Generic Manufacturer Profitability: Business Models and Sustainability

Generic drugs make up 90% of all prescriptions filled in the U.S., but they only cost 10% of what brand-name drugs do. That sounds like a win for patients - and it is. But behind those low prices is a broken system. Many generic drug manufacturers are losing money. Some are barely breaking even. Others are shutting down production entirely. And when that happens, essential medicines disappear from shelves. This isn’t just a business problem. It’s a public health crisis.

The Price Collapse That No One Saw Coming

Ten years ago, a simple generic pill like amoxicillin might have sold for $0.50 per unit. Today, it’s $0.03. That’s not inflation. That’s a race to the bottom. When a brand-name drug loses its patent, dozens of manufacturers jump in. They all make the same thing. The only way to win is to undercut everyone else. And that’s exactly what they do.

The result? Gross margins have collapsed from 50-60% in the early 2000s to under 30% today. For some products, they’re below 10%. Teva, once the world’s largest generic drugmaker, posted a -4.6% profit margin in 2025. That’s a $174 million loss on $3.8 billion in sales. Meanwhile, Mylan - now part of Viatris - managed a modest 4.3% margin. Why the difference? It’s not luck. It’s strategy.

Three Paths to Survival

Generic manufacturers today aren’t all the same. They’re splitting into three distinct groups - and only two of them have a future.

The first group still plays the old game: making simple, off-patent pills like metformin or lisinopril. Thousands of companies do this. The market is flooded. Profit margins are razor-thin. And every time a new player enters, prices drop again. This model is dying. In fact, the U.S. generic drug market shrank by 6.1% over five years through 2025. Companies that stick with this are just waiting to be bought - or shut down.

The second group is moving into complex generics. These aren’t your everyday pills. They’re drugs that are hard to copy. Think inhalers with precise dosing, injectables with unstable ingredients, or combination pills with multiple active drugs. The FDA requires more testing. Fewer companies can make them. That means less competition - and higher prices. Lenalidomide, a cancer drug made as a generic by Teva, now sells for 10 times the price of a basic antibiotic. Why? Because only five companies can produce it reliably. That’s the new game.

The third group? They don’t make drugs at all. They make them for others. These are contract manufacturing organizations (CMOs). Companies like Egis Pharmaceuticals launched their own CMO arms in 2023. They take raw ingredients and turn them into finished products for brand-name companies or other generics makers. This segment is growing at nearly 10% a year - from $51.96 billion in 2024 to $90.95 billion by 2030. Why? Because even big pharma companies don’t want to run their own factories anymore. Too expensive. Too risky. So they outsource.

Why It’s Harder Than Ever to Start Up

You might think, “If the market is so big, why aren’t more companies jumping in?” Because the barriers are brutal.

Getting FDA approval for a single generic drug costs about $2.6 million. That’s just the application fee. Then you need a manufacturing facility that meets current Good Manufacturing Practices (cGMP). Building one? At least $100 million. And that’s before you even start making pills. You need chemists, engineers, quality control teams, supply chain experts. And you need to prove you can do it consistently - month after month, year after year.

Most new entrants fail. McKinsey found that over 65% of companies focusing only on simple generics don’t survive past two years. Why? They run out of cash before they get their first formulary placement. Hospitals and pharmacies won’t buy from a new supplier unless they’re sure the product won’t fail. And no one wants to be the first to test an unknown maker.

The Hidden Costs of Cheap Drugs

The savings from generic drugs are massive. In 2022 alone, they saved the U.S. healthcare system $408 billion. But those savings don’t go to the manufacturers. They go to insurers, PBMs (pharmacy benefit managers), and patients. Meanwhile, manufacturers are left with shrinking revenues and rising costs.

Raw materials - like active pharmaceutical ingredients (APIs) - are often sourced from India or China. Prices swing wildly. A single shipment delay can shut down production. And when a drug goes on shortage - like insulin or chemotherapy agents - it’s often because no one can make it profitably anymore.

Harvard’s Dr. Aaron Kesselheim put it bluntly: “The relentless price competition in generics has created a market failure where essential medicines face shortages because manufacturers cannot profitably produce them.”

Who’s Winning - and How

Teva didn’t survive by making more amoxicillin. They pivoted. In 2024, they spent $998 million on R&D - up 5% - to develop complex generics and biosimilars. Their revenue grew 4% to $16.5 billion. Their profit came from drugs like Austedo XR, a treatment for movement disorders that only three companies can produce.

Viatris took a different path. After merging Mylan and Upjohn in 2020, they sold off their biosimilars unit, their OTC business, and their API division. Why? To focus on what they do best: distributing established generics at scale. They cut costs, streamlined operations, and focused on markets where pricing is less brutal - like parts of Europe and Latin America. In 2024, they grew revenue by 2% - not because they sold more pills, but because they stopped losing money on the wrong ones.

And then there’s the contract manufacturing boom. Companies like Catalent, Lonza, and now Egis Pharma Services are stepping in to fill the gap. They don’t need to own the brand. They just need to make the product. And they get paid regardless of who sells it.

The Global Picture

The U.S. market is the most competitive - and the most broken. But elsewhere, things look different.

In Europe, governments set prices based on value, not just cost. That means manufacturers can charge more for complex generics. In India and China, low labor costs and strong domestic demand make it easier to stay profitable. Emerging markets like Brazil and Indonesia are seeing double-digit growth in generic use - but they come with risks: currency swings, regulatory delays, and corruption.

The global generic market is projected to hit $600 billion by 2033. But that growth won’t come from the U.S. It’ll come from complex drugs, biosimilars, and contract manufacturing - especially in Asia and Latin America.

What’s Next?

The next five years will decide which generic manufacturers survive - and which become footnotes.

If you’re still making simple pills, you’re on borrowed time. The market is saturated. Margins are gone. The only way out is to sell - or pivot.

If you’re building complex generics, you’re in the right place. But you need deep technical expertise, strong regulatory teams, and a willingness to invest in R&D. You can’t compete on price. You compete on skill.

If you’re a contract manufacturer, you’re in the sweet spot. Demand is rising. Barriers to entry are lower. And you don’t have to worry about who owns the brand. Just make it right - and get paid.

The truth is, generic drugs aren’t going away. They’re too important. But the business model that made them cheap is dead. The new model isn’t about making more pills. It’s about making better ones - and making them for people who can’t make them themselves.

The patients still need their medicines. The question is: who will be left to make them?