by The Humira biosimilar market comprises monoclonal antibodies that are biosimilar to AbbVie’s Humira (adalimumab). Biosimilars are used as an alternative to reference biologics to treat various immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. The rising prevalence of chronic immune-mediated inflammatory diseases has created significant growth opportunities for biosimilars due to their cost-effectiveness as compared to reference biologics.
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 2030.
Key Takeaways
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. Key players in the Humira biosimilar market are focused on obtaining regulatory approvals and launching their biosimilars. For instance, in September 2022, Mylan Pharmaceuticals received US FDA approval for its adalimumab biosimilar Hulio. Approvals and subsequent launches of Humira biosimilars are anticipated to increase competition and drive down treatment costs.
Rising approvals of Humira biosimilars across major markets has created significant revenue generation opportunities for biosimilar manufacturers. Additionally, patents expiring on Humira in key markets will further boost biosimilar approvals and uptake. Technological advancements focused on developing biosimilars with indistinguishable quality, safety and efficacy from reference products will support commercialization of Humira biosimilars.
Market Drivers
The rising prevalence of chronic immune-mediated inflammatory diseases is a key driver for the Humira biosimilar market. For instance, according to the National Psoriasis Foundation, psoriasis affects around 125 million people worldwide. Additionally, growing geriatric population susceptible to rheumatoid arthritis and rising healthcare expenditure on biologic drugs will drive the demand for lower-cost biosimilars. Patent expiries of Humira in various regions will disrupt AbbVie’s market monopoly paving way for biosimilar uptake. This will majorly contribute to market growth over the forecast period.
Current Challenges in the Humira Biosimilar Market
The Humira biosimilar market is still in its nascent stage and faces several challenges that are hindering its growth potential. One of the biggest factors restricting the market’s evolution is the dominant position held by the originator brand Humira. AbbVie, which markets Humira, has employed various strategies like patent thickets and citizen petitions to delay the entry of biosimilars in major regions. Development of biosimilars is also an expensive and complex process that deters many small players. Establishing clinical equivalence to reference products is a huge regulatory barrier as well. Lack of interchangeability and automatic substitution favors originators over biosimilars. Educating physicians, payers and patients about biosimilarity to build clinical confidence remains a challenge.
SWOT Analysis
Strength: Biosimilars provide a more affordable treatment alternative to the very expensive originator Humira. They have the same quality, safety and efficacy. Weakness: Humira biosimilars are yet to gain significant market acceptance and mindshare. Long-term safety and immunogenicity data is lacking. Opportunity: As patents expire in different markets, more companies can enter with lower-priced biosimilars. This will drastically improve access and reduce healthcare spending. Threats: Aggressive patent strategies of AbbVie threaten to delay biosimilar competition. Regulatory challenges and lack of automatic substitution policies favor Humira over its biosimilars.
The US market accounted for the largest share in the global Humira biosimilar market in terms of value in 2024, mainly due to the concentration of major players and relatively higher adoption of biosimilars. However, high prices of biologics in the US is expected to shift the growth momentum to the Asian markets in the forecast period. China and India will emerge as high growth avenues due to their huge patient population, increasing healthcare expenditures and focus on generic/biosimilar drugs. The rapidly developing healthcare infrastructure in Asia will further support market growth.
Germany represented about 10% share in terms of value of the global market in 2024 as it has facilitated early availability of biosimilars at lower prices. The adoption has been further encouraged by automatic substitution policies. Countries like Italy, France and Spain will witness significant demand due to rising biosimilar penetration and cost-containment initiatives in these countries.
