Over the past decade, the biosimilar market has undergone a significant transformation, particularly with the recent introduction of biosimilars for the blockbuster drug Humira. This shift has been driven by the urgent need for more affordable medications, potential cost savings associated with biosimilars, the expiration of numerous patents, and increased regulatory support establishing clear approval pathways. Additionally, there is growing acceptance of biosimilars among healthcare providers.
Cost Savings and Market Changes
The entry of multiple Humira biosimilars has led to substantial cost savings for healthcare systems, as these biosimilars are typically priced 15%-30% lower than the original biologic, increasing patient accessibility. Humira’s manufacturer, AbbVie, has seen its market share gradually decline to about 80%, notably after Caremark, one of the big three pharmacy benefit managers (PBMs), excluded Humira from its formulary in April. Despite this, AbbVie has maintained a significant portion of
the market through discounting strategies and by promoting next- generation biologics like Skyrizi and Rinvoq.
Although the biosimilar market is evolving, particularly in the US where the FDA has approved an increasing number of biosimilars, the pace has been slower than initially anticipated. This is due to factors such as prescriber and patient skepticism, the complexity and cost of biosimilar manufacturing, and varied pricing and reimbursement strategies across
different regions. However, the successful approval and launch of Humira biosimilars in major markets like the US have boosted confidence in the biosimilar pathway, encouraging further investment and development.
The global biosimilar market is expected to continue its robust growth, with a projected compound annual growth rate (CAGR) of around 20%-25% over the next few years.
Notably, the introduction of Stelara biosimilars, which have been approved and are awaiting release, is expected to follow a similar pattern of increased access, competition, reduced costs and market share erosion for Janssen Pharmaceuticals. Key factors contributing to this growth include:
- Increased Approvals: Ongoing regulatory approvals and the entry of new biosimilar products into the
- Regulatory Landscape: The success of Humira biosimilars has set a precedent that could streamline the approval process for other Stelara biosimilars and future Regulatory agencies are now more experienced in evaluating and approving biosimilars, which may expedite market entry.
- Expanding Therapeutic Areas: While oncology and autoimmune diseases have been the primary focus, biosimilars for other therapeutic areas such as diabetes, ophthalmology and cardiovascular diseases are
- Global Expansion: Expansion into emerging markets with large patient populations and increasing healthcare
Additionally, strategic shifts are occurring in how biosimilars are brought to market. Notable collaborations and partnerships, such as the one between Caremark and Cordavis with Sandoz to commercialize Hyrimoz®, and the relationship between Express Scripts (ESI) and Quallent Pharmaceuticals, are emerging. There are ongoing efforts to educate healthcare professionals and patients about the benefits and safety of biosimilars to enhance adoption rates. Increased competition is also likely to drive down prices, making biosimilars an even more attractive option.
The biosimilar market is poised for significant growth, led by the emergence of Humira biosimilars driven by the need for affordable biologic therapies, regulatory support and increasing acceptance. While challenges remain, strategic collaborations, market education and favorable policies will be key to realizing the full potential of biosimilars in the global healthcare landscape. As the biosimilar market continues to evolve, these trends will likely contribute to more sustainable and accessible healthcare systems worldwide.
Sources:
- Research and Markets “Global Biosimilars Market Report 2022: Market to Reach $72 Billion by 2026,” Research and Markets, 2022.
- “Biosimilars Market Size Worth $44.7 Billion By 2026,” PR Newswire, 2021.
- IMARC. “Biosimilars Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2024-2032,” IMARC Group.
- “Biosimilars Action Plan,” FDA, 2024.
- Bioprocess “Streamlining and Accelerating Biosimilar Adoption in the United States,” Bioprocess International, 2023.
- “Future Opportunities With Interchangeable Biosimilars,” AMJC, 2023.
- Center for “Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032,” Centers for Biosimilars, 2024.
- European Medicines Agency. “Biosimilar Medicines: Overview,” EMA, 2023.
- “AbbVie’s Humira Continues to Lose Market Share as Biosimilars Gain Ground: Report,” Biospace, 2024.
- Grand View “Biosimilars Market,” GVR, 2021.