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The Market for Contract Manufacturing in IVD, 2022

Publication Date: September 2, 2022

SKU: 22-706

Tags: Coagulation, Contract Research and Manufacturing Orgs, COVID-19, Diagnostic Instruments, Genetic Diseases, Hematology, Histology and Cytology, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, Molecular Diagnostics, Oncology and Cancer, Point-of-Care (POC) Testing

Pages: 140

SKU: 22-706

The Market for Contract Manufacturing in In Vitro Diagnostics (IVD), 2022 provides valuable insights into the global in vitro diagnostic (IVD) industry’s contract manufacturing segment, covering market size, trends, and competitive analysis.

 

Report Highlights:

  • Market Overview:
    • Detailed examination of the multi-billion-dollar contract manufacturing segment within the IVD industry.
    • Analysis of how leading worldwide producers of proprietary IVD systems are increasingly relying on outside contractors to:
      • Expand existing product lines
      • Broaden access to IVD testing technologies
      • Increase manufacturing capacity without capital investment
      • Quickly introduce tests and systems for emerging diseases (e.g., COVID-19, Monkeypox)
      • Gain support for regulatory filings
      • Penetrate high-growth applications, especially in point-of-care (POC) testing
      • Meet specialized testing needs of major end users
  • Benefits for New and Smaller IVD Producers:
    • Discussion on how contract manufacturing enables new and smaller IVD producers to build up product lines and enhance competitiveness in the market.
    • Exploration of the segment’s role as a major source of private label tests, instruments, and accessories sold by medical supply distributors, home healthcare outlets, and drug stores.
    • Analysis of the expansion in private label applications, largely influenced by the COVID-19 pandemic.

 

Scope and Methodology:

  • Technology Segmentation:
    • In-depth analysis of contract IVD manufacturing by technology, including immunoassay, clinical chemistry, molecular assays, microbiology, hematology, histology/cytology, coagulation, blood grouping, and other technologies.
  • Product Segmentation:
    • Detailed segmentation by product, covering reagents and test kits, instruments and systems, and accessories.
  • End-Use Applications:
    • Examination of contract IVD manufacturing by end-use applications, focusing on point-of-care and clinical laboratory testing.
  • Non-Manufacturing Services:
    • Discussion on contract IVD services in non-manufacturing areas such as assay development, instrument design, regulatory filings, and packaging.

 

Market Insights:

  • Principal Customers:
    • Analysis of principal customers for contract IVD manufacturing and non-manufacturing services, including traditional IVD product producers, medical supply distributors, drug stores, mass merchandisers, and internet and mail-order enterprises.
  • Revenue Estimates:
    • Global revenue estimates for the year 2021 and forecasts for each year from 2022 to 2026, expressed in current US dollars.

 

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Table: Global IVD Demand, by Product Group, 2021-2026 (million dollars)

Product Group 2021 2022 2023 2024 2025 2026 CAGR
Reagents & Test Kits: $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Clinical Laboratory $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Point-of-Care $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
Instruments & Systems: $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Clinical Laboratory $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Point-of-Care $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
Supplies & Accessories: $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Clinical Laboratory $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Point-of-Care $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
Global Total $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Clinical Laboratory $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%
   Point-of-Care $XX Million $XX Million $XX Million $XX Million $XX Million $XX Million XX%

Source: Kalorama Information

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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

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