비브가르트(에프가르티기모드) 시장 규모, 점유율, 동향 분석 보고서 : 적응증별, 투여 경로별, 지역별, 부문 예측(2025-2030년)

Vyvgart (Efgartigimod) Market Growth & Trends:

The global Vyvgart (Efgartigimod) market size is anticipated to reach USD 5.50 billion by 2030 and is projected to grow at a CAGR of 13.6% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market for Vyvgart (efgartigimod), a first-in-class neonatal Fc receptor (FcRn) antagonist developed by argenx SE, is rapidly evolving as its therapeutic footprint expands across multiple autoimmune indications. Initially approved for generalized myasthenia gravis (gMG), Vyvgart has since entered the treatment landscapes for Primary Immune Thrombocytopenia (ITP) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), with ongoing exploration into additional FcRn-related immune disorders.

Vyvgart's clinical value lies in its unique mechanism of action that reduces pathogenic IgG autoantibodies by inhibiting the FcRn recycling pathway. This targeted approach allows for selective immunomodulation without broadly suppressing the immune system, offering a favorable safety profile. The treatment has demonstrated robust efficacy in chronic, antibody-driven conditions like gMG and CIDP, with growing evidence supporting its use across other autoimmune indications.

While adult patients represent the largest treated population, especially in well-established indications such as gMG, the therapeutic potential for pediatric use is gaining momentum, particularly in chronic autoimmune neuropathies and hematologic disorders. Early intervention in younger patients could offer long-term benefits by curbing disease progression and reducing reliance on broad-spectrum immunosuppressants.

Specialty pharmacies are at the forefront of Vyvgart's distribution model, particularly due to the drug's infusion-based and subcutaneous formulations, which require precise coordination and patient support. Hospital pharmacies continue to be key partners in managing induction and complex cases, especially for newly diagnosed or severely affected patients. Increasingly, specialty distribution channels are enhancing access and adherence through personalized care programs, infusion scheduling, and remote patient engagement.

In April 2025, the FDA approved a prefilled syringe formulation of VYVGART Hytrulo for self-administration in patients with gMG and CIDP. This enables subcutaneous delivery in under 30 seconds, significantly improving treatment flexibility and adherence.

Also in April 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of VYVGART subcutaneous injection for CIDP in Europe, setting the stage for the first targeted CIDP therapy approval in the region in over three decades.

In November 2024, VYVGART Hytrulo received regulatory approval in China for treating CIDP, following strong results from the ADHERE trial. This further expanded its global footprint and solidified Argenx's position in neuromuscular markets.

As demand grows globally, ensuring consistent product availability remains a strategic priority for argenx. Investments in supply chain scalability and patient-centered digital platforms are reinforcing treatment continuity and empowering both providers and patients. These tools are especially critical in managing long-term, relapsing autoimmune conditions, where seamless care transitions and proactive disease monitoring can significantly impact outcomes.

The success of Vyvgart underscores a broader paradigm shift toward precision immunotherapies that modulate specific disease pathways with durable, targeted effects. As awareness and diagnostic capabilities for autoimmune diseases continue to improve, Vyvgart is poised to remain a leading option in the FcRn inhibition class, driving better outcomes and reshaping the standard of care across a range of debilitating immune-mediated disorders.

Vyvgart (Efgartigimod) Market Report Highlights:

• Based on indication, Generalized Myasthenia Gravis (gMG) remained the leading indication in the Vyvgart (Efgartigimod) market in 2024, accounting for the largest share due to the high prevalence of antibody-positive patients and the drug's targeted mechanism of action through FcRn inhibition. Strong clinical outcomes, favorable safety profile, and updates to treatment guidelines have accelerated adoption across major markets.
• Based on route of administration, Intravenous (IV) Infusion dominated the route of administration segment in 2024, primarily due to its early commercial availability and widespread adoption in hospital settings for induction therapy. However, the market is witnessing a rapid shift towards subcutaneous formulations, particularly the recently approved prefilled syringe, which offers self-administration and greater patient convenience.
• North America led the Vyvgart market in 2024, supported by high diagnosis and treatment rates of autoimmune diseases, favorable reimbursement policies, and a robust specialty pharmacy infrastructure. The region also benefits from increasing clinical trial activity and early adoption of innovative immunotherapies.
• Argenx SE continued to lead the Vyvgart (Efgartigimod) market globally, leveraging its robust R&D pipeline, expanding international approvals, and strategic partnerships with regional players like Zai Lab in China. The company's focus on supply chain resilience, patient assistance programs, and platform-based development supports its long-term growth across multiple indications and geographies.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Indication
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Vyvgart (Efgartigimod) Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
• 3.4. Pipeline Analysis
• 3.5. Patent Expiry Analysis
• 3.6. Pricing Analysis

Chapter 4. Vyvgart (Efgartigimod) Market: Indication Business Analysis

• 4.1. Indication Market Share, 2024 & 2030
• 4.2. Indication Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Indication, 2018 to 2030 (USD Million)
• 4.4. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • 4.4.1. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Market, 2018 - 2030 (USD Million)
• 4.5. Generalized Myasthenia Gravis (gMG)
  • 4.5.1. Generalized Myasthenia Gravis (gMG) Market, 2018 - 2030 (USD Million)
• 4.6. Others
  • 4.6.1. Others Market, 2018 - 2030 (USD Million)

Chapter 5. Vyvgart (Efgartigimod) Market: Route of Administration Business Analysis

• 5.1. Route of Administration Market Share, 2024 & 2030
• 5.2. Route of Administration Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Route of Administration, 2018 to 2030 (USD Million)
• 5.4. Intravenous (IV) Infusion
  • 5.4.1. Intravenous (IV) Infusion Market, 2018 - 2030 (USD Million)
• 5.5. Subcutaneous (SC) Injection
  • 5.5.1. Subcutaneous (SC) Injection Market, 2018 - 2030 (USD Million)
• 5.6. Prefilled Syringes
  • 5.6.1. Prefilled Syringe Market, 2018 - 2030 (USD Million)

Chapter 6. Vyvgart (Efgartigimod) Market: Regional Estimates & Trend Analysis

• 6.1. Regional Market Share Analysis, 2024 & 2030
• 6.2. Regional Market Dashboard
• 6.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 6.4. North America
  • 6.4.1. North America Vyvgart (Efgartigimod) Market Estimates and Forecasts, By Country, 2018 - 2030 (USD Million)
  • 6.4.2. U.S.
    • 6.4.2.1. Key Country Dynamics
    • 6.4.2.2. Target Disease Prevalence
    • 6.4.2.3. Regulatory Framework
    • 6.4.2.4. Reimbursement Framework
    • 6.4.2.5. U.S. Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.3. Canada
    • 6.4.3.1. Key Country Dynamics
    • 6.4.3.2. Target Disease Prevalence
    • 6.4.3.3. Regulatory Framework
    • 6.4.3.4. Reimbursement Framework
    • 6.4.3.5. U.S. Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.4. Mexico
    • 6.4.4.1. Key Country Dynamics
    • 6.4.4.2. Target Disease Prevalence
    • 6.4.4.3. Regulatory Framework
    • 6.4.4.4. Reimbursement Framework
    • 6.4.4.5. Mexico Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Europe
  • 6.5.1. Europe Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.2. UK
    • 6.5.2.1. Key Country Dynamics
    • 6.5.2.2. Target Disease Prevalence
    • 6.5.2.3. Regulatory Framework
    • 6.5.2.4. Reimbursement Framework
    • 6.5.2.5. Uk Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.3. Germany
    • 6.5.3.1. Key Country Dynamics
    • 6.5.3.2. Target Disease Prevalence
    • 6.5.3.3. Regulatory Framework
    • 6.5.3.4. Reimbursement Framework
    • 6.5.3.5. Germany Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.4. France
    • 6.5.4.1. Key Country Dynamics
    • 6.5.4.2. Target Disease Prevalence
    • 6.5.4.3. Regulatory Framework
    • 6.5.4.4. Reimbursement Framework
    • 6.5.4.5. France Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.5. Italy
    • 6.5.5.1. Key Country Dynamics
    • 6.5.5.2. Target Disease Prevalence
    • 6.5.5.3. Regulatory Framework
    • 6.5.5.4. Reimbursement Framework
    • 6.5.5.5. Italy Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.6. Spain
    • 6.5.6.1. Key Country Dynamics
    • 6.5.6.2. Target Disease Prevalence
    • 6.5.6.3. Regulatory Framework
    • 6.5.6.4. Reimbursement Framework
    • 6.5.6.5. Spain Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.7. Denmark
    • 6.5.7.1. Key Country Dynamics
    • 6.5.7.2. Target Disease Prevalence
    • 6.5.7.3. Regulatory Framework
    • 6.5.7.4. Reimbursement Framework
    • 6.5.7.5. Denmark Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.8. Sweden
    • 6.5.8.1. Key Country Dynamics
    • 6.5.8.2. Target Disease Prevalence
    • 6.5.8.3. Regulatory Framework
    • 6.5.8.4. Reimbursement Framework
    • 6.5.8.5. Sweden Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.9. Norway
    • 6.5.9.1. Key Country Dynamics
    • 6.5.9.2. Target Disease Prevalence
    • 6.5.9.3. Regulatory Framework
    • 6.5.9.4. Reimbursement Framework
    • 6.5.9.5. Norway Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Asia Pacific
  • 6.6.1. Asia Pacific Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.2. Japan
    • 6.6.2.1. Key Country Dynamics
    • 6.6.2.2. Target Disease Prevalence
    • 6.6.2.3. Regulatory Framework
    • 6.6.2.4. Reimbursement Framework
    • 6.6.2.5. Japan Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.3. China
    • 6.6.3.1. Key Country Dynamics
    • 6.6.3.2. Target Disease Prevalence
    • 6.6.3.3. Regulatory Framework
    • 6.6.3.4. Reimbursement Framework
    • 6.6.3.5. China Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.4. India
    • 6.6.4.1. Key Country Dynamics
    • 6.6.4.2. Target Disease Prevalence
    • 6.6.4.3. Regulatory Framework
    • 6.6.4.4. Reimbursement Framework
    • 6.6.4.5. India Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.5. Australia
    • 6.6.5.1. Key Country Dynamics
    • 6.6.5.2. Target Disease Prevalence
    • 6.6.5.3. Regulatory Framework
    • 6.6.5.4. Reimbursement Framework
    • 6.6.5.5. Australia Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.6. South Korea
    • 6.6.6.1. Key Country Dynamics
    • 6.6.6.2. Target Disease Prevalence
    • 6.6.6.3. Regulatory Framework
    • 6.6.6.4. Reimbursement Framework
    • 6.6.6.5. South Korea Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.6.7. Thailand
    • 6.6.7.1. Key Country Dynamics
    • 6.6.7.2. Target Disease Prevalence
    • 6.6.7.3. Regulatory Framework
    • 6.6.7.4. Reimbursement Framework
    • 6.6.7.5. Thailand Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Latin America
  • 6.7.1. Latin America Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.2. Brazil
    • 6.7.2.1. Key Country Dynamics
    • 6.7.2.2. Target Disease Prevalence
    • 6.7.2.3. Regulatory Framework
    • 6.7.2.4. Reimbursement Framework
    • 6.7.2.5. Japan Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.7.3. Argentina
    • 6.7.3.1. Key Country Dynamics
    • 6.7.3.2. Target Disease Prevalence
    • 6.7.3.3. Regulatory Framework
    • 6.7.3.4. Reimbursement Framework
    • 6.7.3.5. China Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.8. Middle East and Africa
  • 6.8.1. Middle East and Africa Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2017 - 2030 (USD Million)
  • 6.8.2. South Africa
    • 6.8.2.1. Key Country Dynamics
    • 6.8.2.2. Target Disease Prevalence
    • 6.8.2.3. Regulatory Framework
    • 6.8.2.4. Reimbursement Framework
    • 6.8.2.5. South Africa Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.3. Saudi Arabia
    • 6.8.3.1. Key Country Dynamics
    • 6.8.3.2. Target Disease Prevalence
    • 6.8.3.3. Regulatory Framework
    • 6.8.3.4. Reimbursement Framework
    • 6.8.3.5. Saudi Arabia Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.4. UAE
    • 6.8.4.1. Key Country Dynamics
    • 6.8.4.2. Target Disease Prevalence
    • 6.8.4.3. Regulatory Framework
    • 6.8.4.4. Reimbursement Framework
    • 6.8.4.5. UAE Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.8.5. Kuwait
    • 6.8.5.1. Key Country Dynamics
    • 6.8.5.2. Target Disease Prevalence
    • 6.8.5.3. Regulatory Framework
    • 6.8.5.4. Reimbursement Framework
    • 6.8.5.5. Kuwait Vyvgart (Efgartigimod) Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Participant Overview
• 7.2. Company Market Position Analysis
• 7.3. Company Categorization
• 7.4. Strategy Mapping
• 7.5. Company Profiles/Listing
  • 7.5.1. Argenx SE
    • 7.5.1.1. Overview
    • 7.5.1.2. Financial Performance
    • 7.5.1.3. Product Benchmarking
    • 7.5.1.4. Strategic Initiatives

Chapter 8. Conclusion