DEMAND ANALYSIS

Mapping Gene Therapy Demand for
Smarter, Low‑Risk Scale‑Up

A large Germany‑based bioprocess company used our demand‑modeling intelligence to build a clear, volume‑based view of gene therapy APIs, enabling stronger capacity planning, lower investment risk and better alignment of technology platforms with high‑growth therapeutic indications.

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The Challenge

Transforming Ambiguity in Gene Therapy
Demand into Informed Capacity Strategies

Building a View of API
Volume Requirements

With gene therapy rapidly evolving into a high‑growth segment, the client sought to build a robust view of demand, translating clinical and commercial activity into projections that could confidently guide their long‑term investments in single‑use bioreactor platforms and process intensified manufacturing strategies

Clinical Demand Planning
and Patient Assessment

The fast-changing landscape of gene therapies hindered the client’s ability to estimate annual treatment volumes, quantify API requirements (in liters) and prioritize indications where demand justified capacity expansion on scalable single‑use production platforms

Preclinical to Commercial
Capacity Planning

Uncertainty in API utilization from preclinical through commercial stages created ambiguities in scaling decisions, exposing the client to under‑ or over‑build single‑use and process intensified manufacturing capacity and reducing confidence in multi‑year facility and technology planning

The Roots Way

How Roots Helped?

By applying a structured, bottom-up demand modeling framework, Roots Analysis quantified global gene therapy API requirements to support capacity planning, investment decisions and platform selection.
Commercial Demand: We estimated commercial demand by identifying the target patient population for all gene therapies that are either approved or in late stages of development (phase II / III and above). For all the assets, we then gathered information on dose (in mL) and frequency of administration. Based on various parameters, such as target population, dose and frequency, we calculated the overall commercial demand for gene therapies (in liters).
Clinical and Preclinical Demand:The clinical demand for gene therapies was calculated by taking into consideration the number of patients enrolled across different ongoing clinical trials. The preclinical demand was estimated on the basis of annual number of preclinical studies being conducted for gene therapies.
Demand Segmentation:To further inform the outcome, we segmented the global demand by expression system, type of bioreactor, scale of operation and geographical region.
Change We Created

Results You Can Quantify & Impact
Our Clients Can Count On

35%
Capacity Confidence
Enabled the client to plan long‑term gene therapy capacity with 35% greater confidence in forecasted utilization, reducing the risk of both unused capacity and supply gaps
30%
Lifecycle Continuity
Established a holistic view of the preclinical‑to‑commercial demand scenario that reduced scale‑up uncertainty by 30%, enabling smoother technology transfer and faster readiness for pivotal and launch‑stage volumes
20%
Portfolio Fit Uplift
Reprioritized the usage of single‑use bioreactor platforms, improving their alignment with high‑growth gene therapy segments by 20% and enhancing geographical reach and targeted customer outreach for future offerings

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