PREFILLED SYRINGES MARKET ANALYSIS

Global Prefilled Syringes Market is estimated to be valued at US$ 6.44 billion in 2023 and is expected to exhibit a CAGR of 5.6% during the forecast period (2023-2030). Increase in launch of products by key market players is expected to drive the market growth over forecast period. Moreover, increase in prevalence of chronic and infectious diseases is expected to drive the market growth over forecast period (2023-2030).

Analysts’ Views on Global Prefilled Syringes Market:

The prefilled syringes market's growth is expected have a positive impact over the forecast period, owing to increasing technology developments and robotic implementation in manufacturing prefilled syringes. For instance, in June 2021, Shilpa Medicare Limited, an India-based specialty generic pharmaceutical company, expanded its oncology drug production with Robotic Pilot Line. The new pilot line will help process vials, pre-filled syringes (PFS), and cartridges for injectable oncology drugs. Shilpa Medicare Limited worked with Steriline, an Italy-based provider of aseptic processing machinery and 10-year partner to Shilpa Medicare, to develop an innovative filling, stoppering, and capping system. Steriline designed a robotic line composed of a semiautomatic Robotic Nest Filling Machine (RNFM1-Lab) and a Vial Capping Machine (VCM50), both able to process the vials, prefilled syringes (PFS), and cartridges for injectable oncology drugs.

Figure 1.Global Prefilled Syringes Market Share (%), by Drug Type, 2023

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Global Prefilled Syringes Market- Driver

Increasing Product Launches by Market Players

Major companies operating in the global prefilled syringes market are focused on organic growth strategies such as product launches, which is expected to drive growth of the global prefilled syringes market over the forecast period. For instance, in October 2022, Hikma Pharmaceuticals PLC., a pharmaceutical company, launched Succinylcholine Chloride Injection, in prefilled syringe (PFS) form. Succinylcholine Chloride is an important medicine used in hospitals for general anesthesia, to facilitate tracheal intubation, and to provide muscle relaxation during surgery or mechanical ventilation. The U.S. FDA-approved 100mg/5mL prefilled syringes for medication to introduced in the U.S.

Increasing Prevalence of chronic and infectious diseases

The increasing prevalence of chronic and infectious diseases such as diabetes and cancer, among others, who require care for a longer duration of time is a major factor contributing to the market growth. For instance, according to the Centers for Disease Control and Prevention data on chronic diseases updated in July 2022, around six in ten adults in the U.S. were affected by a type of chronic disease, and over four in ten adults were affected by two or more chronic diseases.

Figure 2. Global Prefilled Syringes Market Share (%), by Region, 2023

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Global Prefilled Syringes Market- Regional Analysis

Among all regions North America region is expected to dominate the market over the forecast period. This is attributed owing to market players in the region focusing on gaining approvals and for new pre-filled safety syringes from regulatory bodies and launching new pre-filled safety syringes. For instance, on March 2, 2023, Nexus Pharmaceuticals Inc., a pharmaceutical company, received the U.S. FDA approval for single-dose prefilled syringe Emerphed (ephedrine sulfate injection). The newly approved injection is available in 25mg/5mL and 50mg/10mL strengths and is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

The Europe region is expected to second largest region over the forecast period owing to increasing number of facility expansions and investments by market players for the development of prefilled syringes. For instance, in October 2022, Recipharm, a global contract development and manufacturing organization (CDMO) had invested in a new high-speed filling line for pre-filled syringes and cartridges at its facility in Wasserburg, Germany.

Global Prefilled Syringes Market– Impact of Coronavirus (COVID-19) Pandemic

Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to World Health Organization (WHO) as of April 06, 2023, 762,201,169 people are affected worldwide.

For treatment of COVID-19, government with the pharmaceutical companies launched vaccines for the COVID-19. Due to the launches of vaccine, there was increase in demand for prefilled syringes, and this is expected to positively impact the growth of global prefilled syringes market over forecast period. For instance, in July 2022, Novavax, Inc., a biotechnology company that is dedicated to developing and commercializing next-generation vaccines for critical infectious illnesses, signed an agreement with its partner, SK bioscience, a global vaccine and biotechnology company, for the manufacture and supply of an Omicron variant of the Novavax COVID-19 vaccine (NVX-CoV2373), as well as the manufacture of the vaccine in prefilled syringe.

Global Prefilled Syringes Market Segmentation:

The Global Prefilled Syringes Market report is segmented into material, drug type, design, product type, usability, manufacturing method, end user and region

Based on Material, the market is segmented into Glass and Plastic/Polymer. Out of which, Plastic/polymer segment is expected to dominate the prefilled syringes market during the forecast period and this is attributed due to rising demand and increasing approvals by regulatory bodies for plastic syringes.  

Based on Drug Type, the market is segmented into Biologics, Vaccines, Insulin, Anticoagulants, Flush Saline Syringes and Others. Out of which, Biologics segment is expected to dominate the market over the forecast period and this is attributed to increasing investments by key market players for establishing new facilities in order to increase the manufacturing capacity of biologics.

Based on Design, the prefilled syringes market is segmented into Single-chamber, Dual-chamber and Multi-chambered. Single-chamber segment is expected to dominate the market over the forecast period and this is attributed to increase in the number of approvals by regulatory authorities of new single-chambered type syringes.

Based on Product Type, the prefilled syringes market is segmented into Staked in-needle pre-filled syringes and Needle-free pre-filled syringes. Staked in-needle pre-filled syringes segment is expected to dominate the market over the forecast period and this is attributed to increase in the launch of safety systems for staked in-needle pre-filled syringes that can help prevent accidental needle stick injuries.

Based on Usability, the prefilled syringes market is segmented into Disposable and Reusable syringes. Disposable pre-filled syringes segment is expected to dominate the market over the forecast period and this is attributed to increase in the launch of disposable prefilled syringes by the key market players.

Based on Manufacturing Method, the prefilled syringes market is segmented into Captive and Merchant. Merchant segment is expected to dominate the market over the forecast period and this is attributed to market players outsourcing the manufacturing of their products to contract development and manufacturing organizations (CDMOs).

Based on End User, the prefilled syringes market is segmented into Hospitals, Clinics, Ambulatory Surgical Centers and Others. Hospitals segment is expected to dominate the market over the forecast period and this is attributed to the development of smart concepts such as smart labels for prefilled syringes for optimizing hospital routine management.

Based on Region, Global Prefilled Syringes Market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East and Africa. North America is expected to dominate the market over the forecast period and this is attributed to the increase in number of product approvals from regulatory authorities.

Among all segmentation, drug type segment has highest potential due to increasing expansions of biologics manufacturing, increasing launches of prefilled syringes for vaccinations and other factors. For instance, in September 2022, BD (Becton, Dickinson and Company), a global medical technology company, launched a next-generation glass prefilled syringe (PFS) named Effivax Glass Prefillable Syringe for administration of vaccines. Effivax glass prefillable syringe reduces risk of line stoppage, and improves the total cost of ownership, manufacturing, and supply availability.

Global Prefilled Syringes Market Cross Sectional Analysis:

In drug type segment, biologics segment is dominant in North America region due to increasing number of product launches or approvals containing monoclonal antibodies. For instance, in April 2021, Novartis, a pharmaceutical company, received the U.S. FDA approval for Xolair prefilled syringe for self-injection. Xolair contains omalizumab as active pharmaceutical ingredient and is indicated for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU), and nasal polyps.

In material segment, Plastic/ Polymer held as a dominant segment in Asia Pacific region due to the increasing launches by medical device companies in the region. For instance, in May 2022, Terumo Pharmaceutical Solutions (TPS), a pharmaceutical and medical device manufacturer based in Japan, launched a prefillable polymer syringe named PLAJEX for low-dose applications such as ophthalmic drugs. This is a Luer Lock Silicone oil-free pre-fillable syringe, and is used for lowdose Pre-Filled Syringe (PFS) products, which makes it suitable for high-value drug applications such as intravitreal injection.

Global Prefilled Syringes Market: Key Developments

For instance, on January 4, 2023, Hikma Pharmaceuticals PLC, a multinational pharmaceutical company, announced that it had launched Naloxone Hydrochloride Injection, USP, 2mg/2mL, in prefilled syringe (PFS) form in the U.S. It is used for the emergency treatment of a known or suspected opioid overdose.

For instance, Clemson University, a public research institution, and Nephron Pharmaceuticals Corporation, a privately held company, developed a benchtop robot in March 2021 that can fill, cap, and seal sterile prefilled syringes, which can reduce costs by preventing drug overfill and minimizing contamination. Filling syringes in the absence of a robot is a highly regulated process that needs to be undertaken by specialized technicians under ISO-certified clean rooms. The robot is expected to help in addressing the shortage of prefilled syringes in hospitals and healthcare facilities.

In November 2022, Tjoapack, a contract packaging organization, invested in a new packaging line for pre-filled syringes (PFS) and vials at its production facilities in both Europe and the U.S. The PFS line can pack pre-filled syringes of 1 to 5ml, with or without safety devices, and other customer-specific components can also be added.

In April 2021, Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) had approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only U.S. FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU), and nasal polyps.

Global Prefilled Syringes Market: Restraint

Product Recalls

Several syringes have been recalled owing to defects in the container or plunger design, which makes the filling of drugs in them inefficient. The recent recalls of prefilled and pre-fillable syringes around the world are expected to significantly hamper the growth of the market over the forecast period.

For instance, in June 2022, Nephron Pharmaceuticals, a company that manufactures generic respiratory medications, issued a voluntary recall of some of its pre-filled syringe products due to concerns over the lack of assurance of sterility. The manufacturer indicated that the product recall was issued out of an abundance of caution and that there was no impact on patient safety.

To overcome the restraint, market players should focus on developing more safe and efficient devices adhering to all regulations and avoiding any contamination.

Availability of Alternate Drug Delivery Methods

Novel drug delivery systems involve creative formulations, new technology, and novel approaches for safely delivering pharmaceutical drugs into the body as needed to produce their intended pharmacological effects.

For instance, in 2021, Jabil Healthcare, a manufacturing services company, launched a new reusable autoinjector platform called Qfinity, a spring-driven, reusable device for use with a variety of drugs, including larger volume, higher viscosity medicines. The reusable injector operates with disposable cassettes in 1- and 2.25-ml sizes and a viscosity target of 30cP.

Market players should focus on strategies such as technology advancement of prefilled syringes, which would shift the customers to adopt prefilled syringes as the drug delivery methods instad of any alternatives, thus driving the market growth over forecast period

Global Prefilled Syringes Market: Key Players

Major players operating in the global prefilled syringes market include Gerresheimer AG, Becton Dickinson and Company, West Pharmaceutical Services, Inc., Terumo Corporation, Nipro Europe Group Companies, B. Braun SE, Sanofi, GSK plc., Pfizer Inc., Bayer AG, Polymedicure, Amsino International, Inc., Leeford Healthcare Limited, Torrent Pharmaceuticals Ltd., Regeneron Pharmaceuticals Inc.,   Ypsomed AG, SOL-Millennium, and Stevanato Group S.p.A.

Definition: A prefilled syringe is a single-dose container of medication or a vaccination, to which the manufacturer has attached a needle. Pre-filled syringes give improved dosage accuracy, require fewer steps for injection, and pose less danger of harm and cross-contamination. Pre-filled syringes are frequently taken into consideration as early as Phase II in the drug development process and are now a generally acknowledged component of the medication life-cycle. Prefilled syringe cartridges are made to fit into particular syringes that are used to give different liquid drugs. These replace traditional syringes, which healthcare professionals must manually fill before each dose is given. Prefilled syringe cartridges provide the benefits of simplicity, low cost, precision, sterility, and safety.