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Graves' Disease Market Assessment: Epidemiology, Treatment Landscape, Unmet Needs, Emerging Therapies, and Value & Access

  • Report

  • 22 Pages
  • June 2023
  • Region: Global
  • REACH Market Research
  • ID: 5996432
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: Review the evidence needed to assess and communicate value to key stakeholders (e.g., providers, payers, regulators) and learn what competitors have done or are doing

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 this 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
An analyst from the research firm, stated: '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.'

Table of Contents

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

Samples

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Companies Mentioned

  • Immunovant Inc.
  • Novartis Pharmaceuticals
  • AV7
  • Worg Pharmaceuticals
  • Crinetics
  • Septerna