Ustekinumab for AS Market Size and Forecast
Ustekinumab, marketed as Stelara, is a major biologic drug used for treating various autoimmune conditions, including Ankylosing Spondylitis (AS), where it targets IL-12 and IL-23 cytokines. The overall Ustekinumab market size was estimated at USD 10.76 billion in 2024, reflecting its strong position in the complex autoimmune disease landscape. While the drug is approved for Crohn’s Disease and Psoriatic Arthritis, its use for AS contributes significantly to its robust market presence.
The Ustekinumab industry is projected to grow from USD 11.31 billion in 2025 to USD 18.53 billion by 2035, exhibiting a CAGR of 5.06%. This growth is fueled by the rising global prevalence of autoimmune disorders, including AS, and the drug’s established efficacy and long-term safety profile. The market forecast remains positive despite imminent competition, as clinicians continue to rely on proven therapeutic options for chronic conditions.
However, the market dynamics are expected to shift drastically due to the entry of biosimilars. Ustekinumab biosimilars, such as Pyzchiva, Yesintek, and Selarsdi, began launching in the US market in early 2025, which will introduce price competition and expand patient access. This competitive environment will likely temper revenue growth for the branded product but increase overall volume consumption across all indications, including AS.
Ustekinumab for AS Market Drivers
A significant driver is the increasing prevalence and improved diagnosis of Ankylosing Spondylitis and related spondyloarthropathies globally. Greater awareness among healthcare professionals and rising rates of diagnosed cases lead to higher demand for effective targeted treatments like Ustekinumab. This expanded patient pool forms a reliable base for market growth, especially in developed healthcare systems.
The drug’s mechanism of action, targeting the IL-12/IL-23 pathway, provides a therapeutic option for patients who do not respond adequately to traditional TNF-alpha inhibitors, driving its clinical adoption. Ustekinumab offers an alternative in complex or refractory cases of AS, distinguishing it from other biologics. Improved patient outcomes and quality of life associated with the treatment further solidify its demand.
Regulatory approvals and expanded geographical availability are further driving the market. As healthcare infrastructure improves in emerging economies, access to advanced biologic therapies like Ustekinumab increases. Furthermore, inclusion in clinical guidelines for specific therapeutic steps in AS management supports its continued prescription by rheumatologists worldwide, boosting market utilization.
Ustekinumab for AS Market Restraints
The most immediate and substantial restraint is the patent expiration of Stelara, the originator product, leading to the rapid market entry of multiple Ustekinumab biosimilars starting in 2025. This intense price competition is expected to erode the revenue share of the branded drug significantly over the forecast period. Companies must prepare for substantial market shifts due to biosimilar availability.
The high cost of branded Ustekinumab treatment poses a significant restraint, particularly in regions with limited healthcare reimbursement coverage. This financial barrier limits access for many patients with AS, often necessitating strict prior authorization policies or reliance on cheaper alternatives. Even with biosimilars, the initial cost remains high compared to generic small molecule drugs.
Competition from other established and emerging treatment modalities for AS is a major challenge. The market includes other effective biologics, such as TNF inhibitors and IL-17 inhibitors (e.g., secukinumab and ixekizumab), which also show high efficacy in treating AS. This crowded therapeutic landscape makes it difficult for any single drug to achieve market dominance without continuous innovation and differentiation.
Ustekinumab for AS Market Opportunities
A prime opportunity lies in the continued clinical investigation into Ustekinumab’s application across a wider range of autoimmune and inflammatory conditions beyond its current indications. Discovering new uses and expanding its approved label could open significant untapped patient populations, strengthening its market appeal and extending its product lifecycle, even amid biosimilar competition.
The development and commercialization of next-generation Ustekinumab formulations or enhanced drug delivery systems present a compelling opportunity. Innovations such as pre-filled pens, autoinjectors, or different dosing regimens could improve patient convenience, compliance, and clinical preference. Differentiation through delivery mechanism can help maintain a premium value proposition against biosimilars.
Penetration into untapped emerging markets offers vast potential for market expansion. As regulatory pathways mature and disposable incomes rise in regions like Asia-Pacific and Latin America, pharmaceutical companies can strategically launch Ustekinumab and its biosimilars. This geographical expansion addresses high unmet needs and provides new revenue streams for market players.
Ustekinumab for AS Market Challenges
The primary challenge remains managing the transition to a biosimilar environment without severely impacting patient access or brand reputation. Companies must navigate complex legal and intellectual property disputes while ensuring seamless supply chain integration and maintaining quality standards. Market fragmentation and pricing pressures require sophisticated commercial strategies.
Ensuring favorable reimbursement policies for both the originator and biosimilar versions of Ustekinumab is a constant challenge. Payers often favor lower-cost options, demanding robust head-to-head clinical data to justify continued use of the reference product or to secure formulary placement for biosimilars. Navigating the evolving payer landscape requires significant strategic effort.
The complexity of clinical trial design for AS remains a challenge, particularly in demonstrating superiority or interchangeability between the reference product and biosimilars. Proving long-term safety and immunogenicity profiles for new entrants is critical for gaining regulatory and clinical confidence, necessitating large-scale, costly post-marketing surveillance and studies to address physician hesitation.
Ustekinumab for AS Role of AI
Artificial Intelligence is playing a growing role in optimizing the application of Ustekinumab therapies, particularly in personalized medicine approaches. AI algorithms can analyze complex patient data, including genetic markers and disease progression rates, to predict which AS patients are most likely to respond optimally to Ustekinumab, enhancing treatment efficiency and patient selection.
AI models are being deployed to accelerate the development of future iterations or next-generation treatments targeting the IL-12/IL-23 pathway. Machine learning facilitates the identification of novel small molecule candidates or alternative biologics that could act synergistically with Ustekinumab. This computational approach reduces trial-and-error in R&D, potentially lowering development costs.
In the clinical setting, AI assists in pharmacovigilance and real-world data analysis, monitoring the safety and efficacy of Ustekinumab across large patient cohorts, including those with AS. By quickly identifying potential adverse events or patient subgroups experiencing suboptimal response, AI aids in refining treatment protocols and ensuring high standards of patient care throughout the drug’s lifecycle.
Ustekinumab for AS Latest Trends
The most significant trend is the rapid commercialization and adoption of Ustekinumab biosimilars following patent expiration, marking a crucial shift towards increased market accessibility and affordability. Companies like Celltrion, with its STEQEYMA (ustekinumab-stba), are actively launching products, fundamentally altering the competitive dynamics of the anti-IL-12/23 space in key markets like the US.
There is a noticeable trend towards the use of Ustekinumab in combination therapies for complex autoimmune diseases, including AS, where monotherapy may prove insufficient. Researchers are exploring synergistic effects when Ustekinumab is paired with other targeted treatments or conventional DMARDs to achieve deeper remission, representing a key area of clinical innovation and trial focus.
A further trend is the focus on real-world evidence (RWE) generation for Ustekinumab across all its approved indications. RWE studies are increasingly valuable for informing treatment guidelines, demonstrating long-term cost-effectiveness, and supporting payer negotiations. This data-driven approach helps secure market stability and justifies the drug’s positioning against newer therapeutic options.
Ustekinumab for AS Market Segmentation
The market for Ustekinumab is segmented primarily by therapeutic indication, with Crohn’s Disease, Psoriatic Arthritis, and Plaque Psoriasis historically accounting for the largest revenue shares. While AS is a key market, the revenue contribution is often grouped within the broader spondyloarthropathies segment, reflecting the diversity of conditions treated by this mechanism.
Segmentation is also heavily defined by product type: the originator drug (Stelara) versus the newly launched biosimilars. The patented brand initially commands a dominant share but is expected to lose ground rapidly as biosimilars penetrate major global markets. The shift toward biosimilar market share is a critical segmentation aspect influencing pricing and volume dynamics in the coming years.
Geographical segmentation places North America and Europe as the major revenue contributors due to high diagnosis rates, advanced healthcare infrastructure, and favorable reimbursement policies for biologics. However, the Asia-Pacific region is projected to exhibit the fastest growth, driven by increasing patient affordability and improved regulatory pathways for complex biologic drugs.
Ustekinumab for AS Key Players and Share
Johnson & Johnson (Janssen) is the primary key player and originator company, historically holding nearly 100% of the brand-name Ustekinumab (Stelara) market share. Their extensive patent strategy and early market entry for multiple indications established their market dominance, which they leverage through large-scale manufacturing and global distribution networks.
The competitive landscape is rapidly evolving with the entry of biosimilar developers like Celltrion, Samsung Bioepis, and Alvotech. These companies are now key players challenging the originator’s share by launching cost-effective alternatives such as STEQEYMA and Pyzchiva. The intense rivalry among these biosimilar manufacturers will determine future market share distribution and pricing levels.
Market share dynamics will increasingly be influenced by strategic partnerships between biosimilar manufacturers and regional distributors to ensure broad market access and formulary inclusion. Companies that successfully achieve interchangeable status for their biosimilars and secure favorable payer contracts are poised to capture a significant portion of the patient volume previously held by the originator product.
Ustekinumab for AS Latest News
A major news event is the widespread launch of Ustekinumab biosimilars in the US market throughout 2025, including products from Teva/Alvotech and Samsung Bioepis. These launches mark the end of the market monopoly for Stelara and initiate a new phase of cost-competition in the treatment of autoimmune diseases like AS, benefiting both patients and healthcare systems.
Regulatory news highlights the FDA’s approval and review of various Ustekinumab biosimilars, with some achieving interchangeability status, such as Wezlana (ustekinumab-auub). This designation is highly impactful, as it allows pharmacists to substitute the biosimilar for the reference product without physician intervention, potentially accelerating patient uptake and market penetration in the AS therapeutic area.
In terms of corporate developments, collaboration announcements, such as those detailing licensing and distribution agreements for biosimilars across different global territories, are frequently reported. These strategic alliances demonstrate the industry’s commitment to maximizing the geographical reach and commercial potential of Ustekinumab biosimilars in the complex treatment landscape for conditions including Ankylosing Spondylitis.