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IVD Contract Manufacturing Services Market by Type (Assay Development, Manufacturing), Category (Reagents, Systems), Technology (Immunoassay, Molecular Diagnostics, Clinical Chemistry, Hematology, Microbiology, Urinalysis) - Global Forecast to 2028

December 2021 | 147 pages | ID: I636791E2765EN
Meticulous Market Research Pvt. Ltd.

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IVD Contract Manufacturing Services Market by Type (Assay Development, Manufacturing), Category (Reagents, Systems), Technology (Immunoassay, Molecular Diagnostics, Clinical Chemistry, Hematology, Microbiology, Urinalysis)—Global Forecast to 2028

The global IVD contract manufacturing services market is expected to grow at a CAGR of 7.7% from 2021–2028 to reach $20.6 billion by 2028.

After an extensive primary and secondary research, and in-depth analysis of the market scenario, the report provides insights on the key industry drivers, restraints, challenges, and opportunities in the IVD contract manufacturing services market. The growth in the IVD contract manufacturing services market is mainly attributed to the increasing need for IVD devices due to the rising prevalence of infectious diseases, the shift in focus from centralized laboratories to point-of-care testing services, regulatory complexities faced by IVD companies, and the growing necessity for cost-effective manufacturing of IVD tests.

In addition, high economic and increased outsourcing to emerging countries provides significant growth opportunities for the players operating in this market. However, factors such as maintaining the product quality and protection of proprietary knowledge hinder this market's growth.

Based on the service type, the manufacturing services segment is slated to register the highest growth rate during the forecast period. These services are mostly in demand by the IVD companies since they provide cost-efficiency during outsourcing the manufacture of IVD devices.

Based on technology, the immunoassay segment is expected to account for the largest share of the IVD contract manufacturing services market in 2021. The large market share of this segment is attributed to the emergence of advanced diagnostic immunoassay formats and the higher preference of this method for immune diagnostics tests due to its high accuracy standards, inherent specificity, high throughput, high sensitivity.

An in-depth analysis of the geographical scenario of the IVD contract manufacturing services market provides detailed qualitative and quantitative insights about the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region.

North America is expected to account for the largest share of the IVD contract manufacturing services market in 2021, followed by Europe, Asia-Pacific, Latin America, and Middle East & Africa.

The key players operating in the global IVD contract manufacturing services market include Savyon Diagnostics (Israel), KMC Systems, Inc. (U.S.), Cenogenics Corporation (U.S.), Nova Biomedical (U.S.), Cone Bioproducts (U.S.), Invetech, Inc. (Australia), Avioq, Inc. (U.S.), Meridian Bioscience, Inc. (U.S.), In Vitro Diagnostics Developers Inc. (U.S.), LRE Medical (Germany), TCS Biosciences Ltd (U.K.), Affinity Life Sciences, Inc. (U.S.), CorisBioConcept (Belgium), Affinity Biologicals Inc. (Canada), Biokit S.A. (Spain), Merck KGaA (Germany), Thermo Fisher Scientific Inc. (U.S.), and Maxim Biomedical, Inc. (U.S.).

Scope of the Report:

Global IVD Contract Manufacturing Services Market, by Type
  • Manufacturing Services
  • Assay Development Services
  • Other Services
Global IVD Contract Manufacturing Services Market, by Category
  • Reagents & Consumables
  • Instruments & Systems
Global IVD Contract Manufacturing Services Market, by Technology
  • Immunoassay
  • Clinical Chemistry
  • Microbiology
  • Molecular Diagnostics
  • Hematology
  • Urinalysis
Global IVD Contract Manufacturing Services Market, by Geography
  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest of Europe (RoE)
  • Asia-Pacific (APAC)
    • China
    • Japan
    • India
    • Rest of APAC (RoAPAC)
  • Latin America
  • Middle East & Africa
1. INTRODUCTION

1.1. Market Definition
1.2. Market Ecosystem
1.3. Currency
1.4. Key Stakeholders

2. RESEARCH METHODOLOGY

2.1. Research Process
2.2. Data Collection & Validation
  2.2.1. Secondary Research
  2.2.2. Primary Research
2.3. Market Assessment
  2.3.1. Market Size Estimation
    2.3.1.1. Bottom-Up Approach
    2.3.1.2. Top-Down Approach
    2.3.1.3. Growth Forecast
2.4. Assumptions for this Study
2.5. Limitations for the Study

3. EXECUTIVE SUMMARY

4. MARKET INSIGHTS

4.1. Introduction
4.2. Market Dynamics
  4.2.1. Drivers
    4.2.1.1. Rising Prevalence of Infectious Diseases
    4.2.1.2. Shift in Focus From Centralized Laboratories to Point-Of-Care Testing Services
    4.2.1.3. Regulatory Complexities Faced by IVD Companies
    4.2.1.4. Need for Cost-Effective Manufacturing of IVD Tests
  4.2.2. Restraints
    4.2.2.1. Maintaining Product Quality And Protection of Proprietary Information
  4.2.3. Opportunities
    4.2.3.1. High Economic Growth and Increased Outsourcing to Emerging Countries
  4.2.4. Challenges
    4.2.4.1. Lack of Skilled Professionals
  4.2.5. Impact of COVID-19 Pandemic

5. IVD MARKET OVERVIEW

5.1. Market Opportunity Analysis [ USD Million]
  5.1.1. IVD Instruments Market, by Technology (2021 Vs. 2028)
  5.1.2. IVD Reagents Market, by Technology (2021 Vs 2028)
5.2. IVD Market – Regulatory Analysis
  5.2.1. North America
  5.2.2. Europe
  5.2.3. Asia-Pacific
  5.2.4. Latin America
  5.2.5. Middle East And Africa

6. GLOBAL IVD CONTRACT MANUFACTURING SERVICES MARKET, BY TYPE

6.1. Introduction
6.2. Manufacturing Services
6.3. Assay Development Services
6.4. Other Services

7. GLOBAL IVD CONTRACT MANUFACTURING SERVICES MARKET, BY CATEGORY

7.1. Introduction
7.2. Reagents & Consumables
7.3. Instruments & Systems

8. GLOBAL IVD CONTRACT MANUFACTURING SERVICES MARKET, BY TECHNOLOGY

8.1. Introduction
8.2. Immunoassay
8.3. Molecular Diagnostics
8.4. Clinical Chemistry
8.5. Hematology
8.6. Microbiology
8.7. Urinalysis

9. GLOBAL IVD CONTRACT MANUFACTURING SERVICES MARKET, BY REGION

9.1. Introduction
9.2. North America
  9.2.1. U.S.
  9.2.2. Canada
9.3. Europe
  9.3.1. Germany
  9.3.2. France
  9.3.3. U.K.
  9.3.4. Italy
  9.3.5. Spain
  9.3.6. Rest of Europe (Roe)
9.4. Asia-Pacific
  9.4.1. China
  9.4.2. Japan
  9.4.3. India
  9.4.4. Rest of Asia-Pacific (Roapac)
9.5. Latin America
9.6. Middle East & Africa

10. COMPETITIVE LANDSCAPE

10.1. Introduction
10.2. Key Growth Strategies
10.3. Competitive Benchmarking

11. COMPANY PROFILES

11.1. Cenogenics Corporation
  11.1.1. Business Overview
  11.1.2. Service Portfolio
11.2. In-Vitro Diagnostic Developers Inc.
  11.2.1. Business Overview
  11.2.2. Service Portfolio
11.3. Savyon Diagnostics
  11.3.1. Business Overview
  11.3.2. Service Portfolio
11.4. Elbit Systems Ltd. [KMC Systems, Inc.]
  11.4.1. Business Overview
  11.4.2. Financial Overview
  11.4.3. Service Portfolio
11.5. Nova Biomedical
  11.5.1. Business Overview
  11.5.2. Service Portfolio
  11.5.3. Strategic Developments
11.6. LRE Medical
  11.6.1. Business Overview
  11.6.2. Service Portfolio
  11.6.3. Strategic Developments
11.7. Cone Bioproducts
  11.7.1. Business Overview
  11.7.2. Service Portfolio
11.8. Invetech, Inc. [Subsidiary of Fortive Corporation]
  11.8.1. Business Overview
  11.8.2. Financial Overview
  11.8.3. Service Portfolio
  11.8.4. Strategic Developments
11.9. Avioq, Inc
  11.9.1. Business Overview
  11.9.2. Service Portfolio
11.10. TCS Biosciences Ltd
  11.10.1. Business Overview
  11.10.2. Service Portfolio
11.11. Affinity Life Sciences, Inc.
  11.11.1. Business Overview
  11.11.2. Service Portfolio
11.12. Coris BioConcept
  11.12.1. Business Overview
  11.12.2. Service Portfolio
11.13. Meridian Bioscience, Inc.
  11.13.1. Business Overview
  11.13.2. Financial Overview
  11.13.3. Service Portfolio
11.14. Affinity Biologicals Inc.
  11.14.1. Business Overview
  11.14.2. Service Portfolio
11.15. Biokit S.A.
  11.15.1. Business Overview
  11.15.2. Financial Overview
  11.15.3. Service Portfolio
  11.15.4. Strategic Developments
11.16. Merck KGaA
  11.16.1. Business Overview
  11.16.2. Financial Overview
  11.16.3. Service Portfolio
  11.16.4. Strategic Developments
11.17. Thermo Fisher Scientific Inc.
  11.17.1. Business Overview
  11.17.2. Financial Overview
  11.17.3. Service Portfolio
  11.17.4. Strategic Developments
11.18. Maxim Biomedical, Inc.
  11.18.1. Business Overview
  11.18.2. Service Portfolio

12. APPENDIX

12.1. Questionnaire
12.2. Available Customization

LIST OF TABLES

Table 1 Global IVD Contract Manufacturing Services Market Drivers: Impact Analysis (2021-2028)
Table 2 Requirements for Clia-Waived and Moderate- Or High-Complexity PoC Molecular Diagnostic Tests
Table 3 Global IVD Contract Manufacturing Services Market Restraints: Impact Analysis (2020-2027)
Table 4 Recent Molecular Diagnostic Tests Launched for Covid-19
Table 5 Europe: Countrywise Medical Devices Regulatory Authority
Table 6 Asia-Pacific: Countrywise Medical Devices Regulatory Authority
Table 7 Countrywise IVD Regulatory System
Table 8 IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 9 Global Manufacturing Services Market Size, by Country/Region, 2019–2028 (USD Million)
Table 10 Global Assay Development Services Market Size, by Country/Region, 2019–2028 (USD Million)
Table 11 Global Other Services Market Size, by Country/Region, 2019–2028 (USD Million)
Table 12 IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 13 Global IVD Contract Manufacturing Services Market Size, for Reagents & Consumables, by Country/Region, 2019–2028 (USD Million)
Table 14 Global IVD Contract Manufacturing Services Market Size, for Instruments & Systems, by Country/Region, 2019–2028 (USD Million)
Table 15 IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 16 Global IVD Contract Manufacturing Services Market Size for Immunoassay, by Country/Region, 2019-2028 (USD Million)
Table 17 Global IVD Contract Manufacturing Services Market Size for Molecular Diagnostics, by Country/Region, 2019-2028 (USD Million)
Table 18 Global IVD Contract Manufacturing Services Market Size for Clinical Chemistry, by Country/Region, 2019-2028 (USD Million)
Table 19 Global IVD Contract Manufacturing Services Market Size for Hematology, by Country/Region, 2019-2028 (USD Million)
Table 20 Global IVD Contract Manufacturing Services Market Size for Microbiology, by Country/Region, 2019-2028 (USD Million)
Table 21 Global IVD Contract Manufacturing Services Market Size for Urinalysis, by Country/Region, 2019-2028 (USD Million)
Table 22 Global IVD Contract Manufacturing Services Market Size, by Country/Region, 2019-2028 (USD Million)
Table 23 North America: IVD Contract Manufacturing Services Market Size, by Country, 2019-2028 (USD Million)
Table 24 North America: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 25 North America: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 26 North America: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 27 U.S.: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 28 U.S.: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 29 U.S.: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 30 Canada: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 31 Canada: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 32 Canada: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 33 Top Five Countries with Coronavirus Cases (As of 15th August 2021)
Table 34 Europe: IVD Contract Manufacturing Services Market Size, by Country, 2019-2028 (USD Million)
Table 35 Europe: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 36 Europe: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 37 Europe: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 38 Germany: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 39 Germany: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 40 Germany: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 41 France: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 42 France: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 43 France: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 44 Number of Acute Respiratory Illness Outbreaks in The U.K. by Institution Type: 2015-2019
Table 45 U.K.: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 46 U.K.: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 47 U.K.: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USDMillion)
Table 48 Cancer Prevalence
Table 49 Italy: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 50 Italy: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 51 Italy: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 52 Spain: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 53 Spain: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 54 Spain: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 55 New Hiv Diagnoses and Rates Per 100,000 Population
Table 56 Covid-19 Cases in European Countries (19th July)
Table 57 Roe: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 58 Roe: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 59 Roe: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 60 Asia-Pacific: IVD Contract Manufacturing Services Market Size, by Country, 2019-2028 (USD Million)
Table 61 Asia-Pacific: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 62 Asia-Pacific: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 63 Asia-Pacific: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 64 China: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 65 China: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 66 China: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 67 Japan: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 68 Japan: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 69 Japan: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 70 India: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 71 India: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 72 India: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 73 Roapac: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 74 Roapac: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 75 Roapac: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 76 Latin America: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 77 Latin America: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 78 Latin America: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 79 Middle East & Africa: IVD Contract Manufacturing Services Market Size, by Type, 2019-2028 (USD Million)
Table 80 Middle East & Africa: IVD Contract Manufacturing Services Market Size, by Category, 2019-2028 (USD Million)
Table 81 Middle East & Africa: IVD Contract Manufacturing Services Market Size, by Technology, 2019-2028 (USD Million)
Table 82 Recent Developments, by Company, 2018–2021

LIST OF FIGURES

Figure 1 Research Process
Figure 2 Key Secondary Sources
Figure 3 Primary Research Techniques
Figure 4 Key Executives Interviewed
Figure 5 Breakdown of Primary Interviews (Supply-Side & Demand-Side)
Figure 6 Market Size Estimation
Figure 7 Global IVD Contract Manufacturing Services Market Size, by Type, 2021 Vs. 2028 (USD Million)
Figure 8 Global IVD Contract Manufacturing Services Market Size, by Technology, 2021 Vs. 2028 (USD Million)
Figure 9 Reagents & Consumables Expected to Dominate the Global IVD Contract Manufacturing Services Market
Figure 10 IVD Contract Manufacturing Services Market Snapshot, by Region
Figure 11 Market Dynamics
Figure 12 IVD Instruments Market, by Technology, 2021 - 2028 (USD Million)
Figure 13 IVD Reagents Market, by Technology, 2021 - 2028 (USD Million)
Figure 14 IVD Contract Manufacturing Services Market Size, by Type, 2021 Vs 2028 (USD Million)
Figure 15 IVD Contract Manufacturing Services Market Size, by Category, 2021 Vs 2028 (USD Million)
Figure 16 IVD Contract Manufacturing Services Market Size, by Technology, 2021 Vs 2028 (USD Million)
Figure 17 Burden of Diseases Worldwide
Figure 18 Global IVD Contract Manufacturing Services Market Size, by Region, 2021-2028 (USD Million)
Figure 19 North America: IVD Contract Manufacturing Services Market Snapshot
Figure 20 Geographic Snapshot: European IVD Contract Manufacturing Services Market
Figure 21 France: Percentage of Older People (65 Years And Above), 2012–2050
Figure 22 Geographic Snapshot: Asia-Pacific IVD Contract Manufacturing Services Market
Figure 23 Japan: Percentage Geriatric Population (65 Years And Above)
Figure 24 Key Growth Strategies Adopted by Leading Players, 2018–2021
Figure 25 IVD Contract Manufacturing Services Market: Competitive Benchmarking, by Services
Figure 26 Elbit Systems Ltd.: Financial Snapshot, 2020
Figure 27 Fortive Corporation: Financial Snapshot, 2020
Figure 28 Meridian Bioscience, Inc.: Financial Snapshot, 2020
Figure 29 Werfen: Financial Snapshot, 2019
Figure 30 Merck KGaA: Financial Overview, 2020
Figure 31 Thermo Fisher Scientific Inc.: Financial Overview, 2020


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