Q1. Could you start by giving us a brief overview of your professional background, particularly focusing on your expertise in the industry?

I have a broad background that includes work in the pharmaceutical, FMCG, and chemical industries. I began my career in the chemical business before moving into the fast-moving consumer goods (FMCG) sector, where I gained solid experience in supply chain dynamics, production procedures, and product development. Over the years, I transitioned into the pharmaceutical space, where I’ve been focusing more intensively on the manufacturing of drugs, including sterile and non-sterile tropical products, as well as business dynamics. My experience across these industries has given me a comprehensive understanding of both fast-moving product cycles and the stringent quality and regulatory requirements of pharma, allowing me to bring a unique, cross-functional perspective to problem-solving and strategy execution.”

Q2. How is the adoption of Industry 4.0 and digital manufacturing evolving in the pharma sector?

The adoption of Industry 4.0 and digital manufacturing in the pharmaceutical sector is accelerating, though unevenly across regions and company sizes. Here’s a structured view of how it’s evolving

Drivers of Adoption

• Regulatory Pressure: Agencies like the FDA and EMA are encouraging data integrity, real-time monitoring (e.g., PAT, QbD), and continuous manufacturing.
• Cost and Efficiency: Companies aim to reduce batch failures, optimize throughput, and lower costs through predictive maintenance and real-time analytics.
• Quality and Compliance: Digital systems enable better traceability, audit readiness, and faster deviation handling.

Q3. How is sustainability being embedded into manufacturing and operations strategies in pharma?

As a result of corporate ESG objectives, investor expectations, and regulatory pressure, sustainability is fast emerging as a key component of pharmaceutical manufacturing and operations strategy. This is an organized perspective of its embedding:

Key Focus Areas in Manufacturing & Operations

a. Energy Efficiency & Decarbonization

• Transition to renewable energy sources (solar, wind, bioenergy).
• Installation of energy-efficient HVAC, chillers, and cleanroom systems.
• Green buildings and LEED-certified manufacturing sites.
• Use of digital energy monitoring for real-time optimization.

b. Green Chemistry & Process Optimization

• Adoption of green chemistry principles to reduce hazardous solvents and reagents.
• Process intensification and continuous manufacturing to reduce waste, water, and energy usage.
• Minimizing API loss during manufacturing to reduce the environmental footprint.

c. Management of Waste and Water

• Zero liquid discharge (ZLD) plant implementation.
• Methods for recycling, incineration, and waste segregation in manufacturing facilities.
• Wherever practical, recover solvents and reuse water.

d. Supply Chain Sustainability

• Audits of suppliers using ESG standards.
• To cut down on transportation-related emissions, move toward local sourcing.
• Using packaging materials that are recyclable or biodegradable.

e. Digital Tools for Sustainability

• Use of AI and digital twins to simulate and optimize resource use.
• IoT for water, energy, and emission tracking at the unit level.
• Sustainability metrics integrated into ERP and ESG dashboards.

Q4. What’s your take on the current size and future trajectory of the CDMO market in India? Are we seeing a tipping point in outsourcing trends?

The CDMO (Contract Development and Manufacturing Organization) market in India is indeed at an inflection point, driven by structural shifts in the global pharmaceutical industry and growing capabilities within India. Here’s a detailed take on the current size and future trajectory:

1. Current Size of the Indian CDMO Market

• Market Size (2024 estimate): ~USD 12–14 billion, with exports contributing ~60–70%.
• Segment Split:
• API / intermediates: ~60–65% of market
• Formulations (solid orals, injectables, topicals): ~25–30%
• Development Services (CMC, analytical, tech transfer): ~5–10%
• Growth Rate: ~10–12% CAGR, higher than global CDMO growth (~7–8%)

2. Drivers Behind Outsourcing Growth

Global Factors

• Big Pharma’s asset-light strategy: Moving away from owning manufacturing sites.
• China+1 strategy: Increasing preference for India as an alternative to China, particularly for APIs and key intermediates.
• Shorter innovation cycles: Biotech and specialty pharma firms need agile manufacturing partners.

India-Specific Factors

• Strong base of FDA/EMA-approved facilities (India has ~700+ USFDA-approved plants).
• Cost arbitrage in labor, utilities, and capital expenditure.
• Growing investments in high-potency API (HPAPI), biologics, and sterile manufacturing.
• Increasing adoption of digital and regulatory compliance practices (e.g., data integrity, serialization, ESG reporting).

3. Challenges to Watch

• Capacity constraints in niche technologies (sterile, biologics, HPAPI).
• Need for upskilling in regulatory sciences, IP handling, and project management.
• Rising input costs and dependency on China for some raw materials.
• Competition from Southeast Asia (e.g., Vietnam, Indonesia) offering similar cost advantages.

 

Q5. Which areas within pharmaceutical manufacturing do you believe hold the most untapped potential over the next 5–10 years?

There are a number of pharmaceutical production fields with substantial unrealized technological and commercial promise over the next five to ten years. The most potential chances are broken down as follows:

1. Continuous Manufacturing

• Why it’s untapped: Most pharma manufacturing is still batch-based; only a handful of drugs are approved via continuous processes.
• Opportunity: Huge efficiency gains, lower footprint, real-time quality monitoring (RTRT), and fewer deviations.
• Potential impact: Could transform how oral solids, injectables, and even biologics are produced, especially high-volume generics and chronic disease therapies.

2. Advanced Biologics & Cell/Gene Therapy Manufacturing

• Why it’s untapped: High cost, complex tech transfer, and capacity constraints globally.
• Opportunity: Scalable, modular, and closed-system manufacturing for ATMPs (Advanced Therapy Medicinal Products) like CAR-T, mRNA vaccines, and gene therapies.
• India angle: Early but growing — potential for regional CDMOs to invest here and become preferred partners.

3. High-Potency APIs (HPAPIs) and Oncology Drugs

• Why it’s untapped: Need for specialized containment, handling, and regulatory compliance.
• Opportunity: HPAPIs are one of the fastest-growing API segments globally. Oncology remains the top therapeutic area in pharma pipelines.
• Barriers: Capex-intensive, skilled workforce, safety protocols — but high margin and long-term demand.

4. Pharma and Digitization 4.0

• Why it's unexplored: A large number of midsize companies in India and throughout the world continue to use outdated technology and paper-based procedures.
• Possibility: integrating digital twins, eBMR, MES, AI-based predictive analytics, and digital QMS.
• Future shift: Digital maturity will soon set you apart when it comes to partner selection and regulatory inspections.

5. Green Chemistry and Sustainable Manufacturing

• Why it’s untapped: Environmental norms are tightening globally, but adoption of green synthesis and ZLD (Zero Liquid Discharge) is inconsistent.
• Opportunity: Regulatory and investor incentives for low-carbon, low-waste operations. Additionally, a key point of differentiation between CDMOs and export businesses.

Q6. How is the competitive landscape evolving in pharmaceutical manufacturing — is it still largely cost-driven, or are capabilities and compliance taking center stage?

The competitive landscape in pharmaceutical manufacturing is evolving rapidly — while cost remains important, the game is increasingly shifting toward capability, compliance, and readiness for strategic partnerships. Here’s a breakdown of how the dynamics are changing:

Past (pre-2015)-Focus on low-cost labor, bulk APIs, generics scale

Present- Focus on complex dosage forms, regulatory maturity, digital QMS

Future-Rapid tech transfer, continuous Mfg, ESG, digital infrastructure

Q7. If you were an investor looking at companies within the space, what critical question would you pose to their senior management?

If I were an investor evaluating pharmaceutical manufacturing companies (including CDMOs, API players, or formulation manufacturers), I would focus on questions that reveal strategic positioning, operational resilience, regulatory robustness, and growth capability.

Bottom Line

The competitive edge in pharmaceutical manufacturing is shifting from “cheapest per unit” to “most compliant, capable, and collaborative partner.”