Patent cliff to drive next phase of growth for Indian pharma industry
The global pharmaceutical industry is entering a decisive phase, with an estimated $200+ billion worth of blockbuster drugs expected to lose exclusivity between 2026 and 2032. While semaglutide has drawn immediate attention, it is only one part of a much larger structural shift that spans oncology, cardiovascular disease, immunology, and specialty biologics.
For Indian pharmaceutical companies, this is not a cyclical opportunity. It is a strategic inflection point. India’s strength has traditionally been anchored in its ability to deliver high quality, affordable generics at scale. Over the past two decades, this capability has evolved significantly. Today, Indian companies are not only volume-driven manufacturers but increasingly complex product developers with growing expertise in injectables, biosimilars, and regulated market compliance.
The upcoming patent expiries of molecules such as pembrolizumab, apixaban, nivolumab, and daratumumab signal a clear shift towards high-value, specialty-led opportunities. Unlike traditional small-molecule generics, these segments demand deeper scientific capability, robust clinical understanding, and strong regulatory execution. Companies that can invest ahead of the curve in these areas will be best positioned to capture disproportionate value.
Equally important is the export opportunity. As healthcare systems globally face cost pressures, the role of Indian pharma in expanding access to affordable therapies will become even more critical. India already supplies a significant share of the world’s generics, and the next phase of growth will be defined by its ability to move up the value chain into complex and specialty products.
At the same time, the domestic market presents a parallel opportunity. As seen with semaglutide, patent expiry can unlock access in therapy areas where affordability has historically limited adoption. This is particularly relevant in chronic diseases such as diabetes, cardiovascular disorders, and cancer, where treatment gaps remain substantial. However, realising this opportunity will require a balanced approach. Scale must be matched with quality. Speed must be aligned with compliance. And commercial ambition must remain grounded in patient-centricity.
As highlighted earlier, affordability, accessibility, and availability remain the three defining levers of impact in India’s healthcare journey . The patent cliff will test how effectively the industry can operationalise these principles across both domestic and global markets. The opportunity is significant, but it will favour those who are prepared.
US patent cliff (2026–2032) likely to disrupt pharma market
The value at risk is substantial. According to GlobalData’s Pharma Intelligence Center, the cumulative sales risk from blockbuster drugs losing patent protection between 2026 and 2032 is estimated to exceed US$200 billion in the US. A total of 33 blockbuster biologics and 28 blockbuster small molecule drugs are expected to lose patent protection during this period. The opportunities arising from the expiration of blockbuster biologic drugs are projected to exceed US$137 billion, while those from small molecule blockbuster drugs are expected to surpass US$63 billion.
Some of the leading biologics set to expire include Dupixent, Keytruda, Wegovy, and Opdivo. Similarly, notable small molecule drugs include Kisqali, Jakafi, Erleada, and Eliquis. Indian firms, such as Biocon Biologics, are developing biosimilars for Opdivo, Keytruda, Herceptin, and others. Zydus Lifesciences has secured rights for a Keytruda biosimilar with the aim of commercialising it in the US and Canada.
Major US payers and formulary systems are becoming increasingly receptive to biosimilars and generics, particularly for expensive biologics and oncology drugs, especially as drug prices and healthcare costs come under scrutiny.
The US patent cliff between 2026 and 2032 is likely to significantly disrupt the pharmaceutical market. For Indian pharmaceutical companies, this represents a generational opportunity to make substantial inroads— from generics and complex generics to biosimilars, particularly in oncology and immunology—if they can meet the necessary quality, regulatory, and commercial benchmarks. While the groundwork is being established, the speed, scale, and strategic focus will determine how much of this opportunity India can capture.
Historically, Indian companies have dominated the generics market in the US due to their strong capabilities in small molecule chemistry, process development, and cost-efficient manufacturing.
However, their presence in the biosimilars market is relatively limited, with Biocon being a major player from India in the US. The limited presence in the biosimilars space can be attributed to the need for advanced manufacturing capabilities, clinical comparability trials, and significant capital investment for the development and manufacturing of biosimilars.
Given the sales risk associated with blockbuster biologics and small molecules between 2026 and 2032, biosimilars present a greater opportunity compared to generics. Therefore, it is crucial for Indian companies to enhance their market position within the biosimilars market as well.
The upcoming patent cliff is not merely a volume opportunity it represents a strategic inflection point
The wave of patent expiries expected between 2026 and 2032 represents one of the most significant opportunities for the global generics industry. While much of the current focus is on semaglutide and the rapidly expanding GLP-1 market, a broader set of blockbuster molecules across oncology, immunology and diabetes are expected to lose exclusivity over the next few years.
Drugs such as pembrolizumab, apixaban and palbociclib are among several high value therapies approaching patent expiry. Collectively, these therapies represent billions of dollars in annual global sales, creating a large opportunity for companies that possess scientific, manufacturing and regulatory capabilities.
Indian pharmaceutical companies have built a strong reputation over the past two decades as reliable suppliers of high-quality generics to regulated markets. However, the opportunity today is more complex than in earlier patent cycles. Pricing pressure in mature markets such as the United States remains intense, with several molecules experiencing rapid price erosion following multiple generic launches. In many segments of the generics market, annual price erosion in the range of 5–10 percent (many times even significantly higher than this range) has become common due to heightened competition and buyer consolidation.
As a result, companies are increasingly shifting toward complex generics and specialty formulations, where entry barriers are higher and competition is relatively limited. These include areas such as respiratory inhalers, long-acting injectables, drug device combinations and ophthalmic products.
Biosimilars are another important growth area, particularly in therapeutic segments such as oncology, immunology and diabetes. Biosimilars of widely used biologics such as trastuzumab, bevacizumab, insulin glargine and adalimumab are expanding access to advanced therapies while also creating new growth avenues for manufacturers with strong biologics capabilities.
Strategic partnerships are also becoming an important part of the industry’s evolution. Increasingly, companies are collaborating with global biotechnology firms and research organisations to co-develop complex therapies, accelerate regulatory approvals and expand commercial reach across markets
At the same time, companies are diversifying geographically beyond traditional markets into Europe, Japan, Latin America, Southeast Asia and the Middle East, where demand for affordable specialty medicines and biosimilars are growing.
Ultimately, the upcoming patent cliff is not merely a volume opportunity it represents a strategic inflection point. Companies that combine scientific capability, regulatory strength and disciplined portfolio choices will be best positioned to capture value and strengthen India’s role as a global leader in affordable and complex medicines.
This is only the beginning of a much larger global patent-cliff cycle
As the patent expiry of semaglutide is almost there in India, several Indian pharma firms are preparing to introduce generic versions, highlighting the sector’s agility in responding to high-value loss-of-exclusivity opportunities. However, this is only the beginning of a much larger global patent-cliff cycle expected in next 5-6 years, when numerous blockbuster drugs across the therapies are set to lose exclusivity. Indian pharmaceutical companies are strongly positioned to capture a meaningful share of this opportunity due to their globally recognised generics manufacturing base, cost-efficient chemistry capabilities, and large number of USFDA-approved production facilities. Over the past decade, the industry has also steadily strengthened its R&D capabilities and regulatory expertise, enabling faster filings and quicker entry into regulated markets when patents expire.
Importantly, the next phase of the patent cliff will increasingly favour companies that can develop complex generics and specialty formulations rather than simple dosage forms. Many upcoming opportunities lie in areas such as sterile injectables, peptides, inhalation products and biosimilars, which require advanced manufacturing capabilities and strong regulatory compliance. Indian pharma companies have already begun investing heavily in these segments, building expertise in complex dosage forms and strengthening global supply chains to serve both regulated and emerging markets. As a result, the industry is transitioning from a volume-driven generics model to a more innovationled, technology-intensive generics strategy, positioning it well to benefit from the upcoming wave of global patent expiries.
India pharma poised to tap patent cliff with generics and complex drug capabilities
India’s pharmaceutical industry is well positioned to capitalise on the upcoming patent cliff through its strong generics expertise, cost-efficient manufacturing, and expanding capabilities in the manufacturing of complex formulations of small molecules and biologics. As several blockbuster therapies lose exclusivity between 2026 and 2032, Indian generics companies have a significant opportunity to play a larger role in enabling faster, more affordable global access to critical medicines.
Over the past two decades, India has built one of the world’s most sophisticated generics ecosystems, supported by a large base of US FDA-approved manufacturing facilities, deep regulatory experience, and strong chemistry and process development expertise. This foundation allows Indian pharmaceutical companies to rapidly develop high-quality generic versions of small-molecule drugs once patents expire, helping healthcare systems manage costs while expanding patient access.
At the same time, the nature of drugs approaching the patent cliff is evolving. Many upcoming opportunities involve complex formulations, highly potent APIs, peptide-based therapies, and biologics rather than traditional small molecules. Indian pharmaceutical companies have increasingly invested in advanced manufacturing technologies, high-potency containment, and specialised development capabilities to support these more sophisticated therapies. These investments are positioning the industry to move beyond traditional generics and participate in higher-value segments of the market.
Contract development and manufacturing organisations (CDMOs) will also play a critical role in this landscape. As innovator and emerging biotech companies seek to bring follow-on products and alternative formulations to market quickly and efficiently, experienced partners with global regulatory track records become essential.
By combining manufacturing scale with growing innovation and technical expertise, well-established Indian CDMOs such as Piramal Pharma Solutions can support partners across the development and commercialisation lifecycle. From complex API development and advanced drug product manufacturing to specialised capabilities such as antibodydrug conjugates and high-potency compounds, these partnerships can help accelerate the delivery of high-quality, affordable medicines to patients worldwide.
Future opportunities in biologics and biosimilars will demand significant investment
Semaglutide’s patent expiry in India in March 2026 has become the immediate trigger for the next wave of pharmaceutical development activity, but the larger opportunity goes well beyond semaglutide itself. Semaglutide is the molecule behind Ozempic and Wegovy, and its loss of exclusivity in markets like India is only the beginning of a broader patent-cliff cycle that will unfold across small molecules, peptides, complex injectables, device-led products and, later, biologics.
India is well positioned to benefit from this cycle because of its strong manufacturing base, cost competitiveness and long experience with regulatory filings in the US, EU and ROW markets. However, the opportunity today is very different from the traditional generics cycle. Many of the upcoming products involve complex delivery systems, peptides, advanced injectables or biologics, which require deeper scientific capabilities and significantly higher investment in development and analytical infrastructure. In conventional small molecules, companies with strong formulation capability, filing experience and cost discipline can move quickly. For example, molecules such as Eliquis (apixaban) and Entresto represent important future opportunities, although timelines and market entry strategies can vary due to litigation, exclusivity provisions and regulatory pathways.
The next layer of opportunity lies in more complex therapies. Products such as semaglutide require peptide chemistry expertise, formulation stability work, device strategy and strong regulatory planning. Similarly, future opportunities in biologics and biosimilars will demand significant investment in analytical characterisation, process development and manufacturing infrastructure.
At HAB Pharmaceuticals, we see this patent-cliff cycle as a long-term capability-building opportunity rather than a short-term launch cycle. We are currently setting up a new R&D centre in Vasai specifically focused on developing future off-patent molecules for India, ROW and regulated markets including Europe. Our development programs will focus on oral solids, complex injectables, peptides and device-led combination products, while we are also building early capabilities in monoclonal antibody development for the future.
At the same time, some caution is necessary. Every high-value molecule that goes off patent tends to attract a large number of entrants very quickly, which can lead to intense competition and margin compression. Therefore, the companies that ultimately succeed in this next phase will be those that combine cost competitiveness with the ability to develop complex products and maintain high regulatory standards over the long term.