Multiple Prefilled Syringe Combination Products are Available in the Market, While Several Are Under

According to experts in the healthcare industry, one in three adults are estimated to be suffering from some type of chronic clinical condition, such as multiple sclerosis, diabetes, rheumatoid arthritis and cardiovascular diseases. Chronic clinical conditions are considered to be among the leading causes of death and disability across the world. Typically, in such cases, individuals are required to medicate on a daily basis. In addition to the cost of medication, such individuals are also burdened with a deteriorating quality of life, and often struggle with medication adherence. According to the US Centers for Disease Control (CDC), the overall annual expense incurred by those living with chronic diseases is steadily growing and is currently estimated to be more than USD 3 trillion. The development and commercialization of self-administrable dosage forms of drugs indicated to treat chronic clinical conditions has made a significant positive impact not only on the healthcare expenses borne by patients but also on compliance to prescribed therapeutic regimens. As the number of patients suffering from such disorders increase, the demand for more convenient and patient friendly drug delivery solutions is also on the rise.

Most self-injection devices / systems, such as autoinjectors and pen-injectors, rely on prefilled syringes, which serve as primary drug containers in the aforementioned products. Moreover, despite having been in the market for more than three decades now, the overall interest in prefilled syringes continues to grow. In fact, the recent increase in use of biologics, which are usually administered via parenteral routes, has had a significant impact on the demand for prefilled syringes. This is primarily due to reason that, prefilled syringes have been the container of choice for many biologic molecules, including monoclonal antibodies (mAbs) and vaccines. Some factors responsible for this preference include:

• Most biologics require parenteral administration
• Biologics are costlier than pharmaceutical drugs and packaging of biologics in prefilled syringes reduces overfills, saving costs
• Prefilled syringes allow product differentiation
• Ease of use and ability to save time helps to deploy vaccines in mass immunization programs
• Ease of use allows self-administration of drugs for chronic conditions

As mentioned above, in addition to end-users, prefilled syringes also offer several advantages to manufacturers. However, some technical issues, such as functionality issues and syringe siliconization, are yet to be addressed to ensure better compatibility between the drug and the device. It is worth highlighting that development of biologics in combination with prefilled syringes has garnered a lot of interest in the biopharma industry. In the last few years (2013-2019), close to 90 drugs have been approved in combination with prefilled syringes. Humira®, Rituxan®, REMICADE®, STELARA®, Enbrel®, GARDASIL® and PREVNAR 13® are examples of some of the blockbuster drugs (with annual sales of more than USD 5 billion) that are being extensively administered via prefilled syringes.

In addition, over 50 drugs are being developed in combination with prefilled syringes. Majority (51%) of these combination products are used for delivery of antibody therapeutics, followed by protein therapeutics. Presently, more than 60% prefilled syringe combination products are under phase III of clinical development, while 30% combination products are in phase II trials. It is worth mentioning that around 45% combination products have been approved / being developed for the treatment of autoimmune disorders and 19 vaccines have been approved (in the last seven years) in combination of prefilled syringes for treating infectious diseases. Examples of the approved vaccines include (in alphabetical order, no selection criteria) BEXSERO®, HEPLISAV-B™, Hexacima® / Hexyon®, Nimenrix™, TRUMENBA® and VAXELIS™.

Presently, prefilled syringes are widely used to administer a variety of therapeutics, including vaccines, anticoagulants, anti-arthritic drugs and anti-anemic drugs. In addition, the use of prefilled diluent syringes and flush syringes is also increasing. It is worth highlighting that maximum number of combination products (27) were approved in 2018. Further, majority (93) of the prefilled syringe combination products have been approved in the US, followed by Europe and Australia, where 68 and 29 combination products have been approved respectively.

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