체외진단용 기기 수탁제조 시장 규모, 점유율, 성장 분석 : 제품 유형별, 기술별, 서비스 유형별, 지역별 - 업계 예측(2026-2033년)

IVD Contract Manufacturing Market size was valued at USD 18.44 Billion in 2024 and is poised to grow from USD 20.57 Billion in 2025 to USD 49.51 Billion by 2033, growing at a CAGR of 11.6% during the forecast period (2026-2033).

The IVD contract manufacturing market is poised for significant growth, fueled by the rising focus on personalized medicine, gene expression, and biomarker discovery. This trend is propelling demand for standardized diagnostic solutions, particularly in emerging markets where healthcare costs continue to climb. Advancements in diagnostic technologies like digital pathology, next-generation sequencing, and advanced imaging are further driving the need for innovative diagnostics. A diverse array of in vitro diagnostics, from personalized pregnancy tests to complex clinical assays, enhances market dynamics. Additionally, the increasing adoption of IVD devices within the pharmaceutical sector and the rising interest in point-of-care monitoring contribute to the market's expansion. Collaboration among key players will play a crucial role in advancing this segment of the industry.

Top-down and bottom-up approaches were used to estimate and validate the size of the IVD Contract Manufacturing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

IVD Contract Manufacturing Market Segments Analysis

Global IVD Contract Manufacturing Market is segmented into Product Type, Technology, Service Type, and region. By Product Type, the market is classified into Consumables, and Equipment. Depending on the Technology, it is categorized into Immunoassays, Clinical Chemistry, Molecular Diagnostics, Hematology, Microbiology, Coagulation & Hemostasis, and Other Technologies. According to Service Type, the market is divided into Manufacturing Services, Assay Development, and Other Services. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Driver of the IVD Contract Manufacturing Market

The rising prevalence of chronic conditions like diabetes, cancer, and heart disease is significantly boosting the demand for sophisticated In Vitro Diagnostics (IVD) devices. This surge is propelling the growth of the IVD contract manufacturing market, as manufacturers strive to enhance productivity to tackle global health challenges effectively. In this context, contract manufacturers are essential in delivering cost-efficient, high-quality solutions to IVD companies, enabling them to comply with stringent regulatory requirements. As healthcare needs evolve, the partnership between IVD firms and contract manufacturers becomes increasingly vital in ensuring the availability of innovative diagnostic tools that address pressing health concerns.

Restraints in the IVD Contract Manufacturing Market

The IVD contract manufacturing market encounters notable challenges associated with costs. The process of developing and producing in vitro diagnostic devices demands substantial financial investments in research, regulatory compliance, and manufacturing infrastructure. Such elevated expenses can serve as a barrier for small and medium-sized enterprises, making it difficult for them to enter the market and hindering overall growth in the industry. Consequently, the financial burden of innovation and production capabilities may limit competition and the introduction of new technologies, affecting the market dynamics and potential advancements within the IVD sector.

Market Trends of the IVD Contract Manufacturing Market

The IVD Contract Manufacturing market is witnessing a significant trend towards outsourcing production to emerging markets, particularly in the Asia-Pacific region. Companies are increasingly attracted to these areas due to lower labor costs and the availability of skilled personnel, which facilitate efficient manufacturing processes. This shift not only helps reduce operational expenses but also allows manufacturers to leverage the burgeoning demand for in vitro diagnostic products in these fast-growing markets. As a result, the focus on cost-effective production solutions and access to a skilled workforce is reshaping the landscape of the IVD industry, driving growth and innovation.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Driver & Opportunities
  • Restraints & Challenges
• Porters Analysis & Impact
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Technological Advancement
• Regulatory Landscape
• Patent Analysis
• Value Chain Analysis
• Case Study Analysis
• Customer & Buying Criteria Analysis
• Market Attractiveness Index
• Supply Chain Analysis
• Pricing Analysis

Global IVD Contract Manufacturing Market Size by Product Type & CAGR (2026-2033)

• Market Overview
• Consumables
• Equipment

Global IVD Contract Manufacturing Market Size by Technology & CAGR (2026-2033)

• Market Overview
• Immunoassays
• Clinical Chemistry
• Molecular Diagnostics
• Hematology
• Microbiology
• Coagulation & Hemostasis
• Other Technologies

Global IVD Contract Manufacturing Market Size by Service Type & CAGR (2026-2033)

• Market Overview
• Manufacturing Services
• Assay Development
• Other Services

Global IVD Contract Manufacturing Market Size & CAGR (2026-2033)

• North America, (Product Type, Technology, Service Type)
  • US
  • Canada
• Europe, (Product Type, Technology, Service Type)
  • UK
  • Germany
  • Spain
  • France
  • Italy
  • Rest of Europe
• Asia-Pacific, (Product Type, Technology, Service Type)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America, (Product Type, Technology, Service Type)
  • Brazil
  • Rest of Latin America
• Middle East & Africa, (Product Type, Technology, Service Type)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

• Jabil Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanmina Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• TE Connectivity
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celestica, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• West Pharmaceutical Services, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Savyon Diagnostics, Ltd.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• KMC Systems
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cenogenics Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nova Biomedical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cone Bioproducts
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Kimball Electronics, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Roche Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Viant Medical Holdings, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Stratec SE
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific, Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fujirebio
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biokit (Werfen)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sekisui
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Prestige Diagnostics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendation