Managing Risk in the Pharma
and Biotech Supply Chain

For greater resilience

Need a cure for disruption? Prevention is the best medicine.

In pharma and biotech, lives and health are at stake. That’s why customer demands are high. Yet supply chains are ill-equipped for pipelines with small-volume, personalized medicines, or biologic drugs that require sub-zero handling. At the same time, shortages and quality issues can put company reputation on the line. Supply chain disruptions can cost pharma companies 2.4% of EBITDA per year, according to McKinsey Global Institute.

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Three Reasons Why Your Pharma and Biotech Supply Chain Is at Risk

How Our Customers Master Supply Chain Risk


“The riskmethods Solution is a key element of our supply chain risk management, and it has enabled us to deliver impressive results overall. We’ve shortened lead times by 64%, improved production quality by 27% and increased savings by 53%.”

James Klotz, Senior Vice President of Global Sourcing, Douglas Dynamics

Why Manage Risk with The riskmethods SolutionTM?


Be risk aware

Ensure business continuity. Get sub-tier visibility to make your end-to-end supply chains more resilient


React faster

Avoid cost. Leverage real-time data and streamline your actions to prevent risk from materializing


Be proactive

Make better decisions. Remove vulnerabilities and prepare mitigation plans for all kinds of risk

Use a Total View of Risk to Overcome Your Supply Chain Challenges

Risk #1: Regional Supplier Clusters

Drug components, production, and packaging are concentrated in the Asia-Pacific region

Challenges: Between 20% and 40% of active pharmaceutical ingredients (API), and small-molecule drugs sold globally come from China and India. Overdependence on Asia-Pacific suppliers and producers leaves drugs supply chains vulnerable to geopolitical factors, shortages, and extreme weather events. As one remedy, the EU and US are evaluating supply chain security, with a focus on reducing imports by nearshoring some supply and production.


With The riskmethods Solution, you can:

  • Secure critical supply. Continuously monitor your end-to-end supply chain for all types of risk, especially regional, geopolitical, and supplier risk. Use riskmethods risk score to make better decisions when qualifying alternate sources
  • Prepare risk mitigation plans for all possible risk scenarios, so your team knows exactly what to do when risk strikes. React faster with streamlined mitigation actions to safeguard your business
  • Protect your patients. With real-time data, advanced analytics, and streamlined risk mitigation, you’re the first to react to events that could lead to shortages or disruption. Ensure business continuity and make sure patients get their medicines

Risk #2: Regulatory Requirements

Medicines are heavily regulated by governments, authorities, and industry along the entire supply chain. Meanwhile, counterfeiting remains a chronic threat

Challenges: Strict laws, standards, and guidelines govern how medicines are made, produced and distributed. Examples include Active Pharmaceutical Ingredients Committee (APIC), ISO 9001, Good Manufacturing Practice (GMP), and International Council for Harmonization (ICH) requirements. Lapses could have disastrous human, financial, and reputational consequences. In addition, counterfeits put people at risk, and rob companies of revenue.


Use The riskmethods Solution to ensure compliance:

  • Get insights into the interconnections in your global supply chain and understand your business partner’s criticality to your business. You can make sure your suppliers adhere to regulatory requirements
  • Comprehensive risk profiles help you assess your business partners with regards to quality, sustainability, cyber risk, work practices, and more. Act fast on compliance issues in your network thanks to sub-tier visibility, real-time monitoring, and mitigation plans
  • Analytics tools and reports help you closely observe trends your supply chain, and measure the influence of remediation actions. Track all your risk mitigation efforts so you can demonstrate to stakeholders such as the EMA or FDA that you have risk under control

Risk #3: Supply Network Complexity

With advances in technology and therapies, producing and distributing drugs has become even more challenging

Challenges: Supply chains link laboratories to manufacturers, hospitals, pharmacies, physicians, and consumers. Thousands of products must arrive safely for millions of people. These include over-the-counter (OTC) medicines and generics, biologics, and specialist therapies. Critics say the drugs supply chain is inefficient and under-utilized. Advanced supply chain risk management can treat these ills.


With The riskmethods Solution, you improve the transparency of your supply chains:

  • Stay vigilant. Gain visibility into your sub-tier suppliers, manufacturers, distributors, transport routes, and on to customers downstream. Understand how incidents in your supply network affect your order fulfillment and business
  • Visualize your end-to-end supply chain on a world map. Identify vulnerabilities such as supplier clusters or single-sourcing situations. You immediately see who is affected by potential events and can establish the right priorities
  • Avoid costs: Stay informed about irregularities such as unstable financial health, site disasters, or compliance violations at your (sub)suppliers, vendors, and contractors. Identify negative trends and use mitigation tools to take action before things get worse

Customers all over the world rely on our solution

Have a question about managing risk in the pharma and biotech supply chain?

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