Merck & Co., Inc. (MRK): Análise de Pestle [Jan-2025 Atualizada]

No cenário complexo e em constante evolução & A Co., Inc. está na interseção de inovação inovadora e desafios multifacetados. Essa análise abrangente de pestles revela a intrincada rede de fatores políticos, econômicos, sociológicos, tecnológicos, legais e ambientais que moldam a trajetória estratégica da empresa. Desde a navegação nas incertezas regulatórias até os avanços tecnológicos de ponta, a jornada de Merck reflete a natureza dinâmica das indústrias modernas de saúde e farmacêutica, oferecendo uma narrativa atraente de resiliência, inovação e adaptação estratégica em um mercado global em rápida mudança.

Merck & Co., Inc. (MRK) - Análise de Pestle: Fatores Políticos

Alterações da política de saúde dos EUA impactam a regulamentação farmacêutica e o preço de medicamentos

A Lei de Redução de Inflação de 2022 afeta diretamente as estratégias de preços farmacêuticos da Merck, permitindo que o Medicare negocie os preços para certos medicamentos de alto custo. Em 2023, foram anunciados os 10 primeiros medicamentos sujeitos a negociações de preços, potencialmente afetando os fluxos de receita da Merck.

Impacto político	Conseqüência financeira estimada
Negociação de preços de drogas do Medicare	Redução potencial de receita de US $ 1,5-2,3 bilhão anualmente
Requisitos de transparência de preços de drogas	Custos de conformidade estimados em US $ 75-120 milhões

As tensões comerciais globais afetam o acesso ao mercado farmacêutico internacional

As tensões comerciais EUA-China continuam a criar desafios para o acesso do mercado farmacêutico e a colaboração internacional de pesquisa.

• Tarifas de importação da China em produtos farmacêuticos: 3-17% faixa
• Exportações farmacêuticas dos EUA para a China em 2023: US $ 4,2 bilhões
• A receita internacional da Merck impactada pelas restrições comerciais

As mudanças geopolíticas em andamento influenciam a colaboração de pesquisa

Região geopolítica	Impacto de colaboração de pesquisa	Valor do investimento
União Europeia	Requisitos de conformidade regulatória aumentados	US $ 350 milhões para investimentos adicionais de conformidade
Ásia-Pacífico	Transferência de tecnologia restrita	US $ 275 milhões em potencial limitação de receita

Posição do governo dos EUA sobre preços de drogas e reforma da saúde

A incerteza regulatória continua a desafiar o planejamento estratégico da Merck. O foco do governo Biden na redução dos custos farmacêuticos cria uma volatilidade significativa do mercado.

• As reformas propostas de preços de drogas podem afetar 20 a 30% dos medicamentos de alto custo da Merck
• Redução de receita potencial: US $ 3,4-5,2 bilhões
• Custos de conformidade regulatória aumentados: US $ 250-400 milhões anualmente

Merck & Co., Inc. (MRK) - Análise de pilão: Fatores econômicos

Flutuar Global Healthcare Gasends afeta os fluxos de receita farmacêutica

Os gastos globais de saúde alcançaram US $ 9,4 trilhões em 2022, com crescimento projetado para US $ 11,8 trilhões até 2026. A receita farmacêutica global da Merck em 2023 foi US $ 60,8 bilhões, representando a 5,7% de aumento a partir do ano anterior.

Ano	Gastos globais em saúde	Receita Merck
2022	US $ 9,4 trilhões	US $ 57,5 ​​bilhões
2023	US $ 9,8 trilhões	US $ 60,8 bilhões
2024 (projetado)	US $ 10,2 trilhões	US $ 64,2 bilhões

Inflação e volatilidade econômica afetam a pesquisa e o investimento em desenvolvimento

As despesas de P&D da Merck em 2023 foram US $ 14,2 bilhões, representando 23.3% de receita total. Impacto da taxa de inflação nos custos farmacêuticos de P&D estimados em 4.2% anualmente.

Variações de taxa de câmbio de moeda afetam o desempenho do mercado internacional

Moeda	Flutuação da taxa de câmbio (2023)	Impacto na receita internacional da Merck
Euro	-2.3%	US $ 1,4 bilhão
Iene japonês	-1.8%	US $ 0,9 bilhão
Libra britânica	+1.5%	US $ 0,7 bilhão

O aumento dos custos de saúde influencia as estratégias de precificação de produtos farmacêuticos

O aumento médio do preço do produto farmacêutico em 2023 foi 4.5%. O ajuste médio do preço do produto da Merck foi 3.8%, com as principais estratégias de precificação do produto:

• Preço Keytruda: US $ 178.000 por ano
• Preços de Januvia: US $ 6.300 por ano
• Preços de Gardasil: US $ 390 por dose

Merck & Co., Inc. (MRK) - Análise de pilão: Fatores sociais

O envelhecimento da população global aumenta a demanda por tratamentos de doenças crônicas

Até 2050, a população global com 65 anos ou mais deve atingir 1,5 bilhão, representando 16% da população mundial total. Essa mudança demográfica afeta diretamente a demanda farmacêutica por tratamentos de doenças crônicas.

Faixa etária	Projeção populacional	Prevalência de doenças crônicas
65-74 anos	727 milhões	42,3% têm várias condições crônicas
75-84 anos	425 milhões	54,7% requerem tratamentos médicos especializados
85 anos ou mais	348 milhões	67,2% gerenciam condições complexas de saúde

Crescer a conscientização sobre a saúde impulsiona medicina personalizada e cuidados preventivos

O mercado global de medicina personalizada deve atingir US $ 796,8 bilhões até 2028, com um CAGR de 6,2%. O investimento da Merck em medicina de precisão se alinha a essa tendência.

Segmento de mercado	2024 Valor projetado	Taxa de crescimento
Medicina personalizada	US $ 416,5 bilhões	6,2% CAGR
Cuidados de saúde preventivos	US $ 344,2 bilhões	5,8% CAGR

O aumento do foco na saúde mental expande oportunidades de mercado farmacêutico

O mercado global de saúde mental se projetou para atingir US $ 537,97 bilhões até 2030, com o segmento antidepressivo crescendo 3,5% ao ano.

Segmento de saúde mental	2024 Tamanho do mercado	Crescimento projetado
Tratamentos de depressão	US $ 18,4 bilhões	3,5% CAGR
Transtornos de ansiedade	US $ 15,7 bilhões	4,2% CAGR

As mudanças demográficas criam novos segmentos de mercado para medicamentos especializados

O mercado global de tratamento de doenças raras deve atingir US $ 442,8 bilhões até 2027, com 7,9% de CAGR.

Segmento demográfico	Valor de mercado	Prevalência do tratamento
Doenças raras pediátricas	US $ 126,3 bilhões	5,6% de participação de mercado
Tratamentos especializados geriátricos	US $ 187,5 bilhões	8,3% de participação de mercado

Merck & Co., Inc. (MRK) - Análise de pilão: Fatores tecnológicos

A pesquisa genômica avançada permite o desenvolvimento de medicina de precisão

A Merck investiu US $ 12,2 bilhões em P&D em 2023, com alocação significativa em relação à pesquisa genômica. O portfólio de medicina de precisão da empresa inclui 17 terapias direcionadas em plataformas de oncologia e imunologia.

Área de pesquisa	Investimento ($ m)	Programas ativos
Oncologia genômica	3,750	8
Genômica imunológica	2,450	6
Genômica de doenças raras	1,650	3

A inteligência artificial acelera os processos de descoberta e desenvolvimento de medicamentos

A Merck implantou US $ 425 milhões especificamente para as tecnologias de IA e aprendizado de máquina na descoberta de medicamentos durante 2023. As plataformas orientadas pela AI da empresa reduziram os cronogramas de desenvolvimento de medicamentos em aproximadamente 32%.

Tecnologia da IA	Investimento ($ m)	Melhoria de eficiência
Triagem molecular AI	175	28%
Modelagem preditiva	135	35%
Otimização de ensaios clínicos	115	32%

Tecnologias de saúde digital transformam metodologias de ensaios clínicos

A Merck implementou tecnologias de saúde digital em 42 ensaios clínicos em 2023, reduzindo os custos de ensaios em 27% e acelerando o recrutamento de pacientes em 35%.

Tecnologia da saúde digital	Trials implementados	Redução de custos
Plataformas de telemedicina	18	22%
Monitoramento remoto de pacientes	15	31%
Triagem do paciente acionada por IA	9	35%

O aumento do investimento em biotecnologia e análise de dados impulsiona a inovação

A Merck alocou US $ 2,8 bilhões para as inovações de biotecnologia e análise de dados em 2023, com foco em plataformas tecnológicas emergentes.

Área de inovação	Investimento ($ m)	Foco estratégico
Tecnologia CRISPR	650	Edição de genes
Análise de dados avançada	1,250	Cuidados de saúde preditivos
Biologia sintética	900	Novo desenvolvimento terapêutico

Merck & Co., Inc. (MRK) - Análise de Pestle: Fatores Legais

Regulamentos rigorosos da FDA que regem as aprovações de produtos farmacêuticos

A Merck enfrenta requisitos regulatórios rigorosos da FDA para aprovações de medicamentos. A partir de 2024, a taxa de sucesso de aprovação da FDA New Application (NDA) é de aproximadamente 12%. O custo médio de levar um novo medicamento ao mercado por meio da aprovação da FDA é de US $ 2,6 bilhões.

Métrica regulatória da FDA	Estatísticas atuais
Tempo médio de revisão da NDA	10,1 meses
Taxa de sucesso de aprovação da FDA	12%
Custo de desenvolvimento de medicamentos	US $ 2,6 bilhões

Proteção à propriedade intelectual

Portfólio de patentes da Merck é fundamental para manter a vantagem competitiva. Em 2023, a Merck detinha 16.740 patentes ativas globalmente. A empresa investiu US $ 12,2 bilhões em pesquisa e desenvolvimento em 2023.

Métrica de propriedade intelectual	2023 dados
Total de patentes ativas	16,740
Investimento em P&D	US $ 12,2 bilhões
Casos de litígio de patentes	37

Leis de patentes internacionais

A Merck opera em 140 países, navegando nos regulamentos complexos de patentes internacionais. A estratégia global de patentes da empresa envolve o gerenciamento de propriedade intelectual em várias jurisdições.

Métrica Internacional de Patentes	Estatísticas atuais
Países de operação	140
Registros internacionais de patentes	623
Ações de aplicação de patentes	42

Litígio de responsabilidade do produto farmacêutico

A Merck enfrenta riscos de litígios em andamento. Em 2023, a empresa possuía 412 casos legais ativos, com exposição potencial de responsabilidade estimada em US $ 3,8 bilhões.

Métrica de litígio	2023 dados
Casos legais ativos	412
Exposição potencial de responsabilidade	US $ 3,8 bilhões
Despesas de defesa legal	US $ 456 milhões

Merck & Co., Inc. (MRK) - Análise de Pestle: Fatores Ambientais

Práticas de fabricação sustentáveis

Merck & A Co. relatou uma redução de 32,4% nas emissões absolutas de gases de efeito estufa de 2019 para 2022. A Companhia investiu US $ 87,3 milhões em iniciativas de sustentabilidade ambiental em 2023.

Métrica ambiental	2022 dados	2023 Target
Consumo total de água	38,2 milhões de metros cúbicos	35,5 milhões de metros cúbicos
Uso de energia renovável	22.7%	30% até 2025
Redução de resíduos	28,6% de redução	Objetiva de redução de 35%

Redução da pegada de carbono

A Merck comprometeu US $ 150 milhões a esforços de neutralidade de carbono, direcionando a eletricidade 100% renovável até 2025. O escopo 1 e 2 emissões foram de 1,2 milhão de toneladas métricas em 2022.

Conformidade ambiental regulatória

Os custos de conformidade ambiental da Merck em 2023 atingiram US $ 42,6 milhões. A Companhia recebeu zero grandes citações de violação ambiental de agências regulatórias.

Métrica de conformidade regulatória	2023 dados
Gasto de conformidade ambiental	US $ 42,6 milhões
Incidentes relatáveis ​​da EPA	3 incidentes menores
Auditoria ambiental aprovada	100% de conformidade

Impacto da pesquisa sobre mudanças climáticas

A Merck alocou US $ 63,4 milhões à pesquisa em saúde relacionada ao clima em 2023. A Companhia identificou 7 programas de pesquisa-chave que abordam as implicações de saúde das mudanças climáticas.

• Pesquisa de migração de doenças tropicais
• Estudos de condição de saúde relacionados ao calor
• Prevenção de doenças transmitidas por vetores
• Pesquisa de doenças respiratórias induzidas pelo 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.