IVD Contract Manufacturing Market worth $25.5 billion | MarketsandMarkets

CHICAGO, June 22, 2023 /PRNewswire/ -- The in vitro diagnostics (IVD) contract manufacturing industry is poised for substantial growth and transformation in the near future. With advancements in technology, increasing demand for diagnostic tests, and the rising complexity of IVD products, outsourcing manufacturing to specialized contract manufacturers is becoming an attractive option for IVD companies. These contract manufacturers offer expertise in production, quality control, regulatory compliance, and supply chain management, allowing IVD companies to focus on research, development, and commercialization. Moreover, the IVD contract manufacturing industry is expected to witness advancements in automation, digitization, and integration of advanced technologies, streamlining manufacturing processes and improving efficiency. This will enable faster turnaround times, higher production volumes, and reduced costs, addressing the growing need for scalable and cost-effective IVD solutions. Additionally, contract manufacturers will play a crucial role in navigating the evolving regulatory landscape and ensuring compliance with stringent quality standards, helping IVD companies bring innovative and reliable diagnostic products to market swiftly. As the demand for personalized and point-of-care diagnostics continues to rise, the IVD contract manufacturing industry will emerge as a key enabler, providing essential manufacturing capabilities and expertise to support the development and production of cutting-edge diagnostic technologies, ultimately improving patient care and healthcare outcomes.

IVD Contract Manufacturing Market in terms of revenue was estimated to be worth $15.0 billion in 2023 and is poised to reach $25.5 billion by 2028, growing at a CAGR of 11.2% from 2023 to 2028 according to a new report by MarketsandMarkets™. Growth in this market can primarily be attributed to the adoption of new technology to develop efficient products by IVD contract manufacturers, and the increased need to outsource manufacturing to CMOs by large manufacturers to reduce the manufacturing burden and focus on the development of newer technology. The surge in the requirement for IVD testing kits post Covid 19 pandemic, for RT-PCR tests, glucose testing, hematology testing, and other types of testing, also influenced the market growth.

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IVD Contract Manufacturing Market Scope:

IVD equipment accounted for the largest share of the IVD contract manufacturing market.

Based on the device type, the IVD contract manufacturing market is segmented into IVD equipment and IVD consumables. In 2022, IVD equipments held the major share of IVD contract manufacturing market. The large share of the IVD equipment segment can be attributed to the the growing number of hospitals and clinical laboratories in developing countries, automation and technological advancements in instruments with high-throughput capabilities.

The assay development segment is growing at the highest rate in the IVD contract manufacturing market.

Based on the services, the IVD contract manufacturing market is segmented into manufacturing services, assay development services, and others. In 2022, the expertise in the area of assay development, resource availability, speed and efficiency of development, reduced development time, reduced costs, improved quality, and increased focus on core competencies, are the factors attributing to the segmental growth. The presence of numerous outsourcing companies in the IVD space have limited financial capabilities,a nd thus, they prefer providing assay development services.

North America segment accounted for the largest share of the IVD contract manufacturing market

The global IVD contract manufacturing market is segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America segment accounted for the second largest share of the IVD contract manufacturing market after Asia Pacific. Factors attributing to the market share include the presence of a large number of large scaled contract manufacturing companies in the region, improved healthcare and industrial infrastructure and GDP expenditure, improved developmental capabilities of the contract manufacturing organizations in this region, and presence of lifelong collaborative and partnership agreements by large scale OEMs with CMOs in this region.

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IVD Contract Manufacturing Market Dynamics:

Drivers:

1. Growth in the IVD devices market in Developing Countries

Restraints:

1. Protecting IP is a key challenge in contract manufacturing

Opportunities:

1. Increasing healthcare expenditure, infrastructure, and awareness in developing countries

Challenges:

1. Lack of constant innovation to balance technological capabilities against costs and budgetary cuts observed by end users

Key Market Players:

The major players in the IVD contract manufacturing market include Jabil Inc. (US), Sanmina Corporation (US), TE Connectivity (Switzerland), Celestica Inc.(Canada), Savyon Diagnostics (Israel), West Pharmaceutical Services, Inc.(US), and Thermofisher (US)

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Recent Developments:

• In November 2022, Jabil Inc., expanded its developmental capabilities by opening a design center in Wrolaw, Poland. This would allow the company to develop leading-edge technologies for multiple industries including the automotive and healthcare sectors.
• In September 2021, TE connectivity acquired Toolbox Medical Innovations (US), Wi Inc. (US), and microLIQUID (Spain). The entities leverage design and manufacturing capabilities in the United States and Europe and are focused on serving a global client base ranging from startups to multinationals in the life science, IVD and cell therapy markets.

IVD Contract Manufacturing Market Advantages:

• Specialized Expertise: IVD contract manufacturers possess specialized knowledge and experience in IVD manufacturing processes, quality control, and regulatory compliance, ensuring high-quality products that meet regulatory standards.
• Scalability and Flexibility: Contract manufacturers offer scalability and flexibility, allowing IVD companies to respond to fluctuating market demands efficiently. They can quickly adjust production volumes based on requirements without the need for significant investments in infrastructure and equipment.
• Faster Time-to-Market: Partnering with contract manufacturers can significantly reduce time-to-market for IVD products. Contract manufacturers have streamlined processes, efficient supply chain management, and dedicated resources, enabling faster product development and commercialization.
• Cost Savings: Contract manufacturing provides cost advantages for IVD companies. Contract manufacturers benefit from economies of scale and operational efficiencies, leading to cost savings compared to in-house manufacturing. Companies can avoid upfront investments in facilities, equipment, and personnel, optimizing financial resources.
• Regulatory Compliance Support: IVD contract manufacturers have a deep understanding of regulatory requirements and compliance in the IVD industry. They stay updated with evolving regulations and possess expertise in navigating complex regulatory pathways, reducing the regulatory burden on IVD companies and ensuring compliance before market entry.
• Innovation and Collaboration: Contract manufacturers foster innovation and collaboration by working closely with IVD companies. They provide valuable insights, recommendations, and expertise, contributing to product improvements and manufacturing optimization. This collaboration drives the development of cutting-edge diagnostic technologies.
• Focus on Core Competencies: Outsourcing manufacturing to contract manufacturers allows IVD companies to focus on their core competencies such as research, development, and marketing. They can dedicate resources to areas of expertise while relying on contract manufacturers for efficient and reliable manufacturing processes.
• Access to Advanced Technologies: IVD contract manufacturers often invest in advanced technologies, automation, and digitization, enhancing manufacturing capabilities and efficiency. IVD companies can leverage these technologies without the need for substantial upfront investments.
• Risk Mitigation: Partnering with contract manufacturers can help mitigate risks associated with manufacturing, quality control, and regulatory compliance. Contract manufacturers have established processes and quality systems in place, reducing the risk of production issues and regulatory non-compliance.
• Global Reach and Market Expansion: Contract manufacturers often have a global presence and established distribution networks, enabling IVD companies to expand their market reach without the need for extensive infrastructure and logistics setup.

In summary, the IVD contract manufacturing market provides advantages such as specialized expertise, scalability, faster time-to-market, cost savings, regulatory compliance support, innovation and collaboration, focus on core competencies, access to advanced technologies, risk mitigation, and global market expansion. These advantages make contract manufacturing an attractive option for IVD companies seeking efficient and reliable manufacturing solutions.

IVD Contract Manufacturing Market – Objectives of the Study:

• To describe, analyze, and forecast the IVD Contract Manufacturing Market, by device type, service type, technology, and region.
• To describe and forecast the IVD Contract Manufacturing Market for key regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa
• To provide detailed information regarding the drivers, restraints, opportunities, and challenges influencing the growth of the IVD Contract Manufacturing Market
• To strategically analyze the ecosystem, regulations, patenting trend, value chain, Porter's five forces, and prices pertaining to the market under study
• To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall market
• To analyze market opportunities for stakeholders and provide details of the competitive landscape for market players.
• To profile key players and comprehensively analyze their market shares and core competencies2 in the IVD Contract Manufacturing Market.
• To analyze competitive developments such as collaborations, acquisitions, product launches, expansions, and R&D activities in the IVD Contract Manufacturing Market

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