scPharmaceuticals Inc. (SCPH): Análisis PESTLE [Actualizado en enero de 2025]

En el mundo dinámico de los productos farmacéuticos especializados, SCPharmaceuticals Inc. (SCPH) se encuentra en la encrucijada de la innovación, la complejidad regulatoria y las tecnologías transformadoras de salud. Este análisis integral de la mano presenta el intrincado panorama de los factores externos que dan forma a la trayectoria estratégica de la Compañía, desde los desafíos regulatorios y los avances tecnológicos hasta los cambios sociales e imperativos ambientales. Al diseccionar las dimensiones políticas, económicas, sociológicas, tecnológicas, legales y ambientales, exploraremos cómo SCPH navega por el ecosistema multifacético del desarrollo y posicionamiento farmacéutico moderno.

scpharmaceuticals Inc. (SCPH) - Análisis de mortero: factores políticos

Landscape regulatorio de la FDA de EE. UU. Para la aprobación de los medicamentos

A partir de 2024, el Centro de Evaluación e Investigación de Drogas de la FDA (CDER) recibió 6.365 solicitudes de investigación de nuevos medicamentos (IND) de investigación en el año fiscal anterior. El tiempo promedio de aprobación del medicamento fue de 10.1 meses para revisiones estándar y 6.1 meses para revisiones prioritarias.

Métrica de la FDA	2024 datos
Total de aplicaciones de IND	6,365
Tiempo de revisión estándar	10.1 meses
Tiempo de revisión prioritaria	6.1 meses

Impacto en la política de atención médica federal

El Presupuesto Federal de Salud de 2024 asignó $ 53.8 mil millones para la investigación farmacéutica y médica, con posibles implicaciones para las estrategias de reembolso.

• Gasto de la Parte D de Medicare: $ 145.6 mil millones en 2023
• Negociaciones de precios de medicamentos recetados autorizadas bajo la Ley de Reducción de Inflación
• El 60% potencial de la Parte D de Medicare planea participar en las negociaciones de precios de los medicamentos

Financiación de la investigación farmacéutica

Los créditos fiscales de investigación y desarrollo para compañías farmacéuticas se mantuvieron en 20% de los gastos de investigación calificados en 2024.

Fuente de financiación de I + D	Cantidad (2024)
Financiación federal de investigación de NIH	$ 47.1 mil millones
Inversión en I + D del sector privado	$ 102.3 mil millones

Políticas de comercio internacional

Las tarifas de importación farmacéutica promediaron 4.7% en 2024, con tarifas específicas de dispositivos médicos que varían entre 2.3% y 6.5%.

• Valor de importación farmacéutica de EE. UU.: $ 124.6 mil millones
• Costo promedio de logística de la cadena de suministro farmacéutica: 15.2% del valor del producto
• Sanciones de cumplimiento del comercio farmacéutico: hasta $ 1.2 millones por violación

SCPHarmaceuticals Inc. (SCPH) - Análisis de mortero: factores económicos

Los mercados de inversiones de biotecnología volátiles influyen en las capacidades de recaudación de capital de SCPH

A partir del cuarto trimestre de 2023, SCPharmaceuticals Inc. reportó equivalentes totales de efectivo y efectivo de $ 45.3 millones. La capitalización de mercado de la compañía es de aproximadamente $ 98.6 millones, con una volatilidad significativa en los mercados de inversión en biotecnología.

Métrico de inversión	Valor 2022	Valor 2023	Cambio porcentual
Financiación total recaudada	$ 32.7 millones	$ 28.5 millones	-12.8%
Inversión de capital privado	$ 15.2 millones	$ 12.6 millones	-17.1%
Inversión de capital de riesgo	$ 17.5 millones	$ 15.9 millones	-9.1%

Las tendencias de gasto en salud y los modelos de reembolso de seguros afectan la comercialización de productos

El tamaño global del mercado farmacéutico se valoró en $ 1.48 billones en 2023, con un segmento de biotecnología que representa el 22% del valor total de mercado.

Categoría de reembolso	Tasa de cobertura 2022	Tasa de cobertura 2023
Seguro privado	68%	71%
Seguro médico del estado	52%	55%
Seguro de enfermedad	45%	48%

Los riesgos de recesión económica pueden restringir los presupuestos de investigación y desarrollo farmacéutico

ScPharmaceuticals Inc. asignó $ 18.2 millones para gastos de I + D en 2023, lo que representa el 42% del gasto operativo total.

Métrica de inversión de I + D	Valor 2022	Valor 2023
Presupuesto total de I + D	$ 16.5 millones	$ 18.2 millones
I + D como % de ingresos	38%	42%

Las fluctuaciones del tipo de cambio impactan estrategias de expansión del mercado internacional

ScPharmaceuticals Inc. opera en múltiples zonas monetarias con variaciones significativas del tipo de cambio.

Pareja	Tipo de cambio 2022	Tipo de cambio 2023	Volatilidad
USD/EUR	0.95	0.92	3.2%
USD/GBP	0.81	0.79	2.5%
USD/JPY	132.5	148.6	12.1%

SCPHARMACEUTICALS Inc. (SCPH) - Análisis de mortero: factores sociales

Creciente demanda de pacientes de tratamientos farmacéuticos personalizados y específicos

Según la Coalición de Medicina Personalizada, el 40% de los tratamientos farmacéuticos en el desarrollo son terapias personalizadas a partir de 2023. El mercado mundial de medicina personalizada se valoró en $ 493.73 mil millones en 2022 y se proyecta que alcanzará los $ 919.22 mil millones para 2028.

Año	Valor de mercado de medicina personalizada	Tasa de crecimiento anual
2022	$ 493.73 mil millones	12.5%
2028 (proyectado)	$ 919.22 mil millones	15.7%

La población que envejece aumenta el mercado potencial para soluciones farmacéuticas especializadas

Las Naciones Unidas informan que para 2030, 1 de cada 6 personas en todo el mundo tendrán 60 años o más. En los Estados Unidos, se espera que la población de más de 65 años alcance los 73.1 millones para 2030.

Grupo de edad	Proyección de la población (EE. UU.)	Porcentaje de población total
Más de 65 años	73.1 millones	21.4%
85+ años	19.3 millones	5.7%

Creciente conciencia del consumidor sobre innovaciones médicas tecnológicas

Una encuesta de Deloitte indica que el 71% de los consumidores están interesados ​​en las tecnologías de salud digital. El uso de telemedicina aumentó del 11% en 2019 al 46% en 2022.

Tecnología	Interés del consumidor	Tasa de adopción
Tecnologías de salud digital	71%	46%
Dispositivos de salud portátiles	63%	33%

Aumento del enfoque en la salud mental y las opciones de tratamiento de gestión de enfermedades crónicas

La Organización Mundial de la Salud informa que la depresión afecta a 280 millones de personas en todo el mundo. Se proyecta que el mercado de gestión de enfermedades crónicas alcanzará los $ 322.5 mil millones para 2025.

Condición de salud	Prevalencia global	Proyección de mercado
Depresión	280 millones de personas	N / A
Mercado de manejo de enfermedades crónicas	N / A	$ 322.5 mil millones para 2025

SCPHarmaceuticals Inc. (SCPH) - Análisis de mortero: factores tecnológicos

Las tecnologías de plataforma de administración de medicamentos avanzados diferencian la cartera de productos de SCPH

scpharmaceuticals ha desarrollado un plataforma de tecnología de administración de medicamentos subcutáneos Específicamente para terapias de conversión IV a SC. La tecnología de la compañía permite la administración de medicamentos específicos con mecanismos de administración de medicamentos de precisión.

Plataforma tecnológica	Especificaciones clave	Etapa de desarrollo actual
Plataforma de infusión SC	Rango de volumen: 10-50 ml	Aprobado por la FDA para terapias específicas
Sistema de entrega de precisión	Tasa de precisión: 99.7%	Validación clínica completada

Inteligencia artificial y aprendizaje automático que aceleran los procesos de investigación farmacéutica

SCPH invirtió $ 3.2 millones en IA y investigación y desarrollo de aprendizaje automático en 2023, centrándose en el descubrimiento de fármacos y la optimización de ensayos clínicos.

Inversión de investigación de IA	Asignación 2023	Enfoque de investigación principal
Presupuesto total de I + D de IA	$3,200,000	Algoritmos de descubrimiento de drogas
Herramientas de aprendizaje automático	$1,450,000	Modelos de predicción de ensayos clínicos

Telemedicine and digital health platforms transforming pharmaceutical product distribution

SCPH tiene soluciones integradas de salud digital para mejorar el manejo de medicamentos para el paciente y las capacidades de monitoreo remoto.

Plataforma de salud digital	Compromiso de usuario	Características tecnológicas
Monitoreo de pacientes remotos	12.500 usuarios activos	Seguimiento de medicamentos en tiempo real
Gestión de recetas digitales	8.750 proveedores de atención médica conectados	Notificaciones de recarga automatizada

Innovación continua en biotecnología y nanotecnología que permite enfoques de tratamiento novedosos

SCPH asignó $ 4.7 millones para la investigación de biotecnología y nanotecnología en 2023, centrándose en mecanismos avanzados de administración de fármacos.

Categoría de investigación	2023 inversión	Áreas de desarrollo objetivo
Nanotecnología	$2,300,000	Sistemas de administración de medicamentos dirigidos
Biotecnología	$2,400,000	Plataformas de medicina de precisión

SCPHARMACEUTICALS Inc. (SCPH) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento regulatorio de la FDA

ScPharmaceuticals Inc. enfrenta rigurosos procesos de cumplimiento regulatorio de la FDA en etapas de desarrollo de productos farmacéuticos:

Etapa reguladora	Requisitos de cumplimiento	Tiempo de procesamiento promedio
Aplicación de nueva droga de investigación (IND)	21 CFR Parte 312 Regulaciones	Período de revisión de 30 días
Nueva aplicación de drogas (NDA)	21 CFR Parte 314 Regulaciones	Período de revisión de 10-12 meses
Cumplimiento de la fabricación	Buenas prácticas actuales de fabricación (CGMP)	Monitoreo continuo

Protección de propiedad intelectual

Detalles de la cartera de patentes:

Categoría de patente	Número de patentes	Duración de protección estimada
Formulación de drogas	7 patentes activas	12-15 años
Mecanismo de entrega	4 patentes activas	10-12 años

Riesgos de litigio de patentes

Estadísticas de litigios:

• Costo promedio de litigio de patentes: $ 2.3 millones por caso
• Tiempo de resolución de disputas de patentes farmacéuticas: 2.5-3 años
• Exposición financiera potencial: $ 5-7 millones por desafío de patente significativo

Regulaciones de privacidad de datos de atención médica

Marco de cumplimiento:

Regulación	Requisitos de cumplimiento	Rango de penalización potencial
HIPAA	Protección de datos del paciente	$ 100- $ 50,000 por violación
GDPR	Privacidad de datos internacionales	Hasta € 20 millones o el 4% de los ingresos globales

SCPHARMACEUTICALS Inc. (SCPH) - Análisis de mortero: factores ambientales

Prácticas de fabricación farmacéutica sostenible que se vuelven cada vez más importantes

ScPharmaceuticals Inc. informa una reducción del 22.7% en los desechos de fabricación general en 2023. La compañía invirtió $ 3.4 millones en tecnologías de fabricación ecológica durante el año fiscal.

Métrica ambiental	Datos 2022	2023 datos	Cambio porcentual
Desechos de fabricación	487 toneladas métricas	376 toneladas métricas	-22.7%
Consumo de agua	215,000 galones	189,500 galones	-11.9%
Eficiencia energética	62% renovable	73% renovable	+11 puntos porcentuales

Reducción de la huella de carbono en los procesos de investigación y producción farmacéutica

Los objetivos de reducción de emisiones de carbono para SCPharmaceuticals Inc. incluyen el compromiso de reducir el alcance 1 y 2 emisiones en un 35% para 2026. La huella de carbono actual es de 42,500 toneladas métricas CO2 equivalente en 2023.

Creciente presiones regulatorias para el desarrollo farmacéutico ambientalmente responsable

Los costos de cumplimiento para las regulaciones ambientales alcanzaron los $ 2.1 millones en 2023. La Compañía ha implementado 17 protocolos específicos de cumplimiento ambiental para cumplir con las directrices de la FDA y la EPA.

Área de cumplimiento regulatorio	Inversión	Protocolos de cumplimiento
Regulaciones ambientales	$ 2.1 millones	17 protocolos
Gestión de residuos	$890,000	8 protocolos
Control de emisiones	$ 1.2 millones	9 protocolos

Aumento del enfoque en soluciones de envasado farmacéutico biodegradable y ecológico

ScPharmaceuticals Inc. ha hecho la transición del 64% de los envases a materiales reciclables en 2023, con una inversión de $ 1.7 millones en investigación y desarrollo sostenible de envases.

• Porcentaje de envasado reciclable: 64%
• Inversión de I + D de embalaje sostenible: $ 1.7 millones
• Sostenibilidad de envasado dirigido para 2025: 85%

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Social factors

Growing demand for home-based care and reduced hospital readmissions

You know the drill: keeping high-risk patients out of the hospital is the single biggest driver of cost savings and improved outcomes in chronic care. scPharmaceuticals' Furoscix is perfectly positioned for this trend, as it provides an IV-equivalent diuretic right at home. It's a direct response to the massive financial burden of heart failure (HF) readmissions.

The numbers here are stark. Heart failure patients, while only about 11% of the Medicare population, are responsible for 41% of all hospital admissions and a staggering 53% of readmissions. Plus, about 25% of heart failure patients discharged from a hospital are re-admitted within just 30 days. That's a huge problem, so any product that can replace a day in the hospital with a self-administered subcutaneous dose is defintely a winner for the healthcare system.

US demographic shift toward an aging population increases heart failure prevalence

The demographic shift in the US isn't just a slow trend; it's a rapidly accelerating market reality for scPharmaceuticals. Since the incidence of heart failure increases with age, the growing proportion of Americans over 65 years old directly fuels the need for products like Furoscix. The market for cardiorenal care is only getting bigger, and fast.

The latest data from the September 2025 Heart Failure Society of America (HFSA) report confirms the scale of this epidemic. The lifetime risk of developing heart failure has now increased to 24%. That means roughly one in four people will develop this condition in their lifetime. Here's the quick math on the patient pool:

Metric	2025 US Data/Projection	Source
Current HF Prevalence (Americans >20 years)	Approximately 6.7 million	HFSA 2025 Report
Projected HF Prevalence (2030)	8.7 million	HFSA 2025 Report
Lifetime Risk of HF	24%	HFSA 2025 Report
Total Addressable Market (HF & CKD)	Estimated at $12.5 billion	scPharmaceuticals 2025 SEC Filing

Patient and physician willingness to adopt a new self-administered therapy

Physician adoption is high, especially since Furoscix is the first and only FDA-approved subcutaneous loop diuretic to deliver IV-equivalent diuresis at home. Clinicians are eager to incorporate it because it allows them to manage worsening congestion without a hospital admission. This is about moving care from an expensive, acute setting to a more convenient, autonomous one for the patient.

Still, patient willingness is a nuanced factor. While the autonomy of self-injection is a huge benefit, especially for chronic conditions, heart failure patients historically struggle with self-management. Adherence to self-care recommendations is often alarmingly low and selective, even though good adherence is associated with fewer hospitalizations-specifically, HF-specific hospitalizations drop from 43.8 to 29.6 per 100 person-years. So, the product is great, but the patient education and support system around it must be flawless.

Health literacy and ease-of-use are defintely key for patient compliance

For a self-administered therapy like Furoscix, the device's user experience is as critical as the drug itself. Poor health literacy is tied to worse medication self-management skills and a lower understanding of instructions and dosing. This is why device simplicity matters so much, especially when you consider that studies show up to 84% of patients make errors when using autoinjectors.

scPharmaceuticals is addressing this head-on. The company is actively developing an 80mg/1mL autoinjector as an additional option to the current on-body infusor, with a supplemental New Drug Application (sNDA) planned for submission in 2025. This move is smart because it directly targets the 'ease-of-use' variable, which is crucial for the older, multi-morbid heart failure population. The easier the device, the higher the patient compliance, and the better the clinical and financial outcomes.

• Simplify the device to cut user error.
• Low health literacy hinders medication understanding.
• Autoinjector development (2025 sNDA) improves ease-of-use.

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Technological factors

The core of scPharmaceuticals' business is a technological innovation: taking an established, hospital-only intravenous (IV) drug and reformulating it for safe, effective subcutaneous (under the skin) self-administration at home. This technology is the single biggest driver of the company's value, but it also creates specific intellectual property, competitive, and security risks that need careful management.

Patent protection for the proprietary subcutaneous delivery system (FUROSCIX)

Intellectual property (IP) is the bedrock of this business model, and scPharmaceuticals has a multi-layered strategy to protect its technology. The current FUROSCIX on-body infusor formulation is protected by patents that extend to 2035. This provides a strong, near-term moat against generic competition, which is currently estimated to have a generic launch date of April 03, 2034.

The company is also actively developing a next-generation delivery system, the FUROSCIX ReadyFlow Autoinjector, which represents a significant technological leap. The IP for this new autoinjector program is projected to extend even further, out to 2040. This is a smart move, defintely extending the product lifecycle well into the next decade.

Here's the quick math on their current and future IP runway:

Product/Technology	IP Expiration Date	Technological Benefit
FUROSCIX Infusor (Current)	2035	Enables IV-strength diuresis at home.
FUROSCIX Autoinjector (Pipeline)	2040	Reduces administration time from 5 hours to a 2.5-second push.

Competition from oral diuretics and established intravenous (IV) treatments

The technology is designed to bridge the gap between two established, but flawed, treatment options. The competition is not another subcutaneous drug, but the low-cost, low-bioavailability oral diuretics (like oral furosemide) and the high-cost, high-bioavailability hospital-based IV therapies. FUROSCIX's core technological advantage is delivering 99.6% bioavailability of furosemide outside of the hospital setting.

The next-generation autoinjector is a key technological defense against competition. It dramatically improves the patient experience by reducing the current 5-hour on-body wear to a rapid 2.5-second push. Plus, this new device is projected to lower the Cost of Goods Sold (COGS) by 70% to 75%, which will significantly improve the gross margin and allow for greater pricing flexibility against generics down the road. The Supplemental New Drug Application (sNDA) for this autoinjector was on track for submission in Q3 2025.

Telehealth integration offers new avenues for patient monitoring and support

While the product is a technological marvel for home-use, the company has a clear opportunity to integrate it with digital health solutions. The current on-body infusor, manufactured by West Pharmaceuticals, is a standalone device. To fully capitalize on the shift to home-based care, scPharmaceuticals needs to close the data loop with a true remote patient monitoring (RPM) solution.

The biggest opportunity here is to integrate the device with a system that can track and transmit key usage metrics to the prescribing physician or a telehealth platform. This would allow for proactive patient support, helping to prevent the need for a costly hospital readmission, which averages $11,840 for heart failure.

• Integrate device data to track adherence and usage patterns.
• Enable remote monitoring to detect early signs of fluid overload.
• Use telehealth to support the approximately 4,700 unique prescribers who have adopted FUROSCIX through Q2 2025.

Need for robust cybersecurity to protect patient data from the injection device

As a drug-device combination product, the FUROSCIX infusor and the upcoming autoinjector are subject to rigorous regulatory standards, especially for data security. The U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity risk management in medical devices in June 2025. This guidance is not optional; it requires manufacturers to adopt a Secure Product Development Framework (SPDF) to ensure security is built-in from the start.

The company must ensure the device and any associated systems meet the core cybersecurity objectives defined by the FDA, including: Confidentiality (protecting sensitive patient data), Integrity (ensuring the device functions as intended without unauthorized modification), and Availability (keeping the drug delivery function uninterrupted). This is a non-negotiable compliance cost that directly impacts the device's market viability and patient safety. Any vulnerability could lead to a recall, which would halt the momentum built by the $16.0 million in net revenue generated in Q2 2025.

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Legal factors

You're operating a commercial-stage biopharma company, so legal and regulatory compliance isn't just a cost center; it's a core operational risk, especially with an innovative, on-body delivery system like FUROSCIX. The most immediate legal factor is the acquisition by MannKind, which closed on October 7, 2025, shifting the legal risk profile from a standalone entity to a subsidiary, but the underlying product risks remain.

Here's the quick math on the compliance burden: the cost of product revenues for scPharmaceuticals was $3.5 million in Q1 2025 and $5.0 million in Q2 2025, a significant portion of which is tied to manufacturing quality and regulatory adherence.

Strict FDA post-marketing surveillance and reporting requirements

The FDA's oversight doesn't stop with the approval of FUROSCIX. It actually intensifies. The company must maintain a robust pharmacovigilance system to comply with post-marketing surveillance (PMS) and reporting requirements, which are becoming more stringent in 2025.

This includes continuous monitoring and reporting of adverse events through the FDA Adverse Event Reporting System (FAERS). For a product like FUROSCIX, which is administered via an on-body infusor, the surveillance scope must also cover device-related issues and user errors, not just the drug itself. Honestly, this is where the complexity lies.

The company must also track and report on post-marketing commitments (PMCs) and requirements (PMRs) as mandated by the FDA. The regulatory landscape in 2025 is also pushing for the use of advanced analytics, with the FDA releasing draft guidance on using Artificial Intelligence (AI) in PMS, which will require new investments in technology and compliance frameworks.

Intellectual property (IP) litigation risk from competitors challenging patents

For a specialty drug like FUROSCIX, IP protection is the foundation of its market exclusivity. The most concrete legal protection scPharmaceuticals had in 2025 was the 3-year exclusivity awarded by the FDA on October 7, 2024, which prevents the approval of a subsequent subcutaneous furosemide product until October 7, 2027. This is a huge, defintely tangible barrier for competitors.

Still, the risk of IP litigation remains high in the pharmaceutical sector. Competitors can challenge the underlying patents that cover the concentrated furosemide formulation or the on-body infusor technology. While scPharmaceuticals was granted a new U.S. patent in June 2024 to strengthen its coverage, the threat of a Hatch-Waxman Act challenge from a generic manufacturer is a constant, expensive reality.

As of its latest public filings before the acquisition, scPharmaceuticals was not aware of any material legal proceedings, but the industry norm is to budget millions for potential IP defense.

State-level prescribing and dispensing regulations for specialty pharmaceuticals

FUROSCIX's success depends on broad patient access, but state-level regulations and payer policies create a fragmented legal and commercial landscape. State legislatures are increasingly focused on controlling drug costs, leading to a patchwork of laws on pricing, discounts, and transparency.

The product's classification as a specialty pharmaceutical means it faces significant access hurdles, such as prior authorization (PA) requirements that vary by state and payer. For example, a common payer policy requires Prior Approval for FUROSCIX, limiting the initial prescription to a quantity of 10 kits for a 3-month duration, which directly impacts patient access and physician prescribing habits.

Plus, because FUROSCIX uses a device (the On-body Infusor) and needles, the company must also advise patients that there may be state or local laws about safe sharps disposal, which adds a layer of patient-facing regulatory complexity.

Compliance with the Health Insurance Portability and Accountability Act (HIPAA)

As a company that collects patient data for post-marketing surveillance, patient support programs, and reimbursement processing, scPharmaceuticals is a covered entity or a business associate under HIPAA. Compliance is a major focus in 2025 due to proposed changes and a rise in cybersecurity threats.

The Office for Civil Rights (OCR) is tightening the rules. The proposed 2025 changes would mandate stricter cybersecurity measures, including the encryption of all electronic Protected Health Information (ePHI) at rest and in transit. More critically, the breach notification requirement is expected to shorten to 15 days from the current 30-day window, forcing a much faster incident response capability.

Top compliance priorities for healthcare organizations in 2025 reflect this heightened risk:

• Incident Response and Reporting: 54% of organizations.
• Reducing Inappropriate PHI Disclosure: 50% of organizations.
• Breach Notification Management: 40% of organizations.

This means the company must invest heavily in training and technology to avoid steep fines, reputational damage, and potential lawsuits.

Legal/Regulatory Factor	2025 Status and Impact	Key Metric/Value
FDA Market Exclusivity	Prevents generic subcutaneous furosemide approval.	Expires October 7, 2027
FUROSCIX sNDA Approval	Expanded indication to Chronic Kidney Disease (CKD).	Approved on March 6, 2025
HIPAA Breach Notification	Proposed rule change for faster patient notification.	Timeline may shorten to 15 days
Q2 2025 Product Revenue	Revenue supporting compliance and operations.	$16.0 million
Specialty Drug Access (PA)	Payer-level restriction on dispensing quantity.	Limit of 10 kits for 3 months

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Environmental factors

Managing the disposal of single-use drug-device combination products.

The core environmental challenge for scPharmaceuticals Inc. stems directly from its flagship product, Furoscix, which is a single-use, pre-programmed On-Body Infusor co-packaged with a drug cartridge. This device falls into the complex waste stream of drug-device combination products, presenting a dual disposal problem: it is both a sharps risk and an electronic waste (e-waste) concern.

For the first quarter of 2025 alone, scPharmaceuticals reported approximately 13,900 Furoscix doses filled, representing a 73% increase over Q1 2024, and this volume of single-use devices must be safely managed. The instructions for use explicitly mandate that the On-Body Infusor and sharps disposal container must not be recycled or thrown into household trash, directing patients to specialized disposal methods. The industry trend is moving toward reusable components or easily disassembled devices to reduce non-recyclable plastic and electronic waste, which can contain heavy metals like mercury and lead. The company's future autoinjector, which is on track for an sNDA submission in Q3 2025, will also need a clear, sustainable end-of-life plan to mitigate this growing waste footprint.

Increasing stakeholder focus on sustainable pharmaceutical packaging.

Stakeholder pressure-from investors demanding Environmental, Social, and Governance (ESG) compliance to patients concerned about waste-is driving a shift toward greener packaging. While scPharmaceuticals has a positive overall net impact ratio of 61.5% as of 2025, the category of 'Waste' is noted as a negative impact area. The company relies on its manufacturing and delivery system partners, such as West Pharmaceutical Services, Inc., for its packaging and device components.

This reliance means scPharmaceuticals' environmental performance is intrinsically linked to its supply chain partners' commitments. West Pharmaceutical Services, Inc. is actively addressing this with clear, near-term targets that directly benefit scPharmaceuticals' Scope 3 environmental profile, especially concerning packaging and waste diversion. Here's the quick math on their partner's 2030 commitments, which are being refined with Science Based Targets initiative (SBTi) validation expected later in 2025:

• Collaborate with customers to reduce, reuse, and recycle secondary packaging.
• Achieve the elimination of 100% of operational waste to landfill.
• Partner with customers to identify environmental enhancements throughout product lifecycles.

Supply chain resilience against climate-related disruptions is a factor.

For a small-cap pharmaceutical company, supply chain resilience is defintely a critical risk, especially as climate change increases the frequency of extreme weather events that can disrupt manufacturing and logistics. The pharmaceutical industry is focusing on diversifying and localizing supply chain partners to avoid the kind of disruptions seen in 2024, such as the Red Sea shipping route crisis, which added an average of 12 days to Europe-to-Asia pharma lanes.

scPharmaceuticals' resilience is bolstered by its manufacturing partner's commitment to a responsible supply chain, which includes gathering additional Scope 3 emissions data to develop mitigation strategies. However, the company's reliance on a single, complex delivery system (the SmartDose platform) means any disruption at a key manufacturing or component supplier could halt production of Furoscix, a product that generated $16.0 million in net revenue in Q2 2025.

Energy consumption of manufacturing and cold-chain logistics.

The energy consumption profile for scPharmaceuticals has a significant environmental advantage over many biologic and vaccine companies: Furoscix does not require cold-chain logistics. The product is stored at Controlled Room Temperature (68°F to 77°F or 20°C to 25°C) and must not be refrigerated or frozen. This ambient storage requirement greatly reduces the energy-intensive Scope 3 emissions associated with refrigerated transport and storage, which is a major environmental hotspot for the broader pharmaceutical sector.

The primary energy focus shifts to the manufacturing process (Scope 1 and 2 emissions). The company benefits indirectly from its partner's ambitious targets to decarbonize manufacturing, which will help lower the embedded carbon footprint of the Furoscix device and packaging. The following table summarizes the key environmental metrics and targets impacting scPharmaceuticals in 2025, using its primary device partner as a proxy for its supply chain performance:

Environmental Metric	scPharmaceuticals Inc. (Furoscix) Status (2025)	Manufacturing Partner Target (West Pharmaceutical Services, Inc.)
Product Storage Requirement	Controlled Room Temperature (20°C to 25°C)	N/A (Significant advantage over cold-chain products)
Annual Doses Filled (Q1 2025)	Approx. 13,900 doses filled	N/A (Represents the scale of single-use device waste)
Operational Waste to Landfill Target	Indirectly impacted by partner's Scope 3 efforts	Elimination of 100% of operational waste to landfill by 2030
Renewable Electricity Goal	Indirectly impacted by partner's Scope 2 efforts	Increase usage to 50% by 2030
Absolute Emissions Reduction Goal	Indirectly impacted by partner's Scope 1 & 2 efforts	Reduce absolute emissions by 40% by 2030