Biosimilars are biologic drugs that have the same function and structure and are made of proteins or pieces of proteins, either artificial or natural. Interestingly, biosimilars must be made in a living system like bacteria and yeast, unlike other drugs. The main functions of biosimilars are to stimulate the body’s immune system and to identify and destroy cancer cells more effectively. Although biosimilars are called as “exact copies” of biologic drugs, however, they’re different in many ways based on their source of formation and paths for FDA approval. Such approved biosimilars like Zarxio, Hulio, Avsola, etc. are widely utilized for cost saving in healthcare systems.
The increasing demand for biosimilar drugs due to their cost-effectiveness is the main factor estimated to drive the global biosimilar market growth by 2028. In addition, encouraging support from governments in the development and approval of biosimilars is expected to further boost the market growth during the analysis timeframe. Moreover, patent expiry of biologics along with increasing R&D activities on new biosimilars are the factors projected to offer ample market growth opportunities during the forecast years. However, high complexities in manufacturing biosimilars is expected to impede the global biosimilar market’s growth by 2028.
Regionally, the biosimilar market in the Europe region is anticipated to have an extensive growth and gather a revenue of $34,121.40 million in the 2021-2028 timeframe due to dominant prevalence of chronic disorders, existence of new market players, and launch of new and advanced biosimilars. In addition, the patent expiry of biologic products is also estimated to boost the market growth in the Europe region during the analysis years.
According to the report published by Research Dive, the global biosimilar market is anticipated to garner a revenue of $83,836.40 million, growing rapidly at a CAGR of 24.90% in the 2021–2028 timeframe. Some significant players of the biosimilar market include Synthon Pharmaceuticals, Inc., LG Life Sciences, Hospira, Teva Pharmaceutical Industries Ltd., Biogen idec, Inc., Novartis (Sandoz), Celltrion, Genentech (Roche Group), Merck Serono (Merck Group), Biocon, and many others.
Key Market Developments:
The prominent organizations operating in the industry are adopting numerous growth strategies & business tactics such as partnerships, collaborations, mergers & acquisitions, and launches to maintain a robust position in the overall market, which is subsequently helping the global biosimilar market to grow exponentially. For instance:
In January 2022, AbbVie, an American pharmaceutical company, submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for upadacitinib (RINVOQ) to treat non-radiographic axial spondyloarthritis, or, nr-axSpA. Rinvoq is a selective JAK inhibitor that is currently being analyzed in many immune-related inflammatory diseases. AbbVie also assessed the efficacy and safety of Rinvoq in adult nr-axSpA patients.
In December 2021, South Korea’s Samsung Group announced its decision to acquire Biogen Inc., a renowned US based drug maker for some neurological conditions like Alzheimer’s and dementia. The Nasdaq-listed Biogen’s acquired shares are worth $42 billion, and the company is all set to produce huge operating profits at a stable rate. In addition, this acquisition will mark Samsung’s largest transaction.
In January 2022, Amneal Pharmaceuticals Inc., an American-based generics and specialty pharmaceutical company, announced its acquisition of Saol Therapeutics’ Baclofen franchise, a leading biotech pharmaceutical company. This acquisition will help Amneal expand its institutional, commercial, and specialty portfolio in neurology, and will also promote the infrastructure before its entry in the global biosimilar market.
Covid-19 Impact on the Market:
The outbreak of the Covid-19 pandemic had a negative impact on all businesses and industries, including the global biosimilar market due to disruptions in the manufacturing capacity and supply chain across the world. Strict lockdowns, travel bans, and mobility restrictions imposed by governments across the globe led to several challenges faced by the pharma companies. In addition, FDA approval for non-COVID therapeutics also reduced greatly which delayed the process of launching new biosimilars, thus hampering the market revenue.