Prefilled Syringe (PFS) is a new type of drug packaging material developed in recent years. It has two functions: storing drugs and ordinary injection. It is currently widely used in the packaging of high-value products such as biological products, biochemical products, antithrombotic drugs, and beauty products. Bare PFS can be loaded with disposable needles and used directly for injection; because of its good compatibility with automatic injection pens, it can be loaded into automatic injection pens for chronic patients to use at home, such as SHL’s Molly injection pen.
( 1) Structure of PFS
- The key components of a typical prefilled auto-injector include:
- Tip cap: Usually made of polypropylene, used to protect the needle. Tip caps without needles are divided into cone-shaped caps and spiral-shaped caps, usually made of butyl rubber.
- Glass barrels: usually made of borosilicate glass, plastics such as cyclic olefin polymer (COP) and cyclic olefin copolymer (COC). Glass provides a good inert barrier, but there is a risk of delamination or breakage. COP has the characteristics of plasticity and high transparency, which reduces the interaction with proteins, but the oxygen barrier is poorer than glass.
- Rubber piston (Plunger Stopper): usually halogenated butyl rubber, the surface can be plated or coated. It needs to be compatible with the drug and have appropriate mechanical properties.
- Plunger Rod: Colorless plunger rods are usually made of polystyrene (PS), and colored plunger rods are made of PP/PE/colorant.
There are two main types of prefilled syringes, glass prefilled syringes and polymer prefilled syringes. The products are mainly divided into two categories: with injection needles and without injection needles. Prefilled syringes without needles can be connected to injection needles through Luer connectors. The Luer connection was invented by Germans, and the inventor is called Luer. Due to its conical surface matching design, the Luer connector (Luer Lock) can achieve a fast, safe, and leak-free sealing effect. Luer connectors can be divided into two categories: male Luer connectors and female Luer connectors, which are generally used in conjunction. In the male Luer connector, there are two ways of connection: screw-on (luer lock) and sleeve-on (luer slip). Luer slip: fixed by sliding, such as the connection between ordinary syringes and needles; Luer lock: locked by rotation, mostly used in places with high pressure, such as the connection of three-way connections\the connection of analgesic pump tubes.
(2) Development history of PFS
The world’s first prefilled syringe was created by BD in the United States in 1984. Since then, it has gradually become familiar and accepted by the US and European markets. Since around 2000, in the US market, a number of biologics have gradually adopted prefilled syringes (PFS) as packaging materials. The main players in the global PFS include BD, Gerresheimer Buende GmbH, SCHOTT Schweiz AG, Nipro Pharma Packaging International, Terumo Corporation, and Daisei Chemical Co., Ltd. China’s first glass prefilled syringe was born in 2005 by Shandong Weigao Group. With the continuous improvement of Chinese technology, Weigao currently has a market share of about 70% in China, exceeding that of BD in the United States. The main players in China’s PFS include Shandong Weigao Purui Pharmaceutical, Shandong Zibo Minkang Pharmaceutical, Shandong Pharmaceutical Glass Co., Ltd., Shandong Yongju Pharmaceutical Technology, Ningbo Zhengli Pharmaceutical Packaging, Suzhou Healthy Tree Medical Technology Co., Ltd., etc.
(3) Advantages of PFS
Prefilled syringes PFS is a new packaging method widely used by international high-end pharmaceutical preparations in recent years. It has been widely used in the packaging of medical beauty, vaccine and biological preparations, and emergency drug preparations. Prefilled syringes realize the integration of storage and drug administration, which can reduce the waste of drug residues and the risk of drug contamination. Its safety and convenience have been widely recognized by pharmaceutical companies and medical institutions, and have been gradually introduced into the packaging of more high-value preparations.
The use of PFS allows patients to better adhere to treatment, especially for chronic diseases such as rheumatoid arthritis and multiple sclerosis, while helping to reduce overall treatment costs. In addition, PFS contains the exact dose of medication required by the patient, thus avoiding drug loss and waste. This is crucial to controlling the cost of expensive drugs and can increase the yield of filled PFS units per batch of API. Especially in terms of drug manufacturing costs, prefilled syringes can significantly reduce overfilling and costs compared to injection vials.
PFS only requires an average of 5 % excess, while vials require more than 30 % . Taking 150mg/mL antibody as an example, the 1mL dose is 10,000 yuan per gram. The cost of 5% excess quantity of PFS is 1,575 yuan, and the cost of 30 % excess quantity of vials is 1,950 yuan. PFS can save 24 % of the cost, which shows the cost advantage of PFS. Significantly.
Another important reason for the increased demand for PFS packaging is their compatibility with auto-injection pens, which enables patients to be independent from medical staff and have greater control over their treatment. Additionally, new smart auto-injector devices can monitor patient compliance with treatment regimens.
(4) The market space for PFS is huge
More and more drugs are approved for prefilled syringes PFS. Since biologics have high viscosity and are more susceptible to contamination, many pharmaceutical companies prefer to use PFS for the administration of biologics. Data from Weigao Co., Ltd. shows that in 2020, global sales of prefilled syringes PFS reached 2.78 billion units, and sales in China reached 470 million units. It is estimated that in 2030, global and Chinese PFS sales will reach 9.25 billion and 2.0 billion units, respectively, and China will account for about 21.6% of the global market .
Although bare PFS brings a lot of convenience to the biological products industry and medical staff, there are still safety risks such as disease transmission. Currently, Europe has banned bare PFS drugs from being marketed. The World Health Organization has also issued the “WHO Guidelines for Intramuscular, Intradermal and Subcutaneous Injections of Medical Safety Syringes”, calling for the global adoption of “smart” safety syringes to solve the widespread injection safety problems in the world. According to Sullivan research data, the global market size of safety needles and syringes in 2020 was US$4.31 billion, and it is expected to reach US$18.37 billion in 2030.
As the overall solution provider or self-administration devices, Healthy Tree Medical has an integrated industrial chain of design, R&D, production and sales. Healthy Tree Medical currently provides 1.0mL and 2.25mL PFS with completely independent intellectual property design (domestic patents and international PCT patents have been applied for). It can be customized in a variety of personalized shapes and colors according to customer needs. It has complete DHF documents, drug packaging material registration numbers and medical device certificates for domestic and foreign declarations. Healthy Tree Medical adheres to the technical concept of “letting professionals do professional things” and is committed to providing self-administration devices and corresponding injection solutions for pharmaceutical companies.