Over the next two years, 85 major biologics are set to lose patent exclusivity. The global biosimilar market grew from 12.5 billion dollars in 2019 to over 30 billion dollars by 2024, and Precedence Research projects it will reach nearly 200 billion dollars by 2035, with almost all of the current wave of patent expiries concentrated between 2025 and 2028.
Mordor Intelligence puts the unlock even higher, estimating over 400 billion dollars in reference-product sales will lose exclusivity between 2029 and 2034. Sun Pharma’s proposed acquisition of Organon and Amneal Pharmaceuticals’ move on Kashiv BioSciences mark the start of a decade-long restructuring of global pharmaceutical power. Running alongside the M&A activity is a quieter, harder race: the contest for leadership talent capable of executing the biosimilar opportunity at scale. Demand has already outrun supply.
Why This Cycle Is Different
The patent cliffs of the early 2000s belonged to small molecules. Generics entered quickly, and the commercial playbook was familiar. Biosimilars are a different game. A biosimilar must demonstrate analytical, clinical, and functional similarity to the originator product, which means mammalian cell culture at scale, exhaustive comparability studies, and technology transfer across regulated facilities. In the US, approval runs through the 351(k) pathway under the Biologics Price Competition and Innovation Act.
Regulatory maturity differs sharply by region, and the talent market has followed suit. The EU approved its first biosimilar in 2006, two years after building the pathway. The US passed the BPCIA in 2009 but didn’t see its first approval until 2015. Asia-Pacific is now growing fastest, with CAGR estimates between roughly 23 and 29% through 2031-2035, though its regulatory frameworks are still catching up to EMA and FDA standards.
Most pharmaceutical companies have simply never had to recruit for this kind of expertise before. Boards want one executive who carries scientific credibility, financial discipline, and regulatory judgment all at once. That combination is rare.
The Talent Problem
In practice, the biosimilar leadership profile is three jobs compressed into one. The first is scientific-operational depth: real, lived experience with large-scale mammalian cell culture, yield optimisation, and technology transfer, not just familiarity with the concepts. The second is regulatory sophistication beyond filing requirements: managing Warning Letters, resolving compliance crises, and holding multi-site quality systems together across FDA, EMA, and WHO GMP standards. The third is commercial and strategic acumen: reading payer environments, shaping market access strategy, and sequencing launches across the US, Europe, and emerging markets.
Each of these skill sets is scarce on its own. Together, they narrow the field considerably. Executive search professionals keep encountering the same handful of names across competing mandates. When a major Indian biosimilar player opens a COO search for someone who can run multi-billion-dollar global manufacturing, hold regulatory credibility across three jurisdictions, and lead capacity expansion at once, there usually isn’t a wide field to choose from. Often, there isn’t one at all.
A BIO industry survey found that 80% of biopharma firms struggle to fill critical roles in research, manufacturing, and regulatory affairs. The gap is sharpest in the three-to-eight-year experience band, the group that will form tomorrow’s C-suite. India has strong scientific talent at entry level, but the pipeline thins fast as seniority rises.
The India Dimension
India’s biosimilar ambitions have never been more concrete. The domestic market, valued at roughly one billion dollars, is projected to grow more than 16% annually through 2034, and the country already has over 135 approved biosimilars. The government’s Biopharma SHAKTI initiative, announced in the Union Budget 2026-27 with an outlay of 10,000 crore rupees, signals real commitment to building end-to-end biologics capability, from research through manufacturing.
But policy commitment and talent supply are not the same thing. The 2025-2026 window is especially active as several Indian biosimilar companies target US launches, making senior commercial and C-suite hires mission-critical. Regulatory affairs VPs with FDA compliance-crisis experience, Chief Scientific Officers who have scaled cell culture platforms for global launch, and commercial leaders who understand payer trust and formulary placement in the US are all in short supply. Many of these people sit in the Boston-Cambridge biotech corridor or in established European biosimilar operations, which makes relocation an additional barrier on top of scarcity.
What Boards Need to Do Differently
Companies that navigate this well share a few habits. They define the mandate precisely before opening a search, rather than starting with a title and a list of responsibilities. A COO hired to build manufacturing resilience for a US launch needs a different profile than one hired to lead expansion into a new modality, and getting that distinction wrong costs at least a year. They also start succession planning earlier, since these searches need far more runway than a conventional pharma hire, and waiting for a resignation or a gap to appear means starting behind.
The most agile hirers look beyond the obvious universe: CDMO operations, oncology devices, and market access functions within innovator companies, for leaders whose skills transfer even without a biosimilar title. CDMOs are on track to control more than 54% of global biologics manufacturing capacity by 2028, which means a growing share of tomorrow’s biosimilar leaders will have trained outside biosimilar companies altogether.
The patent cliff is a structural opportunity the pharmaceutical industry hasn’t seen before. Who captures it won’t come down to pipelines or M&A capital alone, but to whether companies can build the leadership infrastructure to execute at this scale, infrastructure that takes longer to build than any manufacturing facility.
This aticle is authored by By Sonal Bahl, Partner, Positive Moves.
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