Great reinvention of generics industry for smarter future

AT CPHI Frankfurt 2025, as 66,000 delegates filled the halls and 260 speakers dissected the future of pharma, one statistic cut through the noise like a thunderclap: 118 biologics will lose patent protection by 2034, unlocking a $234 billion opportunity.

- Sanobar Syed

Yet, as of now, only a dozen has biosimilars in active development. That gap — between what's coming and who's ready — may be the most valuable whitespace in modern pharmaceuticals. And it tells the story of an industry standing at its most dramatic inflection point since the Hatch-Waxman Act of 1984.

Act I: The end of easy money

“Change is the law of life. And those who look only to the past or present are certain to miss the future.” — John F. Kennedy

For decades, generics were the industry's dependable cash machine — scale up, compete on price, ride the erosion curve, repeat. But by 2035, the rules will be unrecognizable.

Plain, commoditized trade generics — once the heart of the business — are becoming an economic dead end. Margins in the US and EU are collapsing toward 30 per cent variable cost, 20 per cent gross contribution, and single-digit EBITDA. Only the leanest, most frugal operators will survive, mostly “no-frills” players from India and China.

For everyone else, the game has shifted from volume to value. As one senior executive quipped in Frankfurt, “We've trimmed the tail, now we need to grow a spine.”

Act II: The biosimilar gold rush

“In the middle of difficulty lies opportunity.” — Albert Einstein

If you want to see where the next fortune lies, follow the biologics. Between 2025 and 2035, the global biosimilars market will more than double — from $35 billion to $72 billion. Recent launches routinely capture 60–80 per cent market share within three years.

When Keytruda, the world's most lucrative cancer drug, loses European exclusivity in 2031, the first biosimilar to hit the market could be worth tens of billions. But here's the rub: despite the vast opportunity, development pipelines remain shockingly thin. Only 12 biosimilars are currently in motion for that pool of 118 expiring biologics.