Ustekinumab Injection Market Size and Share Analysis - Growth Trends and Forecasts (2025-2032)

Market Size and Trends

The Ustekinumab Injection Market is estimated to be valued at USD 4.1 billion in 2025 and is expected to reach USD 7.3 billion by 2032, growing at a compound annual growth rate (CAGR) of 8.4% from 2025 to 2032. This robust growth reflects increasing adoption of biologic therapies for autoimmune conditions, expanded indications, and rising prevalence of related diseases globally, driving demand for Ustekinumab-based treatments across various healthcare settings.

A key market trend is the continuous innovation in delivery systems and biosimilars, improving patient compliance and affordability. Additionally, strategic collaborations between pharmaceutical companies and advancements in personalized medicine are enhancing treatment efficacy. Increasing awareness and early diagnosis of chronic inflammatory diseases, coupled with expanding healthcare infrastructure in emerging economies, are further fueling market expansion, positioning Ustekinumab injections as a preferred therapeutic option in the immunology space.

Segmental Analysis:

By Therapeutic Indication: Dominance of Psoriasis Driven by Increasing Prevalence and Treatment Advancements

In terms of By Therapeutic Indication, Psoriasis contributes the highest share of the Ustekinumab injection market owing to its rising global prevalence and the expanding demand for effective biologic therapies. Psoriasis, a chronic autoimmune skin disorder characterized by inflamed, scaly plaques, has significant impacts on patients' quality of life, prompting a growing need for targeted treatments. Ustekinumab's ability to specifically inhibit interleukin-12 and interleukin-23 cytokines, which play crucial roles in inflammatory pathways, makes it highly effective in managing moderate to severe psoriasis symptoms. This targeted mechanism results in improved clinical outcomes, supporting its dominance in this segment. Additionally, increasing awareness among healthcare providers and patients about biologics as a preferred treatment option over traditional systemic therapies has further propelled market growth in this indication. Access to reimbursement programs and improved healthcare infrastructure in developed and emerging economies also facilitate the uptake of ustekinumab for psoriasis management. Moreover, ongoing research and expanded label approvals reinforce confidence in its long-term safety and efficacy profile, encouraging clinicians to prescribe ustekinumab more frequently. Collectively, these factors drive the psoriasis segment to command the largest proportion of the therapeutic indication market.

By Dosage Form: Pre-filled Syringe Gains Traction Due to Convenience and Patient Compliance

By Dosage Form, the Pre-filled Syringe segment holds the largest market share, primarily driven by advantages centered on ease of use, dosing accuracy, and improved patient adherence. Pre-filled syringes offer a ready-to-administer format that eliminates the need for manual drawing of medication, reducing preparation time and minimizing dosing errors. This convenience is particularly valuable for patients requiring long-term treatment, as it simplifies self-administration schedules and enhances overall treatment experience. The ability to deliver precise doses with minimal wastage supports healthcare providers in maintaining treatment consistency and safety. Furthermore, pre-filled syringes contribute to lowering the risk of contamination compared to multi-use vials, which enhances patient safety. The portability of pre-filled syringes also gives patients greater flexibility in managing their treatment outside clinical settings, fostering greater independence and adherence. Combined with increasing patient preference for user-friendly administration devices, biopharmaceutical companies are heavily investing in developing and marketing pre-filled syringe formulations. This trend is further reinforced by healthcare providers' recommendations favoring options that improve compliance and reduce administration errors, solidifying the pre-filled syringe's prominent role in the ustekinumab injection market.

By Route of Administration: Subcutaneous Injection Preferred for Enhanced Patient Convenience and Efficacy

By Route of Administration, Subcutaneous Injection dominates the ustekinumab injection market, largely driven by its balance of efficacy, safety, and patient-centric benefits. Subcutaneous delivery allows the medication to be absorbed steadily into the bloodstream, maintaining therapeutic drug levels with fewer systemic side effects compared to intravenous administration. This route also supports self-administration, reducing the dependency on hospital visits, which is particularly advantageous for chronic conditions requiring regular dosing. The less invasive nature of subcutaneous injections is generally preferred by patients due to reduced discomfort and the ease with which they can integrate treatment into daily life. The ability to administer ustekinumab subcutaneously has expanded its applicability in managing multiple autoimmune disorders beyond psoriasis, such as Crohn's disease and ulcerative colitis, contributing to segment growth. Healthcare providers endorse subcutaneous injections for their manageable safety profiles and streamlined administration protocols, which optimize resource utilization in clinical practice. Additionally, advancements in injector device design, including needle size reduction and ergonomic syringes, enhance patient experience, thus reinforcing the preference for subcutaneous administration. These combined factors establish subcutaneous injection as the leading route in the ustekinumab injection market landscape.

Regional Insights:

Dominating Region: North America

In North America, the Ustekinumab Injection market holds a dominant position driven by a well-established healthcare infrastructure, strong presence of biopharmaceutical companies, and supportive government policies favoring biologics and innovative therapies. The region benefits from advanced clinical research capabilities and extensive reimbursement frameworks that facilitate patient access to specialty drugs like Ustekinumab. Major pharmaceutical players such as Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), AbbVie, and Amgen actively contribute to the market growth through continuous product development, strategic partnerships, and comprehensive patient support programs. Additionally, the robust patent ecosystem and stringent regulatory standards act as both barriers and enablers, fostering innovation while maintaining safety and efficacy in the market.

Fastest-Growing Region: Asia Pacific

Meanwhile, the Asia Pacific exhibits the fastest growth in the Ustekinumab Injection market due to increasing healthcare expenditure, rising prevalence of autoimmune and inflammatory diseases, and expanding biopharmaceutical manufacturing capabilities. Rapid urbanization, improving healthcare access, and favorable government initiatives aimed at enhancing biologics availability have catalyzed demand for advanced treatments in countries such as China, India, Japan, and South Korea. The region is witnessing significant investments from global and regional players like Novartis, Pfizer, and local companies in research and development, as well as distribution networks. Moreover, regulatory agencies in key APAC markets are streamlining approval processes and encouraging biosimilar development, which is further accelerating market expansion.

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Ustekinumab Injection Market Outlook for Key Countries

United States

The United States remains the cornerstone of the Ustekinumab Injection market within North America, underpinned by strong healthcare infrastructure and high patient awareness about biologic treatments. Janssen Pharmaceuticals plays a pivotal role here with its extensive product portfolio and focused clinical trials. Government programs like Medicare and Medicaid also enhance patient affordability and uptake. The presence of advanced specialty clinics and well-established distribution channels ensures effective market penetration and sustained demand.

Germany

Germany's market is spearheaded by its highly regulated healthcare system that emphasizes quality and accessibility. The country's structured reimbursement environment and patient-centric policies encourage adoption of innovative therapies such as Ustekinumab. Local subsidiaries of multinational companies like Novartis and Pfizer, along with regional distributors, actively facilitate market growth. Furthermore, Germany's strong clinical research base continues to innovate indications for Ustekinumab, broadening its therapeutic applications.

China

China is a focal point in the Asia Pacific market with expanding healthcare access and increasing incidence of autoimmune disorders. Government reforms promoting biologics registrations and reimbursement policies are creating an environment conducive to rapid adoption. Janssen, Novartis, and Pfizer have intensified their operations through local partnerships and manufacturing facilities. Additionally, domestic firms are emerging in biosimilar development, positioning China as a significant growth hub in the near future.

India

India's Ustekinumab market reflects rapid growth stemming from increasing healthcare awareness and government initiatives to improve access to specialty drugs. Despite affordability challenges, the presence of generic manufacturers and biosimilar approvals are enhancing market accessibility. Major multinational companies maintain robust marketing and educational programs to expand patient reach. Additionally, growing investments in healthcare infrastructure support demand from both urban and semi-urban populations.

Japan

Japan continues to lead with its technologically advanced healthcare system and strong patient compliance culture. The government's regulatory framework actively supports biologics and innovative treatments, facilitating market expansion. Janssen and other multinational companies hold significant presence through direct supply and distribution agreements. Japan's aging population and rising autoimmune disease prevalence further drive the penetration of Ustekinumab therapies, supported by comprehensive insurance coverage schemes.

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This regional and country-specific analysis underscores the complex dynamics shaping the Ustekinumab Injection market, highlighting how healthcare structures, policy environments, and key industry players collectively influence growth and adoption across various global territories.

Market Report Scope

Market Segmentation

Therapeutic Indication Insights (Revenue, USD, 2020 - 2032)

• Psoriasis
• Crohn's Disease
• Ulcerative Colitis
• Other Autoimmune Disorders
• Others

Dosage Form Insights (Revenue, USD, 2020 - 2032)

• Pre-filled Syringe
• Vial
• Prefilled Pen Injector
• Others

Route Of Administration Insights (Revenue, USD, 2020 - 2032)

• Subcutaneous Injection
• Intravenous Injection
• Others

End-user Insights (Revenue, USD, 2020 - 2032)

• Hospitals
• Specialty Clinics
• Ambulatory Care Centers
• Home Care Settings
• Others

Regional Insights (Revenue, USD, 2020 - 2032)

• North America
• U.S.
• Canada
• Latin America
• Brazil
• Argentina
• Mexico
• Rest of Latin America
• Europe
• Germany
• U.K.
• Spain
• France
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East
• GCC Countries
• Israel
• Rest of Middle East
• Africa
• South Africa
• North Africa
• Central Africa

Key Players Insights

• Janssen Pharmaceuticals
• AbbVie Inc.
• Novartis AG
• Pfizer Inc.
• Merck & Co.
• Amgen Inc.
• Boehringer Ingelheim
• Eli Lilly and Company
• Biogen Inc.
• Bristol-Myers Squibb
• Samsung Bioepis
• Celltrion Inc.
• Sandoz (a Novartis division)
• Mylan N.V.
• Lupin Pharmaceuticals
• Sun Pharmaceutical Industries