Sjogren’s Syndrome Overview: From Pathophysiology to Pipeline Activity

Health Apr 20, 2025 26 Add to Reading List

Sjogren’s syndrome is a persistent autoimmune disorder that predominantly targets the body’s exocrine glands, particularly those responsible for producing saliva and tears. The immune system, in an abnormal response, mistakenly attacks healthy glandular tissue, sparking inflammation that disrupts normal gland function. The most common consequences are dry mouth and dry eyes, but the disease can also affect mucous membranes in areas such as the nose, throat, airways, and, in women, the vaginal region—making it more than just a glandular issue.

Epidemiological Breakdown (2020–2034) – 7MM Insights

The epidemiology of Sjogren’s syndrome spans several key segmentation categories:

Overall diagnosed prevalence
Gender-specific cases
Primary versus secondary Sjogren’s
Severity spectrum (mild to severe)
Autoantibody-positive subgroups (e.g., anti-Ro/SSA, anti-La/SSB)
Treated patient population

Highlights from Recent Data

In 2023, the United States reported nearly 1.5 million diagnosed cases of Sjogren’s syndrome, with projections indicating a steady climb over the coming decade. A significant share of these individuals were autoantibody-positive, particularly those exhibiting anti-Ro/SSA and anti-La/SSB markers.

Across the 7MM (US, EU4, UK, Japan), mild cases outnumbered more severe presentations, with women accounting for the majority of patients—especially notable in the UK, which led in diagnosis rates. The U.S. saw the highest volume of treated patients, while Japan had the fewest at around 54,000 individuals in 2023. Treatment coverage is anticipated to expand as awareness and diagnostic tools improve. For a detailed epidemiological assessment, explore this comprehensive market report.

Market Dynamics of Sjogren’s Syndrome

The Sjogren’s syndrome market in the 7MM was valued at around USD 2 billion in 2023, supported by an evolving therapeutic landscape and improved diagnostic rates.

What’s Driving Growth?

Enhanced disease categorization and more personalized treatment protocols.
Advances in genetic and environmental research, shedding light on the underlying causes of the disorder.
A shift in focus toward early detection and immune-modulating therapies.

Ongoing Barriers

No disease-modifying cure currently exists—most treatments only manage symptoms.
Limited clinical trials that adequately address fatigue, dryness, and systemic symptoms.
Gaps remain in effective, targeted therapies for patients with extra-glandular complications.

To dive deeper into market trends and unmet needs, check out the latest market infographic.

Emerging Treatment Landscape

Researchers and pharmaceutical innovators are actively developing novel treatments to improve the standard of care. Some of the most promising candidates include:

Dazodalibep
OXERVATE
CFZ 533
VAY736
SOTYKTU
RSLV-132
Nipocalimab
And additional therapies in early and late-stage trials

These investigational drugs aim to go beyond symptom control, offering potential relief for systemic manifestations and restoring immune tolerance. For further insights, browse the full Sjogren’s Syndrome pipeline analysis.

Key Pharmaceutical Players in the Sjogren’s Syndrome Market

An array of pharmaceutical and biotech firms are driving innovation and therapeutic development in this space. Key stakeholders include:

Pfizer, Sanofi, AbbVie, GlaxoSmithKline, AstraZeneca
Roche, Eli Lilly, Amgen, Novartis, Biogen
Johnson & Johnson, Takeda, Bristol Myers Squibb, Merck & Co.
Resolve Therapeutics, VIELABIO, TearSolutions, RemeGen, Advanz Pharma
Celgene, Daiichi Sankyo, Gilead Sciences, Vertex Pharmaceuticals, Boehringer Ingelheim, Bayer AG
And a range of emerging biotech firms enhancing competition and research depth