PUBLISHER: Grand View Research | PRODUCT CODE: 1771589
PUBLISHER: Grand View Research | PRODUCT CODE: 1771589
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.