Prefilled Syringes Market Size, Share & Industry Analysis, By Material (Glass and Plastic), By Closing System (Staked Needle System, Luer Cone System, and Luer Lock Form System), By Product (Complete Syringe Set and Components & Accessories), By Application (Cancer, Rheumatoid Arthritis, Diabetes, and Others), By Design (Single-chamber, Double-chamber, and Multiple-chamber), By End User (Pharmaceutical & Biotechnology Companies, Contract Research & Manufacturing Organizations, and Others), and Regional Forecast, 2024-2032

The global prefilled syringes market size was USD 7.91 billion in 2023. The market is projected to grow from USD 8.70 billion in 2024 to USD 20.62 billion by 2032, exhibiting a CAGR of 11.4% during the forecast period.

Prefilled syringes are injectable drug delivery containers designed to administer drugs via the parenteral route. There are several advantages associated with these syringes, such as reduced chances of contamination, prevention of drug wastage due to overfilling, eliminating of dosing errors, enabling quick drug delivery in case of emergencies, and ease of use. Owing to the above-mentioned advantages, pharmaceutical companies are considering them as one of the most effective ways of delivering a wide range of injectable drugs, including biologics and biosimilars.

The rising incidence of chronic diseases, such as diabetes and other autoimmune diseases, is likely to fuel the demand for prefilled syringes in the forthcoming years. For instance, according to the American Autoimmune Related Diseases Association Inc. (AARDA), about 50 million Americans suffer from autoimmune disorders currently. There are more than 100 autoimmune disorders, and they are among the top 10 leading causes of death among American women. The growing demand for biological drugs and innovations in pre-fillable syringe technologies to fulfill the unmet needs for treating chronic diseases across the globe is likely to support global market growth. Combined with this, the increasing number of product launches by key players and the high adoption of the products by healthcare professionals are factors that are likely to boost the market during the forecast period. 

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Market Dynamics

Market Growth Drivers

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

The growing demand for biologics is resulting in the introduction of innovative injectable drug delivery solutions. This innovation is creating a huge demand for prefilled syringes in the market. This, along with the growing focus of manufacturers on receiving 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, and others. This number is expected to rise in the future, leading to increased demand for biologics.

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 toward 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.

Other Prominent Drivers:

• Increasing R&D Activities for Prefilled Syringes to Foster Market Growth


• Technological Advancements for Prefilled Syringes to Drive Market Growth


• Increasing Strategic Mergers & Acquisitions among Key Players

Market Restraints

Complex Manufacturing Process and Product Recalls to Hamper Market Growth

Prefilled syringes are becoming an increasingly attractive option for complex biotechnology products. However, various product recalls due to certain impurities or leakage in the syringes restrict the market growth during the forecast period.

• In May 2023, Sun Pharma recalled over 24,000 prefilled syringes of generic medication in the U.S. due to impurities found in these syringes.


• In July 2022, Nephron Pharmaceuticals Corporation, a U.S.-based company, recalled 20 prefilled syringes containing medicines such as ketamine, epinephrine, and oxytocin. The reason for the recall was a lack of assurance of sterility. Similarly, in March 2022, Adamis Pharmaceuticals Corporation announced the voluntary recall of SYMJEPI (epinephrine) Injections of 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL). SYMJEPI is a pre-filled single-dose syringe that witnesses clogging needles that obstruct the proper drug dispensing.

Thus, strict regulatory requirements, manufacturing complexity and rising recall of these products are major restraining factors for the market’s growth.

Other Restraints:

• Lack of Adequate Reimbursement Policies for Chronic Diseases in Emerging Countries


• Stringent Government Regulations for Drug Approval to Limit Adoption

Market Opportunities

Widening of Applications for Prefilled Syringes Presents a Lucrative Opportunity

There is a growing prevalence of chronic conditions such as macular degeneration, diabetic retinopathy, and others among the patient population. The growing prevalence of these disorders is supporting the demand for the introduction of novel drug delivery methods, including prefilled syringes and others, for these diseases among the patient population.

Certain advantages of prefilled syringes among patients include accuracy, precision, ease of use, sterility, convenience, reduced waste, and others. Moreover, these syringes also allow auto-injection, which enables the elimination of dosage errors and provides ease of administration.

Along with this, the key players are also focusing on research and development activities to develop and introduce novel prefilled syringes with an aim to cater to the growing demand among the patient population globally.

• In August 2023, Regeneron Pharmaceuticals, Inc. received approval for Eylea HD (Aflibercept) injection 8mg for the treatment of wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

Other Opportunities:

• Untapped and Underserved Population in Emerging Countries Presents a Lucrative Opportunity

Technological Advancements and Innovations

Material Innovations

The advent of technology has allowed the development of glass and plastic materials by utilizing polymers, such as Cyclic Olefin Copolymer (COC) and Cyclic Olefin Polymer (COP), which enabled enhanced drug compatibility and stability with auto-injectors.

Safety Features

There is an increasing prevalence of chronic conditions, such as cancer, diabetes, and others, that require treatment by subcutaneous injection, further supporting the growing demand for these procedures in the homecare settings. Medication delivery using a prefilled retractable safety syringe provides needle protection safety features, which further ensures safety regulations among patients.

Automation and Smart Syringes

Integration of smart technology into prefilled syringes, such as the installation of electronic modules and the development of customized plunger rods, allows the prefilled syringes to monitor the parameters among the population.

Environmental Considerations

There is a growing focus among the prominent players on sustainability initiatives, such as the use of thermos elastic polymers, optimization of the filling process for syringes, and others, to reduce the carbon footprint of these syringes globally. 

Market Challenges

Alternative Drug Delivery Methods to Hamper Market Growth

There are few alternative drug administration technologies, such as auto-injectors, pen-injectors, transdermal patches, among others, that is hampering the adoption rate for prefilled syringe products in the market. The benefits of these alternative drug administration technologies, such as less pain, user-friendliness, among others, are resulting in the preferential shift towards these products in the market.

Moreover, the prominent players are also focusing on the development and introduction of novel alternative drug administration products, such as transdermal patches, among others, further limiting the demand for prefilled syringes among healthcare professionals in the market.

• According to a 2019 article published by Drake University, it was reported that some 3.6 million people rely on epinephrine auto-injectors to save their lives in a severe allergic reaction.

Prefilled Syringes Market Trends

Increasing Demand for Biologics and Biosimilars in the Market

The global life science industry is facing a drastic shift from chemical-based drugs to biologics and biosimilars. Biologics are excellent for targeted delivery and are less prone to drug-drug interaction, leading to increased inclination. The rise in biologics to treat chronic diseases has urged drug and packaging manufacturers to seek more sophisticated container closures and drug delivery systems.

• For instance, according to data published by BIOLOGICS HQ in 2023, there were 40 FDA-approved biosimilars. Also, according to a study published in the American Journal of Managed Care (AJMC), in April 2022, over 90% of patients preferred biosimilar delivery with a pre-filled pen versus a syringe. The study compared the adalimumab biosimilar PF-06410293 to the E.U. reference product (Humira) in rheumatoid arthritis (R.A.) and evaluated the usability of pre-filled pens (PFP) by patients and their caregivers.

Therefore, this has led to a significant increase in the use of these syringes for safely delivering biologics and biosimilars.

Impact of COVID-19

Immediate Effects on Demand and Supply: The COVID-19 pandemic positively impacted the market owing to the high demand for pre-filled products amid the pandemic. Increased production of vaccines for coronavirus led to the focus of manufacturers on increasing their production capacity for pre-filled products. Thus, increased production capacity resulted in increased revenue among manufacturers and, therefore, impacted the market positively.

Long-Term Market Changes: The huge demand for prefilled syringes during the pandemic enabled the healthcare settings to purchase huge stock of products to support the demand among the patient population. However, the market experienced normalization in demand for the drugs post-pandemic.

Lessons Learned and Preparedness for Future: The pandemic allowed researchers and manufacturers to focus on the strategic initiatives to invest in public and private health infrastructure to advance the research and development activities as a counter step for the future.

Segmentation Analysis

By Material Analysis

Rise in Technological Innovations to Drive Plastic Segment Growth

Based on material, the market is segmented into glass and plastic.

The glass segment held a significant market share in 2023. It is a highly preferred material for manufacturing due to its substantial barrier property. Also, it has the advantage of being highly compatible with several filling drug machines. Therefore, increasing the focus of key players toward launching new glass pre-filled syringes is likely to support the growth of the segment in the market.

• For instance, in September 2022, BD launched the BD Effivax Glass Prefillable Syringe to create the required efficiencies in end-to-end production.

The plastic segment is anticipated to grow significantly during the forecast period due to key players involved in developing plastic syringes and producing technological innovations offering advantages over glass syringes.

• For instance, in May 2022, ApiJect Systems, Corp. raised USD 111.0 million in a private investment round led by Royalty Pharma and Jefferies Financial. The funds were to be used to develop ApiJect's blow-fill-seal (BFS) plastic profiled injection system and for other “general working capital” purposes.

By Closing System Analysis

Rising Technological Advancements in Luer Lock Form System to Exhibit a Significant Rate in Market

Based on the closing system, the market is segmented into a staked needle system, luer cone system, and luer lock form system.

Technological advancements in the luer lock form systems make them more secure by preventing needle stick accidents. Moreover, the twisting mechanism forming a locked connection in the luer lock form system has reduced the leakage of liquid drugs. Such technological advancements, along with new product launches, will further augment the segment growth at a faster pace during the forecast period.

• For instance, in June 2022, Terumo Pharmaceutical Solutions launched PLAJEX 0.5mL, a Luer Lock Silicone oil-free pre-fillable syringe for low-dose applications, such as ophthalmic drugs.

The staked needle system segment captured a significant share of the market owing to its speedy usage. However, the rising incidence of needle-stick injuries is likely to reduce the growth rate of the staked needle system segment in the coming years.

By Product Analysis

Increasing Demand for Complete Syringe Leads to its Segment Dominance in Global Market

Based on product, the market is segmented into complete syringe set and components & accessories.

Among products, the complete syringe set segment captured a significant share of the market owing to the growing demand for these products for effective drug delivery and the rising demand for self-injectable delivery systems among patients.

• For instance, in January 2023, Wirthwein Medical launched a complete syringe set with prefillable plastic syringes with a Luer-lock connection.

The components & accessories segment is expected to witness moderate growth in the market in the forthcoming years. This is attributed to the lower demand among drug manufacturing companies for independent components for pre-filled injections compared to the complete set.

By Application Analysis

Increasing Prevalence of Rheumatoid Arthritis Leads to Its Dominant Position in Global Market

Based on application, the market is segmented into cancer, rheumatoid arthritis, diabetes, and others.

The rheumatoid arthritis segment dominated the market in 2023. This growth is due to the rising prevalence of rheumatoid arthritis, which results in an increasing number of patient admissions in healthcare settings. This, along with the growing number of key players launching novel prefilled syringes for rheumatoid arthritis, is likely to support the growth of the segment in the market.

• For instance, in May 2024, Lupin launched biosimilar Etanercept for the treatment of severe rheumatoid arthritis, juvenile idiopathic arthritis, and others among the patient population.

The cancer segment is also expected to grow during the forecast period. The growth is due to the rising prevalence of cancer among patients, resulting in the rising number of patient admissions in hospitals & clinics. This, along with growing technological advancements in these syringes is also likely to boost the adoption rate for these syringes in the market.

By Design Analysis

Increasing Approval of Single Chamber Prefilled Syringes to Capture Largest Market Share

Based on design, the market is segmented into single-chamber, double-chamber, and multiple-chamber.

The single-chamber segment captured a significant share of the market and is likely to exhibit a significant CAGR during the forecast period. The growth is due to the rising focus of the key players on receiving the approval for their single-chamber prefilled syringes in the market.

• For instance, in September 2022, Otsuka Pharmaceutical Co., Ltd. and H. LUNDBECK A/S received the USFDA’s acceptance of the NDA for Aripiprazole, a long-acting injectable, provided in a single-chamber-type pre-filled syringe, to treat Schizophrenia and Bipolar I Disorder in adults.

Moreover, the growing technological innovations and shifts in preference from single-chamber syringes to a double-chamber system are likely to enhance the demand for the double-chamber system during the forecast period. Double-chamber syringes are highly efficient for storing biological components that cannot retain their stability for a longer period. Also, the growing penetration of lyophilized drugs globally is likely to surge the demand for these syringes during the forecast period.

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By End User Analysis

Growing Interest in Injectable is Propelling Pharmaceutical & Biotechnology Companies Segment to Dominate Market

Based on end-user, the market is categorized into pharmaceutical & biotechnology companies, contract research & manufacturing organizations, and others.

The pharmaceutical & biotechnology companies segment captured a majority share in the global market. Fast-expanding pharmaceutical companies worldwide are majorly engaged in biologics, vaccines, and biosimilars. These companies have increased their demand for new drug delivery systems, such as syringes, prescribed with a unit dose of medication for better patient compliance.

Moreover, a rising number of early-stage and government-funded biotech players are focusing on drug discovery and development, which is likely to boost the demand for syringes for the effective delivery of drugs. The rise in demand for innovative injectable drug delivery systems is expected to boost the pharmaceutical & biotechnology companies’ segment growth during the forecast period.

The contract research & manufacturing organizations segment is likely to expand at a significant rate during the forecast period due to innovative technologies offering filling services.

PREFILLED SYRINGES MARKET REGIONAL OUTLOOK

Geographically, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

Europe:

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Europe dominated the global market and generated a revenue of USD 3.19 billion in 2023.  The increasing number of patients using biologics as treatment options for chronic diseases and the strong adoption of advanced delivery methods for self-injection of drugs are the major factors likely to boost the demand in the region. In addition, the presence of key players engaged in developing pre-fillable syringes in European countries such as Germany, France, and the U.K. is likely to boost market growth. The increasing prevalence of chronic diseases, developed healthcare infrastructure, and the growing focus of key players on R&D activities to develop and introduce novel products are some of the factors contributing to the growth of the market in the region.

• In November 2022, Schreiner Group and SCHOTT Pharma launched a pre-filled syringe with RFID. This enabled optimized processes in hospital inventory management.

Impact of Healthcare Infrastructure:

Governmental and non-governmental organizations are increasingly focused on developing healthcare infrastructure, which is likely to support the growth of the market in the region.

• According to statistics published by the Office for National Statistics, it was reported that government-financed healthcare expenditure was around USD 258.7 billion in 2023 in the U.K.

North America:

North America is likely to hold the second-largest market share after Europe, owing to the rise in several chronic diseases, such as diabetes and rheumatoid arthritis. These diseases are likely to enhance the demand for prolonged drug administration at an accurate dosage. Increasing product launches and the growing presence of leading players with strong distribution networks are likely to boost market growth in the region.

U.S.:

The growth is due to the growing prevalence of chronic conditions such as rheumatoid arthritis among patients in the U.S., resulting in the increasing focus of key players toward R&D activities to cater to the growing demand. This factor is likely to support the growth of the market.

Canada:

The increasing focus of prominent players toward inorganic growth strategies, including expanding their geographical presence in Canada, is further expected to support the growth of the prefilled syringes market in the region.

Asia Pacific:

The Asia Pacific prefilled syringes market is likely to witness a fast-paced growth during the forecast period, majorly owing to the increasing prevalence of chronic and lifestyle diseases, rising usage of these syringes, and rapidly growing patient population. Moreover, there is a huge potential in Asia Pacific countries, including China, Japan, and India, regarding innovations in these syringes and growth in contract manufacturing companies outsourcing packaging & filling services. Thereby, likely to play a pivotal role in boosting the market growth in the region.

The increasing number of geriatric population is contributing to the rising prevalence of chronic conditions among the patient population. The rising impact of chronic diseases, along with a growing focus on strategic initiatives, such as acquisitions and mergers, among the other players to strengthen their presence, is expected to support market growth in the region.

Latin America:

Latin America is likely to grow in the market during the forecast period. The growth is due to rising awareness about innovative products in countries including Brazil, Mexico, and others, further boosting the demand for products in the market. Governmental and non-governmental organizations are focusing on shaping their healthcare landscape and determining the initiatives used by healthcare providers and organizations to cater to the growing demand for treating chronic diseases among patients.

Middle East & Africa:

Middle East & Africa is also expected to grow during the forecast period. This growth is due to the increasing focus of key players on research and development activities to launch novel prefilled syringes in the market.

COMPETITIVE LANDSCAPE

Key Market/Industry Players

Strong Product Offerings by Key Players to Propel Market Growth

Becton Dickinson and Company (B.D.), Gerresheimer AG, SCHOTT AG, and West Pharmaceutical Services Inc. accounted for the leading global prefilled syringes market share in 2023. These players are likely to continue their dominance and generate significant revenue in the forthcoming years. Dominance is attributable to the robust research activities and continuous investments in innovative product development to launch a cost-effective and highly effective parenteral drug delivery system.

• For instance, in May 2023, SCHOTT AG launched pre-filled polymer syringes for deep-cold drugs with an aim to strengthen its product portfolio.

Moreover, a strong focus on strategic partnerships with other key players is likely to support expanding their footprints in the global market. For instance, in May 2022, B.D. announced its collaboration with Mitsubishi Gas Chemical Company to investigate the potential uses of Oxycapt technology developed by Mitsubishi Gas Chemical Company for the development of prefilled syringes.

LIST OF KEY COMPANIES PROFILED:

• BD (U.S.)


• Gerresheimer AG (Germany)


• SCHOTT AG (Germany)


• West Pharmaceutical Services Inc. (U.S.)


• Helvoet Rubber & Plastic Technologies BV (Netherlands)


• NIPRO (Japan)


• AptarGroup, Inc. (U.S.)


• Terumo Corporation (Japan)

KEY INDUSTRY DEVELOPMENTS:

• May 2023: BD expanded the availability of all-in-one flush pre-filled syringes with an aim to support a significant reduction in microbial growth associated with catheter-related bloodstream infections among patients.


• December 2022 – Fresenius Kabi AG received the U.S. FDA approval for biosimilar Idacio (adalimumab) for the treatment of chronic autoimmune diseases. The drug is available in a self-administered pre-filled syringe combined with a self-administered pre-filled pen.


• September 2022: BD launched a next-gen prefillable vaccine syringe for efficient vaccine delivery. This helped the company to increase its brand presence.


• June 2022: WuXi Biologics, a global contract research, development, and manufacturing organization (CRDMO), launched the operation of its new drug facility, DP5, with an aim to manufacture 17 million units of pre-filled syringes each year.


• April 2022: Delpharm invested USD 30.3 million in a sterile line with an aim to manufacture prefilled syringes in France.

REPORT COVERAGE

The global market report provides detailed information regarding various insights into the market. Some of them are growth drivers, restraints, competitive landscape, regional analysis, and challenges. It further offers an analytical depiction of the market trends and estimations to illustrate the forthcoming investment opportunities. The market is quantitatively analyzed from 2019 to 2030 to provide the financial competency of the market. The information gathered in the report has been taken from several primary and secondary sources.

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Report Scope & Segmentation