Miserrer & Co., Inc. (MRK): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le paysage complexe et en constante évolution des produits pharmaceutiques mondiaux, Merck & Co., Inc. se tient à l'intersection de l'innovation révolutionnaire et des défis multiformes. 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. De la navigation sur les incertitudes réglementaires pour exploiter les progrès technologiques de pointe, le parcours de Merck reflète la nature dynamique des soins de santé modernes et des industries pharmaceutiques, offrant un récit convaincant de résilience, d'innovation et d'adaptation stratégique dans un marché mondial en évolution rapide.

Miserrer & Co., Inc. (MRK) - Analyse du pilon: facteurs politiques

Les changements de politique de santé américains ont un impact sur la réglementation pharmaceutique et la tarification des médicaments

La loi sur la réduction de l'inflation de 2022 a un impact direct sur les stratégies de tarification pharmaceutique de Merck, permettant à Medicare de négocier des prix pour certains médicaments à coût élevé. En 2023, les 10 premiers médicaments soumis à des négociations de prix ont été annoncés, affectant potentiellement les sources de revenus de Merck.

Impact politique	Conséquences financières estimées
Medicare Drug Price Négociation	Réduction potentielle des revenus de 1,5 à 2,3 milliards de dollars par an
Exigences de transparence des prix du médicament	Coûts de conformité estimés à 75 à 120 millions de dollars

Les tensions commerciales mondiales affectent l'accès au marché pharmaceutique international

Les tensions commerciales américaines-chinoises continuent de créer des défis pour l'accès au marché pharmaceutique et la collaboration internationale de recherche.

• Tarifs d'importation en Chine sur les produits pharmaceutiques: fourchette de 3 à 17%
• Exportations pharmaceutiques américaines vers la Chine en 2023: 4,2 milliards de dollars
• Les revenus internationaux de Merck affectés par les restrictions commerciales

Les changements géopolitiques en cours influencent la collaboration de recherche

Région géopolitique	Impact de la collaboration de recherche	Montant d'investissement
Union européenne	Augmentation des exigences de conformité réglementaire	350 millions de dollars d'investissements de conformité supplémentaires
Asie-Pacifique	Transfert de technologie restreinte	Limitation potentielle des revenus de 275 millions de dollars

La position du gouvernement américain sur les prix des médicaments et la réforme des soins de santé

L'incertitude réglementaire continue de contester la planification stratégique de Merck. L'accent mis par l'administration Biden sur la réduction des coûts pharmaceutiques crée une volatilité importante du marché.

• Les réformes proposées des prix des médicaments pourraient avoir un impact sur 20 à 30% des médicaments à coût élevé de Merck
• Réduction potentielle des revenus: 3,4 à 5,2 milliards de dollars
• Augmentation des coûts de conformité réglementaire: 250 à 400 millions de dollars par an

Miserrer & Co., Inc. (MRK) - Analyse du pilon: facteurs économiques

Les dépenses de santé mondiales fluctuantes ont un impact sur les revenus pharmaceutiques

Les dépenses de santé mondiales ont atteint 9,4 billions de dollars en 2022, avec une croissance projetée à 11,8 billions de dollars d'ici 2026. Les revenus pharmaceutiques mondiaux de Merck en 2023 étaient 60,8 milliards de dollars, représentant un Augmentation de 5,7% de l'année précédente.

Année	Dépenses de santé mondiales	Merck Revenue
2022	9,4 billions de dollars	57,5 milliards de dollars
2023	9,8 billions de dollars	60,8 milliards de dollars
2024 (projeté)	10,2 billions de dollars	64,2 milliards de dollars

L'inflation et la volatilité économique affectent l'investissement de la recherche et du développement

Les dépenses de R&D de Merck en 2023 étaient 14,2 milliards de dollars, représentant 23.3% du total des revenus. Impact du taux d'inflation sur les coûts de R&D pharmaceutique estimés à 4.2% annuellement.

Variations de taux de change impact la performance du marché international

Devise	Fluctuation du taux de change (2023)	Impact sur les revenus internationaux de Merck
Euro	-2.3%	1,4 milliard de dollars
Yen japonais	-1.8%	0,9 milliard de dollars
Livre britannique	+1.5%	0,7 milliard de dollars

La hausse des coûts des soins de santé influence les stratégies de tarification des produits pharmaceutiques

L'augmentation moyenne des prix des produits pharmaceutiques en 2023 était 4.5%. L'ajustement moyen des prix du produit de Merck était 3.8%, avec des stratégies clés de tarification des produits:

• Prix ​​de KeyTruda: 178 000 $ par an
• Prix ​​de Januvia: 6 300 $ par an
• Prix ​​de Gardasil: 390 $ par dose

Miserrer & Co., Inc. (MRK) - Analyse du pilon: facteurs sociaux

Le vieillissement de la population mondiale augmente la demande de traitements de maladies chroniques

D'ici 2050, la population mondiale âgée de 65 ans et plus devrait atteindre 1,5 milliard, ce qui représente 16% de la population mondiale totale. Ce changement démographique a un impact direct sur la demande pharmaceutique de traitements de maladies chroniques.

Groupe d'âge	Projection de population	Prévalence des maladies chroniques
65-74 ans	727 millions	42,3% ont plusieurs conditions chroniques
75-84 ans	425 millions	54,7% ont besoin de traitements médicaux spécialisés
85 ans et plus	348 millions	67,2% Gérer les problèmes de santé complexes

La sensibilisation à la santé croissante entraîne des médicaments personnalisés et des soins préventifs

Le marché mondial de la médecine personnalisée devrait atteindre 796,8 milliards de dollars d'ici 2028, avec un TCAC de 6,2%. L'investissement de Merck dans la médecine de précision s'aligne sur cette tendance.

Segment de marché	2024 Valeur projetée	Taux de croissance
Médecine personnalisée	416,5 milliards de dollars	6,2% CAGR
Soins de santé préventifs	344,2 milliards de dollars	5,8% CAGR

L'accent accru sur la santé mentale élargit les opportunités de marché pharmaceutique

Le marché mondial de la santé mentale devrait atteindre 537,97 milliards de dollars d'ici 2030, le segment antidépresseur augmentant à 3,5% par an.

Segment de santé mentale	2024 Taille du marché	Croissance projetée
Traitements de dépression	18,4 milliards de dollars	3,5% CAGR
Troubles anxieux	15,7 milliards de dollars	4,2% CAGR

Les changements démographiques créent de nouveaux segments de marché pour des médicaments spécialisés

Le marché mondial du traitement des maladies rares devrait atteindre 442,8 milliards de dollars d'ici 2027, avec un TCAC de 7,9%.

Segment démographique	Valeur marchande	Prévalence du traitement
Maladies rares pédiatriques	126,3 milliards de dollars	5,6% de part de marché
Traitements spécialisés gériatriques	187,5 milliards de dollars	8,3% de part de marché

Miserrer & Co., Inc. (MRK) - Analyse du pilon: facteurs technologiques

La recherche génomique avancée permet le développement de la médecine de précision

Merck a investi 12,2 milliards de dollars en R&D en 2023, avec une allocation importante à la recherche génomique. Le portefeuille de médecine de précision de l'entreprise comprend 17 thérapies ciblées sur les plateformes d'oncologie et d'immunologie.

Domaine de recherche	Investissement ($ m)	Programmes actifs
Oncologie génomique	3,750	8
Génomique immunologique	2,450	6
Génomique des maladies rares	1,650	3

L'intelligence artificielle accélère les processus de découverte et de développement de médicaments

Merck a déployé 425 millions de dollars spécifiquement pour les technologies de l'IA et de l'apprentissage automatique dans la découverte de médicaments en 2023. Les plates-formes axées par l'IA de l'entreprise ont réduit les délais de développement de médicaments d'environ 32%.

Technologie d'IA	Investissement ($ m)	Amélioration de l'efficacité
Dépistage moléculaire AI	175	28%
Modélisation prédictive	135	35%
Optimisation des essais cliniques	115	32%

Les technologies de santé numérique transforment les méthodologies des essais cliniques

Merck a mis en place des technologies de santé numérique dans 42 essais cliniques en 2023, réduisant les coûts des essais de 27% et accélérant le recrutement des patients de 35%.

Technologie de santé numérique	Les essais mis en œuvre	Réduction des coûts
Plateformes de télémédecine	18	22%
Surveillance à distance des patients	15	31%
Dépistage des patients dirigés par l'IA	9	35%

L'investissement accru dans la biotechnologie et l'analyse des données stimule l'innovation

Merck a alloué 2,8 milliards de dollars aux innovations de biotechnologie et d'analyse de données en 2023, en mettant l'accent sur les plateformes technologiques émergentes.

Zone d'innovation	Investissement ($ m)	Focus stratégique
Technologie CRISPR	650	Édition de gènes
Analyse de données avancée	1,250	Soins de santé prédictifs
Biologie synthétique	900	Nouvel développement thérapeutique

Miserrer & Co., Inc. (MRK) - Analyse du pilon: facteurs juridiques

Règlements rigoureux de la FDA régissant les approbations de produits pharmaceutiques

Merck fait face à des exigences réglementaires rigoureuses de la FDA pour l'approbation des médicaments. En 2024, le taux d'approbation de la demande de médicament de la FDA (NDA) est d'environ 12%. Le coût moyen de la mise sur le marché d'un nouveau médicament grâce à l'approbation de la FDA est de 2,6 milliards de dollars.

Métrique réglementaire de la FDA	Statistiques actuelles
Temps de révision NDA moyen	10,1 mois
Taux de réussite de l'approbation de la FDA	12%
Coût de développement de médicaments	2,6 milliards de dollars

Protection de la propriété intellectuelle

Portefeuille de brevets de Merck est essentiel pour maintenir un avantage concurrentiel. En 2023, Merck détenait 16 740 brevets actifs dans le monde. La société a investi 12,2 milliards de dollars dans la recherche et le développement en 2023.

Métrique de la propriété intellectuelle	2023 données
Brevets actifs totaux	16,740
Investissement en R&D	12,2 milliards de dollars
Cas de litiges en matière de brevet	37

Lois internationales de brevets

Merck opère dans 140 pays, naviguant des réglementations complexes des brevets internationaux. La stratégie mondiale des brevets de l'entreprise consiste à gérer la propriété intellectuelle dans plusieurs juridictions.

Métrique brevet internationale	Statistiques actuelles
Pays d'opération	140
Déposages de brevets internationaux	623
Actions d'application des brevets	42

Litige de responsabilité pharmaceutique sur les produits

Merck fait face à des risques de litige en cours. En 2023, la Société comptait 412 affaires juridiques actives, avec une exposition à la responsabilité potentielle estimée à 3,8 milliards de dollars.

Métrique du litige	2023 données
Affaires juridiques actives	412
Exposition à la responsabilité potentielle	3,8 milliards de dollars
Dépenses de défense juridique	456 millions de dollars

Miserrer & Co., Inc. (MRK) - Analyse du pilon: facteurs environnementaux

Pratiques de fabrication durables

Miserrer & Co. a déclaré une réduction de 32,4% des émissions de gaz à effet de serre absolues de 2019 à 2022. La société a investi 87,3 millions de dollars dans les initiatives de durabilité environnementale en 2023.

Métrique environnementale	2022 données	Cible 2023
Consommation totale d'eau	38,2 millions de mètres cubes	35,5 millions de mètres cubes
Consommation d'énergie renouvelable	22.7%	30% d'ici 2025
Réduction des déchets	28,6% de réduction	Objectif de réduction de 35%

Réduction de l'empreinte carbone

Merck a engagé 150 millions de dollars dans les efforts de neutralité du carbone, ciblant 100% d'électricité renouvelable d'ici 2025. Les émissions 1 et 2 des étendus étaient de 1,2 million de tonnes métriques CO2E en 2022.

Conformité environnementale réglementaire

Les frais de conformité environnementale pour Merck en 2023 ont atteint 42,6 millions de dollars. La Société n'a reçu aucune citation de violation environnementale majeure des organismes de réglementation.

Métrique de la conformité réglementaire	2023 données
Dépenses de conformité environnementale	42,6 millions de dollars
Incidents à signaler EPA	3 incidents mineurs
Audit environnemental a réussi	Compliance à 100%

Impact de la recherche sur le changement climatique

Merck a alloué 63,4 millions de dollars à la recherche sur la santé liée au climat en 2023. La société a identifié 7 programmes de recherche clés concernant les implications sur la santé du changement climatique.

• Recherche de migration des maladies tropicales
• Études sur les conditions de santé liées à la chaleur
• Prévention des maladies à transmission vectorielle
• Recherche sur les maladies respiratoires induites par le climat

Merck & Co., Inc. (MRK) - PESTLE Analysis: Social factors

Rapid aging population increasing demand for oncology and chronic disease treatments

The demographic shift toward an older global population is a massive tailwind for Merck & Co., Inc., particularly for its oncology and chronic disease portfolio. You're looking at a structural change, not a cyclical one. The population aged 65 and older is projected to grow by almost 3% annually through 2030, and by 2030, about 1 in 6 people globally will be aged 60 or over. That means a higher prevalence of age-related conditions like cancer and cardiovascular issues.

In the U.S. alone, about 93% of adults aged 65 and older had at least one chronic condition in 2023, with nearly 79% living with multiple chronic conditions. This translates directly into sustained demand for drugs like Keytruda, Merck & Co., Inc.'s flagship oncology product. Keytruda sales in the first quarter of 2025 were already strong at $7.2 billion, growing 6% year-over-year, and then hit $8.0 billion in the second quarter, a 9% growth. The global chronic disease treatment market size itself grew to $9.74 billion in 2025, underscoring the immediate opportunity.

Here's the quick math on the opportunity:

• The aging cohort is the primary consumer of complex, high-margin treatments.
• Chronic disease treatment market growth is at a 16.34% CAGR from 2025 to 2034.
• Merck & Co., Inc. is investing over $70 billion in domestic R&D and manufacturing starting in 2025 to capture this growth.

Growing public demand for vaccine accessibility and affordability worldwide

Public health is increasingly focused on prevention, driving a strong market for vaccines, especially for adults. Adult immunization now accounts for the majority of vaccine sales worldwide, representing over 75% of the global vaccine market in 2024, and that share is increasing in 2025. This is a huge shift from a purely pediatric focus.

The global vaccines market is projected to grow from $78.9 billion in 2025 to $145.8 billion by 2034, a compound annual growth rate (CAGR) of 7.1%. Merck & Co., Inc. is a major player, but the social demand for affordability and access is a real pressure point, particularly in emerging markets. For example, sales of Merck & Co., Inc.'s major vaccine, Gardasil/Gardasil 9, were $1.1 billion in the second quarter of 2025, but that was a steep 55% decline, partially due to factors like reduced sales in China. This volatility shows that government procurement and public policy on pricing are critical risks.

The company is responding by bringing new products to market, like the FDA approval of ENFLONSIA for the prevention of Respiratory Syncytial Virus (RSV) in infants, which directly addresses a high-profile public health need in 2025.

Increased focus on health equity and diverse clinical trial participation

The social expectation and regulatory pressure to ensure health equity are now non-negotiable for big pharma. Regulators, including the FDA, have established requirements for diverse representation in clinical trials, pushing companies to implement formal Diversity Plans.

Merck & Co., Inc. has a dedicated 'Diversity, Equity & Inclusion (DE&I) in Clinical Trials' approach, which was rolled out in 2022. The goal is to ensure the trial population reflects the population that will actually use the medicine. By 2022, approximately 50% of Merck & Co., Inc.'s clinical trial patients were from diverse backgrounds, both in the U.S. and globally. What this estimate hides is the ongoing difficulty in sustaining this representation, especially for historically underrepresented groups like Black and Hispanic people who have been systematically under-represented in past studies.

The company has a cumulative goal to enable 'more people' to access innovative medicines and vaccines in markets as of 2025, compared to a 2020 baseline, which is a clear response to this social factor. Honestly, this is about building trust and ensuring efficacy across all populations. It's defintely the right move.

Lifestyle changes influencing the prevalence of metabolic diseases

The global rise in non-communicable diseases (NCDs) driven by urbanization, sedentary lifestyles, and poor diet creates a huge market, but also a social burden. This factor is a double-edged sword: massive opportunity, but also intense scrutiny on drug pricing and public health responsibility.

The statistics for metabolic diseases in the U.S. are alarming as of 2025:

Condition	U.S. Adult Prevalence (2025 Data)	Global Context
High Blood Pressure	Nearly 47%	Cardiovascular diseases were the biggest revenue share (approx. 34%) of the chronic disease treatment market in 2024.
Unhealthy Weight (BMI ≥25)	More than 72%	Nearly 60% of adults globally have an unhealthy weight.
Obesity (BMI ≥30)	Nearly 42%	Globally, obesity accounted for 72 million bisphenol-related metabolic disease cases in 2024.
Diabetes/Prediabetes (Type 2)	More than 57%	The International Diabetes Federation (IDF) Diabetes Atlas (2025) reports 11.1% (1 in 9) of the adult population (20-79 years) is living with diabetes.

Merck & Co., Inc. is actively targeting this space, which is smart. They announced a license agreement for an investigational oral lipoprotein(a) inhibitor targeting cardiovascular disease in 2025 and are developing Enlicitide Decanoate for hyperlipidemia (high cholesterol). The chronic disease treatment market's expected CAGR of 16.34% from 2025 to 2034 shows this is where the money is going, so their pipeline is well-aligned.

Merck & Co., Inc. (MRK) - PESTLE Analysis: Technological factors

Significant investment in mRNA technology for non-infectious disease applications

Merck & Co., Inc. is making substantial technological bets on next-generation nucleic acid platforms, which is critical for future growth beyond traditional small molecules and biologics. This is more than just vaccines; it's about using the body's own machinery to create therapeutic proteins. The core investment is a potential $3.5 billion collaboration with Orna Therapeutics, focused on circular RNA (oRNA), a technology that could offer advantages over linear messenger RNA (mRNA) in stability and protein production.

While the most prominent mRNA program is the personalized cancer vaccine, intismeran autogene (V940/mRNA-4157), with Moderna, Merck is also strategically positioned to capitalize on its partner's broader pipeline. Moderna's pipeline, which uses the same underlying technology, includes candidates for non-infectious diseases like cardiovascular disease and rare genetic disorders such as Propionic Acidemia and Methylmalonic Acidemia. This R&D diversification is how you hedge against the inevitable patent cliffs.

Use of Artificial Intelligence (AI) to accelerate drug discovery and clinical trial design

The company is aggressively integrating Artificial Intelligence (AI) and machine learning to streamline the notoriously slow drug development process. Honestly, this is one of the most immediate, high-impact technological changes in the industry right now. Merck is using an internal generative-AI-powered platform that directly impacts regulatory timelines.

For example, the platform has reduced the time needed to create a fully human-reviewed first draft of a Clinical Study Report (CSR)-a critical regulatory document-from an average of 180 hours to 80 hours. Plus, the AI has increased the quality of these drafts by reducing the number of errors by 50%. This isn't just a cost saver; it accelerates the entire pipeline, getting new treatments to market faster.

AI Application Metric (2025)	Traditional Method	AI-Powered Platform	Improvement
Time to create CSR first draft	Average of 180 hours	80 hours	Reduction of 100 hours
Quality of CSR drafts	Baseline Error Rate	Error Rate reduced by 50%	Significant quality increase

Expansion of the blockbuster Keytruda (pembrolizumab) into new indications

Keytruda remains the technological anchor, and its continued expansion into new indications is a massive driver of revenue. For the first nine months of 2025, Keytruda sales reached $23.3 billion, with full-year sales projected to hit $32.2 billion. The strategy is to move the drug into earlier lines of treatment and combination therapies, expanding the eligible patient population.

In 2025 alone, the FDA approved Keytruda for new indications, including:

• FDA approval in November 2025 for use with Padcev (enfortumab vedotin-ejfv) as a perioperative treatment for cisplatin-ineligible muscle-invasive bladder cancer.
• FDA approval in June 2025 for resectable locally advanced head and neck squamous cell carcinoma.
• Positive Phase III data in August 2025 for muscle-invasive bladder cancer.

This continuous expansion, now spanning over 30 indications, is a testament to the underlying technological versatility of PD-1 inhibition.

Need to defend against biosimilar development through formulation innovation

The biggest near-term technological risk is the impending patent expiration for Keytruda's intravenous (IV) formulation around 2028. To mitigate the projected 30-60% erosion of sales by biosimilars, Merck has executed a classic technological defense strategy: formulation innovation.

The company secured a critical win with the subcutaneous (SC) formulation, Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph), which received FDA approval in September 2025 across all solid tumor indications. This new formulation is a game-changer for patient convenience. The SC injection can be administered in as little as one minute, drastically faster than the approximately 30 minutes required for the IV infusion. Analysts are projecting a 30-40% conversion rate of patients to the SC version within two years of launch. Furthermore, Merck has built a substantial patent thicket around the drug, with nearly 300 patent applications filed and over 100 granted patents to delay generic competition.

Merck & Co., Inc. (MRK) - PESTLE Analysis: Legal factors

Impending patent expiration risks for key revenue drivers like Keytruda

The single largest legal risk for Merck & Co., Inc. is the impending loss of exclusivity (LOE) for its flagship oncology drug, Keytruda (pembrolizumab). This isn't just a business problem; it's a legal one, as the expiration of core patents opens the door to biosimilar competition and a sharp revenue decline. Keytruda generated an estimated $29.5 billion in sales in 2024, accounting for over 40% of Merck's total revenue. The primary U.S. patent is expected to expire at the end of 2028, with European exclusivity lasting until 2031.

To be fair, Merck is fighting this patent cliff with a legal and regulatory strategy called 'lifecycle management.' This involves developing a new subcutaneous (SC) formulation of Keytruda, which is a key move to differentiate the product from intravenous biosimilars. Regulatory submissions for this SC version are expected in 2025, but this strategy is already mired in litigation. For instance, in April 2025, Halozyme Therapeutics Inc. filed an intellectual property (IP) lawsuit against Merck, alleging infringement over the technology used in the new, easier-to-use SC version. This is a defintely a high-stakes legal battle.

Here's the quick math on the patent cliff risk for key products:

Product	Primary Therapeutic Area	Expected U.S. Loss of Exclusivity (LOE)	2024 Revenue (Approximate)
Keytruda	Oncology	End of 2028	$29.5 billion
Januvia & Janumet	Diabetes	2026	(Significant revenue at risk)
Lynparza (in partnership)	Oncology	2027	(Shared revenue at risk)
Gardasil/Gardasil 9	Vaccine (HPV)	2028	(Significant revenue at risk)

Increasing regulatory burden from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

The regulatory environment is getting more complex and costly, particularly in the U.S. The most significant near-term financial threat is the Inflation Reduction Act (IRA), which introduces government price-setting for certain high-cost Medicare drugs. Merck was one of the first drugmakers to sue the U.S. government over the IRA, claiming constitutional violations.

The impact is already being felt on older, high-selling drugs:

• The IRA is set to impose a 79% Medicare price cut on Merck's diabetes drug Januvia starting in 2026.
• Price negotiations for Janumet and Janumet XR are starting in 2025, with negotiated prices taking effect in 2027.
• Keytruda is expected to be selected for the IRA government price-setting process in 2026, with negotiated prices taking effect in January 2028, compounding the impact of the patent expiration.

Also, a growing patchwork of state-level regulations adds administrative burden. For example, in 2025, Merck, along with other pharma companies, voiced opposition to new state laws, like Minnesota's, that regulate the use of PFAS (Per- and polyfluoroalkyl substances) in manufacturing and packaging, arguing the varying state requirements are inconsistent with federal law and create unworkable deadlines. You have to manage a federal agency and fifty state legislatures; it's a lot.

Ongoing litigation related to product liability and intellectual property infringement

Merck faces a constant stream of litigation that ties up resources and poses financial risk, not just from future patent cliffs but from past products and IP disputes. On the IP front, Merck has been aggressive in defending its crown jewel, successfully convincing the Patent Trial and Appeal Board (PTAB) in November 2025 to invalidate the last of nine patents owned by Johns Hopkins University that were at issue in a Keytruda-related lawsuit.

However, product liability cases continue to be a drain. As of December 31, 2024, the company was a defendant in two major categories of product liability lawsuits in the U.S.:

• Gardasil: Approximately 225 cases were pending in federal or state court, alleging various personal injuries following vaccination with Gardasil or Gardasil 9.
• Asbestos-contaminated talc: Approximately 415 cases were pending in various state courts, alleging plaintiffs developed mesothelioma due to exposure.

While Merck's legal team believes the likelihood of a material loss from these product liability cases is remote, the sheer volume of cases represents a significant operational cost in legal defense and potential settlement provisions. You can't ignore hundreds of active lawsuits.

Data privacy regulations (e.g., GDPR) governing patient data handling

As a global pharmaceutical company, Merck handles vast amounts of sensitive patient data, making it highly susceptible to evolving data privacy laws. Merck Group's global data privacy principles are explicitly based on the European General Data Protection Regulation (GDPR), which applies to all its businesses worldwide.

The financial and legal risk here is substantial, as GDPR penalties can reach up to €20 million or 4% of a company's global annual turnover, whichever is higher. In 2025, compliance is getting tougher due to the emergence of:

• GDPR 3.0: Stricter consent rules and extended liability, making cloud providers jointly liable for customer data breaches.
• US State Laws: A growing patchwork of stringent US state laws, requiring regional compliance teams.
• EU Data Act (EDA): The EDA, which came into force in September 2025, changes how companies must handle data from connected products, requiring operational and contractual changes.

Merck must continually invest in its global data privacy framework to ensure the secure and compliant processing of clinical trial data, patient information, and marketing data, especially as the regulatory landscape for health data and artificial intelligence (AI) governance continues to tighten globally.

Merck & Co., Inc. (MRK) - PESTLE Analysis: Environmental factors

Pressure from investors and public on achieving net-zero carbon emissions targets

You're seeing intense pressure from institutional investors and the public for pharmaceutical companies to commit to and, more importantly, execute on net-zero targets. Merck & Co., Inc. is responding with a clear, Science Based Targets initiative (SBTi)-aligned roadmap, but the real work-and risk-lies in Scope 3 emissions (the value chain).

The company has committed to achieving net-zero greenhouse gas (GHG) emissions across its global operations (Scopes 1, 2, and 3) by 2045. That's the long-term goal. For the near-term, the focus is on a major shift in energy sourcing and operational efficiency, and the 2025 target is critical. They are aiming to source 100% of their purchased electricity from renewable sources by the end of 2025. This is a huge undertaking, but it's defintely the right move to de-risk future carbon taxes and energy price volatility.

Here's the quick math on the mid-term targets, using a 2019 baseline:

• Reduce Scope 1 & 2 (direct operations) GHG emissions by $\geq$46% by 2030.
• Reduce Scope 3 (value chain) GHG emissions by $\geq$30% by 2030.

Stricter waste disposal regulations for pharmaceutical manufacturing by-products

The regulatory environment for pharmaceutical waste, especially for active pharmaceutical ingredients (APIs) and manufacturing by-products, is only getting tighter globally. Merck & Co., Inc. has been proactive here, which is a significant operational advantage. The company's 2025 goals are actually being exceeded ahead of schedule, which is a good sign of operational discipline.

Their key strategy is waste diversion, which means keeping waste out of landfills and incinerators without energy recovery. The original 2025 goal was to send $\leq$20% of global operational waste to these disposal methods. The latest data shows they are already performing better than this target.

The table below shows the waste diversion progress, which is a clear opportunity for Merck & Co., Inc. to market its environmental stewardship to B2B partners and regulators:

Waste Metric	2023 Performance	2024 Performance	2025 Target
Operational Waste to Landfill/Incineration (without energy recovery)	15%	11%	$\leq$20%
Sites Sending Zero Waste to Landfill	55%	63%	$\geq$50%

Integration of environmental, social, and governance (ESG) metrics into executive compensation

Linking executive pay to environmental, social, and governance (ESG) performance is no longer a fringe idea; it's a standard for S&P 500 companies, and Merck & Co., Inc. is fully on board. The Compensation and Management Development (C&MD) Committee for the Board reviews and approves corporate goals, including Sustainability Metrics, for executive officer compensation.

While the specific weighting for environmental metrics in the 2025 Named Executive Officer (NEO) Annual Incentive Plan (AIP) Scorecard often focuses on broader 'Sustainability' goals like Access to Health and employee engagement, the strategic integration is clear. The company also integrates climate targets into its Capital Expenditure (CapEx) process, for example, by using an internal $\text{CO}_2$ price. This means that every major investment decision is now filtered through an environmental cost lens, which is a powerful, non-financial driver of change. You can't separate the environmental risk from the financial one anymore.

Scrutiny over water usage in manufacturing processes, especially in water-stressed regions

Water is a critical input in pharmaceutical manufacturing, and the industry is under increasing scrutiny for its withdrawal, especially in regions facing drought or water stress. Merck & Co., Inc.'s strategy is to manage its total water footprint against a fixed historical baseline, regardless of production growth.

The company's 2025 goal is to maintain global water use at or below 2015 levels. The 2015 baseline for total water use was 23 million $\text{m}^3$. The most recent full-year data shows they are well on track, which mitigates a major operational risk.

Here's the breakdown:

• 2015 Baseline Water Use: 23 million $\text{m}^3$
• 2024 Total Water Use: 19.3 million $\text{m}^3$
• Status: Water use in 2024 was 3.7 million $\text{m}^3$ (or 16%) below the 2015 baseline.

What this estimate hides is the local risk. Even with a lower total, a concentration of water usage in an 'extremely high or high stress' region, as defined by the WRI Aqueduct Water Risk Atlas, could still lead to local operational shutdowns or public backlash. Merck & Co., Inc. reported that only 0.1 million $\text{m}^3$ of its 2024 groundwater use came from these high-stress areas, which shows a focused effort to manage that local exposure.