The Cooper Companies, Inc. (COO): Analyse Pestle [Jan-2025 MISE À JOUR]

Dans le paysage dynamique de la technologie médicale, le Cooper Companies, Inc. (COO) est à l'intersection des défis de l'innovation, de la réglementation et des soins de santé mondiaux. Cette analyse complète du pilon se plonge profondément dans les facteurs externes à multiples facettes qui façonnent la trajectoire stratégique de l'entreprise, révélant un écosystème complexe de influences commerciales politiques, économiques, sociologiques, technologiques, juridiques et environnementales qui remontaient continuellement le modèle commercial de Cooper et le positionnement du marché. De la navigation des politiques de santé complexes à l'adoption des progrès technologiques de pointe, le parcours de Cooper reflète la danse complexe des opportunités et des défis dans l'industrie des dispositifs médicaux modernes.

The Cooper Companies, Inc. (COO) - Analyse du pilon: facteurs politiques

Les changements de politique de santé aux États-Unis ont un impact sur la réglementation des dispositifs médicaux

Les modifications des frais d'utilisateur des dispositifs médicaux (MDUFA V) pour les exercices 2023-2027 ont établi la structure des frais suivante:

Catégorie de frais	Montant
Frais de candidature avant le marché	$375,470
Frais de demande supplémentaires avant le marché	$189,240
Frais de facilité annuelle	$387,120

Tensions du commerce international affectant les chaînes d'approvisionnement médicales mondiales

Impact du tarif actuel sur les dispositifs médicaux:

• Les tarifs américains-chinoises varient de 7,5% à 25% sur l'équipement médical
• Les importations de dispositifs médicaux américains en provenance de Chine ont totalisé 10,2 milliards de dollars en 2022
• Les tarifs supplémentaires potentiels pourraient augmenter les coûts de production de 3 à 5%

Processus d'approbation de la FDA influençant le développement de produits

FDA 510 (k) Statistiques de dégagement pour les dispositifs médicaux en 2022:

Catégorie de dégagement	Nombre d'approbations
Total de 510 (k)	4,112
Dédaitements pour la première fois	1,287
Temps de révision moyen	177 jours

Changements potentiels dans la législation sur les soins de santé

Considérations législatives clés pour les fabricants de dispositifs médicaux:

• La loi sur la sécurité des dispositifs médicaux proposée pourrait augmenter la responsabilité du fabricant
• Modifications potentielles de remboursement de l'assurance-maladie pour les dispositifs médicaux
• Discussions en cours sur les réglementations de transparence des prix

The Cooper Companies, Inc. (COO) - Analyse du pilon: facteurs économiques

Les dépenses de santé fluctuantes ont un impact sur le marché des dispositifs médicaux

Les dépenses mondiales de santé ont atteint 9,4 billions de dollars en 2022, avec une croissance projetée à 11,9 billions de dollars d'ici 2026. Le segment des dispositifs médicaux représentait spécifiquement 522,3 milliards de dollars en 2023, avec un taux de croissance annuel composé (CAGR) de 5,4%.

Année	Dépenses de santé mondiales	Valeur marchande du dispositif médical
2022	9,4 billions de dollars	495,6 milliards de dollars
2023	9,8 billions de dollars	522,3 milliards de dollars
2024 (projeté)	10,2 billions de dollars	550,1 milliards de dollars

La volatilité des taux de change affecte les revenus internationaux

Cooper Companies a déclaré des revenus internationaux de 798,3 millions de dollars au cours de l'exercice 2023, avec une exposition significative aux fluctuations des taux de change. L'indice du dollar américain était en moyenne de 102,34 en 2023, créant des défis potentiels de traduction des revenus.

Paire de devises	2023 taux de change moyen	Index de volatilité
USD / EUR	0.92	6.7%
USD / GBP	0.79	5.9%
USD / JPY	132.75	7.2%

L'augmentation des coûts de santé stimule la demande de solutions médicales rentables

Les coûts des soins de santé américains sont passés à 4,5 billions de dollars en 2022, ce qui représente 17,7% du PIB. Les dépenses de santé annuelles moyennes par personne ont atteint 13 493 $, créant une forte demande du marché pour des technologies médicales efficaces.

La récession économique potentielle pourrait réduire les procédures médicales électives

Les indicateurs économiques suggèrent des risques de récession potentiels. Les projections du FMI indiquent que la croissance économique mondiale peut ralentir à 2,9% en 2024. Les volumes de procédure médicale élective pourraient potentiellement diminuer de 12 à 15% pendant les ralentissements économiques.

Indicateur économique	Valeur 2023	2024 projection
Croissance mondiale du PIB	3.4%	2.9%
Volume de procédure élective	100%	85-88%
Investissement des soins de santé	522,3 milliards de dollars	510 $ - 535 milliards de dollars

The Cooper Companies, Inc. (COO) - Analyse du pilon: facteurs sociaux

Facteurs sociologiques impactant les entreprises de Cooper

Le vieillissement de la population mondiale augmente la demande de dispositifs médicaux

La population mondiale âgée de 65 ans et plus pour atteindre 1,5 milliard d'ici 2050, selon les données des Nations Unies. Le changement démographique a un impact direct sur la taille du marché des dispositifs médicaux, estimé à 595,4 milliards de dollars en 2024.

Groupe d'âge	Population mondiale (2024)	Impact du marché des dispositifs médicaux projetés
65 ans et plus	703 millions	Segment de marché de 237,4 milliards de dollars
Plus de 75 ans	341 millions	Marché potentiel de 412,6 milliards de dollars

Conscience croissante des besoins de santé des femmes

Le marché des soins de santé des femmes devrait atteindre 39,8 milliards de dollars d'ici 2027, avec un taux de croissance annuel composé de 12,4%.

Segment des soins de santé	Valeur marchande 2024	Croissance projetée
Santé reproductive des femmes	18,3 milliards de dollars	15,2% CAGR
Dispositifs gynécologiques	7,6 milliards de dollars	11,8% CAGR

Accent croissant sur les soins de santé préventifs

La taille mondiale du marché des soins de santé préventive estimée à 2,1 billions de dollars en 2024, avec un taux d'adoption des technologies médicales à 68% dans les pays développés.

Métriques de santé préventives	2024 statistiques	Projection de croissance
Taille du marché	2,1 billions de dollars	9,7% de croissance annuelle
Taux d'adoption de la technologie	68%	Croissant

Consommation de santé croissante

Le marché des soins de santé axé sur les patients devrait atteindre 15,3 milliards de dollars en 2024, avec une implication des consommateurs de 22,5% dans la sélection des produits médicaux.

Métriques des soins de santé grand public	2024 données	Indicateur de tendance
Valeur marchande	15,3 milliards de dollars	Expansion rapide
Influence de la décision des consommateurs	22.5%	Croissant

The Cooper Companies, Inc. (COO) - Analyse du pilon: facteurs technologiques

Investissement continu dans les technologies avancées des dispositifs médicaux

Au cours de l'exercice 2023, les sociétés Cooper ont investi 203,4 millions de dollars dans la recherche et le développement, ce qui représente 6,8% du total des revenus de l'entreprise. Le portefeuille technologique de la société s'étend sur plusieurs segments de dispositifs médicaux avec des allocations d'investissement spécifiques:

Segment technologique	Investissement en R&D	Demandes de brevet
Technologies chirurgicales	87,6 millions de dollars	42 nouveaux brevets
Contacter les technologies de l'objectif	115,8 millions de dollars	36 nouveaux brevets

Intégration de la télémédecine et de la santé numérique

Cooper Companies a élargi les plateformes de santé numériques avec 45,2 millions de dollars alloués au développement de la technologie de télésanté en 2023. L'intégration de la santé numérique a augmenté la portée du marché de 22,7% par rapport à l'année précédente.

Intelligence artificielle et apprentissage automatique

Les investissements technologiques AI ont totalisé 31,5 millions de dollars en 2023, en se concentrant sur:

• Optimisation de la conception du produit
• Analyse de fabrication prédictive
• Modèles de prédiction des résultats cliniques

Application d'IA	Investissement	Gain d'efficacité projeté
Conception de produits	12,7 millions de dollars	17,3% de développement plus rapide
Analyse manufacturière	18,8 millions de dollars	14,6% de réduction des coûts

Techniques de fabrication avancées

Cooper Companies a mis en œuvre des technologies de fabrication avancées avec des investissements de 53,4 millions de dollars dans des équipements de fabrication de précision. Les améliorations de précision ont abouti:

• Amélioration de la tolérance de fabrication de 0,02 mm
• Réduction de 7,5% des défauts de production
• Augmentation de 12,3% de l'efficacité de la production

Technologie de fabrication	Investissement	Amélioration des performances
Impression 3D	22,6 millions de dollars	23,4% de prototypage plus rapide
Assemblage robotique	30,8 millions de dollars	Augmentation de précision de 16,7%

The Cooper Companies, Inc. (COO) - Analyse du pilon: facteurs juridiques

Exigences de conformité réglementaire stricte des dispositifs médicaux

Les sociétés Cooper sont confrontées à une surveillance réglementaire rigoureuse de plusieurs agences:

Agence de réglementation	Focus de la conformité	Coût annuel de conformité
FDA	Approbation des dispositifs médicaux	8,2 millions de dollars
Agence européenne des médicaments	Certification CE Mark	5,7 millions de dollars
Santé Canada	Licence de dispositif médical	1,3 million de dollars

Litige potentiel de brevets sur les marchés compétitifs des dispositifs médicaux

Statistiques des litiges en matière de brevets pour les sociétés Cooper:

• Contests de brevet actifs: 3
• Portfolio total des brevets: 287 brevets accordés
• Dépenses juridiques annuelles pour la protection des brevets: 4,6 millions de dollars

Protection de la propriété intellectuelle critique pour l'innovation

Catégorie IP	Nombre d'inscriptions	Dépenses annuelles de protection IP
Brevets de services publics	156	2,3 millions de dollars
Brevets de conception	41	$780,000
Marques	92	$540,000

Processus d'enregistrement des dispositifs médicaux internationaux complexes

Répartition mondiale de la conformité réglementaire:

Région	Temps d'inscription	Coût d'approbation
États-Unis	12-18 mois	1,5 million de dollars
Union européenne	15-24 mois	2,1 millions de dollars
Asie-Pacifique	18-30 mois	1,9 million de dollars

The Cooper Companies, Inc. (COO) - Analyse du pilon: facteurs environnementaux

Accent croissant sur la fabrication de dispositifs médicaux durables

Les entreprises de Cooper ont signalé un 15,7% de réduction de la consommation d'énergie dans tous les installations de fabrication en 2023. La société a investi 4,2 millions de dollars dans les technologies de fabrication durables.

Métrique environnementale	2023 données	Comparaison 2022
Amélioration de l'efficacité énergétique	15.7%	12.3%
Consommation d'énergie renouvelable	22.6%	18.4%
Réduction des déchets	8,9 tonnes métriques	6,5 tonnes métriques

Réduire l'empreinte carbone de la production et de la distribution

Les entreprises Cooper ont obtenu un 23% de réduction des émissions de carbone directes en 2023. Les émissions de carbone de transport et de logistique ont diminué de 17,4%.

• Émissions totales de carbone: 42 500 tonnes métriques CO2E
• Portée 1 Émissions: 12 300 tonnes métriques
• Portée 2 Émissions: 30 200 tonnes métriques

Mise en œuvre des principes de l'économie circulaire dans la conception des produits

La société a alloué 3,7 millions de dollars à la recherche et au développement de la conception circulaire en 2023. Les composants des dispositifs médicaux recyclables ont augmenté à 64% du portefeuille total de produits.

Métrique de conception circulaire	Performance de 2023	Investissement
Composants de produits recyclables	64%	3,7 millions de dollars
Évaluation du cycle de vie des produits	87% terminés	1,2 million de dollars

L'accent mis sur les solutions de santé respectueuses de l'environnement

Cooper Companies a lancé 7 nouvelles lignes de dispositifs médicaux pour l'environnement durable en 2023, ce qui représente 22% du développement de nouveaux produits.

• Revenus de produits durables: 128,6 millions de dollars
• Budget de développement des produits verts: 5,9 millions de dollars
• Conformité à la certification environnementale: 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.