에프가르티기모드 PH20 피하주사(Efgartigimod PH20 SC) : 판매 예측 및 시장 규모(2034년)

Key Factors Driving Efgartigimod PH20 SC Growth

• Rapid commercial uptake and blockbuster sales momentum

The VYVGART franchise has demonstrated exceptional commercial growth globally. argenx reported global net product sales of approximately US$790 million in Q1 2025 and US$949 million in Q2 2025, representing 97% operational year-over-year growth in Q2 2025. Much of this momentum has been driven by increasing adoption of the SC formulation, particularly in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).

• Convenient self-administration significantly improves patient accessibility

In April 2025, the FDA approved a prefilled syringe version of VYVGART Hytrulo for self-injection in both gMG and CIDP. The SC injection can be administered in approximately 20-30 seconds, eliminating infusion-center dependence associated with intravenous biologics. This convenience is expected to improve treatment adherence, expand use into community settings, and increase physician willingness to initiate earlier biologic therapy.

• Broad multi-indication expansion supports sustained revenue growth

Efgartigimod is being developed across numerous autoimmune indications beyond gMG and CIDP. argenx disclosed ongoing clinical development in approximately 15 autoimmune diseases, including immune thrombocytopenia (ITP), ocular myasthenia gravis, pemphigus, and inflammatory myopathies. This broad pipeline significantly increases the drug's commercial runway and diversifies revenue sources beyond a single indication.

• FcRn inhibition is now a clinically validated and high-growth therapeutic class

Efgartigimod was the first approved FcRn blocker, helping establish FcRn inhibition as a major therapeutic class in autoimmune medicine. Its mechanism selectively reduces pathogenic IgG antibodies without broad B-cell depletion or generalized immunosuppression. Growing physician familiarity with FcRn biology, combined with strong efficacy in neuromuscular disorders, continues to support increasing adoption worldwide. Multiple subsequent competitors entering the market further validate the class commercially and scientifically.

• Global expansion and reimbursement gains continue to widen the addressable market

VYVGART Hytrulo has expanded into multiple international markets including Europe, Japan, and China. In China, partner Zai Lab reported continued quarterly sales growth driven by increased market penetration and longer treatment duration in CIDP and gMG patients. Additionally, positive EMA opinions and new reimbursement pathways are improving international accessibility, which should accelerate future sales growth.

Efgartigimod PH20 SC Recent Developments

In April 2026, Argenx announced the presentation of new data for VYVGART (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago from April 18-22, 2026. Presentations will also highlight new data for adimanebart in congenital myasthenic syndromes (CMS) and argenx's broader neuromuscular pipeline, including Phase III programs evaluating empasiprubart in CIDP.

"Efgartigimod PH20 SC Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Efgartigimod PH20 SC for approved indication like Chronic inflammatory demyelinating polyradiculoneuropathy and Myasthenia gravis; as well as potential indication like Bullous pemphigoid, Graves ophthalmopathy, Myositis, Pemphigus, Sjogren's syndrome, Lupus nephritis, and Renal transplant rejection in the 7MM. A detailed picture of Efgartigimod PH20 SC's existing usage in approved and 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 Efgartigimod PH20 SC for approved and potential indications. The Efgartigimod PH20 SC market report provides insights about Efgartigimod PH20 SC'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 Efgartigimod PH20 SC performance, future market assessments inclusive of the Efgartigimod PH20 SC market forecast analysis for approved and 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 Efgartigimod PH20 SC sales forecasts, along with factors driving its market.

Efgartigimod PH20 SC Drug Summary

Efgartigimod PH20 SC, marketed as VYVGART HYTRULO, is a subcutaneous formulation of efgartigimod alfa combined with recombinant human hyaluronidase PH20, developed by argenx for the treatment of immunoglobulin G (IgG)-mediated autoimmune diseases, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Efgartigimod is an engineered human IgG1 antibody Fc fragment that targets the neonatal Fc receptor (FcRn), blocking IgG recycling and accelerating degradation of pathogenic autoantibodies responsible for autoimmune disease progression. The addition of hyaluronidase PH20, licensed from Halozyme Therapeutics, enables rapid and convenient subcutaneous administration by enhancing tissue permeability and drug dispersion. Clinical trials have demonstrated significant reductions in disease-related IgG levels along with improvements in muscle strength, disability scores, and quality of life in patients with gMG and CIDP, while maintaining a generally favorable safety profile. The therapy received FDA approval for anti-acetylcholine receptor (AChR) antibody-positive gMG in 2023 and for CIDP in 2024, becoming the first FcRn blocker approved for CIDP. Common adverse events include injection-site reactions, headache, respiratory tract infections, and urinary tract infections. The report provides Efgartigimod PH20 SC's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Efgartigimod PH20 SC Market Report

The report provides insights into:

• A comprehensive product overview including the Efgartigimod PH20 SC MoA, description, dosage and administration, research and development activities in approved indications like Chronic inflammatory demyelinating polyradiculoneuropathy and Myasthenia gravis; as well as potential indication like Bullous pemphigoid, Graves ophthalmopathy, Myositis, Pemphigus, Sjogren's syndrome, Lupus nephritis, and Renal transplant rejection.
• Elaborated details on Efgartigimod PH20 SC regulatory milestones and other development activities have been provided in Efgartigimod PH20 SC market report.
• The report also highlights Efgartigimod PH20 SC's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The Efgartigimod PH20 SC market report also covers the patents information, generic entry and impact on cost cut.
• The Efgartigimod PH20 SC market report contains current and forecasted Efgartigimod PH20 SC sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Efgartigimod PH20 SC market report also features the SWOT analysis with analyst views for Efgartigimod PH20 SC in approved and potential indications.

Methodology:

The Efgartigimod PH20 SC 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.

Efgartigimod PH20 SC Analytical Perspective by DelveInsight

• In-depth Efgartigimod PH20 SC Market Assessment

This Efgartigimod PH20 SC sales market forecast report provides a detailed market assessment of Efgartigimod PH20 SC for approved indication like Chronic inflammatory demyelinating polyradiculoneuropathy and Myasthenia gravis; as well as potential indication like Bullous pemphigoid, Graves ophthalmopathy, Myositis, Pemphigus, Sjogren's syndrome, Lupus nephritis, and Renal transplant rejection 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 Efgartigimod PH20 SC sales data uptil 2034.

• Efgartigimod PH20 SC Clinical Assessment

The Efgartigimod PH20 SC market report provides the clinical trials information of Efgartigimod PH20 SC for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Efgartigimod PH20 SC 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.

Efgartigimod PH20 SC Market Potential & Revenue Forecast

• Projected market size for the Efgartigimod PH20 SC and its key indications
• Estimated Efgartigimod PH20 SC sales potential (Efgartigimod PH20 SC peak sales forecasts)
• Efgartigimod PH20 SC Pricing strategies and reimbursement landscape

Efgartigimod PH20 SC Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Efgartigimod PH20 SC Market positioning compared to existing treatments
• Efgartigimod PH20 SC Strengths & weaknesses relative to competitors

Efgartigimod PH20 SC Regulatory & Commercial Milestones

• Efgartigimod PH20 SC Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Efgartigimod PH20 SC Clinical Differentiation

• Efgartigimod PH20 SC Efficacy & safety advantages over existing drugs
• Efgartigimod PH20 SC Unique selling points

Efgartigimod PH20 SC Market Report Highlights

• In the coming years, the Efgartigimod PH20 SC 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 Efgartigimod PH20 SC companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Efgartigimod PH20 SC's dominance.
• Other emerging products for Chronic inflammatory demyelinating polyradiculoneuropathy and Myasthenia gravis; as well as potential indication like Bullous pemphigoid, Graves ophthalmopathy, Myositis, Pemphigus, Sjogren's syndrome, Lupus nephritis, and Renal transplant rejection are expected to give tough market competition to Efgartigimod PH20 SC 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 Efgartigimod PH20 SC in approved and potential indications.
• Analyse Efgartigimod PH20 SC cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Efgartigimod PH20 SC sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Efgartigimod PH20 SC in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Efgartigimod PH20 SC? How strong is Efgartigimod PH20 SC's clinical and commercial performance?
• What is Efgartigimod PH20 SC's clinical trial status in each individual indications such as Chronic inflammatory demyelinating polyradiculoneuropathy and Myasthenia gravis; as well as potential indication like Bullous pemphigoid, Graves ophthalmopathy, Myositis, Pemphigus, Sjogren's syndrome, Lupus nephritis, and Renal transplant rejection and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Efgartigimod PH20 SC Manufacturers?
• What are the key designations that have been granted to Efgartigimod PH20 SC for approved and potential indications? How are they going to impact Efgartigimod PH20 SC's penetration in various geographies?
• What is the current and forecasted Efgartigimod PH20 SC market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Efgartigimod PH20 SC 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 Efgartigimod PH20 SC for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is Efgartigimod PH20 SC? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Efgartigimod PH20 SC Overview in approved indications like Chronic inflammatory demyelinating polyradiculoneuropathy and Myasthenia gravis; as well as potential indication like Bullous pemphigoid, Graves ophthalmopathy, Myositis, Pemphigus, Sjogren's syndrome, Lupus nephritis, and Renal transplant rejection

• 2.1. Product Detail
• 2.2. Efgartigimod PH20 SC Clinical Development
  • 2.2.1. Efgartigimod PH20 SC Clinical studies
  • 2.2.2. Efgartigimod PH20 SC Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Efgartigimod PH20 SC Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Efgartigimod PH20 SC Therapies)

5. Efgartigimod PH20 SC Market Assessment

• 5.1. Efgartigimod PH20 SC Market Outlook in approved and potential indications
• 5.2. 7MM Analysis
  • 5.2.1. Efgartigimod PH20 SC Market Size in the 7MM for approved and potential indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. Efgartigimod PH20 SC Market Size in the United States for approved and potential indications
  • 5.3.2. Efgartigimod PH20 SC Market Size in Germany for approved and potential indications
  • 5.3.3. Efgartigimod PH20 SC Market Size in France for approved and potential indications
  • 5.3.4. Efgartigimod PH20 SC Market Size in Italy for approved and potential indications
  • 5.3.5. Efgartigimod PH20 SC Market Size in Spain for approved and potential indications
  • 5.3.6. Efgartigimod PH20 SC Market Size in the United Kingdom for approved and potential indications
  • 5.3.7. Efgartigimod PH20 SC Market Size in Japan for approved and potential indications

6. Efgartigimod PH20 SC 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