Prefilled syringes have emerged as a novel, safe, and convenient drug delivery method, which enables you to self-administer drugs, without requiring you to go to a hospital. Prefilled syringes consist of already packed doses of medicines in a packet, to which a syringe has been attached by the manufacturer. This ensures standardized and uniform dose administration, waste reduction, and increased safety for you as a patient, as there is virtually no chance of re-usability of the syringe.

Prefilled syringes have been available in the market, for over 20 years. However, in recent years, the prefilled syringe market has seen significant growth. The current Prefilled syringe market in Europe is estimated at $300 million, with a year-on-year growth rate of around 10%. 1,2

Prefilled syringe vs other delivery methods:

Syringe vs Vial

So, should we make a switch from traditional vials to the prefilled syringes? Prefilled syringes offer multiple advantages as they are easy to administer, deliver the exact quantity of dose, and avoid wastage. There can, however, be some challenges such as that prefilled syringes come at a premium price and they have a high chance of contamination as the drug comes in contact with more external components as compared to a vial, wherein the drug is only in touch with glass and rubber. 3

Prefilled syringe vs autoinjector

Is there a difference at all? Several studies, comparing prefilled syringes with autoinjectors have established that the two delivery mechanisms have been comparable in terms of tolerability and efficacy. The only difference lies in the method of insertion. In the case of a prefilled syringe, the needle is inserted at a 45° angle, directly at the injection site. In the case of an autoinjector, the clear base is placed firmly and flat against the skin, and the injection button is pressed and held in place for 10 seconds.4,5

Ypsomed autoinjector is something that you may be interested in.

Advantages of Prefilled Syringes and why are they important

The advantages are well established, Right? Let's still list them down though.

•  These syringes are convenient to use

•  The medicine stored is more sterile and more effective as compared to other storage methods

•  The prefilled syringes ensure that we have an accurate amount of dose administered.

•  Accuracy in dosage and use of standardized syringes ensures safety

•  Manufacturing advantages as these prefilled syringes require less overfilling

•  Medical advantages as prefilled syringes are convenient for emergency use, accurate, show reduced medication and dosing errors, are usually pre-measured.6

In short, prefilled syringes are important as they are more safe, convenient, avoid overfilling related wastages and ensure compliance to dosages.6

Is it safe to preload syringes?

Manual preloading or self-loading of syringes is never advised due to the risk of contamination by exposure to the environment during the transfer. Pre-loading of the syringes should only be done in a sterilized environment with the help of special equipment that stops exposure to air. Prefilled syringes are preloaded in a very controlled environment and required preservatives are added to ensure the prevention of the growth of microbes. A study conducted to check for the safety and effectiveness of prefilled syringes established that Preloaded syringes are not prone to contamination or bacterial infections for at least 2 weeks on the shelf and the effectiveness of the drug is maintained. 7, 29

Types and examples of prefilled syringes

Prefilled syringes can be of multiple types:

•  The needle-free PFS, commonly used for vaccine products.

•  Needled PFS (PFS with integrated / staked-in needles) are mainly used with pharmaceutical drugs and biologic products.

•  Dual-chamber syringes, which are useful for co-delivery of two drugs or usage in case of lyophilized injectable drugs. 9,10,11

Some of the examples of prefilled syringes include Novolog flex pen prefilled syringe (heparin), Enoxaparin prefilled syringe (enoxaparin sodium injection), Lovenox prefilled syringe, Epinephrine prefilled syringe, Denosumab prefilled Syringe, Tocilizumab prefilled syringe, Pegfilgrastim prefilled syringe, Interferon-beta – 1a prefilled syringe, Chondroitin Sulfate Sodium, and Sodium Hyaluronate Ophthalmic solution prefilled syringe, Recombinant Human Erythropoietin Alpha Prefilled Injection, Cephalexin Neomycin Prednisolone prefilled syringe.12,13,28

Some of the manufacturers of Prefilled syringes include:

•  Baxter International

•  SCHOTT forma vitrum

•  Nipro Corporation

•  Terumo Corporation

•  West Pharmaceutical Services Inc

•  Aptar Stelmi

•  Aguettant

•  Becton Dickinson

•  Datwyler

•  Gerresheimer

•  Nuova Ompi

•  Vetter Pharma

•  Unilife

•  Weigao Group Pharmaceutical Packaging Products Company

•  Biogen Idec

•  Shandong Kexing Bioproducts Co., Ltd 19,20,21,22, 23, 25

Prefilled syringe market

The market is ever-expanding. Prefilled Syringes market size in 2020 exceeded USD 5.8 billion and is forecasted to grow over 11.8% CAGR from 2021 to 2027. The growing demand for this unconventional drug delivery device and medical surgical equipment is a result of accurate dosing and measurement along with improved safety outcomes vs traditional syringe-vial combinations.

Pandemic Impact on the global prefilled syringes market

Pandemic has had a mixed impact on Prefilled syringes market. On one hand, due to which, the supply of prefilled syringes has been negatively impacted due to supply chain issues. However, this impact is short-term and we are already seeing a massive recovery. 16,17

On the other hand, there has been an increased demand for prefilled syringes due to the huge interest in and distribution of vaccines. The US government recently signed a deal worth $138 million with syringe manufacturers to facilitate order of 100 million prefilled coronavirus vaccine syringes by the end of 2020 and 500+ million by the end of 2021.18

Not everything is going south in the pandemic!

Prefilled Syringe Packaging

Prefilled syringes typically require extensive care, because of the nature of drugs they carry, their higher cost, and risks of contamination from the environment. The packaging materials used should comply with the strict regulatory standards, should be truly traceable and should be sustainable under environmental changes. The packaging solutions should also support code checking, inserts, integrated labeling, auto-checking of variable data, and should require minimized machine setup, and be fully GMP compliant.

Monomaterial packaging solutions are typically used for packaging prefilled syringes as these are more durable, are extensively flexible, less polluting, and recyclable. 24

Prefilled Syringe Price

The price of prefilled syringes is around $7,500. However, the price would vary depending on the type of drug used. 26

Prefilled Syringe Challenges

Manufacturing Prefilled syringes involves challenges as the sizes of the prefilled syringe batch are typically smaller, thus needing manufacturing optimization and potential innovation to deliver sustainable value. Global regulatory compliance requirements for contract manufacturing prefilled syringes are also stringent. This means that a specific structural alteration required by one customer to ensure regulatory compliance may affect the other customers using a similar manufacturing line. 27

FAQ Section:

Q1. How to use prefilled syringe?

Following steps should be followed while using Prefilled syringes:

1. Take the syringe out of the refrigerator. Wait 30 minutes

2. Gather supplies for injection

3. Inspect syringe for damage

4. Wash hands before injecting

5. Choose the injection site (abdomen, thigh, back of arm, buttocks)

6. Prepare the skin

7. Pull off the needle cap (do not put the cap back on or touch the needle)

8. Gently pinch and hold a fold of skin at the injection site

9. Insert the needle at a 45° angle

10. Release the skin and push in the plunger

11. Repeat if doing two injections

12. Dispose of the syringe 4

Q2. How long does a prefilled syringe remain sterile?

A prefilled syringe can remain sterile for almost 2 to 3 years.6

Sources:

1. https://www.medica-tradefair.com/en/News/Future_of_Prefilled_Syringes_Manufacturer_s_Perspective_%E2%80%93_Challenges_and_Opportunities#:~:text=A%20prefilled%20syringe%20is%20a,been%20fixed%20by%20the%20manufacturer.&text=There%20has%20been%20great%20development,package%20injectable%20drugs%20and%20diluents.

2. https://www.pharmaceuticalonline.com/doc/an-introduction-to-prefilled-syringe-selection-prefilled-syringes-with-staked-in-needles-0001

3. http://www.differencebetween.net/science/health/difference-between-ampoule-and-vial/

4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6147689/#:~:text=For%20the%20prefilled%20syringe%2C%20ease,with%20the%20240%20mg%20dose.

5. https://www.researchgate.net/publication/327697721_Comparison_between_prefilled_syringe_and_autoinjector_devices_on_patient-reported_experiences_and_pharmacokinetics_in_galcanezumab_studies

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3465144/

7. https://www.excelmale.com/forum/threads/risk-associated-with-pre-loading-syringes-for-later-use.6729/

8. https://www.nbcnews.com/health/health-news/don-t-pre-fill-those-syringes-fda-says-n423811

9. https://www.pharmaceuticalonline.com/doc/an-introduction-to-prefilled-syringe-selection-needle-free-and-dual-chamber-devices-0001

10. http://www.ijccts.org/fulltext/17-1578386565.pdf

11. https://www.ondrugdelivery.com/wp-content/uploads/2018/11/Sep2006.pdf

12. https://dir.indiamart.com/impcat/prefilled-syringe.html

13. https://www.fda.gov/drugs/drug-safety-and-availability/list-new-drug-products-approved-modified-glass-syringes

14. https://www.gminsights.com/industry-analysis/prefilled-syringes-market

15. https://www.grandviewresearch.com/press-release/global-prefilled-syringes-market

16. https://www.marketsandmarkets.com/Market-Reports/prefilled-syringes-market-16618331.html

17. https://www.businesswire.com/news/home/20201026005509/en/Global-Prefilled-Syringes-Market-2020-2025-Focus-on-Single-Chamber-Dual-Chamber-Customized---ResearchAndMarkets.com

18. https://www.fortunebusinessinsights.com/industry-reports/prefilled-syringes-market-101946

19. https://www.pharmamanufacturingdirectory.com/category/laboratory-equipment/syringes

20. https://www.baxterbiopharmasolutions.com/pdf/Syringe_FactSheet2018.pdf

21. https://www.medicalexpo.com/medical-manufacturer/pre-filled-syringe-5128.html

22. https://www.prnewswire.com/news-releases/prefilled-syringes-market-4th-edition-2016---2026-300435024.html#:~:text=Humira%C2%AE%2C%20Enbrel%C2%AE%2C%20Copaxone%C2%AE%2C%20Lovenox%C2%AE%2C,extensively%20administered%20via%20prefilled%20syringes.

23. http://www.avbaike.cn/products/recombinant-human-erythropoietin-injecti-38253.html

24. https://www.pharmaceutical-networking.com/packaging-for-prefilled-syringes/

25. https://www.indiamart.com/proddetail/avonex-9180833591.html

26. https://www.drugs.com/price-guide/avonex-prefilled-syringe

27. https://www.pharmtech.com/view/prefilled-syringes-challenges-innovations-and-market

28. https://www.google.co.in/url?sa=i&url=https%3A%2F%2Fwww.actemrahcp.com%2Fra%2Fdosing-and-monitoring%2Fdosing-schedule.html&psig=AOvVaw0qPdJv2AQvSIqc-rzPuo4w&ust=1617348207261000&source=images&cd=vfe&ved=0CA0QjhxqFwoTCNDz4d7B3O8CFQAAAAAdAAAAABAJ

29. https://pubmed.ncbi.nlm.nih.gov/10469100/