IVD Contract Manufacturing Market Size, Share, Opportunities, And Trends By Device Type (IVD Equipment, IVD Consumables), By Service Type (Manufacturing Services, Assay Development Services, Other Services), By Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation & Hemostasis, Others), And By Geography - Forecasts From 2024 To 2029

  • Published : Mar 2024
  • Report Code : KSI061616774
  • Pages : 144

The IVD contract manufacturing market is expected to witness significant growth during the forecasted period.

The In Vitro Diagnostics (IVD) contract manufacturing market involves outsourcing the production of diagnostic tests and equipment by diagnostic companies to specialized manufacturers. This sector is crucial in providing cost-effective and efficient solutions to meet the growing demand for diagnostic products. Companies opt for contract manufacturing to leverage expertise, reduce production costs, and focus on core competencies. Key players offer services ranging from assay development and optimization to full-scale production and packaging. Factors driving market growth include the increasing prevalence of chronic diseases, technological advancements, and stringent regulatory requirements.

Additionally, the COVID-19 pandemic has further accelerated demand for IVD products. The market is highly competitive, with players continually investing in research and development to innovate and expand their product portfolios, catering to diverse diagnostic needs globally.

Market Drivers 

  • Increasing demand for IVD products is anticipated to boost the IVD contract manufacturing market.

The market for IVD contract manufacturing is expanding as a result of the rising demand for IVD products. Companies look for contract manufacturers to effectively meet production demands as the necessity for diagnostic tests increases due to reasons including aging populations and the incidence of chronic diseases. Contract manufacturers can take advantage of these opportunities to grow their businesses, provide specialized knowledge, and achieve economies of scale by expanding their service offerings. In order to satisfy changing client needs, it also encourages investment in cutting-edge technology and regulatory compliance strategies, which adds to the general vibrancy and expansion of the IVD contract manufacturing industry.

In June 2022, Roche declared the next-generation VENTANA DP 600 slide scanner (marked CE-IVD) would be available in CE. This high-capacity slide scanner offers the pathology lab workflow flexibility and convenience of use, all while producing exceptional image quality of stained histology slides from patient tissue samples. roughly 10 million deaths, or roughly one in six deaths, globally will be attributable to cancer in 2020. If identified early and given appropriate treatment, many cancers are curable. Better, more individualized healthcare is made possible by the Roche Digital Pathology solution, which also supports the digital transformation of pathology.

  • Cost efficiency and outsourcing trends in the IVD industry are expected to boost the IVD contract manufacturing market.

Cost efficiency is a paramount factor driving the IVD contract manufacturing market growth. Outsourcing manufacturing to specialized contract manufacturers offers economies of scale, reducing production costs through bulk purchasing and optimized processes. This approach allows companies to allocate resources strategically, focusing on core competencies such as research and development, while minimizing overhead expenses associated with in-house production facilities. By leveraging the cost efficiencies provided by contract manufacturers, IVD companies can enhance profitability, allocate capital more effectively, and remain competitive in a rapidly evolving market landscape.

 In January 2024, to enhance decentralized clinical trial capabilities for pharmaceutical, biotech, and medical device sponsors looking to reduce site burden, speed up enrollment and clinical study timelines, and increase patient diversity and inclusion, LabCorp, a leading global provider of cutting-edge and comprehensive laboratory services, and Hawthorne Effect, Inc., a comprehensive clinical trials solution integrating technology announced a strategic collaboration.

  • Technological advancements anticipated to boost the IVD contract manufacturing market.

The IVD contract manufacturing industry is driven by technological improvements that allow for the production of more specialized and complicated diagnostic items. With state-of-the-art technology, contract manufacturers may provide clients with enhanced capabilities without large capital expenditures. This increases competitiveness, promotes innovation, and quickens the development of new products.

Furthermore, improvements in digitization and automation have streamlined production processes, increased productivity, and cut time to market. Consequently, contract manufacturers are able to satisfy the changing demands of IVD firms, propelling market expansion and enabling the provision of superior diagnostic solutions to patients and healthcare providers worldwide.

In May 2022, in collaboration with Genes2Me Pvt. Ltd., Cipla Limited announced the launch of the "RT-Direct" multiplex COVID-19 RT PCR Test kit for sale in India. By doing this, Cipla is able to provide a wider range of sophisticated and cutting-edge diagnostic devices. Cipla has started supplying RT Direct kits and will be in charge of their distribution in India. This kit has been validated at a center accredited by the Indian Council of Medical Research (ICMR). It is based on the "gold standard RT-PCR method," which is far more advanced than others that just have one or two target genes and covers three target genes specific to SARS-COV-2 along with IC. The RT-PCR test's sensitivity is significantly raised by this.

Asia Pacific region is expected to grow significantly

The need for diagnostic services is rising, the healthcare infrastructure is expanding, and there is an increased focus on cost-effective production solutions. These factors are driving the significant expansion of the IVD contract manufacturing market in the Asia Pacific region. Manufacturers of IVDs are choosing to outsource their manufacturing operations to the area due to a combination of factors, including lower labor costs in nations like China and India, better regulatory frameworks, and rising R&D investments.

The strategic location of the area also makes it possible to reach quickly developing markets, which increases demand for contract manufacturing services. This pattern is anticipated to persist, propelling more expansion in the IVD contract manufacturing market throughout the Asia Pacific.

In May 2023, Reagent IVD Resources Pvt. Ltd. (RIVDR), a Jaipur-based biotech start-up with a focus on diagnostics, and TechInvention Lifecare Pvt. Ltd., a Mumbai-based biotech start-up, partnered strategically to develop and produce an extensive variety of diagnostics. For international supply, the portfolio would include both human and veterinary parts.

Market Restraints

  • Stringent regulatory requirements can constrain the market for IVD contract manufacturing market.

The market for IVD contract manufacturing is significantly hampered by difficulties with regulatory compliance. Contract manufacturers are required to uphold complicated standards and maintain strong quality management systems due to the strict rules governing medical devices and diagnostics. The ability to navigate these regulatory obstacles requires a great deal of knowledge, money, and time. As a result, existing manufacturers may face increased expenses associated with compliance, which may hinder their ability to grow and compete in the market.

Market Development

  • January 2024- Improved digital commerce capabilities at a recently expanded center of excellence in Chihuahua, Mexico, including design, development, and production of retail and warehouse automation solutions, were announced by Jabil Inc. With the recent construction of this third factory in Chihuahua, the region's fifth, customers now have access to more than one million square feet of production capacity in the area. Customers can gain from more nearshoring opportunities, improved access to robotics and process automation, artificial intelligence (AI), and additive manufacturing, in addition to better operational efficiency and flexibility from Jabil.
  • October 2023- Leading life science company Fapon and Indonesia's biggest telehealth platform, Halodoc, have inked a strategic cooperation deal. Through this cooperation, Halodoc's robust sales channels and local service offerings will be combined with Fapon's expertise in in-vitro diagnostics (IVD) technology and integrated solutions. The collaboration intends to advance Indonesia's IVD sector, improve local communities, and raise the country's healthcare standards.

Market Segmentation

  • By Device Type:
    • IVD Equipment
    • IVD Consumables
  • By Service Type:
    • Manufacturing Services
    • Assay Development Services
    • Other Services
  • By Technology:
    • Immunoassay
    • Clinical Chemistry
    • Molecular Diagnostics
    • Microbiology
    • Hematology
    • Coagulation & Hemostasis
    • Others
  • By geography:
    • North America
      • United States
      • Canada
      • Mexico
    • South America
      • Brazil
      • Argentina
      • Others
    • Europe
      • United Kingdom
      • Germany
      • France
      • Italy
      • Spain
      • Others
    • Middle East and Africa
      • Saudi Arabia
      • UAE
      • Others
    • Asia Pacific
      • Japan
      • China
      • India
      • South Korea
      • Taiwan
      • Thailand
      • Indonesia
      • Others


1.1. Market Overview

1.2. Market Definition

1.3. Scope of the Study

1.4. Market Segmentation

1.5. Currency

1.6. Assumptions

1.7. Base, and Forecast Years Timeline

1.8. Key Benefits to the Stakeholder


2.1. Research Design

2.2. Research Processes


3.1. Key Findings

3.2. Analyst View


4.1. Market Drivers

4.2. Market Restraints

4.3. Porter’s Five Forces Analysis

4.3.1. Bargaining Power of Suppliers

4.3.2. Bargaining Power of Buyers

4.3.3. Threat of New Entrants

4.3.4. Threat of Substitutes

4.3.5. Competitive Rivalry in the Industry

4.4. Industry Value Chain Analysis

4.5. Analyst View


5.1. Introduction

5.2. IVD Equipment

5.2.1. Market Trends and Opportunities

5.2.2. Growth Prospects

5.3. IVD Consumables

5.3.1. Market Trends and Opportunities

5.3.2. Growth Prospects


6.1. Introduction

6.2. Manufacturing Services

6.2.1. Market Trends and Opportunities

6.2.2. Growth Prospects

6.3. Assay Development Services

6.3.1. Market Trends and Opportunities

6.3.2. Growth Prospects

6.4. Other Services

6.4.1. Market Trends and Opportunities

6.4.2. Growth Prospects


7.1. Introduction

7.2. Immunoassay

7.2.1. Market Trends and Opportunities

7.2.2. Growth Prospects

7.3. Clinical Chemistry

7.3.1. Market Trends and Opportunities

7.3.2. Growth Prospects

7.4. Molecular Diagnostics

7.4.1. Market Trends and Opportunities

7.4.2. Growth Prospects

7.5. Microbiology

7.5.1. Market Trends and Opportunities

7.5.2. Growth Prospects

7.6. Hematology

7.6.1. Market Trends and Opportunities

7.6.2. Growth Prospects

7.7. Coagulation & Hemostasis

7.7.1. Market Trends and Opportunities

7.7.2. Growth Prospects

7.8. Others

7.8.1. Market Trends and Opportunities

7.8.2. Growth Prospects


8.1. Introduction

8.2. North America

8.2.1. By Device Type

8.2.2. By Service Type

8.2.3. By Technology

8.2.4. By Country United States Market Trends and Opportunities Growth Prospects Canada Market Trends and Opportunities Growth Prospects Mexico Market Trends and Opportunities Growth Prospects

8.3. South America

8.3.1. By Device Type

8.3.2. By Service Type

8.3.3. By Technology

8.3.4. By Country Brazil Market Trends and Opportunities Growth Prospects Argentina Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects

8.4. Europe

8.4.1. By Device Type

8.4.2. By Service Type

8.4.3. By Technology

8.4.4. By Country United Kingdom Market Trends and Opportunities Growth Prospects Germany Market Trends and Opportunities Growth Prospects France Market Trends and Opportunities Growth Prospects Italy Market Trends and Opportunities Growth Prospects Spain Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects

8.5. Middle East and Africa

8.5.1. By Device Type

8.5.2. By Service Type

8.5.3. By Technology

8.5.4. By Country Saudi Arabia Market Trends and Opportunities Growth Prospects UAE Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects

8.6. Asia Pacific

8.6.1. By Device Type

8.6.2. By Service Type

8.6.3. By Technology

8.6.4. By Country Japan Market Trends and Opportunities Growth Prospects China Market Trends and Opportunities Growth Prospects India Market Trends and Opportunities Growth Prospects South Korea Market Trends and Opportunities Growth Prospects Taiwan Market Trends and Opportunities Growth Prospects Thailand Market Trends and Opportunities Growth Prospects Indonesia Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects


9.1. Major Players and Strategy Analysis

9.2. Market Share Analysis

9.3. Mergers, Acquisitions, Agreements, and Collaborations

9.4. Competitive Dashboard


10.1. Thermo Fisher Scientific Inc.

10.2. Siemens Healthineers AG

10.3. Danaher Corporation

10.4. Roche Diagnostics

10.5. Abbott Laboratories

10.6. Bio-Rad Laboratories, Inc.

10.7. Sysmex Corporation

10.8. Quidel Corporation

10.9. BioMérieux SA

Thermo Fisher Scientific Inc.

Siemens Healthineers AG

Danaher Corporation

Roche Diagnostics

Abbott Laboratories

Bio-Rad Laboratories, Inc.

Sysmex Corporation

Quidel Corporation

BioMérieux SA