Vyvgart (Efgartigimod) Market to Reach USD 6.21 Billion by 2032, Driven by Expanding Indications and Innovative Drug Delivery

The global Vyvgart (Efgartigimod) Market was valued at USD 2.23 billion in 2024 and is forecast to reach USD 6.21 billion by 2032, growing at a CAGR of 13.67% over the 2025–2032 period. Market expansion is supported by rising adoption of FcRn inhibitors in autoimmune diseases, strong clinical outcomes, and continued regulatory approvals across key geographies.

Vyvgart, developed as a first-in-class FcRn antagonist, has rapidly gained clinical acceptance due to its targeted mechanism of action, favorable safety profile, and expanding label indications. Increasing physician confidence, broader payer reimbursement, and the introduction of more patient-friendly formulations are accelerating uptake in both established and emerging markets.

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Market Segmentation Analysis

By Indication

Generalized Myasthenia Gravis (gMG) dominated the Vyvgart (Efgartigimod) market in 2024, accounting for 97.68% of total revenue. This leadership is primarily attributed to early FDA approval in 2021, extensive real-world evidence, and strong prescriber familiarity. A large diagnosed patient base, coupled with rising disease awareness and favorable clinical guideline recommendations, has positioned Vyvgart as the preferred FcRn blocker in gMG.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is expected to be the fastest-growing indication during the forecast period. Momentum is driven by the FDA’s 2024 approval and positive Phase 3 ADHERE study outcomes. Expanded access to patients seeking alternatives to steroids and IVIg, along with Argenx’s focused R&D investments and regional expansion through partners such as Zai Lab in China, are expected to significantly accelerate growth.

By Route of Administration

The Intravenous (IV) infusion segment led the market in 2024, capturing a 95.78% share. Its dominance stems from earlier regulatory approvals, established hospital and infusion-center usage, and long-standing clinician confidence in its safety and dosing profile.

The prefilled syringe segment is projected to grow at the fastest CAGR through 2032. The FDA approval of Vyvgart Hytrulo in April 2025 has enabled self-administration at home, reducing dependency on clinical visits and improving long-term treatment adherence. This convenience-driven innovation is expected to see rapid adoption among neurologists and immunologists managing chronic autoimmune conditions.

Regional Outlook

North America

North America remained the leading regional market in 2024, accounting for 88.2% of global revenue. Early FDA approvals, advanced healthcare infrastructure, and comprehensive reimbursement frameworks have driven widespread adoption. The U.S. Vyvgart (Efgartigimod) market was valued at USD 1.51 billion in 2024 and is projected to reach USD 3.82 billion by 2032, expanding at a CAGR of 12.38% during 2025–2032. Strong patient assistance programs and high diagnostic rates further reinforce U.S. market leadership.

Europe

Europe represents the second-fastest-growing regional market, supported by rising autoimmune disease prevalence and favorable regulatory developments, including CHMP’s positive opinion for CIDP. Germany leads the region due to robust reimbursement systems and high clinical trial participation. France and the UK continue to see increasing penetration through rare disease advocacy and protocol adoption, while Italy and Spain benefit from expanded hospital-based reimbursement coverage.

Asia Pacific and Rest of the World

Asia Pacific is the fastest-growing regional market, fueled by regulatory approvals, strategic partnerships, and rising disease awareness. China is a major growth driver following approval of Vyvgart Hytrulo for CIDP, supported by the Argenx–Zai Lab collaboration. Japan remains a high-adoption market, while India and South Korea are witnessing improved diagnosis rates and regulatory streamlining. Early access programs in Singapore and Australia are further supporting regional expansion.

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Recent Developments

• In 2024, Vyvgart received FDA approval for CIDP, opening access to a substantially larger patient population beyond gMG.
• Vyvgart Hytrulo achieved FDA approval in April 2025, introducing a self-administered prefilled syringe that is expected to significantly improve patient compliance.
• Clinical data from Phase 3 programs demonstrated consistent reductions in pathogenic IgG levels of over 60%, reinforcing long-term efficacy and safety.
• Strategic collaborations in Asia strengthened commercial reach, with China emerging as one of the fastest-expanding markets post-approval.

Key Market Players

Argenx SE, Zai Lab Limited, Halozyme Therapeutics Inc., Pfizer Inc., UCB Pharma, Johnson & Johnson (Janssen), Alexion Pharmaceuticals (AstraZeneca), Horizon Therapeutics, Immunovant Inc., and Takeda Pharmaceutical Company Limited.

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