Biosimilars are biologic medical products that are developed to be similar to an already approved biological product, known as reference product or originator biologic. Biosimilars contain similar active ingredients to the originator biologic and are usually administered via injection or infusion. Biosimilars provide a cost-effective alternative to costly biologic therapies for various diseases like cancer, arthritis and autoimmune disorders. Regulatory agencies have approved biosimilars for treatment of conditions like breast cancer, colorectal cancer, rheumatoid arthritis, inflammatory bowel disease and others. The global biosimilars market is estimated to be valued at US$ 29.4 Bn in 2023 and is expected to exhibit a CAGR of 5.9% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Dynamics:
Booming approvals of biosimilars drugs by regulatory bodies is expected to drive the growth of the global biosimilars market over the forecast period. For instance, U.S. Food and Drug Administration (FDA) approved 28 biosimilar products between 2015 and 2022. Similarly, European Commission (EC) has approved 75 biosimilars till January 2022. Increased biosimilar approvals lead to more treatment options and affordability for patients. Additionally, expiry of patents of biologic reference drugs provide opportunities for biosimilar manufacturers to enter the market. For example, patent expiry of biologics like infliximab, etanercept and adalimumab during 2023-2030 will open windows for biosimilar versions. Thus, growing availability of cost-effective biosimilars coupled with patent expiry of biologic reference drugs will fuel the market growth over the projection period.
Segment Analysis
The biosimilars market is segmented based on products, disease indication, distribution channel, and geography. The product segment dominates the market and is further divided into monoclonal antibodies, recombinant human growth hormone, erythropoietin, granulocyte-colony stimulating factor, insulin, and others. Monoclonal antibodies hold a significant share owing to rising emphasis on increasing cost-effective treatment options for cancer, autoimmune disorders, and inflammatory diseases.
PEST Analysis
Political: Stringent government regulations towards biosimilar approvals and use in Europe and North America are positively impacting the market. Various initiatives are promoting biosimilar developments and adoption.
Economic: Cost-savings afforded by biosimilars compared to reference biologics are driving increased utilization. Developing regions have allocated higher healthcare budgets to biologics.
Social: Growing incidence of chronic diseases and aging populations worldwide are major market drivers. Increased awareness about treatment alternatives is benefiting the market.
Technological: Advancements in analytical techniques enable in-depth product characterization during development. Streamlined manufacturing technologies facilitate large-scale production.
Key Takeaways
The Global Biosimilars Market Share is expected to witness high growth over the forecast period.
North America currently dominates the market owing to established regulatory guidelines and high penetration of biologics in disease management. However, Europe is expected to emerge as the fastest growing regional market due to the presence of major developers and a highly developed regulatory framework promoting biosimilar use.
Key players operating in the biosimilars market are Pfizer Inc., Sandoz International GMBH, Teva Pharmaceutical Industries Ltd., Amgen Inc., Biocon, Dr. Reddy’s Laboratories Ltd. Patent expiries of major biologics and rising healthcare expenditures are encouraging these players to strengthen their biosimilar pipelines. However, complex analytical characterization requirements during development and stringent regulations for interchangeability are key challenges. Marketing strategies targeting physicians and payers will be crucial for gaining higher market acceptance.
