Global Ustekinumab Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2031

Ustekinumab Market Analysis

The ustekinumab market is witnessing robust growth driven by its effectiveness in treating autoimmune diseases such as psoriasis, Crohn’s disease, and ulcerative colitis. This monoclonal antibody, marketed under the brand name Stelara, targets interleukin-12 and interleukin-23 pathways, offering significant therapeutic benefits to patients with chronic inflammatory conditions. Recent developments include expanded indications and ongoing clinical trials exploring its efficacy in other diseases, such as ankylosing spondylitis. The market is characterized by increasing awareness and diagnosis rates of autoimmune disorders, prompting heightened demand for innovative therapies. Furthermore, advancements in formulation and delivery methods are enhancing patient compliance and outcomes. Competitive strategies, including partnerships and collaborations among pharmaceutical companies, are also contributing to market dynamics. Overall, the Ustekinumab market is poised for continued expansion as healthcare providers increasingly recognize its potential to improve the quality of life for patients with complex autoimmune diseases.

Ustekinumab Market Size

The global ustekinumab market size was valued at USD 11.4 billion in 2023 and is projected to reach USD 18.03 billion by 2031, with a CAGR of 5.90% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Ustekinumab Market Trends

“Increasing Prevalence Rates of Autoimmune Diseases”

The ustekinumab market is evolving rapidly, fueled by increasing prevalence rates of autoimmune diseases such as psoriasis, Crohn’s disease, and ulcerative colitis. This monoclonal antibody, effective in targeting interleukin-12 and interleukin-23, is gaining popularity for its significant therapeutic benefits and favorable safety profile. Recent innovations include the development of biosimilars, providing cost-effective alternatives and increasing accessibility for patients. Another notable trend is the growing interest in combination therapies that enhance the efficacy of Ustekinumab by integrating it with other treatment modalities. In addition, advancements in patient monitoring and personalized medicine are driving tailored treatment approaches, improving patient outcomes. As healthcare providers and patients increasingly recognize the importance of managing chronic inflammatory conditions effectively, the ustekinumab market is expected to see substantial growth, positioning it as a cornerstone in the treatment of autoimmune diseases. Overall, the market is on a positive trajectory, driven by innovation and heightened awareness.

Report Scope and Ustekinumab Market Segmentation         

Ustekinumab Market Definition

Ustekinumab is a monoclonal antibody that selectively targets interleukin-12 (IL-12) and interleukin-23 (IL-23), two key cytokines involved in the inflammatory processes of autoimmune diseases. Approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis, Crohn's disease, and ulcerative colitis, Ustekinumab works by inhibiting these cytokines, thereby reducing inflammation and the immune response associated with these conditions. Administered via subcutaneous injection, it has shown significant efficacy in improving symptoms and the quality of life for patients suffering from chronic inflammatory disorders. s

Ustekinumab Market Dynamics

Drivers

• Expanded Therapeutic Indications

The increasing availability of advanced diagnostic technologies has significantly improved the detection and diagnosis of autoimmune disorders, such as Crohn's disease, psoriasis, and ulcerative colitis. Tools like advanced imaging, biomarker testing, and genetic profiling enable earlier and more accurate identification of these conditions. Simultaneously, growing awareness campaigns, both from healthcare providers and patient advocacy groups, have educated the public on the symptoms and risks of autoimmune diseases. This heightened awareness leads to earlier medical consultations and diagnoses, enabling timely treatment interventions. As a result, the demand for biologic therapies like Ustekinumab has risen, as patients are identified and treated earlier in the disease progression. This trend serves as a key market driver, fostering growth in the Ustekinumab market as more patients seek effective treatments.

•  Development of Biosimilars

The introduction of ustekinumab biosimilar is set to significantly enhance accessibility and affordability for patients suffering from autoimmune diseases. As healthcare costs continue to rise, biosimilars provide a cost-effective alternative to the original ustekinumab therapy, making it more accessible to a broader patient population. This increased affordability can lead to higher treatment adherence and improved patient outcomes, particularly in underserved communities where financial constraints often limit access to advanced therapies. Furthermore, the availability of biosimilars is likely to foster healthy competition in the market, driving prices down and encouraging further innovation among pharmaceutical companies. As healthcare systems recognize the benefits of biosimilars, the overall demand for ustekinumab and its biosimilars will likely increase, further propelling market growth and ensuring that more patients receive effective treatment for chronic inflammatory conditions.

Opportunities

• Development of Combination Therapies

Investigating ustekinumab's efficacy in combination with other therapies presents a promising market opportunity for enhancing treatment outcomes in patients with complex autoimmune conditions. Research indicates that using ustekinumab alongside conventional therapies or other biologics may lead to improved efficacy and reduced disease activity. This synergistic approach can address the multifaceted nature of autoimmune diseases, which often require a combination of therapeutic strategies for optimal management. By exploring various combination therapies, healthcare providers can offer more personalized treatment plans that cater to individual patient needs, ultimately improving quality of life. Furthermore, the potential success of these combinations may attract additional clinical interest and investment, driving innovation in the ustekinumab market and expanding its application across various therapeutic areas.

• Telemedicine Integration

The rise of telemedicine presents significant opportunities for improved patient management and monitoring in the ustekinumab market. With the increasing adoption of telehealth services, healthcare providers can offer real-time consultations, follow-ups, and support, making it easier for patients to engage with their treatment plans. This enhanced accessibility can lead to more consistent use of ustekinumab, as patients can communicate with their healthcare teams without the barriers of travel or time constraints. Furthermore, telemedicine enables healthcare providers to monitor patient progress closely, allowing for timely adjustments to treatment protocols when necessary. Improved communication and support can also boost patient adherence to prescribed therapies, ultimately leading to better health outcomes and reinforcing the role of ustekinumab as a critical component in managing autoimmune diseases.

Restraints/Challenges

• High Costs of Treatments

The high expense associated with ustekinumab therapy poses a significant challenge for many patients, particularly in regions with limited insurance coverage or high out-of-pocket costs. For individuals diagnosed with chronic autoimmune conditions such as psoriasis, Crohn's disease, or ulcerative colitis, the financial burden of Ustekinumab can be overwhelming, leading to treatment delays or discontinuation. This economic barrier affects access to the medication and  diminishes patient adherence to prescribed treatment protocols. Patients who struggle to afford their medications may be more likely to miss doses or abandon treatment altogether, which can result in a deterioration of their condition. Consequently, the high costs associated with ustekinumab therapy present a substantial challenge in ensuring equitable access and optimal treatment outcomes for patients in need.

• Underdeveloped Healthcare Infrastructures

In regions with underdeveloped healthcare infrastructures, the effective deployment of ustekinumab is often hindered by several significant challenges. Inadequate healthcare access means that patients may struggle to receive timely diagnoses and appropriate treatments, limiting their opportunities to benefit from Ustekinumab therapy. Furthermore, limited treatment options in these areas can exacerbate the problem, as patients may not have access to specialists familiar with biologics or advanced therapies. This lack of access can result in delayed treatment initiation or a complete lack of treatment for those in need. In addition, inadequate infrastructure can impact the supply chain, making it difficult for healthcare providers to obtain ustekinumab consistently. Consequently, these barriers restrict patient access to this crucial medication and  impede overall market growth in these regions.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Ustekinumab Market Scope

The market is segmented on the basis of drug class, demographic, application, dosage form, end-users, and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Drug Class

• Interleukin Inhibitors
• Others

Demographic

• Adult
• Pediatric

  Application

• Arthritis
• Colitis
• Lupus Erythematosus
• Myositis Multiplex with Palmoplantar Pustulosis
• Cirrhosis of the Liver
• Sarcoidosis
• Diabetes
• Others

Dosage Form

• Intravenous Solution
• Subcutaneous Solution

End-Users

• Clinics
• Hospitals
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Ustekinumab Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, drug class, demographic, application, dosage form, end-users, and distribution channel as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America leads the Ustekinumab market, primarily due to the concentration of major pharmaceutical companies and a strong presence of key players in the industry. The region benefits from high disposable incomes, which enable patients to access advanced treatment options. In addition, a well-established healthcare infrastructure supports the efficient distribution and administration of Ustekinumab, further solidifying its dominance in this market.

Asia-Pacific region is projected to experience significant growth from 2024 to 2031, fueled by a surge in research and development activities aimed at enhancing treatment options. Increased government support for healthcare initiatives and innovation in this area is expected to bolster the market further. In addition, the growing demand for advanced therapies among the region's large population will contribute to the positive outlook for the Ustekinumab market in Asia-Pacific.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Ustekinumab Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Ustekinumab Market Leaders Operating in the Market Are:

• Fuji Pharma Co., Ltd. (Japan)
• Meiji Holdings Co., Ltd. (Japan)
• Mitsubishi Tanabe Pharma Corporation (Japan)
• STADA Arzneimittel AG (Germany)
• Formycon AG (Germany)
• NeuClone (Australia)
• Outlook Therapeutics, Inc. (U.S.)
• BioXpress Therapeutics SA (Switzerland)
• Johnson & Johnson Private Limited (U.S.)
• Janssen Pharmaceuticals, Inc. (U.S.)
• Apino Pharma CO., Ltd. (Japan)
• Synergia Life Sciences Pvt. Ltd. (India)

Latest Developments in Ustekinumab Market

• In July 2024, Celltrion announced that Health Canada granted approval for its new drug submission (NDS) for Steqeyma (development name CT-P43), a biosimilar designed for treating autoimmune diseases. This biosimilar is modeled after Stelara, expanding treatment options for patients with conditions such as psoriasis and Crohn's disease. The approval represents a significant milestone for Celltrion, enhancing access to effective therapies for managing autoimmune disorders in Canada
• In July 2020, Fujifilm Kyowa Kirin Biologics gained approval in Japan for the country’s first adalimumab biosimilar, covering conditions like psoriasis, ankylosing spondylitis, and Crohn's disease. This approval improves access to biologic therapies for chronic inflammatory diseases. The introduction of biosimilars promotes competition and affordability, indirectly boosting demand for biologics like Ustekinumab
• In August 2020, Lupin Limited and Mylan launched their biosimilar etanercept, Nepexto, after receiving marketing authorization from the European Commission in May 2020. Approved for conditions like psoriatic arthritis and plaque psoriasis, Nepexto offers more accessible and affordable treatment options. This launch enhances competition in the European biologics market, further driving demand for alternatives like Ustekinumab

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