Biosimilars Market Size & Share, by Product Type (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins, Recombinant Peptides), Technology (Bioassay Technology, Recombinant DNA Technology, Monoclonal Antibody Technology), Application (Hematology, Oncology, Autoimmune Diseases) - SWOT Analysis, Competitive Strategic Insights, Regional Trends 2025-2037

Growth Drivers

• Upsurge in the Approval Rates of Biosimilars – which now many other countries are involved in, as biosimilars are safe and effective medications for treating many illnesses and chronic conditions. The surge in the approval of these drugs worldwide is expected to drive the global biosimilar market in the forecasted period. For instance, it was found that 9 new biosimilars were approved in the European Union in 2020 and 7 were approved in 2021.
• Growing Number of Cancer Cases – One of the biggest causes of mortality in the world is cancer, and it is predicted that there will be an increase in the number of new cancer cases. The rise in cancer incidence is driving up demand for biological medications, which are frequently used in cancer therapy. It was found that there were approximately 19 million new cancer cases registered worldwide in 2020.
• Rising Prevalence of Crohn’s disease – The global market for biosimilars is expanding owing to the increased frequency of Crohn's disease. Inflammation of the digestive system is brought on by the inflammatory bowel disorder (IBD) known as Crohn's disease. Although the precise etiology of Crohn's disease is unknown, and it is thought to be the result of a confluence of the immune system, environmental, and genetic variables. As per the data, in North America and Western Europe, 100 to 300 per 100,000 people suffer from Crohn’s disease every year.
• Increasing Number of People Suffering from Kidney Disease – End-stage renal disease (ESRD), which necessitates dialysis or a kidney transplant, can develop from kidney disease. Moreover, Erythropoiesis-stimulating agents (ESAs), among other biologic medications, are frequently used to treat anemia in ESRD patients. The high cost of these medications, however, makes biosimilars a desirable substitute for both patients and healthcare professionals. It was estimated that worldwide over 850 million people were suffering from some form of kidney disease in 2021.
• Rising Cases of Arthritis – Inflammation in the joints is a typical symptom of arthritis, which affects millions of people worldwide. An autoimmune condition called rheumatoid arthritis (RA) damages and inflames the joints, resulting in pain and incapacity. Therefore, the escalating ratio of RA is boosting the requirement of rheumatoid arthritis treatment, which in turn estimated to drive the demand for biological medications. It is observed that in 2021 about 350 million people had arthritis globally.

Challenges

• Increasing Competition in the Market - There is intense competition in the market for both biosimilar manufacturers and originator biologic manufacturers. When new biosimilar products enter the market, the originator manufacturer may use a variety of strategies to compete with the competition, such as competitive pricing, launching second-generation products, reformulations, and improved dosing measures. Hence, such a factor is projected to impede market growth in the coming years.
• Manufacturing Process Concerns for Biosimilar Agents
• The difficulty of Generating an Exact Copy of Biosimilars and Biologics