Transform biomanufacturing from single source to smart supply

Until recently, biomanufacturing success meant one thing: Efficiency. Companies focused on cutting costs, consolidating production in affordable locations and maximizing scale. This approach delivered predictable supply at competitive prices.

Then everything changed. Global health crises, political tensions and climate disruptions exposed the fragility of efficiency-focused supply chains. A single facility delay or policy shift could now disrupt medicine access worldwide.

Today's biomanufacturers are asking a different question. Instead of "How cheap can we produce?" they're asking "How do we ensure patients get the medicines they need, no matter what happens?"

This new reality demands a fresh approach—one that balances efficiency with adaptability and scale with flexibility. It's the shift from single source to smart supply.

Reshaping global supply chains isn’t a small scale project. Building and qualifying a new commercial-scale facility can take three to five years. That timeline becomes even longer when factoring in regulatory approvals, workforce ramp-up and technology transfers.

Meanwhile, other risks continue to mount:

• Geopolitics – rising tariffs, trade disputes and protectionist policies.
• Sustainability – increasing energy costs and natural disasters inflate production costs, logistics routes and raw material availability.
• Market fragility – lingering pandemic-era bottlenecks and capacity mismatches.

Many biomanufacturers are already responding. Some are investing in U.S. facilities now to hedge against policy changes. Others are redesigning their networks to reduce dependency on a single geography. What’s clear: Waiting is no longer a viable strategy.

“We're seeing an increasing need for resilience. It's a strategy; it's not a cost center. And maybe working with the executive leadership to clearly communicate (particularly given the cost structure and the global market right now), these increasing costs may have to be absorbed in order to remain resilient and flexible.”

Traditional biomanufacturing concentrated production in a few global hubs, prioritizing efficiency and cost. The US now relies heavily on this approach—over half of active pharmaceutical ingredients for US prescription medicines come from India and the European Union, with China and India accounting for 57.6% of total pharmaceutical imports by weight.

But this creates dangerous vulnerabilities: When facilities in key regions falter or trade policies shift, entire supply chains collapse, putting patient access at risk. Smart supply strategies offer a better path forward.

Instead of massive, inflexible plants, companies can use modular manufacturing systems and strategic location intelligence to build resilience without sacrificing efficiency. By combining owned facilities for core products with trusted contract partners for surge capacity and applying digital analytics for smarter demand planning, organizations create redundancy only where it matters most.

The key insight? Resilience doesn't have to mean ballooning costs. A smart supply approach balances diversification with efficiency, using data and flexible infrastructure to strengthen supply chains without unnecessary capital waste.

Here's what that looks like in practice:

• Data-driven forecasting: Digital twins and demand analytics prevent costly overbuilding.
• Modular manufacturing: Single-use systems and plug-and-play suites shorten setup times and enable multi-product use.
• Targeted redundancy: Critical APIs and sterile injectables get dual sourcing, while lower-risk products remain consolidated.
• Hybrid networks: Mixing owned facilities with trusted contract manufacturers (CMOs) to cover both core and flexible needs.

This model not only lowers exposure to disruption but also creates a platform for faster pivots—whether that's launching a new therapy, scaling in response to demand or complying with new regulations. The result is a measurable strategy that strengthens supply chain performance while ensuring patients get the medicines they need, regardless of global disruptions.

One of the biggest misconceptions is that resilience always equals higher cost. The truth is more nuanced:

• Capital expenditure (CapEx) impact: Instead of one massive, inflexible facility, smart supply favors staged investments. Modular units, digital retrofits and targeted upgrades spread out costs while keeping options open.
• Operating expenditure (OpEx) impact: With better forecasting and process intensification, companies cut recurring costs—from excess inventory to energy usage. Over time, these operational savings can help offset new capital spending.
   

When modelled together, the lifetime costs of a smart supply network are often more predictable, more sustainable and more resilient than a single-source model.

For leaders ready to act, the first year of a smart supply strategy should focus on quick wins and building optionality:

• Map critical inputs. Identify the APIs, dose lines and components that would bring operations to a halt if disrupted.
• Run scenario models. Test the impact of tariffs, shipping delays or climate disruptions against your portfolio economics.
• Prioritize modular capacity. Invest in flexible manufacturing assets that can be repurposed across multiple therapies.
• Leverage partnerships. Use CMOs for immediate needs while building long-term in-house capabilities.
• Apply location intelligence. Evaluate real estate, workforce availability, logistics and incentives together—rather than in silos.
   

These steps don’t just create resilience; they also build investor and partner confidence in your ability to weather shocks.

The biomanufacturing industry is at a crossroads. Geopolitical pressures and policy shifts are moving faster than traditional capital planning cycles. Those who wait risk being caught flat-footed by tariffs, disruptions or cost shocks.

The answer is not simply to build more, but to build smarter. Companies that embrace smart supply—blending diversification, modular investment and data-driven decision-making—will be best positioned to deliver consistent supply and sustainable growth.

Resilience is no longer a defensive play. It’s a strategic choice that can unlock long-term stability, protect margins and strengthen relationships across the healthcare ecosystem.