Oncology Biosimilars Market (2026-2036)

The growth of this market is mainly driven by the expiry of exclusivity on high-value oncology biologics, which brings successive molecules into biosimilar competition across the forecast period; regulatory reform that has materially reduced the cost and duration of biosimilar development and thereby widened the set of molecules that can be developed economically; payer and health system pressure to realise savings on oncology budgets, which has made biosimilar substitution a formulary rather than a clinical decision in many markets; and the increasing experience of oncologists and pharmacists with biosimilars, which has removed much of the clinical hesitancy that slowed earlier launches. In addition, the entry of denosumab and pertuzumab biosimilars, preparation for checkpoint inhibitor exclusivity expiry later in the forecast period, and the expansion of biosimilar access in emerging markets are further supporting the growth of this market.

The Oncology Biosimilars Market, also referred to as the cancer biosimilars market or oncology biologics follow-on market, comprises biological medicines approved as highly similar to an originator oncology biologic whose exclusivity has expired. The market includes therapeutic monoclonal antibodies used to treat cancer, principally trastuzumab, bevacizumab, rituximab and pertuzumab, and supportive care biologics used to manage the consequences of cancer and its treatment, principally pegfilgrastim and filgrastim for neutropenia, epoetin and darbepoetin for anaemia, and denosumab for skeletal-related events in bone metastases. It covers intravenous and subcutaneous presentations, supply through hospital, retail and specialty channels, and the tendering and formulary mechanisms through which these products are purchased. The market ecosystem extends from biosimilar developers and contract manufacturers to oncologists, hospital pharmacies, group purchasing organizations, payers, health technology assessment bodies and the regulators whose approval and interchangeability frameworks determine what may be substituted.

This market has matured from a question of clinical acceptance into a question of commercial execution. The first wave of oncology biosimilars, covering trastuzumab, bevacizumab and rituximab, has achieved high penetration in most developed markets, prices have fallen substantially from originator levels, and the clinical debate about switching has largely concluded. What determines commercial outcomes now is tender strategy, cost of goods, breadth of presentation and the number of competitors on a molecule.

Revenue nonetheless continues to compound at a rate that reflects successive molecules entering competition rather than deeper penetration of existing ones. In the first half of 2026, Sandoz Group AG reported net sales of USD 5.761 billion, up 5% at constant currencies, with biosimilar sales of USD 1.875 billion, up 20% at constant currencies and up 47% in North America, representing 33% of net sales against 29% a year earlier, and a core EBITDA margin of 20.9% against 20.0%. Biosimilar sales growing 20% at constant currencies, and 47% in North America, while reaching 33% of net sales against 29% a year earlier, indicates a portfolio expanding through launches rather than one defending mature positions.

Among those launches, the denosumab products are directly relevant to oncology practice. Sandoz confirmed full-year 2026 guidance of mid-to-high single-digit net sales growth at constant currencies with core EBITDA margin expansion of approximately 100 basis points, and reported that recent biosimilar launches including Wyost and Jubbonti performed well. Denosumab biosimilars address both osteoporosis and the prevention of skeletal-related events in patients with bone metastases from solid tumours, and the oncology indication represents a substantial treated population in which the originator held exclusivity until recently, which makes this the most significant near-term addition to the oncology biosimilar set.

The most consequential development for the longer term is regulatory rather than commercial. On 9 March 2026, the U.S. Food and Drug Administration published new and revised draft questions and answers on biosimilar development and the Biologics Price Competition and Innovation Act, revision 4, under which sponsors may meet requirements by submitting analytical data in place of pharmacokinetic studies, applicants may use clinical data generated outside the United States without a three-way pharmacokinetic study including the United States-licensed reference product, and a comparator approved outside the United States may be used where scientifically justified, with the agency indicating that the changes could reduce pharmacokinetic study costs by up to 50%. Removing the requirement for a clinical pharmacokinetic study against the United States-licensed reference product, and permitting analytical data in its place, reduces both the cost and the logistical burden of a development programme, particularly the need to source and compare multiple regional versions of the originator.

The reduction in clinical requirements is larger still. A separate draft guidance published in October 2025 limits the circumstances in which comparative efficacy studies may be required, providing that a comparative analytical assessment together with pharmacokinetic similarity and immunogenicity data may be sufficient in some cases, with reported potential savings in the hundreds of millions of dollars per programme against pharmacokinetic and pharmacodynamic studies averaging approximately USD 40 million and representing around 30% of total development cost. Where comparative efficacy studies are no longer routinely required, the dominant cost and time element of a biosimilar programme is removed, and molecules that could not previously support the expense of a development programme become economically viable. The consequence over the forecast period is more competitors per molecule and biosimilar development extending to smaller oncology products, which increases volume while compressing price.

Against that, the defence mounted by originators has changed in a way that materially affects this market. Merck & Co., Inc. has brought a subcutaneous formulation of pembrolizumab to market under the Keytruda Qlex name, and its regulatory filings record that formulation as a combination partner alongside intravenous pembrolizumab in new approvals and clinical programmes, including the June 2026 approval of Welireg in combination with Keytruda or Keytruda Qlex for adjuvant clear cell renal cell carcinoma following nephrectomy. Converting an installed patient base to a subcutaneous formulation ahead of exclusivity expiry means that intravenous biosimilars, when they arrive, compete for a reduced share of treated patients, because a subcutaneous presentation is a different product for substitution purposes and is typically protected separately. This is the principal commercial risk to the checkpoint inhibitor biosimilar opportunity that dominates expectations for the second half of the forecast period.

Pricing behaviour in this market is now well established and should inform any revenue forecast. Molecules with several approved biosimilars have seen price erosion that significantly exceeds early expectations, particularly in tendered hospital channels in Europe, so volume gains translate into revenue gains at a much reduced rate. A forecast built on penetration rates alone, without allowance for price, overstates the value available to suppliers by a wide margin, and this is why value growth in this market runs well below volume growth.

The market includes diversified generic and biosimilar companies, specialist biosimilar developers and originator companies competing in biosimilars, among them Sandoz, Celltrion, Samsung Bioepis, Amgen, Pfizer, Teva, Biocon Biologics, Viatris, Organon, Fresenius Kabi, Accord Healthcare, Alvotech, Shanghai Henlius Biotech, Formycon, STADA Arzneimittel and Zydus Lifesciences. Participants compete on cost of goods and manufacturing scale, breadth of presentation including subcutaneous and device options, tender and contracting capability, the number of markets in which a product is approved, supply reliability across multi-year hospital contracts, and the ability to launch at the earliest lawful date.

At the same time, the market faces challenges, including price erosion that outpaces volume growth on crowded molecules, the conversion of originator franchises to formulations biosimilars do not address, patent and regulatory exclusivity litigation that delays launch, the capital and time required to build manufacturing capacity for molecules whose price will fall on entry, concentration of purchasing in tenders that award on price alone, and uneven interchangeability and substitution rules across jurisdictions. As a result, companies that combine low cost of goods, broad presentation and market coverage, disciplined molecule selection and the capability to launch first are expected to capture the largest share of growth over the forecast period.