Global Biosimilars Market: Penetration, Price Erosion and the Next Wave of Molecules

Discover how the biosimilars market across 21 countries is evolving through patent expiries on blockbuster biologics, hospital and tender buying, steep price erosion, and a wave of new molecules such as denosumab, aflibercept and ustekinumab.

Executive Summary

The biosimilars market across the 21 countries covered (the EU-5, China, Latin America, Middle East and North Africa and Southeast Asia, excluding the United States and India) is modelled at USD 7,677 million in 2026 and USD 16,971 million by 2033, a CAGR of 12.0%. It was USD 6,854 million in 2025 and USD 2,152 million in 2018, an 18.0% CAGR over 2018–2025. Volumes grow more slowly than value, from about 1,667 kg of active substance in 2026 to 2,844 kg in 2033.

Demand is anchored in hospitals and public tenders, which together make up about three-quarters of 2026 value. Immunology and inflammation is the largest therapeutic group at 44.7%, led by adalimumab and etanercept. At the same time, prices fall hard once biosimilars arrive: in Italy, biosimilar adalimumab packs were priced 86.7% below the originator in December 2025, and biosimilars hold 98.4% of adalimumab packs bought directly by hospitals in January 2026.

Introduction

A biosimilar is a biological medicine approved as highly similar to an already authorised originator (reference) biologic, with no clinically meaningful difference. The covered portfolio spans 27 molecules, from monoclonal antibodies such as adalimumab, trastuzumab and denosumab to older biologics such as epoetin, filgrastim, somatropin and, in smaller volume, insulins and enoxaparin.

The study covers 21 countries: Germany, France, Italy, Spain and the United Kingdom (EU-5); China; Brazil, Mexico, Argentina, Chile and Colombia (Latin America); Saudi Arabia, Turkey, the UAE and Egypt (MENA); and Indonesia, Singapore, Thailand, the Philippines, Vietnam and Malaysia (Southeast Asia). The United States and India are excluded. The European Medicines Agency (EMA) register lists 150 centrally authorised biosimilars, and 148 of them resolve to a named originator across 27 distinct reference products. Every figure in this post carries a basis in the underlying database: reported, derived or modelled. The market size and share figures are modelled.

Key Factors Driving Demand for Biosimilars

Several structural trends support the expansion of the market.

• Patent expiries and a deep pipeline of approvals. The EMA authorised 44 biosimilars in 2025 and 13 more in 2026 to date, after 17 in 2024, so 74 of the 150 on the register arrived in just three years. Denosumab leads the register with 29 products (16 referencing Prolia and 13 referencing Xgeva), followed by aflibercept (12), ustekinumab (11), adalimumab (10) and pegfilgrastim (10).
• Institutional buying that rewards price. Hospitals account for 52.7% of 2026 value and public tenders for 22.0%, and tenders are the fastest-growing channel at 14.4% a year to 2033. Chile's public buyers awarded 1,785 biosimilar purchase lines worth CLP 81,090 million over thirteen months to January 2026, led by adalimumab (30.0% of value), trastuzumab (27.4%) and somatropin (14.8%).
• Deep and fast price erosion. Italian hospitals paid biosimilar prices 80% or more below the originator per pack for adalimumab, rituximab, filgrastim, bevacizumab and trastuzumab in December 2025. Those savings let health systems treat more patients and push conversion.
• Growth in autoimmune and oncology care. Immunology and inflammation (44.7% of 2026 value) and oncology (20.8%) are the two groups where biosimilars are most established and where newer molecules such as ustekinumab (18.5% a year) and tocilizumab (18.6%) are expected to grow fastest.

Therapeutic Groups and Molecules Driving Biosimilar Demand, 2026

Because a biosimilar copies a specific originator, demand follows the largest biologic franchises: autoimmune disease, cancer, anaemia and neutropenia, growth disorders and bone disease. Immunology and inflammation alone is worth more than the next two groups combined, and the top five molecules make up about 62% of the market.

Regulation and Reimbursement: How a Biosimilar Reaches the Market

In Europe, a biosimilar is approved centrally by the EMA, which flags biosimilars explicitly in its register. A central approval says a product may be sold in a member state, not that it is. Launch depends on each country's own lists, price negotiations and tenders, and the database records launch status as "not known" for most country-product pairs rather than guessing.

Outside Europe, regulators and payers differ. Brazil's price regulator CMED lists ex-factory and maximum prices by pack, but its product type stops at "biological" and cannot identify biosimilars on its own. Municipal and state buyers in Brazil and public buyers in Chile purchase through tenders and framework contracts, so the award price rather than the list price sets the market. For suppliers, this means a separate registration, pricing file and tender capability in each country.

Pricing Benchmark

Where biosimilars are established, they win on price and then on volume. In Italy's hospital direct-purchase channel, discounts to the originator by December 2025 were largest on the oldest molecules and smallest, or reversed, where pack sizes differ or competition is thin. The comparison is per pack, not per milligram, so a negative discount reflects a larger or differently priced biosimilar pack rather than a higher true price.

Penetration tracks the same pattern. Between January 2024 and January 2026, biosimilars of ustekinumab went from 0% to 69.0% of packs, eculizumab from 7.0% to 66.4% and ranibizumab from 0.3% to 81.7%. Tocilizumab (23.8%) and natalizumab (38.3%) are still early.

Regional and Channel Snapshot

Europe dominates today, and China is the single largest country. In the model every country grows at the same 12.0% rate, so shares stay constant to 2033; differences between countries are in size, not pace.

Business Opportunities Across the Biosimilars Ecosystem

The largest segments are the ones where biosimilars are already entrenched, and the fastest-growing ones are newer. Adalimumab (USD 1,356 million in 2026), trastuzumab (1,037) and etanercept (925) are the biggest franchises, but prices there are already 60–87% below the originator in Italy. Ustekinumab and tocilizumab, growing about 18.5% a year from USD 452 million and USD 135 million, are earlier in the conversion curve: biosimilar ustekinumab holds 69.0% of Italian packs after starting from zero in January 2024, and tocilizumab only 23.8%.

The approvals pipeline points to the next opportunities. Denosumab has 29 EU biosimilar products and aflibercept 12, yet they were worth only USD 79 million and USD 6 million in the covered markets in 2026, so volume still has to follow the approvals. In Chile, adalimumab and rituximab are 65% and 85% converted by volume while infliximab is 3% and ustekinumab and denosumab are 0%, which shows the same molecule class can be converted or untouched depending on tender design. Specialists can compete on tender readiness, supply reliability and portfolio breadth rather than plant scale alone.

Competitive Landscape

The market is led by a handful of specialists, but half of it sits with companies that do not disclose biosimilar revenue separately. The residual "others" group holds an estimated 51.3% of value in the covered markets and includes Teva, Fresenius Kabi, Stada, Accord, Viatris, Pfizer, Coherus and Gan & Lee. On the EMA register, 31 holder groups hold three or fewer of the 150 biosimilars each, and Sandoz (17 products) and Biosimilar Collaborations Ireland (14) are the largest single holders, followed by Celltrion (12) and Samsung Bioepis (11).

Future Outlook: Where Is the Biosimilars Market Heading?

The market is expected to keep growing in double digits, from USD 7,677 million in 2026 to USD 16,971 million in 2033, with value shifting from adalimumab, trastuzumab and epoetin toward ustekinumab, tocilizumab, denosumab and other newly approved molecules. Volume grows more slowly than value, at roughly 7.9% a year, so mix and new molecules, not simple unit growth, carry the forecast.

The main commercial risk is price: where biosimilars are established, discounts of 80% or more are normal and Organon already reports pricing pressure on Renflexis and Ontruzant in the US and Europe. The main forecast risk is the model itself. It applies a single 12.0% growth rate to every country, slower than the 18.0% of 2018–2025, and it is built on modelled shares rather than published totals.

Emerging Trends Shaping the Market

• Wave of Denosumab, Aflibercept and Ustekinumab Biosimilars
• Rapid Conversion Once Originators Lose Exclusivity (Adalimumab, Rituximab, Trastuzumab)
• Growth of Public Tender and Hospital Purchasing
• Deepening Price Erosion of 80% or More on Mature Molecules
• Consolidation Among Specialist Suppliers and Large Generics Houses

Conclusion

The biosimilars market across 21 countries is well positioned for sustained growth, expanding from a modelled USD 7,677 million in 2026 to USD 16,971 million by 2033. Patent expiries, a record flow of EMA approvals, and institutional buyers who reward price support demand, while steep price erosion and a fragmented supplier base keep margins under pressure.

In a market where about half of value sits outside the six largest disclosed players, success will go to companies that win tenders early on new molecules, keep supply reliable across many countries and compete on portfolio breadth. Health systems should expect savings of 80% or more on mature molecules and plan for faster conversion on the next wave.