Graves’ Disease (U.S.), June 2023
The MarketVue®: Graves’ Disease market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
- Disease overview: Review the disease pathophysiology and potential druggable targets
- Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
- Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
- Unmet needs: Identify opportunities to address treatment or disease management gaps
- Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
- Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
Methodology:
Research for the MarketVue®: Graves’ Disease report is supported by 4 qualitative interviews with key opinion leaders, a quantitative survey with 25 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- Immunovant Inc.
- Novartis Pharmaceuticals
- AV7
- Worg Pharmaceuticals
- Crinetics
- Septerna
Key drugs mentioned:
- Levothyroxine
- Methimazole (Northyx, Tapazole)
- Rituximab
- Belimumab (Benlysta)
- Batoclimab / IMVT-1401
- Iscalimab / CFZ533
- K1-70
- WP1302
- VA-K-14
- ANTAG-3
- S37a
Key takeaways from the report:
Graves’ Disease (GD) is an autoimmune disease and the leading cause of overactive thyroid. For the last several decades, the GD treatment landscape has included three main options:
- Anti-thyroid drugs (methimazole and propylthiouracil)
- Radioiodine ablation
- Thyroidectomy
The majority of GD patients elect for anti-thyroid drugs (ATDs) as first-line because it is the only non-definitive treatment option and can also induce and sustain remission off therapy, although less than half of patients will successfully achieve this outcome. Patients who relapse can opt for another round of ATDs or choose a definitive option like radioiodine ablation or surgery – both of which irreversibly destroy the thyroid gland and require patients to take lifelong thyroid hormone replacement therapy. According to REACH Market Research’s MarketVue® assessment, endocrinologists are eager for novel, targeted therapeutics for GD that do not irreversibly destroy the thyroid gland.
Endocrinologist, U.S.— “Patients want a treatment, and we do too, that targets the source of the problem, which is the antibody to the TSH receptor, rather than treating the downstream consequences with some fairly extreme options.”
Despite high disease prevalence of GD (over 75,000 newly diagnosed cases per year in the US), the pipeline remains sparse with only a few biologics in early-stage development, including:
- Immunovant’s FcRn monoclonal antibody, batoclimab, which recently initiated a Phase 2 trial
- Anti-TSHR monoclonal antibodies, peptides, and antagonist small molecules that are in preclinical stages or early Phase 1 trials
Tyler Jakab, Analyst at REACH: “Graves’ patients hope for disease remission off ATD therapy, but relapse rates remain high. The introduction of another therapy may offer an additional opportunity for remission among those who relapse and are otherwise hesitant to undergo a definitive treatment like ablation or surgery.”
1. DISEASE OVERVIEW
An autoimmune disease that is the leading cause of hyperthyroidism
Figure 1.1. Common signs and symptoms of GD
Table 1.1. Risk factors for GD
Disease mechanism
Figure 1.2. Pathogenesis of GD and associated drug targets
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. Diagnosed incident cases of Graves disease by region
Table 2.1 Diagnosed incident and treated GD patients in the US and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Overview
Figure 3.1. Referral and diagnostic pathway for GD
Figure 3.2. Treatment goals for GD1
A majority of patients are prescribed anti-thyroid drugs as first-line therapy for Graves’ Disease
Figure 3.3. Treatment algorithm for the management of Graves’ Disease
Figure 3.4. First-line treatment share
Limited second-line therapy options following failure to achieve remission
Figure 3.5. Efficacy outcomes following ATD therapy
Figure 3.6. Second-line treatment share
Key treatment dynamics that will shape disease management and drug use in GD
Figure 3.7. Physician-reported perspectives on GD treatment
Figure 3.8. Important dynamics of GD market evolution
Table 3.1. Upsides and downsides of current treatments used for GD
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in Graves’ disease
Figure 4.2. Physician-reported unmet needs in Graves’ disease
Physician perspectives on unmet needs in GD
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Physician-reported perspectives on promising mechanisms of action for GD
Pipeline is sparse with one ongoing trial for GD
Table 5.1. Comparison of trials of immune-targeted biologics for GD
Table 5.1. Comparison of trials of immune-targeted biologics for GD (cont.)
Table 5.2. Comparison of trials of TSHR-specific biologics for GD
Pipeline for TSHR-specific GD therapeutics remains in preclinical phase
Table 5.3. Comparison of TSHR-specific small molecules for GD in the preclinical phase
Physician perspectives on drug development in GD
6. VALUE & ACCESS
Overview
Table 6.1. Current GD drug pricing, U.S.
Table 6.2. Definitive GD treatment option costs, U.S.
Patient support programs for Graves’ Disease
Figure 6.1. GD patients by insurance type
Figure 6.2. Available GD patient resources
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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By deploying our senior team to each of our reports, we can begin insight generation on day 1. The REACH team also recruits Key Opinion Leaders from our internal panel rather than outsourcing recruitment which enables us to quickly begin primary market research interviews.
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Each REACH report is produced by one of our senior US-based team members with 10+ years of experience in life sciences market research. We are deeply committed to ensuring REACH reports are high quality and strategic to enable informed decision-making for our clients.
Does REACH cover both rare and non-rare diseases?
REACH specializes in covering diseases and subpopulations that are not addressed by traditional market research reports. As such, we focus on rare diseases and niche subpopulations of more common conditions (e.g., Dupixent-refractory atopic dermatitis). Our flexible model enables in-depth assessments across all disease types, allowing us to support research for non-rare conditions as well.
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