Adult-Onset Still Disease Market - A Global and Regional Analysis: Focus on Therapy and Region - Analysis and Forecast, 2025-2035

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Introduction of the Adult-Onset Still Disease Market

The global adult-onset still disease market, initially valued at $323.1 million in 2024, is projected to witness substantial growth, surging to $455.2 million by 2035, marking a remarkable compound annual growth rate (CAGR) of 3.30% over the period from 2025 to 2035.

The adult-onset still disease market has been witnessing gradual evolution, largely driven by growing clinical recognition of the condition, advances in immunopathogenesis research, and the expanding use of biologic therapies targeting key inflammatory pathways. Adult-onset still disease, a rare systemic autoinflammatory disorder characterized by recurrent fevers, arthritis, and skin rash, is increasingly being identified through improved diagnostic criteria and greater awareness among rheumatologists and immunologists. The disease's heterogeneous presentation often leads to diagnostic delays, which continue to underscore the need for more effective and specific biomarkers as well as targeted treatment options.

Rising understanding of the disease's underlying cytokine-driven mechanisms, particularly the roles of interleukin (IL)-1, IL-6, and IL-18, has catalyzed interest in targeted biologic therapies. The introduction of cytokine inhibitors such as IL-1 and IL-6 antagonists has transformed disease management, offering improved symptom control and reduction in systemic inflammation for patients refractory to conventional corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs). Ongoing clinical investigations evaluating newer agents, including IL-18 binding proteins and Janus kinase (JAK) inhibitors, are expected to further diversify the therapeutic landscape over the coming years.

Market Introduction

The adult-onset still disease market has been undergoing steady transformation, propelled by advances in cytokine-targeted biologics and strengthened clinical guidelines for early intervention. Companies and researchers are prioritizing interleukin (IL)-1 and IL-6 inhibitors, alongside emerging IL-18 blockers, to address refractory cases and achieve sustained remission. Key developments include the FDA approval of canakinumab (Ilaris) for active still's disease encompassing adult-onset still's disease and tadekinig alfa's orphan drug status. These innovations underscore a shift toward first-line biologic therapy, reducing reliance on glucocorticoids and enhancing outcomes in this rare autoinflammatory condition. As focus intensifies on molecular diagnostics and combination regimens, adult-onset still's disease treatments are set to expand access and efficacy across global rheumatology practices.

Industrial Impact

The adult-onset still disease market has been experiencing a significant shift, driven by the increasing demand for cytokine-targeted biologics and the growing focus on early intervention in autoinflammatory disorders. Key players such as Novartis AG, F. Hoffmann-La Roche Ltd, and Swedish Orphan Biovitrum AB have been playing a central role in advancing adult-onset still's disease therapies, supporting the development of novel IL-1, IL-6, and IL-18 inhibitors beyond traditional corticosteroids. These innovations are crucial for managing refractory cases, systemic inflammation, and complications, including macrophage activation syndrome, enabling more efficient, targeted disease control with improved remission rates. By enhancing the speed and precision of therapeutic response, reducing glucocorticoid dependency, and facilitating global clinical collaborations, adult-onset still's disease treatment advancements are contributing to more effective, streamlined management. The market's impact is further amplified by its alignment with the global shift toward precision medicine, positioning biologics as a cornerstone of adult-onset still disease care.

Market Segmentation:

Segmentation 1: By Therapy

• NSAIDs
• Corticosteroids
• Biologics
• Other Therapies

Biologics to Dominate the Adult-Onset Still Disease Market (by Therapy)

Based on the method, the global adult-onset still disease market was led by biologics, which held a 70.39% share in 2024. This segment is essential in managing refractory adult-onset still disease cases, where blocking key cytokines such as IL-1, IL-6, and IL-18 is critical for achieving remission and preventing complications such as macrophage activation syndrome. Among the most widely adopted biologics are IL-1 inhibitors, including anakinra and canakinumab, alongside IL-6 blockers, including tocilizumab, both of which are pivotal in rapidly controlling systemic inflammation. Anakinra provides daily blockade for acute flares, while canakinumab enables extended dosing intervals with strong guideline endorsement. As demand for precision autoinflammatory therapies grows, these biologics are crucial for complex systemic disorders, outpacing NSAIDs and corticosteroids in efficacy for severe presentations. The rising adoption of biologics reflects their central role in reshaping adult-onset still's disease treatment and driving sustained market expansion.

Segmentation 2: By Region

• North America
  • U.S.
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
• Asia-Pacific
  • Japan
• Rest-of-the-World

North America to Witness the Highest Growth in the Adult-Onset Still Disease Market (by Region)

The adult-onset still disease market in North America dominates globally, accounting for approximately 37% share in 2024. Meanwhile, the Asia-Pacific region is expected to witness a growth rate of 5.36% during the forecast period 2025-2035, driven by expanding healthcare infrastructure, rising disease awareness, and increased investments in biologic therapies. Asia-Pacific, with its diverse and rapidly evolving healthcare systems, is witnessing notable advancements in adult-onset still's disease management, particularly in countries including China, Japan, India, and South Korea, where governments and private entities are prioritizing rare disease research and orphan drug access. The region's large population, coupled with a growing burden of autoinflammatory conditions, has heightened demand for innovative cytokine inhibitors such as IL-1 and IL-6 blockers. Furthermore, increasing adoption of advanced diagnostics and biosimilars is enhancing treatment accessibility, positioning Asia-Pacific for accelerated expansion in the adult-onset still disease market.

Recent Developments in the Adult-Onset Still Disease Market

• In June 2025, the FDA approved Swedish Orphan Biovitrum AB's Gamifant as the first treatment for adults and children with macrophage activation syndrome in still's disease, including adult-onset still's disease.
• In January 2025, AB2 Bio Ltd. partnered with Japan's Nippon Shinyaku Co., Ltd., granting it an option for exclusive U.S. commercialization rights to Tadekinig alfa.

Demand - Drivers, Challenges, and Opportunities

Market Drivers:

Expansion of Diagnostic Capabilities: The advancement of diagnostic tools for adult-onset still's disease has played a crucial role in propelling market expansion by enabling earlier detection, precise differentiation from similar conditions, and personalized treatment strategies. Key biomarkers such as glycosylated ferritin and elevated serum ferritin levels (>500 ng/mL) are pivotal in distinguishing adult-onset still's disease from other inflammatory disorders. These developments, integrated into clinical guidelines in certain countries, including Japan, facilitate rapid initiation of targeted biologics such as IL-1 and IL-6 inhibitors, reducing misdiagnosis and improving patient outcomes in this rare autoinflammatory condition. Additionally, emerging AI and machine learning applications in systems biology models are optimizing therapy selection, validating early biologic intervention over conventional treatments, and supporting sustained remission. As diagnostic precision evolves alongside biomarker-driven monitoring and flare prediction, these innovations are addressing critical unmet needs, positioning advanced diagnostics as a cornerstone for adult-onset still disease market growth and enhanced disease management.

Market Challenges:

High Costs of Biologic Treatments: The high costs associated with biologic therapies for adult-onset still's disease present a significant challenge to market growth, limiting patient access and straining healthcare systems. Biologics such as anakinra (Kineret), tocilizumab (Actemra), and canakinumab (Ilaris), essential for managing refractory cases, require substantial investment in complex manufacturing, specialized facilities, and rigorous quality control, resulting in annual treatment expenses. The elevated prices, far exceeding traditional therapies, restrict affordability, particularly in low- and middle-income countries and among uninsured patients. Additionally, stringent eligibility for such financial aid programs leaves many underinsured individuals facing high out-of-pocket burdens, hindering widespread adoption. Overcoming these financial barriers through biosimilars, expanded insurance coverage, and enhanced access initiatives will be crucial for broadening adult-onset still's disease treatment reach and ensuring equitable care across diverse healthcare settings.

Market Opportunities:

Regulatory Incentives and Designations: Regulatory incentives, particularly Orphan Drug Designation and Breakthrough Therapy Designation, present a significant growth opportunity for the adult-onset still disease market, accelerating development timelines and providing essential financial and market exclusivity benefits. These designations, including FDA tax credits covering up to 50% of clinical trial costs, fee waivers, and seven years of U.S. market exclusivity alongside EMA's ten-year protection, are driving investment into rare disease therapies such as canakinumab and tadekinig alfa. In regions such as North America and Europe with robust regulatory frameworks, these incentives facilitate expedited approvals through intensive FDA guidance, rolling reviews, and priority evaluations. Additionally, collaborations between biopharma developers and regulatory bodies are enhancing adult-onset still's disease therapy pipelines, positioning these incentives as a cornerstone for broader market expansion and improved patient access.

How can this report add value to an organization?

Product/Innovation Strategy: The global adult-onset still disease market has been extensively segmented based on various categories, such as therapy and region. This can help readers get a clear overview of which segments account for the largest share and which ones are well-positioned to grow in the coming years.

Growth/Marketing Strategy: Regulatory approval has accounted for the majority of key developments, comprising nearly 85% of the total developments in the global adult-onset still disease market between January 2021 and October 2025.

Competitive Strategy: The global adult-onset still disease market has numerous established players with product portfolios. Key players in the global adult-onset still disease market, analyzed and profiled in the study, include established players offering therapies for adult-onset still's disease.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

• Years from 2023 to 2035 have been considered for the global market size estimation, 2024 has been considered as the base year, and 2025 to 2035 as the forecast period.
• The scope of this report has been carefully developed based on insights from experts across various companies worldwide. It presents a comprehensive market study of the therapies within the adult-onset still disease market.
• The market contribution of adult-onset still's disease is anticipated to grow steadily in the future, with projections based on historical analysis of available solutions.
• Revenues from companies have been sourced from their annual reports for FY2023 and FY2024. For private companies, revenue estimates are derived from primary research inputs, funding history, market collaborations, and operational performance.
• The market has been mapped based on the existing adult-onset still's disease therapies. Key companies with significant offerings in this field have been identified and profiled in this report.

Primary Research

The primary sources involve industry experts in adult-onset still's disease, including the market players offering therapies. Resources such as CEOs, vice presidents, marketing directors, and medical directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

• validation and triangulation of all the numbers and graphs
• validation of report segmentations and key qualitative findings
• understanding the competitive landscape and business model
• current and proposed production values of a product by market players
• validation of the numbers of different segments of the market in focus
• percentage split of individual markets for regional analysis

Secondary Research

Open Sources

• Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
• Annual reports, SEC filings, and investors' presentations of the leading market players
• Company websites and a detailed study of their product portfolio
• Gold standard magazines, journals, white papers, press releases, and news articles
• Paid databases

The key data points taken from the secondary sources include:

• segmentations and percentage shares
• data for market value
• key industry trends of the top players in the market
• qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
• quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

The companies profiled have been selected based on inputs gathered from an analysis of company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

• Novartis AG
• F. Hoffmann-La Roche Ltd
• Swedish Orphan Biovitrum AB
• AB2 Bio Ltd
• Apollo Therapeutics
• AO Generium