Scaling biotech companies face a particular supply chain challenge: making long-term manufacturing and supply commitments while future demand is still uncertain.
As companies move from clinical development to commercial scale, more markets, products and partners bring new requirements, and the processes and tools that supported the first launch can struggle to keep pace.
Having worked with the life science industry over the last years, and more recently on the supply planning application for biotech at Bluecrux, I've seen how important it is to develop the right capabilities at the right time.
This is the first of four articles on the planning challenges biotechs face as they grow. The fourth will look at Helion™, the biotech planning application we've developed at Bluecrux. The first three focus on the challenges, decisions and capabilities themselves, regardless of the technology used to support them.
Why supply chain planning changes as biotechs grow
Many biotechs begin with simple, spreadsheet-based planning. This can work well during clinical development and early commercialization, but that typically doesn’t last long.
For most asset-light biotechs, manufacturing takes place across an external network of CMOs. Capacity is limited, production slots often need to be reserved years in advance, and minimum order quantities can result in inventory commitments that exceed actual demand. Each new market brings its own regulatory requirements, packaging configurations and launch timelines, and a single batch can represent substantial working capital.
Demand adds another layer of uncertainty. Uptake of new therapies can be faster or slower than expected, with limited historical data to support forecasting, yet supply decisions often need to be made long before the commercial picture becomes clear. Regulatory timing matters too: an earlier-than-expected approval may create a significant opportunity, but only if manufacturing capacity, product availability and regulatory requirements can be aligned.
Four stages of biotech supply chain maturity
1. Clinical Stage. Supply planning is driven by clinical trials, with small volumes and few partners, and simple tools are often sufficient. But decisions made here have long-term consequences. Selecting CMO partners with future commercial volumes in mind and establishing reliable master data early make the transition to launch considerably easier.
2. Commercial Launch. Supply planning becomes the first process to break in spreadsheets. Overall, there is a higher need for planning processes that bring commercial, finance, quality and supply chain teams together, with clear decision ownership and enough visibility to support commercial commitments.
3. Scale-Up. As markets, SKUs and partners multiply, companies need greater visibility across their external manufacturing network, more advanced scenario planning, and the ability to balance capacity and inventory across sites and markets.
4. Mature Operations. Planning & execution needs to become integrated across the wider value chain. Teams can evaluate changes in demand, capacity or regulatory timelines and understand the implications for supply, service levels and financial performance.
Which themes matter most?
To assess supply chain maturity, I like looking at it across four interconnected themes:
- Operating Model and Culture: clear decision ownership, cross-functional collaboration and the transition from an R&D-focused organization to commercial operations.
- Supply and Value Chain: management of CMOs, capacity, inventory and distribution across the external network.
- Data and Digital: reliable master data, connected systems and timely access to the information needed for planning decisions.
- Quality and Regulatory: market approvals, batch release, shelf life and compliance integrated into supply chain planning.
The relative importance of each area changes as the business grows, and timing to invest is critical. Investing too early adds unnecessary cost and complexity; waiting too long leaves the organization unable to respond when demand changes or capacity becomes constrained. CMO capacity is a good example: by the time a biotech has enough demand for certainty to justify additional production, the slots it needs may already be committed elsewhere.
A more accurate forecast has limited value if it cannot be translated into manufacturing commitments. The strongest approach is to look at these themes holistically and prioritize the right investments in each theme that address the biggest risks at each stage of growth.
How can you assess your planning readiness?
A practical test is how effectively your organization can respond to unexpected changes:
- If a market approval arrives six months early, how quickly can you determine whether enough capacity and inventory is available?
- If demand increases significantly, can you evaluate the implications for CMO commitments, supply and working capital?
- If a CMO cancelled a production slot, could you assess the service level impact and compare alternative scenarios?
If answering these takes days of gathering information from different teams and systems, there are likely gaps in visibility, processes or decision-making.
Ultimately, planning maturity is about anticipating change, understanding your options and making informed decisions while there's still time to act.
In the next article, I'll explore the capabilities a commercial biotech needs, and why the order in which they're developed matters.
I'd be interested to hear where others see the greatest challenges as biotechs scale. Is it securing CMO capacity, managing regulatory uncertainty, or connecting planning decisions across functions?
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