Key Takeaways
- Spain is Europe’s undisputed clinical research leader: in 2025, the Spanish Agency for Medicines and Health Products (AEMPS) authorised 962 clinical studies, a new record and more than any other EU regulatory agency, making Spain the top destination in Europe for pharmaceutical R&D and one of the top three locations globally, alongside the US and China.
- The next frontier is data: unlocking real-world data (RWD) and scaling real-world evidence (RWE), accelerated by the newly enacted European Health Data Space (EHDS) regulation, will determine long-term competitiveness.
- Spain’s structural challenge is not ambition, but fragmentation: decentralised governance across 17 autonomous regions creates uneven data access, variable patient outcomes, and barriers to EHDS compliance.
- Sqilline Health enables the transition from trial execution to continuous evidence generation, acting as a trusted data partner to accelerate clinical research, RWE generation, and patient access across Spain and the wider EU.
A New Signal from Europe
Across Europe, there are renewed signs of momentum in healthcare innovation and Spain stands out as one of the most compelling stories on the continent. Once primarily known as a strong but regional player in pharmaceutical markets, Spain has rapidly transformed into the top-tier destination for clinical research in Europe, leading the EU in clinical trial authorisations, achieving a sustained growth rate for more than 10 years and ranking among the top three locations globally alongside the United States and China.[1]
This shift is not accidental. As highlighted in the Farmaindustria report The Great Opportunity: Spain as a Global Hub for Pharmaceutical Innovation and Manufacturing, Spain demonstrates what is possible when policy alignment, regulatory efficiency, and industry collaboration converge.[2]
For companies like Sqilline Health, Spain represents more than a market. It is a strategic platform for the future of data-driven healthcare in Europe and, with the EHDS now in force, the window of opportunity has never been clearer.
Why Spain Is Winning in Clinical Research
Spain’s ascent is rooted in a combination of structural strengths and deliberate strategic choices.
The Numbers Are Unambiguous
In 2025, the Spanish Agency for Medicines and Health Products (AEMPS) authorised a total of 962 clinical studies – a new record, and the highest number of any regulatory agency in the European Union, ahead of France and Germany, sustaining more than a decade of uninterrupted growth.[1] Spain led the EU in oncology research with 378 cancer drug trials, accounting for nearly 40% of all authorised studies nationally, and maintained EU leadership in advanced therapy trials and rare disease research.[1] Spain also strengthened its leadership in European initiatives, such as the first fast-track procedure (FAST-EU) for multinational clinical trials in the EU, promoted by the Heads of Medicines Agencies (HMA) network, chaired by the director of the AEMPS, María Jesús Lamas.[1]
In global terms, Spain is firmly among the top three locations worldwide for industry-sponsored clinical trial activity, alongside the United States and China.[3]
Public-Private Collaboration at Scale
One of Spain’s defining advantages is its deeply integrated research ecosystem. According to Farmaindustria, approximately half of all pharmaceutical R&D investment in Spain is directed toward collaborative projects with hospitals, universities, and both public and private research centres – a model that positions the pharmaceutical industry as one of the largest contributors to national R&D spending, accounting for roughly one in every five euros of total investment in research across Spain.[4]
Pharmaceutical companies are behind more than 80% of clinical trials conducted in Spain, and for many global multinationals, Spain is the primary destination for studies outside the United States.[5] This collaborative model enables faster patient recruitment, higher-quality data, and more efficient trial delivery.
Regulatory and Policy Alignment
Spain was the first European country to fully implement the EU Clinical Trials Regulation (EU Regulation No. 536/2014), and Royal Decree 1090/2015 harmonised and simplified national procedures well ahead of the EU-wide CTIS transition.[6]
In 2024, Spain also launched a dedicated Pharmaceutical Industry Strategy 2024-2028, developed through an interministerial working group involving the Ministries of Health, Finance, Industry and Tourism, and Science, Innovation, alongside Farmaindustria and leading industry associations, with a focus on innovation, manufacturing, and digital transformation.[7] R&D investment by innovative pharmaceutical companies exceeded €1.5 billion in 2024, a new record.[8]
Infrastructure and Talent
Spain’s NHS encompasses nearly 1,000 hospital centres actively involved in clinical research over the past five years, with one of the best patient recruitment rates in Europe and a highly skilled investigator workforce.[9] Barcelona’s Prime Site hub has seen sustained growth since 2018, and Sanofi’s Barcelona hub, dedicated to the generation of real-life evidence (RWE), supported by expert teams in biostatistics, statistical programming, clinical data analytics, engineering, and data science, signals continued confidence from global sponsors.[10]
The Epidemiological Imperative
Recent insights from Las Cifras del Cáncer en España 2026 further reinforce the strategic importance of Spain’s healthcare ecosystem. With an estimated 301,884 new cancer cases in 2026, projected to exceed 350,000 annually by 2050, and cancer now the leading cause of death in Spain (115,578 deaths in 2024), the scale and urgency of oncology challenges are clear. At the same time, survival rates have doubled over the past 40 years, driven by early detection, therapeutic innovation, and the gradual adoption of precision medicine. [11] This dual dynamic of rising incidence alongside improving outcomes highlights a critical inflection point. There is a need to move beyond episodic clinical research toward continuous, data-driven evidence generation across the full patient journey.
In this context, Spain’s growing cancer burden sits alongside a rapidly advancing innovation landscape, creating both pressure and opportunity for the healthcare system. While clinical research and therapeutic progress continue to improve survival, the next step is to ensure that these advances translate consistently into real-world patient outcomes. This requires going beyond innovation alone and strengthening how care is delivered, accessed, and evaluated across regions. By enabling better use of health data and supporting more coordinated, outcome-focused care pathways, platforms like Sqilline can help close the gap between scientific progress and everyday clinical reality, improving access to high-quality care and delivering more tangible benefits to patients.
The Next Frontier: Spain as a Data-Driven Innovation Hub
While Spain’s clinical trial leadership is now firmly established, its next strategic opportunity lies in data and the regulatory environment has fundamentally shifted in its favour.
The EHDS: A Game-Changing Framework
Regulation (EU) 2025/327, establishing the European Health Data Space (EHDS), was published in the Official Journal of the EU on 5 March 2025 and officially entered into force on 26 March 2025.[12] This is one of the most significant regulatory developments in European healthcare in decades.
The EHDS establishes a unified legal and technical framework for accessing and reusing electronic health data across all EU Member States – from hospital records and registries to clinical trial data and medical imaging. Crucially, it creates a mandatory infrastructure for the secondary use of health data for research, regulatory decision-making, public health, and AI development, with core obligations taking effect from approximately 2027-2028.[12]
For clinical research, the EHDS directly addresses one of the sector’s most persistent bottlenecks: fragmented access to real-world data. Historically, clinical trial feasibility and recruitment have been constrained by patient populations locked within national registries or hospital systems that are not easily searchable or interoperable across borders.[13] The EHDS is designed to change this.
Spain’s Data Strengths and Its Structural Challenge
Spain’s healthcare system generates vast amounts of high-quality patient data across hospitals, registries, and regional systems and is well-positioned to become a European leader in RWD/RWE generation. However, significant structural challenges remain, and they are more specific than a generic reference to “fragmentation” conveys.
Spain’s 17 autonomous regions govern their own healthcare systems, creating persistent variability in access to innovative medicines, formulary decisions, and funding. As noted by industry experts, decentralisation poses significant challenges for new therapies – these inequalities persist, resulting in better or worse outcomes depending on where patients receive care.[14]
On the data side, the EHDS implementation in Spain is indeed complex due to the decentralized structure of its health system and the involvement of three key ministries overseeing the national framework: the Ministry of Health, the Ministry of Economy, and the Ministry of Science. According to an EIT Health roundtable analysis, Spain’s starting point is “favourable compared to other EU countries,” but full realisation remains “far from where we need to be.”[15]
Bridging this gap is not optional – it is strategic. Europe has already lost approximately 25% of its global R&D share over the past two decades to the US and Asia, as those markets pursue aggressive policies to attract innovation.[16] The EHDS and Spain’s clinical research infrastructure together represent the best European response to this challenge, but only if the data layer catches up with the trial execution capability.
Sqilline Health Enabling the Next Phase of Innovation
This is where Sqilline Health plays a pivotal role. As a provider of real-world data (RWD) and real-world evidence (RWE) solutions, Sqilline supports healthcare providers, pharmaceutical companies, and policymakers in unlocking the full value of health data ecosystems, operating at precisely the intersection where Spain’s strengths meet its remaining gaps.
Unlocking Real-World Data at Scale
Sqilline Health ingests healthcare data in any format, including scanned notes, PDFs, and clinical text, and applies automated, irreversible anonymization to remove all personally identifiable information. At its core, Sqilline’s platform structures, integrates, and harmonises complex medical data from multiple sources such as hospitals, registries, and longitudinal patient records, transforming fragmented inputs into standardised, interoperable, and research-ready datasets.
This structured data foundation is then activated through advanced analytics and visualisation, enabling clear insights into trends, treatments, and outcomes. Fully aligned with EU data governance frameworks and interoperability standards, Sqilline enables scalable, high-quality real-world evidence generation across the healthcare ecosystem.
This is not just a technical service; it is a compliance and governance capability that becomes increasingly essential as EHDS obligations take effect.
Enhancing Clinical Trial Performance
By leveraging real-world insights, Sqilline enables:
- Data-driven feasibility assessments, using real patient population data rather than assumptions
- More accurate patient identification and recruitment, reducing screen failure rates and accelerating enrolment timelines
- Benchmarking of site performance across Spain’s fragmented regional infrastructure
This leads to faster, more efficient trials with improved outcomes, directly addressing the variability introduced by Spain’s decentralised NHS model.
Accelerating Real-World Evidence Generation
Beyond trial execution, Sqilline supports the full evidence lifecycle, from data structuring to decision-grade insights:
- Health Economics and Outcomes Research (HEOR) to demonstrate real-world value, cost-effectiveness, and patient outcomes
- Scientific publications and study support, enabling robust dissemination of real-world insights in peer-reviewed journals
- EMA-aligned evidence generation, including readiness for frameworks such as the EMA Real-World Data (RWD) Catalogue
As regulators and payers increasingly require evidence of real-world performance alongside trial data, this capability is no longer a differentiator – it is a prerequisite.
Acting as a Trusted Data Partner Under the EHDS Framework
Under the European Health Data Space (EHDS), trust becomes a structural foundation of how innovation will operate across Europe.
The introduction of Health Data Access Bodies (HDABs) in each member state formalises access, governance, and oversight of health data. This shifts the landscape from fragmented, bilateral data exchanges to a regulated, multi-stakeholder ecosystem where transparency, compliance, and interoperability are mandatory.
In this new environment, the ability to act as a neutral, trusted data partner is not optional. It is essential. Sqilline is designed to fulfil exactly this role, enabling secure, compliant collaboration across a complex ecosystem, and supporting the involved stakeholders to benefit from the emerging EHDS infrastructure ahead of mandatory timelines.
Sqilline in Spain is A Blueprint for Europe
Spain’s progress sends a clear signal: Europe can compete globally in healthcare innovation when the right conditions are aligned. The country’s clinical trial performance in 2025, with 962 authorised studies, leadership in oncology and advanced therapies, and a top-three global position, demonstrates what coordinated policy, strong infrastructure, and ecosystem collaboration can deliver.
To sustain and expand this momentum, the focus must now evolve:
- From trial execution to continuous evidence generation
- From siloed regional systems to EHDS-compliant, integrated data ecosystems
- From national excellence to scalable, cross-border European models
By combining Spain’s structural strengths with Sqilline’s capabilities in data structuring and real-world evidence, there is a clear opportunity to define an operational blueprint for data-driven healthcare innovation in Europe. This is increasingly what regulators, payers, and patients expect.
From Opportunity to Execution
Spain is no longer an emerging market. It is a proven leader, and the regulatory environment now favours those who can operationalise its full potential. The EHDS is in force. High-quality data exists. Clinical trial infrastructure is world-class. What remains is the execution layer.
For pharmaceutical companies, the message is clear. Spain’s combination of clinical research leadership, EHDS momentum, and access to diverse patient populations creates a strategic window that will not remain open indefinitely. Capturing this opportunity requires the right partners, strong data governance, and a trusted position within the ecosystem.
Sqilline Health is positioned to be one of those partners, supporting the translation of Spain’s potential into measurable impact for patients, providers, and innovators across Europe.
Q&A: Spain and the Future of Health Innovation
What is the biggest untapped opportunity in Spain’s healthcare ecosystem?
Real-world data. Spain generates high-quality clinical data at scale, but regional fragmentation, multi-ministry EHDS governance, and limited cross-system interoperability mean its full potential is not yet realised. The combination of EHDS obligations and Spain’s existing digital health infrastructure creates a narrowing window to build the governance structures that unlock this data for research and market access purposes.
How does real-world evidence (RWE) complement clinical trials?
Clinical trials provide controlled efficacy evidence under ideal conditions. RWE reflects how treatments perform across real patient populations, including subgroups, comorbidities, and care settings that trials typically exclude. Together, they enable better regulatory submissions, more robust HTA dossiers, stronger market access arguments, and the outcomes-based contracting models that payers are increasingly requiring. In Spain’s decentralised system, regional-level RWE is also increasingly important for local formulary decisions.
How can Sqilline Health support pharmaceutical companies in Spain?
Sqilline supports pharma companies across the research and commercialisation lifecycle: improving patient identification and recruitment for clinical trials, enabling feasibility studies, generating RWE for scientific research and patient access, and acting as a neutral data trustee in multi-stakeholder data partnerships. This is particularly valuable in Spain’s complex regional environment, where a trusted governance partner can reduce friction across the 17 autonomous health systems.
Can Spain’s clinical research model be replicated across Europe?
Yes, with caveats. Spain’s success is built on specific foundations: early regulatory harmonisation, strong public-private collaboration, a high-quality NHS infrastructure, and sustained investment in R&D. Other EU countries can replicate the policy elements, but Spain has a decade’s head start in the clinical research ecosystem. What the EHDS does is create a shared European framework within which Spain’s model can scale and in which the data governance infrastructure that companies like Sqilline provide becomes the connective tissue between national clinical excellence and cross-border evidence generation.
References
[1] AEMPS / REec, Jan 2026. Spain leads clinical research in the EU: 962 trials authorised and record administrative agility. Distefar del Sur. https://distefar.com/en/espana-lidera-la-investigacion-clinica-en-la-ue-962-ensayos-autorizados-y-agilidad-administrativa-record-2/
[2] Farmaindustria, 2025. Spain as a Global Hub for Pharmaceutical Innovation and Manufacturing. https://www.farmaindustria.es/web/wp-content/uploads/sites/2/2025/11/FI.LGO_Nacional-ENG_V4.pdf
[3] European Biotechnology Magazine, Dec 2025; ITIF, Jun 2025. German pharma association publishes clinical trial ranking; China Has Surpassed the US in the Number of Drug Clinical Trials. https://european-biotechnology.com/latest-news/german-pharma-association-publishes-clinical-trial-ranking/
[4] Farmaindustria / ICEX Invest in Spain, 2024. Pharmaceutical companies beat R&D investment record in Spain in 2023. https://www.investinspain.org/content/icex-invest/en/noticias-main/2024/farmaindustria.html
[5] ScienHub, 2025. Spain, European Leader in Clinical Trials. https://scienhub.org/en/post/spain-european-leader-in-clinical-trials/
[6] European Biotechnology Magazine, Oct 2025. Spain again tops Europe in clinical trials. https://european-biotechnology.com/background/spain-again-tops-europe-in-clinical-trials/
[7] DLA Piper, Dec 2024. Spanish Pharmaceutical Industry Strategy 2024-2028. https://www.dlapiper.com/en/insights/blogs/cortex-life-sciences-insights/2024/spanish-pharmaceutical-industry-strategy-2024-2028
[8] Laboratorios Rubio / Farmaindustria, Jan 2026. Impact and Relevance of the Pharmaceutical Industry in Spain. https://www.laboratoriosrubio.com/en/pharmaceutical-industry-in-spain/
[9] Distefar del Sur, Jan 2026. Spain again leads clinical trials in Europe. https://distefar.com/en/espana-vuelve-a-liderar-los-ensayos-clinicos-en-europa-pero-afronta-el-reto-de-competir-en-la-carrera-biomedica-global-2/
[10] Catalonia Trade & Investments, 23 Apr 2025. Multinational company Sanofi will open an innovation center in Barcelona, creating 300 jobs. https://catalonia.com/w/multinational-company-sanofi-will-open-an-innovation-center-in-barcelona-creating-300-jobs#:~:text=The%20hub%20is%20expected%20to,informed%20decisions%20across%20the%20organization.
[11] Sociedad Española de Oncología Médica (SEOM). Las cifras del cáncer en España 2026. Madrid: SEOM, 2026. https://seom.org/images/Las_Cifras_del_Cancer_en_Espanya_2026.pdf
[12] European Health Data Space, 2025. Regulation (EU) 2025/327. https://european-health-data-space.com/
[13] The PBC Group, Mar 2026. The European Health Data Space in 2026. https://www.thepbcgroup.com/post/the-european-health-data-space-in-2026
[14] European Medical Journal, Nov 2025. Pharma in Spain. https://www.emjreviews.com/emj-gold/article/pharma-in-spain/
[15] EIT Health / Farmaindustria, 2024. Implementation of European Health Data Space in Spain: is it really feasible?. https://www.eit.europa.eu/sites/default/files/2024-12/Report%20EHDS_Spain_ENG.pdf
[16] Distefar del Sur, Jan 2026. Spain again leads clinical trials in Europe. https://distefar.com/en/espana-vuelve-a-liderar-los-ensayos-clinicos-en-europa-pero-afronta-el-reto-de-competir-en-la-carrera-biomedica-global-2/
