Life Sciences Supply Chain Visibility: A Strong Link in the Chain | Blog

Improved supply chain visibility can help global pharmaceutical and medical device suppliers overcome the many logistics challenges they face post-pandemic. Internet of things (IoT) and blockchain technologies offer promise to address the growing demand for product traceability and transparency. Read our second blog in this series to learn more.

The COVID-19 pandemic exposed major supply chain weaknesses in the life sciences industry as the industry experienced skyrocketing demand for innovative medical products.

Enterprises struggled to keep operations running amid the pandemic without adequate supply chain product visibility or unified systems to provide needed data to improve logistics performance.

Most companies lack the analytical tools to completely integrate and analyze data from various systems at all levels – from the plant’s local work centers to the world’s end-to-end supply chain.

As a result, the massive data generated during the pandemic provided little usable information and insights.

Supply chain visibility: right time for real time?

Supply chain visibility can help enterprises overcome these challenges and build more robust and effective supply chains by tracking medical products in transit and providing a clear view of the inventory and activity.

Let’s look at the factors that are driving enterprises to invest in supply chain visibility.

• Product loss and recall: Theft is costly to the industry and needs to be stopped. The pharmaceutical industry experienced its largest theft in 2020 when $1.2 million worth of oncology drugs were stolen from a cold storage warehouse. In the second largest theft that year, $600,000 in pharmaceuticals were taken from a distributor.

 The industry also is being hit by losses due to expired, non-compliant, or recalled products that have problems with temperature parameters or other issues. According to the U.S. Food and Drug Administration (FDA), 281 drugs and 50 medical devices were recalled during the two years of the pandemic

• Counterfeit products: Increasing numbers of fake drugs and medical devices have found their way into customers’ medicine cabinets. Counterfeit drugs are valued at an estimated US$200 billion annually. Since the World Health Organization (WHO) established a global surveillance and monitoring system in 2013, it has received 1,500 reports of substandard or falsified products. Of these, antimalarials and antibiotics are the most reported. Geographically, 42% come from the African region and 21% each from the Americas and Europe.

Local regulatory frameworks are being implemented to provide more product visibility. For example, the Indian government has mandated life sciences enterprises include Quick Response (QR) codes on Active Pharmaceutical Ingredients (APIs), effective January 2023

• Regulatory frameworks: The Drug Supply Chain Security Act (DSCSA), amended by the FDA in 2013, mandates enterprises to create an electronic system to track and trace certain prescription drugs. Manufacturers and trading partners are required to encode their products with unique identifiers on the individual packages and track products at the unit level by November 2023.

Similarly, the European Union (EU) Medical Device Regulation (MDR), which regulates the production and distribution of medical devices, mandates MedTech enterprises place a Unique Device Identifier (UDI) for better visibility and tracking of products across the supply chain

• Sustainable supply chain: Enterprises are looking for ways to monitor the supply chain’s carbon footprint, track package waste, and create a sustainable, green, transparent, and circular supply chain ecosystem by 2030.

A recent analysis found the top 15 global pharmaceutical companies emit 55% more greenhouse gas emissions per million dollars of revenue than the automotive sector. Medical waste has also become a significant issue, particularly with the spread of single-use personal protective equipment and testing kits. As a result, life sciences enterprises are taking initiatives to build more transparent supply chains to track and trace carbon emissions, medical device decommissioning, and secondary package waste

Everest Group’s view of end-to-end supply chain visibility solutions

Let’s explore more on the supply chain visibility framework:

• Make/Manufacture – Inbound logistics that includes procuring raw materials, drug packaging, and moving finished goods to the supply chain

Use Cases: Addressing drug serialization and aggregation, strategic sourcing, fleet tracking, drug e-labelling, artwork management, and API tracking

• Deliver – Outbound logistics that include order confirmation, shipping, last-mile delivery, and customer service

Use Cases: Addressing drug expiry monitoring, network management, demand forecasting, and warehouse management 

• Stakeholders experience – Unifies vendors, suppliers, distributors, pharmacies, patients, and others in the life sciences supply chain with one platform 

Use Cases: Asset tracking, anomaly detection, and condition monitoring alerts

• Returns management: Communicating with end-customers, stakeholders, and life sciences enterprises to obtain and restock goods. Having visibility of goods in reverse logistics helps enterprises make calls on whether to discard, repurpose or recycle drugs and medical devices

Use cases: Case and compliance management, returns tracking and scheduling, conditional monitoring alerts, and drug serialization

Service provider landscape

IT service providers are increasingly offering solutions to address these needs as these instances gain traction. One example is HCL’s serialization and authorization solution that helps track product returns in real time.

Recognizing the need for greater insights into supply chain performance, enterprises have invested in Enterprise Resource Planning (ERP), Laboratory Information Systems (LIMS), Electronic Batch Records (EBR), Manufacturing Equipment Systems (MES), Quality Management Systems (QMS), and other IT systems to capture transactional and performance data.

Information sharing, data interoperability, security, and trust are the major hurdles for life sciences enterprises to implement supply chain visibility solutions. Blockchain and the Internet of Things (IoT) offer promising prospects to tackle these challenges by maintaining the continuity of information, realizing the link between physical and information flow, and providing fraud detection alerts.

IBM, KPMG, Merck, and Walmart successfully completed an FDA pilot program in 2020 that found blockchain technology can be used to meet the DSCSA requirements to track and trace prescription drugs and vaccines distributed in the U.S.

We recommend life sciences enterprises partner with IT service providers that have point solutions for supply chain visibility or engage with niche platform providers to build end-to-end supply chain visibility solutions.

Keep following this space as we explore the technology in supply chain visibility platforms, and see our prior blog on Five Factors Transforming the Life Sciences Supply Chain and Creating IT Opportunities.

What are your views on life sciences supply chain visibility? Reach out to [email protected] and [email protected] to discuss.

You can also learn about planning for a sustainability in your organization in our webinar, Sustainability and the CIO’s Office: A Powerful Connection.

Five Factors Transforming the Life Sciences Supply Chain and Creating IT Opportunities | Blog

Supply chain visibility, strategic sourcing, cold chain requirements, sustainability demands, and personalized medicine are creating opportunities in the life sciences supply chain for IT partners delivering digital solutions. Read this first part of our blog series to understand the shift that is underway.

New security requirements, industry mandates, and changing customer needs require the contemporary life sciences supply chain to become more efficient, transforming the logistics network.

The worldwide value of pharmaceutical goods traded has grown six-fold in the past two decades from US$113 billion in 2000 to US$629 billion in 2019, according to the United Nations Comtrade Database.

This growth has driven more companies to outsource production to Contract Manufacturing Organizations (CMOs) to meet the pent-up demand. Let’s explore the factors impacting these increasingly global and complex chains.

• Pandemic-driven supply-demand fluctuations: Rising consumerism and pandemic-driven proliferation of precision medicines, wearables, and telehealth applications have left enterprises struggle to meet increased demand. One example of this is Bristol Myers Squibb’s struggling to meet the strong demand of BCMA-targeted CAR-T cell therapy Abecma
• Ever-changing regulatory oversight: Many industry-wide regulations have been implemented to strengthen the safety and effectiveness of medical devices and drugs commercialized across the globe. These include the European Union Falsified Medicines Directives (EU FMD) in 2011, Drug Supply Chain Security Act (DSCSA) in 2013, European Union Medical Device Regulation (EU MDR) in 2017, and the UK Medicine and Medical Devices Act (MMD) in 2021
• Need to reduce product diversion and recall: Increasing numbers of black-market activities and illegal drugs are finding their way into the supply chain and affecting companies’ brand values. The most common drug diversions are class benzodiazepines, opioids, stimulants, antipsychotics, anesthetic drugs, and GABA agonists
• Supply chain data sharing and data security: Broad threats, ranging from cybersecurity to data breaches, have led to unplanned financial and intellectual property losses. A case in point: IBM detected cyberattacks against the cold chain drugs specifically associated with GAVI, the vaccine alliance, and government agencies involved in the drugs’ distribution

Five key investment areas in the life sciences supply chain

1. Supply chain visibility: Implementing visibility platforms could have saved 1 billion vaccines during the pandemic, according to the United Nations Environment Programme. This creates opportunities for IT service providers to partner with enterprises to enable end-to-end supply chain track and trace models.

Additionally, the Drug Supply Chain Security Act (DSCSA) outlines requirements to achieve interoperable, electronic product tracing at the package level to identify prescription drugs distributed in the United States by November 2023. Similar laws are in effect in Europe and other parts of the world. (For more on supply chain visibility, see our next blog.) 

2. Strategic sourcing: With the growing awareness post-pandemic of the supply chain risk of overdependence on raw material procurement from India and China, enterprises are starting to reshore pharmaceutical manufacturing in the US and Europe. 

Also, since sourcing and procurement account for roughly half of drug development and manufacturing costs, firms are focusing on optimizing spending by using technology to gain real-time spending views, structure budget accountabilities, and align purchasing with production

3. Emerging cold chain requirements: Various factors have pushed enterprises to increase their focus on temperature-sensitive drugs that contain high-value active ingredients and have shorter shelf lives. Cold chain adoption also has been accelerated by the rapid growth of consolidated distribution houses and online retailers’ improved last-mile connectivity 

4. Sustainable supply chains: The growing importance of sustainability initiatives is evident from the surge we have seen in Environment, Social and Governance (ESG) report. ESG funds in biopharma companies increased 27% in 2021 from the prior year.

Sustainable secondary packaging, carbon footprint tracking, responsible raw materials procurement, effective medical device decommissioning, and scrap minimization are gaining more traction in the life sciences industry. Additionally, the European Union directive 94/62/EC, in conjunction with directive 2018/852, demands a significant reduction in packaging waste by 2025 

5. Supply chain tailored to personalized medicine: Specialized logistics partners are needed to handle the extremely delicate and patient-specific components of innovative and personalized medications – from collecting cells/genes from healthy donors to delivering innovative medicine to patients.

Life sciences enterprises have invested approximately US$ 13 billion in cell and gene technologies since 2018. More than 900 enterprises worldwide are developing cutting-edge advanced therapeutics, and approximately 1,000 advanced therapy clinical trials are underway. This changing landscape requires supply chains that provide temperature-sensitive environments, closed loops, Chains of Identity (COI), and Chains of Custody (COC)

Implications for service providers

In response to these factors, next-generation connected supply chain ecosystems are beginning to emerge. Life sciences enterprises will need the right complementary digital technologies to optimize costs, drive productivity through streamlined route selection, and improve the customer experience.

This will create new opportunities for IT service providers that bring niche talent and a balanced portfolio of engineering and digital services, as well as supply chain-specific platform providers who will become partners of choice for life sciences enterprises.

Follow the second part of this blog series as we explore supply chain visibility platforms and enterprise initiatives.

To share your views on the life sciences supply chain, please reach out to [email protected] and [email protected].

For more details on the service provider outlook, watch our webinar, Outsourcing Services Pricing: What to Expect Next.