Ustekinumab Market By Indication (Psoriasis {Plaque Psoriasis, Erythrodermic Psoriasis, Guttate Psoriasis}, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis, Other Autoimmune Disorders), By Dosage Form (Pre-filled Syringes, Vials, Auto-injectors), By Route of Administration (Subcutaneous Injection, Intravenous Infusion), By Strength (45 mg, 90 mg, 130 mg), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By End User (Hospitals, Specialty Clinics, Ambulatory Surgical Centers, Others), By Country Analysis (U.S., Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, Brazil, Argentina, Mexico, Saudi Arabia, UAE, South Africa), Company share analysis And Market Forecast

Industry Outlook

The Ustekinumab Market accounted for USD 11.85 Billion in 2024 and is expected to reach USD 22.73 Billion by 2035, growing at a CAGR of around 6.1% between 2025 and 2035. Medical practitioners utilize ustekinumab as a biologic pharmaceutical agent that treats psoriasis and Crohn’s disease in combination with psoriatic arthritis.

This medication operates through protein inhibition at interleukin-12 and interleukin-23, which are the key proteins that initiate inflammatory processes in the immune system. The treatment of these diseases improves through ustekinumab by blocking these proteins, which control inflammatory processes. Stelara represents the brand form of this medication, which healthcare providers inject into patients. The global Ustekinumab market increases because healthcare providers adopt this medication to treat chronic autoimmune diseases effectively.

Report Scope:

Market Dynamics

Increasing prevalence of autoimmune diseases boosts Ustekinumab demand.

The growing prevalence of autoimmune illnesses is one of the main causes of the increased demand for Ustekinumab, a monoclonal antibody used to treat psoriasis, Crohn's disease, and ulcerative colitis. The prevalence of autoimmune diseases has increased worldwide owing to several factors, including genetic predisposition, environmental factors, and changing lifestyles. As a result, there is a need for efficient treatments. Furthermore, the support of healthcare awareness, better diagnostics, and available treatments promotes the demand for this market.

As per the NIH, autoimmune diseases affect almost 5-8% of the population worldwide, and this again emphasizes the burden of the need for drugs capable of treating these ailments, such as Ustekinumab. With more understanding of these diseases, newer and more targeted therapies are being developed, providing Ustekinumab with a solid market presence for practitioners and patients. The ongoing approvals of newer indications for Ustekinumab also drive this market's interest, thus broadening the therapeutic indications for Ustekinumab in various autoimmune diseases.

Advancements in biotechnology increase Ustekinumab's therapeutic applications.

Clinical expansion of Ustekinumab for autoimmune diseases, which include psoriasis, Crohn's disease, and ulcerative colitis, is gradually expanding the Ustekinumab market. The market for the product will continue to broaden with more clinical trials to determine the efficacy of the drug in additional possible conditions. The rising global incidence of autoimmune disorders boosts the acceptance of Ustekinumab.

Emerging biotechnology advances are perfecting drug formulations, ensuring better safety profiles and wider accessibility. This difference, plus other indications on the sustained remission that this drug provides for patients and the improvement in patient's health, strengthens market positioning. This is increasing Ustekinumab's peripheral acceptance by healthcare professionals, as is the fact that it is more affordable than other biologics for chronic diseases. Therefore, it is anticipated that the introduction of biosimilars will increase competition for additional market expansion.

Adverse effects of biologics may discourage patient adherence.

Several constraints limit the growth of the Ustekinumab market. The most important among them is the cost of biologics, including Ustekinumab, which restricts patients' access to and compliance with treatment in countries where funding for healthcare is limited. Another reason may be the adverse effects, such as infections, allergic reactions, and other related side effects that patients may face. Meanwhile, strict regulatory requirements for approval and manufacturing further add to the delays of the market opening or expansion.

The competition created by other alternatives like oral therapies and other biologics makes it an even tougher market. For patients, it becomes inconvenient as infusions and injections need to be administered periodically. They lose their interest in taking the treatment for a longer period. Concerns about long-term safety and efficacy may also hinder widespread acceptance of Ustekinumab among healthcare providers.

Managing biological therapies, including monitoring for possible adverse effects, is also quite complicated for clinicians. Geographic inequities in healthcare access would restrict the global uptake of Ustekinumab. Future patent expirations and biosimilar competition could put more pressure on the market growth and further erode profitability.

Expanding indications offer new patient populations for Ustekinumab.

The expanding indications for Ustekinumab are a significant opportunity in the biopharmaceutical sector. Ustekinumab was first authorized to treat psoriasis and Crohn's disease, but it is now demonstrating effectiveness in several other illnesses, such as those with indications for psoriatic arthritis or ulcerative colitis, and new indications under investigation, like asthma, ankylosing spondylitis, and potential treatment in certain pediatric populations. It makes care accessible to a completely new patient population, which speeds up growth in several therapeutic areas.

A major player in the market going forward, where there is an increasing need for biologics and targeted therapy, is ustekinumab due to its role in treating autoimmune and inflammatory illnesses in addition to its wider range of applications. The increase in indications adds to the competitiveness and further uplifts its market share as it becomes a very kind of treatment for newly considered and established patient groups. It is attractive for such added favorable safety and simplicity of administration (subcutaneous injection). Ustekinumab is well set to win a larger market share internationally as health systems shift to more cost-effective yet efficacious treatments. It has further indications, and the continuous R&D pipeline is slated to expand its reach and commercial success even further.

Increasing demand for personalized medicine can boost Ustekinumab use.

Another major opportunity that exists in the Ustekinumab market arises from the increasing demand for personalized medicine. Ustekinumab as a targeted biologic therapy fits within the concept of personalized treatment approaches and is indeed used for autoimmune diseases like psoriasis, Crohn's disease, and ulcerative colitis. Genetic studies and diagnostics have been improving such that the identification of patients expected to benefit the most from such therapies is much improved. The more understanding we have regarding precision medicine, the more chances it gets onto the market, and this drives dependability among prescribers. There are further regional growth prospects in addition to growing indications and increased knowledge of Ustekinumab's advantages.

As medicine adopts a patient-centered approach, ustekinumab is emerging as a significant treatment option for a growing number of ailments. Access to this treatment will be further enhanced by the expansion of healthcare facilities in developing nations. As personalized medicine continues to advance, it is anticipated that Ustekinumab's importance in the area will grow, increasing its profit potential. Long-term use of the medication to treat chronic conditions will boost patient demand and eventually improve clinical outcomes. Growing awareness of Ustekinumab's benefits is expected to lead to significant market expansion and product adoption.

Industry Experts Opinion

"Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, has revolutionized the treatment of chronic inflammatory diseases such as psoriasis, psoriatic arthritis, and Crohn’s disease. By specifically inhibiting these cytokines, ustekinumab offers a targeted approach with a favorable safety profile compared to broad immunosuppressants. Clinical trials have demonstrated its long-term efficacy, making it a cornerstone therapy for patients with moderate to severe autoimmune conditions."

• Dr. Emily Robertson, MD, PhD, Immunologist and Autoimmune Disease Specialist.

Patient Journey Analysis

Based on the Indication, the Ustekinumab Market is classified into Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis, and Other Autoimmune Disorders. The Ustekinumab market's leading segment is psoriasis since this disorder affects numerous patients, and Ustekinumab proves successful for moderate to severe case management. The sales of Ustekinumab depend heavily on psoriasis treatment because this medication provides sustained relief and decreases flare-up occurrences for patients. The drug stands out in the market because it specifically targets the main inflammatory pathways linked to psoriasis. The psoriasis segment maintains leadership in the market because an expanding number of people continue to receive diagnoses and begin psoriasis treatment.

Based on the Dosage Form, the Ustekinumab Market is classified into pre-filled Syringes, Vials, and Auto-injectors. Ustekinumab delivers maximum market share through its auto-injector dosage form segment. Auto-injectors function as reliable treatment methods because they offer patients simple home administration needed to enhance their treatment adherence. Auto-injectors prove especially valuable for psoriasis and psoriatic arthritis patients due to their capability of lowering required clinic attendance. The Ustekinumab market has established auto-injectors as its leading dosage form because patients increasingly prefer self-administration with treatment formats that are friendly to their needs.

Based on the Route of Administration, the Ustekinumab Market is classified into Subcutaneous Injection and intravenous Infusion. Subcutaneous injection stands as the primary segment through which Ustekinumab reaches patients within the market. Patients find subcutaneous injections suitable because they can take them themselves at home without needing to visit hospitals. Patients with psoriasis and psoriatic arthritis mainly opt for subcutaneous injection since it enables independent self-care during long-term treatment. Subcutaneous injection has emerged as the main route of administration in the Ustekinumab market because patients prefer noninvasive treatment methods that they can use at home.

Regional  Analysis

The North American Ustekinumab market is leading due to its effectiveness in treating autoimmune diseases like psoriasis, Crohn's disease, and ulcerative colitis. The U.S. is the largest market, where, among healthcare providers, biologic therapy enjoys great adoption. The growing prevalence of chronic inflammatory diseases along with growing awareness about various options available for treatment has stoked the demand for Ustekinumab. The newly approved indications and various biosimilars are expected to create an intense atmosphere of competitive markets.

North America, endowed with advanced healthcare infrastructure and reimbursement schemes, continues to remain a lucrative region for Ustekinumab sales. Meanwhile, studies focusing on other applications of the drug will assist further market growth in this region. Increasing treatment centers and specialists have also favored market penetration. In addition, with increasing emphasis on personalized medicine, there is growing interest in targeted biologic therapies like Ustekinumab.

The Asia-Pacific Ustekinumab market is expanding because people are becoming more aware of autoimmune diseases and healthcare providers are performing more diagnoses. The ustekinumab and other biological treatments have recently started to gain acceptance at increasing rates in Japan, China, and India, although the market remains less developed than in North America and Europe. The market keeps expanding because better healthcare standards enable greater access to treatment. The growing number of psoriasis and inflammatory bowel disease cases and more willingness toward advanced medicine treatments created substantial market demand.

Price sensitivity and regulatory hurdles currently act as minor impediments to adoptive behaviors across particular regions. Worldwide pharmaceutical companies join forces with local producers to support both the accessibility and cost-effectiveness of these medical treatments. The ascendancy of the market will remain consistent due to new treatment alternatives entering the area.

Healthcare reforms alongside expanded insurance coverage in major nations will provide patients with better availability to biologic treatments. The rising burden of chronic diseases will cause the market demand for Ustekinumab, along with other effective treatments, to increase significantly during the upcoming years.

Competitive Landscape

Significant key players like Johnson & Johnson, AbbVie, Merck & Co., Bristol Myers Squibb, and Amgen have dominated the competitive landscape of the Ustekinumab market that displays every landmark contribution to the development of immunology and biologics segments of the industry. Their most successful product, Stelara, keeps Johnson & Johnson at the top of the market, followed closely by AbbVie and Merck & Co., which are keen on widening their immuno-oncology indexes.

Amgen plans to strengthen its presence in the space dedicated to autoimmune treatments after it acquires Horizon Therapeutics. Bristol Myers Squibb has also been focusing recently on combination therapy aimed at improved outcomes in inflammatory diseases, which puts it on the same direct competition level with Johnson & Johnson's Ustekinumab. There are also other players, such as Pfizer and Novartis, going ahead with research and clinical trials to wrestle with the established market leaders. Overall, the market is at the forefront of competition owing to further development in biologics, and all entries are investing highly in expanding treatments.

Ustekinumab Market, Company Shares Analysis, 2024

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Recent Developments:

• In March 2025, STEQEYMA®, a biosimilar to STELARA®, became available in the United States. The product received approval for the same indications as the reference drug. It provided patients with more treatment options. This launch marked a significant development in the market, increasing competition and potentially lowering treatment costs.
• In February 2025, SELARSDI™ (ustekinumab-aekn), a biosimilar, became available in the U.S. Teva and Alvotech announced the launch after the product received FDA approval in April 2024. This biosimilar is part of a collaboration between the two companies, which have developed multiple biosimilars. The introduction of SELARSDI™ provides an additional treatment option for patients, increasing competition in the market.

Report Coverage:

By Indication

• Psoriasis
  • Plaque Psoriasis
  • Erythrodermic Psoriasis
  • Guttate Psoriasis
• Psoriatic Arthritis
• Crohn’s Disease
• Ulcerative Colitis
• Other Autoimmune Disorders

By Dosage Form

• Pre-filled Syringes
• Vials
• Auto-injectors

By Route of Administration

• Subcutaneous Injection
• Intravenous Infusion

By Strength

• 45 mg
• 90 mg
• 130 mg

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By End User

• Hospitals
• Specialty Clinics
• Ambulatory Surgical Centers
• Others

By Region

North America

• The U.S.
• Canada

Europe

• Germany
• France
• U.K.
• Italy
• Spain

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea

Latin America

• Brazil
• Argentina
• Mexico

MEA

• Saudi Arabia
• United Arab Emirates
• South Africa

List of Companies

• Johnson & Johnson
• AbbVie
• Merck & Co.
• Bristol Myers Squibb
• Novartis
• Amgen
• Sanofi
• Pfizer
• Eli Lilly and Company
• AstraZeneca

Frequently Asked Questions (FAQs)