PUBLISHER: Bizwit Research & Consulting LLP | PRODUCT CODE: 1881364
PUBLISHER: Bizwit Research & Consulting LLP | PRODUCT CODE: 1881364
Global IVD Contract Manufacturing Market Size Study & Forecast, by Device Type by Technology and Service and Regional Forecasts 2025-2035
The Global IVD Contract Manufacturing Market is valued at approximately USD 14.2 billion in 2024 and is projected to expand at a robust CAGR of 11.50% during the forecast period 2025-2035. IVD contract manufacturing encompasses the outsourcing of production and assay development for in-vitro diagnostic devices, allowing companies to leverage specialized manufacturing expertise, ensure regulatory compliance, and optimize cost-efficiency. The growing emphasis on diagnostic testing, increasing prevalence of chronic diseases, and rising demand for rapid, reliable diagnostic solutions are driving the market's expansion. Technological advancements in molecular diagnostics and immunoassay platforms, coupled with strategic partnerships and collaborations, further propel market growth globally.
The intensifying focus on precision diagnostics and scalable production has led to a surge in demand for IVD contract manufacturing services. With hospitals, diagnostic laboratories, and biotech firms seeking specialized contract partners to streamline production and enhance assay performance, the market is witnessing significant traction. According to recent industry data, global demand for in-vitro diagnostic tests continues to accelerate, underpinned by the need for early disease detection and personalized medicine. Simultaneously, increasing regulatory complexities and the high cost of advanced diagnostic platforms challenge market participants, shaping the competitive landscape throughout the forecast period.
The detailed segments and sub-segments included in the report are:
By Device Type:
- Consumables
- Equipment
By Technology:
- Immunoassay
- Clinical Chemistry
- Molecular Diagnostics
- Microbiology
- Hematology
- Coagulation
By Service:
- Manufacturing
- Assay Development
By Region:
North America
- U.S.
- Canada
Europe
- UK
- Germany
- France
- Spain
- Italy
- ROE
Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- RoAPAC
Latin America
- Brazil
- Mexico
Middle East & Africa
- UAE
- Saudi Arabia
- South Africa
- Rest of Middle East & Africa
Consumables Segment Expected to Dominate the Market
Consumables represent the dominant device type segment, primarily due to their recurring demand across diagnostic laboratories and healthcare facilities. The segment's preeminence is supported by high-volume usage, the continuous need for reagent kits, and advancements in consumable technologies that enhance assay sensitivity and throughput. As laboratories increasingly adopt automated workflows, the demand for high-quality consumables continues to accelerate, solidifying its market leadership.
Immunoassay Technology Leads in Revenue Contribution
Currently, immunoassay-based diagnostics account for the largest revenue share, attributed to their widespread application in detecting infectious diseases, hormones, and biomarkers. This technology benefits from extensive clinical validation, broad adoption across laboratories, and continuous innovation in multiplexed assay formats, making it the principal revenue driver within the IVD technology segment.
The Global IVD Contract Manufacturing Market exhibits substantial regional variation, with North America leading due to advanced healthcare infrastructure, stringent quality standards, and high adoption of cutting-edge diagnostic technologies. Europe maintains a significant presence supported by strong regulatory frameworks and established diagnostic manufacturing hubs. Asia Pacific is anticipated to emerge as the fastest-growing market owing to increasing healthcare expenditure, expansion of diagnostic laboratories, and rising prevalence of chronic and infectious diseases. Latin America and the Middle East & Africa are gradually increasing their market share, fueled by growing diagnostic awareness and strategic investments in manufacturing partnerships.
Major market players included in this report are:
- Thermo Fisher Scientific Inc.
- Danaher Corporation
- Agilent Technologies, Inc.
- Roche Diagnostics
- Siemens Healthineers
- PerkinElmer, Inc.
- QIAGEN N.V.
- Bio-Rad Laboratories, Inc.
- Charles River Laboratories International, Inc.
- Abbott Laboratories
- Lonza Group AG
- Wuxi AppTec
- Maccura Biotechnology
- Greiner Bio-One International
- Sysmex Corporation
Global IVD Contract Manufacturing Market Report Scope:
- Historical Data - 2023, 2024
- Base Year for Estimation - 2024
- Forecast period - 2025-2035
- Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
- Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
- Customization Scope - Free report customization (equivalent to up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*
The objective of the study is to define market sizes of different segments and countries in recent years and to forecast the values for the coming years. The report incorporates both qualitative and quantitative aspects of the industry, providing detailed insights into growth drivers, market challenges, and emerging opportunities. Additionally, it highlights competitive dynamics, key strategies of leading players, and prospective investment opportunities in micro-markets.
Key Takeaways:
- Market Estimates & Forecast for 10 years from 2025 to 2035.
- Annualized revenues and regional-level analysis for each market segment.
- Detailed analysis of the geographical landscape with country-level insights.
- Competitive landscape with information on major players in the market.
- Analysis of key business strategies and recommendations on future market approach.
- Analysis of the competitive structure of the market.
- Demand side and supply side analysis of the market.
Table of Contents
Chapter 1. Global IVD Contract Manufacturing Market Report Scope & Methodology
- 1.1. Research Objective
- 1.2. Research Methodology
- 1.2.1. Forecast Model
- 1.2.2. Desk Research
- 1.2.3. Top Down and Bottom-Up Approach
- 1.3. Research Attributes
- 1.4. Scope of the Study
- 1.4.1. Market Definition
- 1.4.2. Market Segmentation
- 1.5. Research Assumption
- 1.5.1. Inclusion & Exclusion
- 1.5.2. Limitations
- 1.5.3. Years Considered for the Study
Chapter 2. Executive Summary
- 2.1. CEO/CXO Standpoint
- 2.2. Strategic Insights
- 2.3. ESG Analysis
- 2.4. key Findings
Chapter 3. Global IVD Contract Manufacturing Market Forces Analysis
- 3.1. Market Forces Shaping The Global IVD Contract Manufacturing Market (2024-2035)
- 3.2. Drivers
- 3.2.1. growing emphasis on diagnostic testing
- 3.2.2. increasing prevalence of chronic diseases
- 3.3. Restraints
- 3.3.1. increasing regulatory complexities and the high cost of advanced diagnostic platforms
- 3.4. Opportunities
- 3.4.1. rising demand for rapid, reliable diagnostic solutions
Chapter 4. Global IVD Contract Manufacturing Industry Analysis
- 4.1. Porter's 5 Forces Model
- 4.1.1. Bargaining Power of Buyer
- 4.1.2. Bargaining Power of Supplier
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
- 4.2. Porter's 5 Force Forecast Model (2024-2035)
- 4.3. PESTEL Analysis
- 4.3.1. Political
- 4.3.2. Economical
- 4.3.3. Social
- 4.3.4. Technological
- 4.3.5. Environmental
- 4.3.6. Legal
- 4.4. Top Investment Opportunities
- 4.5. Top Winning Strategies (2025)
- 4.6. Market Share Analysis (2024-2025)
- 4.7. Global Pricing Analysis And Trends 2025
- 4.8. Analyst Recommendation & Conclusion
Chapter 5. Global IVD Contract Manufacturing Market Size & Forecasts by Device Type 2025-2035
- 5.1. Market Overview
- 5.2. Global IVD Contract Manufacturing Market Performance - Potential Analysis (2025)
- 5.3. Consumables
- 5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.3.2. Market size analysis, by region, 2025-2035
- 5.4. Equipment
- 5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.4.2. Market size analysis, by region, 2025-2035
Chapter 6. Global IVD Contract Manufacturing Market Size & Forecasts by Technology 2025-2035
- 6.1. Market Overview
- 6.2. Global IVD Contract Manufacturing Market Performance - Potential Analysis (2025)
- 6.3. Immunoassay
- 6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.3.2. Market size analysis, by region, 2025-2035
- 6.4. Clinical Chemistry
- 6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.4.2. Market size analysis, by region, 2025-2035
- 6.5. Molecular Diagnostics
- 6.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.5.2. Market size analysis, by region, 2025-2035
- 6.6. Microbiology
- 6.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.6.2. Market size analysis, by region, 2025-2035
- 6.7. Hematology
- 6.7.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.7.2. Market size analysis, by region, 2025-2035
- 6.8. Coagulation
- 6.8.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.8.2. Market size analysis, by region, 2025-2035
Chapter 7. Global IVD Contract Manufacturing Market Size & Forecasts by Service 2025-2035
- 7.1. Market Overview
- 7.2. Global IVD Contract Manufacturing Market Performance - Potential Analysis (2025)
- 7.3. Manufacturing
- 7.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.3.2. Market size analysis, by region, 2025-2035
- 7.4. Assay Development
- 7.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.4.2. Market size analysis, by region, 2025-2035
Chapter 8. Global IVD Contract Manufacturing Market Size & Forecasts by Region 2025-2035
- 8.1. Growth IVD Contract Manufacturing Market, Regional Market Snapshot
- 8.2. Top Leading & Emerging Countries
- 8.3. North America IVD Contract Manufacturing Market
- 8.3.1. U.S. IVD Contract Manufacturing Market
- 8.3.1.1. Device Type breakdown size & forecasts, 2025-2035
- 8.3.1.2. Technology breakdown size & forecasts, 2025-2035
- 8.3.1.3. Service breakdown size & forecasts, 2025-2035
- 8.3.2. Canada IVD Contract Manufacturing Market
- 8.3.2.1. Device Type breakdown size & forecasts, 2025-2035
- 8.3.2.2. Technology breakdown size & forecasts, 2025-2035
- 8.3.2.3. Service breakdown size & forecasts, 2025-2035
- 8.3.1. U.S. IVD Contract Manufacturing Market
- 8.4. Europe IVD Contract Manufacturing Market
- 8.4.1. UK IVD Contract Manufacturing Market
- 8.4.1.1. Device Type breakdown size & forecasts, 2025-2035
- 8.4.1.2. Technology breakdown size & forecasts, 2025-2035
- 8.4.1.3. Service breakdown size & forecasts, 2025-2035
- 8.4.2. Germany IVD Contract Manufacturing Market
- 8.4.2.1. Device Type breakdown size & forecasts, 2025-2035
- 8.4.2.2. Technology breakdown size & forecasts, 2025-2035
- 8.4.2.3. Service breakdown size & forecasts, 2025-2035
- 8.4.3. France IVD Contract Manufacturing Market
- 8.4.3.1. Device Type breakdown size & forecasts, 2025-2035
- 8.4.3.2. Technology breakdown size & forecasts, 2025-2035
- 8.4.3.3. Service breakdown size & forecasts, 2025-2035
- 8.4.4. Spain IVD Contract Manufacturing Market
- 8.4.4.1. Device Type breakdown size & forecasts, 2025-2035
- 8.4.4.2. Technology breakdown size & forecasts, 2025-2035
- 8.4.4.3. Service breakdown size & forecasts, 2025-2035
- 8.4.5. Italy IVD Contract Manufacturing Market
- 8.4.5.1. Device Type breakdown size & forecasts, 2025-2035
- 8.4.5.2. Technology breakdown size & forecasts, 2025-2035
- 8.4.5.3. Service breakdown size & forecasts, 2025-2035
- 8.4.6. Rest of Europe IVD Contract Manufacturing Market
- 8.4.6.1. Device Type breakdown size & forecasts, 2025-2035
- 8.4.6.2. Technology breakdown size & forecasts, 2025-2035
- 8.4.6.3. Service breakdown size & forecasts, 2025-2035
- 8.4.1. UK IVD Contract Manufacturing Market
- 8.5. Asia Pacific IVD Contract Manufacturing Market
- 8.5.1. China IVD Contract Manufacturing Market
- 8.5.1.1. Device Type breakdown size & forecasts, 2025-2035
- 8.5.1.2. Technology breakdown size & forecasts, 2025-2035
- 8.5.1.3. Service breakdown size & forecasts, 2025-2035
- 8.5.2. India IVD Contract Manufacturing Market
- 8.5.2.1. Device Type breakdown size & forecasts, 2025-2035
- 8.5.2.2. Technology breakdown size & forecasts, 2025-2035
- 8.5.2.3. Service breakdown size & forecasts, 2025-2035
- 8.5.3. Japan IVD Contract Manufacturing Market
- 8.5.3.1. Device Type breakdown size & forecasts, 2025-2035
- 8.5.3.2. Technology breakdown size & forecasts, 2025-2035
- 8.5.3.3. Service breakdown size & forecasts, 2025-2035
- 8.5.4. Australia IVD Contract Manufacturing Market
- 8.5.4.1. Device Type breakdown size & forecasts, 2025-2035
- 8.5.4.2. Technology breakdown size & forecasts, 2025-2035
- 8.5.4.3. Service breakdown size & forecasts, 2025-2035
- 8.5.5. South Korea IVD Contract Manufacturing Market
- 8.5.5.1. Device Type breakdown size & forecasts, 2025-2035
- 8.5.5.2. Technology breakdown size & forecasts, 2025-2035
- 8.5.5.3. Service breakdown size & forecasts, 2025-2035
- 8.5.6. Rest of APAC IVD Contract Manufacturing Market
- 8.5.6.1. Device Type breakdown size & forecasts, 2025-2035
- 8.5.6.2. Technology breakdown size & forecasts, 2025-2035
- 8.5.6.3. Service breakdown size & forecasts, 2025-2035
- 8.5.1. China IVD Contract Manufacturing Market
- 8.6. Latin America IVD Contract Manufacturing Market
- 8.6.1. Brazil IVD Contract Manufacturing Market
- 8.6.1.1. Device Type breakdown size & forecasts, 2025-2035
- 8.6.1.2. Technology breakdown size & forecasts, 2025-2035
- 8.6.1.3. Service breakdown size & forecasts, 2025-2035
- 8.6.2. Mexico IVD Contract Manufacturing Market
- 8.6.2.1. Device Type breakdown size & forecasts, 2025-2035
- 8.6.2.2. Technology breakdown size & forecasts, 2025-2035
- 8.6.2.3. Service breakdown size & forecasts, 2025-2035
- 8.6.1. Brazil IVD Contract Manufacturing Market
- 8.7. Middle East and Africa IVD Contract Manufacturing Market
- 8.7.1. UAE IVD Contract Manufacturing Market
- 8.7.1.1. Device Type breakdown size & forecasts, 2025-2035
- 8.7.1.2. Technology breakdown size & forecasts, 2025-2035
- 8.7.1.3. Service breakdown size & forecasts, 2025-2035
- 8.7.2. Saudi Arabia (KSA) IVD Contract Manufacturing Market
- 8.7.2.1. Device Type breakdown size & forecasts, 2025-2035
- 8.7.2.2. Technology breakdown size & forecasts, 2025-2035
- 8.7.2.3. Service breakdown size & forecasts, 2025-2035
- 8.7.3. South Africa IVD Contract Manufacturing Market
- 8.7.3.1. Device Type breakdown size & forecasts, 2025-2035
- 8.7.3.2. Technology breakdown size & forecasts, 2025-2035
- 8.7.3.3. Service breakdown size & forecasts, 2025-2035
- 8.7.1. UAE IVD Contract Manufacturing Market
Chapter 9. Competitive Intelligence
- 9.1. Top Market Strategies
- 9.2. Thermo Fisher Scientific Inc.
- 9.2.1. Company Overview
- 9.2.2. Key Executives
- 9.2.3. Company Snapshot
- 9.2.4. Financial Performance (Subject to Data Availability)
- 9.2.5. Product/Services Port
- 9.2.6. Recent Development
- 9.2.7. Market Strategies
- 9.2.8. SWOT Analysis
- 9.3. Danaher Corporation
- 9.4. Agilent Technologies, Inc.
- 9.5. Roche Diagnostics
- 9.6. Siemens Healthineers
- 9.7. PerkinElmer, Inc.
- 9.8. QIAGEN N.V.
- 9.9. Bio-Rad Laboratories, Inc.
- 9.10. Charles River Laboratories International, Inc.
- 9.11. Abbott Laboratories
- 9.12. Lonza Group AG
- 9.13. Wuxi AppTec
- 9.14. Maccura Biotechnology
- 9.15. Greiner Bio-One International
- 9.16. Sysmex Corporation
