As more biologics lose patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets
“The rise of biologics has revolutionised treatments for traditionally hard-to-treat diseases, leading to the growth of the biosimilar market. As more biologics lose patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. This dynamic shift promises broader access to critical therapies,” states GlobalData.
GlobalData’s report, “State of the Biopharmaceutical Industry 2024 Edition (Mid-Year Update) (1),” highlights the impact of biosimilars and other developments in the pharmaceutical industry. For example, the Crohn’s disease (CD) market is expected to experience significantly slowed growth over the next decade due to biologic patent expiry and biosimilar erosion.
The report forecasts biosimilar sales to increase from 5.7 per cent in 2022 to 18.3 per cent in 2032 of the total sales throughout the eight major markets (8MM: The US, Canada, France, Germany, Spain, Italy, the UK, and Japan). This rise in market share translates to expansion from $0.5 billion to $2.8 billion in biosimilar sales.
Adeleke Badejo, Managing Analyst of Immunology at GlobalData comments, “It should be noted the stark difference of countries with primarily public healthcare payers, such as Canada, France, Germany, and Japan, compared to the largely private system of the US. Due to the established regulatory laws and negotiated pharmaceutical prices of countries with public healthcare, the prices of biological therapies are significantly lower in relation to the drug costs in the US.”
“The loss of exclusivity of AbbVie’s blockbuster drug Humira in 2023 in the US serves as an ideal example to illustrate the impact of biosimilars in the US compared to international markets. The erosion of Humira sales in the international markets over the initial year was nearly matched by the loss of revenue in the first quarter year-to-year sales in the US following the biosimilars launches into that market,” adds Badejo.
In 2019, after a full year of adalimumab biosimilars being available on the international market outside of US, AbbVie reported Humira international sales had an erosion of 31.1 per cent (a reduction of $4.305 billion in 2019 from $6.251 billion in 2018, and a decline of $1.946 billion).
This in comparison to AbbVie’s 2024 first-quarter financial report, where the company declared biosimilar competition the cause of a 39.9 per cent decrease in US Humira year-over-year revenue, a decline in sales from $2.948 billion to $1.771 billion (a drop of $1.177 billion). GlobalData forecasts an US sales erosion of Humira for 2024 of 36.8 per cent, a fall of $4.474 billion.
Badejo concludes, “In recent years, there has been growing support in the US, both by the public and across the political spectrum, for added regulations and laws to address the high cost of pharmaceutical drugs. This has led to the stipulations within the Inflation Reduction Act, passed in 2022, to reduce drug prices and promote the use of biosimilars. It should be expected that this support should drive the growth of the biosimilar market in the US.”
References:
- https://www.globaldata.com/store/report/state-of-biopharmaceutical-industry-analysis/?utm_source=cision&utm_medium=press%20release&utm_campaign=gd_press%20release_cision_pharma_biopharmaceutical%20industry_report