Merck & Co., Inc. (MRK): Análisis PESTLE [Actualizado en Ene-2025]

En el paisaje complejo y en constante evolución de los productos farmacéuticos globales, Merck & Co., Inc. se encuentra en la intersección de innovación innovadora y desafíos multifacéticos. Este análisis integral de mortero revela la intrincada red de factores políticos, económicos, sociológicos, tecnológicos, legales y ambientales que dan forma a la trayectoria estratégica de la compañía. Desde la navegación de las incertidumbres regulatorias hasta el aprovechamiento de los avances tecnológicos de vanguardia, el viaje de Merck refleja la naturaleza dinámica de la atención médica y las industrias farmacéuticas modernas, ofreciendo una narración convincente de resiliencia, innovación y adaptación estratégica en un mercado global que cambia rápidamente.

Merck & Co., Inc. (MRK) - Análisis de mortero: factores políticos

Los cambios en la política de salud de los Estados Unidos impactan la regulación farmacéutica y los precios de los medicamentos

La Ley de Reducción de Inflación de 2022 impacta directamente en las estrategias de precios farmacéuticos de Merck, lo que permite a Medicare negociar los precios de ciertos medicamentos de alto costo. En 2023, se anunciaron los primeros 10 medicamentos sujetos a negociaciones de precios, lo que potencialmente afecta los flujos de ingresos de Merck.

Impacto de la política	Consecuencia financiera estimada
Negociación del precio de los medicamentos de Medicare	Reducción de ingresos potenciales de $ 1.5-2.3 mil millones anualmente
Requisitos de transparencia de precios de drogas	Costos de cumplimiento estimados en $ 75-120 millones

Las tensiones comerciales globales afectan el acceso internacional al mercado farmacéutico

Las tensiones comerciales de US-China continúan creando desafíos para el acceso al mercado farmacéutico y la colaboración de investigación internacional.

• Aranceles de importación de China sobre productos farmacéuticos: rango de 3-17%
• Exportaciones farmacéuticas de EE. UU. A China en 2023: $ 4.2 mil millones
• Los ingresos internacionales de Merck afectados por las restricciones comerciales

Los cambios geopolíticos continuos influyen en la colaboración de investigación

Región geopolítica	Impacto de la colaboración de investigación	Monto de la inversión
unión Europea	Aumento de los requisitos de cumplimiento regulatorio	$ 350 millones en inversiones de cumplimiento adicionales
Asia-Pacífico	Transferencia de tecnología restringida	Limitación de ingresos potenciales de $ 275 millones

La postura del gobierno de los Estados Unidos sobre los precios de las drogas y la reforma de la salud

La incertidumbre regulatoria continúa desafiando la planificación estratégica de Merck. El enfoque de la administración Biden en reducir los costos farmacéuticos crea una volatilidad significativa del mercado.

• Las reformas propuestas de precios de drogas podrían afectar el 20-30% de los medicamentos de alto costo de Merck
• Reducción de ingresos potenciales: $ 3.4-5.2 mil millones
• Aumento de los costos de cumplimiento regulatorio: $ 250-400 millones anualmente

Merck & Co., Inc. (MRK) - Análisis de mortero: factores económicos

Fluctúa de los gastos de salud globales impactos en flujos de ingresos farmacéuticos

El gasto mundial en la salud alcanzó $ 9.4 billones en 2022, con un crecimiento proyectado para $ 11.8 billones para 2026. Los ingresos farmacéuticos globales de Merck en 2023 fueron $ 60.8 mil millones, representando un Aumento del 5,7% del año anterior.

Año	Gasto global de atención médica	Ingresos de Merck
2022	$ 9.4 billones	$ 57.5 mil millones
2023	$ 9.8 billones	$ 60.8 mil millones
2024 (proyectado)	$ 10.2 billones	$ 64.2 mil millones

La inflación y la volatilidad económica afectan la investigación y la inversión en desarrollo

El gasto de I + D de Merck en 2023 fue $ 14.2 mil millones, representando 23.3% de ingresos totales. Impacto de la tasa de inflación en los costos farmacéuticos de I + D estimados en 4.2% anualmente.

Variaciones de tipo de cambio de divisas Impacto el desempeño del mercado internacional

Divisa	Fluctuación del tipo de cambio (2023)	Impacto en los ingresos internacionales de Merck
Euro	-2.3%	$ 1.4 mil millones
Yen japonés	-1.8%	$ 0.9 mil millones
Libra británica	+1.5%	$ 0.7 mil millones

El aumento de los costos de atención médica influye en estrategias de precios de productos farmacéuticos

El aumento promedio del precio del producto farmacéutico en 2023 fue 4.5%. El ajuste promedio del precio del producto de Merck fue 3.8%, con estrategias clave de precios de productos:

• Precio de KeyTRUDA: $ 178,000 por año
• Precio de Januvia: $ 6,300 por año
• Precios de Gardasil: $ 390 por dosis

Merck & Co., Inc. (MRK) - Análisis de mortero: factores sociales

El envejecimiento de la población global aumenta la demanda de tratamientos con enfermedades crónicas

Para 2050, se proyecta que la población mundial de 65 años o más alcanzará 1.500 millones, lo que representa el 16% de la población mundial total. Este cambio demográfico afecta directamente la demanda farmacéutica de tratamientos de enfermedades crónicas.

Grupo de edad	Proyección de población	Prevalencia de enfermedades crónicas
65-74 años	727 millones	El 42.3% tiene múltiples condiciones crónicas
75-84 años	425 millones	El 54.7% requiere tratamientos médicos especializados
85+ años	348 millones	67.2% gestiona afecciones de salud complejas

La creciente conciencia de la salud impulsa la medicina personalizada y la atención preventiva

Se espera que el mercado global de medicina personalizada alcance los $ 796.8 mil millones para 2028, con una tasa compuesta anual del 6.2%. La inversión de Merck en medicina de precisión se alinea con esta tendencia.

Segmento de mercado	2024 Valor proyectado	Índice de crecimiento
Medicina personalizada	$ 416.5 mil millones	6.2% CAGR
Atención médica preventiva	$ 344.2 mil millones	5.8% CAGR

El aumento del enfoque en la salud mental expande las oportunidades de mercado farmacéutico

El mercado mundial de salud mental proyectado para alcanzar los $ 537.97 mil millones para 2030, con un segmento antidepresivo que crece al 3.5% anual.

Segmento de salud mental	Tamaño del mercado 2024	Crecimiento proyectado
Tratamientos de depresión	$ 18.4 mil millones	CAGR de 3.5%
Trastornos de ansiedad	$ 15.7 mil millones	4.2% CAGR

Turnos demográficos Crear nuevos segmentos de mercado para medicamentos especializados

Se espera que el mercado global de tratamiento de enfermedades raras alcance los $ 442.8 mil millones para 2027, con un 7,9% de CAGR.

Segmento demográfico	Valor comercial	Prevalencia del tratamiento
Enfermedades raras pediátricas	$ 126.3 mil millones	5.6% de participación de mercado
Tratamientos especializados geriátricos	$ 187.5 mil millones	8.3% de participación de mercado

Merck & Co., Inc. (MRK) - Análisis de mortero: factores tecnológicos

La investigación genómica avanzada permite el desarrollo de medicina de precisión

Merck invirtió $ 12.2 mil millones en I + D en 2023, con una asignación significativa hacia la investigación genómica. La cartera de medicamentos de precisión de la compañía incluye 17 terapias específicas en las plataformas de oncología e inmunología.

Área de investigación	Inversión ($ m)	Programas activos
Oncología genómica	3,750	8
Genómica inmunología	2,450	6
Genómica de enfermedades raras	1,650	3

La inteligencia artificial acelera los procesos de descubrimiento y desarrollo de fármacos

Merck desplegó $ 425 millones específicamente para AI y tecnologías de aprendizaje automático en el descubrimiento de fármacos durante 2023. Las plataformas impulsadas por la IA de la compañía redujeron los plazos de desarrollo de fármacos en aproximadamente un 32%.

Tecnología de IA	Inversión ($ m)	Mejora de la eficiencia
Detección molecular ai	175	28%
Modelado predictivo	135	35%
Optimización del ensayo clínico	115	32%

Las tecnologías de salud digital transforman las metodologías de ensayos clínicos

Merck implementó tecnologías de salud digital en 42 ensayos clínicos en 2023, reduciendo los costos de los ensayos en un 27% y acelerando el reclutamiento de pacientes en un 35%.

Tecnología de salud digital	Pruebas implementadas	Reducción de costos
Plataformas de telemedicina	18	22%
Monitoreo de pacientes remotos	15	31%
Detección de paciente impulsado por IA	9	35%

El aumento de la inversión en biotecnología y análisis de datos impulsa la innovación

Merck asignó $ 2.8 mil millones para innovaciones de biotecnología y análisis de datos en 2023, con enfoque en las plataformas tecnológicas emergentes.

Área de innovación	Inversión ($ m)	Enfoque estratégico
Tecnología CRISPR	650	Edición de genes
Análisis de datos avanzado	1,250	Atención médica predictiva
Biología sintética	900	Desarrollo terapéutico novedoso

Merck & Co., Inc. (MRK) - Análisis de mortero: factores legales

Regulaciones estrictas de la FDA que rigen las aprobaciones de productos farmacéuticos

Merck enfrenta rigurosos requisitos regulatorios de la FDA para las aprobaciones de drogas. A partir de 2024, la tasa de éxito de aprobación de la solicitud de medicamentos de la FDA (NDA) es de aproximadamente el 12%. El costo promedio de llevar un nuevo medicamento al mercado a través de la aprobación de la FDA es de $ 2.6 mil millones.

Métrica reguladora de la FDA	Estadísticas actuales
Tiempo promedio de revisión de NDA	10.1 meses
Tasa de éxito de aprobación de la FDA	12%
Costo de desarrollo de drogas	$ 2.6 mil millones

Protección de propiedad intelectual

Portafolio de patentes de Merck es crítico para mantener una ventaja competitiva. En 2023, Merck tenía 16,740 patentes activas a nivel mundial. La compañía invirtió $ 12.2 mil millones en investigación y desarrollo en 2023.

Métrica de propiedad intelectual	2023 datos
Patentes activas totales	16,740
Inversión de I + D	$ 12.2 mil millones
Casos de litigio de patentes	37

Leyes de patentes internacionales

Merck opera en 140 países, navegando por el complejo regulaciones internacionales de patentes. La estrategia global de patentes de la Compañía implica la gestión de la propiedad intelectual en múltiples jurisdicciones.

Métrica de patentes internacionales	Estadísticas actuales
Países de operación	140
Presentaciones de patentes internacionales	623
Acciones de aplicación de patentes	42

Litigio de responsabilidad por productos farmacéuticos

Merck enfrenta riesgos de litigios en curso. En 2023, la compañía tuvo 412 casos legales activos, con una posible exposición de responsabilidad estimada en $ 3.8 mil millones.

Litigio métrico	2023 datos
Casos legales activos	412
Exposición potencial a la responsabilidad	$ 3.8 mil millones
Gasto de defensa legal	$ 456 millones

Merck & Co., Inc. (MRK) - Análisis de mortero: factores ambientales

Prácticas de fabricación sostenibles

Merck & Co. informó una reducción del 32.4% en las emisiones absolutas de gases de efecto invernadero de 2019 a 2022. La compañía invirtió $ 87.3 millones en iniciativas de sostenibilidad ambiental en 2023.

Métrica ambiental	Datos 2022	2023 objetivo
Consumo total de agua	38.2 millones de metros cúbicos	35.5 millones de metros cúbicos
Uso de energía renovable	22.7%	30% para 2025
Reducción de desechos	Reducción del 28,6%	Objetivo de reducción del 35%

Reducción de la huella de carbono

Merck comprometió $ 150 millones a los esfuerzos de neutralidad de carbono, apuntando al 100% de electricidad renovable para 2025. El alcance 1 y 2 emisiones fueron 1.2 millones de toneladas métricas CO2E en 2022.

Cumplimiento ambiental regulatorio

Los costos de cumplimiento ambiental para Merck en 2023 alcanzaron los $ 42.6 millones. La Compañía recibió cero importantes citas de violación ambiental de agencias reguladoras.

Métrico de cumplimiento regulatorio	2023 datos
Gasto de cumplimiento ambiental	$ 42.6 millones
Incidentes reportables de la EPA	3 incidentes menores
Auditoría ambiental pasada	100% Cumplimiento

Impacto en la investigación del cambio climático

Merck asignó $ 63.4 millones a la investigación de salud relacionada con el clima en 2023. La compañía identificó 7 programas de investigación clave que abordan las implicaciones de la salud del cambio climático.

• Investigación de migración de enfermedades tropicales
• Estudios de condición de salud relacionadas con el calor
• Prevención de enfermedades transmitidas por el vector
• Investigación de enfermedades respiratorias inducidas por el clima

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.