Saurabh Agarwal, Director, HAB Pharmaceuticals and Research
Saurabh Agrawal, Director at HAB Pharmaceuticals & Research Limited, is a pharmaceutical industry leader with over 18 years of experience. He drives the company’s growth by strengthening strategic partnerships, leading product commercialization, and enhancing operational efficiency. Combining entrepreneurial legacy with a forward-looking approach, he is focused on building a future-ready, globally competitive pharmaceutical organization.
The article shares how India’s pharmaceutical industry is moving beyond its traditional focus on high-volume generics. It explores the growing opportunities in peptides, sterile injectables and complex generics, while highlighting why skilled talent, strong processes, quality standards and the ability to manage complexity will be important for India to build the next phase of pharma growth.
India’s pharmaceutical industry has spent three decades building a global reputation as the world’s leading supplier of affordable medicines. The volume-led generics model transformed India into the “pharmacy of the world”, enabling millions of patients worldwide to access cost-effective treatments. However, the next decade will require a different growth engine — one driven not just by the ability to manufacture more medicines, but by the ability to manufacture more complex, differentiated and high-value products.
Peptides, sterile injectables and complex generics represent this next phase of evolution. These categories offer stronger pricing potential, longer product lifecycles and higher barriers to entry compared with traditional generics. As global pharmaceutical companies increasingly seek reliable manufacturing partners for technically challenging products, India has an opportunity to move from being a volume-driven supplier to a value-driven innovation and manufacturing hub.
However, this transition will not be defined only by investments in capacity or infrastructure. The real challenge will be whether the industry can build the expertise, operational discipline and cross-functional capabilities required to successfully develop and commercialize complex products at global standards.
In complex pharmaceutical programs, challenges rarely emerge from a single failure. They often result from multiple interconnected factors — manufacturing timelines, technology transfers, supplier dependencies, regulatory requirements and quality processes. In a multi-vendor, multi-geography environment, even small delays can quickly compound. A delay in a critical component, equipment qualification or documentation process can impact manufacturing schedules, validation timelines, regulatory submissions and commercial launch plans. This highlights a reality that the trade conversation often overlooks: India’s next pharma decade will not be determined only by whether the country can produce medicines at scale. It will be determined by whether it can consistently execute complexity at scale.
The next decade will belong to those who can transform complexity into capability, and capability into sustainable value for Indian pharma.
There is growing consensus within Indian pharma that the next wave of growth will come from complex generics, sterile injectables and peptides — particularly the expanding GLP-1 opportunity. Global demand for GLP-1 agonists such as semaglutide and tirzepatide is projected to approach $150 billion by 2030, while patent expiries and increasing global demand are accelerating interest among manufacturers. India’s sterile injectable contract manufacturing market is also expected to witness significant expansion, while the broader CDMO sector continues to grow rapidly.
This shift represents a fundamental change in India’s pharmaceutical opportunity. Traditional generics were built on scale, cost efficiency and manufacturing excellence. The next generation of growth will require deeper scientific capabilities, specialized manufacturing expertise and the ability to manage products where technical complexity itself becomes a competitive advantage. Volume-led generics, which built modern Indian pharma, are facing structural pressures due to pricing erosion, tightening margins and increasing competition. Global buyers are increasingly seeking differentiated products rather than additional suppliers for the same molecules.
Complex generics, sterile injectables and peptides offer stronger commercial potential because they require specialized capabilities that create meaningful barriers to entry. The opportunity is clear. The question is whether India can build the capabilities required to capture it.
When companies discuss challenges in transitioning towards complex, high-value manufacturing, the conversation often centers around capital requirements. A greenfield aseptic facility can require significant investment and years of qualification. Regulatory complexity, EU-GMP compliance, USFDA inspection cycles and documentation requirements add further challenges.
These concerns are valid. However, capital is arguably no longer the biggest barrier India’s pharma sector faces. Government initiatives increased private equity interest in CDMO assets, and stronger investor confidence has improved access to funding.
Advanced manufacturing equipment — isolators, RABS lines, lyophilizers, single-use systems and advanced analytical technologies — can also be acquired. The challenge is ensuring that these assets deliver consistent outcomes. Equipment can enable capability, but it cannot replace experience. A world-class sterile facility still requires trained operators, quality professionals and manufacturing leaders who understand how to maintain performance under regulatory scrutiny.
Professionals who have operated sterile manufacturing facilities at global audit standards, scaled peptide purification processes commercially, managed regulatory submissions and built quality cultures remain limited. In peptides especially, technical knowledge of advanced purification, process optimization and scale-up is critical. Similarly, sterile injectable manufacturing requires years of experience in maintaining aseptic discipline, contamination control and regulatory readiness. These capabilities cannot be built overnight through infrastructure investments alone.
When such expertise is developed, it is often vulnerable to attrition as larger companies, GCCs, multinational organizations and well-funded entrants compete aggressively for experienced professionals. When regulatory specialists, manufacturing leaders or quality experts leave midway through critical projects, they take institutional knowledge with them. This creates execution gaps that cannot be solved through additional capital expenditure. India’s talent pipeline is also struggling to keep pace. Advanced purification techniques, peptide manufacturing expertise, bioprocess engineering, digital manufacturing capabilities and specialized quality functions require skills that traditional education pathways are still catching up to provide.
Most companies exploring complex generics, peptides or sterile injectables today may be underestimating what “complex” demands from an organization. It is not simply a formulation challenge solved in R&D and transferred to manufacturing. It requires sustained operational discipline — batch record integrity, deviation management, aseptic practices that remain consistent under production pressure and documentation that withstands regulatory scrutiny.
That discipline exists in people, not in equipment specification sheets. A quality culture cannot be commissioned; it must be built over years through experience, training and consistency. The companies that succeed in the next decade may not necessarily be those with the largest capital expenditure plans. They will be organizations that treat talent retention, cross-functional coordination and institutional knowledge as strategic capabilities alongside manufacturing investments.
Scale alone is no longer a competitive advantage. Institutional memory is.
The companies that succeed in this next phase will not necessarily be those that build the largest facilities. They will be those who develop the strongest organizational capability around complexity. Complex products require seamless coordination between research teams, process development specialists, manufacturing units, regulatory functions, quality teams and external partners. A delay or disconnect in any one function can impact the entire product lifecycle.
This is why institutional knowledge will become one of the most valuable assets in pharma. Experienced teams understand not only processes, but also the judgment required to anticipate risks, interpret regulatory expectations and solve problems before they become disruptions.
If India aims to lead the next phase of pharmaceutical innovation, several fundamental shifts are required. First, companies need stronger apprenticeship and conversion pathways — not one-off training programs, but multi-year, hands-on learning models that allow engineers and scientists to build sterile and peptide manufacturing expertise under experienced mentorship. A university degree provides scientific knowledge; it does not create the operational expertise required to manage validated manufacturing environments.
Second, talent retention in R&D, regulatory affairs, manufacturing and quality functions must become a board-level priority. Losing a critical regulatory or manufacturing leader during a submission or launch phase can result in significant delays and financial impact. This risk deserves the same attention as supply chain, vendor or currency risks.
Third, mid-sized manufacturers — the backbone of India’s pharmaceutical ecosystem — require support aligned to their realities. Challenges related to energy costs, API dependency, compliance investments and global expansion affect smaller organizations differently compared with large enterprises.
Finally, vendor and partner coordination must become a core organizational capability rather than a project-management afterthought. Complex programs involving multiple suppliers, geographies and regulatory requirements require leaders who can see the complete ecosystem and prevent smaller delays from becoming major disruptions.
India’s pharmaceutical industry has spent three decades proving its ability to manufacture at scale, compete on cost and meet stringent global regulatory standards. The next decade will require a different capability: the ability to manage complexity consistently and sustainably.
The transition from volume to value will not happen through capacity announcements alone. It will happen through the ability to consistently develop, manufacture and deliver complex medicines that meet the expectations of global regulators and patients.
The molecules are ready. The opportunity is clear. The next decade will belong to those who can transform complexity into capability — and capability into sustainable value for Indian pharma.
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