The global Humira biosimilar market is witnessing increased research and development activities directed at developing biosimilar versions of Humira (adalimumab) since the patent for the reference biologic is set to expire in the US and Europe in 2023. Humira, developed and marketed by AbbVie, is the highest-selling drug globally with sales of over $20 billion in 2019. It is approved for several autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and others. The introduction of Humira biosimilars after patent expiry is expected to significantly drive down treatment costs and increase accessibility of the drug for more patients globally.
The global Humira Biosimilar Market is estimated to be valued at US$ 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 impending patent expiry of Humira in 2023 is one of the key drivers expected to significantly boost the global Humira biosimilar market during the forecast period. Once Humira loses exclusivity in major markets like the US and Europe, several companies are expected to launch their respective biosimilar versions. This will increase competition and drive down prices, making adalimumab treatment more affordable to a larger patient base globally. Increased demand for biosimilars due to their cost-effectiveness compared to reference biologics is another major factor expected to propel the growth of the Humira biosimilar market between 2024-2031.
SWOT Analysis
Strength: Humira (adalimumab), the biologic drug is off-patent in 2023 which opens up opportunities for biosimilars to enter the market. Biosimilars offer significant cost savings of up to 30% compared to the originator biologic. This will make treatment more affordable and accessible to more patients.
Weakness: Developing biosimilars is complex process which requires extensive characterization, manufacturing and clinical evaluation. This results in high investment and development costs for biosimilar manufacturers. Issues related to interchangeability and automatic substitution remain challenges.
Opportunity: The expiry of Humira's patents in major markets in 2023 will unlock a large lucrative market size estimated to be worth approximately $20 billion annually. This will attract many biotech companies to develop biosimilars and gain first-mover advantage in the market.
Threats: The originator biologic company AbbVie is engaged in "patent thickets" and "patent evergreening" strategies to extend Humira's market exclusivity beyond 2023. They have approached settlements with biosimilar developers to delay launches which can impede biosimilar uptake.
Key Takeaways
The Global Humira Biosimilar Market Demand is expected to witness high growth over the forecast period of 2024 to 2031 supported by expiry of Humira's patents and launch of many biosimilars. The market size is estimated to reach US$ 889.46 billion by 2024.
Regional analysis:
North America and Europe currently dominate the Humira biosimilar market and are expected to maintain their lead positions. This is due to early adoption of biosimilars in these regions supported by favorable regulatory pathways and reimbursement systems. Asia Pacific region is expected to offer lucrative growth opportunities owing to increasing patient access to biologics and emergence of local biosimilar manufacturing capabilities.
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.
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