For years, the story of Indian pharma and the US has been told through the lens of opportunity. However, as the terms of that relationship begin to shift, so too does the certainty around a market Indian pharma has long known.
The American Dream, once imported almost as freely as the products and ideas that helped build it, now sits rather awkwardly beside “Make America Great Again”. The change is not confined to rhetoric, with the much awaited India-US trade deal still being worked out and its fine print yet to be settled
So perhaps the question facing Indian pharma is not simply whether to look beyond the US, but which shores to reach next, how to make landfall, and how to build a business once there.
How exposed is Indian pharma to the US?
Before asking where Indian pharma can go next, it is worth establishing how much of its global business has been shaped by the US.
For decades, serving the US market has meant building capabilities around its regulatory requirements, manufacturing standards and commercial systems. Those capabilities have, in turn, travelled with Indian companies as they entered other markets.
Harish Jain, President, FOPE, points out that India’s pharma exports now span around 191 countries and are estimated at $32-33 billion in 2025-26. The US, however, accounts for around 45-55 per cent of the business of some leading Indian companies.
“The thing is, the market that made Indian pharma globally competitive may also be the market that exposes its geopolitical pricing and regulatory risk.”
That exposure is being tested by tariffs, localisation requirements and generic price erosion. However, the US relationship has also given Indian pharma an important advantage: experience and credibility in a closely regulated market.
And that is why, for Jain, exposure to the US is not a strategic risk in itself, but a position from which Indian pharma can diversify without withdrawing from the market.
Namit Joshi, Chairman, Pharmexcil, offers another reason why the US will remain central to this equation, by highlighting the scale of the ecosystem built around generic medicines.
“See, if you believe in the theory of assumptions, then it looks a very remote possibility that we will lose the total market share in US because to rebuild a sort of ecosystem for generic medicine manufacturing, I think a lot of investments goes into that particular segment.”
Uday Harle, CEO of Shilpa Biologicals, brings the same question to the level of products and future value pools. For him, diversification does not mean finding another market of the same scale as the US.
“I don’t think there is a single market that replaces the US. The bigger opportunity is a diversified global portfolio, particularly as the pharmaceutical value pool increasingly shifts towards biologics and other advanced therapies.”
The focus, therefore, shifts from replacing the US to understanding what other markets can offer, and what it takes for Indian pharma to build a sustainable presence in them.
What makes a market worth entering?
If diversification is the direction, market size alone cannot determine where Indian pharma goes next.
For Archana Jatkar, Associate Secretary General, IPA, the starting point is the combination of patient need, commercial viability and regulatory predictability. A large market may offer scale, but that does not necessarily translate into a sustainable opportunity for an Indian company, particularly when pharma investments are made over long time horizons.
“Market size is one important consideration, but the focus is on how effectively Indian pharma company can address that opportunity and build a sustainable long-term presence.”
Regulatory access, pricing, reimbursement and competition therefore, become an important part of the assessment. So does the company’s own portfolio. Jatkar argues that companies need to examine where they have a genuine competitive advantage.
“We also need to assess where the Indian pharma has a genuine competitive advantage, right? Whether it is in generics, complex generics, are we good in APIs, biosimilars or what areas?”
The difference between market size and actual export opportunity can be seen across geographies. Jatkar points to Europe and Africa as an example.
“If you look at Europe, it has a larger gross market in say this year of financial year 2026, while Africa generated higher net export earnings for India. It shows why market selection must go beyond the headline of market size.”
The criteria therefore extend beyond demand. A company has to assess whether its products fit the market, whether it can navigate its regulatory system and whether it has the commercial infrastructure to build a sustainable presence.
Beyond the familiar coast
That makes it difficult to identify one country as a replacement to the US. Europe offers scale but is fragmented across markets and pricing systems. Africa brings population and healthcare needs. ASEAN offers proximity and growing healthcare demand, while Latin America provides further diversification. The Middle East is linked to healthcare investment and localisation, while Japan presents a longer-term opportunity for companies prepared to meet its regulatory requirements.
“So, the point I’m trying to make is, these are different opportunities for the Indian industry, and I do not see choosing one upon the other,” concludes Jatkar.
The decision also depends on the company’s starting point. Dharmesh Kharwar, Joint Secretary, FPME; distinguishes between entering a new market and expanding an existing presence. Approvals, dossiers, infrastructure and reference country requirements can shape the regulatory pathway, while the commercial model depends on whether a company works through a distributor, importer, local partner or its own sales force.
For Jain, the focus should be on the Global South, particularly ASEAN, Africa and Latin America, with Brazil as a key market within the latter.
The opportunity, however, is not simply about competing on price. Jain argues that India’s experience in regulated markets has created credibility that can support a broader role.
“But they (other countries) are not looking for cheaper medicines. They are looking for reliable supply, regulatory credibility, as I said earlier, India has such an enormous amount of regulatory credibility due to US business, technology partnerships, and increasingly local manufacturing.”
Therefore as Jain highlights, “our next export strategy cannot be sell more generics to more countries, it has to be build deeper healthcare partnership with more countries.”
For Shilpa Biologicals, that portfolio already extends across Europe, Japan, Latin America, the GCC and Middle East, ASEAN, Australia, Canada and Africa. Harle points to healthcare modernisation in the GCC, increasing biologics adoption in Latin America and demand for advanced therapies across Asia, with partnerships already developing across these regions.
“So the opportunity beyond America is not theoretical — it is already developing,” he confirms.
Diversification is already taking shape
The idea of a diversified portfolio is also visible in the experience of companies that have had to rebalance their export portfolios. Joshi points to the loss of US revenue alongside growth in other regions.
“Last year, we diversified basically because we lost approximately 1 billion of revenue from the US. There was a big growth of 9 per cent.” Latin America, particularly Brazil, was among the markets that recorded growth.
“But then parallelly, we have a double digit growth in certain Latin American market, in particular Brazil, I would say. We have grown by 17 to 21 per cent in all of Latin America. And particularly Brazil, if you talk, about 21 per cent growth, was registered.”
Europe remains another significant part of the export portfolio.
“And in parallel to Brazil, then Europe still stands tall as a partner. Approximately more than $6 billion of pharmaceuticals to Europe, and which is growing again with a rate of 14 per cent to 15 per cent.” Joshi adds.
He also points to the recovery of some African markets that had lost momentum. “Plus, certain African markets, which we lost to this issue of cough syrup, the trust was lost. I think we have regained all those markets and we see now a double digit growth in same continent where we were losing earlier.”
For Amit Patni, Co-founder and Chairman of Nirvana Venture Advisors and Founder of Raay Investments, whose company is building its international business, the approach is centred on markets where the route to entry and portfolio fit make sense rather than simply pursuing the largest markets. “In the international business as strategy, We aren’t chasing the biggest markets rather focusing on the emerging markets or some of them call it as ROW markets. Here we chase the ones where the registration pathway is fastest and where our therapeutic categories fill a real gap.”
His approach takes into account regulatory predictability, the quality of distribution partners, therapeutic gaps, currency and payment stability, and the structure of institutional purchasing. The broader strategy is to avoid replacing one concentration with another.
“As our growth strategy, We build a portfolio of markets the same way we build a therapeutic portfolio — so no single regulatory regime or currency bloc or trade barrier can take out our revenue base.”
But a portfolio of markets alone does not create a viable international business. Companies still need to convert that geographical spread into businesses that can sustain themselves.
From approval to business
For companies entering new markets, securing regulatory approval is only the beginning. Kharwar points to instances where companies have spent years registering products without achieving the sales they had expected.
“There are some examples where companies have spent, 24 to 36 months and even more on registrations, spend a lot of money trying to get their long list of portfolio products thinking these are niche therapies or mass therapies. But then there is absolutely actually no sales happening to the quantum of which there was expectation of.”
The issue, he argues, is treating market entry primarily as a regulatory exercise. Once approvals are secured, companies still need to decide who will lead the operation, how products will be priced, how much working capital is required and how the business will manage local credit cycles and tender dependence.
“The real solution lies in the capital allocation and the entire business planning post the registration and the approval of these products.” Kharwar estimates that the regulatory and quality component represents a smaller share of the overall commercial planning.
“So my thumb rule is that the regulatory part and the quality part is just about 20 per cent of your cost of that business planning. But 80 per cent would be actually sales, marketing, distribution and a credit cycle capital allocation.”
For younger companies, there is an additional hurdle: establishing trust before there is a track record. Patni highlights that, “For a young company, the barriers are less about product and business offerings but more about trust and infrastructure. Everyone wants to avoid to be a first customer.”
Patni’s approach is to build credibility through experienced international business development leadership and face-to-face engagement at trade shows, while positioning the company as ‘R&D-led, partner-executed’ rather than overstating the infrastructure it owns.
The financial equation also affects the pace of expansion. Registration fees, dossier licensing, samples and other market-entry costs begin accumulating before revenue starts flowing, while distributor payment cycles can extend for months. For a young company, that makes the choice of market and partner as important as the choice of product.
This also changes the role of partnerships. Joshi argues that geopolitical uncertainty makes operating in isolation less practical. “It’s the time of collaboration. And we need to know our capabilities, our differentiators and our benefits for the customer or a consumer.”
For Kharwar, that collaboration can extend beyond conventional distribution into local manufacturing, business set-ups and government-togovernment projects.
“The key should be that we should be the first preferred choice partner for any local manufacturing, any business setup, any innovation, as compared to anyone else.”
Jain predicts this shift in the Global South. Rather than reproducing the traditional model of manufacturing in India and selling through distributors, he argues that companies will increasingly need to work with local partners across functions.
“I think that we should be looking at this next business model is how we can partner on the technology side, how we can partner on the formulation development, regulatory capability, manufacturing, local partnership and overall, what we should be looking at is a long-term healthcare platform.”
The emerging model is therefore more complex than simply registering products in more countries. It involves choosing where to invest directly, where to work with partners and where Indian manufacturing and capabilities can be combined with local infrastructure.
The road to $120 billion
Five years from now, the measure of India’s global pharma footprint may not be how many markets it serves, but what it contributes to each of them.
The IPA has set a target of a $120 billion industry by 2030. Reaching it will require both continued generic volumes and greater participation in highervalue products and capabilities. Joshi sees both elements as necessary, with the next phase requiring a combination of volume and value.
While generic exports will continue to drive volumes, higher-value segments could provide the next source of growth. Kharwar sees particular potential in large molecules. “The number is not aspirational. It’s doable. And I would like to put it a little bit more granularly that I would say that the opportunity lies in the large molecules.” He states it confidently.
For Jatkar, the change is also about the role India plays in global healthcare. “Our aim is also to move from being a major supplier to being a trusted global partner, delivering quality and affordable medicines, someone who is driving innovation and keeping patient welfare at the centre.”
Overall, she distils the ambition into a simple operating principle: “These companies will have to understand locally and they will have to execute consistently. So think globally, understand locally and execute consistently.”
For an in-depth discussion on the future of Indian pharma exports and the strategic priorities shaping global market diversification, the full episode of the Pharma Frontiers podcast will be released shortly.
neha.aathavale@expressindia.com
nehaaathavale75@gmail.com