Pharmaceutical logistics is a critical sector that ensures the availability of medicines and healthcare products by managing the storage and distribution of pharmaceutical goods from the supplier to the final point of sale, with a particular focus on temperature control and traceability.
The industry is continuously growing, driven by increasing demand for medicines and the need to manage increasingly complex supply chains.
This growth requires rigorous management of inventory, distribution, and quality control, alongside the adoption of new technologies and management models to improve efficiency and reduce costs.
The Growth of the Sector
Pharmaceutical logistics has seen significant growth in recent years, with global revenue surpassing 75 billion euros in 2018 and an estimated annual growth rate of 3.5% through 2025. This growth has been supported by several factors, including the expansion of pharmaceutical companies, rising demand for pharmaceutical products, and the implementation of advanced technologies such as artificial intelligence (read the article on 10 Uses of AI in Pharma) and process automation. The pharmaceutical supply chain has become increasingly complex and sophisticated, with a strong focus on temperature control to ensure the quality and safety of products during transportation.
In Italy, the healthcare distribution chain is structured across four levels and involves six main nodes, with specialized carriers managing primary transportation from industry warehouses to intermediaries and healthcare facilities, and increasingly, directly to pharmacies and home care patients. From 2018 to 2023, there was a significant increase in outbound flows from industry warehouses, with a 22% growth in shipments in 2023 alone compared to the previous year.
This growth has been accompanied by greater order fragmentation, with an increase in the number of packages handled and the total weight of shipments. Pharmaceutical companies have adopted logistics outsourcing strategies to improve efficiency and reduce costs, entrusting warehouse and transportation management to specialized service providers.
The adoption of innovative and collaborative solutions has enabled better management of healthcare logistics challenges, such as handling seasonal peaks and optimizing distribution flows. This has led to greater supply chain resilience and an overall improvement in the service provided to end customers, from pharmacies to hospitals, and even home care patients.
Regulations and Compliance
Regulations and compliance in pharmaceutical logistics are fundamental to ensuring the safety and quality of pharmaceutical products throughout all stages of their handling.
In Europe, Good Distribution Practices (GDP) are mandatory for all supply chain operators, ensuring that every step, from storage to transportation, adheres to strict standards.
In Italy, the regulatory framework is outlined by the Ministerial Decree of July 6, 1999, which approves the guidelines on good distribution practices for medicinal products for human use. This is complemented by the 2013 and 2015 guidelines, which specify practices for the distribution of active substances.
These regulations cover crucial aspects such as record-keeping, quality management, and staff training. Additionally, the European Parliament’s Directive 2011/62/EU, introduced in 2019, aims to prevent counterfeit medicines from entering the supply chain through a unique identification system for drugs. Compliance with these regulations is essential for all pharmaceutical companies and their logistics partners, ensuring that pharmaceutical products reach the final consumer in optimal conditions and without health risks.
Key Aspects of Pharmaceutical Logistics
Storage Conditions
In pharmaceutical logistics, storage conditions are crucial for maintaining the quality and safety of pharmaceutical products. These products require environments with controlled temperature, humidity, and atmospheric pressure to preserve their integrity.
Storage facilities must be designed to ensure quick and secure access to goods while optimizing space utilization. This is particularly important in cold storage and temperature-controlled warehouses, where an efficient layout can make a significant difference in drug preservation.
Storage solutions must also meet stringent safety and quality standards to prevent any risk of contamination or product deterioration. The use of advanced technologies, such as real-time monitoring systems and artificial intelligence, can help maintain optimal conditions and ensure full traceability of batches, minimizing errors and improving operational efficiency.
Logistics Outsourcing
Outsourcing warehouse and transportation activities is a widespread practice in pharmaceutical logistics. This approach involves entrusting the entire logistics process to specialized providers who manage both warehouse operations and transportation.
Such a strategy allows pharmaceutical companies to focus on their core competencies while delegating the management of complex and regulated activities to expert partners. Pharmaceutical logistics requires controlled temperature conditions and strict regulatory compliance, aspects that logistics service providers can guarantee thanks to advanced infrastructure and cutting-edge technologies.
Outsourcing not only improves operational efficiency but also allows for better handling of seasonal challenges and demand fluctuations through collaborative solutions and a network of specialized carriers.
Seasonal Fluctuations
Pharmaceutical logistics exhibits clear seasonal peaks that influence distribution flows, with particularly pronounced variations in July and September. These peaks have been further affected by the COVID-19 pandemic, which imposed new challenges and collaborative solutions among logistics players.
Collaboration among various operators has allowed for better management of the volumes handled, distributing loads more evenly over time. In July, there is an increase in flows destined for wholesalers, while September sees a rise in shipments to hospital pharmacies and healthcare facilities. This collaborative management has been crucial in addressing operational capacity issues and ensuring the continuity of the pharmaceutical supply chain.
Order Picking and Management
Order preparation in pharmaceutical logistics presents unique challenges, such as managing numerous SKUs and storing in reduced load units. The use of stacker cranes and dynamic gravity shelving can accelerate picking procedures, reducing retrieval times and improving operational efficiency.
Additionally, warehouse management software (WMS) is essential for improving efficiency and reducing errors. These systems enable optimized order management, ensuring greater accuracy and traceability.
The integration of advanced technologies such as artificial intelligence and pick-to-light devices can further enhance the speed and accuracy of picking, making pharmaceutical logistics more efficient and secure.
Quality Control and Risk Management
Inventory Control
Real-time inventory control is crucial to preventing stockouts and ensuring the traceability of drug batches. In pharmaceutical logistics, accurate inventory management is essential to ensure that pharmaceutical products are available when needed, avoiding interruptions that could compromise patient health.
The adoption of warehouse management systems (WMS) enables continuous and detailed monitoring of inventory, facilitating the management of expiration dates and controlled temperature conditions. These systems not only improve operational efficiency but also support compliance with Good Distribution Practices (GDP), ensuring that every product can be traced throughout the supply chain. Pharmaceutical companies can thus optimize drug logistics processes, reducing risks associated with human error and improving the quality of service offered to end customers, whether hospital pharmacies or home care patients.
Cold Chain Transportation
Maintaining the cold chain is crucial for pharmaceutical logistics, especially for thermolabile drugs. Active and passive control systems in transportation vehicles ensure the appropriate temperature throughout the distribution process.
In 2023, temperature-controlled transportation (2°-8° and below zero) saw a prevalence of flows managed below 25°C, representing 90% of total flows. This trend reflects an adaptation to market needs and current regulations, ensuring that pharmaceutical products maintain their efficacy and safety until the final point of use.
The use of advanced technologies such as smart packaging and IoT devices enables continuous monitoring of environmental conditions, minimizing the risk of drug deterioration. These systems, integrated with IT platforms for tracking and control, are essential for pharmaceutical logistics, ensuring optimal supply chain management.
Innovations and Digital Technologies
In the context of pharmaceutical logistics, the implementation of IT platforms for tracking and cold chain management is revolutionizing the sector, increasing visibility and operational efficiency. These platforms enable continuous monitoring of storage conditions, which is essential for ensuring the quality of pharmaceutical products throughout the distribution process.
Smart packaging, which integrates IoT devices, represents a key innovation, allowing real-time data collection on environmental conditions such as temperature and humidity, and detecting any anomalies. This technology is particularly useful for pharmaceutical products sensitive to temperature variations, ensuring that they maintain their efficacy until the final point of use.
Moreover, process automation and the use of advanced software are significantly improving operational efficiency and data management, contributing to safer and more reliable pharmaceutical logistics. Automated warehouses and warehouse management systems (WMS) enable optimal inventory management, reducing the risk of human error and improving batch traceability.
These innovations not only meet regulatory requirements but also offer competitive advantages to pharmaceutical companies, allowing them to ensure a more robust and resilient supply chain capable of facing the challenges of an ever-evolving market.
Challenges and Opportunities in Pharmaceutical Logistics
Pharmaceutical logistics faces numerous challenges that can compromise the efficiency and safety of pharmaceutical product distribution. Among the main issues are limited operational capacity, difficult access to raw materials, and rising production costs. These factors have been further exacerbated by global events such as the COVID-19 pandemic and geopolitical tensions, which have disrupted supply chains and increased the costs of key resources, including fuels and energy.
To address these issues, the pharmaceutical sector is adopting collaborative solutions involving all supply chain actors. Collaboration among pharmaceutical companies, distributors, and carriers is crucial for better managing seasonal demand peaks.
For instance, the adoption and integration of artificial intelligence systems and other advanced technologies are improving demand forecasting and resource optimization, allowing for a more balanced distribution of volumes throughout the year.
Among the new technologies on the market, the Profiter platform offers advanced solutions for logistics management in the pharmaceutical sector. Using artificial intelligence, Profiter optimizes inventory management, provides more accurate demand forecasting, and automates reordering processes, improving overall warehouse efficiency.
