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Prefilled Syringes Market Size, Share & COVID-19 Impact 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 Design (Single-chamber, Double-chamber, and Multiple-chamber), By End-user (Pharmaceutical & Biotechnology Companies, Contract Research & Manufacturing Organizations, and Others), and Regional Forecast, 2023-2030

Region : Global | Format: PDF | Report ID: FBI101946

 

KEY MARKET INSIGHTS

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The prefilled syringes market size was valued USD 7.22 billion in 2022 and is projected to grow USD 7.91 billion in 2023 to USD 16.32 billion by 2030, exhibiting a CAGR of 10.9% during 2023-2030. Europe dominated the global market with a share of 40.30% in 2022.


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 easy 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 likely to boost the market during the forecast period. 


COVID-19 IMPACT


High Demand for Pre-filled Products amid COVID-19 for Vaccine Production 


The impact of COVID-19 on pharmaceutical packaging was high due to the rapid production of vaccines for coronavirus. There was an increasing demand for such syringes over glass ampoules or any other additional needles due to the reduced risk of needle-stick injuries. Therefore, to ramp up the production of the COVID-19 vaccine, the manufacturers increased their production capacity. For instance, the U.S. government signed a deal of USD 138 million with the syringe makers to facilitate the production of 100 million prefilled syringes for the coronavirus vaccines by the end of 2020 and more than 500 million in 2021. Additionally, in December 2020, Becton Dickinson and Co. invested about USD 1.2 billion over four years in manufacturing capabilities and technology for pre-fillable syringes and other drug delivery systems, which could have been used for pandemic response.


Moreover, in 2021, the outbreak of COVID-19 has positively impacted the market. Many players saw a substantial rise in revenue. For instance, the pharmaceutical systems segment of Becton Dickinson and Company (B.D.) medical, including pre-fillable syringes, reported 15.2% growth during 2020-2021, while the total medical segment reported 9.2% growth during 2020-2021. Thus, the COVID-19 outbreak positively impacted the demand for pre-filled injections. The global market was projected to grow by 17.4% in 2020 and 18.1% in 2021 due to the COVID-19 crisis, compared to 10.2% in 2019.


LATEST TRENDS


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Rising Demand for Biologics and Biosimilars to Aid Market Expansion


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 Cardinal Health, as of January 2022, there were 33 FDA-approved biosimilars, out of which 21 are available on the U.S. market. 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.


PREFILLED SYRINGES MARKET GROWTH FACTORS


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


The increasing demand for biological drugs and growing innovations in injectable delivery solutions are likely to drive the global prefilled syringes market growth during the forecast period. Biological drugs have gained the attention of several big players as they target diseases with no or very limited treatment options.



  • In April 2021, F. Hoffmann-La Roche Ltd announced the U.S. Food Drug Administration approval for its supplemental biologics application for Xolair (omalizumab) pre-filled syringe intended for self-injection. Xolair is an IgE blocker indicated for asthma, nasal polyps, and chronic idiopathic urticaria. Similarly, in May 2021, Glenmark Pharmaceuticals Ltd. announced the U.S. Food Drug Administration approval for Icatibant injection, a generic version of Firazyr injection, available in 30 mg/3 mL (10 mg/mL) single-dose.


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 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 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 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, offer multiple advantages for the user.


Owing to the advantages associated with these devices, there is a rising preference among healthcare providers towards 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, 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.


RESTRAINING FACTORS


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 July 2022, Nephron Pharmaceuticals Corporation, a U.S.-based company, recalled 20 prefilled syringes containing medicine 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) Injection 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 obstructed the proper drug dispensing.

  • In December 2021, Novartis Pharmaceuticals U.K. recalled Lucentis 10mg/ml solution for injection in prefilled syringes due to a faulty plunger stopper, leading to increased customer complaints as it was difficult to press down.


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


SEGMENTATION


By Material Analysis


Rise in Technological Innovations to Drive Plastic Segment Growth


Based on material, the market is segmented into glass and plastic. Among them, the glass segment held a significant market share in 2022. It is a highly preferred material for manufacturing due to the substantial barrier property of the glass. Also, it has the advantage of being highly compatible with several filling drug machines. However, certain drawbacks, such as the reaction of glass ions with the drugs and a greater chance of breakage, are expected to shift the preference of the manufacturing companies for material from glass to plastic.


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 by Royalty Pharma and Jefferies Financial. The fund was aimed to be used to develop ApiJect's blow-fill-seal (BFS) plastic profiled injection system and other “general working capital” purposes.


By Closing System Analysis


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


Based on the closing system, the market is segmented into staked needle system, luer cone system, and luer lock form system. Among closing system, the staked needle system segment captured a significant share in the market owing to the speedy usage of the staked needle system. 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.


Technological advancements in the luer lock form systems make them more secure by preventing needle sticks 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 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.


By Product Analysis


Increasing Demand for Complete Syringe Lead the Segment to Hold Lion’s Share 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 rising demand for self-injectable delivery systems among patients.


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 Design Analysis


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


Based on design, the market is segmented into single-chamber, double-chamber, and multiple-chamber. Among them, the single-chamber segment captured a significant share of the market and is likely to exhibit a significant CAGR during the forecast period.



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


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 worldwide is likely to surge the demand for these syringes during the forecast period.


By End-User Analysis


Growing Interest in Injectables is leading the Pharmaceutical & Biotechnology Companies Segment to Dominate the Market


Based on end-user, the market is categorized into pharmaceutical & biotechnology companies, contract research & manufacturing organizations, and others. Among end user, the pharmaceutical & biotechnology companies segment captured a major share in the global market. The fast-expanding pharmaceutical companies across the globe 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, the rising number of early-stage, along with 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.


REGIONAL INSIGHTS


Europe Prefilled Syringes Market Size, 2022 (USD Billion)

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


Among them, Europe dominated the global market and generated a revenue of USD 2.91 billion in 2022. 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 Europe. In addition, the presence of key players engaged in developing pre-fillable syringes in Europe is likely to boost market growth.



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


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, which is 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 North America.


The Asia Pacific prefilled syringes market is likely to witness 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, the rising awareness regarding innovations in these syringes and significant growth in contract manufacturing companies outsourcing packaging & filling services are likely to play a pivotal role in boosting the market growth in the region.


Latin America and the Middle East & Africa regions are likely to experience slow growth in this market due to lower awareness about innovative products and slow penetration of the market.


KEY 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 most of the global prefilled syringes market share in 2022. 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.


Moreover, a strong focus on strategic partnerships with other key market 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 IN PREFILLED SYRINGES MARKET:



KEY INDUSTRY DEVELOPMENTS:



  • March 2023: Nexus Pharmaceuticals, Inc. received U.S. FDA approval for EMERPHED, an ephedrine sulfate injection in 25mg/5mL and 50mg/10mL single-dose prefilled syringes.

  • October 2022: Fresenius Kabi AG received USFDA approval for Stimufend (pegfilgrastim), a biosimilar for cancer patients to reduce the incidence of infection.

  • April 2022: Nevakar Injectables Inc. received USFDA approval for ready-to-use Ephedrine Sulfate Injection, prediluted to 5mg/mL in a pre-filled syringe.

  • April 2021: Nipro Pharma Packaging International expanded its product portfolio by announcing that the Nipro D2F pre- fillable syringes are compatible with Schreiner MediPharm Needle- Trap (safety system).

  • October 2021: Becton, Dickinson and Company partnered with Aptar Pharma and launched BD SCF PremiumCoat Plunger Stopperade to support biologics injection with pre-filled syringe.


REPORT COVERAGE


An Infographic Representation of Prefilled Syringes Market

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The prefilled syringes 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.


Report Scope & Segmentation


































































  ATTRIBUTE



  DETAILS



Study Period



2019-2030



Base Year



2022



Estimated Year



2023



Forecast Period



2023-2030



Historical Period



2019-2021



Growth Rate     



CAGR of 10.9% from 2023-2030



Unit



Value (USD billion)



Segmentation



Material, Closing System, Product, Design, End-user, and Region



By Material




  • Glass

  • Plastic



By Closing System


 




  • Staked Needle System

  • Luer Cone System

  • Luer Lock Form System



By Product




  • Complete Syringe Set

  • Components & Accessories



By Design




  • Single-chamber

  • Double-chamber

  • Multiple-chamber



By End User




  • Pharmaceutical & Biotechnology Companies

  • Contract Research & Manufacturing Organizations

  • Others



By Region




  • North America (By Material, By Closing System, By Product, By Design, By End-User, and By Country)

    • U.S. (By Product)

    • Canada (By Product)



  • Europe (By Material, By Closing System, By Product, By Design, By End-User, and By Country)

    • Germany (By Product)

    • U.K. (By Product)

    • France (By Product)

    • Italy (By Product)

    • Spain (By Product)

    • Scandinavia (By Product)

    • Rest of Europe (By Product)





  • Asia Pacific (By Material, By Closing System, By Product, By Design, By End-User, and By Country)





    • China (By Product)

    • India (By Product)

    • Japan (By Product)

    • Australia (By Product)

    • Southeast Asia (By Product)

    • Rest of Asia Pacific (By Product)



  • Latin America (By Material, By Closing System, By Product, By Design, By End-User, and By Country)

    • Brazil (By Product)

    • Mexico (By Product)

    • Rest of Latin America (By Product)



  • Middle East & Africa (By Material, By Closing System, By Product, By Design, By End-User, and By Country)

    • GCC (By Product)

    • South Africa (By Product)

    • Rest of Middle East & Africa (By Product)





Frequently Asked Questions

Fortune Business Insights says that the global market size was USD 7.22 billion in 2022 and is projected to reach USD 16.32 billion by 2030.

In 2022, the Europe market stood at USD 2.91 billion.

Growing at a CAGR of 10.9%, the market will exhibit steady growth during the forecast period (2023-2030).

The plastic segment is expected to be the leading segment by material in this market during the forecast period.

The rising prevalence of chronic disease diseases, increasing demand for biologics as treatment options, growing awareness of advanced products, and product launches are the key factors driving the growth of the market.

BD, Gerresheimer AG, SCHOTT AG, and West Pharmaceutical Services Inc. are the top players in the market

Europe dominated the market share in 2022.

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