VRDN-001 : 판매 예측 및 시장 규모(2034년)

Key Factors Driving VRDN-001 Growth

• Strong Phase III efficacy in both active and chronic TED

VRDN-001 achieved all primary and secondary endpoints in the pivotal Phase III THRIVE study in active TED. The trial demonstrated a 70% proptosis responder rate at week 15, with a placebo-adjusted response rate of 64% (p<0.0001). Additionally, 54% of patients achieved complete diplopia resolution and 64% achieved Clinical Activity Score (CAS) reduction to 0 or 1. Importantly, THRIVE-2 later confirmed efficacy in chronic TED, significantly expanding the addressable population beyond active disease.

• Potential best-in-class profile versus TEPEZZA

VRDN-001 is being positioned as a differentiated anti-IGF-1R therapy with fewer infusions, lower drug exposure, and potentially improved tolerability compared with Amgen's TEPEZZA. Viridian highlighted that veligrotug achieved strong efficacy with reduced overall drug burden, while hearing impairment adverse events occurred at a placebo-adjusted rate of only 5.5%, lower than historical concerns associated with TEPEZZA. This may improve physician confidence and long-term patient adoption.

• Breakthrough Therapy Designation supports accelerated commercialization

In May 2025, the FDA granted Breakthrough Therapy Designation (BTD) to veligrotug for TED based on rapid proptosis response and significant diplopia improvements. The designation supports eligibility for Priority Review and may accelerate regulatory timelines. Viridian stated that a Biologics License Application (BLA) submission remains on track for the second half of 2025, with planned US commercialization beginning in 2026 if approved.

• Durability of response strengthens long-term treatment value

Long-term follow-up data from THRIVE demonstrated that 70% of week-15 proptosis responders maintained their response through week 52. Durable disease control is particularly important in TED because relapse and persistent orbital changes remain major clinical concerns. Sustained efficacy may help position VRDN-001 as a preferred long-term biologic option among endocrinologists and ophthalmologists.

• Large and expanding TED market opportunity

TED remains significantly underdiagnosed and undertreated globally. The success of TEPEZZA has validated the commercial attractiveness of the TED market, with annual sales already exceeding blockbuster levels. Analysts cited by Reuters estimate that Viridian's TED franchise could target a US$1 billion+ opportunity by 2030, especially if both intravenous VRDN-001 and subcutaneous follow-on candidates succeed. Some analyst commentary has projected peak sales for veligrotug alone approaching US$2 billion under favorable competitive positioning.

VRDN-001 Recent Developments

In May 2026, Viridian Therapeutics announced positive topline data from the REVEAL 2 Phase III clinical trial of elegrobart in patients with chronic thyroid eye disease (TED). Elegrobart is a subcutaneously delivered, half life extended monoclonal antibody targeting the insulin like growth factor 1 receptor (IGF 1R). REVEAL 2 evaluated two dosing regimens, every four weeks (Q4W) and every eight weeks (Q8W), compared with placebo.

"VRDN-001 Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of VRDN-001 for potential indication like Graves ophthalmopathy in the 7MM. A detailed picture of VRDN-001's existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the VRDN-001 for potential indications. The VRDN-001 market report provides insights about VRDN-001's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current VRDN-001 performance, future market assessments inclusive of the VRDN-001 market forecast analysis for potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of VRDN-001 sales forecasts, along with factors driving its market.

VRDN-001 Drug Summary

VRDN-001 (veligrotug) is an investigational fully human monoclonal antibody developed by Viridian Therapeutics for the treatment of thyroid eye disease (TED), a rare autoimmune disorder associated with Graves' disease. The drug targets and antagonizes the insulin-like growth factor-1 receptor (IGF-1R), a clinically validated pathway involved in the inflammation, tissue remodeling, fibrosis, and proptosis characteristic of TED. Designed as a differentiated alternative to existing IGF-1R therapies, VRDN-001 has demonstrated potent and complete receptor blockade in preclinical studies and has shown encouraging efficacy in reducing proptosis, diplopia, and inflammatory symptoms in Phase I/II and Phase III clinical trials involving both active and chronic TED patients. Administered intravenously, the therapy has generally exhibited favorable tolerability and a potentially improved dosing profile compared with currently approved therapies. Viridian is also developing subcutaneous follow-on formulations to improve patient convenience and enable at-home administration. Recent late-stage clinical data have reinforced the drug's potential as a competitive treatment option in TED, with regulatory submissions anticipated in the coming years. The report provides VRDN-001's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the VRDN-001 Market Report

The report provides insights into:

• A comprehensive product overview including the VRDN-001 MoA, description, dosage and administration, research and development activities in potential indication like Graves ophthalmopathy.
• Elaborated details on VRDN-001 regulatory milestones and other development activities have been provided in VRDN-001 market report.
• The report also highlights VRDN-001's cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The VRDN-001 market report also covers the patents information, generic entry and impact on cost cut.
• The VRDN-001 market report contains current and forecasted VRDN-001 sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The VRDN-001 market report also features the SWOT analysis with analyst views for VRDN-001 in potential indications.

Methodology:

The VRDN-001 market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

VRDN-001 Analytical Perspective by DelveInsight

• In-depth VRDN-001 Market Assessment

This VRDN-001 sales market forecast report provides a detailed market assessment of VRDN-001 for potential indication like Graves ophthalmopathy in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted VRDN-001 sales data uptil 2034.

• VRDN-001 Clinical Assessment

The VRDN-001 market report provides the clinical trials information of VRDN-001 for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

VRDN-001 Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

VRDN-001 Market Potential & Revenue Forecast

• Projected market size for the VRDN-001 and its key indications
• Estimated VRDN-001 sales potential (VRDN-001 peak sales forecasts)
• VRDN-001 Pricing strategies and reimbursement landscape

VRDN-001 Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• VRDN-001 Market positioning compared to existing treatments
• VRDN-001 Strengths & weaknesses relative to competitors

VRDN-001 Regulatory & Commercial Milestones

• VRDN-001 Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

VRDN-001 Clinical Differentiation

• VRDN-001 Efficacy & safety advantages over existing drugs
• VRDN-001 Unique selling points

VRDN-001 Market Report Highlights

• In the coming years, the VRDN-001 market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The VRDN-001 companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence VRDN-001's dominance.
• Other emerging products for Graves ophthalmopathy are expected to give tough market competition to VRDN-001 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of VRDN-001 in potential indications.
• Analyse VRDN-001 cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted VRDN-001 sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of VRDN-001 in potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of VRDN-001? How strong is VRDN-001's clinical and commercial performance?
• What is VRDN-001's clinical trial status in each individual indications such as Graves ophthalmopathy and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the VRDN-001 Manufacturers?
• What are the key designations that have been granted to VRDN-001 for potential indications? How are they going to impact VRDN-001's penetration in various geographies?
• What is the current and forecasted VRDN-001 market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of VRDN-001 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to VRDN-001 for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is VRDN-001? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. VRDN-001 Overview in potential indication like Graves ophthalmopathy

• 2.1. Product Detail
• 2.2. VRDN-001 Clinical Development
  • 2.2.1. VRDN-001 Clinical studies
  • 2.2.2. VRDN-001 Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. VRDN-001 Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging VRDN-001 Therapies)

5. VRDN-001 Market Assessment

• 5.1. VRDN-001 Market Outlook in potential indications
• 5.2. 7MM Analysis
  • 5.2.1. VRDN-001 Market Size in the 7MM for potential indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. VRDN-001 Market Size in the United States for potential indications
  • 5.3.2. VRDN-001 Market Size in Germany for potential indications
  • 5.3.3. VRDN-001 Market Size in France for potential indications
  • 5.3.4. VRDN-001 Market Size in Italy for potential indications
  • 5.3.5. VRDN-001 Market Size in Spain for potential indications
  • 5.3.6. VRDN-001 Market Size in the United Kingdom for potential indications
  • 5.3.7. VRDN-001 Market Size in Japan for potential indications

6. VRDN-001 SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options