世界の体外診断（IVD）受託製造市場は、2024年に約142億米ドルに達すると推定され、2025年から2035年の予測期間中は年平均成長率（CAGR）11.50%で堅調に成長すると予測されています。体外診断用（IVD）受託製造には、体外診断用機器の製造およびアッセイ開発のアウトソーシングが含まれており、企業は専門的な製造ノウハウを活用し、規制遵守を確保し、コスト効率を最適化することができます。診断検査への関心の高まり、慢性疾患の有病率の増加、そして迅速で信頼性の高い診断ソリューションへの需要の高まりが、市場の拡大を牽引しています。分子診断および免疫測定プラットフォームにおける技術の進歩は、戦略的パートナーシップや協業と相まって、世界的な市場成長をさらに促進します。
精密診断とスケーラブルな生産への注目が高まるにつれ、体外診断（IVD）の受託製造サービスに対する需要が急増しています。病院、診断ラボ、バイオテクノロジー企業が生産効率の向上と検査性能の向上を目指す専門の契約パートナーを求めていることから、市場は大きな牽引力を見せています。最近の業界データによると、早期疾患発見と個別化医療へのニーズを背景に、体外診断検査の世界的な需要は加速を続けています。同時に、規制の複雑化と高度な診断プラットフォームの高コスト化が市場参加者にとって課題となっており、予測期間全体を通して競争環境を形成しています。
消耗品は、主に診断ラボや医療施設における継続的な需要により、デバイスセグメントの中で主要な地位を占めています。このセグメントの優位性は、大量使用、試薬キットの継続的な需要、そしてアッセイの感度とスループットを向上させる消耗品技術の進歩によって支えられています。ラボにおける自動化ワークフローの導入が進むにつれて、高品質の消耗品に対する需要は加速し続け、市場リーダーシップを確固たるものにしています。
現在、免疫測定法に基づく診断は、感染症、ホルモン、バイオマーカーの検出における幅広い応用により、最大の収益シェアを占めています。この技術は、広範な臨床検証、検査室における幅広い導入、そしてマルチプレックスアッセイフォーマットの継続的なイノベーションの恩恵を受けており、IVD技術セグメントにおける主要な収益源となっています。
世界の体外診断用医薬品（IVD）契約製造市場は地域によって大きく異なり、先進的な医療インフラ、厳格な品質基準、最先端の診断技術の導入率の高さから、北アメリカが市場をリードしています。ヨーロッパは、強力な規制枠組みと確立された診断製造拠点に支えられ、大きな存在感を維持しています。アジア太平洋地域は、医療費の増加、診断ラボの拡大、慢性疾患および感染症の蔓延により、最も急速に成長する市場になると予想されています。ラテンアメリカと中東・アフリカは、診断への意識の高まりと製造パートナーシップへの戦略的投資を背景に、徐々に市場シェアを拡大しています。
本調査の目的は、近年における様々なセグメントおよび国における市場規模を定義し、今後数年間の価値を予測することです。本レポートは、業界の定性的および定量的側面の両方を網羅し、成長要因、市場課題、そして新たな機会に関する詳細な洞察を提供しています。さらに、競争のダイナミクス、主要プレーヤーの主要戦略、そしてマイクロ市場における潜在的な投資機会についても焦点を当てています。
目次
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
8.4. 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
8.5. 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
8.6. 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
8.7. 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
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
List of Tables
Table 1. Global IVD Contract Manufacturing Market, Report Scope
Table 2. Global IVD Contract Manufacturing Market Estimates & Forecasts By Region 2024-2035
Table 3. Global IVD Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 4. Global IVD Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 5. Global IVD Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 6. Global IVD Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 7. Global IVD Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 8. U.S. IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 9. Canada IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 10. UK IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 11. Germany IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 12. France IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 13. Spain IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 14. Italy IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 15. Rest Of Europe IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 16. China IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 17. India IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 18. Japan IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 19. Australia IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 20. South Korea IVD Contract Manufacturing Market Estimates & Forecasts, 2024-2035
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List of Figures
Fig 1. Global IVD Contract Manufacturing Market, Research Methodology
Fig 2. Global IVD Contract Manufacturing Market, Market Estimation Techniques
Fig 3. Global Market Size Estimates & Forecast Methods
Fig 4. Global IVD Contract Manufacturing Market, Key Trends 2025
Fig 5. Global IVD Contract Manufacturing Market, Growth Prospects 2024-2035
Fig 6. Global IVD Contract Manufacturing Market, Porter’s Five Forces Model
Fig 7. Global IVD Contract Manufacturing Market, Pestel Analysis
Fig 8. Global IVD Contract Manufacturing Market, Value Chain Analysis
Fig 9. IVD Contract Manufacturing Market By Application, 2025 & 2035
Fig 10. IVD Contract Manufacturing Market By Segment, 2025 & 2035
Fig 11. IVD Contract Manufacturing Market By Segment, 2025 & 2035
Fig 12. IVD Contract Manufacturing Market By Segment, 2025 & 2035
Fig 13. IVD Contract Manufacturing Market By Segment, 2025 & 2035
Fig 14. North America IVD Contract Manufacturing Market, 2025 & 2035
Fig 15. Europe IVD Contract Manufacturing Market, 2025 & 2035
Fig 16. Asia Pacific IVD Contract Manufacturing Market, 2025 & 2035
Fig 17. Latin America IVD Contract Manufacturing Market, 2025 & 2035
Fig 18. Middle East & Africa IVD Contract Manufacturing Market, 2025 & 2035
Fig 19. Global IVD Contract Manufacturing Market, Company Market Share Analysis (2025)
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