Patent expiry to unlock USD 3-5 billion opportunity for India: CareEdge
New Delhi, June 19
India's pharmaceutical industry is poised to gain significantly from an upcoming wave of patent expiries, with CareEdge Ratings estimating a USD 3-5 billion opportunity for Indian drugmakers over the next five years.
According to a report released by CareEdge Ratings, patents on drugs generating nearly USD 142 billion in annual sales in calendar year 2025 are expected to expire between 2026 and 2030, paving the way for generic and biosimilar manufacturers to enter the market.
The report noted that after accounting for steep price erosion following the loss of exclusivity, the global opportunity could exceed USD 30-40 billion over five years, of which Indian companies are expected to capture around USD 3-5 billion.
"Drugs generating nearly USD 142 billion in annual sales in CY25 are expected to lose exclusivity by 2030. After accounting for significant price erosion, this is expected to create a market opportunity exceeding USD 30-40 billion over five years, of which, Indian companies are expected to capture nearly USD 3-5 billion," the report stated.
CareEdge said India is well-positioned to benefit from the patent cliff due to its favourable patent framework, strong generic drug manufacturing base, growing biosimilar capabilities, and cost-efficient production ecosystem.
The report highlighted that more than 60 per cent of the drugs losing exclusivity during the period are large-molecule biologics, marking a structural shift from previous patent cycles that were largely dominated by small-molecule medicines.
Commenting on the outlook, Samyuktha R, Assistant Director at CareEdge Ratings, 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 further said India's proven strength in generics, expanding biosimilar capabilities and ability to scale rapidly provide a structural advantage as the next phase of the patent cliff unfolds.
The report also pointed to changing competitive dynamics in the pharmaceutical sector, noting that speed of execution will become increasingly important.
"As the next phase of the patent cliff unfolds, a significant proportion of drugs losing exclusivity are in chronic therapy areas, where patients require continuous treatment over extended periods. In such categories, speed to market becomes critical," the report said.
According to the report, early entrants in chronic therapy segments are likely to gain a durable competitive advantage as prescribing habits and patient preferences become established early in the treatment cycle.
Pritesh Rathi, Associate Director at CareEdge Ratings, said the current patent cliff differs from earlier cycles because it is increasingly focused on biologics rather than conventional small-molecule drugs.
"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," Rathi said.
He added that India's legal framework, which limits practices such as patent evergreening, along with its strong manufacturing and regulatory capabilities, could help domestic generic and biosimilar companies capitalise on the emerging opportunity.
The report also noted that innovator companies are expected to deploy various lifecycle-management and patent-protection strategies, including secondary patents, strategic partnerships, pricing measures and litigation, to delay generic competition, making regulatory and legal expertise critical for market entrants.
— ANI
Reader Comments
Interesting analysis from CareEdge. As someone working in global pharma compliance, I can tell you that Indian companies have seriously stepped up their game in the last decade. The biosimilar space is particularly promising - it's not easy to replicate complex biologics.
Let's not get too carried away. Yes, it's good news, but Indian companies have been saying this for years. Actually capturing that $3-5 billion requires strong regulatory compliance, patent litigation skills, and distribution networks. Not all our companies have that yet. Hope we don't miss the bus again.
Good timing for India. The biologics focus is key - that's where the future is. Our companies like Biocon and Dr. Reddy's have been preparing for this. But speed to market is everything in chronic therapies. First movers will dominate.
This is excellent news for Indian patients too! When generics come in, prices drop dramatically. My mother's diabetes medication went from ₹2000 to ₹200 after the patent expired. Hopefully, these biosimilars will make treatments for cancer and autoimmune diseases affordable for common people.
The report's point about patent evergreening is crucial. India's strong legal framework against it gives our companies an edge. However, innovator companies will fight tooth and nail with secondary patents. Indian firms need deep pockets for litigation - that's where the real battle will be.
We welcome thoughtful discussions from our readers. Please keep comments respectful and on-topic.