Humira is a monoclonal antibody used for the treatment of various conditions like rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It works by blocking tumor necrosis factor alpha (TNF-α), a protein that can cause inflammation. Humira biosimilars are the copies of the original biologic medicine and are approved based on demonstrating similarities to an existing approved biologic in quality, safety, and efficacy. They have the potential to increase patient access to biologic treatment options that are more affordable.

The global Humira Biosimilar Market is estimated to be valued at Us$ 889.46 Bn in 2024 and is expected to exhibit a CAGR Of 10.% over the forecast period 2024 To 2031, as highlighted in a new report published by Coherent Market Insights.

Market Dynamics:

The growing demand for affordable biosimilars is expected to drive the growth of the Humira biosimilar market. Biosimilars cost 30-50% less than their reference biologics due to their less intensive R&D costs. This makes them accessible to more patients. Furthermore, the patent exclusivity of Humira is soon expiring in some regions like Europe which will pave the way for biosimilar versions to enter the market. However, developing biosimilars is complex and capital intensive which may restrain their market growth initially. Also, demonstrating biosimilarity and interchangeability are major regulatory challenges faced by biosimilar manufacturers.

Segment Analysis

The global Humira biosimilar market is dominated by the autoimmune disease segment, which accounts for over 50% share of the total market. The autoimmune disease segment dominated due to the large patient pool suffering from autoimmune conditions like rheumatoid arthritis, plaque psoriasis and Crohn’s disease globally. Humira biosimilar are majorly used for the treatment of these autoimmune diseases, driving the growth of this segment.

PEST Analysis

Political: Regulations around biosimilars development and approval differ internationally. Streamlining of regulations to encourage competition can positively impact the market.

Economic: Lower drug prices due to biosimilars can reduce healthcare costs. However, R&D and clinical trials require significant investments.

Social: Growing aging population and incidence of chronic diseases increase the patient pool. However, acceptance of biosimilars depends on educating people about their safety and efficacy.

Technological: Advancements in analytical techniques aid in demonstrating similarity to reference products. Continued research can help address challenges around manufacturing complexity of monoclonal antibodies.

Key Takeaways

The Global Humira Biosimilar Market Demand  is expected to witness high growth over the forecast period led by product launches and strong pipeline candidates.

Regionally, North America dominates currently due to established markets for biosimilars. However, Asia Pacific is expected to witness fastest growth due to large patient population, growing healthcare industry and cost-saving pressures driving biosimilar adoption.

Key players operating in the Humira biosimilar market are Nestlé S.A., Groupe Danone, Abbott Nutrition, Mead Johnson Nutrition, The Kraft Heinz Company, Meiji Holdings Co. Ltd., Beingmate Baby & Child food Co. Ltd., Synutra International Inc., Pfizer Inc., and FrieslandCampina. N.V. Pipeline candidates from Samsung Bioepis, Coherus, Mylan and Fresenius Kabi are expected to intensify competition post patent expiry of originator Humira. The market is poised to evolve further with continued product approvals in new geographies

Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it