스페인의 체외(In-vitro) 진단 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The Spain IVD market size stands at USD 2.51 billion in 2025 and is forecast to reach USD 3.13 billion by 2030, expanding at a 4.55% CAGR.

Continued momentum is rooted in an aging population, higher chronic-disease incidence, and the country's full transition to the EU In Vitro Diagnostic Regulation (IVDR). Strong demand for frequent renal, diabetes, and hypertension screening is lifting test volumes, while hospital groups in Madrid and Catalonia are modernizing laboratories with AI-enabled analyzers that shorten turnaround times. Molecular assay innovators are benefiting from European Investment Bank financing, and Spain's Digital Health Strategy is steering budgets toward connected instruments that meet IVDR traceability rules. At the same time, decentralized procurement across 17 autonomous communities is nudging suppliers toward value-based contracts that link reagent spending to clinical outcomes.

Spain In-vitro Diagnostics Market Trends and Insights

Rising Burden of Chronic & Lifestyle Diseases

About 15.1% of Spanish adults live with chronic kidney disease, a figure that continues to climb with population aging. Higher prevalence of diabetes, cancer, and cardiovascular disorders is prompting earlier, more frequent testing in primary care clinics. The CARABELA-CKD program standardizes nephrology pathways and lifts demand for creatinine, eGFR, and micro-albumin tests across the Spain IVD market. Laboratories in Galicia and Asturias report double-digit yearly increases in renal panels, pushing reagent distributors to boost stock levels. Regional health authorities now bundle screening targets into hospital financing agreements, an approach that ties purchasing volumes to chronic-care metrics. Collectively, these factors underpin consistent baseline growth for routine and specialty assays.

Rapid Technological Innovation in Molecular & Immunodiagnostics

The European Investment Bank's EUR 20 million loan to Universal DX accelerates liquid-biopsy development for early colorectal-cancer detection. Spanish startups mix next-generation sequencing with machine-learning algorithms to profile multiple biomarkers in one run, lowering per-test costs. University hospitals in Valencia validate multiplex respiratory panels that deliver 90-minute results and reduce inpatient isolation days. Immunodiagnostic platforms now integrate chemiluminescent detection with automated calibration, raising sensitivity for thyroid and cardiac markers. As IVDR pushes traceability and performance benchmarking, local firms adopt cloud-based quality-control dashboards that feed directly into notified-body audits, strengthening compliance while sharpening competitive differentiation.

Stringent & Evolving EU IVDR Regulatory Landscape

Seventy-three percent of Spanish laboratories say they lack adequate guidance to complete IVDR conformity files. High-risk assays must meet new performance-study and post-market-surveillance rules by May 2025, yet notified-body capacity remains tight. The 2024/1860 amendment extends certain timelines but also adds supply-chain traceability duties, raising administrative workloads. Smaller reagent makers divert R&D budgets toward documentation, slowing product-pipeline turnover. Because each autonomous community interprets EU law through its own procurement filters, suppliers face variable local checklists that complicate national launches.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Point-of-Care Testing Across Primary & Home Settings
2. Government & EU Investment Programs for Digital Lab Modernization
3. Regional Reimbursement Delays & Budget Constraints

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Clinical chemistry generated 28.5% of the Spain IVD market size in 2024, supported by its central role in metabolic, renal, and hepatic panels. Routine analyzers achieve high throughput and cost efficiency, which stabilizes reagent demand. However, molecular diagnostics is posting a 9.6% CAGR as hospitals expand oncology and infectious-disease gene testing. The Spain IVD market benefits from Seegene and Werfen's joint venture, which promises syndromic PCR menus tailored to local antimicrobial-resistance profiles. As next-generation sequencing costs fall, regional centers pilot cancer-risk screening programs financed through EU innovation funds, cementing growth.

A shift toward hybrid panels that combine immunoassay and PCR markers blurs traditional segment boundaries. Laboratories deploy reflex-testing protocols that trigger confirmatory molecular runs after abnormal chemistry results, raising cross-segment reagent consumption. IVDR mandates traceable lot-release data, encouraging integration of chemistry and molecular middleware. These developments reinforce molecular diagnostics' strategic importance while ensuring clinical chemistry retains volume leadership in the Spain IVD market.

Reagents & consumables represented 71% of the Spain IVD market share in 2024, reflecting high test frequency and replenishment cycles. Automated inventory modules tied to laboratory-information systems trim expiry-related wastage, yet tight tender pricing keeps margins thin. Software & services-currently under 10% of revenues-will outpace other categories at an 8.2% CAGR as digital pathology, cloud middleware, and AI analytics become procurement priorities. Hospitals adopt subscription models that bundle instrument leasing with predictive-maintenance modules, converting capital outlays into operating expenses.

Instrument vendors now embed open APIs so third-party algorithms can interrogate analyzer data, turning platforms into clinical-decision hubs. Spain's Digital Health Strategy sets interoperability standards that favor HL7-FHIR messaging, nudging suppliers to certify integrations. In turn, reagent makers collaborate with software firms to package quality-control dashboards, tying consumable sales to analytical-performance guarantees. This convergence between hardware, reagents, and analytics drives holistic purchasing decisions across the Spain IVD market.

The Spain In-Vitro Diagnostics Market Report is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, and More), Product (Instruments & Analyzers, Reagents, and More), Usability (Disposable IVD Devices and Reusable IVD Devices), Application (Infectious Diseases, Oncology, Cardiology, and More), and End Users (Diagnostic Laboratories, Hospitals and More). The Market Forecasts are Provided in Terms of Value (USD).

List of Companies Covered in this Report:

1. Abbott Laboratories
2. Danaher Corporation (Beckman Coulter, Cepheid)
3. Roche
4. Siemens Healthineers
5. Thermo Fisher Scientific
6. bioMerieux
7. Beckton Dickinson
8. Bio-Rad Laboratories
9. QIAGEN
10. Sysmex
11. Werfen Group (Instrumentation Laboratory)
12. Grifols
13. Diasorin S.p.A.
14. Eurofins
15. Illumina
16. Hologic
17. Nova Biomedical
18. Sekisui Diagnostics
19. Randox Laboratories
20. Operon S.A.
21. Fujifilm Wako

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Burden of Chronic & Lifestyle Diseases (Diabetes, CVD, Cancer)
  • 4.2.2 Rapid Technological Innovation in Molecular & Immunodiagnostics
  • 4.2.3 Expansion of Point-of-Care Testing Across Primary & Home Settings
  • 4.2.4 Government & EU Investment Programs for Digital Lab Modernization
  • 4.2.5 Growth of Precision Medicine & Companion Diagnostics Adoption
• 4.3 Market Restraints
  • 4.3.1 Stringent & Evolving EU IVDR Regulatory Landscape
  • 4.3.2 Regional Reimbursement Delays & Budget Constraints
  • 4.3.3 Shortage of Skilled Laboratory Personnel & Training Gaps
• 4.4 Regulatory Outlook
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Competitive Rivalry Intensity

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Test Type
  • 5.1.1 Clinical Chemistry
  • 5.1.2 Immunodiagnostics
  • 5.1.3 Molecular Diagnostics
  • 5.1.4 Hematology
  • 5.1.5 Microbiology
  • 5.1.6 Coagulation
  • 5.1.7 Point-of-Care (POC) Tests
• 5.2 By Product
  • 5.2.1 Instruments & Analyzers
  • 5.2.2 Reagents & Consumables
  • 5.2.3 Software & Services
• 5.3 By Usability
  • 5.3.1 Disposable IVD Devices
  • 5.3.2 Reusable IVD Devices
• 5.4 By Application
  • 5.4.1 Infectious Disease
  • 5.4.2 Diabetes
  • 5.4.3 Oncology (Cancer)
  • 5.4.4 Cardiology
  • 5.4.5 Autoimmune Disorders
  • 5.4.6 Other Applications
• 5.5 By End-User
  • 5.5.1 Hospitals & Clinics
  • 5.5.2 Diagnostic Laboratories
  • 5.5.3 Academic & Research Institutes
  • 5.5.4 Home-Care / Ambulatory POC Settings
  • 5.5.5 Other End-Users

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Danaher Corporation (Beckman Coulter, Cepheid)
  • 6.3.3 F. Hoffmann-La Roche AG
  • 6.3.4 Siemens Healthineers AG
  • 6.3.5 Thermo Fisher Scientific Inc.
  • 6.3.6 bioMerieux SA
  • 6.3.7 Becton, Dickinson and Company
  • 6.3.8 Bio-Rad Laboratories Inc.
  • 6.3.9 QIAGEN N.V.
  • 6.3.10 Sysmex Corporation
  • 6.3.11 Werfen Group (Instrumentation Laboratory)
  • 6.3.12 Grifols S.A.
  • 6.3.13 Diasorin S.p.A.
  • 6.3.14 Eurofins Scientific SE
  • 6.3.15 Illumina Inc.
  • 6.3.16 Hologic Inc.
  • 6.3.17 Nova Biomedical
  • 6.3.18 Sekisui Diagnostics
  • 6.3.19 Randox Laboratories
  • 6.3.20 Operon S.A.
  • 6.3.21 Fujifilm Wako

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment