by Humira, also known as adalimumab, is a monoclonal antibody used for autoimmune conditions like rheumatoid arthritis, Crohn’s disease, etc. Biosimilars are biopharmaceuticals developed to be similar to an existing approved biologic drug whose patent has expired. Biosimilars provide less expensive treatment options as compared to their reference products. The increasing acceptance of biosimilars as an affordable treatment option is expected to drive the growth of the Humira biosimilar market over the forecast period.
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.
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 opportunities in the Humira Biosimilar Market Size include regulatory approvals for biosimilars in new regions and increasing uptake in emerging markets. For instance, Cipleucel-T biosimilar by Amgen received approval in Turkey in 2021.
Technological advancements like highly precise analytical techniques are enhancing biosimilarity assessments and accelerating approval timelines. Patented manufacturing platforms like Pfizer’s Xcelerate+ allow accelerated development of stable and scalable processes.
Market Drivers
The high treatment costs associated with reference biologics is a key factor driving patients and payers to switch to more affordable biosimilar options. As patent exclusivity expires for major biologics, biosimilar manufacturers see commercial opportunities to offer similar yet more affordable options. This drives investments in biosimilar development and approvals over the forecast period.
Current Challenges in Humira Biosimilars Market
Some of the key challenges being faced by the players in the Humira Biosimilar Market Size include lengthy clinical trials and regulatory approvals. Developing biosimilars requires extensive research and clinical trials to establish biosimilarity. This high investment and lengthy approval timelines pose significant challenges. Additionally, establishing strong bioequivalence remains a complex task due to the inherent variability and structural complexity of biologics. Persuading physicians and patients is also challenging due to perceptions around the efficacy and safety of biosimilars.
SWOT Analysis
Strength: Multiple companies are focusing on developing affordable biosimilar versions of Humira helping to boost treatment access and lower costs.
Weakness: Extensive research and manufacturing complexity makes biosimilar development a long and capital intensive process.
Opportunity: Humira faces biosimilar competition in Europe from 2024 with US market opening up in 2023, opening lucrative opportunities.
Threats: Biosimilar approvals could see lower prices squeezing branded drugmaker’s revenues posing market share challenges.
Geographically, North America is expected to dominate the Humira biosimilars market owing to the large patient pool in the US and fast approvals of biosimilars. Europe is also a major market currently with various biosimilars approved and launched. However, Asia Pacific is expected to witness the fastest growth over the forecast period due to improving healthcare access, increasing medical tourism, and rising focus of established players.
The North America region currently accounts for the largest share in the global Humira biosimilars market due to increasing incidence of chronic diseases such as rheumatoid arthritis and rising biosimilar approvals. However, Asia Pacific region is expected to witness the highest CAGR over the forecast period owing to rapidly improving healthcare infrastructure, rise in medical tourism, and growing focus of leading market players in emerging Asia Pacific countries.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
