Introduction: India’s Biologics Leap Forward
India is redefining its position in the global biologics landscape. With over a decade of experience in biosimilars, vaccines, and monoclonal antibodies, the country is now gearing up for its next chapter: advanced biologics manufacturing, digital transformation, and innovation-driven scale-up.
As new facilities emerge and established players upgrade infrastructure, India’s biopharma ecosystem is increasingly open to collaboration with technology providers, automation experts, and digital innovators.
This report explores the key trends shaping India’s biologics manufacturing future — and where vendors and solution partners can make the biggest impact.
1. Smart Manufacturing
Indian biologics manufacturers are actively modernizing production — and digitalization is leading the way.
- Process Analytical Technology (PAT): Adoption is rising to achieve real-time monitoring and consistent product quality.
- Automation: Integration of robotics and automated control systems is improving throughput and reducing variability.
- Digital Twins: Leading players are piloting digital-twin models for bioprocess simulation and optimization.
- Data Integration: Unified data platforms are becoming critical for managing batch records and regulatory compliance.
2. The Move Toward Continuous Bioprocessing
Batch production remains the norm, but the shift to continuous processing is gaining momentum. This approach promises lower costs, smaller footprints, and higher productivity — ideal for India’s fast-growing biologics sector.
Current drivers:
- Pressure to reduce cost of goods (COGs) in biosimilar production
- Growing regulatory acceptance for continuous bioprocessing
- Interest in modular and scalable systems for new facilities
3. Sustainability and Efficiency as Core Strategies
India’s biomanufacturing sector is also becoming more environmentally conscious.
- Single-use technologies are replacing stainless steel to reduce water and energy consumption.
- Companies are investing in energy-efficient cleanrooms, waste recycling systems, and green utilities.
- Regulators and investors increasingly favor sustainability metrics in plant operations.
4. Quality, Compliance, and Global Market Readiness
As Indian biologics manufacturers expand exports to regulated markets, GMP compliance and quality control are under intense focus.
Key needs include:
- Advanced analytics for impurity profiling and comparability studies
- Electronic Batch Records (EBR) and LIMS integration
- Regulatory data harmonization to meet USFDA, EMA, and MHRA standards
5. The Future: From Biosimilars to Biologic Innovation
India’s biopharma companies are evolving beyond biosimilars to novel biologics, antibody-drug conjugates (ADCs), and cell & gene therapies. This shift will reshape manufacturing needs:
- Smaller, more agile production lines
- Higher analytical precision
- Tighter cold-chain integration
- Customized modular facilities
India’s Biologics Boom: Where Market Opportunities Are Accelerating
1. Expansion of Domestic Biologics Pipelines
What’s happening:
India’s leading pharma companies (e.g., Biocon, Dr. Reddy’s, Zydus, Intas) are rapidly building biologics and biosimilar pipelines.
Market opportunity:
Growing need for bioprocessing equipment, single-use systems, chromatography resins, and upstream optimization solutions.
Hot hubs: A rapidly growing pharmaceutical hub such as Hyderabad, Ahmedabad, and Bengaluru with strong capabilities in biologics manufacturing, process development, and formulation, supported by established players expanding into biosimilars and large molecule production.
2. Focus on Large-Scale Biomanufacturing Capacity
What’s happening:
New investments in large-scale biologics manufacturing plants with GMP capabilities and modular facilities.
Market opportunity:
High demand for automation, process control, filtration, and facility design technologies.
Example: Biocon Biologics has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru.
3. Rise of Contract Development and Manufacturing (CDMO) Partnerships
What’s happening:
More companies are outsourcing process development and scale-up to CDMOs for flexibility and cost efficiency.
Market opportunity:
CDMOs are top customers for analytical instruments, process monitoring tools, and QC automation.
Leading CDMOs in India: Aurigene Pharmaceutical Services, a subsidiary of Dr. Reddy’s, has established a state-of-the-art biologics facility in Genome Valley, Hyderabad to advance innovative drug development. Additionally, Laurus Labs invested INR 9.9 billion (US$114M) to pivot from APIs to antiretroviral and intermediate drug production.
4. Digital & Data-Driven Manufacturing
What’s happening:
Adoption of AI, IoT, and digital twins for process monitoring, predictive maintenance, and quality control.
Market opportunity:
Demand for digital infrastructure, MES, PAT, and AI-based analytics platforms.
Trend driver: Government push for “Digital Biopharma India 2030”. India's strategic plan to enhance its pharmaceutical and biopharmaceutical sector through digital innovation, automation, and R&D, aiming for a global leadership position. Key goals include growing the bioeconomy to $300 billion by 2030.
5. Sustainability and Green Manufacturing
What’s happening:
Companies are moving toward sustainable bioprocessing, energy-efficient facilities, and eco-friendly materials.
Market opportunity:
Need for energy-efficient equipment, recyclable single-use components, and waste management systems.
Example: Serum Institute & Biocon integrating green energy in production lines
