Panel Discussion Reveals Strategic Inflection Point as Regulatory Barriers Fall and Technology Advances
The inaugural day of analytica Lab India and Pharma Pro&Pack Expo 2025 at HITEX Exhibition Centre featured a pivotal panel discussion that laid bare both the enormous opportunity and competitive challenges facing India’s biologics industry as it attempts to capture a significant share of what is projected to become a $1.3 trillion global market by 2034.
The Scale of Opportunity
Dr. Mahesh Bhalgat, Group CEO and Managing Director of Veeda Lifesciences, who moderated the session titled “Future Trends in Biologics & Biosimilars,” opened with striking market projections. The current $527 billion biologics, biosimilars, and advanced therapeutics industry is expected to more than double to $1.3 trillion within the next decade. Within this landscape, the biosimilars segment alone—currently valued at $35 billion—is positioned to double in less than ten years.
“The size of the market, the size of the opportunity, the number of patients that you can reach is growing at a very rapid pace,” Bhalgat emphasized, noting that U.S. biosimilar spending is expected to reach $50 billion by 2027.
Regulatory Revolution Creates New Pathways
The discussion revealed a fundamental shift in the regulatory landscape that panelists believe represents an inflection point for Indian companies. The FDA’s recent acceptance of a biosimilar application without requiring clinical efficacy studies marks a paradigm change that could dramatically alter the industry’s risk-return calculus.
Dr. Pavan Bhat, CEO of Inventia Healthcare Limited, highlighted how this regulatory evolution addresses the primary barrier that has prevented Indian companies from competing in regulated markets. “Until now, what has been rate limiting to India being a real dominant player in biologics is the fact that the need for doing efficacy trials or clinical trials which cost anywhere from 20 to 40 million dollars,” Bhat explained.
This shift toward analytical similarity rather than clinical demonstration represents more than a cost reduction—it fundamentally changes the business model for biosimilar development. As Bhat noted, even India’s largest pharmaceutical companies have historically been reluctant to allocate $30-50 million toward products with uncertain returns when that capital could generate higher returns in small molecules.
Technology as the Great Equalizer
The panel identified advanced analytical technologies as both an enabler of regulatory change and a competitive advantage. Dr. Ravi Krovidi, Founder and CEO of Protein Advanced Analytics, described the “reverse pyramid model” where molecular similarity at the fundamental level becomes paramount.
“If you show at a molecular level, both the structural level and the functional level… if you are able to show those post-translational modifications that the molecule is safe, you don’t need a lot of immunogenic testing required,” Krovidi explained, illustrating how sophisticated analytical capabilities can replace expensive clinical studies.
The discussion highlighted several technological advances reshaping the industry:
Process Innovation: Companies like Enzine are disrupting traditional batch manufacturing through continuous manufacturing approaches, offering smaller footprints, higher titers, and lower cost of goods.
Advanced Analytics: High-resolution mass spectrometry (HRMS), NMR, and other sophisticated analytical tools are becoming standard for comprehensive molecular characterization.
Perfusion Technology: Newer companies benefit from advanced bioprocessing technologies that require smaller reactor footprints while achieving higher yields.
The Manufacturing Transformation
Dr. Gopal Lakkireddy, Senior Vice President at MSN Laboratories, represented the wave of traditionally small-molecule companies entering biologics. His perspective illuminated how the industry’s maturation has lowered barriers to entry.
“The 20-25 years of what India has spent has been more of a learning and getting to a stage where we can get the technology or the ecosystem developed. I think now we are in a stage where we can really capture the market,” Lakkireddy observed.
This sentiment reflects a broader industry transformation where established pharmaceutical companies are leveraging decades of accumulated knowledge and improved technologies to enter biologics markets that were previously dominated by specialized biotechnology companies.
The Innovation Imperative
Dr. Ramesh Mathur, Senior Vice President and Head of R&D at Biological E Limited, brought a unique perspective from vaccine development, having recently achieved approval for one of the world’s most complex vaccines after eight years of development. His comments underscored India’s scientific capabilities while highlighting the need for strategic focus.
“India has the talent, resources are there, and intelligence is there. Only thing is you just have to direct them and then have a vision to develop this novel molecule,” Mathur stated, emphasizing that the country’s technical capabilities are not the limiting factor.
AI and Advanced Manufacturing
The discussion touched on artificial intelligence and machine learning as transformative technologies, though with appropriate caution. Mathur warned against blind trust in AI outputs while acknowledging their utility: “Do not believe it 100%. Test it, validate it.”
However, the panelists recognized AI/ML as particularly suited to biologics manufacturing, where large datasets and complex variables make human analysis challenging. Applications range from glycan analysis automation to predictive batch quality assessment based on growth patterns and process parameters.
The China Challenge
Perhaps the most sobering aspect of the discussion was the acknowledgment of competitive pressure from China and Korea. Bhalgat noted that while India built its “pharmacy of the world” reputation on small molecules, China and Korea have established dominant positions in biologics manufacturing.
The comparison with China proved particularly stark—similar population, five times the GDP, yet dramatically more innovative molecule approvals in recent years. The success of companies like BeiGene, which recently secured billion-dollar deals with Pfizer, illustrates the scale of competition India faces.
When audience members questioned India’s “right to win” against China, panelists identified several potential advantages:
- Manufacturing volume capacity leveraging India’s established pharmaceutical infrastructure
- Niche technology specialization in specific therapeutic areas
- Cost-competitive CDMO services for global biotechnology companies
- Government biotechnology initiatives supporting infrastructure development
Critical Gaps and Challenges
The panel identified several areas requiring immediate attention:
Quality Control Evolution: Lakkireddy noted that Indian companies remain “very, very conservative” in adopting advanced quality control technologies, continuing to rely on traditional testing approaches even as regulators accept more sophisticated methods.
Scale and Technology Gaps: The discussion revealed that India operates at smaller scales and with less advanced technology compared to Korean and Chinese facilities, affecting both manufacturing efficiency and global competitiveness.
Academia-Industry Disconnect: Multiple panelists highlighted the persistent gap between academic research and industry application as a constraint on innovation.
Market Entry Strategies
The discussion revealed evolving strategies for market entry. While historical approaches relied heavily on partnerships with Western companies to navigate regulatory and financial challenges, panelists predicted a shift toward independent market entry as regulatory barriers fall and Indian companies grow larger.
Bhat predicted that the next 2-3 years will see more Indian companies “take it over the finish line” independently rather than relying on partnership models that characterized the industry’s first decade.
CDMO Opportunities
The conversation identified contract development and manufacturing organization (CDMO) services as a significant growth opportunity. Government initiatives supporting bio-manufacturing facilities and the emergence of specialized CDMOs across southern India suggest this sector could provide a pathway for Indian companies to build capabilities while serving global markets.
Looking Forward
The panel discussion painted a picture of an industry at a critical juncture. Regulatory changes, technological advances, and growing market demand are creating unprecedented opportunities for Indian companies to establish significant positions in global biologics markets.
However, success will require more than simply following established biosimilar pathways. The discussion emphasized the need for strategic investments in advanced manufacturing technologies, sophisticated analytical capabilities, and talent development to compete with established biotechnology centres in China, Korea, and the West.
As Dr. Bhalgat concluded, the opportunity exists for India to replicate its small-molecule success in biologics, but it will require coordinated efforts across industry, academia, and government to build the capabilities necessary to compete at global scale.
The biologics revolution is underway, and India’s position in this transformation will be determined by how quickly and effectively the industry can implement the strategic changes outlined by these industry leaders.
- Naresh Nunna
