Análisis PESTLE de The Cooper Companies, Inc. (COO) [Actualizado en enero de 2025]

En el panorama dinámico de la tecnología médica, Cooper Companies, Inc. (COO) se encuentra en la intersección de la innovación, la regulación y los desafíos globales de atención médica. Este análisis integral de mano de mortero profundiza en los factores externos multifacéticos que dan forma a la trayectoria estratégica de la compañía, revelando un complejo ecosistema de influencias políticas, económicas, sociológicas, tecnológicas, legales y ambientales que continuamente remodelan el modelo comercial y el posicionamiento comercial de Cooper. Desde navegar por las intrincadas políticas de atención médica hasta adoptar los avances tecnológicos de vanguardia, el viaje de Cooper refleja la intrincada danza de la oportunidad y el desafío en la industria moderna de dispositivos médicos.

The Cooper Companies, Inc. (COO) - Análisis de mortero: factores políticos

Los cambios en la política de salud de EE. UU. Impactan la regulación del dispositivo médico

Las enmiendas de tarifas del usuario del dispositivo médico (MDUFA V) para los años fiscales 2023-2027 establecieron la siguiente estructura de tarifas:

Categoría de tarifa	Cantidad
Tarifa de solicitud previa al mercado	$375,470
Tarifa de solicitud suplementaria previa al mercado	$189,240
Tarifa de la instalación anual	$387,120

Tensiones comerciales internacionales que afectan las cadenas de suministro médico global

Impacto arancelario actual en dispositivos médicos:

• Las tarifas de US-China varían de 7.5% a 25% en equipos médicos
• El dispositivo médico de EE. UU. Las importaciones de China totalizaron $ 10.2 mil millones en 2022
• Los posibles aranceles adicionales podrían aumentar los costos de producción en un 3-5%

Procesos de aprobación de la FDA que influyen en el desarrollo de productos

Estadísticas de autorización de la FDA 510 (k) para dispositivos médicos en 2022:

Categoría de autorización	Número de aprobaciones
Total 510 (k) espacios libres	4,112
Espacios por primera vez	1,287
Tiempo de revisión promedio	177 días

Posibles cambios en la legislación de atención médica

Consideraciones legislativas clave para fabricantes de dispositivos médicos:

• La Ley de Seguridad de Dispositivos Médicos Propuesta podría aumentar la responsabilidad del fabricante
• Cambios potenciales de reembolso de Medicare para dispositivos médicos
• Discusiones continuas sobre las regulaciones de transparencia de los precios

Cooper Companies, Inc. (COO) - Análisis de mortero: factores económicos

Fluctuando el gasto de atención médica impactos en el mercado de dispositivos médicos

El gasto mundial de atención médica alcanzó los $ 9.4 billones en 2022, con un crecimiento proyectado a $ 11.9 billones para 2026. El segmento de dispositivos médicos representó específicamente $ 522.3 mil millones en 2023, con una tasa de crecimiento anual compuesta (CAGR) de 5.4%.

Año	Gasto global de atención médica	Valor de mercado del dispositivo médico
2022	$ 9.4 billones	$ 495.6 mil millones
2023	$ 9.8 billones	$ 522.3 mil millones
2024 (proyectado)	$ 10.2 billones	$ 550.1 mil millones

La volatilidad del tipo de cambio de divisas afecta los ingresos internacionales

Cooper Companies informó ingresos internacionales de $ 798.3 millones en el año fiscal 2023, con una exposición significativa a las fluctuaciones del tipo de cambio. El índice de dólar estadounidense promedió 102.34 en 2023, creando posibles desafíos de traducción de ingresos.

Pareja	2023 tipo de cambio promedio	Índice de volatilidad
USD/EUR	0.92	6.7%
USD/GBP	0.79	5.9%
USD/JPY	132.75	7.2%

El aumento de los costos de atención médica impulsan la demanda de soluciones médicas rentables

Los costos de atención médica de los Estados Unidos aumentaron a $ 4.5 billones en 2022, lo que representa el 17.7% del PIB. El gasto anual promedio de atención médica por persona alcanzó los $ 13,493, creando una fuerte demanda del mercado de tecnologías médicas eficientes.

La recesión económica potencial podría reducir los procedimientos médicos electivos

Los indicadores económicos sugieren riesgos potenciales de recesión. Las proyecciones del FMI indican que el crecimiento económico global puede disminuir a 2.9% en 2024. Los volúmenes de procedimientos médicos electivos podrían disminuir potencialmente en un 12-15% durante las recesiones económicas.

Indicador económico	Valor 2023	2024 proyección
Crecimiento global del PIB	3.4%	2.9%
Volumen de procedimiento electivo	100%	85-88%
Inversión en salud	$ 522.3 mil millones	$ 510- $ 535 mil millones

Cooper Companies, Inc. (COO) - Análisis de mortero: factores sociales

Factores sociológicos que afectan a las empresas de Cooper

El envejecimiento de la población global aumenta la demanda de dispositivos médicos

La población global de más de 65 años proyectada para llegar a 1.500 millones para 2050, según datos de las Naciones Unidas. El cambio demográfico impacta directamente el tamaño del mercado del dispositivo médico, estimado en $ 595.4 mil millones en 2024.

Grupo de edad	Población global (2024)	Impacto en el mercado de dispositivos médicos proyectados
Más de 65 años	703 millones	Segmento de mercado de $ 237.4 mil millones
Más de 75 años	341 millones	$ 412.6 mil millones de mercado potencial

Conciencia creciente de las necesidades de atención médica de las mujeres

El mercado de la salud de las mujeres proyectó alcanzar los $ 39.8 mil millones para 2027, con una tasa de crecimiento anual compuesta del 12.4%.

Segmento de atención médica	Valor de mercado 2024	Crecimiento proyectado
Salud reproductiva de las mujeres	$ 18.3 mil millones	15.2% CAGR
Dispositivos ginecológicos	$ 7.6 mil millones	11.8% CAGR

Aumento del enfoque en la atención médica preventiva

El tamaño del mercado mundial de atención médica preventiva estimada en $ 2.1 billones en 2024, con una tasa de adopción de tecnología médica en 68% en los países desarrollados.

Métricas de atención médica preventiva	2024 estadísticas	Proyección de crecimiento
Tamaño del mercado	$ 2.1 billones	9.7% de crecimiento anual
Tasa de adopción de tecnología	68%	Creciente

Aumento del consumismo de la salud

Se espera que el mercado de salud impulsado por el paciente alcance los $ 15.3 mil millones en 2024, con un 22.5% de participación del consumidor en la selección de productos médicos.

Métricas de salud del consumidor	2024 datos	Indicador de tendencias
Valor comercial	$ 15.3 mil millones	En rápida expansión
Influencia de la decisión del consumidor	22.5%	Creciente

Cooper Companies, Inc. (COO) - Análisis de mortero: factores tecnológicos

Inversión continua en tecnologías avanzadas de dispositivos médicos

En el año fiscal 2023, las compañías de Cooper invirtieron $ 203.4 millones en investigación y desarrollo, lo que representa el 6.8% de los ingresos totales de la compañía. La cartera de tecnología de la compañía abarca múltiples segmentos de dispositivos médicos con asignaciones de inversión específicas:

Segmento tecnológico	Inversión de I + D	Solicitudes de patentes
Tecnologías quirúrgicas	$ 87.6 millones	42 nuevas patentes
Tecnologías de lente de contacto	$ 115.8 millones	36 nuevas patentes

Integración de telemedicina e salud digital

Las empresas de Cooper ampliaron las plataformas de salud digital con $ 45.2 millones asignados al desarrollo de tecnología de telesalud en 2023. La integración de salud digital aumentó el alcance del mercado en un 22.7% en comparación con el año anterior.

Inteligencia artificial y aprendizaje automático

AI Technology Investments totalizaron $ 31.5 millones en 2023, centrándose en:

• Optimización del diseño del producto
• Análisis de fabricación predictiva
• Modelos de predicción de resultados clínicos

Aplicación de IA	Inversión	Ganancia de eficiencia proyectada
Diseño de productos	$ 12.7 millones	17.3% de desarrollo más rápido
Análisis de fabricación	$ 18.8 millones	14.6% Reducción de costos

Técnicas de fabricación avanzadas

Cooper Companies implementaron tecnologías de fabricación avanzada con una inversión de $ 53.4 millones en equipos de fabricación de precisión. Las mejoras de precisión dieron como resultado:

• Mejora de tolerancia de fabricación de 0.02 mm
• Reducción del 7,5% en los defectos de producción
• Aumento del 12.3% en la eficiencia de producción

Tecnología de fabricación	Inversión	Mejora del rendimiento
Impresión 3D	$ 22.6 millones	23.4% de prototipos más rápido
Asamblea robótica	$ 30.8 millones	Aumento de precisión del 16,7%

Cooper Companies, Inc. (COO) - Análisis de mortero: factores legales

Requisitos de cumplimiento regulatorio de dispositivos médicos estrictos

Las compañías de Cooper enfrentan una rigurosa supervisión regulatoria de múltiples agencias:

Agencia reguladora	Enfoque de cumplimiento	Costo de cumplimiento anual
FDA	Aprobación del dispositivo médico	$ 8.2 millones
Agencia Europea de Medicamentos	Certificación CE Mark	$ 5.7 millones
Salud de Canadá	Licencias de dispositivos médicos	$ 1.3 millones

Litigio potencial de patentes en mercados competitivos de dispositivos médicos

Estadísticas de litigios de patentes para empresas de Cooper:

• Disputas de patente activas: 3
• Portafolio de patentes totales: 287 patentes otorgadas
• Gastos legales anuales para la protección de patentes: $ 4.6 millones

Protección de propiedad intelectual crítica para la innovación

Categoría de IP	Número de registros	Gastos anuales de protección de IP
Patentes de servicios públicos	156	$ 2.3 millones
Patentes de diseño	41	$780,000
Marcas registradas	92	$540,000

Procesos de registro de dispositivos médicos internacionales complejos

Desglose de cumplimiento regulatorio global:

Región	Tiempo de registro	Costo de aprobación
Estados Unidos	12-18 meses	$ 1.5 millones
unión Europea	15-24 meses	$ 2.1 millones
Asia-Pacífico	18-30 meses	$ 1.9 millones

Cooper Companies, Inc. (COO) - Análisis de mortero: factores ambientales

Aumento del enfoque en la fabricación de dispositivos médicos sostenibles

Cooper Companies informó un 15.7% de reducción en el consumo de energía En todas las instalaciones de fabricación en 2023. La compañía invirtió $ 4.2 millones en tecnologías de fabricación sostenible.

Métrica ambiental	2023 datos	Comparación 2022
Mejora de la eficiencia energética	15.7%	12.3%
Uso de energía renovable	22.6%	18.4%
Reducción de desechos	8.9 toneladas métricas	6.5 toneladas métricas

Reducción de la huella de carbono en la producción y distribución

Cooper Companies logró un Reducción del 23% en las emisiones directas de carbono en 2023. Las emisiones de carbono de transporte y logística disminuyeron en un 17,4%.

• Emisiones totales de carbono: 42,500 toneladas métricas CO2E
• Alcance 1 emisiones: 12,300 toneladas métricas
• Alcance 2 emisiones: 30,200 toneladas métricas

Implementación de principios de economía circular en diseño de productos

La compañía asignó $ 3.7 millones para la investigación y el desarrollo de diseño circular en 2023. Los componentes de dispositivos médicos reciclables aumentaron al 64% de la cartera total de productos.

Métrico de diseño circular	2023 rendimiento	Inversión
Componentes de productos reciclables	64%	$ 3.7 millones
Evaluación del ciclo de vida del producto	87% completado	$ 1.2 millones

Creciente énfasis en soluciones de salud ambientalmente responsables

Cooper Companies lanzaron 7 nuevas líneas de dispositivos médicos ambientalmente sostenibles en 2023, lo que representa el 22% del desarrollo de nuevos productos.

• Ingresos de productos sostenibles: $ 128.6 millones
• Presupuesto de desarrollo de productos verdes: $ 5.9 millones
• Cumplimiento de la certificación 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.