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IVD Contract Manufacturing Services Market

Release date:

Dec-2021

Region:

global

Research Code:MRHC -104539

Sku:MRHC -104539

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

  • Report ID: MRHC -104539
  • Pages: 147
  • Dec-2021
  • Formats*: PDF
  • Category: Healthcare
  • Delivery: 2 to 4 Hours
COVID-19

This report provides pre & post COVID-19 market estimates.

The IVD Contract Manufacturing Services Market is expected to reach $20.6 billion by 2028, at a CAGR of 7.7% during the forecast period of 2021–2028. 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 need for cost-effective manufacturing of IVD tests are the major factors contributing to the growth of this market. In addition, the high economic and increased outsourcing to emerging countries provides significant growth opportunities for the players operating in this market.

Impact of COVID-19 on the IVD Contract Manufacturing Services Market

The COVID-19 pandemic adversely impacted numerous economies around the globe. Testing is one of the greatest tools in understanding and managing the COVID-19 outbreak. In response to the COVID-19 pandemic and shortages of laboratory-based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices to facilitate testings outside of laboratory settings. These simple test kits detect proteins from the SARS-CoV-2 virus in respiratory samples (e.g., sputum, throat swab), blood, or serum, of patients infected with COVID-19.

Organizations worldwide, including the Forum and its partners, are coming together with innovations to minimize the impact on public health and limit disruptions to economies and supply chains. Some of the initiatives undertaken by manufacturers and organizations are as follows:

  • European governments pledged over $7.67 billion (€7 billion) in initial funding as part of a global effort to respond to the COVID-19 pandemic.
  • Partner of the World Economic Forum, Novo Nordisk Foundation, has taken an innovative approach since the beginning of the COVID-19 pandemic to invest millions into research and development, preparing Denmark for future viral epidemics. The Novo Nordisk Foundation has awarded a grant to TestCenter Denmark to carry out up to 3 million tests.
  • Cisco Systems, Inc. (U.S.) committed $225 million to help combat the COVID-19 pandemic.
  • Infosys Limited (India) has dedicated $13.6 million (₹1000 million) in funding for increasing hospital capacity, ventilators, testing kits, and protective gear for frontline health workers to mitigate the impacts of COVID-19 across India.

Further, amidst the pandemic, companies are collaborating with contract manufacturers to develop various diagnostic kits and assays for diagnosing diseases as contract manufacturers have experience in new assay developments and manufacturing new IVD devices. Such developments are expected to drive the in-vitro diagnostics market in the upcoming years.

IVD Contract Manufacturing Services Market

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Shift in Focus from Centralized Laboratories to Point-of-Care Testing Services Propelling the Growth of the IVD Contract Manufacturing Services Market

Point-of-care (POC) testing is largely performed for diagnosis at or near the site where a patient initially encounters the healthcare system. POC tests improve patient management in cases of infectious diseases. POC tests for various infectious diseases such as chlamydia, gonorrhea, and influenza help provide early diagnosis and treatment. POC testing in decentralized setups enables physicians to monitor infectious diseases and improve clinical workflows. Additionally, improvements in information technology have contributed significantly to the decentralization of clinical laboratory testing.

POC instruments must be simple to use since end users are not trained as lab technicians. Specific POC device features should include minimal maintenance requirements and onboard calibrations to ensure accurate test results, a user-friendly software interface, integration with laboratory and hospital information systems, and easy-to-use disposables containing all the reagents for sample processing and testing. POC instrumentation should also have a small footprint and be portable in some cases since both hospital clinics and physician offices have limited space.

Although these requirements may seem simple, they present IVD companies with a variety of design and manufacturing challenges. Most notably, several POC technologies require more complex disposable cartridges containing multiple reagents to process only one patient sample at a time, compared with simpler disposables in higher volume laboratory instruments. With this added complexity, product development teams must work together to ensure smooth integration of the disposable cartridges with the instrument design and minimize costly redesigns. Thus, working with a contract manufacturing partner with experience in integrating disposable cartridge technologies with instrument design is the preferred option, which drives the IVD contract manufacturing services market.

Key Findings of the Global IVD Contract Manufacturing Services Market Study:

Reagents and Consumables Segment Expected to Account for the Largest Share of IVD Contract Manufacturing Services Market.

The frequent use of reagents to detect various chronic diseases, increase in the volume of testing for infectious diseases such as COVID-19 and influenza, and rise in demand for molecular and immunoassay reagents across the globe, boosts the growth of the contract manufacturing of reagents and consumables.

Manufacturing Services Segment Expected to Account for Largest Share of the Market.

The manufacturing services have ISO-certified manufacturing facilities and can carry out full project and production management, quality and regulatory support, flexibility in scale and process, which results in increased demand for manufacturing services.

Immunoassay Segment Expected to Grow at the Highest CAGR During Forecast Period.

Numerous immunoassay techniques find application in cancer marker identification or testing cancer markers, infectious diseases diagnostics, cardiac analysis, therapeutic drug monitoring, and allergen tests. As the demand for these techniques for screening various disorders increases, the number of contract services for the development of immunoassay IVD products is also expected to witness a significant increase.

Asia Pacific: Fastest Growing Market

In 2021 North America is expected to account for the largest share of the IVD contract manufacturing services market at the regional level. However, Asia-Pacific is expected to grow at the highest CAGR during the forecast period. The increasing burden of infectious diseases and the need for early diagnosis and treatment, improvements in healthcare infrastructure, growing efforts to improve the accessibility of diagnostic services to enhance the prevention of infectious diseases by developing products or platforms required for their diagnosis, rising awareness towards overall health and treatment availability, the increasing number of middle-class population and their level of disposable income, increasing health insurance penetration, growing aging population, and rising focus of the key players to expand in emerging countries such as China and India, are the factors propelling the regional market growth.

Key Players

The report includes a competitive landscape based on an extensive assessment of the service portfolio offerings, geographic presence, and key strategic developments adopted by leading market players in the industry during 2018–2021. Some of the key players profiled in the global IVD contract manufacturing services market are 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.), Coris BioConcept (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:

IVD Contract Manufacturing Services Market, by Type

  • Manufacturing Services
  • Assay Development Services
  • Other Services

IVD Contract Manufacturing Services Market, by Category

  • Reagents & Consumables
  • Instruments & Systems

IVD Contract Manufacturing Services Market, by Technology

  • Immunoassay
  • Molecular Diagnostics
  • Clinical Chemistry
  • Microbiology
  • Hematology
  • Urinalysis

IVD Contract Manufacturing Services Market, by Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Rest of Europe (RoE)
  • Asia-Pacific (APAC)
    • China
    • Japan
    • India
    • Rest of APAC (RoAPAC)
  • Latin America
  • Middle East & Africa

Key questions answered in the report:

What is the Focus of the IVD Contract Manufacturing Services Market?

The IVD contract manufacturing services market covers the market sizes & forecasts of services. The IVD contract manufacturing services market studied in this report involves the value analysis of various segments and sub-segments of IVD contract manufacturing services at the regional and country level.

What is the Value of Revenue Generated from the IVD Contract Manufacturing Services Across the Globe? At what Rate is the Demand Expected to Grow During the next 5–7 Years?

The global IVD contract manufacturing services market is projected to reach $20.6 billion by 2028, at a CAGR of 7.7% during the forecast period.

Based on Service Type, Which Segment is Estimated to Hold the Major Share of the Market?

The manufacturing services segment is expected to account for the largest share of the IVD contract manufacturing services market in 2021.

Which Technology is Projected to Create More Traction in the Global IVD Contract Manufacturing Services Market?

Based on technology, the immunoassay segment is expected to witness an increase in adoption rate in the IVD contract manufacturing services market due to the increasing prevalence of infectious diseases, fueling the demand for immunoassays techniques for the diagnosis of these diseases.

What are the Key Factors Supporting the Growth of This Market? What are the Major Opportunities for Existing Market Players and New Entrants in the Global IVD Contract Manufacturing Services Market?

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 rising need for cost-effective manufacturing of IVD tests are the major factors supporting the growth of this market. In addition, high economic and increased outsourcing to emerging countries provides significant growth opportunities for the players operating in this market.

Who are the Major Players Operating in the Global IVD Contract Manufacturing Services Market?

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.), Coris BioConcept (Belgium), Affinity Biologicals Inc. (Canada), Biokit S.A. (Spain), Merck KGaA (Germany), Thermo Fisher Scientific Inc. (U.S.), and Maxim Biomedical, Inc. (U.S.).

Which Regions/Countries are Likely to Offer Significant Growth Opportunities for the Vendors in this Market During the Analysis Period?

The emerging countries from Asia-Pacific are projected to offer significant growth opportunities for the vendors in this market.

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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Related Research

The IVD Contract Manufacturing Services Market is expected to reach $20.6 billion by 2028, at a CAGR of 7.7% during the forecast period of 2021–2028. 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 need for cost-effective manufacturing of IVD tests are the major factors contributing to the growth of this market. In addition, the high economic and increased outsourcing to emerging countries provides significant growth opportunities for the players operating in this market.

Impact of COVID-19 on the IVD Contract Manufacturing Services Market

The COVID-19 pandemic adversely impacted numerous economies around the globe. Testing is one of the greatest tools in understanding and managing the COVID-19 outbreak. In response to the COVID-19 pandemic and shortages of laboratory-based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices to facilitate testings outside of laboratory settings. These simple test kits detect proteins from the SARS-CoV-2 virus in respiratory samples (e.g., sputum, throat swab), blood, or serum, of patients infected with COVID-19.

Organizations worldwide, including the Forum and its partners, are coming together with innovations to minimize the impact on public health and limit disruptions to economies and supply chains. Some of the initiatives undertaken by manufacturers and organizations are as follows:

  • European governments pledged over $7.67 billion (€7 billion) in initial funding as part of a global effort to respond to the COVID-19 pandemic.
  • Partner of the World Economic Forum, Novo Nordisk Foundation, has taken an innovative approach since the beginning of the COVID-19 pandemic to invest millions into research and development, preparing Denmark for future viral epidemics. The Novo Nordisk Foundation has awarded a grant to TestCenter Denmark to carry out up to 3 million tests.
  • Cisco Systems, Inc. (U.S.) committed $225 million to help combat the COVID-19 pandemic.
  • Infosys Limited (India) has dedicated $13.6 million (₹1000 million) in funding for increasing hospital capacity, ventilators, testing kits, and protective gear for frontline health workers to mitigate the impacts of COVID-19 across India.

Further, amidst the pandemic, companies are collaborating with contract manufacturers to develop various diagnostic kits and assays for diagnosing diseases as contract manufacturers have experience in new assay developments and manufacturing new IVD devices. Such developments are expected to drive the in-vitro diagnostics market in the upcoming years.

IVD Contract Manufacturing Services Market

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Shift in Focus from Centralized Laboratories to Point-of-Care Testing Services Propelling the Growth of the IVD Contract Manufacturing Services Market

Point-of-care (POC) testing is largely performed for diagnosis at or near the site where a patient initially encounters the healthcare system. POC tests improve patient management in cases of infectious diseases. POC tests for various infectious diseases such as chlamydia, gonorrhea, and influenza help provide early diagnosis and treatment. POC testing in decentralized setups enables physicians to monitor infectious diseases and improve clinical workflows. Additionally, improvements in information technology have contributed significantly to the decentralization of clinical laboratory testing.

POC instruments must be simple to use since end users are not trained as lab technicians. Specific POC device features should include minimal maintenance requirements and onboard calibrations to ensure accurate test results, a user-friendly software interface, integration with laboratory and hospital information systems, and easy-to-use disposables containing all the reagents for sample processing and testing. POC instrumentation should also have a small footprint and be portable in some cases since both hospital clinics and physician offices have limited space.

Although these requirements may seem simple, they present IVD companies with a variety of design and manufacturing challenges. Most notably, several POC technologies require more complex disposable cartridges containing multiple reagents to process only one patient sample at a time, compared with simpler disposables in higher volume laboratory instruments. With this added complexity, product development teams must work together to ensure smooth integration of the disposable cartridges with the instrument design and minimize costly redesigns. Thus, working with a contract manufacturing partner with experience in integrating disposable cartridge technologies with instrument design is the preferred option, which drives the IVD contract manufacturing services market.

Key Findings of the Global IVD Contract Manufacturing Services Market Study:

Reagents and Consumables Segment Expected to Account for the Largest Share of IVD Contract Manufacturing Services Market.

The frequent use of reagents to detect various chronic diseases, increase in the volume of testing for infectious diseases such as COVID-19 and influenza, and rise in demand for molecular and immunoassay reagents across the globe, boosts the growth of the contract manufacturing of reagents and consumables.

Manufacturing Services Segment Expected to Account for Largest Share of the Market.

The manufacturing services have ISO-certified manufacturing facilities and can carry out full project and production management, quality and regulatory support, flexibility in scale and process, which results in increased demand for manufacturing services.

Immunoassay Segment Expected to Grow at the Highest CAGR During Forecast Period.

Numerous immunoassay techniques find application in cancer marker identification or testing cancer markers, infectious diseases diagnostics, cardiac analysis, therapeutic drug monitoring, and allergen tests. As the demand for these techniques for screening various disorders increases, the number of contract services for the development of immunoassay IVD products is also expected to witness a significant increase.

Asia Pacific: Fastest Growing Market

In 2021 North America is expected to account for the largest share of the IVD contract manufacturing services market at the regional level. However, Asia-Pacific is expected to grow at the highest CAGR during the forecast period. The increasing burden of infectious diseases and the need for early diagnosis and treatment, improvements in healthcare infrastructure, growing efforts to improve the accessibility of diagnostic services to enhance the prevention of infectious diseases by developing products or platforms required for their diagnosis, rising awareness towards overall health and treatment availability, the increasing number of middle-class population and their level of disposable income, increasing health insurance penetration, growing aging population, and rising focus of the key players to expand in emerging countries such as China and India, are the factors propelling the regional market growth.

Key Players

The report includes a competitive landscape based on an extensive assessment of the service portfolio offerings, geographic presence, and key strategic developments adopted by leading market players in the industry during 2018–2021. Some of the key players profiled in the global IVD contract manufacturing services market are 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.), Coris BioConcept (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:

IVD Contract Manufacturing Services Market, by Type

  • Manufacturing Services
  • Assay Development Services
  • Other Services

IVD Contract Manufacturing Services Market, by Category

  • Reagents & Consumables
  • Instruments & Systems

IVD Contract Manufacturing Services Market, by Technology

  • Immunoassay
  • Molecular Diagnostics
  • Clinical Chemistry
  • Microbiology
  • Hematology
  • Urinalysis

IVD Contract Manufacturing Services Market, by Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Rest of Europe (RoE)
  • Asia-Pacific (APAC)
    • China
    • Japan
    • India
    • Rest of APAC (RoAPAC)
  • Latin America
  • Middle East & Africa

Key questions answered in the report:

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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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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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