Indian pharmaceutical companies are poised to benefit from a major global patent expiry cycle, with drugs generating nearly $142 billion in sales in CY25 set to lose exclusivity between 2026 and 2030, according to a report by CareEdge Ratings.
The report estimates that the upcoming patent cliff could create a market opportunity of over $30-40 billion globally over the next five years after accounting for price erosion. Indian drugmakers are expected to capture $3-5 billion of this opportunity, aided by the country’s favourable patent framework and established strengths in cost-efficient generic manufacturing.
Patent expiries open new growth avenue
Patents in the pharmaceutical industry grant innovators exclusive rights to market a drug, typically for up to 20 years from the filing date. Once patent protection expires, a process known as the loss of exclusivity (LOE), other manufacturers can introduce generic or biosimilar versions of the drug.
CareEdge Ratings noted that the upcoming patent cliff represents one of the largest opportunities for generic and biosimilar manufacturers in recent years, particularly as healthcare systems globally seek more affordable treatment options.
Shift towards biologics reshapes competition
A key trend highlighted in the report is the increasing dominance of large-molecule biologic drugs among products losing exclusivity.
More than 60% of the drugs expected to lose patent protection by 2030 are biologics, marking a structural shift from earlier patent cycles that were largely dominated by small-molecule medicines.
While generic versions of small-molecule drugs can be developed relatively quickly and at lower costs, biosimilars require significantly higher investments, extensive clinical testing, complex manufacturing processes and stringent regulatory approvals.
As a result, biosimilar launches often face delays even after patent expiry, creating both challenges and opportunities for pharmaceutical companies.
Speed-to-market becoming critical
The report also pointed to a growing concentration of patent expiries in chronic therapy segments, where patients remain on treatment for extended periods.
In these categories, first-mover advantage is becoming increasingly important. Companies that launch products early are more likely to establish prescribing habits among physicians and secure long-term patient loyalty, making execution speed a critical competitive differentiator.
According to CareEdge Ratings, speed-to-market is emerging as a more decisive factor than pure cost competitiveness in several therapeutic areas.
Innovators deploy strategies to delay competition
The report noted that innovator companies frequently employ lifecycle-management strategies to extend the commercial life of blockbuster drugs beyond their primary patent period.
These include filing secondary patents on formulations and new therapeutic uses, creating patent thickets, entering strategic partnerships with generic manufacturers, implementing pricing strategies, migrating patients to newer patented products and launching combination therapies.
Such measures can significantly delay generic and biosimilar competition. The report cited the example of Humira, whose primary patent expired in 2016, while biosimilar competition entered the market only in 2023 following multiple patent-protection strategies.
India positioned to benefit
CareEdge Ratings said India’s patent regime offers structural advantages by limiting practices such as evergreening and enabling faster generic entry compared with several developed markets.
Combined with strong manufacturing capabilities, growing biosimilar expertise and regulatory experience, Indian companies are well positioned to capitalise on the upcoming wave of patent expiries.
CareEdge Ratings Assistant Director Samyuktha R said, “The global pharmaceutical industry is approaching a significant inflection point as a large number of blockbuster drugs with sales of more than USD 142 billion near patent expiry during FY26-FY30. Factoring in deep price erosion following loss of exclusivity, this is expected to translate into a market opportunity of more than USD 3-5 billion for Indian companies.”
She added that India’s strengths in generics, expanding biosimilar capabilities and ability to scale rapidly provide a strong structural advantage, although success will increasingly depend on execution speed, regulatory sophistication and strategic product selection.
CareEdge Ratings Associate Director Pritesh Rathi said, “Unlike previous patent cliffs that were largely driven by small-molecule drugs, this cycle is increasingly focused on large-molecule biologics, which are inherently more complex to develop, manufacture, and replicate.”
He noted that India’s legal framework, manufacturing strength and regulatory capabilities provide important support for domestic generic and biosimilar companies as they navigate patent-protection strategies employed by innovator firms.
M&A activity expected to rise
The report further observed that the upcoming patent cliff is likely to accelerate mergers and acquisitions activity across the pharmaceutical sector as companies seek to strengthen product pipelines, expand capabilities and secure a larger share of the emerging opportunity.
With blockbuster drugs worth billions of dollars approaching patent expiry, the next five years are expected to be a defining period for Indian pharmaceutical companies seeking to deepen their presence in global generic and biosimilar markets.