Drug Developers are Considering such Devices for Product Life Cycle Manage
by Roots Analysis Roots Analysis - Leaders in Pharmaceutical & Biote
According to the Centers for Disease Control and Prevention, diabetes, migraine and cancer are responsible for 7 out of 10 deaths in the US. Further, as per the WHO, the prevalence of such chronic diseases is expected to reach 57% by 2020. On the treatment side, the rise in prevalence of such clinical conditions is expected to translate into an increase in the need for medications that are required to be administered frequently. For patients who need to medicate several times a day, self-administration is now a preferred option using devices, such as prefilled syringes, pen-injectors and autoinjectors.
Further, a number of biologics have received approval in the last decade. Owing to their large size and unstable nature, these drugs are usually formulated for parenteral delivery and prefilled syringes have become the primary container of choice for many such drugs / therapies, including monoclonal antibodies 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. It is worth highlighting that development of biologics in combination with prefilled syringes has garnered a lot of interest in the biopharma industry. 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.
In addition, the growth of prefilled syringes will also be impacted by the launch of biosimilars, since the expiry of patents of blockbuster mAbs is likely to be followed by the launch of biosimilar drugs. According to a study, as of February 2019, around 1,041 biosimilar molecules were being evaluated in clinical trials. Despite the fact that development of biosimilar requires huge money and time investment, the potential returns are enormous. As per a study conducted by GaBI, biologics with estimated revenues of over USD 68 billion have already lost patent protection. Further, biologics with estimated revenues of USD 100 billion are anticipated to lose patent exclusivity by 2020; this will lead to the expansion of the biosimilars market.
Over time, prefilled syringes have become indispensable to modern drug delivery practices. Moreover, their use as primary packaging for various other next generation therapeutic administration devices makes them an important lifecycle management tool as well. Examples of approved autoinjectors that use prefilled syringes as their primary container include (no selection criteria, in alphabetical order) Emgality prefilled pen (Eli Lilly), Nucala autoinjector (GSK), Vyleesi autoinjector (AMAG Pharmaceuticals / Palatin Technologies) and Xyosted autoinjector (Antares Pharma).
Moreover, our analysis has revealed nine approved products and 160 clinical drug candidates that are likely to be evaluated for delivery via prefilled syringes. It is worth mentioning that the abovementioned drugs / drug candidates are designed for the treatment of chronic conditions, require frequent dosing, and are not currently available in self-administration systems. We are led to believe that they are likely to soon be evaluated in different drug-device combinations.
Additionally, based on likely partner analysis, 61% companies are likely to be evaluated for partnership for development of prefilled syringe combination products. Majority (33) of these likely partners are headquartered in North America, followed by Europe. It is worth highlighting that, among Asia-Pacific and RoW based companies, BioLineRx, Genexine and Jiangsu HengRui Medicine are most likely to be evaluated for partnership for the development of prefilled syringe combination products.
Further, an analysis on top 20 big pharma players (based on the annual revenues) highlighted that Sanofi has the maximum number of approved and under development prefilled syringe combination products. On the other hand, Johnson & Johnson, with a strong pipeline of injectable drugs, across various therapeutic areas, has the maximum number of drugs that are likely to be developed in combination of prefilled syringes.
Furthermore, majority of the big pharma players have strong pipeline of injectables for treating autoimmune disorders. Within autoimmune disorders, Johnson & Johnson has maximum number of approved and under development prefilled syringe combination products. On the other hand, Amgen has higher likelihood of developing its pipeline drugs in combination with prefilled syringes.
Created on Jul 15th 2020 03:33. Viewed 63 times.