Sjögren's Syndrome Market 2025 | Strategic Partnerships & M&A Accelerate Expansion | Global Companies - Haleon Group of Companies, Horizon Therapeutics plc, and Bausch Health Companies Inc, AstraZeneca, Sanofi SA

Sjögren's Syndrome Market reached US$201.70 Million in 2023, with a rise of US$207.84 Million in 2024 and is expected to reach US$277.82 Million by 2033, growing at a CAGR of 3.3% during the forecast period 2025-2033

DataM Intelligence has published a new research report on "Sjogrens Syndrome Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

A study conducted by Mayo Clinic researchers and collaborators estimates that around 15 million people in the U.S. are living with one or more of 105 autoimmune diseases, marking the first reported estimate of its kind.

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Clinical Approvals in October 2025

No new standalone drug approvals specifically for Sjögren's Syndrome were reported in October 2025.

However, Ianalumab (Novartis) reported positive Phase III results in August 2025, targeting regulatory submissions soon; it is a first-in-class B-cell targeted therapy with dual action, showing statistically significant improvement in active disease.​

Nipocalimab (Johnson & Johnson) continues active Phase III enrollment with FDA Fast Track designation for moderate-to-severe Sjögren's.​

Telitacicept has shown positive Phase III data in China with FDA Fast Track designation pending for broader approvals.

Ongoing Clinical Approvals & Trials (October 2025)

Multiple Phase III trials for biologics and immunomodulators targeting systemic and glandular manifestations of Sjögren's are ongoing globally, notably:

NEPTUNUS trials (Ianalumab, Novartis),

DAFFODIL study (Nipocalimab, J&J),

Telitacicept phase III (China),

Efgartigimod alfa-fcab (FcRn blocker) phase II with promising results indicating potential FDA filing in near term.​

Latest Mergers & Acquisitions (M&A)

Moderate M&A activity continues in autoimmune and rare disease biotech fields, with companies like Novartis focusing on advancing candidates such as ianalumab for Sjögren's Syndrome while strengthening pipeline portfolios and collaborations.​

Smaller biotech firms developing novel biologics and immunomodulatory therapies for Sjögren's have attracted investments and potential buyout interest, driven by unmet treatment needs

Key Players:

Amgen, F. Hoffmann-La Roche Ltd., Pfizer Inc., Haleon Group of Companies, AstraZeneca, Sanofi SA, Bristol-Myers Squibb Company, Teva Pharmaceutical Industries Ltd, Horizon Therapeutics plc, and Bausch Health Companies Inc.

FDA Approvals (October 2025)

No new FDA approvals for Sjögren's therapies specifically issued in October 2025.

Fast Track and Breakthrough Therapy designations have been granted to promising candidates like Nipocalimab earlier in 2025, facilitating accelerated regulatory review.​

FDA continuously advances frameworks to evaluate digital biomarkers and innovative endpoints in related autoimmune clinical trials, indirectly benefiting Sjögren's therapy approvals.

Growth Forecast Projected:

The Global Sjogrens Syndrome Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Sjogrens Syndrome Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

The corticosteroids segment within the drug class is projected to account for 48.51% of the Sjögren's Syndrome market.

By Type: (Primary Sjögren's Syndrome, Secondary Sjögren's Syndrome)

By Drug Class: (Corticosteroids, Immunosuppressive agents, Monoclonal antibodies, Others)

By Route of Administration; (Oral, Injectable)

By Distribution Channel: (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)

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FAQ's

Q: How fast is the Sjogrens Syndrome Market growing?

A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of 3.3% from 2025 to 2032

Regulatory and Reimbursement Updates Affecting Sjögren's

Regulatory emphasis centers on facilitating clinical trial efficiency via integration of digital biomarkers and decentralized protocols, promoting accelerated pathways for therapies addressing unmet autoimmune needs.​

The US Centers for Medicare & Medicaid Services (CMS) have updated reimbursement coding and fee structures for rheumatology telemedicine and autoimmune treatment episodes effective January 2025, impacting patient access and trial recruitment dynamics.​

Value-based reimbursement models are evolving globally, giving preferential coverage to novel Sjögren's therapies that demonstrate improved patient quality of life and disease modification, encouraging payer-adopted pricing based on outcomes.

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