Spain Biosimilars Market Research Report, 2030

Spain has been one of the leaders in the use of biosimilars, with a robust regulatory framework and policies in place to promote the use of these drugs. Biosimilars are an important part of the pharmaceutical industry in Spain, offering a more affordable and accessible alternative to biological drugs. Currently, there are a number of biosimilars available in Spain, including versions of drugs used to treat cancer, autoimmune diseases, and other conditions. These drugs are approved by the Spanish Agency for Medicines and Medical Devices (AEMPS), which follows the European Medicines Agency (EMA) guidelines for the approval and use of biosimilars. It is anticipated that the Spanish biosimilar market would expand over the coming years, propelled by reasons including the desire to lower healthcare costs and the rise in demand for low-cost, efficient treatments for chronic illnesses. The Spanish government's initiatives to encourage the use of biosimilars are anticipated to be a major factor in the market's expansion. The Spanish government has taken several measures to promote the use of biosimilars, such as encouraging the prescription of biosimilars over reference biologics and promoting the development of a biosimilar industry in Spain. The Spanish regulatory agency responsible for approving biosimilars is the Spanish Agency of Medicines and Medical Devices (AEMPS). Biosimilars are required to undergo a rigorous approval process that includes comprehensive preclinical and clinical testing. According to the research report, “Spain Biosimilars Market Research Report, 2030” published by Actual Market Research, the Spain Biosimilars market is projected to grow with 18.85% CAGR by 2025-30. Many of the original biologic drugs that are used to treat diseases in Spain are coming off patent, making way for biosimilars to enter the market. Biosimilars are typically priced lower than their reference biologics, providing significant cost savings to patients and healthcare systems. Moreover, with lower prices and increased availability, biosimilars can provide wider access to essential treatments for patients. The Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) is the national authority responsible for regulation of drugs, including biosimilars, in Spain. Although Spain supports the early entry of biosimilars, automatic substitution in community pharmacies is not allowed. Biosimilars are classified in Spain as HOM (hospital only medicine), meaning that they are only dispensed to outpatients attending hospitals, which could offer one explanation for the low uptake of biosimilars in Spain. However, the trend is that a patient, who has received a certain biosimilar in the inpatient phase of their treatment, will continue with the same biosimilar in the outpatient phase. The Spain Biosimilars market will grow as there is a shortage of qualified radiologists and imaging technologists in some areas, leading to longer wait times and delays in diagnosis and treatment. In Spain, biosimilars are reimbursed through the National Health System (SNS) in the same way as reference biologics. Biosimilars are subject to the same pricing and reimbursement regulations as reference biologics, which includes a reference price system and negotiated prices between the Spanish government and manufacturers. Biosimilars are also included in the Spanish Biosimilars Plan, which aims to promote the use in the Spanish healthcare system.

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The adoption of biosimilars in Spain has led to substantial cost savings for the healthcare system. A study estimated that from 2020 to 2023, biosimilars contributed to savings exceeding €1 billion, primarily through reduced drug acquisition costs and increased market competition. These savings are particularly significant given that biological medicines account for a substantial portion of the pharmaceutical budget in Europe. For instance, the introduction of bevacizumab biosimilars has been projected to generate significant savings in Spain's pharmacological budget. Spain's regulatory framework supports the integration of biosimilars into the healthcare system. Biosimilars are typically priced 30% below the reference biological medicine price, according to agreements with the Interministerial Commission for Pricing. Additionally, pharmacotherapeutic committees at the hospital level decide which biologicals are included in the hospital pharmaceutical formulary, and biosimilars are generally welcomed. Acquisitions are made through various methods, including tendering and direct purchase. Biosimilars have found applications in various therapeutic areas, including oncology, immunology, and ophthalmology. The Spanish Psoriasis Working Group has updated its guidelines to support the use of biosimilars as first-line treatments for moderate to severe psoriasis, reflecting growing confidence in their efficacy and safety. In Spain, the growth of the biosimilars industry is notably concentrated in major cities such as Madrid, Barcelona, Valencia, and Seville, which serve as key hubs for pharmaceutical manufacturing, research, and healthcare delivery. Madrid and Barcelona, in particular, stand out due to their advanced biomedical research centers, well-established pharmaceutical industries, and large networks of hospitals and universities that facilitate clinical trials and biosimilar adoption. These cities attract significant investment from both multinational and local biosimilar manufacturers, driving innovation and production capacity. Valencia and Seville are also emerging as important centers, benefiting from regional initiatives aimed at boosting biopharmaceutical manufacturing and improving healthcare infrastructure. The presence of contract manufacturing organizations (CMOs) and contract research organizations (CROs) in these urban areas supports the efficient development and commercialization of biosimilars. Monoclonal antibodies (mAbs) are leading the biosimilars industry in Spain due to their pivotal role in treating a wide range of complex and chronic diseases, particularly in oncology, autoimmune disorders, and inflammatory conditions, which are highly prevalent in the Spanish population. These biologics have revolutionized therapeutic approaches by offering targeted mechanisms of action that improve treatment efficacy and patient outcomes, making them indispensable in modern medicine. However, the high cost of originator monoclonal antibody therapies has imposed significant financial strain on Spain’s healthcare system, prompting an urgent need for more affordable alternatives. Biosimilar monoclonal antibodies provide a cost-effective solution without compromising clinical efficacy or safety, making them highly attractive to hospitals and healthcare providers aiming to optimize budgets while maintaining quality care. Spain’s regulatory framework, supported by policies from the Ministry of Health and regional healthcare authorities, actively encourages the adoption of biosimilars through pricing incentives, prescribing guidelines, and hospital tendering systems that prioritize biosimilar uptake. Furthermore, increasing physician and patient confidence in biosimilar mAbs fostered by extensive clinical evidence, real-world data, and education campaigns has accelerated their integration into treatment protocols. The expiration of patents on blockbuster monoclonal antibody drugs has also opened the market for biosimilar competition, resulting in enhanced accessibility and expanded use across various indications. Additionally, Spanish pharmaceutical companies and contract manufacturing organizations are investing heavily in the development and production of monoclonal antibody biosimilars, supported by the country’s robust biopharmaceutical infrastructure and skilled workforce.

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Nikita Jabrela

Business Development Manager

The biosimilars segment addressing chronic and autoimmune disorders is experiencing rapid growth in Spain due to the rising prevalence of these conditions and the increasing demand for more affordable, effective treatment options. Chronic autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease, and multiple sclerosis impose a significant burden on patients and the healthcare system, often requiring long-term biologic therapies to control symptoms and prevent disease progression. Originator biologics, while effective, are costly and limit patient access due to budget constraints within the Spanish National Health System. Biosimilars offer a financially sustainable alternative, providing comparable safety and efficacy at substantially lower prices, which encourages broader adoption across hospitals and outpatient settings. Spain’s healthcare authorities have implemented policies that actively promote biosimilar uptake, including favorable pricing agreements, formulary inclusion, and educational initiatives aimed at increasing physician and patient confidence in biosimilar therapies. Furthermore, regional differences in healthcare delivery have been bridged by national guidelines supporting biosimilar use, fostering consistent market growth across the country. The expiration of patents on key biologics used for autoimmune diseases has created opportunities for biosimilar manufacturers to enter the market, intensifying competition and further driving down costs. Additionally, growing awareness among patients and healthcare professionals about the efficacy of biosimilars is reducing hesitancy and expanding their use in treatment protocols. The dominance of in-house manufacturing in Spain’s biosimilars industry is largely driven by the country’s well-established pharmaceutical infrastructure, strategic emphasis on quality control, and the desire for greater operational autonomy among biosimilar developers. Many leading pharmaceutical companies in Spain prefer to maintain direct control over the entire production process to ensure stringent adherence to regulatory standards and high manufacturing quality, which is critical given the complexity of biosimilar molecules. In-house manufacturing also facilitates quicker adjustments in production in response to market demand, regulatory changes, or supply chain disruptions, enhancing flexibility and reliability. Additionally, Spain’s robust network of skilled scientists, engineers, and specialized manufacturing facilities supports the capability of biosimilar companies to produce at scale domestically, reducing dependence on external suppliers and minimizing risks related to intellectual property and confidentiality. The country’s healthcare policies further incentivize local production by promoting innovation and supporting investments in advanced biomanufacturing technologies. Moreover, by controlling manufacturing processes internally, companies can better manage costs and timelines, enabling competitive pricing and faster time-to-market for biosimilar products. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030

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Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.