Vyvgart Hytrulo Global Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

The vyvgart hytrulo market research report is one of a series of new reports that provides vyvgart hytrulo market statistics, including vyvgart hytrulo industry global market size, regional shares, competitors with vyvgart hytrulo market share, detailed vyvgart hytrulo market segments, market trends and opportunities, and any further data you may need to thrive in the vyvgart hytrulo industry. This vyvgart hytrulo market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The growth in the forecast period can be attributed to increasing demand for targeted therapies, expansion of healthcare access in emerging markets, increasing adoption of biologics in chronic disease management, rising patient demand for effective and personalized treatments, and growth of healthcare reimbursement options for biologic therapies. Major trends in the forecast period include increased investment in autoimmune disease research, a rise in biologics-driven market competition, the development of next-generation immunotherapies, an emphasis on patient-reported outcomes and real-world evidence, and growth in partnerships between pharmaceutical companies and biotech startups.

The increasing prevalence of autoimmune disorders is expected to drive the growth of the vyvgart hytrulo market. Autoimmune diseases occur when the immune system mistakenly attacks the body’s own healthy cells and tissues, recognizing them as foreign. This rise in autoimmune conditions is largely due to factors such as genetic predisposition, environmental influences, infections, and lifestyle changes, including diet and exposure to chemicals. Vyvgart Hytrulo is specifically used to treat autoimmune diseases such as generalized myasthenia gravis (gMG), working by reducing pathogenic antibodies through inhibition of the neonatal Fc receptor (FcRn). For example, the Myasthenia Gravis Foundation of America reported in August 2024 that myasthenia gravis affects between 150 to 200 individuals per million people globally, with approximately 37 out of every 100,000 people in the United States diagnosed with the condition. As the prevalence of autoimmune diseases rises, so too does the demand for treatments such as vyvgart hytrulo.

The growing focus on personalized medicine is expected to further drive the vyvgart hytrulo market. Personalized medicine tailors healthcare treatment plans based on an individual’s genetic makeup, lifestyle, and environmental factors to achieve more effective outcomes. This shift toward personalized treatment is fueled by advancements in genomics, technology, and data analytics, along with an increasing demand for more precise and targeted therapies. Vyvgart Hytrulo aligns with this trend by specifically targeting autoimmune mechanisms in patients with gMG, particularly those who test positive for anti-AChR antibodies. The Personalized Medicine Coalition reported in February 2024 that the FDA approved 16 new personalized treatments for rare diseases in 2023, a significant increase from six in the previous year. As personalized medicine becomes more central to healthcare, the demand for treatments such as vyvgart hytrulo is expected to grow.

Advancements in targeted therapy are also contributing to the market growth of vyvgart hytrulo by providing more flexible and effective treatment options for patients with gMG. Targeted therapy involves using drugs designed to specifically target molecules involved in disease progression, minimizing damage to healthy cells. In June 2023, argenx SE, a Netherlands-based immunology company, received FDA approval for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous use in treating gMG. This approval represents a significant development in gMG treatment, offering patients the flexibility to use a subcutaneous injection, which has shown comparable efficacy to the intravenous version while maintaining a favorable safety profile. This option provides greater convenience for patients, allowing them to administer the treatment in various settings, such as at home or in infusion centers, thus improving treatment adherence and overall patient satisfaction.

The key company operating in the vyvgart hytrulo market is Argenx SE.

North America was the largest region in the vyvgart hytrulo market in 2024. The regions covered in vyvgart hytrulo report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the vyvgart hytrulo market report are Australia, India, China, South Korea, Japan, UK, France, Germany, USA, Canada.

VYVGART Hytrulo is a subcutaneous formulation of Vyvgart (efgartigimod alfa-fcab), designed to treat generalized myasthenia gravis (gMG) in adults who test positive for anti-acetylcholine receptor (AChR) antibodies. Unlike the intravenous (IV) version, Vyvgart Hytrulo is administered via subcutaneous injection, offering patients a more convenient and time-efficient treatment option.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The main formulations of vyvgart hytrulo include intravenous (IV) and subcutaneous versions. The intravenous (IV) formulation is delivered directly into the bloodstream to target generalized myasthenia gravis, providing therapeutic benefits through a controlled delivery method. Vyvgart Hytrulo is used for indications such as generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The end users include adults and geriatric patients, with distribution through hospital pharmacies, retail pharmacies, and online pharmacies.

The vyvgart hytrulo market consists of sales of injections and solutions. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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