In Vitro Diagnostics (IVD) contract Manufacturing Market Analysis Asia, North America, Europe, Rest of World (ROW) - US, Germany, China, Japan, India - Size and Forecast 2023-2027

In Vitro Diagnostics (IVD) Contract Manufacturing Market Forecast 2023-2027

The  In Vitro Diagnostics (IVD) Contract Manufacturing Market size is estimated to grow by USD 9.37 billion at a CAGR of 11.84% between 2022 and 2027. There is an increasing demand for one-stop-shop IVD contract manufacturing across IVD enterprises. IVD contract manufacturing offers support through all stages of assay development for various types of drugs. Additionally, they provide secondary packaging services to IVD device manufacturing enterprises such as packaging of user sets, labeling, cartons, packaging into blister packs, and serialization services. Furthermore, additional offerings of these IVD contract manufacturers include customization of the packaging depending on requirements, such as product safety, patient friendliness, cost efficiency, and country-specific requirements. Hence, such factors are positively impacting the market growth during the forecast period. This market analysis and report also includes an in-depth analysis of drivers, trends, and challenges. Our report examines historic data from 2017 to 2021, besides analyzing the current market scenario.

What will be the size of the IVD contract Manufacturing Market During the Forecast Period?

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The market thrives on collaboration between in vitro diagnostics (IVD) companies and third-party manufacturers, leveraging their expertise and facilities to streamline operations. With a focus on research and development, the market specializes in producing diagnostic testing materials, including reagents, assay kits, and diagnostic instruments, catering to disease detection and monitoring needs worldwide. Contract manufacturers play a pivotal role in reducing production costs and enhancing the efficiency of IVD operations.

Market Segmentation

In the realm of In Vitro Diagnostics (IVD) contract manufacturing, the device segment plays a pivotal role in advancing patient care and disease management. With the increasing prevalence of diseases and an aging population, there's a growing need for early detection methods and specialized manufacturing capabilities. Molecular diagnostics and point-of-care testing have emerged as key technologies, offering rapid and accurate results to healthcare providers worldwide. To meet regulatory requirements and ensure diagnostic accuracy, manufacturers are investing in advanced technologies and strategic collaborations. Moreover, the rise of personalized medicine has spurred the development of innovative devices tailored to individual patient needs. Global healthcare spending continues to drive market growth, with a focus on AI-driven solutions for infectious diseases and other health challenges. In essence, the device segment of the market remains at the forefront of innovation, enabling timely and effective diagnostic solutions for improved patient outcomes.

By Device

IVD consumables

The IVD consumables segment is estimated to witness significant growth during the forecast period. In-vitro diagnostics (IVD) can be referred to as consumables that are intricate and diverse, with thin-walled, translucent, fragile, or complex-shaped components. IVD consumables must adhere to strict tolerances requirements as features like dosing accuracy, snap-in catches, and seals are essential in in-vitro diagnostics.

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The IVD consumables segment was the largest segment and was valued at USD 5.72 billion in 2017. There is increasing adoption of the IVD consumables segment which is fuelled by the growing importance of molecular, clinical, and immunoassay diagnostic techniques. The main advantage of IVD consumables is that they help clinicians, researchers, and scientists identify different cellular components to diagnose diseases for an improved understanding of the biology of cells. For example, specific tumor markers are widely used by physicians to diagnose the presence of malignant tumors or cells using immunohistochemistry (IHC) technology. Hence, such factors are expected to fuel the growth of this segment which, in turn, will drive the market growth during the forecast period.

Regional Analysis

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Asia is estimated to contribute 37% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. One of the main reasons that significantly contributed to the global market in Asia is due to factors such as the large population base, which provides significant scope for market companies to penetrate these countries.

Additionally, there is an increasing partnership between small and medium-sized market players with the leading players expanding into hitherto untapped regions. Furthermore, some of the key factors such as increasing healthcare budgets, the growing number of hospitals and other healthcare facilities, and low labor costs, supported by the commitment of governments globally to expand access to healthcare services are driving the market growth in the region during the forecast period.

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Market Dynamics and Customer Landscape

The market is thriving due to strategic collaborations and specialized manufacturing capabilities offered by third-party manufacturers. With rising global healthcare spending and the prevalence of diseases, there's a growing demand for diagnostic testing materials and assay kits. Contract manufacturers leverage expertise and facilities to ensure high diagnostic accuracy in disease detection and monitoring. They play a crucial role in research and development, particularly in molecular diagnostics and point-of-care testing. As the aging population increases, there's a greater focus on early detection and personalized medicine, driving the need for rapid diagnostic tests and compliance with regulatory requirements, including AI integration for enhanced efficiency in infectious disease management. There are multiple factors influencing market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges. 

Key Market Driver

High growth market potential in emerging countries is notably driving the market growth. Growing awareness levels about the availability of a wide range of IVD medical devices are compelling OEMs to develop new innovative devices. This is leading to substantial growth in R&D investments and has forced OEMs to shift to contract outsourcing as an effective cost-curbing tool. In emerging economies, contract outsourcing of IVD device manufacturing is receiving widespread attention. Due to improvements in production process technologies and manufacturing facilities, MedTech manufacturing networks are emerging

However, developing economies such as China and India are anticipated to experience market growth owing to longer life expectancy, increasing expenditure on healthcare, and the growing demand for technologically prominent products in these countries can direct to in vitro diagnostics contract manufacturing market expansion. These developments are anticipated to boost the growth of the market during the forecast period

Significant Market Trends

A key factor shaping the market growth is the leasing of IVD equipment. There is an increase in the leasing of costly IVD equipment as it is the most effective and convenient option for purchasing for end-users, mainly those with budgetary constraints.  Additionally, the main advantage of leasing is that it increases flexibility and offers tax benefits that enhance the business operations of IVD manufacturers.

Furthermore, there is increasing adoption of leasing by several companies due to fast and easy credit approval and documentation processes. Additionally, the key advantage of leasing is that it enhances the opportunities for growth irrespective of the size of the business and its financial needs. Hence, such benefits are expected to positively impact the in market growth. Therefore, such factors are expected to drive market growth during the forecast period.

Major Market Challenges

The threat of infringement of intellectual property (IP) rights is one of the key challenges hindering the IVD contract manufacturing market growth. IP mainly comprises innovative ideas and concepts that are developed by a person or an enterprise. It is one of the most crucial resources for healthcare companies, and its protection is vital for the future success of the enterprise. The development of new drugs or medicines and their successful launch in the in vitro Diagnostics (IVD) contract manufacturing market is an expensive and time-consuming process. Therefore, several enterprises outsource the manufacturing of IVD equipment to IVD contract manufacturers to speed up the manufacturing process and make the product available in the market quickly before the IP rights expire.

However, the major concern regarding outsourcing is that it can lead to chances of IP infringements which can negatively impact market growth. Hence such factors are expected to hinder the market growth during the forecast period.

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Customer Landscape

The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Market Customer Landscape

Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

Avioq Inc: The company offers IVD (in-vitro diagnostics) contract manufacturing services with bio-manufacturing and analytical capabilities including recombinant protein production either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates produced from large-scale cell cultures.

• Argonaut Manufacturing Services Inc.
• Bio-Techne Corp.
• CorDx
• Danaher Corp
• FlexMedical Solutions Ltd
• Genemed Biotechnologies Inc.
• HDA Technology Inc.
• Jena Bioscience GmbH
• Merck KGaA
• More Diagnostics Inc
• Neogen Corp
• PHC Holdings Corp.
• Prestige Diagnostics UK Ltd
• Seyonic SA
• TCS Biosciences Ltd
• TE Connectivity Ltd.
• Veracyte Inc.
• West Pharmaceutical Services Inc.
• Wanrun Co. Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Analyst Overview

The global market is thriving due to increasing demand for diagnostic testing materials and a surge in the prevalence of diseases worldwide. Third-party manufacturers play a crucial role in meeting this demand through strategic collaboration with healthcare companies. These partnerships leverage specialized manufacturing capabilities and expertise in producing reagents, assay kits, and diagnostic instruments. With a growing emphasis on personalized medicine and early disease detection, the market is witnessing a rise in point-of-care testing and rapid diagnostic tests, driven by advancements in AI technology. Regulatory requirements ensure diagnostic accuracy and patient safety, while the aging population underscores the importance of continuous monitoring and patient care for various infectious diseases.

The market is witnessing significant growth driven by factors such as the need for production costs optimization and the growing importance of early detection in disease management. With advancements in molecular diagnostics and the rise in global healthcare spending, there's a heightened focus on leveraging innovations in diagnostic technologies. Strategic collaborations between IVD companies and manufacturers play a pivotal role in navigating the complex healthcare landscape and implementing effective market strategies. Ensuring quality standards through quality management systems and fostering public awareness initiatives are essential for enhancing digital technologies integration and driving further market expansion.

In the realm of global IVD contract manufacturing, ensuring intellectual property safety is paramount to prevent failures and maintain trust in the market. Despite challenges such as budgetary cuts, the rising healthcare expenditure underscores the importance of addressing chronic and infectious diseases through innovation. Leveraging technological capabilities, manufacturers strive to meet demands for quality infrastructure and accommodate trends like home healthcare. The market also witnesses a growing demand for refurbished devices and flexibility in contract lots quantity to optimize operations. Overcoming hurdles and embracing opportunities for innovation, the IVD contract manufacturing sector continues to play a pivotal role in advancing global healthcare initiatives.

Segment Overview

The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest market growth and trends and growth opportunities from 2017 to 2027. 

• Device Outlook 
  • IVD-consumables
  • IVD-equipment/instrument
• Service Outlook 
  • Assay development
  • Manufacturing
  • Others
• Geography Outlook 
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of the World (ROW)
    • Australia
    • Argentina
    • Brazil

Market Scope
Report Coverage	Details
Page number	149
Base year	2022
Historic period	2017-2021
Forecast period	2023-2027
Growth momentum & CAGR	Accelerate at a CAGR of 11.84%
Market growth 2023-2027	USD 9.37 billion
Market structure	Fragmented
YoY growth 2022-2023(%)	9.91
Regional analysis	Asia, North America, Europe, and the Rest of the World (ROW)
Performing market contribution	Asia at 37%
Key countries	US, Germany, China, Japan, and India
Competitive landscape	Leading companies, Market Positioning of companies, Competitive Strategies, and Industry Risks
Key companies profiled	Argonaut Manufacturing Services Inc., Avioq Inc, Bio-Techne Corp., CorDx, Danaher Corp., FlexMedical Solutions Ltd, Genemed Biotechnologies Inc., HDA Technology Inc., Jena Bioscience GmbH, Merck KGaA, More Diagnostics Inc., Neogen Corp., PHC Holdings Corp., Prestige Diagnostics UK Ltd., Seyonic SA, TCS Biosciences Ltd., TE Connectivity Ltd., Veracyte Inc., West Pharmaceutical Services Inc., and Wanrun Co. Ltd.
Market dynamics	Parent market analysis, Market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period.
Customization purview	If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting of the market between 2023 and 2027
• Precise estimation of the size of the market size and its contribution to the parent market
• Accurate predictions about upcoming market trends and analysis and changes in consumer behavior
• Growth of the market industry across Europe, North America, APAC, South America, and Middle East and Africa
• Thorough market growth analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive market analysis and report on the factors that will challenge the market research and growth of market companies

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