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Ustekinumab Market

The market for Ustekinumab was estimated at $12.3 billion in 2024; it is anticipated to increase to $17.7 billion by 2030, with projections indicating growth to around $24.1 billion by 2035.

Report ID:DS1802091
Author:Debadatta Patel - Senior Consultant
Published Date:
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Life Science
Pharmaceutical
Ustekinumab
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Market Data
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Global Ustekinumab Market Outlook

Revenue, 2024

$12.3B

Forecast, 2034

$22.7B

CAGR, 2025 - 2034

6.3%

The Ustekinumab industry revenue is expected to be around $13.1 billion in 2025 and expected to showcase growth with 6.3% CAGR between 2025 and 2034. Building on this projected expansion, the ustekinumab market continues to hold strong clinical and commercial significance, driven by its proven efficacy across multiple chronic inflammatory conditions and its favorable dosing schedule that enhances patient adherence. Increasing diagnosis rates of autoimmune disorders, particularly in dermatology and gastroenterology, are reinforcing sustained demand. Additionally, broader reimbursement coverage in developed healthcare systems and expanding access in emerging economies are supporting uptake. The growing preference for targeted biologic therapies over conventional systemic treatments further strengthens its positioning. Strategic lifecycle management by manufacturers, including label expansions and real-world evidence generation, continues to reinforce physician confidence. However, the evolving biosimilar landscape and pricing pressures are encouraging stakeholders to focus on differentiation through innovation, patient support programs, and optimized delivery mechanisms.

Ustekinumab, also known as Stelara, is a human monoclonal antibody that selectively inhibits interleukin-12 and interleukin-23, key cytokines involved in inflammatory and immune responses. It is widely utilized in the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, offering durable efficacy with a relatively low dosing frequency compared to other biologics. Its mechanism of action enables targeted immune modulation while maintaining a favorable safety profile, making it a preferred option for long-term disease management. Recent trends shaping demand include increasing biologic penetration in inflammatory bowel disease treatment algorithms, earlier adoption in moderate cases, and rising patient preference for convenient dosing regimens. Additionally, ongoing research into expanded indications and the anticipated entry of biosimilars are expected to influence pricing dynamics and accessibility, further shaping market evolution.

Ustekinumab market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Ustekinumab Market Outlook

Market Key Insights

  • The Ustekinumab market is projected to grow from $12.3 billion in 2024 to $22.7 billion in 2034. This represents a CAGR of 6.3%, reflecting rising demand across Psoriasis Treatment, Psoriatic Arthritis Management, and Crohn's Disease Therapy.

  • Janssen Biotech Inc / Johnson & Johnson is the sole producer in this market, holding full control over supply and pricing.

  • U.S. and Germany are the top markets within the Ustekinumab market and are expected to observe the growth CAGR of 4.1% to 6.0% between 2024 and 2030.

  • Emerging markets including Brazil, India and China are expected to observe highest growth with CAGR ranging between 7.2% to 8.7%.

  • Industry players are pushing the adoption of transitions like Transition from originator biologics to competitive biosimilar driven market landscape for future years due to existing low growth of 6.3% ; but are also expected to invest $726 million by 2030.

  • The Ustekinumab market is set to add $10.4 billion between 2024 and 2034, with manufacturer targeting Psoriatic Arthritis & Crohn's Disease Application projected to gain a larger market share.

  • With

    rising prevalence of autoimmune disorders and increasing adoption of biologic therapies, and

    Expanding clinical indications and regulatory approvals enhancing biologic therapy utilization globally, Ustekinumab market to expand 84% between 2024 and 2034.

ustekinumab market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Ustekinumab - Country Share Analysis

Opportunities in the Ustekinumab

The growing burden of inflammatory bowel diseases is also creating new opportunities for ustekinumab, particularly in Crohn’s disease and emerging ulcerative colitis applications. Increasing diagnosis rates and demand for advanced biologics are driving its use among patients unresponsive to traditional therapies. The intravenous induction followed by subcutaneous maintenance approach is gaining preference for its effectiveness and sustained remission outcomes. Growth is expected to be strongest in gastroenterology-focused healthcare settings in North America and Europe, where biologic adoption rates are high and clinical guidelines increasingly support targeted immunotherapies.

Growth Opportunities in North America and Europe

North America remains the largest market for ustekinumab, driven by high biologics adoption, strong reimbursement systems, and a large patient pool with autoimmune diseases such as psoriasis and inflammatory bowel disease. The U.S. market alone reached significant scale and continues to grow rapidly due to improved diagnosis rates, rising disease prevalence, and expanding indications supported by clinical research. A key opportunity lies in lifecycle expansion and broader patient access as awareness increases. However, competition has intensified sharply following patent expiry in 2023, with at least seven FDA-approved biosimilars launching or entering the market in 2025, significantly increasing pricing pressure and payer-driven substitution. Despite this, Janssen’s originator benefits from strong brand equity and established clinical outcomes, sustaining demand among physicians. Overall, growth is now volume-driven rather than price-driven, with insurers favoring lower-cost biosimilars while maintaining ustekinumab in treatment guidelines.
Europe represents the second-largest ustekinumab market, characterized by strong public healthcare systems and widespread biologic adoption across countries such as Germany, France, and the UK. Growth is supported by increasing penetration of biologics and ongoing expansion into emerging Eastern European markets with improving healthcare access. A major opportunity in the region is volume expansion, as lower-priced biosimilars enable treatment access to previously underserved patient populations, potentially increasing total treated populations significantly. However, competition is particularly intense due to early and rapid biosimilar uptake Europe approved multiple ustekinumab biosimilars in 2024–2025, with high penetration rates in several countries. Pricing pressure is further amplified by strict reimbursement controls and cost-containment policies. While Janssen retains a presence due to proven efficacy, market share erosion is more pronounced here than in the U.S., making differentiation and contracting strategies critical.

Market Dynamics and Supply Chain

01

Driver: Rising prevalence of autoimmune disorders and increasing adoption of biologic therapies

The growing prevalence of autoimmune disorders such as psoriasis, psoriatic arthritis, and Crohn’s disease is also a primary driver for the ustekinumab market. Globally, lifestyle changes, genetic predisposition, and environmental factors are also contributing to a steady rise in these chronic conditions, expanding the patient pool requiring long-term treatment. At the same time, there is also a significant shift from conventional systemic therapies toward targeted biologic therapies, which offer improved efficacy and safety profiles. Ustekinumab, as a monoclonal antibody targeting interleukin pathways, benefits from this transition due to its ability to provide sustained disease control with less frequent dosing. Additionally, increasing awareness among patients and physicians regarding advanced biologics is also accelerating early diagnosis and treatment adoption. These combined factors are also strengthening demand, particularly in specialty care settings where precision therapies are also becoming standard practice.
The expansion of clinical indications and ongoing regulatory approvals is also a key driver supporting the growth of the ustekinumab market. Originally approved for psoriasis, ustekinumab has also gained broader acceptance across multiple autoimmune conditions, including psoriatic arthritis and Crohn’s disease, increasing its therapeutic reach. Continuous clinical research and trials are also exploring its potential in additional inflammatory disorders, further strengthening its market position. Regulatory support in major healthcare markets has also improved accessibility and reimbursement scenarios, encouraging wider adoption. This trend is also particularly evident in developed regions where healthcare systems actively support biologic therapies. As a result, the drug’s lifecycle is also being extended, and its usage is also expanding across diverse patient populations, reinforcing sustained market growth.
02

Restraint: Patent expiry and rapid biosimilar competition significantly eroding pricing power

The expiration of ustekinumab’s core patent has triggered a wave of biosimilar entries, creating one of the most significant restraints on market growth. With multiple biosimilars entering from 2025 onward at prices typically 15–40% lower, strong pricing pressure is emerging across key markets. This shift is directly impacting revenue for the originator, as healthcare providers and payers increasingly favor lower-cost alternatives. For example, price-sensitive regions and public healthcare systems are actively switching to biosimilars, reducing brand market share. As a result, overall market value growth is slowing despite stable patient demand, fundamentally reshaping competitive dynamics and profit margins.
03

Opportunity: Development of biosimilar ustekinumab products expanding access across cost sensitive patient populations and Rising biologic therapy adoption among moderate autoimmune patients in emerging markets

The development of biosimilar versions of ustekinumab represents a significant opportunity to expand market reach, particularly among cost-sensitive patient groups. As patents expire, biosimilar manufacturers are introducing more affordable alternatives, increasing accessibility in both developed and emerging markets. This trend is encouraging healthcare providers and payers to broaden treatment coverage, driving higher patient volumes. Subcutaneous biosimilar formulations are expected to dominate due to ease of administration and lower overall treatment costs. This shift is likely to accelerate adoption in public healthcare systems and emerging economies, unlocking new growth avenues.
Emerging markets present a strong opportunity as biologic therapies gain traction among patients with moderate autoimmune conditions who were previously managed with conventional treatments. Increasing healthcare awareness, improving insurance coverage, and expansion of specialty care are enabling earlier adoption of targeted therapies like ustekinumab. Countries in Asia Pacific and Latin America are witnessing growing demand, particularly in psoriasis and psoriatic arthritis segments. Subcutaneous formulations are expected to see the highest uptake due to convenience and suitability for outpatient settings, supporting broader patient access and long-term treatment adherence.
04

Challenge: High treatment costs and reimbursement limitations restricting patient access globally

The high cost of ustekinumab therapy remains a critical barrier, particularly in developing regions and cost-constrained healthcare systems. As a biologic drug, treatment expenses can be prohibitive, limiting accessibility for uninsured or underinsured patients. Reimbursement challenges further influence prescribing behavior, with payers often imposing restrictions or requiring prior authorization, delaying treatment initiation. For instance, hospitals and insurers may prefer lower-cost biologics or biosimilars, reducing demand for premium-priced therapies. This cost sensitivity directly affects market penetration, slows adoption in emerging markets, and creates uneven demand patterns, ultimately constraining overall revenue expansion despite strong clinical efficacy.

Supply Chain Landscape

1

Raw Materials Supply

Lonza GroupThermo Fisher Scientific IncMerck KGaA
2

Biologics Manufacturing

Janssen Biotech Inc / Johnson & Johnson
3

Fill Finish Packaging

Catalent IncLonza GroupVetter Pharma International GmbH
4

End Use Applications

Psoriasis TreatmentPsoriatic Arthritis ManagementCrohn's Disease Therapy
Ustekinumab - Supply Chain

Use Cases of Ustekinumab in Psoriasis Treatment & Psoriatic Arthritis Management

Psoriasis Treatment : Psoriasis treatment represents the primary application of ustekinumab, particularly for patients with moderate to severe plaque psoriasis who require systemic therapy. In this setting, ustekinumab is administered as a subcutaneous injectable biologic, typically delivered in prefilled syringes or auto-injectors for ease of use in clinical and home environments. It works by targeting interleukin pathways involved in inflammatory responses, providing long-lasting symptom control with relatively infrequent dosing intervals. Its advantages include sustained efficacy, improved patient adherence, and a favorable safety profile compared to traditional systemic therapies, making it widely adopted across dermatology practices and specialty care centers.
Psoriatic Arthritis Management : Psoriatic arthritis management is another key application where ustekinumab is used to control both joint inflammation and associated skin symptoms. The drug is primarily administered via subcutaneous injection, often in outpatient or homecare settings under physician guidance. It is particularly beneficial for patients who do not respond adequately to conventional disease-modifying antirheumatic drugs. Ustekinumab helps reduce joint pain, swelling, and progression of structural damage while also addressing dermatological manifestations. Its dual-action capability and convenient dosing schedule enhance patient compliance and quality of life, supporting its growing use in rheumatology clinics and integrated care approaches.
Crohn's Disease Therapy : Crohn's disease therapy has emerged as a significant application, especially for patients with moderate to severe disease who are refractory to other biologics. In this indication, treatment typically begins with an intravenous induction dose followed by subcutaneous maintenance injections. This combination approach ensures rapid onset of action and sustained disease control. Ustekinumab targets specific immune pathways involved in gastrointestinal inflammation, helping to reduce symptoms, maintain remission, and improve mucosal healing. Its effectiveness in difficult-to-treat cases and lower immunogenicity risk compared to some alternatives have increased its adoption in gastroenterology practices and specialized inflammatory bowel disease centers.

Recent Developments

Recent developments in the ustekinumab market reflect a clear strategic shift toward biosimilar competition, cost optimization, and broader biologic therapy access. Multiple biosimilar approvals and launches across the U.S. and Europe during 2024–2025 have intensified competition, reducing pricing power of the originator and expanding patient access. A key market trend is the rapid adoption of ustekinumab biosimilars, driven by payer preference and healthcare cost-containment strategies, reshaping demand patterns across psoriasis and Crohn’s disease treatment. This transition is accelerating market penetration while increasing competitive intensity within the immunology biologics segment.

October 2025 : Johnson & Johnson (via Janssen Biotech) submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA to expand ustekinumab use into pediatric ulcerative colitis, marking a regulatory expansion effort
June 2025 : Johnson & Johnson submitted an additional sBLA to the FDA seeking approval of ustekinumab for pediatric Crohn’s disease, expanding its lifecycle management in inflammatory bowel disease

Impact of Industry Transitions on the Ustekinumab Market

As a core segment of the Pharmaceutical industry, the Ustekinumab market develops in line with broader industry shifts. Over recent years, transitions such as Transition from originator biologics to competitive biosimilar driven market landscape and Shift toward broader immunology portfolio integration and combination therapy approaches have redefined priorities across the Pharmaceutical sector, influencing how the Ustekinumab market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Transition from originator biologics to competitive biosimilar driven market landscape

The ustekinumab market is undergoing a major transition from a single originator dominated model to a competitive biosimilar landscape following patent expiry. This shift is significantly impacting pricing strategies, procurement models, and market access across healthcare systems. Biosimilar entrants are offering cost-effective alternatives, prompting hospitals and insurers to revise formularies and prioritize affordability. For example, public healthcare providers in Europe are increasingly switching to biosimilars to reduce treatment costs, directly affecting originator revenues. This transition is expanding patient access while intensifying competition among pharmaceutical companies in the broader biologics and immunology market.
02

Shift toward broader immunology portfolio integration and combination therapy approaches

Another key transition is the integration of ustekinumab into broader immunology treatment portfolios and combination therapy strategies. Pharmaceutical companies and healthcare providers are focusing on optimizing treatment pathways by combining biologics with other therapeutic approaches to improve patient outcomes. This is particularly evident in complex conditions like Crohn’s disease, where personalized treatment regimens are gaining traction. For instance, gastroenterology practices are increasingly adopting multi-drug strategies to manage refractory cases, enhancing demand for flexible biologic options. This transition is driving innovation, clinical research, and strategic positioning within the competitive autoimmune therapeutics market.