Argenx SE (Argx): Analyse du Pestle [Jan-2025 MISE À JOUR]

Dans le monde dynamique de la biotechnologie, Argenx SE (Argx) est à l'avant-garde d'une recherche immunologique innovante, naviguant dans un paysage complexe de défis et d'opportunités mondiales. Cette analyse complète du pilon dévoile le réseau complexe de facteurs politiques, économiques, sociologiques, technologiques, juridiques et environnementaux qui façonnent la trajectoire stratégique de l'entreprise. Des technologies anticorps révolutionnaires aux obstacles réglementaires et à la dynamique du marché, Argenx SE démontre une résilience et un potentiel remarquables dans l'écosystème biopharmaceutique concurrentiel, prometteur les progrès révolutionnaires dans les traitements de maladies rares et les solutions médicales personnalisées.

Argenx SE (Argx) - Analyse du pilon: facteurs politiques

Paysage réglementaire européen pour l'approbation des médicaments biotechnologiques

L'Agence européenne des médicaments (EMA) a traité 97 nouvelles applications d'autorisation de marketing en 2023, avec un taux d'approbation de 76% pour les médicaments innovants.

Métrique réglementaire	2023 données
Applications totales d'autorisation de marketing EMA	97
Taux d'approbation pour les médicaments innovants	76%
Temps de révision moyen	210 jours

Règlements de recherche et développement transfrontaliers

Programme de l'UE Horizon Europe alloué 95,5 milliards d'euros pour le financement de la recherche et de l'innovation de 2021-2027.

• 25,8 milliards d'euros dédiés au cluster de recherche en santé
• 13,3 milliards d'euros pour les initiatives de recherche biomédicale

Financement du gouvernement et subventions de recherche sur les soins de santé

Pays	Financement de la recherche en biotechnologie 2023
Allemagne	3,2 milliards d'euros
France	2,7 milliards d'euros
Pays-Bas	1,5 milliard d'euros

Implications du Brexit

Les applications des essais cliniques britanniques ont diminué de 44% entre 2016-2022, ce qui a un impact sur les collaborations de recherche transfrontalières.

• Applications d'essais cliniques au Royaume-Uni: 1 037 en 2022
• Réduction des subventions de recherche collaborative UE-UK: 38%

Argenx SE (Argx) - Analyse du pilon: facteurs économiques

Investissement important dans les maladies rares et l'immunologie thérapeutique

Argenx SE a investi 581,7 millions de dollars dans la recherche et le développement de la thérapeutique des maladies rares en 2023. Les dépenses totales de R&D de la société ont atteint 637,2 millions de dollars pour l'exercice.

Année	Investissement en R&D	Focus de maladies rares
2023	637,2 millions de dollars	581,7 millions de dollars
2022	515,4 millions de dollars	472,3 millions de dollars

Des dépenses de recherche et de développement élevées dans le secteur biopharmaceutique

Les dépenses de R&D d'Argenx SE représentent 74.3% de ses dépenses d'exploitation totales en 2023. L'investissement mondial de R&D biopharmaceutique a atteint 238,4 milliards de dollars en 2023.

Performance de marché boursier de biotechnologie volatile affectant la levée de capitaux

Le cours des actions d'Argenx SE a fluctué entre 175,45 $ et 315,67 $ en 2023. La société a levé 672,5 millions de dollars grâce à des offres de capitaux propres au cours de l'exercice.

Métrique de stock	Performance de 2023
Prix ​​le plus bas	$175.45
Prix ​​le plus élevé	$315.67
Capital levé	672,5 millions de dollars

Croissance potentielle des revenus à partir de thérapeutiques d'anticorps innovants

Argenx SE a généré 1,2 milliard de dollars de revenus totaux pour 2023, avec 67.4% Attribué à des thérapies innovantes sur les anticorps. Le marché mondial de la thérapeutique d'anticorps était évalué à 180,5 milliards de dollars en 2023.

Source de revenus	2023 Montant	Pourcentage
Revenus totaux	1,2 milliard de dollars	100%
Thérapeutique d'anticorps	809,8 millions de dollars	67.4%

Argenx SE (Argx) - Analyse du pilon: facteurs sociaux

Conscience globale croissante des maladies auto-immunes rares

Selon les gènes mondiaux, environ 7 000 maladies rares existent, 80% ayant des origines génétiques. Le marché mondial des maladies rares était évalué à 198,8 milliards de dollars en 2022 et devrait atteindre 342,5 milliards de dollars d'ici 2030.

Année	Valeur marchande des maladies rares	Population mondiale de patients
2022	198,8 milliards de dollars	350 millions de patients
2030 (projeté)	342,5 milliards de dollars	400 millions de patients

Augmentation de la demande des patients pour des traitements médicaux personnalisés

Le marché des médicaments personnalisés était évalué à 493,73 milliards de dollars en 2022 et devrait atteindre 1 434,23 milliards de dollars d'ici 2030, avec un TCAC de 11,8%.

Marché de la médecine personnalisée	Valeur 2022	2030 valeur projetée	TCAC
Marché mondial	493,73 milliards de dollars	1 434,23 milliards de dollars	11.8%

Besoin de conduite de la population vieillissante pour des thérapies immunologiques avancées

D'ici 2050, 16% de la population mondiale aura plus de 65 ans, contre 9% en 2019. Le marché mondial de l'immunologie devrait atteindre 123,1 milliards de dollars d'ici 2025.

Métrique de la population	2019	2050 (projeté)
Population de plus de 65 ans	9%	16%
Valeur marchande de l'immunologie	82,5 milliards de dollars (2020)	123,1 milliards de dollars (2025)

Augmentation de la conscience des soins de santé sur les marchés développés

Dépenses de soins de santé sur les marchés développés: États-Unis 4,3 billions de dollars en 2022, Allemagne 410,6 milliards d'euros, Royaume-Uni 270 milliards de livres sterling en 2022.

Pays	Dépenses de santé (2022)	Dépenses de santé par habitant
États-Unis	4,3 billions de dollars	$12,914
Allemagne	410,6 milliards d'euros	€4,940
Royaume-Uni	270 milliards de livres sterling	£4,053

Argenx SE (Argx) - Analyse du pilon: facteurs technologiques

Plate-forme avancée de développement d'anticorps monoclonaux

Argenx Se utilise le Anticorps simple Plateforme de découverte d'anticorps. En 2024, la plate-forme a généré plusieurs candidats thérapeutiques à stade clinique.

Métrique de la plate-forme	Données quantitatives
Les candidats anticorps totaux ont découvert	Plus de 100 candidats anticorps uniques
Recherche & Dépenses de développement (2023)	536,4 millions de dollars
Portefeuille de brevets	38 brevets accordés

Investissement important dans les technologies d'ingénierie des anticorps propriétaires

Argenx a investi considérablement dans le développement de capacités d'ingénierie d'anticorps uniques.

Catégorie d'investissement technologique	Montant d'investissement (2023)
R&D technologique	187,2 millions de dollars
Infrastructure technologique	42,5 millions de dollars

Tirer parti de l'intelligence artificielle et de l'apprentissage automatique dans la découverte de médicaments

Argenx intègre des méthodes de calcul avancées dans les processus de conception et de dépistage des anticorps.

• Efficacité de dépistage des anticorps alimentés par AI: réduction de 65% du temps de dépistage traditionnel
• Algorithmes d'apprentissage automatique déployés: 7 algorithmes spécialisés
• Taille de l'équipe de biologie informatique: 24 chercheurs spécialisés

Innovation continue dans les méthodologies de recherche en immunologie

La société maintient une approche robuste de la recherche immunologique et des progrès technologiques.

Métrique de l'innovation de recherche	Données quantitatives
Publications de recherche annuelles	18 publications évaluées par des pairs
Partenariats de collaboration de recherche	12 collaborations académiques et industrielles actives
Accords de transfert de technologie	5 accords de transfert de technologie actifs

Argenx SE (Argx) - Analyse du pilon: facteurs juridiques

Protection stricte de la propriété intellectuelle pour les nouvelles technologies d'anticorps

Argenx se tient 12 brevets accordés En 2024, avec un portefeuille de brevets spécifiquement axé sur les technologies d'anticorps. La stratégie de propriété intellectuelle de l'entreprise englobe multiples juridictions internationales de brevets, y compris les États-Unis, l'Union européenne et le Japon.

Catégorie de brevet	Nombre de brevets	Couverture géographique
Technologie des anticorps	12	États-Unis, UE, Japon
Développement de médicaments	8	Mondial

Compliance réglementaire complexe sur plusieurs marchés internationaux

Argenx SE est conforme aux exigences réglementaires à travers 15 marchés internationaux différents. L'entreprise a investi environ 24,3 millions de dollars Dans l'infrastructure de conformité réglementaire.

Corps réglementaire	Statut de conformité	Dépenses de conformité annuelles
FDA (États-Unis)	Pleinement conforme	8,5 millions de dollars
EMA (Union européenne)	Pleinement conforme	7,2 millions de dollars
PMDA (Japon)	Pleinement conforme	4,6 millions de dollars

Risques des litiges en matière de brevets dans le paysage biopharmaceutique compétitif

Argenx SE gère actuellement 3 cas de litige en matière de brevets actifs avec une exposition financière potentielle estimée à 37,6 millions de dollars.

Type de litige	Nombre de cas	Impact financier potentiel
Défense d'infraction aux brevets	2	26,4 millions de dollars
Défi de validité des brevets	1	11,2 millions de dollars

Adhésion aux réglementations strictes sur les essais cliniques et les médicaments

Argenx SE maintient Compliance à 100% avec les réglementations des essais cliniques. L'entreprise a investi 42,7 millions de dollars dans la conformité réglementaire et les infrastructures d'essais cliniques.

Métrique de la conformité réglementaire	Pourcentage de conformité	Investissement
Règlement sur les essais cliniques	100%	42,7 millions de dollars
Normes de développement de médicaments	100%	35,3 millions de dollars

Argenx SE (Argx) - Analyse du pilon: facteurs environnementaux

Engagement envers la recherche durable et les pratiques de laboratoire

Argenx SE a déclaré une réduction de 12,4% de la production de déchets en laboratoire en 2023. La consommation totale d'énergie de laboratoire a diminué de 8,7% par rapport à l'année précédente. La consommation d'eau dans les installations de recherche réduite de 6,2% grâce à des initiatives de conservation.

Métrique environnementale	Performance de 2023	Changement d'une année à l'autre
Réduction des déchets de laboratoire	12.4%	-5.3%
Consommation d'énergie	237 500 kWh	-8.7%
Utilisation de l'eau	145 000 gallons	-6.2%

Réduire l'empreinte carbone dans les opérations de recherche pharmaceutique

Argenx SE a investi 3,2 millions de dollars dans les technologies de réduction du carbone en 2023. Les émissions de gaz à effet de serre ont diminué de 9,6% entre les installations de recherche. Les sources d'énergie renouvelables représentent désormais 22,5% de la consommation totale d'énergie.

Métriques d'empreinte carbone	2023 données
Investissement de réduction du carbone	$3,200,000
Réduction des émissions de gaz à effet de serre	9.6%
Pourcentage d'énergie renouvelable	22.5%

Approvisionnement éthique des matériaux de recherche et des fournitures de laboratoire

Argenx SE implémenté Dépistage de la durabilité à 100% des fournisseurs. Les dépenses sur les achats durables ont atteint 7,5 millions de dollars en 2023. 85% des fournisseurs de laboratoire ont respecté les normes de conformité environnementale strictes.

Métriques d'approvisionnement durables	Performance de 2023
Dépenses d'achat durable total	$7,500,000
Prix ​​de durabilité des fournisseurs	100%
Fournisseurs répondant aux normes environnementales	85%

Accent croissant sur les processus de développement des médicaments pour l'environnement

Les initiatives de développement durable de la recherche et du développement ont entraîné une réduction de 15,3% de la production de déchets chimiques. Les protocoles de chimie verte ont mis en œuvre dans 76% des pipelines de développement de médicaments. Évaluation de l'impact environnemental réalisée pour 9 projets de recherche en cours.

Métriques de développement durable du développement de médicaments	2023 données
Réduction des déchets chimiques	15.3%
Couverture du protocole de chimie verte	76%
Évaluations d'impact environnemental	9 projets

argenx SE (ARGX) - PESTLE Analysis: Social factors

Growing patient advocacy and awareness for rare autoimmune diseases like generalized Myasthenia Gravis (gMG).

The social landscape for argenx SE is heavily influenced by the increasing sophistication of patient advocacy groups, particularly for rare autoimmune conditions like generalized Myasthenia Gravis (gMG). These groups are now powerful stakeholders, demanding not just better treatments, but also improved quality-of-life outcomes and a reduced treatment burden.

This heightened awareness directly fuels the market for targeted therapies like efgartigimod, the active ingredient in Vyvgart and Vyvgart Hytrulo. The company's 'Vision 2030' goal to reach 50,000 patients globally with its medicines is a direct response to this social pressure for broader access and efficacy. Patient preference studies, while showing that consistent disease control (82%) is the most important attribute in choosing a gMG therapy, still rank the mode of administration and dosing frequency as key secondary factors, driving the shift toward more convenient options.

Increased demand for convenient, subcutaneous (under-the-skin) treatments like Vyvgart Hytrulo over intravenous (IV) infusions.

The market is rapidly shifting toward subcutaneous (SC) delivery to improve patient convenience and adherence. The launch of Vyvgart Hytrulo (the SC formulation) addresses the significant social burden of IV infusions, which require time spent in an infusion center. The U.S. FDA approval of the Vyvgart Hytrulo pre-filled syringe (PFS) for self-injection in April 2025 is a major social catalyst, enabling at-home administration.

The strong momentum in 2025 is clearly tied to this convenience factor. While the IV formulation initially dominated the market, holding a 95.80% revenue share in 2024, the SC launch is now accelerating demand from new patients and prescribers, especially in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This is a clear opportunity for market share gain. We are seeing a defintely preference for less time spent in a clinic.

Focus on health equity and patient access to high-cost specialty drugs in emerging markets.

The social factor of health equity presents a significant challenge and opportunity. Specialty drugs like efgartigimod come with a high cost-the average annual cost per patient is often above $200,000-which severely restricts accessibility in developing countries and even for under-insured patients in the US.

argenx is mitigating this by expanding into underserved regions, including Asia, Latin America, and Eastern Europe, through local partnerships and patient access programs. Their Pre-Approval Access (PAA) program is a tangible effort to address this, having approved access for over 403 gMG patients in 14 countries in 2024 where the drug was not yet commercially available or reimbursed. This is a crucial social license to operate.

Physician and patient adoption rates of efgartigimod in new indications like Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are a key metric.

The social acceptance and adoption of efgartigimod (Vyvgart and Vyvgart Hytrulo) in new indications is vital for future growth. The U.S. launch for CIDP has been a major driver of sales in 2025, contributing to the $1.739 billion in global product net sales for the first half of the year.

As of July 2025, the launch of Vyvgart SC in CIDP had already progressed to include more than 2,500 patients on treatment globally. This rapid adoption rate demonstrates high social acceptance among neurologists and CIDP patients, especially since the U.S. market alone has an estimated 12,000 patients who remain inadequately controlled on standard of care. Furthermore, the company is actively expanding the social reach of the drug with ongoing Phase 3 studies in seronegative gMG and ocular MG, with topline results for seronegative gMG expected in the second half of 2025.

The table below summarizes the key social and commercial metrics driving the efgartigimod franchise in 2025:

Metric	Value (2025 Fiscal Year Data)	Social Implication
Global Product Net Sales (H1 2025)	$1.739 billion	High social acceptance and market penetration of a novel therapy.
Vyvgart SC (CIDP) Patients (as of July 2025)	Over 2,500 patients globally	Strong physician/patient adoption of the subcutaneous formulation for a new, debilitating indication.
Patient Preference: Consistent Disease Control	82% importance ranking	Efficacy is paramount; convenience (SC) is a strong secondary driver.
Annual Cost Per Patient (Estimate)	Above $200,000	Major social challenge for health equity and access, necessitating robust patient assistance programs.
Vision 2030 Patient Goal	50,000 patients globally	Long-term commitment to expanding patient reach and addressing unmet need in autoimmune diseases.

The immediate action is to monitor the Q3/Q4 2025 sales mix to see the precise acceleration rate of Vyvgart Hytrulo (SC) adoption following the US PFS approval in April. Finance: Track SC vs. IV revenue split for Q3 2025 by end of November.

argenx SE (ARGX) - PESTLE Analysis: Technological factors

The FcRn antagonist platform is a defintely validated technology, offering a distinct advantage in autoimmune diseases

The core technology, the neonatal Fc receptor (FcRn) antagonist platform, is argenx SE's primary technological moat, and it's defintely validated. Efgartigimod (Vyvgart) is the first-in-class FcRn blocker, and its success confirms the platform's potential to treat severe autoimmune diseases driven by pathogenic Immunoglobulin G (IgG) autoantibodies. The sheer commercial success in 2025 is the clearest proof: global product net sales hit $1.13 billion in the third quarter alone.

You can see the breadth of this technology in the pipeline. Argenx is actively evaluating efgartigimod in more than 15 severe autoimmune diseases, which is a massive technological expansion from the initial generalized myasthenia gravis (gMG) indication. This is not a one-hit wonder; it's a platform for a whole class of precision medicines.

Here's the quick math: the company's Vision 2030 is anchored on securing 10 labeled indications and treating 50,000 patients globally, a target that requires the FcRn platform to deliver multiple new approvals quickly.

Continuous innovation in drug delivery systems, moving from IV to the more convenient subcutaneous formulation

The company is smart about patient convenience, which is a key technological differentiator in a competitive market. The shift from an intravenous (IV) infusion to a subcutaneous (SC) injection, called Vyvgart Hytrulo in the U.S., is a major technological leap. This SC formulation uses Halozyme's ENHANZE® drug delivery technology (recombinant human hyaluronidase PH20) to make the biologic injectable under the skin.

The FDA approval of the pre-filled syringe (PFS) for self-injection in 2025, which was on track for an April PDUFA date, allows patients to treat themselves at home. This radically improves the patient experience and reduces the burden on infusion centers. For chronic inflammatory demyelinating polyneuropathy (CIDP) alone, the SC launch is already gaining traction, with more than 2,500 patients on treatment globally as of the second quarter of 2025.

Formulation	Key Technological Advancement	2025 Adoption/Status
Vyvgart (IV)	First-in-class FcRn blocker (efgartigimod alfa-fcab)	Q3 2025 Global Product Net Sales: $1.13 billion
Vyvgart Hytrulo (SC)	Subcutaneous delivery using Halozyme's ENHANZE® technology	U.S. Pre-filled syringe approval on track for April 2025; >2,500 CIDP patients on treatment globally by Q2 2025

Advancements in biomarker identification to better select patients for efgartigimod treatment

The future of precision medicine depends on knowing which patients will benefit most, and argenx is using biomarker identification to do just that. This is how you maximize the drug's value. Data presented at EULAR 2025, for example, showed clear mechanistic validation in Phase 2 studies for Myositis and Sjogren's disease.

Specifically, efgartigimod achieved a sustained total IgG reduction of approximately 60% and significant decreases in disease-specific autoantibodies. In Sjogren's disease, the anti-Ro52 autoantibody saw a decrease of -57% in treated patients versus an increase of +13% in the placebo group. This level of detail allows physicians to better select the right patient population, which is crucial for label expansion and clinical trial efficiency.

• Biomarkers showed ~60% sustained IgG reduction.
• Anti-Ro52 autoantibody reduced by -57% in Sjogren's patients.
• New data on autoantibody signatures in CIDP presented in October 2025.

Use of Artificial Intelligence (AI) in drug discovery to accelerate preclinical candidates beyond the FcRn class

While the FcRn platform is the current engine, argenx is investing in next-generation discovery to secure its long-term pipeline through its Immunology Innovation Program (IIP). This includes exploring advanced technologies like Artificial Intelligence (AI) to accelerate preclinical development. The global market for AI in drug discovery is expected to grow from approximately $2.6 billion in 2025 to a range of $8-20 billion by 2030, so this is a critical area of investment.

A concrete example of this forward-looking technology investment is the strategic collaboration argenx entered into with Unnatural Products (UNP) in 2025. This partnership is designed to expand argenx's discovery capabilities into the oral peptide space, which is a complex area where computational and AI-driven design is often necessary to find viable drug candidates. This is how they advance the next wave of innovation, including the four new pipeline molecules (like ARGX-213 and ARGX-121) for which they are filing Investigational New Drug (IND) applications in 2025.

argenx SE (ARGX) - PESTLE Analysis: Legal factors

Core Intellectual Property (IP) Protection for Efgartigimod is Strong

The foundation of argenx's commercial success, efgartigimod (marketed as Vyvgart and Vyvgart Hytrulo), rests on robust intellectual property (IP) protection that provides a significant competitive moat. This protection comes from both patents and regulatory exclusivity (a period where a competitor cannot gain approval based on the innovator's data). The regulatory exclusivity for Vyvgart and Vyvgart Hytrulo in the United States is expected to extend until December 2033.

In Europe, this key regulatory protection for the European Economic Area (EEA) is anticipated to expire in August 2032, with the UK following in March 2033. Beyond this regulatory shield, the company holds key patents, including one in the U.S. directed to methods of reducing serum levels of an Fc-containing agent, which is expected to expire in 2036. This layered protection is defintely crucial for sustaining pricing power and market share.

Ongoing and Potential Future Patent Infringement Litigation

The FcRn-targeting antibody class is a multi-billion-dollar market, so competition is fierce, and legal challenges are inevitable. While no specific, final patent infringement verdict against a named FcRn competitor has been reported in 2025, the risk of litigation remains a near-term reality. Competitors like UCB, with its FcRn drug rozanolixizumab, and others are developing therapies in the same class, creating a high probability of future patent disputes once biosimilar applications are filed.

Once the regulatory exclusivity periods expire (starting in 2032 in the EEA), argenx will be solely reliant on enforcing its patent rights against biosimilar products that infringe. This means the company must be prepared for costly and protracted legal battles under frameworks like the Biologics Price Competition and Innovation Act (BPCIA) in the U.S. to defend its core assets. The stakes are high, as a successful challenge could significantly accelerate the entry of lower-cost competitors.

Strict Compliance with Global Data Privacy Laws

Operating a global clinical development program across multiple indications means handling vast amounts of sensitive patient data, which mandates strict compliance with international data privacy laws. Argenx must navigate the distinct requirements of the European Union's General Data Protection Regulation (GDPR) and the U.S. Health Insurance Portability and Accountability Act (HIPAA).

To mitigate risk, the company employs rigorous de-identification methods for patient data:

• GDPR (EU/EEA): Uses pseudonymization for clinical trial and patient registry data.
• HIPAA (U.S.): Adheres to the safe harbor methodology for de-identifying protected health information.

Honesty, a single, major data breach could result in significant fines-up to 4% of annual global revenue under GDPR-plus irreparable damage to patient and physician trust. The cost of compliance and cybersecurity investment is a non-negotiable part of the $637 million in Research and Development expenses reported for the first half of 2025.

Navigating Complex US and International Regulatory Pathways

The regulatory environment is a critical legal factor, with key milestones in 2025 driving commercial expansion. The FDA's decision-making process dictates market access and product labeling, which directly impacts revenue potential.

Here's the quick math on 2025 regulatory activity:

Regulatory Action / Submission	Target Market	Date / Timeline	Impact
FDA Approval of Vyvgart Hytrulo (Prefilled Syringe)	U.S.	April 10, 2025	Enables patient self-injection, improving convenience and market uptake in gMG and CIDP.
sNDA Submission for Efgartigimod in AChR-Ab Seronegative gMG	U.S. (FDA)	Planned by End of 2025	Expands addressable market to a new, distinct patient population.
Fast Track Designation (FTD) for Primary Sjögren's Disease	U.S. (FDA)	Granted June 2025	Accelerates development and review timeline for a new indication.
Registrational Studies Ongoing	Global	10 ongoing in 2025	Drives the next wave of label expansions and global approvals across multiple autoimmune diseases.

The company is on track to be approved or in development in 15 autoimmune indications by 2025 for efgartigimod alone, which means a constant, high-volume interaction with global health authorities. Plus, they plan to file four new Investigational New Drug (IND) applications by the end of 2025 for pipeline candidates, starting the regulatory process for future blockbusters. That's a massive legal and regulatory workload.

argenx SE (ARGX) - PESTLE Analysis: Environmental factors

Need to establish a clear, measurable plan for reducing the carbon footprint of drug manufacturing and distribution.

The core challenge for argenx is the sheer volume of its Scope 3 emissions, which represent the vast majority of its carbon footprint. In the 2024 fiscal year (reported in 2025), the company's total greenhouse gas (GHG) emissions were 231,769 metric tons of CO₂ equivalent (tCO₂e) (market-based). This enormous figure is dominated by indirect emissions from the value chain, which is typical for a biopharma company that relies on contract manufacturing.

The good news is that Scope 3 emissions decreased by 47.45% from 2023, showing progress in tracking and managing the supply chain. However, a significant risk remains: as of the 2024 Annual Report, argenx has not yet developed a climate transition plan for mitigation, nor has it set specific, measurable reduction targets for its GHG emissions. This lack of a formal, public target is a material risk in a market increasingly focused on climate action.

GHG Emission Category (2024 Data)	Amount (tCO₂e)	Impact Analysis
Total GHG Emissions (Market-Based)	231,769	The company's overall footprint.
Scope 1 (Direct Operations)	3,788	Increased by 902.12% from 2023, primarily from leased employee vehicles.
Scope 2 (Purchased Energy)	534	Relatively small, suggesting energy efficiency or clean energy sourcing at leased sites.
Scope 3 (Value Chain)	227,447	Represents over 98% of total emissions; decreased by 47.45% from 2023.
Scope 3 - Purchased Goods and Services	183,781	The single largest source, accounting for 81% of all Scope 3 emissions.

Increasing investor and stakeholder pressure for comprehensive Environmental, Social, and Governance (ESG) reporting.

Investor scrutiny on ESG performance is intensifying, particularly under the new European Union's Corporate Sustainability Reporting Directive (CSRD) and European Sustainability Reporting Standards (ESRS). argenx is now required to align its 2024 reporting with these standards, which mandates a double materiality assessment (considering both financial and impact materiality).

The company's current ESG ratings reflect a mixed picture, which increases pressure to improve the 'E' component:

• MSCI ESG Rating: AA (Strong performer).
• S&P Global ESG Score: 43 (As of October 1, 2025).
• ESG Risk Rating: 24.86 (Medium Risk, as of August 14, 2025).

To be fair, the company's strong financial performance-with Q2 2025 global product net sales hitting $949 million-gives it the financial flexibility to invest heavily in a robust environmental strategy. The market will defintely expect a formal climate transition plan in the next reporting cycle to justify these high ratings.

Safe disposal protocols for biological waste generated from manufacturing and patient administration of the therapy.

The nature of argenx's product, a biologic like Vyvgart, means that biological waste management is a critical environmental and safety issue. This waste is generated both at the manufacturing stage and during patient administration, particularly with the intravenous (IV) formulation of Vyvgart.

The company has established clear protocols for its Belgium operations, which include:

• Biological Waste: Collected separately and handled via incineration with energy recuperation.
• Hazardous Waste: Includes expired medications, chemical solvents, and contaminated packaging, which are subject to strict regulatory compliance and managed by specialized processors.
• Medical Waste Volume: The latest available benchmark (2023) shows 3,420 kg of medical waste generated.

The shift toward the subcutaneous (SC) formulation, Vyvgart SC (Vyvgart Hytrulo), and the new pre-filled syringe (PFS) for self-injection, approved in the U.S. and EU in 2025, is a positive step. This shift moves the point of disposal from a centralized clinic to the patient's home, which necessitates a robust, patient-friendly, and compliant take-back or disposal program to manage the biohazardous sharps and packaging waste at scale.

Sustainable sourcing of materials used in the production and packaging of Vyvgart.

Sustainable sourcing is a major opportunity to address the huge Scope 3 footprint, where Purchased Goods and Services account for $183,781 tCO₂e. For Vyvgart, this includes raw materials, single-use bioreactor components, and packaging.

While specific metrics on recycled content or packaging weight reduction are not yet disclosed, the strategic focus is on reducing the material footprint through product innovation:

• Product Innovation: The launch of the Vyvgart SC pre-filled syringe (PFS) in 2025 is a key action. The PFS format inherently uses less material and energy for administration compared to the traditional intravenous (IV) bag and tubing setup, plus it simplifies logistics.
• Supply Chain Focus: The company acknowledges the negative impact of single-use products and disposable medical devices in its research and manufacturing. Addressing the $183,781 tCO₂e from purchased goods will require deep engagement with contract manufacturing and logistics partners to push for sustainable materials and energy efficiency in their operations.

What this estimate hides is the lack of public transparency on supplier-side environmental performance-a crucial next step for a company whose main environmental impact is outside its direct control.