Shining A Light on Sjogren's: A New Autoimmune Opportunity

What You Need to Know:

• Sjogren’s disease is a chronic autoimmune condition with no approved systemic therapies, creating significant unmet need.
• We estimate the U.S. market at about 500,000 patients and a TAM of roughly $26 billion.
• More than 10 drug programs are in development, with room to differentiate by efficacy, safety, dosing and patient subsets.
• New therapies could raise disease awareness, improve diagnosis rates and expand treatment options.
• The global Sjogren’s market could exceed $32 billion by 2035, supported by novel drug uptake and orphan-level pricing.

The TD Cowen Insight

Sjogren's disease (SjD) is a growing, underappreciated autoimmune opportunity. We've identified more than 10 programs with differentiated profiles on dosing, efficacy, safety and other critical metrics. In the full report, we highlight nine companies that are among those well-positioned in this growing market that we size at US$26 billion in the U.S. alone, including $5 billion for systemic and $21 billion for symptomatic.

Our Thesis

Sjogren's disease (SjD) is a chronic autoimmune inflammatory disease characterized by compromised lacrimal (tear) and salivary gland function along with systemic involvement including articular, glandular and pulmonary manifestations. The latter is the most debilitating and potentially fatal systemic manifestation. Primary SjD affects around half a million patients in the U.S. with an estimated TAM of approximately $26 billion.

As of Q1 2026, one company has estimated the diagnosed population could be as high as 587,000 in the U.S.; 356,000 in EU; 140,000 in Japan and 1.37 million in China, inclusive of uninsured patients. While SjD can be either symptomatic (glandular) or systemic (extra-glandular), key opinion leaders (KOLs) emphasize that it is not a benign disease.

The disease is driven by immune-mediated destruction of the exocrine glands via a chronic, self-perpetuating process of innate immune activation, autoreactive B and T cells and glandular epithelial cells acting as immune amplifiers. Disease severity ranges from mild glandular dryness (glandular, or symptomatic disease) to severe glandular involvement along with extraglandular manifestations and systemic autoimmune features. The disease heterogeneity affords multiple approaches for differentiation and ability to address systemic vs. symptomatic manifestations.

Symptomatic disease is treated with topical agents and supportive care. There are currently no approved treatments for systemic manifestations. Biologics are used off-label in severe patients.

New products are in late-stage development or gearing up to enter the market. We believe these products will ultimately raise overall disease awareness, diagnoses and more opportunities to treat patients who don't respond to available therapies or who eventually relapse after receiving standard of care or one of these potential new entrants. Ultimately, we believe that each mechanism offers unique benefits, risks and opportunities to differentiate on dosing regimen, route of administration, onset, efficacy and activity in different patient subsets.

With a large, heterogenous patient population, we believe that multiple companies could be successful in what we view as a market worth over $26 billion based on orphan drug pricing.

What You'll Find in Our Full Research Report

We have been focused on this underappreciated market across our company coverage, therapeutic panels at conferences, KOL webinars and research reports. In this multi-analyst, collaborative report, we delve into the disease pathology of SjD, available therapies and the emerging pipeline of new drug candidates. Our research is supported by KOL and company checks as well as a proprietary survey of rheumatologists who treat Sjogren's patients. Our full report offers an analysis of the potential market size and thorough research of the existing candidates and companies that are bringing these agents into the clinic.

Key takeaways include:

• The eagerness of the KOL community cannot be overstated, creating upside opportunity for just about all companies in this space.
• As data unfolds and rheumatologists gain more experience with these agents, we could start to see new sequencing patterns for various mechanisms akin to current practices in rheumatoid arthritis and/or drugs deployed based on mechanism and systemic disease manifestations.

Financial and Industry Model Implications

Sjogren's disease is a sizable market with an estimated 500,000 primary SjD patients in the U.S. (per one company's estimates as of Q126), roughly half of whom have moderate-to-severe disease. Around three-quarters of patients have symptomatic (glandular) disease, and the remaining have systemic (extra-glandular) disease — although these subsets are not always mutually exclusive. Around 30% of systemic patients and about 45% of symptomatic patients fail first-line therapy, equating to a roughly $26 billion TAM in the U.S. alone, conservatively assuming $250,000 per year net pricing benchmarked to what we view as likely pricing.

The current standard of care (SOC) is hydroxychloroquine (HCQ), methotrexate (MTX), steroids, analgesics and non-pharmacological therapies. HCQ remains the most common approach, but it is often ineffective in severe disease and is not ideal given gastrointestinal (GI) toxicity, providing ample room for novel agents to capture share in a growing market. As new drugs are developed and approved, awareness surrounding SjD should increase, and patients who were previously diagnosed but did not achieve symptom relief on HCQ/steroids will be able to seek other treatment options. We have seen this "rising tide lifts all boats" phenomena in other immunology and inflammation markets, including atopic dermatitis (AD) and myasthenia gravis (MG).

Based on our analysis, we project the Sjogren's market reaching over $32 billion by 2035 globally. We estimate that the annual cost of a SjD drug is likely to be from $250,000–$450,000 based on orphan drug pricing. We foresee substantial market growth in the next five years driven by robust uptake of several novel classes of drugs with unique pros and cons that could help them find their niche in a heterogenous patient population.

Our surveyed rheumatologists expect swift uptake for novel agents by about a third of systemic SjD patients. Beyond these assets, we see room for several drugs across many lines of therapy given the chronic nature of SjD.