Sunday, February 15


India’s Contract Research, Development and Manufacturing Organisation (CRDMO) sector is entering a phase of sustained and structural expansion. A 2025 report by Boston Consulting Group (BCG) and the Innovative Pharmaceutical Services Organisation (IPSO) projects that India’s CRDMO market could reach $ 22–25 billion by 2035, while McKinsey & Company estimates that India could account for 8–10% of global CDMO outsourcing by 2033 as innovators diversify supply chains and seek resilient, end-to-end partners.

Medical research

Yet, these numbers tell only part of the story. For much of the past decade, India’s role in global pharmaceutical outsourcing was defined narrowly, efficient execution, strong chemistry and cost advantage. That narrative is now being rewritten. What we are witnessing is not incremental growth, but a fundamental shift in how global pharmaceutical companies view partnership, risk, and ownership across the drug development lifecycle. The more important question, therefore, is not how large the market becomes, but why global innovators are increasingly choosing integrated CRDMO partners in India and why this shift is happening now.

One of the most significant catalysts for this shift has been global supply chain realignment. Geopolitical uncertainty, regulatory scrutiny and pandemic-era disruptions have prompted pharmaceutical companies to reassess concentration risk across discovery, development, and manufacturing. The widely discussed China Plus One strategy reflects a broader reassessment of dependency and resilience rather than a short-term geographic adjustment.

Industry analyses indicate that while India has already begun to benefit from this transition, the more substantial gains are expected to accrue over the medium term as companies redesign long-term development and sourcing strategies. In this context, India’s growing CRDMO ecosystem is increasingly being evaluated not just as an alternative location, but as a strategic pillar within diversified global supply chains.

Beyond geographic diversification, global innovators are also recognising the depth of India’s supply chain integration at an operational level. Indian CRDMO partners are embedded across the pharmaceutical value chain, from local sourcing of key raw materials and intermediates to process optimisation, vendor qualification and logistics coordination. This proximity to suppliers and on-ground execution capabilities enables tighter control over timelines, costs and quality, particularly during scale-up and commercialisation phases. Rather than functioning as distant service providers, Indian partners are increasingly involved at the grassroots level of supply chain planning and execution, contributing to resilience through hands-on management and faster response to disruptions.

As supply chains diversify, outsourcing models themselves are undergoing change. The traditional fragmented approach, engaging multiple vendors across medicinal chemistry, biology, DMPK, toxicology, process development and manufacturing, has become increasingly difficult to sustain in an environment defined by complexity and speed.

Integrated CRO–CDMO platforms address this challenge by enabling continuity across the drug development lifecycle. When discovery and development activities are aligned within a single scientific and quality framework, programmes benefit from faster decision-making, reduced handovers, and clearer accountability. From an industry perspective, this shift reflects a move away from transactional execution toward partnerships designed around program outcomes rather than individual deliverables.

The evolution of outsourcing models is closely linked to changes in global R&D pipelines. Today, a growing proportion of development programmes involve complex small molecules, peptides, ADCs, degraders, lipids, carbohydrates and emerging modalities, which require close coordination between research and manufacturing teams.

Supporting such programmes demands more than capacity; it requires scientific depth, process understanding, and the ability to anticipate downstream implications early in development. As highlighted in a recent Kotak Mutual Fund analysis on India’s CRDMO sector, outsourcing growth is increasingly being driven by high-value, innovation-led work where integrated capabilities and scientific judgment play a decisive role. This shift has created space for Indian CRDMOs to engage earlier and more meaningfully across the value chain.

As complexity increases, regulatory expectations have risen in parallel. Global innovators today assess partners not only on compliance status, but on their ability to operate consistently within evolving regulatory frameworks.

India’s CRDMO ecosystem has made notable progress on this front. The growing prevalence of US FDA–approved facilities, stronger quality systems, and deeper regulatory expertise has helped bridge historical perception gaps. According to a 2025 EY–Parthenon and OPPI report, India’s pharmaceutical exports are nearing $ 30 billion, with CRDMOs and global capability centers playing a central role in driving the sector’s next phase of innovation-led growth. These developments underscore the increasing credibility of India as a location for complex, regulated development work.

This transformation has been supported by sustained investment across discovery, development, and manufacturing infrastructure. Expanded research centers, development laboratories, and gram-to-kilogram scale-up facilities are enabling Indian CRDMOs to support faster project initiation and improved execution predictability.

Such investments signal a deliberate shift away from cost-led positioning toward capability-led differentiation. For global innovators, this translates into partners who can support programs across critical stages without compromising on quality, timelines, or regulatory expectations.

For emerging biotech companies, development efficiency often determines viability. For large pharmaceutical companies, the challenge lies in managing diverse portfolios while balancing risk, compliance, and speed. In both cases, expectations from outsourcing partners have evolved significantly.

Innovators are increasingly seeking partners who can manage continuity across the drug lifecycle, preserve institutional knowledge and contribute to informed decision-making.

Looking ahead, the outsourcing landscape is likely to continue shifting toward long-term, strategic partnerships. As therapies grow more complex and competition intensifies, value will increasingly be defined by a partner’s ability to combine scientific capability with accountability and foresight.

In this evolving paradigm, the question for global innovators is no longer whether to outsource, but whom to partner with. Integrated CRDMOs in India, supported by growing scale, regulatory maturity and expanding scientific capabilities, are well positioned to play this role. For Indian pharma and biotech, this represents an opportunity to move beyond execution and become integral contributors to global innovation. For global pharma, it offers a pathway to de-risk pipelines, accelerate timelines, and build resilience into development strategies.

As the industry enters its next decade, integrated CRDMO platforms will increasingly influence which programmes progress efficiently and which fall behind. For innovators seeking to translate discovery into clinical and commercial success, the direction is becoming clear: end-to-end scientific partners, many of them in India, will play a defining role in shaping the future of global drug development.

This article is authored by Tushar Gupta, COO, Jubilant Biosys Limited (CRDMO).



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