Biotechnology in pharma worldwide statistics and facts

Biotechnology in pharma worldwide

For most of the twentieth century, medicines were chemistry. Drugs were small molecules, mixed and synthesised in factories, cheap to copy once patents expired. That world still exists, but it is no longer where the money and the science are. The centre of gravity in pharma has shifted to biotechnology: medicines made from living cells rather than chemical reactions. These biologics, from antibodies to gene therapies, are now the most valuable, fastest-growing and most talked-about part of the drug industry.

The scale of the shift is easy to miss because it happened drug by drug. Yet by 2025 the single best-selling medicine brand in the world was a biologic, biologics made up around 42 percent of all drug spending, and the market for these products had grown into the hundreds of billions of dollars. Biotechnology did not just enter pharma, it took over its commercial peak.

This report brings the key statistics together: how big the biologics market is, which drugs and companies lead, how biosimilars are reshaping prices, and where the next wave, cell and gene therapy and mRNA, is heading. A note on the data before we start. Drug sales are 2025 full-year figures reported by companies. Market-size and share numbers come from industry trackers such as IQVIA and from company filings; where firm estimates differ they are given as ranges rather than as single precise figures.

How big is the biologics market?

Start with the whole. The global medicines market was worth about 1.8 trillion US dollars in 2025. Biologics accounted for roughly 42 percent of that spending, on the order of 750 billion dollars, up from just 34 percent in 2021, according to industry tracker IQVIA. Narrower definitions of the biopharmaceutical market, which count a tighter set of product categories, land closer to 450 to 500 billion dollars. Whichever measure you use, the direction is the same: biologics are taking an ever larger slice of a huge and growing market.

The single clearest way to see the takeover is as a share of the whole market. The chart splits the 2025 global medicines market into biologics and everything else.

Nearly half and rising: biologics have climbed from 34 percent of the market in 2021 to about 42 percent in 2025.

What makes that share climb relentlessly is the growth gap. Biologics are expanding at roughly 14 percent a year, while the rest of pharma grows at only about 5 percent. A segment that grows nearly three times faster than the market around it will keep taking share year after year, and that is exactly what has happened. The reason is that biologics sit precisely where medicine is heading: complex, chronic and hard-to-treat diseases such as cancer, autoimmune conditions and rare genetic disorders, where targeted biological drugs work when older chemistry does not.

How biologics conquered the top of pharma

The best-seller list tells the same story. In 2025 the top-selling drug brand in the world was Keytruda, a monoclonal antibody and a classic biologic, and the antibodies Dupixent, Skyrizi and Darzalex all ranked inside the global top seven. The other names near the top, the GLP-1 blockbusters Mounjaro, Ozempic and Zepbound, are themselves biotechnology products, peptides produced with the same recombinant methods rather than old-style chemistry. By almost any reading, biotech now owns the commanding heights of the drug market.

Biotech tops the whole market: the number-one drug is a biologic, and biotech-made products fill most of the top ten.

Put together, the leading biologics of 2025, led by Keytruda and including Dupixent, Skyrizi, Darzalex, Opdivo, Eylea and the fading Humira, generated well over 100 billion US dollars in sales in a single year, with the top four alone worth more than 80 billion. No group of chemically synthesised drugs comes close to that concentration of value. Biologics are not a niche within pharma; they are its commercial summit, and the gap over traditional drugs keeps widening as new antibodies and cell therapies reach the market.

The difference between the two kinds of medicine is worth spelling out. A small-molecule drug is a simple chemical, often small enough to be swallowed as a pill and easy to copy exactly once its patent lapses. A biologic is a large, complex protein grown inside living cells, delivered by injection or infusion, and almost impossible to reproduce perfectly. That complexity is precisely why biologics command such high prices and hold their sales for so long: a rival cannot simply mix an identical copy, and even biosimilar versions take years and hundreds of millions of dollars to develop and approve. The economics of the two worlds could hardly be more different, and it is the biologic economics that now set the pace for the whole industry.

The pipeline tells the same story as the sales charts. A large and growing share of the drugs in late-stage development, and of the new medicines approved each year by regulators, are biologics rather than small molecules. Oncology and immunology, the two therapy areas where biologics are strongest, dominate research budgets. For the major drugmakers, the strategic question is no longer whether to invest in biotechnology but how quickly they can build or buy their way deeper into it.

The best-selling biologic drugs

One drug towers over the rest. The chart ranks the leading biologic medicines by their 2025 global sales.

Keytruda leads by a wide margin: at about 31.7 billion dollars it out-sold the next biologic, Dupixent, by well over one and a half to one.

Keytruda, from Merck, made about 31.7 billion US dollars in 2025, up around 7 percent on the year, and now accounts for roughly half of Merck total revenue on its own. It works across more than 40 approved uses in many cancer types, which is why it dwarfs the field. Dupixent, an immunology drug co-marketed by Sanofi and Regeneron, was second at about 18.1 billion, followed by AbbVie fast-rising Skyrizi at 17.6 billion after a 50 percent jump, and the Johnson and Johnson cancer drug Darzalex at 14.4 billion. Opdivo, Eylea and the once-dominant Humira, now shrinking under biosimilar pressure, round out the group. It is a striking picture: a handful of antibodies, each worth as much as a mid-sized company, carrying the profits of the entire drug industry.

The companies behind the biologics

Behind these drugs sits a small group of companies that have bet their futures on biotechnology. Merck rides on Keytruda, which alone is equal to roughly half of the entire firm revenue, an unusually heavy dependence on a single product just as its 2028 patent cliff approaches. AbbVie offers the clearest case study in managing the biologic life cycle: as Humira collapsed under biosimilar pressure, shedding another 4.5 billion dollars in 2025, the company leaned on the newer immunology drugs Skyrizi, up nearly 50 percent, and Rinvoq, which grew almost 39 percent to 8.3 billion, and together they have more than replaced what Humira lost.

Managing the cliff: as Humira sinks, Skyrizi and Rinvoq climb fast enough to carry AbbVie through its patent cliff.

Johnson and Johnson runs a multi-biologic engine in Darzalex and the rising Tremfya, even as biosimilars gut its former top seller Stelara. Sanofi and Regeneron share the profits of Dupixent under a partnership that has turned a single antibody into an 18 billion dollar product treating more than a million patients. Older biologics leaders such as Roche, long the biggest maker of antibody drugs through franchises like Herceptin, Avastin and Rituxan, and Amgen, a pioneer of the whole field, are now defending mature products against biosimilars while pushing new ones. The common thread is that for every one of these firms, the biologic portfolio is the part of the business that decides whether the company grows or shrinks.

Monoclonal antibodies, the workhorse of biotech

Almost every drug on that list belongs to one family: monoclonal antibodies. These are lab-made proteins engineered to lock onto a single target, such as a protein on a cancer cell or a signal that drives inflammation. They are the largest single class of biologic drugs, making up the biggest share of biologic sales, and their reach keeps expanding into oncology, autoimmune disease, eye disease and beyond.

The numbers are large. Industry estimates put total monoclonal antibody sales above 200 billion dollars, with the class growing at a double-digit annual rate, faster than the drug market as a whole. Oncology alone accounts for roughly a third of the biologics market, and antibodies are the main reason why. From Keytruda and Opdivo in cancer immunotherapy to Dupixent and Skyrizi in immunology, the monoclonal antibody has become the default shape of a modern blockbuster, a reversal of the small-molecule era that dominated pharma for decades.

Part of what makes antibodies so powerful commercially is that a single molecule can be approved for many different diseases over time. Keytruda is the extreme example, with dozens of approved uses across many tumour types, each new indication adding another stream of sales to the same product. This ability to expand into new patient groups, combined with the difficulty of copying the drug, lets a successful antibody grow for a decade or more before biosimilars eventually arrive. The category is also branching out beyond simple antibodies into engineered variants such as antibody-drug conjugates, which attach a toxic payload to an antibody to deliver it straight to cancer cells, and bispecific antibodies that hit two targets at once. These newer formats are among the most active areas of research and dealmaking in the whole industry.

Biosimilars and the fall of Humira

Biologics are expensive and, for years, hard to copy. But once their patents expire, rival firms can make near-identical versions called biosimilars, and prices tumble. The most dramatic example is Humira, the AbbVie anti-inflammatory that was for years the best-selling drug in the history of pharma. The chart shows what biosimilar competition did to it.

A blockbuster undone: Humira fell from about 21.2 billion dollars in 2022 to around 4.5 billion in 2025 after biosimilars arrived.

Humira sales dropped from about 21.24 billion dollars in 2022 to 14.4 billion in 2023, 8.99 billion in 2024 and roughly 4.5 billion in 2025, a fall of nearly 80 percent in three years, after the first US biosimilars launched in January 2023. At least ten biosimilar versions now compete with it. The same story is now repeating with Johnson and Johnson Stelara, which lost its US protection at the start of 2025: eight ustekinumab biosimilars launched at discounts of up to 90 percent, and Stelara sales fell by roughly a third in the first quarter alone, with a further blow coming from a mandated 66 percent Medicare price cut from January 2026.

The contrast between regions is one of the most important facts about biosimilars. Europe moved first and moved hardest: its regulator, the European Medicines Agency, has approved more than 70 biosimilar medicines, and public health systems actively push doctors and pharmacists toward the cheaper versions, so prices fall quickly and savings are large. The European Union accounts for about 47 percent of complex biosimilar use against roughly 37 percent for the United States, which despite having a bigger market has been slower, held back by patent litigation and complex rebate deals. The Humira story captures the gap perfectly, with European biosimilar adalimumab taking a far larger share than in the US.

The wave is only building. According to IQVIA, 118 biologics are set to lose patent protection by 2034, and about 60 percent of the drugs in mid and late-stage development are biologics. Over the next five years alone, roughly 88 biologics worth more than 100 billion dollars in combined sales, including Keytruda, Opdivo and Darzalex, face loss of exclusivity. For health systems that promises huge savings; for the original manufacturers it is a recurring threat, which is why companies race to launch the next generation of products before the current one is copied.

The next wave: cell, gene and mRNA

If monoclonal antibodies are the present of biotech, cell and gene therapies are widely seen as its future. These treatments do not just manage disease, they re-engineer the body cells or genes, sometimes offering a potential one-time cure for conditions that were previously untreatable. CAR-T cell therapies re-programme a patient own immune cells to attack cancer, while gene therapies replace or repair faulty genes behind rare inherited diseases.

The market is still small but expanding at extraordinary speed. Estimates place the cell and gene therapy market at roughly 22 to 27 billion US dollars in 2025, with forecast growth of around 25 to 31 percent a year, among the highest rates anywhere in medicine. Gene therapy alone was valued near 9 billion dollars in 2024 and is expected to grow fourfold within a decade. The catch is cost: some of these one-time treatments carry list prices in the millions of dollars, which is forcing new payment models on health systems.

A small base, growing fast: gene therapy alone is forecast to grow around fourfold between 2024 and 2032.

Alongside them sits mRNA, the technology that powered the COVID-19 vaccines and proved that genetic instructions could be turned into medicine at scale. Having validated the platform during the pandemic, companies are now pushing mRNA into cancer vaccines and other diseases. Together, cell therapy, gene therapy and mRNA represent the frontier where biotechnology is pushing pharma into genuinely new territory, even if their sales today are a fraction of the antibody market.

Which segments grow fastest

Not all of biotech grows at the same pace. The chart compares the approximate annual growth rates expected across the main segments, from the mature core to the fast-moving frontier.

The frontier grows fastest: cell and gene therapy is expanding several times quicker than the biologics market overall.

The gap starts at the base. Non-biologic medicines grow at only about 5 percent a year, while biologics as a whole expand at around 14 percent, and monoclonal antibodies a little faster still. But the newer segments race further ahead: biosimilars near 18 percent, gene therapy around 19 percent, and cell and gene therapy as a whole in the mid-to-high twenties. These rates start from very different bases, so a fast-growing frontier segment can still be small in absolute terms, but they show clearly where investment, research and dealmaking are flowing. The money follows the growth, which is why big pharma keeps acquiring biotech companies to buy into these areas.

Who leads biotech in pharma

Geographically, the biologics industry has a clear centre of gravity: North America, and above all the United States. The US and the European Union together account for about 85 percent of the global biologics market, with the US alone around 65 percent and the EU about 21 percent. The US has the deepest venture funding, the most biotech start-ups and many of the leading companies and research universities, and it is where most new biologics are launched first and priced highest.

Two markets dominate: the United States alone is about two-thirds of the global biologics market.

Europe is the second pillar, strong in research, manufacturing and, notably, in biosimilar adoption, where its health systems have embraced lower-cost copies far faster than the US. Asia-Pacific is the fastest-growing region, with China and India building large biomanufacturing and biosimilar industries and rising domestic demand. The same tools reshaping the rest of technology are also arriving here, and artificial intelligence is increasingly used to speed up biologic drug discovery, a theme explored in our report on generative AI users worldwide. The long-term trend is a gradual rebalancing toward Asia, even as North America keeps its lead in value and innovation.

What drives biotech, and what holds it back

Several forces push biologics forward. The first is disease: ageing populations and rising rates of cancer, diabetes and autoimmune conditions create huge demand for exactly the targeted therapies that biotech produces. The second is science: advances in genetics, protein engineering, cell culture and, increasingly, artificial intelligence keep opening up new drug targets that chemistry alone could never reach. The third is money: biologics command high prices and long revenue runs, which draws in investment and makes them the strategic priority for almost every large drugmaker.

The challenges are just as real. Biologics are grown in living cells, which makes manufacturing slow, complex and expensive compared with chemical drugs, and quality control is far harder. Prices are high enough to strain health systems and attract political pressure, including drug-pricing reforms in the United States that target exactly these blockbuster products. Patent cliffs loom for many top sellers, promising more Humira-style declines as biosimilars arrive. And cell and gene therapies, for all their promise, face daunting questions about cost, durability and how to deliver a million-dollar one-time treatment fairly.

The outlook for biotechnology in pharma

The direction is not in doubt. Biologics will keep taking share from traditional drugs, pushing past 42 percent of the market and, on the broad measure, toward and beyond a trillion dollars within a few years, while the frontier of cell, gene and mRNA therapies expands even faster from its small base. The one near-term wobble is the wave of patent cliffs: Keytruda and Opdivo both face loss of exclusivity around 2028, so even the current leaders will soon feel the biosimilar pressure that has already hit Humira and Stelara.

The open questions are about who captures the value and how society pays for it. Biosimilars will keep eroding the old blockbusters, forcing companies to innovate faster to replace lost revenue. Pricing pressure and reform will shape margins. And the race to turn cell, gene and mRNA science into affordable, scalable medicine will decide whether the next wave becomes as commercially huge as antibodies are now. What is certain is that biotechnology is no longer a branch of pharma. It has become its main stem.

For anyone tracking the industry, the numbers in this report are the ones to watch as they update each year: the size and growth of the biologics market, the shifting order of the best-selling drugs, the speed at which biosimilars erode the leaders, and the emergence of the first genuinely large cell and gene therapy products. Together they map an industry in the middle of a long, decisive shift from chemistry to biology, and the direction of travel is only becoming clearer.

Biotech in pharma in numbers

A few figures capture the whole picture. Biologics are about 42 percent of a 1.8 trillion dollar market, growing near 14 percent a year against 5 percent for the rest of pharma; a single antibody, Keytruda, sells 31.7 billion dollars a year; and the fastest-growing therapies expand at more than three times the market rate. Biotechnology owns the commercial peak of medicine.

These numbers explain why every large drug company is now, at heart, a biotechnology company. The science, the pipelines and the profits have all moved to medicines made from living cells.

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