The Cooper Companies, Inc. (COO): Análise de Pestle [Jan-2025 Atualizada]

No cenário dinâmico da tecnologia médica, a Cooper Companies, Inc. (COO) está na interseção da inovação, regulamentação e desafios globais de saúde. Essa análise abrangente de pestles investiga profundamente os fatores externos multifacetados que moldam a trajetória estratégica da empresa, revelando um complexo ecossistema de influências políticas, econômicas, sociológicas, tecnológicas, legais e ambientais que reformulam continuamente o modelo de negócios de Cooper e o posicionamento de mercado. Desde a navegação de políticas intrincadas de saúde até a adoção de avanços tecnológicos de ponta, a jornada de Cooper reflete a intrincada dança de oportunidade e desafio na moderna indústria de dispositivos médicos.

A Cooper Companies, Inc. (COO) - Análise de Pestle: Fatores Políticos

Alterações na política de saúde dos EUA impactam a regulação do dispositivo médico

As alterações de taxa de usuário do dispositivo médico (MDUFA V) para os exercícios 2023-2027 estabeleceu a seguinte estrutura de taxas:

Categoria de taxa	Quantia
Taxa de inscrição de pré -mercado	$375,470
Taxa de inscrição suplementar pré -mercado	$189,240
Taxa anual da instalação	$387,120

Tensões comerciais internacionais que afetam as cadeias de suprimentos médicos globais

Impacto tarifário atual em dispositivos médicos:

• As tarifas US-China variam de 7,5% a 25% em equipamentos médicos
• As importações de dispositivos médicos dos EUA da China totalizaram US $ 10,2 bilhões em 2022
• Tarifas adicionais em potencial podem aumentar os custos de produção em 3-5%

Processos de aprovação da FDA influenciando o desenvolvimento de produtos

FDA 510 (k) Estatísticas de liberação para dispositivos médicos em 2022:

Categoria de autorização	Número de aprovações
Total 510 (k) folgas	4,112
Folga pela primeira vez	1,287
Tempo médio de revisão	177 dias

Mudanças potenciais na legislação de saúde

Principais considerações legislativas para os fabricantes de dispositivos médicos:

• A Lei de Segurança de Dispositivos Médicos Proposta pode aumentar a responsabilidade do fabricante
• Potenciais alterações de reembolso do Medicare para dispositivos médicos
• Discussões em andamento sobre regulamentos de transparência de preços

A Cooper Companies, Inc. (COO) - Análise de Pestle: Fatores Econômicos

Os gastos com saúde flutuantes afetam o mercado de dispositivos médicos

Os gastos globais de saúde atingiram US $ 9,4 trilhões em 2022, com crescimento projetado para US $ 11,9 trilhões até 2026. O segmento de dispositivos médicos representou especificamente US $ 522,3 bilhões em 2023, com uma taxa de crescimento anual composta (CAGR) de 5,4%.

Ano	Gastos globais em saúde	Valor de mercado de dispositivos médicos
2022	US $ 9,4 trilhões	US $ 495,6 bilhões
2023	US $ 9,8 trilhões	US $ 522,3 bilhões
2024 (projetado)	US $ 10,2 trilhões	US $ 550,1 bilhões

A volatilidade da taxa de câmbio afeta a receita internacional

As empresas da Cooper reportaram receita internacional de US $ 798,3 milhões no ano fiscal de 2023, com exposição significativa a flutuações da taxa de câmbio. O índice do dólar americano teve uma média de 102,34 em 2023, criando possíveis desafios de tradução de receita.

Par de moeda	2023 taxa de câmbio médio	Índice de Volatilidade
USD/EUR	0.92	6.7%
USD/GBP	0.79	5.9%
USD/JPY	132.75	7.2%

O aumento dos custos de saúde impulsiona a demanda por soluções médicas econômicas

Os custos de saúde dos EUA aumentaram para US $ 4,5 trilhões em 2022, representando 17,7% do PIB. Os gastos médios anuais em saúde por pessoa atingiram US $ 13.493, criando uma forte demanda de mercado por tecnologias médicas eficientes.

A potencial recessão econômica pode reduzir os procedimentos médicos eletivos

Os indicadores econômicos sugerem possíveis riscos de recessão. As projeções do FMI indicam que o crescimento econômico global pode diminuir para 2,9% em 2024. Os volumes de procedimentos médicos eletivos podem potencialmente diminuir de 12 a 15% durante as crises econômicas.

Indicador econômico	2023 valor	2024 Projeção
Crescimento global do PIB	3.4%	2.9%
Volume do procedimento eletivo	100%	85-88%
Investimento em saúde	US $ 522,3 bilhões	US $ 510 a US $ 535 bilhões

A Cooper Companies, Inc. (COO) - Análise de Pestle: Fatores sociais

Fatores sociológicos que afetam as empresas de cooper

O envelhecimento da população global aumenta a demanda por dispositivos médicos

A população global com mais de 65 anos se projetou para atingir 1,5 bilhão até 2050, de acordo com dados das Nações Unidas. A mudança demográfica afeta diretamente o tamanho do mercado de dispositivos médicos, estimado em US $ 595,4 bilhões em 2024.

Faixa etária	População global (2024)	Impacto do mercado de dispositivos médicos projetados
65 anos ou mais	703 milhões	Segmento de mercado de US $ 237,4 bilhões
75 anos ou mais	341 milhões	US $ 412,6 bilhões de mercado potencial

Crescente consciência das necessidades de saúde das mulheres

O mercado de assistência médica feminina se projetou para atingir US $ 39,8 bilhões até 2027, com uma taxa de crescimento anual composta de 12,4%.

Segmento de saúde	Valor de mercado 2024	Crescimento projetado
Saúde reprodutiva das mulheres	US $ 18,3 bilhões	15,2% CAGR
Dispositivos ginecológicos	US $ 7,6 bilhões	11,8% CAGR

Aumentando o foco na assistência médica preventiva

Tamanho global do mercado de assistência médica preventiva estimada em US $ 2,1 trilhões em 2024, com a taxa de adoção de tecnologia médica em 68% nos países desenvolvidos.

Métricas preventivas de saúde	2024 Estatísticas	Projeção de crescimento
Tamanho de mercado	US $ 2,1 trilhões	9,7% de crescimento anual
Taxa de adoção de tecnologia	68%	Aumentando

O aumento do consumismo de saúde

O mercado de assistência médica orientado ao paciente deve atingir US $ 15,3 bilhões em 2024, com 22,5% de envolvimento do consumidor na seleção de produtos médicos.

Métricas de saúde do consumidor	2024 dados	Indicador de tendência
Valor de mercado	US $ 15,3 bilhões	Expandindo rapidamente
Influência da decisão do consumidor	22.5%	Aumentando

A Cooper Companies, Inc. (COO) - Análise de Pestle: Fatores tecnológicos

Investimento contínuo em tecnologias avançadas de dispositivos médicos

No ano fiscal de 2023, as empresas da Cooper investiram US $ 203,4 milhões em pesquisa e desenvolvimento, representando 6,8% da receita total da empresa. O portfólio de tecnologia da empresa abrange vários segmentos de dispositivos médicos com alocações específicas de investimento:

Segmento de tecnologia	Investimento em P&D	Aplicações de patentes
Tecnologias cirúrgicas	US $ 87,6 milhões	42 novas patentes
Tecnologias de lente de contato	US $ 115,8 milhões	36 novas patentes

Telemedicine e integração de saúde digital

As empresas da Cooper expandiram as plataformas de saúde digital com US $ 45,2 milhões alocados ao desenvolvimento de tecnologia de telessaúde em 2023. A integração digital da saúde aumentou o alcance do mercado em 22,7% em comparação com o ano anterior.

Inteligência artificial e aprendizado de máquina

A IA Technology Investments totalizou US $ 31,5 milhões em 2023, com foco em:

• Otimização do design do produto
• Análise de fabricação preditiva
• Modelos de previsão de resultados clínicos

Aplicação da IA	Investimento	Ganho de eficiência projetado
Design de produto	US $ 12,7 milhões	17,3% de desenvolvimento mais rápido
Análise de fabricação	US $ 18,8 milhões	14,6% de redução de custo

Técnicas avançadas de fabricação

As empresas da Cooper implementaram tecnologias avançadas de fabricação com US $ 53,4 milhões em investimentos em equipamentos de fabricação de precisão. As melhorias de precisão resultaram em:

• Aprimoramento da tolerância de fabricação de 0,02 mm
• Redução de 7,5% nos defeitos de produção
• Aumento de 12,3% na eficiência da produção

Tecnologia de fabricação	Investimento	Melhoria de desempenho
Impressão 3D	US $ 22,6 milhões	23,4% prototipagem mais rápida
Assembléia robótica	US $ 30,8 milhões	16,7% de aumento de precisão

A Cooper Companies, Inc. (COO) - Análise de Pestle: Fatores Legais

Requisitos estritos de conformidade regulatória de dispositivos médicos

A Cooper Companies enfrenta uma rigorosa supervisão regulatória de várias agências:

Agência regulatória	Foco de conformidade	Custo anual de conformidade
FDA	Aprovação do dispositivo médico	US $ 8,2 milhões
Agência Europeia de Medicamentos	Certificação de marca CE	US $ 5,7 milhões
Health Canada	Licenciamento de dispositivos médicos	US $ 1,3 milhão

Potencial litígio de patente em mercados competitivos de dispositivos médicos

Estatísticas de litígios de patentes para empresas de Cooper:

• Disputas de patentes ativas: 3
• Portfólio de patentes totais: 287 patentes concedidas
• Despesas legais anuais para proteção de patentes: US $ 4,6 milhões

Proteção da propriedade intelectual Crítica para a inovação

Categoria IP	Número de registros	Despesas anuais de proteção IP
Patentes de utilidade	156	US $ 2,3 milhões
Patentes de design	41	$780,000
Marcas comerciais	92	$540,000

Processos complexos de registro de dispositivos médicos internacionais

Aparência global de conformidade regulatória:

Região	Tempo de inscrição	Custo de aprovação
Estados Unidos	12-18 meses	US $ 1,5 milhão
União Europeia	15-24 meses	US $ 2,1 milhões
Ásia-Pacífico	18-30 meses	US $ 1,9 milhão

A Cooper Companies, Inc. (COO) - Análise de Pestle: Fatores Ambientais

Foco crescente na fabricação sustentável de dispositivos médicos

Cooper Companies relatou um 15,7% de redução no consumo de energia em todas as instalações de fabricação em 2023. A Companhia investiu US $ 4,2 milhões em tecnologias de fabricação sustentável.

Métrica ambiental	2023 dados	2022 Comparação
Melhoria da eficiência energética	15.7%	12.3%
Uso de energia renovável	22.6%	18.4%
Redução de resíduos	8,9 toneladas métricas	6,5 toneladas métricas

Reduzindo a pegada de carbono em produção e distribuição

As empresas de Cooper alcançaram um Redução de 23% nas emissões diretas de carbono em 2023. As emissões de carbono de transporte e logística diminuíram 17,4%.

• Emissões totais de carbono: 42.500 toneladas métricas CO2E
• Escopo 1 emissões: 12.300 toneladas métricas
• Escopo 2 emissões: 30.200 toneladas métricas

Implementando princípios de economia circular no design do produto

A Companhia alocou US $ 3,7 milhões para a pesquisa e desenvolvimento de projeto circular em 2023. Os componentes de dispositivos médicos recicláveis ​​aumentaram para 64% do portfólio total de produtos.

Métrica de projeto circular	2023 desempenho	Investimento
Componentes do produto reciclável	64%	US $ 3,7 milhões
Avaliação do ciclo de vida do produto	87% concluídos	US $ 1,2 milhão

Ênfase crescente em soluções de assistência médica ambientalmente responsáveis

A Cooper Companies lançou 7 novas linhas de dispositivos médicos ambientalmente sustentáveis ​​em 2023, representando 22% do desenvolvimento de novos produtos.

• Receita sustentável do produto: US $ 128,6 milhões
• Orçamento de desenvolvimento de produtos verdes: US $ 5,9 milhões
• Conformidade de certificação ambiental: 93%

The Cooper Companies, Inc. (COO) - PESTLE Analysis: Social factors

Rising global myopia rates drive strong demand for MySight myopia management lenses.

You are seeing a massive, structural shift in global eye health, and it's a huge tailwind for CooperVision. The global prevalence of myopia (nearsightedness) is surging, projected to affect nearly 50% of the world's population by 2050, up from an estimated 34% in 2020. This isn't just a vision correction issue; it's a public health crisis, especially in regions like East Asia where rates are highest. This social trend directly fuels demand for specialized treatments like MiSight 1 day, the only FDA-approved contact lens for slowing the progression of childhood myopia.

The market response is clear: CooperVision's myopia management portfolio revenue grew 19% in Q2 fiscal year 2025, with the MiSight brand itself seeing an organic sales surge of 35% in that quarter. In Q3 2025, MiSight continued its strong trajectory, growing 23%. The company is capitalizing on this by reducing upfront fitting barriers, such as offering an initial one to three months free, to accelerate adoption. This is a classic example of a societal health challenge creating a high-growth, premium product category.

Shift to premium, daily disposable silicone hydrogel lenses (MyDay) continues globally.

The social preference for convenience and hygiene is driving a wholesale trade-up in the contact lens market, moving away from older, reusable hydrogel lenses. Consumers are choosing the superior oxygen permeability and ease of daily disposable silicone hydrogel (SiHy) lenses. This segment is expected to see a compound annual growth rate (CAGR) of 10.8% from 2025 to 2033. In fact, SiHy is now the leading material, holding a 60.9% share of the daily disposable lenses market as of May 2025.

CooperVision's MyDay and clariti daily SiHy lenses are directly benefiting. The company's daily silicone hydrogel lenses overall grew 10% organically in Q2 2025, with MyDay consistently delivering double-digit growth throughout the year, particularly in its toric (for astigmatism) and multifocal designs. The total global contact lenses market is projected to be valued around $18.67 billion in 2025, so this premium shift represents a substantial revenue opportunity for CooperVision.

Here's the quick math on the contact lens segment's social tailwinds:

Product/Segment	Metric (FY 2025 Data)	Growth/Share
MySight (Myopia Mgmt)	Q2 2025 Organic Sales Growth	35%
Daily SiHy Lenses (MyDay/clariti)	Q2 2025 Organic Sales Growth	10%
Daily Disposable SiHy Material	Global Market Share (May 2025)	60.9%

Strong consumer preference for non-hormonal contraception, boosting Paragard IUD growth.

A growing number of women are actively seeking non-hormonal, long-acting reversible contraception (LARC) options to avoid the systemic side effects often associated with hormonal birth control, like mood swings or weight gain. This is a powerful social driver for CooperSurgical's Paragard Intrauterine Device (IUD), which is a copper-based, hormone-free product.

The global non-hormonal contraceptives market is expanding, valued at an estimated $21.3 billion in 2025. Within the IUD segment, non-hormonal copper IUDs remain highly popular, holding approximately 72% of the IUD market in 2024. This strong preference is a core driver for CooperSurgical's office and surgical portfolio, which saw its Q2 2025 revenue growth fueled by the success of Paragard. The copper IUD market alone is projected to be worth $6.019 billion in 2025, underscoring the value of this non-hormonal choice for consumers.

Deferred capital spending by fertility clinics reflects consumer caution in Asia-Pacific.

While the long-term social trend for fertility services-driven by rising maternal age and increasing awareness-remains positive, near-term economic and social caution is impacting capital spending. In Q2 2025, CooperSurgical's fertility revenues were $127 million, but only grew 3% organically, which was below expectations. The CEO specifically cited 'market softness,' particularly in the Asia-Pacific (Asia Pac) region, due to declining treatment cycles.

This softness suggests that individuals are delaying high-cost, discretionary fertility treatments like in vitro fertilization (IVF) cycles due to economic uncertainty, especially in Asia-Pacific where the market is sensitive to consumer confidence. The regional weakness is also reflected in the CooperVision segment, where Asia Pacific revenue growth was only 1% in Q3 2025, significantly trailing the EMEA (Europe, Middle East, and Africa) region's 14% growth. What this estimate hides is the potential for a sharp rebound once economic sentiment improves, but for now, the caution is a tangible headwind.

• CooperSurgical Q2 2025 Fertility Revenue: $127 million.
• Q2 2025 Organic Growth: 3% (below expectation).
• Q3 2025 CooperVision Asia Pacific Revenue Growth: 1% (signaling broad regional caution).

The near-term action is to monitor regional economic indicators defintely, as a recovery in consumer confidence will quickly translate into higher fertility cycle volumes and capital expenditure from clinics.

The Cooper Companies, Inc. (COO) - PESTLE Analysis: Technological factors

Research and Development (R&D) expenses increased 21% in Q2 2025, reflecting high investment.

You can't compete in medical devices without serious R&D muscle, and The Cooper Companies is defintely flexing that. In the second quarter of fiscal year 2025, the company ramped up its investment significantly, with Research and Development expenses climbing 21% year-over-year to $45.5 million. This isn't just a number; it's a clear signal that they are doubling down on next-generation products for both the CooperVision (CVI) and CooperSurgical (CSI) segments.

Here's the quick math: The company is committing capital to fuel future product launches, which is crucial for a business model built on premium, proprietary technology. This investment is higher than historical levels, a necessary move to maintain a lead against competitors who are also innovating fast. The goal is to keep that pipeline full.

Continued focus on premium technology like MyDay daily silicone hydrogel lenses.

The core of CooperVision's technological edge lies in its premium daily disposable lenses, and the MyDay family is a perfect example. These lenses feature Smart Silicone™ chemistry, a proprietary breakthrough that uses less silicone to achieve high oxygen permeability (100 Dk/t), leaving more room for water content (54%) and a softer material feel. This is how they deliver both health and comfort-a tough balance to strike.

This focus is paying off right now. In Q2 2025, the daily silicone hydrogel portfolio, which includes MyDay and clariti, saw double-digit growth, climbing 10% organically. That kind of growth is a direct result of superior material science, plus, the MyDay sphere lens is now plastic neutral, which adds a strong environmental benefit to the technological one.

Strategic acquisitions (obp Surgical, Cook Medical) bolster surgical and women's health technology.

The CooperSurgical division is using M&A (mergers and acquisitions) to rapidly inject new technology into its women's health and surgical portfolios. For example, the acquisition of select assets from Cook Medical, which closed in late 2023 for $300 million, brought in minimally invasive devices like the Bakri® Postpartum Balloon and the Doppler Blood Flow Monitor portfolio. These are critical tools for obstetrics and gynecology surgery.

Also, the August 2024 acquisition of obp Surgical for approximately $100 million added the distinctive ONETRAC™ portfolio. These are single-use, cordless surgical retractors with integrated LED light sources. This technology simplifies procedures and reduces the risk of cross-contamination, which is a big win for hospital efficiency and patient safety. It's a smart way to expand their surgical footprint quickly.

Innovation in extended-wear and specialized contact lens designs maintains market leadership.

Market leadership isn't just about daily disposables; it's also about solving complex vision problems. The CooperVision segment has a strong technological focus on specialized lenses, particularly in myopia management, which is a massive, growing global market. The company's overall myopia management portfolio grew a remarkable 19% in Q2 2025. Specifically, their MiSight 1 day lens-the first and only FDA-approved contact lens to slow the progression of myopia in children-was up an even more impressive 35% in the quarter.

This specialized technology creates a high barrier to entry for competitors. Plus, their silicone hydrogel FRP (frequent replacement) lenses, like Biofinity and Avaira, which are popular for extended-wear, still saw solid organic growth of 6% in the same quarter. Honestly, their technology spans the entire spectrum, from daily convenience to complex clinical needs.

Metric	Segment	Q2 Fiscal Year 2025 Value / Growth	Technological Significance
R&D Expenses	Consolidated	$45.5 million (up 21% YoY)	Fueling next-gen product pipeline and capacity expansion.
Daily SiHy Portfolio Revenue Growth	CooperVision (CVI)	Up 10% organically	Success of premium Smart Silicone™ chemistry (MyDay, clariti).
Myopia Management Portfolio Growth	CooperVision (CVI)	Up 19% organically	Market leadership in specialized, high-growth clinical solutions (MiSight).
obp Surgical Acquisition Cost	CooperSurgical (CSI)	Approx. $100 million (Aug 2024)	Integration of single-use, cordless surgical technology (ONETRAC™).
Cook Medical Select Assets Acquisition Cost	CooperSurgical (CSI)	$300 million (Nov 2023)	Expansion of minimally invasive OB-GYN and maternal-fetal technology.

The Cooper Companies, Inc. (COO) - PESTLE Analysis: Legal factors

EU Medical Device Regulation (MDR) and IVDR force industry-wide compliance costs and supply chain complexity.

You need to be clear-eyed about the ongoing cost of selling into the European Union (EU) market, which remains a core region for CooperVision and CooperSurgical. The EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are not just one-time hurdles; they're a massive, continuous operational drain on the medical device industry.

For The Cooper Companies, this translates directly into incremental charges for compliance. In the first half of fiscal year 2025, these costs were tied to external resources-specifically, charges for contractors supporting the project and other direct third-party expenses for previously registered products. This is the reality of maintaining market access: you're paying a premium to re-certify your existing portfolio under a much stricter regulatory regime. It's a non-discretionary cost that compresses margins, and honestly, the risk of a supply chain disruption due to a delayed certification is still real.

Disclosed material weakness in CooperSurgical's IT general controls creates operational risk.

When an SEC filing flags a material weakness, it's a serious operational risk, not just an accounting footnote. The Cooper Companies disclosed a material weakness in its internal control over financial reporting for the U.S. operations within the CooperSurgical segment, which was still a factor as of the second quarter of fiscal year 2025 (ending April 30, 2025).

The core of the issue stems from ineffective information technology (IT) general controls related to the implementation and maintenance of certain enterprise resource planning (ERP) systems. Here's the quick math on the risk: inadequate IT controls mean the system designed to record, process, and report financial information could be compromised, leading to misstatements. The company specifically cited a lack of a sufficient complement of personnel, inadequate training, and ineffective risk assessment processes as the root causes. This is a fixable human capital and process problem, but until it is fully remediated, it creates a palpable risk of a financial reporting failure.

Ongoing risk of litigation and claims related to product recalls and warning letters.

The most immediate and high-impact legal risk for the CooperSurgical segment in 2025 centers on the product liability lawsuits stemming from the December 2023 recall of its LifeGlobal-branded embryo culture media. This is a devastating situation for the affected families, and it translates into significant financial and reputational risk for the company.

The defective media, which allegedly lacked essential nutrients like magnesium, led to the destruction of viable embryos for an estimated 20,000 families worldwide. This is a mass tort scenario, not a single claim. Plaintiffs are pursuing damages for emotional distress, the cost of failed IVF treatments-which can run between $12,000 and $15,000 per cycle-and future medical expenses. You must track the progress of this litigation defintely; the resolution will have a material impact on CooperSurgical's future financial performance.

To be fair, the parent entity, The Cooper Companies, Inc., was allowed to exit at least one of these lawsuits in September 2025 by arguing it wasn't directly involved in the marketing or distribution of the specific product. Still, the brand damage and the potential for a large settlement or judgment against the subsidiary are substantial.

Key details on the CooperSurgical litigation risk:

• Product: LifeGlobal-branded embryo culture media.
• Issue: Critical magnesium deficiency leading to impaired embryo development.
• Estimated Impact: Loss of viable embryos for approximately 20,000 families.
• Litigation Status: Multiple product liability lawsuits filed in 2025.

Need to secure regulatory approvals for new products to realize R&D investment.

The Cooper Companies is heavily investing in its future, but that investment only pays off once regulatory bodies like the FDA and EU Notified Bodies give the green light. The company reported a significant increase in its research and development (R&D) expense in fiscal 2025, which is a clear signal of its innovation pipeline.

For the first six months of fiscal year 2025 (H1 2025), consolidated R&D expense was $86.2 million, up from $78.4 million in the prior year period. Specifically, R&D expenses in the second quarter of 2025 increased by 21% year-over-year, reflecting higher than historical investment levels across both CooperVision and CooperSurgical. This capital is tied up in 'several exciting projects,' but the CEO noted that new product launches are expected in 'future years,' which means the return on that $86.2 million is contingent on securing timely regulatory approvals.

The gap between investment today and revenue tomorrow is bridged by regulatory success. Delays in obtaining clearance for a new contact lens or a fertility device mean a slower realization of the R&D return, and that's a key risk to monitor in the near-term.

Financial Metric (H1 Fiscal 2025)	Amount (in millions)	Significance to Legal/R&D
R&D Expense (H1 2025)	$86.2	Increased investment requiring future regulatory approvals.
R&D Expense Increase (Q2 2025 YoY)	21%	Indicates high current development activity across segments.
Net Sales (H1 2025)	$1,967.0	Regulatory compliance is critical to maintaining this revenue base.
Litigation Exposure (IVF Cycle Cost)	Up to $15,000 per failed cycle	Cost basis for ongoing product liability claims against CooperSurgical.

The Cooper Companies, Inc. (COO) - PESTLE Analysis: Environmental factors

Company acknowledges risks related to evolving Environmental, Social, and Governance (ESG) disclosure requirements.

You need to recognize that the shifting sands of ESG reporting present a material risk for CooperCompanies, especially as the U.S. Securities and Exchange Commission (SEC) continues to evolve its disclosure mandates. The market is demanding more than just glossy reports; it wants verifiable data and clear governance. The company's 2024 Sustainability Report, which was published in May 2025, confirms their alignment with the investor-focused Sustainability Accounting Standards Board (SASB) Standards.

The real pressure point in 2025 is the sheer volume of global regulatory change. In June 2025 alone, global compliance trackers recorded 260 regulatory updates across sustainability reporting, climate disclosures, and supply chain due diligence. This means the compliance team is in a constant state of flux. The general financial risk here is clear: while the average cost of compliance for a multinational is around $5.47 million, the average cost of non-compliance-from fines, litigation, and reputational damage-jumps to $14.82 million. That's a massive gap you need to manage.

Increasing investor and public scrutiny on sustainability and climate change impact.

Investor attention on climate impact is driving concrete operational changes, and CooperCompanies is responding with measurable actions. For the fiscal year 2024 (ending October 31, 2024), the company's total Scope 1 and 2 Greenhouse Gas (GHG) emissions (market-based) stood at 73,846 tons of CO2 equivalent (tCO2e). This number is the critical baseline for tracking 2025 performance and future decarbonization efforts. Plus, they've already established a 2022 baseline for Scope 3 GHG emissions, which is a crucial step in addressing the emissions from their entire value chain, including suppliers and product use.

Their operational strategy is focused and specific. They maintain 100% renewable electricity sourcing at their CooperVision New York and UK facilities, which is a strong signal to the market. Also, seven of their sites achieved the SCS Zero Waste Certification in 2024, demonstrating tangible progress on waste reduction. This is not just feel-good marketing; it's about driving efficiency and securing long-term resource supply.

Here is the recent GHG data you should be tracking:

Metric	Fiscal Year 2024 Value	Significance for 2025
Scope 1 + 2 GHGs (Market-Based)	73,846 tCO2e	The core benchmark for achieving 2025 reduction targets.
Electricity Usage	170,303,021 kWh	Primary source of Scope 2 emissions; focus for renewable energy expansion.
Renewable Electricity Sourcing	100% at NY and UK CooperVision sites	Sets the standard for other global facilities.

Regulatory changes concerning the use of hazardous substances in medical device manufacturing pose a risk.

The medical device industry is under intense scrutiny regarding the chemicals used in products, and CooperCompanies is not immune. Their SEC filings explicitly flag the risk from 'evolving regulations regarding the use of hazardous substances or chemicals in our products.' The most immediate and complex regulatory pressure comes from Europe, which is a major market for both CooperVision and CooperSurgical.

Key regulations to watch in 2025 include:

• EU Medical Devices Regulation (MDR): This is a massive, ongoing compliance challenge that governs the safety and performance of medical devices, including requirements on chemical composition.
• EU REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals): This regulation has seen updates in 2025, specifically restricting hazardous substances and directly impacting the materials used in medical device components.

Compliance is a multi-million dollar annual investment, but the alternative is worse: product recalls, market access denial, and significant litigation. The complexity of managing these substance restrictions across a global supply chain defintely increases operational risk.

Manufacturing and distribution concentration introduces risk from natural disasters.

The concentration of manufacturing in key geographic hubs creates a single point of failure risk from natural disasters. CooperCompanies' major manufacturing and distribution facilities are strategically located globally, but this geographic concentration exposes them to specific, high-frequency natural hazards.

A prime example is their significant presence in Costa Rica, a country ranked as the second most exposed globally to multiple hazards based on land area, with 36.8% of its total area exposed to three or more hazards. The primary risks in this region are:

• Seismic Activity: High risk of earthquakes and volcanic eruptions.
• Hydro-Meteorological Events: Significant exposure to floods, hurricanes, and landslides.

We've seen this play out before: the CooperVision manufacturing facility in Puerto Rico, while not in Costa Rica, experienced a major disruption from Hurricane Maria in 2017, requiring a massive effort to restore operations to 90% capacity. You should assume a similar, multi-week operational hit is a persistent risk for any facility in a high-hazard zone. This is a supply chain vulnerability that warrants robust insurance and a clear business continuity plan.