CAPACITY ANALYSIS

Mapping Biologics Contract Manufacturing
Capacity for Smarter Scale‑Up

In the rapidly evolving competitive innovation landscape, a biopharmaceutical contract manufacturing organization leveraged our capacity assessment framework to identify supply chain gaps and strategize low-risk scale up.

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The Challenge

Transforming Capacity Bottlenecks into
Informed Scale-up Strategies

Building a View of Production
Capacity Requirements

With biologics demand growing rapidly across advanced therapies, the contract manufacturer sought to build a robust view of required capabilities, translating partner clinical and commercial pipelines into projections that will guide long-term investments in manufacturing strategies.

Capacity Planning and
Utilization Assessment

The fast-changing biologics outsourcing landscape hindered the client's ability to estimate annual production volumes, quantify purification capacity needs (in batches), and prioritize programs where demand justified scale-up in the production process.

Preclinical to Commercial
Capacity Planning

Uncertainty in capacity utilization from preclinical through commercial stages created scaling ambiguities, exposing the contract manufacturer to intensified upstream as well as downstream processes, thereby reducing confidence in long term scale-up initiative.

The Roots Way

How Roots Helped?

By applying a structured, bottom-up capacity forecasting framework, Roots Analysis quantified global biologics production capacity requirements to support scale-up planning, investment decisions and technology platform selection.

Overall Capacity Assessment: We estimated the overall manufacturing capacity by identifying capabilities associated with key competitors engaged in the manufacturing of late stage / approved biologics. For all the companies, we then gathered information on annual production capacity, batch size (in liters), yield per batch and production frequency. Based on various parameters, such as batch volume and production frequency, we calculated the overall associated capacity with the key players.

Supply-Chain Bottlenecks: In order to identify early-stage bottlenecks, such as potential constraints in monoclonal antibody production and protein synthesis, the team analyzed clinical capacity requirements to fulfil the demand in ongoing late-stage trials and the associated dosing requirements.

Suggesting Scale-up Roadmaps: Based on the identified production bottlenecks, the team focused on understanding what the other players were doing to mitigate such risks. This enabled the client to prioritize improvements in existing processes and plan for a production scale-up.

Change We Created

Results You Can Quantify & Impact
Our Clients Can Count On

32%

Improved Capacity Utilization

Enabled the client to plan long‑term biologics manufacturing capacity scale-up with 32% better utilization of existing infrastructure, reducing the risk of both unused capacity and supply gaps.

21%

Better Strategic Positioning

Capacity level insights and segmentation strategies enabled the client to refine their scale-up roadmap against competitors, resulting in a 21% improvement in market readiness, backed by clearer integration pathways and regulatory alignment insights.

22%

Quicker Gap Identification

Equipped with in-depth capacity insights into the key competitors, the client pinpointed strategic gaps 22% faster than typical timelines, enabling proactive resolution of market-positioning issues and streamlined decision processes.