre-attached needle or in a luer lock configuration for alternative administration routes. Aside from this, Credence is also working on derivatives of the Dual Chamber System, including glass and polymer barrels, and barrel sizes ranging from 1mL to 20mL.

Environmental Sustainability

Environmental sustainability is becoming a more important aspect in the production of prefilled syringes, owing to increased awareness of environmental issues and governmental actions encouraging eco-friendly procedures. In an effort to lessen the environmental effect of prefilled syringes, manufacturers are looking at sustainable materials including recycled and biodegradable plastics.

For instance, Ypsomed's YpsoMate On is produced following an eco-design principle that allows easy recycling of electronic components. The autoinjector can be recycled, as its electronic components are located in an easily separable element of the autoinjector.  As healthcare stakeholders prioritize sustainability, environmental-focused technology breakthroughs are projected to positively impact the growth of the global prefilled syringes market.

Prefilled Syringes Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on drug type, manufacturing method, therapeutic area, material, design, closing system, and end-user.        

Breakup by Drugs Type:

• Biologics
• Vaccines
• Insulin
• Anticoagulants
• Flush Saline Syringes
• Others
   

The report has provided a detailed breakup and analysis of the market based on the drug type. This includes biologics, vaccines, insulin, anticoagulants, flush saline syringes, and others.

The need for precise dosing and enhanced drug stability in the administration of complex biological therapies is one of the key factors bolstering the demand for prefilled syringes.

Besides this, the increasing vaccination efforts across the world are also fueling the demand for prefilled syringes due to their convenience and safety features.

Moreover, prefilled syringes offer diabetic patients ease of use and accurate dosing for insulin administration, which is further contributing to its expanding demand.

In confluence with this, the demand is also propelled by the critical need for precise dosage administration and the convenience of prefilled syringes in anticoagulant therapy.

Another factor influencing market expansion is the essential role of prefilled syringes in medical procedures, ensuring patient safety and procedural efficiency.

Apart from this, various other therapeutic areas benefit from the convenience, safety, and precise dosing capabilities of prefilled syringes.

Breakup by Manufacturing Method:

• Captive
• Merchant
   

A detailed breakup and analysis of the market based on the manufacturing method have also been provided in the report. This includes captive and merchant.

The demand for captive-manufactured prefilled syringes is rising as pharmaceutical companies opt for in-house production, ensuring stringent quality control and tailored customization to meet specific therapeutic requirements.

Conversely, merchant manufacturing experiences increased demand as pharmaceutical companies outsource prefilled syringe production to specialized manufacturers, providing cost-effectiveness and flexibility to meet dynamic market needs.

Breakup by Therapeutic Area:

• Blood Disorders
• Infectious Diseases
• Metabolic Disorders
• Autoimmune Disorders
• Oncological Disorders
• Neurological Disorders
• Ophthalmic Disorders
• Others
   

Metabolic disorders represents the leading market segment 

The report has provided a detailed breakup and analysis of the market based on the therapeutic area. This includes blood disorders, infectious diseases, metabolic disorders, autoimmune disorders, oncological disorders, neurological disorders, ophthalmic disorders, and others. According to the report, metabolic disorders represented the largest segment.

The increasing prevalence of conditions such as diabetes and obesity worldwide represents one of the significant factors influencing market growth. Prefilled syringes offer precise dosing capabilities essential for administering insulin and other medications used in managing metabolic disorders. Additionally, the convenience and ease of use provided by prefilled syringes are particularly beneficial for patients requiring frequent injections, improving treatment adherence and overall patient outcomes. As the incidence of metabolic disorders continues to rise globally, the demand for prefilled syringes tailored to these therapeutic areas is expected to grow, fueling the market growth.

Breakup by Material:

• Glass
• Plastic
   

Glass exhibits a clear dominance in the market 

A detailed breakup and analysis of the market based on the material have also been provided in the report. This includes glass and plastic. According to the report, glass accounted for the largest market share.

The demand for prefilled syringes made of glass is driven by several factors, including the inert nature of glass, which ensures drug stability and minimizes interaction with pharmaceutical compounds. Glass prefilled syringes offer superior barrier properties, protecting sensitive biologics and high-value drugs from contamination and degradation. Additionally, the transparency of glass allows for easy visual inspection of the drug, ensuring dosage accuracy and product integrity. Moreover, glass prefilled syringes are preferred for long-term storage of medications due to their impermeability to gases and moisture, further bolstering their demand in the pharmaceutical industry.

Breakup by Design:

• Single-chamber Prefilled Syringes
• Dual-chamber Prefilled Syringes
• Customized Prefilled Syringes
   

Single-chamber prefilled syringes dominate the market

The report has provided a detailed breakup and analysis of the market based on the design. This includes single-chamber, dual-chamber, and customized prefilled syringes. According to the report, single-chamber prefilled syringes represented the largest segment.

The demand for single-chamber prefilled syringes is propelled by their simplicity, convenience, and versatility in drug administration. These syringes offer a ready-to-use solution, eliminating the need for manual filling and reducing the risk of dosing errors. Healthcare providers and patients alike appreciate the ease of use and intuitive design of single-chamber prefilled syringes, making them ideal for self-administration and point-of-care settings. Furthermore, their compact size and lightweight construction facilitate storage, transportation, and disposal, enhancing overall efficiency in healthcare delivery. As the trend towards patient-centric care and home-based treatments continues to grow, the demand for single-chamber prefilled syringes is expected to rise accordingly.

Breakup by Closing System:

• Staked Needle System
• Luer Cone System
• Luer Lock Form System
   

Staked needle system is the predominant market segment

A detailed breakup and analysis of the market based on the closing system have also been provided in the report. This includes staked needle, luer cone, and luer lock form systems. According to the report, staked needle system accounted for the largest market share.

The demand for prefilled syringes featuring a staked needle system is primarily driven by its enhanced safety features and improved usability. Staked needle systems provide a secure attachment between the needle and syringe, minimizing the risk of needle detachment during drug administration. This reduces the potential for needlestick injuries and contamination, enhancing both healthcare workers and patients safety. Moreover, the integrated design of staked needle systems streamlines the injection process, eliminating the need for manual assembly and reducing the risk of user error. These benefits make staked needle prefilled syringes a preferred choice for pharmaceutical companies and healthcare providers alike, contributing to their increasing demand in the market.

Breakup by End-User:

• Hospitals
• Ambulatory Surgical Centres
• Clinics
• Others
   

Hospitals account for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the end user. This includes hospitals, ambulatory surgical centres, clinics, and others. According to the report, hospitals represented the largest segment.

The surging demand for prefilled syringes in hospitals due to the growing emphasis on infection control and patient safety is aiding in market expansion. Hospitals prioritize the use of prefilled syringes due to their single-dose format, which reduces the risk of cross-contamination and nosocomial infections. Additionally, prefilled syringes offer convenience and time-saving benefits for healthcare professionals, allowing for efficient medication administration and minimizing the potential for dosing errors. Furthermore, the versatility of prefilled syringes makes them suitable for a wide range of medications and therapeutic applications, meeting the diverse needs of hospital settings and contributing to their widespread adoption in healthcare facilities.

Regional Insights:

• North America
  • United States
  • Canada
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East
• Africa
   

Europe leads the market, accounting for the largest prefilled syringes market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); the Middle East; and Africa. According to the report, Europe represents the largest regional market for prefilled syringes.

In Europe, the demand for prefilled syringes is steered by several factors, including the increasing prevalence of chronic diseases, the growing geriatric population, and the emphasis on patient-centered care. The region's aging population requires more frequent and long-term medication administration, driving the need for convenient and reliable drug delivery systems like prefilled syringes. Moreover, stringent regulatory standards and a strong focus on patient safety in European healthcare systems encourage the adoption of prefilled syringes due to their reduced risk of dosing errors and contamination. Additionally, the growing preference for self-administration devices and advancements in biologics further contribute to the increasing demand for prefilled syringes in Europe's healthcare market.

Analysis Covered Across Each Country:

• Historical, current, and future market performance
• Historical, current, and future performance of the market based on drug type, manufacturing method, therapeutic area, material, design, closing system, and end-user.
• Competitive landscape
• Government regulations

Competitive Landscape:

• The market research report has provided a comprehensive analysis of the competitive landscape covering market structure, market share by key players, market player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant, among others. Detailed profiles of all major companies have also been provided. This includes business overview, product offerings, business strategies, SWOT analysis, financials, and major news and events. Some of the major market players in the prefilled syringes industry include Abbott Laboratories, B. Braun Melsungen AG, Baxter International Inc., Bayer AG, Becton Dickinson and Company., Cardinal Health Inc., Catalent Inc., Fresenius SE & Co. KGa., Gerresheimer AG, Nipro Corporation, etc.
• The global prefilled syringes market boasts a competitive landscape characterized by the presence of prominent players such as Abbott Laboratories, B. Braun Melsungen AG, Baxter International Inc., Bayer AG, and Becton Dickinson and Company. These companies compete based on factors such as product innovation, technological advancements, geographic presence, and strategic partnerships. Key strategies include the development of advanced features like needle safety mechanisms and dosage indicators, customization options to meet specific market demands, and investments in research and development to enhance product differentiation and market competitiveness. Additionally, mergers and acquisitions play a significant role in expanding market reach and diversifying product portfolios.

Analysis Covered for Each Player:

• Market Share
• Business Overview
• Products Offered
• Business Strategies
• SWOT Analysis
• Major News and Events

Prefilled Syringes Market News:

• In May 2023, Fresenius Kabi launched Diazepam Injection, USP in 10 mg per 2 mL Simplist® ready-to-administer prefilled syringes in the U.S. The product is part of the company's proprietary Simplist prefilled syringe portfolio, designed for efficient medication delivery and ease of use.
• In May 2023, BD introduced the PosiFlush™ SafeScrub, an all-in-one prefilled flush syringe with an integrated disinfection unit, to streamline clinical workflow for disinfecting and flushing IV catheters. This innovative device is designed to reinforce compliance with infection prevention guidelines and simplify nursing workflow.

Prefilled Syringes Market Report Scope:

Key Questions Answered in This Report:

• How has the global prefilled syringes market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global prefilled syringes market?
• What is the impact of each driver, restraint, and opportunity on the global prefilled syringes market?
• What are the key regional markets?
• Which countries represent the most attractive prefilled syringes market?
• What is the breakup of the market based on the drugs type?
• Which is the most attractive drugs type in the prefilled syringes market?
• What is the breakup of the market based on the manufacturing method?
• Which is the most attractive manufacturing method in the prefilled syringes market?
• What is the breakup of the market based on the therapeutic area?
• Which is the most attractive therapeutic area in the prefilled syringes market?
• What is the breakup of the market based on the material?
• Which is the most attractive material in the prefilled syringes market?
• What is the breakup of the market based on the design?
• Which is the most attractive design in the prefilled syringes market?
• What is the breakup of the market based on the closing system?
• Which is the most attractive closing system in the prefilled syringes market?
• What is the breakup of the market based on the end-user?
• Which is the most attractive end-user in the prefilled syringes market?
• What is the competitive structure of the market?
• Who are the key players/companies in the global prefilled syringes market?

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the prefilled syringes market from 2018-2032.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global prefilled syringes market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the prefilled syringes industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.