Lonigutamab : 판매 예측 및 시장 규모(2034년)

Key Factors Driving Lonigutamab Growth

(1) Large commercial opportunity in TED with validated market demand

TED remains a high-value rare disease market with significant unmet need. TEPEZZA generated approximately $1.96 billion in global net sales in 2024, according to Amgen (which acquired Horizon Therapeutics in 2023). This validates strong physician demand for IGF-1R-targeting therapies. Despite TEPEZZA's success, penetration remains limited due to infusion burden, hearing-related adverse events, and access barriers-creating room for next-generation entrants like Lonigutamab.

(2) First subcutaneous IGF-1R therapy could significantly improve adoption

A major growth driver is Lonigutamab's subcutaneous administration, which differentiates it from IV-infused TEPEZZA. According to ACELYRIN, Inc., Lonigutamab became the first SC anti-IGF-1R therapy to demonstrate clinical responses in TED patients. The current Phase 1/2 trial evaluated dosing regimens such as:

• 40 mg every 3 weeks
• 50 mg loading dose + 25 mg weekly
• every 4-week dosing

SC administration could reduce infusion-center dependency and improve patient convenience, potentially expanding treatment uptake.

(3) Positive early clinical efficacy data

In March 2024, ACELYRIN announced that Lonigutamab showed rapid improvement in proptosis and Clinical Activity Score (CAS) within just 3 weeks after the first dose in its ongoing Phase 1/2 trial. These are key efficacy metrics in TED treatment.

In January 2025, the company further stated that total Phase 2 data showed potential efficacy "in line with standard of care", strengthening confidence that Lonigutamab could compete with existing therapies.

(4) Potentially improved safety profile vs TEPEZZA

One of TEPEZZA's biggest commercial limitations has been adverse events such as:

• Hearing impairment
• Hyperglycemia
• Muscle spasms

ACELYRIN stated in January 2025 that Lonigutamab demonstrated a potentially more favorable safety profile versus standard care. If confirmed in Phase 3 trials, this could become a major prescribing advantage.

Lonigutamab Recent Developments

In January 2025, Acelyrin announced additional data from its Phase II clinical trial as well as the design for its Phase III LONGITUDE program of lonigutamab in thyroid eye disease (TED) patients.

"Lonigutamab Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Lonigutamab for potential indication like Graves ophthalmopathy in the 7MM. A detailed picture of Lonigutamab'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 Lonigutamab for potential indications. The Lonigutamab market report provides insights about Lonigutamab'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 Lonigutamab performance, future market assessments inclusive of the Lonigutamab 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 Lonigutamab sales forecasts, along with factors driving its market.

Lonigutamab Drug Summary

Lonigutamab is an investigational, subcutaneously administered humanized monoclonal antibody designed to inhibit the Insulin-like Growth Factor 1 Receptor signaling by selectively binding to and blocking IGF-1R activation, thereby reducing downstream signaling involved in inflammation and tissue remodeling. It is being developed by Acelyrin, Inc. for the treatment of Thyroid Eye Disease, a rare autoimmune condition characterized by orbital inflammation and proptosis. Lonigutamab aims to offer a potentially more convenient alternative to intravenous Teprotumumab-trbw through subcutaneous delivery while maintaining efficacy in reducing proptosis and diplopia. The drug is currently in clinical development, with early studies evaluating its safety, pharmacokinetics, and therapeutic potential in TED patients, positioning it as a next-generation IGF-1R-targeted therapy in an evolving competitive landscape. The report provides Lonigutamab's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Lonigutamab Market Report

The report provides insights into:

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

Methodology:

The Lonigutamab 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.

Lonigutamab Analytical Perspective by DelveInsight

• In-depth Lonigutamab Market Assessment

This Lonigutamab sales market forecast report provides a detailed market assessment of Lonigutamab 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 Lonigutamab sales data uptil 2034.

• Lonigutamab Clinical Assessment

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

Lonigutamab 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.

Lonigutamab Market Potential & Revenue Forecast

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

Lonigutamab Competitive Intelligence

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

Lonigutamab Regulatory & Commercial Milestones

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

Lonigutamab Clinical Differentiation

• Lonigutamab Efficacy & safety advantages over existing drugs
• Lonigutamab Unique selling points

Lonigutamab Market Report Highlights

• In the coming years, the Lonigutamab 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 Lonigutamab companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Lonigutamab's dominance.
• Other emerging products for Graves ophthalmopathy are expected to give tough market competition to Lonigutamab 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 Lonigutamab in potential indications.
• Analyse Lonigutamab cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Lonigutamab sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Lonigutamab in potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Lonigutamab? How strong is Lonigutamab's clinical and commercial performance?
• What is Lonigutamab'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 Lonigutamab Manufacturers?
• What are the key designations that have been granted to Lonigutamab for potential indications? How are they going to impact Lonigutamab's penetration in various geographies?
• What is the current and forecasted Lonigutamab market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Lonigutamab 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 Lonigutamab for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is Lonigutamab? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Lonigutamab Overview in potential indication like Graves ophthalmopathy

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

3. Lonigutamab Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Lonigutamab Therapies)

5. Lonigutamab Market Assessment

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

6. Lonigutamab 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