PUBLISHER: DataM Intelligence | PRODUCT CODE: 1319135
PUBLISHER: DataM Intelligence | PRODUCT CODE: 1319135
Global Prefilled Syringe Market reached US$ 6.4 billion in 2022 and is expected to reach US$ 14.4 billion by 2030 growing with a CAGR of 10.9% during the forecast period 2023-2030.
One area of the pharmaceutical and healthcare industries that is expanding quickly is the prefilled syringe market. These syringes are primarily used to treat a variety of chronic illnesses including cancer, arthritis, diabetes, allergy, and ophthalmology. Prefilled syringes have also emerged as the most practical method of drug delivery in recent years. delivering medications with a prefilled syringe can be both safer and easier when compared to regular syringes.
Prefilled syringes are classified into two main categories based on the type of design which include single chamber PFS and dual chamber PFS. Dual chamber PFS has two partitioned chambers where both of the chambers are filled with pre-loaded drugs. Dual chamber PFS have more complex process of administering drugs when compared to the standard prefilled syringes. Moreover, the rising prevalence of chronic diseases, FDA approvals, increasing clinical trials on prefilled syringes, and technical advancements of PFS are the major growth drivers of the market.
Prefilled syringe market has witnessed significant growth due to various technological advancements. Many key players play a major role in these advancements by launching new products and services. These new products can rise the productivity and efficacy of patients who suffered from chronic illness.
For instance, on Oct 24 2022, Hilma Pharmaceuticals launched the Succinylcholine Chloride Injection which is in the prefilled syringe form. This 100mg/5ml PFS is the FDA approved drug. Succinylcholine Chloride is mainly used in hospitals for general anesthesia, facilitating tracheal intubation, and also used for relaxation during surgeries.
Prefilled syringes require a thorough assessment by the FDA to ensure quality, reliability, and performance. Data from clinical trials, preclinical studies, and manufacturing processes are carefully reviewed. Once approved, these products become recognized as safe and effective for their intended use, fulfilling all regulatory requirements.
The FDA has also been approving prefilled syringes as combination products, where drugs or biological products are packaged together with the delivery device. This includes prefilled syringes with fixed-dose combinations of multiple drugs or therapies. Combination products offer convenience, simplify treatment regimens, and improve medication adherence. The FDA plays a crucial role in evaluating the safety and effectiveness of these combination products.
On March 3, 2023, Nexus Pharmaceuticals, Inc. announced that it has received US Food and Drug Administration (FDA) approval for Emerphed (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes. The 10mL presentation is the first and only FDA approved ready to administer 10mL pre-filled syringe available. Nexus Pharmaceuticals EMERPHED (ephedrine sulfate injection) pre-filled syringe is available immediately in cartons of ten single-dose syringes
On Feb 9, 2022, Takeda announced the U.S. Food and Drug Administration (FDA) approval of the Takhzyro injection single-dose prefilled syringe (PFS) to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older. The PFS is ready to use and requires fewer preparation steps than the current Takhzyro vial injection, while also reducing supplies and waste. Hence, owing to the above factors, the market is expected to boost over the forecast period.
Dual chamber PFS has two partitioned chambers where both of the chambers are filled with pre-loaded drugs. Dual chamber PFS has more complex process of administering drugs when compared to the standard prefilled syringes.
For instance, According to Pharmaceuticalonline article, a person using dual chamber syringes needs to be more cautious and take more preparation steps before getting an injection. There is a high chance of losing drugs if the user removes the cap before mixing up the two drug chambers. It can also cause drug loss when the user holds the syringe slightly downward away from the body. This is caused due to the buildup of pressure inside the syringe.
The COVID-19 pandemic has had a significant impact on the global prefilled syringe market. During the height of the pandemic, many healthcare systems were overwhelmed, and non-urgent medical procedures and screenings were postponed or canceled. This led to delays in the diagnosis of chronic diseases and initiation of treatment for patients. As a result, some chronic disease cases were diagnosed at later stages, potentially affecting treatment outcomes.
Moreover, the focus of research and development efforts shifted during the pandemic, with a significant emphasis on developing vaccines and treatments for COVID-19. This diversion of resources and attention has temporarily impacted the progress of PFS-related research and development activities.
Also, to minimize the risk of COVID-19 transmission, healthcare providers implemented changes in treatment delivery, such as reducing in-person clinic visits, increasing telemedicine consultations, and modifying treatment schedules. Therefore, owing to the above factors, prefilled syringe market is expected to be moderately affected over the forecast period.
The conflict between Russia and Ukraine has impacted various prefilled syringe manufacturer companies. The conflict may disrupt supply chains, affecting the production and distribution of prefilled syringes. Both Russia and Ukraine are significant players in the pharmaceutical industry, and any disruption in their manufacturing capabilities or transportation routes could lead to delays or shortages in the supply of prefilled syringes.
During times of conflict, countries imposed export restrictions on certain medical goods. The conflict led to a shift in market dynamics, as companies may reassess their supply chain strategies and seek alternative suppliers or manufacturing locations. This resulted in changes in the competitive landscape of the prefilled syringe market, with new players entering or existing players expanding their market presence.
Furthermore, the conflict and its aftermath impact the data collection and research efforts related to prefilled syringes in the affected regions. This can impact the availability of up-to-date epidemiological data, hinder clinical trials, and limit the understanding of prefilled syringes outcomes in conflict-affected areas. Therefore, considering the above factors, the prefilled syringes market has been moderately affected by the conflict between Russia and Ukraine.
The global prefilled syringes market is segmented based on product type, material type, design, applications, distribution channels, and region.
For instance, on April 18, 2023, CSL Behring announced the U.S. Food and Drug Administration (FDA) approved a 50mL/10gm single chamber prefilled syringe for Hizentra. CSL Behring offers a full range of prefilled syringe sizes to meet the individual needs of people living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Hizentra is the first and only immune globulin (Ig) available in a simple, convenient and ready-to-use prefilled syringe.
Additionally, on April 28, 2023, Otsuka Pharmaceutical Co., Ltd. and Lundbeck Pharmaceuticals LLC announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Abilify Asimtufii (aripiprazole). It is an injectable suspension for intramuscular use once every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar disorder in adults. Each dose is provided in a single-chamber prefilled syringe and is administered by a healthcare professional to appropriate patients via intramuscular injection in the gluteal muscle. Thus, owing to the above factors, the single-chamber prefilled syringe segment is expected to hold the largest market share over the forecast period.
North America, majorly the United States and Canada represents a substantial market for prefilled syringes. The region has a well-established healthcare infrastructure and a high demand for advanced drug delivery systems. The market size of prefilled syringes in North America is growing significantly due to factors such as the increasing prevalence of chronic diseases, the aging population, and technical advancements in prefilled syringes.
North America has stringent regulatory standards for medical devices, including prefilled syringes. The U.S. Food and Drug Administration and Health Canada enforce guidelines to ensure the safety, quality, and performance of prefilled syringes. Compliance with these regulatory requirements is essential for manufacturers to enter and thrive in the North American market.
For instance, on Sep 13, 2022 Becton, Dickinson, and Company, a leading global medical technology company introduced a next-generation BD Effivax glass prefillable syringe (PFS) that sets a new standard in performance for vaccine PFS with new and tightened specifications for processability, cosmetics, contamination and integrity. The new BD Effivax glass prefillable syringe has been designed in collaboration with leading pharmaceutical companies to meet the complex and evolving needs of vaccine manufacturing. Hence, owing to the above factors, the North American region is expected to hold the largest market share over the forecast period.
The major global players in the market include: Gerresheimer AG, Sanofi, Terumo Corporation, B. Braun, Baxter International, West Pharmaceutical Services, Inc., Becton, Dickinson and Company, SCHOTT AG, Catalent Inc. and Cardinal Health Inc among others.
The global prefilled syringe market report would provide approximately 69 tables, 70 figures, and 195 Pages.
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