$180M
40+
vaccine manufacturing sites mapped across biologics and CDMO ecosystem
The Task
Mapping a complex, validation-driven market to find the right entry path.
India’s single-use bioprocessing market presented a genuine opportunity, but also structural complexity that required careful unpacking. The market was heavily dependent on imported benchmark films, had high validation and qualification barriers, and offered limited pricing transparency. Switching behaviour across customer segments was conditional and risk-driven.
The mandate: conduct a comprehensive market entry assessment and deliver a phased strategy that minimised risk, identified the most accessible entry segments, and built a credible path to scale.
The Approach
7 steps. Commercial, technical, regulatory, and ecosystem analysis working together.
Step 01
Ecosystem assessment
Stakeholder engagement across the full value chain including film manufacturers, bag assemblers, and end-users across biologics, vaccines, and CDMOs. Insights were collected through interviews and then cross-referenced via benchmarking.
Step 02
Pricing and cost benchmarking
Conducted a price analysis across standard 2D and 3D bag configurations to establish market benchmarks. Film costs account for a significant proportion of total product value, making them the key driver of pricing and margins.
Step 03
Technical and quality evaluation
Assessment of differentiation across film structure, material properties, validation standards, compliance, and qualification maturity. While performance across films is largely comparable, we found that adoption is driven by quality documentation and in-depth validation.
Step 04
Customer behaviour analysis
Switching behaviour mapped across segments: biologics (validation-driven, low flexibility), vaccines (documentation-driven for export, cost-driven domestically), and CDMOs (commercially driven, highest flexibility).
Step 05
Identifying pain points and unmet needs
Key ecosystem challenges identified including high minimum order quantities, working capital pressure, dependence on imported film, and concerns around validation, integration, and supply reliability.
Step 06
Regulatory landscape assessment
Regulatory factors are a primary consideration for any new entrant in the healthcare sector. Our assessment confirmed that India’s framework does not restrict SUS substitution: no separate CDSCO licence is required for single-use bags, and neither film extrusion nor bag assembly faces any statutory licensing barrier. This regulatory reality was essential in defining the right entry pathway, and to distinguishing between what is procedurally controlled and what is statutorily restricted.
Step 07
Phased entry strategy design
A staged market entry approach built around starting with non-critical applications, entering via flexible segments such as CDMOs, demonstrating like-for-like equivalence through strong documentation, and scaling through partnerships with local assemblers.
The Analysis
Market entry is not about targeting the largest segment first. It is about targeting the segment most willing to adopt.
The most important market-entry signal is not market size but supplier-switching dynamics. With purchasing decisions driven largely by commercial considerations, CDMOs have the highest degree of flexibility. As a result, successful market entry depends on targeting segments in the order they are most likely to adopt, rather than pursuing the largest opportunity first.
The Outcome
A structured, risk-minimised market entry roadmap for one of India's fastest-growing life sciences segments.
Structured market entry strategy
A phased approach that minimises risk by prioritising validation credibility and gradual scale-up, matched to the real dynamics of each customer segment.
Targeted segment prioritisation
CDMOs and non-critical applications identified as the most accessible entry points, enabling faster adoption without triggering the validation lock-in risks of the biologics segment.
Partner-led market access
Key local partners identified to accelerate validation, provide installed base access, and enable scalable growth through the assembler ecosystem.
Long-term strategic clarity
The engagement established that sustainable success in India requires building credibility first, followed by scale and potential localisation, reframing the opportunity from a pricing challenge to a structured growth pathway.
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