Resilience: The new mantra for R&D

The impact of geopolitical instability on the pharma industry is no longer limited to supply chains and exports. Increasingly, it is beginning to reshape the very foundation of pharma R&D. From clinical trial planning and regulatory approvals to manufacturing strategies, sourcing models, and innovation investments, global conflicts and trade disruptions are forcing pharma companies to rethink how and where they develop medicines. 

For years, pharma R&D operated within a highly globalised ecosystem. Clinical trials were spread across continents, APIs and intermediates moved seamlessly between countries, and manufacturing networks were optimised largely around cost efficiency. But the repeated shocks of recent years — the pandemic, Red Sea disruptions, growing US-China tensions, and the ongoing West Asia conflict — have exposed the vulnerabilities of this model. 

Today, resilience has become as important as scientific capability. 

Clinical trials move closer to regional ecosystems 

One of the most visible shifts is the growing move towards regionalised clinical trials and localised manufacturing. According to Yogesh Joshi, Associate Director and Head – Formulation Development (CDMO vertical)/Head Clinical Manufacturing, Piramal Pharma Solutions, geopolitical fragmentation is accelerating the transition away from centralised global operating models toward more regionally resilient frameworks.

“Companies are moving away from centralised global supply models in favour of regionally resilient frameworks that better support business continuity,” he says. “This change is becoming particularly evident in clinical research. Pharma companies are increasingly expanding trials into regions such as Asia-Pacific and Latin America, driven by the need to diversify operational risk while accessing large and diverse patient populations. In the future, resilience and geographic diversification will become just as important as speed and cost efficiency in clinical development planning.” 

“The regionalisation of clinical trials is driven by inconsistencies in trade policies among sponsors and limitations associated with centralised global hubs,” Joshi explains. “As a result, pharma companies are increasingly turning to regions such as Asia-Pacific, particularly India and South Korea, and Latin America.” 

He adds that these regions offer several strategic advantages beyond cost arbitrage. 

“These regions provide lower operational costs, dense patient populations, faster recruitment potential, and increasingly stronger scientific capabilities. However, the shift also introduces new complexities. Companies must now navigate varying regional regulatory requirements, differences in data standards, fragmented approval systems, and evolving compliance expectations. Designing trials that remain globally acceptable while meeting local regulatory realities is becoming a far more complex exercise than before.” 

“Designing trials to meet varying regional regulatory requirements remains challenging, particularly when local regulatory environments lack flexibility,” Joshi adds 

The shift toward decentralised and regionalised trial ecosystems is also changing how pharma companies think about patient diversity, realworld evidence generation, and regulatory submissions. Multiregional clinical strategies are becoming critical not just from a compliance standpoint, but also from a commercial and operational risk-management perspective. 

Resilience becomes new strategy 

Dr Madhusudhan Bommagani, President, FR&D, Cadila Pharmaceuticals believes this transformation reflects a much deeper structural reset underway across the pharma industry.

“Geopolitical fragmentation is undeniably acting as a primary catalyst for a structural shift toward regional clinical trials and localised manufacturing strategies,” he says. 

“Historically, pharma manufacturing decisions were driven almost entirely by cost optimisation, leading to heavy concentration of API and key starting material production in a few geographies. But geopolitical uncertainty has fundamentally altered industry priorities. Geopolitical friction has transformed ‘resilience’ into the new metric of efficiency.” 

According to Dr Bommagani, the global pharma industry is gradually moving away from hyper-centralised supply chain models that dominated the last two decades. “The industry historically depended on a highly interconnected and centralised global manufacturing ecosystem. But repeated disruptions — from the pandemic to geopolitical conflicts — have demonstrated that overdependence on limited geographies creates long-term operational vulnerabilities. Today, governments and pharma companies alike are focusing on building redundancy, supply continuity, and regional self-sufficiency into the system.” 

Governments across the world are now pushing domestic manufacturing and nearshoring strategies to reduce dependency on single geographies for critical medicines. India’s Production Linked Incentive (PLI) schemes, alongside similar policy interventions in the US and Europe, are part of a broader global effort to secure pharma supply chains.

Bommagani believes this transition is also changing the role of R&D itself. Traditionally, R&D focused heavily on speed, formulation efficiency, and regulatory timelines. Today, however, development teams are increasingly expected to integrate supply chain resilience, manufacturing flexibility, and geopolitical risk assessment into development strategies from the earliest stages of product planning. 

At the same time, AI and digitalisation are beginning to play a much larger role in helping pharma companies build more agile R&D systems. Predictive analytics, digital twins, AI-driven process optimisation, and automated documentation systems are helping organisations reduce development delays while improving operational visibility. 

Why localisation may not work for generics 

While localisation is increasingly becoming the dominant narrative globally, some R&D leaders caution against treating it as a universal solution. 

Ravikumar N, President – Formulations R&D, MSN Laboratories argues that for the generics industry, complete onshoring may not be commercially sustainable. “Let’s be brutally honest: as generic R&D leaders, are we designing pipelines for political applause, or are we designing them to survive the market?” he asks 

“The economics of generics are extremely unforgiving. In a hyper-commoditised market governed by aggressive tenders and reference pricing, even a moderate increase in manufacturing costs can destroy the commercial viability of a product. If resilience strategies are implemented without commercial realism, we risk creating development models that look strategically attractive on paper but fail economically in the market.” 

According to Ravikumar, the economics of generics leave very little room for expensive restructuring. In highly commoditised markets driven by aggressive tender systems and reference pricing, even a modest increase in manufacturing costs can destroy commercial viability. 

“If an on-shored supply chain increases our Cost of Goods Sold by even 15 per cent, the product is dead on arrival,” he says. “The generics industry cannot absorb large-scale cost inflation in the same way high margin innovative businesses can. Commercial sustainability must remain central to every localisation discussion,” he adds. 

He also points out that shifting final API synthesis to Western markets does not necessarily eliminate supply vulnerabilities if the foundational key starting materials (KSMs) remain heavily concentrated in Asian manufacturing clusters. 

“If the foundational KSMs remain 80 per cent concentrated in Asian industrial clusters, have we actually removed the single point of failure? No,” Ravikumar notes. “We may simply be relocating the visible part of the supply chain while the real dependency remains unchanged upstream.” 

Instead of pursuing localisation, he advocates what he describes as a ‘bifurcated’ R&D strategy — one that separates low-margin commodity generics from high-value complex products. 

Flexible formulation science and agile manufacturing 

For commodity small molecules, Ravikumar believes the answer lies not in expensive manufacturing duplication but in smarter formulation science. He argues that R&D teams must develop highly robust “platform formulations” capable of tolerating variations in API particle size, polymorphic forms, or impurity profiles across multiple suppliers. 

“If we design formulations that can seamlessly accommodate varying API profiles, we break our dependency on any single synthesis route,” he explains. “The future of generics resilience lies not just in where we manufacture, but in how intelligently we design formulations and regulatory strategies from the very beginning.” 

He also stresses the importance of leveraging regulatory flexibility through frameworks such as ICH Q12 to accelerate supplier substitution during disruptions. By establishing broader pre-approved conditions and multi-source Drug Master Files (DMFs), companies can respond faster when supply routes are interrupted. 

“When a chokepoint closes, the regulatory switch can be executed through an internal protocol rather than waiting through multi-month variation approvals,” he says. “That level of regulatory agility will become increasingly critical in a fragmented global environment.” 

For higher-value therapies such as peptides and complex biologics, however, Ravikumar believes greater localisation and manufacturing redundancy may make commercial sense. In these segments, he sees significant potential for modular Continuous Flow Manufacturing (CFM) technologies that can support smaller, flexible, and geographically distributed production models. 

“CFM units have a shipping container footprint and can be deployed domestically within modern green-chemistry compliance frameworks,” he explains. “For high-value products, the economics of redundancy are fundamentally different. Here, investing in domestic capabilities and upstream integration can become a strategic competitive advantage.” 

At the same time, Ravikumar cautions against unrealistic expectations around complete supply chain decoupling from China, especially in small molecule chemistry. “Let’s be realistic: there is no viable workaround for Chinese small molecule KSMs,” he says. 

“The scale and capital efficiency of East Asian chemical clusters cannot be replicated domestically without a low return on investment that no corporate board will fund. Rather than pursuing unrealistic chemical decoupling, companies should focus on designing structural agility into products and development systems.” 

Instead, he argues that pharma companies should focus on designing structural agility into drug development itself, ensuring products can rapidly adapt to changing supplier ecosystems and geopolitical disruptions. 

India’s opportunity beyond “pharmacy of the world” 

Despite differing approaches, all three R&D leaders agree on one larger reality: geopolitical uncertainty is no longer a temporary disruption for the pharma industry. It is becoming a permanent feature of the operating environment, forcing pharma R&D to evolve from a cost-driven function into a resilience-driven one. 

For India, this transition also presents a major strategic opportunity. Joshi and Bommagani believe the current geopolitical climate could help India move beyond its long-standing role as the “pharmacy of the world” and emerge as a global innovation hub. 

“India is positioned to lever age the current geopolitical environment to emerge as a global innovation hub in pharma and biotechnology,” says Joshi. “The ongoing diversification of global supply chains is encouraging multinational pharma companies to explore alternative destinations for manufacturing, research, and development. India’s scientific talent, manufacturing scale, regulatory experience, and cost competitiveness position it very strongly in this transition.” 

The ongoing diversification of global supply chains has encouraged multinational pharma companies to explore alternative destinations for manufacturing, research, and development. India’s combination of cost competitiveness, scientific talent, manufacturing scale, and regulatory experience makes it a strong contender. 

Importantly, India’s strengths are no longer confined to manufacturing alone. Its large and diverse patient population provides a major advantage in clinical research and data generation.

“With a large and diverse patient population, India offers significant advantages for conducting clinical trials across therapeutic areas,” Joshi says. “This diversity enables the generation of robust and globally relevant clinical data, which becomes increasingly important for precision medicine, biologics, and real-world evidence generation.” 

Bommagani believes the global “China+1” strategy has created a historic opening for India to move up the pharma value chain. He says, “The global desire to diversify supply chains presents a historic window for the Indian pharma industry to pivot from high-volume generics to high-value innovation,” he says. “India now has an opportunity not just to manufacture for the world, but to become a trusted global partner across innovation, CDMO services, clinical development, and advanced therapeutics.” 

India’s growing biotech ecosystem, digital infrastructure, and expanding CDMO sector are increasingly positioning the country as a preferred partner for global clinical research, biologics, biosimilars, and advanced drug delivery systems. 

However, the R&D leaders also acknowledge that India’s ambitions will require deeper structural reforms. Regulatory timelines need greater predictability and alignment with global standards. Investments in advanced research infrastructure, translational science, and talent development will be essential. Stronger intellectual property protections will also remain critical for attracting innovation-led investments. 

Preparing for uncertain future 

Still, the broader direction is becoming increasingly clear. The pharma industry is entering an era where resilience, diversification, and strategic flexibility will define long-term competitiveness. 

The traditional pharma operating model, built heavily around centralisation, efficiency, and lean globalisation is now being replaced by a more distributed and risk-aware framework. 

Future-ready pharma companies will increasingly need – diversified supplier ecosystems, flexible manufacturing platforms, digitally connected supply chains, regionally balanced clinical strategies, and resilient regulatory planning models. 

In many ways, geopolitical uncertainty is now becoming a design parameter for pharma R&D itself. And for India, the next phase of growth may ultimately depend on how effectively it transforms geopolitical disruption into an opportunity in innovation, R&D, and futureready pharma strategy.

swati.rana@expressindia.com 

swatirana.express@gmail.com 

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