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The Market for Contract Manufacturing in In Vitro Diagnostics (IVD)

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SKU: 22-706 Categories: Diagnostics Market Research, in vitro diagnostic, IVD Tags: blood grouping, Clinical Chemistry, clinical laboratory, Coagulation, Contract Manufacturing, cytology, Hematology, histology, Immunoassay, in vitro diagnostics, ivd, Microbiology, molecular assays, POC, point of care Pages: 144
  • Description
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Description

The global in vitro diagnostic (IVD) industry incorporates a sizable contract manufacturing segment that supplies a full range of reagents and test kits, instruments and systems, and testing accessories. Already a multi-billion dollar market, this segment is well positioned to generate favorable long-term growth, as detailed in this report, The Market for Contract Manufacturing in IVD. Most leading worldwide of producers of proprietary IVD systems will increase their reliance on outside contractors as a cost-effective means to:

  • expand existing product lines
  • broaden access to IVD testing technologies
  • increase access to manufacturing capacity without capital investment
  • quickly introduce tests and testing systems for newly emerging diseases and disorders (e.g., COVID-19, Monkeypox, etc.)
  • gain support for regulatory filings
  • penetrate high growth applications especially in the area of point-of-care (POC) testing
  • meet the specialized testing needs of major end users

Contract manufacturing also enables new and smaller IVD producers to build up product lines and increase competitiveness in the marketplace. Moreover, the segment is the major source of private label tests, instruments, and accessories sold by medical supply and device distributors, home healthcare outlets, and drug stores.  Private label applications have expanded considerably over the past few years largely due to the impact of the COVID-19 pandemic.

Scope and Methodology

This report examines global trends in the contract IVD manufacturing business.  The analysis is divided into:

  • technology (immunoassay, clinical chemistry, molecular assays, microbiology, hematology, histology/cytology, coagulation, blood grouping, and other),
  • product (reagents and test kits, instruments and systems, and accessories),
  • and end-use applications (point-of-care and clinical laboratory).

The report also discusses contract IVD services in non-manufacturing areas such as assay development, instrument design, regulatory filings, and packaging.

Principal customers for contract IVD manufacturing and non-manufacturing services include traditional IVD product producers, medical supply distributors, drug stores and mass merchandisers, and Internet and mail order enterprises. Global revenues generated by these services are expressed in current United States dollars and reflect estimates for the year 2021 and forecasts for each year in the 2022 to 2026 period.

Table of Contents

Chapter 1: Executive Summary

Global Market Outlook – Contract IVD Manufacturing

  • Table 1-1: Summary Table – Global Contract IVD Manufacturing Market, 2021-2026 (million dollars)

Scope and Methodology

 

Chapter 2: Market Environment

Overview

Global Economic Outlook

  • Table 2-1: Gross Domestic Product by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (billion dollars)

Per Capita Gross Domestic Product

  • Table 2-2: Per Capita Gross Domestic Product by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (dollars)

Population

  • Table 2-3: Population by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million persons)

Age Distribution

Population 50 Years & Older

  • Table 2-4: Population 50 Years & Older by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million persons)
  • Table 2-5: Percentage of Population 50 Years & Older by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million persons)

Population 65 Years & Older

  • Table 2-6: Population 65 Years & Older by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million persons)
  • Table 2-7: Percentage of Population 65 Years & Older by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million persons)

Global Healthcare Trends

Medical Conditions

Health Expenditures

  • Table 2-8: Health Expenditures by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (billion dollars)
  • Table 2-9: Per Capita Health Expenditures by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (dollars)

Hospital Beds

  • Table 2-10: Number of Hospital Beds by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (thousands)
  • Table 2-11: Number of Hospital Beds Per 1,000 Capita by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026

Physicians

  • Table 2-12: Number of Practicing Physicians by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (thousands)
  • Table 2-13: Number of Practicing Physicians Per 1,000 Capita by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026

Patient Activity

Acute Care Hospital Admissions

  • Table 2-14: Number of Acute Care Hospital Admissions by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (thousands)
  • Table 2-15: Number of Acute Care Hospital Admissions Per 1,000 Capita by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026

Surgical Procedures

  • Table 2-16: Number of Surgical Procedures by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East),  2021-2026 (thousands)
  • Table 2-17: Number of Surgical Procedures Per 1,000 Capita by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026

Physicians’ Consultations

  • Table 2-18: Number of Physicians’ Consultations by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (millions)
  • Table 2-19: Number of Physicians’ Consultations Per Capita by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East),  2021-2026

IVD Tests

  • Table 2-20: Number of IVD Tests by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (millions)
  • Table 2-21: Number of IVD Tests Per Capita by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East),  2021-2026

 

Chapter 3: IVD Products

Industry Overview

  • Table 3-1: Global IVD Product Demand by Technology (Immunoassay, Clinical Chemistry, Molecular, Microbiology, Hematology, Coagulation, Histology/Cytology, and Blood Grouping), 2021-2026 (million dollars)

IVD Product Demand by Technology

Immunoassays

Clinical Chemistry

Molecular IVD Technology

Microbiology

Hematology

Coagulation

Histology/Cytology

Blood Grouping

Other IVD Technologies

Product Groups

  • Table 3-2: Global IVD Demand by Product Group (Reagents & Test Kits, Instruments & Systems, Supplies & Accessories), 2021-2026 (million dollars)

IVD Reagents & Test Kits

  • Table 3-3: Global IVD Reagents & Test Kits Demand by Technology (Point-of-Care, Clinical Laboratory, Immunoassay, Clinical Chemistry, Molecular, Microbiology, Hematology, Coagulation, Histology/Cytology, and Blood Grouping), 2021-2026 (million dollars)

IVD Instruments & Systems

  • Table 3-4: Global IVD Instruments & Systems Demand by Technology (Point-of-Care, Clinical Laboratory, Immunoassay, Clinical Chemistry, Molecular, Microbiology, Hematology, Coagulation, Histology/Cytology, and Blood Grouping), 2021-2026 (million dollars)

IVD Supplies & Accessories

  • Table 3-5: Global IVD Supplies & Accessories Demand by Technology (Point-of-Care, Clinical Laboratory, Immunoassay, Clinical Chemistry, Molecular, Microbiology, Hematology, Coagulation, Histology/Cytology, and Blood Grouping), 2021-2026 (million dollars)

Production by Region

  • Table 3-6: Global IVD Production Value by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million dollars)

 

Chapter 4: Contract IVD Manufacturing

Market Overview

Market Forecast

  • Table 4-1: Global Contract IVD Manufacturing Demand by Technology (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million dollars)

Regional Trends

  • Table 4-2: Global Contract IVD Manufacturing Demand by Country/Region (North America, Western Europe, Asia/Pacific, Central & South America, Eastern Europe, and Africa/Middle East), 2021-2026 (million dollars)

Product Groups

  • Table 4-3: Global Contract IVD Manufacturing Demand by Product Group (Reagents & Test Kits, Instruments & Systems, and Supplies & Accessories), 2021-2026 (million dollars)

Contract Immunoassay Products

Overview

Types of Immunoassays

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-4: Global Contract Immunoassay Demand by Product Group (Immunoassay Demand, Contract Immunoassay demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract Clinical Chemistry Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-5: Global Contract Clinical Chemistry Demand by Product Group (Clinical Chemical Demand, Contract Clinical Chemistry Demand, Instruments/Systems, and Supplies and Accessories), 2021-2026 (million dollars)

Contract Molecular Diagnostic Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-6: Global Contract Molecular IVD Demand by Product Group (Molecular IVD Demand, Contract Molecular IVD Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract Microbiology IVD Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-7: Global Contract Microbiology Demand by Product Group (Microbiology Demand, Contract Microbiology Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract Hematology Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-8: Global Contract Hematology Demand by Product Group (Hematology Demand, Contract Hematology Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract Histology/Cytology Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-9: Global Contract Histology/Cytology Demand by Product Group (Histology/Cytology Demand, Contract Histology/Cytology Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract Coagulation IVD Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-10: Global Contract Coagulation IVD Demand by Product Group (Coagulation IVD Demand, Contract Coagulation IVD Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract Blood Grouping IVD Products

Overview

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-11: Global Contract Blood Grouping Demand by Product Group (Blood Grouping Demand, Contract Blood Grouping Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Other Contract IVD Products

Overview

Types of Tests

Contract Manufacturing Opportunities

Contract Manufacturing Companies

  • Table 4-12: Global Other Contract IVD Demand by Product Group (Other IVD Demand, Other Contract IVD Demand, Instruments/Systems, and Supplies/Accessories), 2021-2026 (million dollars)

Contract IVD Market Segments

  • Table 4-13: Global Contract IVD Demand by Market Segment (Point-of Care: Immunoassay, Clinical Chemistry, Molecular, Hematology, Microbiology, and Coagulation; and Central Laboratory: Immunoassay, Clinical Chemistry, Molecular, Histology/Cytology, Microbiology, Coagulation, and Blood Grouping), 2021-2026 (million dollars)

 

Chapter 5: Industry Structure

Industry Concentration

Regulation

Competitive Strategies

Company Briefs

Aalto Scientific, Ltd.

Abingdon Health

ACON Laboratories, Inc.

Advy Chemical Pvt. Ltd.

Affinity Life Sciences, Inc.

AgaMatrix

Antibodies Incorporated

Arbor Assays LLC

AsureQuality Australia Pty. Ltd.

Auer Precision

BIT Group GmbH

Calbiotech

Calzyme Laboratories, Inc.

Celestica Inc.

Cenogenics Corporation

Core Bioproducts

Coris BioConcept

Custom Diagnostics

DCN Dx

Denka Company Limited

DiAgam

DiaCarta

EKF Diagnostic Holdings plc

Fapon Biotech Inc.

Guilin Royalyze Medical Instrument Co. Ltd.

Hardy Diagnostics

Icosagen AS

IDxDI

In Vitro Diagnostic Solutions LLC

InBios International Inc.

Innovize, Inc.

Inteprod LLC

IXpressGenes, Inc.

Jabil Inc.

KMC Systems, Inc.

Lampire Biological Laboratories Inc.

LRE Medical GmbH

Maxim Biomedical Inc.

MilliporeSigma

Natech Plastics

Nova Biomedical Corporation

Phillips-Medisize

Plexus Corporation

Promega Corporation

Quantimetrix Corporation

Sanmina Corporation

Savyon Diagnostics

Sclavo Diagnostics International srl

SMC Ltd.

STRATEC SE

Surmodics Inc.

TCS Biosciences Ltd.

Teco Diagnostics

Thermo Fisher Scientific Inc.

Tulip Diagnostics Private Limited

Veranex

Werfen

    Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 12th Edition
    May 13, 2025
    In Vitro Diagnostic (IVD) Trends and Market Update, 2025
    April 7, 2025
    In Vitro Diagnostics Business Outlook, 2025 (6 Issues)
    April 3, 2025
    Molecular Diagnostics Quarterly Datastream, 2025
    April 2, 2025

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