The European Commission sanctioned the first-ever biosimilar drug developed by Sandoz called Omnitrope (somatropin) in 2006. Fifteen years later, the biosimilars market is witnessing growth at a breakneck speed with the introduction of new reference molecules each year.
Biosimilars are inspired by specific biopharmaceuticals and are exact copies of these drugs. Biosimilars are different from biological generics, although they happen to share similar biopharmaceuticals’ manufacturing and structural complexities.
Crucial Factors Leading To The Biosimilar Market Growth
Many factors such as cost-cutting initiatives by governments and third-party payers, reduced pricing, increased prevalence of chronic diseases, and the expiration of patents on blockbuster pharmaceuticals are responsible for driving the biosimilar market.
Around 17 drugs are predicted to go off-patent by 2026, including the recent patent expiration of leading biologics such as Avastin, Levemir, and Humira. These expirations have aroused a general interest in developing biosimilars. Similarly, patents of Eylea (Aflibercept) and Lucentis (Ranibizumab) are either reaching or have reached expiration. The way to develop effective biosimilars requires sufficing patient needs by selecting the most efficient systems possible that eliminate unnecessary delays while reaching the target market.
Since the validation of the first biosimilar drug back in 2006, the number of reference molecules added each year has increased dramatically. Around 90 new molecules were introduced to the biosimilar category by the US(FDA) alone. Furthermore, Europe’s large market share consisting of a plethora of new product launches and a strong healthcare system is fueling the constant growth of the biosimilar market.
As per the World Health Organization, NCDs (non-communicable diseases) such as diabetes, chronic lung disease, cancer, and heart disease, cause 70% of all deaths globally. A significant portion of those affected resides in middle or low-income countries, where affording expensive biologics is difficult.
Conclusion
The biosimilar market has considerably impacted the healthcare systems. In recent years, it has seen remarkable growth, but several factors like physician acceptance, patent litigation, sales and marketing, anti-competitive settlements, and others have hindered the biosimilar market growth. Key companies worldwide are working at their best to address these issues.
An escalation in the momentum can be projected in the coming years due to factors such as reduced healthcare costs, reduced disease burden, anticipated changes to the regulatory and market and structure, and biological drugs coming off patent. All these factors will continue to drive biosimilar market growth.
Source: Top Trends and Development Driving the Global Biosimilar Market Growth, By DelveInsight.
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