Graves Disease Market By Treatment Type (Antithyroid Drugs, Radioactive Iodine Therapy, Thyroidectomy, Disease-Modifying Therapies), By Drug/Therapy (Methimazole/Carbimazole, Propylthiouracil (PTU), FcRn Inhibitors, TSH Receptor-Targeting Therapies, IgG Degraders, BTK Inhibitors, Other Investigational Therapies), By End User (Hospitals, Endocrinology Clinics, Specialty Clinics), By Geography, Segment Revenue Estimation, Forecast: 2026–2032

Graves Disease Market: Transitioning From Thyroid Hormone Control to Autoimmune Disease Modification

The Global Graves Disease Market was valued at an estimated USD 2.85 billion in 2025 and is projected to reach USD 4.22 billion by 2032, expanding at a CAGR of 5.8% during 2026–2032.

 

Graves disease is an autoimmune disorder in which the immune system mistakenly stimulates the thyroid gland, leading to excessive production of thyroid hormones (hyperthyroidism). It is the most common autoimmune cause of hyperthyroidism and represents a large patient population that requires ongoing, long-term management rather than short-term treatment.

 

Graves disease treatment has traditionally relied on low-cost antithyroid drugs like methimazole, carbimazole, and PTU to reduce thyroid hormone production, with radioactive iodine or surgery used in more severe or persistent cases to destroy or remove thyroid tissue. These approaches mainly manage symptoms rather than address the underlying autoimmune cause. While additional therapies such as IGF-1R inhibitors (e.g., teprotumumab) help treat eye complications by reducing inflammation and tissue expansion, the overall market has remained simple and cost-driven due to the widespread availability of generics.

 

A therapy capable of producing sustained remission after treatment, reducing dependence on antithyroid medication and allowing patients to avoid radioactive iodine or thyroidectomy would compete on outcomes that conventional low-cost drugs were not designed to deliver. However, such products will also face a demanding commercial benchmark because methimazole controls hyperthyroidism effectively for many patients, has decades of prescribing experience and is inexpensive and widely available.

 

Graves’ disease affects about 0.5% of the U.S. population (approximately 1.6–3.4 million people) and is the leading cause of hyperthyroidism worldwide, which itself affects about 0.2%–1.3% of the global population. It occurs in roughly 3% of women and 0.5% of men globally, with women representing about 80% of all cases. In the U.S., prevalence is estimated at ~3.4 million cases with an annual incidence of about 30 per 100,000 people, while globally it appears in roughly 20–30 per 100,000 individuals, particularly in iodine-sufficient regions. The disease most commonly develops between ages 30 and 50.

 

Antithyroid Drugs Have Become the Dominant Treatment Pathway

Clinical practice has moved strongly toward antithyroid-drug-first management. The 2023 International Graves Disease Practice Survey included 1,252 respondents from 85 countries and found that 91.5% preferred antithyroid drugs for uncomplicated Graves disease, compared with 7.0% for radioactive iodine and 1.5% for thyroidectomy. The change has been particularly pronounced in the United States: first-line preference for radioactive iodine declined from 69% in 1990 to 11.1% in 2023.

Large real-world datasets point in the same direction. A nationwide Korean analysis covering 452,001 Graves disease patients between 2004 and 2020 reported that approximately 98% received antithyroid drugs as their initial treatment, while thyroidectomy and radioactive iodine represented much smaller shares. Although treatment patterns differ by healthcare system, the convergence toward drug-first management creates a broad recurring prescription population and reduces the role of definitive therapy at initial diagnosis.

The commercial effect extends beyond first-line treatment. In the international practice survey, 68.7% of clinicians said they would continue antithyroid therapy when TSH-receptor antibodies remained positive after the initial treatment period, while 59.9% would restart an antithyroid drug after Graves disease relapsed. Among clinicians treating recurrent disease, 16.4% indicated that they would continue antithyroid treatment indefinitely. Graves disease therefore generates repeated and sometimes multi-year treatment exposure even when patients never proceed to surgery or radioactive iodine.

This change in practice is important for market forecasting. Antithyroid therapy is no longer adequately represented as a single 12-to-18-month treatment event. Persistent antibody positivity, patient preference and accumulating evidence supporting prolonged low-dose therapy are extending treatment duration for selected patients, increasing medication use and laboratory monitoring while enlarging the population that could eventually qualify for therapies targeting persistent autoimmune activity.

 

Methimazole Remains the Pharmaceutical Volume Anchor

Methimazole has become the principal antithyroid medication for most non-pregnant Graves disease patients in the United States. Historical U.S. prescription data illustrate how decisively prescribing shifted toward the drug. An FDA-supported analysis of national prescription databases found that annual methimazole prescriptions increased approximately ninefold from 158,000 in 1991 to 1.36 million in 2008, overtaking PTU during the study period.

Methimazole's position is reinforced by long clinical familiarity, convenient oral administration and increasing acceptance of extended treatment. The traditional treatment course remains approximately 12–18 months for patients in whom drug withdrawal and remission are being considered, but evidence now supports longer therapy in selected patients. A randomized study published in 2024 reported that 83% of patients assigned to long-term methimazole therapy remained relapse-free 84 months after treatment withdrawal, compared with 44% after conventional shorter-duration therapy. The study involved patients treated substantially longer than the conventional course, so these results should not be interpreted as a remission rate applicable to every Graves disease patient.

This evidence changes the competitive benchmark for new therapies. Developers are not competing only against an 18-month generic treatment followed by automatic escalation to radioactive iodine or surgery. In clinical practice, physicians can continue low-dose methimazole for years in suitable patients. A new premium-priced treatment will therefore need to demonstrate an advantage such as durable drug-free remission, faster control in inadequately controlled patients, reduction of pathogenic antibodies, lower cumulative treatment burden or avoidance of definitive thyroid destruction.

Methimazole is also embedded in global treatment systems. The current WHO Model List of Essential Medicines includes 5 mg and 10 mg methimazole tablets for thyrotoxicosis, while carbimazole is recognized as a therapeutic equivalent. Broad generic availability supports patient access but limits differentiation among conventional antithyroid drug manufacturers. As a result, the largest future pharmaceutical value creation in Graves disease is more likely to come from novel therapies than from conventional thionamide price expansion.

 

PTU Retains a Small but Clinically Necessary Treatment Role

PTU continues to serve specific patient groups but has lost its former position as a major routine antithyroid therapy in the United States. Its commercial role was reduced substantially by safety concerns. The current U.S. prescribing information carries a boxed warning for severe liver injury and acute liver failure, including fatal cases and cases requiring transplantation, and states that PTU should generally be reserved for patients who cannot tolerate methimazole when radioactive iodine or surgery is not appropriate.

Pregnancy preserves an important clinical niche. In the international Graves practice survey, 91.9% of respondents treating a woman who became pregnant while taking methimazole said they would switch her to PTU, reflecting its established role during early pregnancy. Most respondents subsequently preferred a return to methimazole later in pregnancy. Current U.S. prescribing information similarly recognizes PTU as a treatment option during or just before the first trimester when an antithyroid drug is required.

The result is a highly differentiated two-drug conventional market: methimazole captures routine and often long-duration therapy, while PTU remains important for defined exceptions rather than competing broadly for first-line share. Both drugs remain on the WHO essential-medicines framework, with PTU listed as a 50 mg oral antithyroid medicine. This combination of entrenched generic supply and narrow clinical differentiation creates a difficult environment for incremental antithyroid drugs but leaves substantial room for therapies with a genuinely different treatment objective.

 

Relapse and Persistent Autoimmunity Define the Highest-Value Treatment Gap

The strongest commercial opportunity is not necessarily every newly diagnosed patient. It is the subgroup that remains hyperthyroid despite antithyroid therapy, maintains elevated TSH-receptor antibodies, relapses after treatment withdrawal or wishes to avoid radioactive iodine and surgery.

Existing treatment options can normalize thyroid hormone levels without consistently eliminating the underlying autoimmune stimulus. This distinction is becoming increasingly important as companies design Graves trials around antibody reduction, antithyroid-drug independence and off-treatment remission rather than thyroid-hormone normalization alone.

The international practice survey demonstrates the size of the clinical problem indirectly. When disease persisted after a conventional course, more than two-thirds of clinicians preferred continuing antithyroid medication, and after relapse almost 60% returned to drug therapy. This creates a clear development population for therapies that can be added to, or eventually replace, chronic antithyroid treatment.

Radioactive iodine and thyroidectomy remain effective alternatives, but both can result in permanent hypothyroidism requiring lifelong thyroid-hormone replacement. The declining preference for radioactive iodine, particularly in the United States, indicates that avoidance of definitive thyroid destruction has become an increasingly relevant treatment consideration. For new drug developers, the economically important endpoint is therefore not simply whether a therapy lowers T3 and T4 during dosing, but whether that control persists after therapy is stopped.

 

Disease-Modifying Programs Are Creating a New Competitive Market

As of August 2026, the Graves disease pipeline contains several programs attempting to move treatment beyond suppression of thyroid-hormone production.

Company / Program	Current Development Position	Commercial Relevance
Immunovant/Roivant – IMVT-1402	Two potentially registrational Graves disease studies are enrolling, with topline results expected in 2027.	FcRn blockade is one of the most advanced disease-modifying approaches. Earlier company-reported batoclimab proof-of-concept data showed normal T3/T4 at six months off treatment in 17 of 21 patients, with 8 of those 17 responders in antithyroid-drug-free remission. These are early, small-study results rather than registrational proof.
Biohaven – BHV-1300	A Graves disease pivotal program is advancing in 2026.	BHV-1300 is designed to remove pathogenic IgG subclasses. Biohaven reported preliminary Graves data showing suppression of TSH-receptor-stimulating antibodies and normalization of T3 and T4 in the first treated Graves patient; the findings remain early and company-reported.
argenx – efgartigimod	argenx reported in 2026 that a registrational Graves disease study is expected to initiate during the year.	The program brings an established FcRn development and commercialization platform into Graves disease, raising the competitive standard for other antibody-lowering approaches.
Sanofi – rilzabrutinib	A Phase 2 study involving approximately 30 adults is evaluating rilzabrutinib in Graves disease with or without orbitopathy.	Its oral administration provides a different proposition from injectable antibody-directed approaches, although the Graves program remains substantially earlier in development.
Yarrow Bioscience – YB-101	A randomized Phase 2a/2b study, NCT07682896, has begun evaluating the TSH-receptor-directed antibody; the Phase 2a portion is designed for approximately 32 patients.	Direct TSH-receptor targeting could offer greater disease specificity than broad IgG reduction if clinical efficacy and durability are demonstrated. The FDA has also granted YB-101 Fast Track designation, with Phase 2a data expected in the second half of 2027.
Merida Biosciences – MER511	NCT07305818 is evaluating the program in early clinical development.	The program adds to competition around directly interfering with the disease-causing antibody/TSH-receptor pathway rather than only lowering circulating thyroid hormone.
Septerna – oral TSHR NAM	The company is advancing lead oral TSH-receptor negative allosteric modulators toward development-candidate selection and IND-enabling work.	An effective oral TSHR-targeted therapy could combine disease-specific biology with the convenience expected from established oral Graves treatment, although this program remains preclinical.

The emerging field therefore contains several distinct competitive strategies rather than a single new drug class. FcRn inhibition aims to reduce circulating pathogenic antibodies broadly; antibody-degrader programs seek substantial removal of disease-associated immunoglobulins; TSH-receptor antibodies attempt direct receptor blockade; and small-molecule approaches could provide an oral route to targeted disease control. Multiple competing mechanisms are now represented across clinical and preclinical development.

Clinical differentiation will depend heavily on durability. A product that normalizes thyroid hormones only while administered may compete primarily as another chronic treatment. A therapy producing prolonged remission after a finite treatment course could command a substantially different clinical and commercial position because it would compete against repeated methimazole courses, radioactive iodine and thyroidectomy simultaneously.

 

Reimbursement Will Depend on Demonstrating Value Against Very Low-Cost Standard Therapy

The established Graves treatment market creates an unusual reimbursement challenge. Methimazole and PTU are mature oral generics with worldwide clinical acceptance, and both are represented on the WHO essential-medicines framework. Any biologic, antibody-degrader or other specialty therapy entering Graves disease will therefore face a far larger price gap against standard treatment than is typical in therapeutic areas where incumbent drugs are already expensive.

This makes patient selection commercially important. A premium therapy is more likely to demonstrate an attractive value proposition first in patients with persistent hyperthyroidism despite adequate antithyroid therapy, recurrent disease, continuing pathogenic-antibody elevation or strong reasons to avoid radioactive iodine and surgery. This is an analytical inference from current treatment patterns rather than an established payer policy. Broad first-line use would require substantially stronger evidence because most patients currently begin treatment with inexpensive oral medication.

Endpoints will also affect reimbursement. Normalization of T3 and T4 is clinically relevant but can already be achieved with established therapy. Antithyroid-drug-free remission, sustained response after treatment withdrawal, reduction in relapse and avoidance of definitive thyroid procedures are more commercially discriminating outcomes. Trials that establish these benefits over meaningful follow-up periods would give manufacturers a stronger basis for specialty-drug pricing and coverage discussions.

Administration may become another competitive variable. Subcutaneous FcRn or antibody-degrader therapies could reduce reliance on infusion centers if designed for self-administration, while successful oral agents would fit more naturally into the existing Graves treatment pathway. Immunovant is developing IMVT-1402 for subcutaneous administration and Biohaven is developing a subcutaneous BHV-1300 formulation with an autoinjector. These advantages will matter only if accompanied by durable efficacy and an acceptable safety profile; convenience alone is unlikely to displace low-cost oral methimazole.

 

Regional Analysis: Treatment Preference Is Converging, but Commercial Opportunity Differs by Region

North America represents one of the most commercially important regions for the emerging Graves disease market, accounting for an estimated ~38–42% global market share in 2025, equivalent to approximately USD 1.08–1.20 billion based on the 2025 global market value. This position is supported by the diagnosed patient pool, a marked shift toward drug-first management and strong participation in development of novel autoimmune-directed therapies. NIDDK estimates that nearly 1 in 100 Americans has Graves disease, while Graves disease accounts for about 80% of U.S. hyperthyroidism cases. U.S. treatment practice has also changed significantly. Preference for radioactive iodine as initial Graves treatment fell from 69% in 1990 to 11.1% in the 2023 international survey, expanding the role of antithyroid medication and preserving a larger population that may subsequently require treatment for persistent or recurrent disease.

The region is also central to the next phase of competition. Immunovant is running potentially registrational IMVT-1402 trials with data expected in 2027, while Biohaven is advancing BHV-1300 and Yarrow began Phase 2a/2b YB-101 studies in 2026 after receiving FDA Fast Track designation. Yarrow also raised about USD 200 million in private funding, supporting operations into 2028. North America is therefore likely to be an early launch region for any successful disease-modifying therapies, though these will still need to clearly outperform low-cost generic methimazole.

 

Europe combines a mature antithyroid-drug market with structured use of radioactive iodine and surgery for recurrent or unsuitable cases. The region accounts for an estimated ~28–30% share of the global Graves disease market, equivalent to approximately USD 0.80–0.86 billion in 2025, supported by widespread use of carbimazole-based therapy and established endocrine care pathways. The 2025 British Thyroid Association survey found that 95% of respondents would treat Graves disease with antithyroid drugs, predominantly carbimazole, while radioactive iodine was preferred by 81% for recurrent disease. The results indicate strong use of pharmacological treatment at diagnosis but continuing acceptance of definitive treatment when Graves disease returns.

 

Asia-Pacific has a large Graves disease patient base with strong reliance on antithyroid drugs. In a South Korean study of 452,001 patients between 2004 and 2020, about 98% were treated initially with antithyroid drugs, while only 1.3% received thyroidectomy and 0.7% radioactive iodine, highlighting heavy and repeated use of methimazole or carbimazole and a clear relapse-driven treatment burden. Asia-Pacific represents another sizeable portion of the global market, with growth supported by large treated populations, increasing diagnosis and expanding participation in clinical development.

The region is also becoming more active in clinical development. Yarrow’s partner GenSci is evaluating YB-101, known locally as GenSci-098, in China for Graves disease and thyroid eye disease. Overall, Asia-Pacific’s large treated population, drug-first approach and growing trial activity make it an important development and commercialization region, although pricing and reimbursement differences will likely require country-specific strategies.

 

Competitive Value Is Moving Away From Generic Volume Toward Remission

The near-term Graves disease market will remain dominated by methimazole and other established antithyroid drugs because prescribing practice increasingly favors medication over immediate radioactive iodine or thyroidectomy. The rise of extended low-dose treatment further supports this position. Historical U.S. prescription growth, international treatment surveys and large Asian treatment datasets all point toward sustained drug-first management rather than a return to procedure-led treatment.

Immunovant (Roivant) is advancing IMVT-1402, an FcRn inhibitor, in two potentially registrational Graves disease trials, with topline data expected in 2027. Earlier FcRn-class data from batoclimab showed a key proof-of-concept signal, with 17 of 21 patients achieving normal T3/T4 levels at six months off therapy and approximately 38% achieving antithyroid-drug-free remission, although these findings are based on a small, early dataset.

 

Argenx is also expanding its FcRn platform into Graves disease with a registrational study expected to initiate in 2026, building on its established commercial success in other autoimmune neuromuscular indications and positioning FcRn inhibition as a broader multi-indication autoimmune franchise.

 

Biohaven is developing BHV-1300, an IgG-degradation platform, where early company-reported data in a Graves patient showed suppression of TSH-receptor antibodies with normalization of thyroid hormones, representing an early signal for a broader antibody-depletion strategy.

 

Yarrow Biosciences is advancing YB-101, a TSH receptor–targeting antibody, in a Phase 2a/2b study (NCT07682896) with approximately 32 patients in the Phase 2a portion and FDA Fast Track designation, with first data expected in H2 2027.

 

Sanofi is evaluating rilzabrutinib, a BTK inhibitor, in a Phase 2 study of around 30 patients with Graves disease with or without orbitopathy, representing a B-cell signaling suppression approach distinct from FcRn or receptor-targeting strategies.

 

Septerna is developing oral TSH receptor negative allosteric modulators (NAMs) in the preclinical stage, which—if successful—could introduce the first oral disease-modifying therapy for Graves disease.

 

Merida Biosciences is advancing MER511, a TSH receptor pathway biologic in early clinical development (NCT07305818), focused on direct interference with disease-driving receptor signaling.

 

Analyst Perspective: Graves Disease Could Develop a New Specialty-Therapy Segment Without Replacing the Generic Market

From an analyst perspective, the Graves disease market is unlikely to shift away from low-cost antithyroid drugs like methimazole and carbimazole, which remain highly effective for most patients. Instead, growth is more likely to come from a smaller high-value segment focused on patients with relapse or persistent disease, where standard therapy is not enough.

This group is already well defined in practice. In a large international survey, 68.7% of clinicians continued antithyroid drugs when TRAb remained positive, and 59.9% restarted treatment after relapse. These patients require repeated care, making them the most relevant target for new therapies aimed at long-term remission rather than short-term hormone control.

However, the bar for new drugs is high. A study showed that 83% of patients on long-term methimazole remained relapse-free for up to 84 months after stopping treatment, compared with 44% on shorter courses. This means new therapies must show clear advantages such as durable drug-free remission, not just temporary control of thyroid levels.

The next key catalyst is 2027, when Immunovant is expected to report pivotal IMVT-1402 data and Yarrow Bioscience will release Phase 2a results for YB-101. These readouts will help determine whether FcRn inhibition or TSH-receptor targeting can meaningfully change disease outcomes or whether standard long-term antithyroid therapy remains dominant.

Importantly, competition will not be decided by a single mechanism. FcRn inhibitors, antibody degraders, and TSH-receptor–targeting drugs may each serve different patient groups depending on efficacy, safety, and route of administration. Injectable biologics may focus on difficult-to-treat cases, while oral therapies could have broader use if efficacy is strong.

Overall, the market’s long-term value depends on whether companies can prove sustained remission off therapy and secure reimbursement for that outcome. If successful, Graves disease could evolve into a two-tier market: low-cost generic drugs for most patients and higher-value disease-modifying therapies for those with relapse or persistent autoimmune activity.

 

Graves Disease Market Report Coverage Table

Report Attribute	Details
Forecast Period	2026 – 2032
Market Size Value in 2025	USD 2.85 Billion
Revenue Forecast in 2032	USD 4.22 Billion
Overall Growth Rate	CAGR of 5.8% (2026 – 2032)
Base Year for Estimation	2025
Historical Data	2019 – 2024
Unit	USD Million, CAGR (2026 – 2032)
Segmentation	By Treatment Type, By Drug/Therapy, By End User, By Geography
By Treatment Type	Antithyroid Drugs, Radioactive Iodine Therapy, Thyroidectomy, Disease-Modifying Therapies
By Drug/Therapy	Methimazole/Carbimazole, Propylthiouracil (PTU), FcRn Inhibitors, TSH Receptor-Targeting Therapies, IgG Degraders, BTK Inhibitors, Other Investigational Therapies
By End User	Hospitals, Endocrinology Clinics, Specialty Clinics
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
Country Scope	U.S., Canada, UK, Germany, France, Italy, Spain, China, Japan, South Korea, India, Australia, Brazil, Mexico, Saudi Arabia, UAE, South Africa
Market Drivers	Rising preference for antithyroid drug-based management, increasing focus on durable remission therapies, growing pipeline of autoimmune disease-modifying treatments, rising demand for alternatives to radioactive iodine and thyroidectomy
Customization Option	Available upon request