For more than a decade, pharma and biotech companies have lived with an uncomfortable truth: their supply chains are efficient, but fragile. COVID-19, geopolitical tensions, export controls, and logistics disruptions exposed a harsh reality that overdependence on a limited set of geographies for APIs, intermediates, and key starting materials is a business and patient risk, not just an operational one.
The response from global sponsors has been clear: diversify, de-risk, and redesign. That is where Indian CDMOs (Contract Development and Manufacturing Organizations) are increasingly shifting from “backup option” to strategic supply chain advantage.
India is no longer just the “pharmacy of the world” for generics. It is rapidly becoming a high-value CDMO hub, supporting complex chemistry, oncology, and early-to-late stage development programs for innovators across the US, Europe, and Asia.
A Market Moving Fast: From Volume Provider to Value Partner
The global CDMO market is projected to grow from around USD 185 billion in 2024 to approximately USD 368 billion by 2034 at a CAGR of 7.2%, driven by increased outsourcing in both small molecules and advanced modalities.
Within this, India’s CDMO market is growing even faster. Estimates suggest it was worth USD 3–3.5 billion in 2024 and could reach USD 22-25 billion by 2035, reflecting a double-digit CAGR, thus, capturing a larger market share of over 10-12% from the current 2-3%.
This surge is underpinned by India’s broader pharma ecosystem:
- India’s pharmaceutical industry is valued at about USD 55 billion in 2025 and is expected to reach approximately USD 130 billion by 2030.
- The country accounts for around 20% of global generic medicines exports by volume.
Those numbers signal a structural shift: India is shifting its gears from “capacity story” to a “capability story”.
From Concentration Risk to China+1 Advantage
The industry’s heavy reliance on a single geography for APIs and intermediates created a classic “single point of failure.” In response, global players have adopted the China+1 strategy, deliberately diversifying manufacturing and sourcing footprints beyond China without fully exiting it.
India has emerged as the primary beneficiary of this shift:
- Analysts describe the China+1 transition as a once-in-a-generation opportunity for India to capture a much larger share of pharma value chains.
- Reports indicate that India’s pharma contract services sector, including CDMOs, is already seeing a measurable rise in RFQs, pilot projects, and long-term contracts from global innovators.
In other words, what started as supply chain risk mitigation is now becoming a competitive edge for both sponsors and India-based CDMOs.
Why India Is Now a Strategic Supply Chain Advantage
1. Regulatory-Grade Infrastructure at Scale
India hosts one of the largest clusters of regulated pharmaceutical manufacturing facilities in the world:
- The Government of India notes that the country has more than 262 US FDA–compliant plants (including APIs), nearly 1,400 WHO-GMP approved plants, and over 250 EDQM-approved facilities.
- Other analyses indicate that around 650 plants in India account for roughly one-quarter of all USFDA-approved facilities outside the US, underlining its central role in global supply.
This depth of audited, compliant infrastructure allows sponsors to build redundant, resilient supply chains without compromising quality.
2. Cost-Effective, High-Skill Talent Pool
India offers a unique blend of cost competitiveness and scientific depth:
- A large pool of chemists, chemical engineers, and analytical scientists experienced in complex small molecules, HPAPIs, and oncology
- Strong presence of innovation clusters like Hyderabad, Bengaluru, Mumbai, and Gujarat, which combine academia, startups, CROs, and CDMOs into thriving ecosystems
This talent density enables Indian CDMOs to support end-to-end CMC programs from route scouting and process development to scale-up and commercial manufacturing.
3. Integrated CDMO Models: From Kilo Lab to Commercial
Leading Indian CDMOs are moving beyond “build-to-print” manufacturing into integrated development plus manufacturing models:
- Early engagement in process development, impurity profiling, and solid-state characterization
- Smooth tech transfer into pilot, kilo, and commercial facilities within the same network
- Alignment of development data, scale-up studies, and regulatory documentation, reducing friction and rework
For sponsors, this means fewer handovers, less data loss, and shorter time from concept to clinic and from clinic to market.
Moving Up the Value Chain: Beyond APIs to Complex Modalities
The perception of India as “just an API and generics engine” is becoming outdated. Indian CDMOs are expanding into higher-value, more technically demanding segments, including:
- High-potency APIs (HPAPIs) and oncology payloads
- Complex small molecules requiring multi-step synthesis, hazardous chemistry, or specialized containment
- Emerging capabilities in ADCs, peptides, and complex conjugates, including bioconjugation and handling of potent components
The Indian CDMO Drug Substance segment has already been cited as the fastest-growing segment in several market studies.
This progression up the value chain transforms Indian CDMOs from “low-cost suppliers” into strategic partners for innovation, not just capacity.
From Risk to Advantage: How Sponsors Can Leverage Indian CDMOs
Done right, working with Indian CDMOs can convert supply chain risk into supply chain advantage in three main ways:
- Diversification without Dilution of Quality: Sponsors can build multi-region manufacturing strategies such as US/EU plus India, ensuring continuity during regional disruptions, while retaining alignment with global regulatory expectations.
- Faster Time-to-Market: Integrated Indian CDMOs, with development and commercial assets on one platform, can compress timelines for the most important activities such as route optimization, scale-up & validation followed by stability batches, thus, shaving months off critical CMC pathways, especially for small-molecule and high-potency programs.
- Strategic Cost Reallocation: By leveraging India’s cost-effective but high-quality manufacturing base, sponsors can redirect capital from bricks-and-mortar manufacturing to R&D, clinical programs, and pipeline expansion, improving overall ROI as global prescription-drug sales march towards an estimated USD 1.7 trillion by 2030.
What to Look for in a High-Value Indian CDMO Partner
Not all CDMOs are created equal. To convert risk into advantage, sponsors should prioritize partners that offer:
- Regulatory track record with strong compliance history
- Integrated development and manufacturing capabilities across intermediates, APIs, and drug products including support for advanced modalities
- Specialization in complex chemistry and high-potency, with appropriate containment and safety systems
- Robust quality culture and data integrity practices, beyond check-the-box compliance
- Business continuity planning, dual-site strategies, and transparent risk management frameworks
- Collaborative mindset with willing to co-create CMC strategies rather than simply execute orders
Conclusion: India as a Strategic Node in the Next-Gen Pharma Supply Chain
The global pharma industry is at an inflection point. What used to be seen purely as supply chain risks including geographical concentration, cost pressures, and capacity bottlenecks, are now being reframed as an opportunity to build smarter, more resilient, and strategically diversified networks.
Indian CDMOs sit at the heart of this transition. With rapidly scaling CDMO markets, deep regulatory-grade infrastructure, strong scientific talent, and growing expertise in complex and high-value molecules, India is evolving from a backup option to a primary pillar in global biopharma supply chains.
For innovators, the question is no longer “Should we work with India?” but rather “Which Indian CDMO can become our long-term strategic partner?”
At Lupin Manufacturing Solutions (LMS), we align with this shift, combining our legacy with integrated CDMO capabilities across intermediates, APIs, and complex, high-value small-molecule and oncology programs. Positioned out of India, LMS helps sponsors turn supply chain diversification into a true competitive advantage.
If you are rethinking your CDMO and supply chain strategy in this new era, now is the time to partner with Lupin Manufacturing Solutions to convert supply chain risk into supply chain advantage and move your next molecule confidently from development to market.