Industry Outlook

The Pre-Filled Syringes Market accounted for USD 8.85 Billion in 2024 and is expected to reach USD 26.0 Billion by 2035, growing at a CAGR of around 10.3% between 2025 and 2035. Prefilled syringes are single-dose containers of parenteral medication fitted with a needle by the manufacturer. Prefilled syringes improve patient safety by lowering the risk of unintended needle sticking and harmful product exposure that can occur while drawing medication from vials. Prefilled syringes offer various benefits, such as increased efficiency, improved safety, better drug stability, and increased patient comfort. The Pre-Filled Syringes Market offers products like ready-to-use syringes pre-filled with medications, along with services related to drug delivery systems, including design, manufacturing, and packaging solutions for safe and efficient administration. 

Report Scope:

Market Dynamics

Growing Innovations in Pre-filled Products for Biologic Drugs to Propel Market Growth

Growing demand for biologics is resulting in the introduction of innovative injectable drug delivery solutions. The growing innovation in drug delivery solutions for injectable drugs is creating a huge demand for prefilled syringes in the market. This, along with the growing focus of manufacturers on receiving the approvals from regulatory bodies is likely to support the global prefilled syringes market growth during the forecast period. In October 2023, Novartis AG received the U.S. FDA approval for Cosentyx as the first biologic treatment option for hidradenitis suppurativa patients among adult patients. Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS.

Additionally, the rising prevalence of cancer, autoimmune diseases, and other non-communicable diseases is likely to increase the demand for biological drugs. For instance, according to the International Agency for Research on Cancer (IARC), by 2040, the global burden of cancer is expected to grow to 27.5 million new cases. Moreover, according to the National Stem Cell Foundation (NSFC), around 4.0% of the world population is affected by any autoimmune disease, and the most common are lupus, type 1 diabetes, multiple sclerosis, etc. This number is expected to rise, leading to increased demand for biologics.

Availability of Cheaper Alternatives

The prefilled syringes are much more expensive as compared to the disposable syringes because of the high costs associated with their production. The availability of its alternative that is disposable syringes at a lower cost is projected to pose a major challenge for the prefilled syringes market in the forecast period of 2022-2029. This prefilled syringes market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. 

Rising Adoption of Self-Injecting Parenteral Devices to Spur Market Growth

The use of pre-filled injections as a self-injecting device is the modern way to administer parenteral drugs. These are convenient and help ease the administration process. These products help provide greater patient safety and reduce exposure to toxic products while drawing medications from the drug vials. Therefore, self-injecting devices with their pre-measured dosage reduced dosing errors and increased patient safety, offering multiple advantages for the user. Owing to the advantages associated with these devices, there is a rising preference among healthcare providers for prefilled syringes. Citing this, many companies are investing in R&D to develop innovative drugs to be delivered through these syringes, enabling self-injection. For instance, in February 2023, the FDA announced the approval of Tezspire (tezepelumab), a human monoclonal antibody developed by AstraZeneca in collaboration with Amgen. The drug is the only biologic approved for severe asthma in the U.S. for self-administration in a pre-filled, single-use pen for patients aged 12 years and older. Thus, such increasing adoption leading to new product approvals bodes well for the growth of the global market.

Industry Experts Opinion

Stated that "the growing demand for biologics and the convenience offered by pre-filled syringes are driving significant market expansion."

• Dr. Fiona M. Stewart, Chief Scientific Officer at PharmaTech Insights

Emphasized that "innovations in syringe materials and design are expected to enhance safety and usability, further propelling market growth."

• Michael J. Carter, Healthcare Analyst at MedMarket Research

Segment Analysis

Based on the End-use: The market is segmented into glass, plastic, stainless steel, and elastomers. Plastic offers a more economical option than glass syringes due to lower material and manufacturing costs. This affordability is crucial for making prefilled syringes accessible in various healthcare settings, particularly in emerging markets. Plastic offers greater design flexibility compared to glass. This allows for the development of innovative features like multi-chamber syringes or integrated needle guards, enhancing functionality and safety. These advantages associated with plastic-prefilled syringes are anticipated to fuel the demand for plastic-prefilled syringes.

Based on By Application: Based on applications, the market is segmented into Diabetes, Rheumatoid Arthritis, and Anaphylaxis. The Diabetes segment is projected to witness the fastest CAGR over the forecast period. Many diabetes treatments involve frequent injections, and prefilled syringes offer significant advantages for patients undergoing injectable therapies.  They are easier to transport and self-administer compared to traditional vials and syringes, improving patient comfort and independence during treatment. Advancements in prefilled syringe technology, such as multi-chamber syringes, are facilitating the delivery of combination therapies used in some cancer treatment regimens. These features offer greater flexibility and convenience for both patients and healthcare providers. 

Regional Analysis

North America holds the highest share in the prefilled syringe market due to robust healthcare infrastructure, high adoption rates of advanced medical technologies, and significant investments in pharmaceutical research and development. The region's leading position is supported by stringent regulatory standards that favor the use of prefilled syringes for safe and effective drug delivery. Additionally, the increasing prevalence of chronic diseases drives the demand for prefilled syringes in North America. The presence of major pharmaceutical companies and biotechnology firms further stimulates market growth, ensuring a strong market foothold in this region.

The Asia-Pacific region is the largest and fastest-growing market for pre-filled syringes. This growth is driven by increasing demand for advanced drug delivery systems, the rising prevalence of chronic diseases like diabetes and rheumatoid arthritis, and the expansion of the healthcare sector. Countries like China, India, and Japan are leading the charge due to their large populations, increasing healthcare expenditure, and growing awareness about the benefits of pre-filled syringes. Additionally, the region's strong pharmaceutical manufacturing base, coupled with regulatory support for biologics and biosimilars, is fueling the adoption of pre-filled syringes. The market is further boosted by technological advancements and collaborations between local and global pharmaceutical companies.  

Competitive Landscape

Some of the major players operating in the prefilled syringes market are BD, Gerresheimer AG, SCHOTT, West Pharmaceutical Services, Inc., Baxter, Catalent, Inc., Weigao Group, Vetter Pharma, Nipro, Elcam Medical, YPSOMED AG, F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Bruker, Abbott, Immunexpress Inc., Oval Medical Technologies Ltd., Boditech Med Inc., SHL Medical AG and Terumo Corporation among others.

West Pharmaceutical Services, Inc. is a significant player in the prefilled syringes market, known for manufacturing critical components like rubber stoppers and syringe plungers. These components are essential for ensuring the integrity and safety of injectable medications, minimizing contamination, and improving dosing accuracy. West's pre-fillable syringe systems are highly regarded for their ability to reduce drug overfill, control costs, and support patient safety through consistent and reliable performance. The company leverages its advanced materials and technologies, such as FluroTec® and NovaPure®, to meet the stringent quality requirements of the pharmaceutical industry. As the demand for pre-filled syringes continues to grow, driven by trends like self-administration and biologic drugs, West is well-positioned to capture a significant share of this expanding market.

Baxter International Inc. is a significant player in the prefilled syringes market, known for its innovation and market presence. According to recent industry reports and journals, Baxter has strengthened its position through advanced technologies and strategic partnerships. The company's pre-filled syringes are noted for their safety features, including integrated needle safety mechanisms and tamper-evident packaging, which address key concerns in drug delivery. Baxter’s focus on enhancing patient convenience and compliance has been highlighted in various magazines and papers, emphasizing the ease of use and reduced risk of dosage errors associated with their products. The company’s investments in R&D and manufacturing capabilities are well-documented, reflecting its commitment to meeting the growing demand for biologics and injectable medications. Market analyses often cite Baxter's extensive experience and broad product portfolio as critical factors contributing to its leadership in the pre-filled syringes sector.

Recent Developments:

• In August 2023, Becton Dickinson expanded its collaboration with the Bill & Melinda Gates Foundation, Children’s Investment Fund Foundation (CIFF), and Pfizer to deliver over 320 million doses of Pfizer’s injectable contraceptive, Sayana® Press, which is administered by BD’s Uniject™ Auto-Disable Prefillable Injection System, through 2030.
• In July 2023, Fresenius Kabi launched Simplist® Ready-to-Administer Prefilled Syringes comprising of Fentanyl Citrate Injection.

Report Coverage:

By Type

• Conventional
• Safety

By Material

• Glass
• Plastic
• Stainless Steel
• Elastomer

By Design

• Single-chamber
• Dual-chamber
• Customized

By Delivery

• Intravenous
• Subcutaneous
• Intramuscular
• Others

By Application

• Diabetes
• Rheumatoid Arthritis
• Anaphylaxis
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Baxter International Inc
• Becton Dickinson
• Biocon
• Cardinal Health
• Catalent
• Datwyler Holding Inc.
• Debiotech S.A
• Elcam Medical
• Fresenius Kabi AG
• Gerresheimer
• Jiangsu Micsafe Medical Technology Co., Ltd
• MedXL Inc
• Nipro Corporation
• Owen Mumford Ltd
• Scandinavian Health Limited (SHL) Group
• Schott
• Stevanato Group
• Terumo Corporation
• Unilife Corporation
• Vetter Pharma

Frequently Asked Questions (FAQs)