IVD Contract Manufacturing Market by Device Type (Consumables, Equipment), Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation), Service (Manufacturing, Assay Development) - Global Forecast to 2028
Updated on : June 25, 2023
The global IVD contract manufacturing market in terms of revenue was estimated to be worth $15.4 billion in 2023 and is poised to reach $26.7 billion by 2028, growing at a CAGR of 11.5% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Growth in this market can primarily be attributed to the growing need for less costly and better equipments, increased need for IVD OEMs to establish themselves in the high potential market and emerge as a budding player in other allied markets, reduced risk of development failure, and reduction in cross contamination of IVD consumables at the CMO facility, and emergence of small scaled outsourcing facilities in emerging nations. However, the rising shortage of skilled labour, risk of patent infringement, and other Intellectual property safety failures, create a barrier to the growth of the market.
Attractive Opportunities in IVD Contract Manufacturing Market
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IVD Contract Manufacturing Market Dynamics
Driver: Growth in the IVD devices market in developing countries
In the coming years, China and India are expected to drive growth in the Asia Pacific region. Over 100% GDP growth is anticipated in China and India between 2020 and 2040. Emerging economies may benefit from the growth. In order to take advantage of the numerous opportunities and set up businesses in the Asia Pacific region, foreign investment will also rise in this region. Additionally, the region will use IVD devices more frequently as a result of the rising number of diagnostic public-private partnerships and government grants, which will spur a rise in contract manufacturing.
Restraint: Protecting IP is a key challenge in contract manufacturing
Protecting IP is a key challenge in contract manufacturing, as OEMs need to ensure that their proprietary information and technology are not shared with competitors or third parties. When a brand outsources its production to a third-party manufacturer, it exposes itsintellectual property(IP) to the risk of theft or infringement. It is particularly true for products that rely heavily on patented or proprietary technology or processes. This creates a glitch in obtaining contracts from mid to large scale manufcturers.
Opportunity: Increasing healthcare expenditure, infrastructure, and awareness in developing countries
China, India, and other emerging economies offer significant growth opportunities for companies operating in the medical device contract manufacturing market. China and India have laxer regulatory standards than other developing nations. One of the main factors influencing the demand for IVD devices in emerging nations is the rising prevalence of various chronic and infectious diseases, together with the rising cost of healthcare. Another important driver is the rising desire for home healthcare. Due to this, numerous manufacturers have established operations in these nations.
Challenge: Lack of constant innovation to balance technological capabilities against costs and budgertory cuts observed by end users
For firms to compete in a complicated industry like IVD, ongoing innovation is essential. These developments aid contract manufacturers by accelerating the process, lowering the margin of error, and luring clients. In recent years, CMOs have developed a number of significant capabilities, including automated manufacturing, automated labs, and automated processes. All of this, however, has a price. CMOs have substantial difficulties managing the need for cutting-edge technologies while juggling intense financial pressures.
Additionally, the budgetary cuts are observed in end users in the European region, mainly due to the economic slowdown in the past few years. Owing to such budget cuts, many end users cannot afford costly medical devices and prefer lower-priced alternatives (such as refurbished devices) or undertake the upgradation of existing medical equipment and devices. This inturn reduces the contract lots quantity obtained by the CMOs from IVD brands.
IVD Contract Manufacturing Market Ecosystem
Leading players in this market include well-established and financially stable manufacturers of IVD devices & consumables and service providers. These companies have been operating in the market for several years and possess a diversified product portfolio, advanced technologies, and strong global presence. Prominent companies in this 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).
The IVD consumables segment of IVD contract manufacturing industry is expected to register the highest CAGR during the forecast period.
Based on device type, the IVD contract manufacturing market is segmented into IVD consumables and IVD equipments. In 2022, the IVD consumables segment is expected to register the highest CAGR during the forecast period. Numerous advantages like cost savings, reduced risk, reduced period length to market the product post production, increased speed of development, and acceesibility to new technologies. CMOs can provide greater flexibility in terms of production volume, batch size, and product mix. This can be helpful for companies that are developing new products or that have fluctuating demand. For example, a CMO may be able to produce small batches of a new product to test the market, or they may be able to increase production volume to meet demand for an existing product.
The immunoassay segment of the IVD contract manufacturing industry, acquired the largest share in the technology market.
Based on technology, the IVD contract manufacturing market is segmented into immunoassay, clinical chemistry, molecular diagnostics, microbiology, hematology, and coagulation & hemosatsis. . The imunoassay segment is acquired the largest share in the market followed by the clinical chemistry segment. The adoption of enzyme linked immunoassay rapid tests has increased due to their ability to provide testing in remote areas or emergencies where no sophisticated or advanced technology is available for disease screening. This supports the market growth.
The assay development segment of the IVD contract manufacturing industry is expected to grow at the highest CAGR during the forecast period.
Based on the service type, the IVD contract manufacturing market is segmented into manufacturing services, assay development services, and other services like maintenance services, testing services, distributorship services, and post sales customer support services. The assay development services segment is expected to grow at the highest CAGR during the forecast period. Large number of contract manufacturers providing assay services for numerous analyzers and consumables developed by the OEMs and the enormous rise in new and efficient tests for immunoassays, molecular diagnostic tests, clinical chemistry testing, etc. are factors that influence the growth of the market.
APAC is estimated to be the fastest-growing region of the IVD contract manufacturing industry.
The global IVD contract manufacturing market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2022, APAC is estimated to be the fastest-growing regional market for IVD. The high growth in this market can majorly be attributed to the increased government initiatives to boost the outsourcing capabilities of small-scale outsourced players, the low raw material to finished goods production costs, and cheap labour is obtained in this region.
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The IVD contract manufacturing market is dominated by a few globally established players such as Jabil Inc. (US), Sanmina Corporation (US), TE Connectivity (Switzerland), Celestica Inc.(Canada), Savyon Diagnostics (Israel), West Pharmaceutical Services, Inc.(US), and Thermofisher (US). Major players adopt growth strategies to expand their geographical presence and garner higher shares in the global market, such as product launches and approvals, expansions, collaborations, and acquisitions.
Scope of the IVD Contract Manufacturing Industry
|
Report Metric |
Details |
|
Market Revenue in 2023 |
$15.0 billion |
|
Projected Revenue by 2028 |
$25.5 billion |
|
Revenue Rate |
Poised to Grow at a CAGR of 11.2% |
|
Market Driver |
Growth in the IVD devices market in developing countries |
|
Market Opportunity |
Increasing healthcare expenditure, infrastructure, and awareness in developing countries |
The study categorizes the IVD Contract Manufacturing Market to forecast revenue and analyze trends in each of the following submarkets:
By Device Type
- IVD Equipment
- IVD Consumables
By Technology
- Immunoassay
- Clinical Chemistry
- Molecular Diagnostics
- Microbiology
- Hematology
- Coagulation & Hemostasis
- Others
By Service Type
- Manufacturing Services
- Assay Development Services
- Other Services
By Region
-
North America
- US
- Canada
-
Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe
-
Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia Pacific
-
Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
Recent Developments of IVD Contract Manufacturing Industry
- 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.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global IVD contract manufacturing market?
The global IVD contract manufacturing market boasts a total revenue value of $26.7 billion by 2028.
What is the estimated growth rate (CAGR) of the global IVD contract manufacturing market?
The global IVD contract manufacturing market has an estimated compound annual growth rate (CAGR) of 11.5% and a revenue size in the region of $15.4 billion in 2023.
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This study involved the extensive use of both primary and secondary sources. The research process involved the study of various factors affecting the industry to identify the segmentation types, industry trends, key players, competitive landscape, key market dynamics, and key player strategies.
Secondary Research
This research study involved the usage of comprehensive secondary sources; directories; databases such as Bloomberg Business, Factiva, and Dun & Bradstreet; white papers; annual reports; company house documents; investor presentations; and SEC filings of companies. Secondary research was used to identify and collect information useful for an extensive, technical, market-oriented, and commercial study of the IVD Contract Manufacturing Industry. It was also used to obtain important information about the key players, market classification and segmentation according to industry trends to the bottommost level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Extensive primary research was conducted after obtaining information regarding the IVD Contract Manufacturing Market scenario through secondary research. Several primary interviews were conducted with market experts from both, the demand and supply sides across major countries of North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America. Primary data was collected through questionnaires, emails, and telephonic interview. The primary sources included various industry experts, such as Chief X Officers (CXOs), Vice Presidents (VPs), Directors, from business development, marketing, product development/innovation teams, and related key executives from IVD contract manufacturer; system integrators; component providers; distributors; and key opinion leaders/consultants.
Primary interviews were conducted to gather insights such as market statistics, data of revenue collected from the products and services, market breakdowns, market size estimations, market forecasting, and data triangulation. The primary sources from the supply side and demand side are detailed below.
A breakdown of the primary respondents is provided below:
Breakdown Of Primary Interviews: Supply-Side Participants, By Company Type, Designation, And Region
Note 1: C-level primaries include CEOs, COOs, CTOs, and VPs.
Note 2: Other primaries include sales managers, marketing managers, and product managers.
Note 3: Companies are classified into tiers based on their total revenue. As of 2020: Tier 1 = >USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3 = <USD 500 million.
Breakdown of Primary Interviews: By Company Type, Designation, and Region
Note: Others include department heads and research scientists
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Market Size Estimation
The total size of the IVD Contract Manufacturing Industry was arrived at after data triangulation from two different approaches, as mentioned below. After each approach, the weighted average of all approaches was taken based on the level of assumptions used in each approach.
Global IVD Contract Manufacturing Market Size: Bottom-Up Approach
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Global IVD Contract Manufacturing Market Size: Top-Down Approach
Data Triangulation
After arriving at the market size, the total market was divided into several segments and sub-segments. To complete the overall market engineering process and arrive at the exact statistics for all segments and sub-segments, data triangulation and market breakdown procedures were employed, wherever applicable. The following figure shows the market validation, source structure, and data triangulation methodology implemented in this report’s market engineering process.
Market Definition
IVD contract manufacturing is a process wherein a manufacturing company makes IVD equipment or consumables that can be sold later by other companies. IVD contract manufacturers specialize in a certain process or task and offer expertise due to their frequent practice of manufacturing. These companies may also offer assay development, maintenance services, testing services, and distribution services to Original Equipment Manufacturers or Small and Mid-Size organizations.
Key Stakeholders
- Original Equipment Manufacturers
- Suppliers and distributors of IVD equipment
- Small and Mid-size IVD manufactures
- Government bodies/municipal corporations
- Venture capitalists
- US Food and Drug Administration (US FDA)
- European Union (EU)
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 Industry 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 Industry
- 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 Industry.
- To analyze competitive developments such as collaborations, acquisitions, product launches, expansions, and R&D activities in the IVD Contract Manufacturing Market
Available customizations
With the given market data, MarketsandMarkets offers customizations as per your company’s specific needs. The following customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional market players (up to 5)
Geographic Analysis
- Further breakdown of the RoE IVD Contract Manufacturing Industry into Austria, Finland, and others
- Further breakdown of the RoLATAM IVD Contract Manufacturing Industry into Argentina, Colombia, Chile, and others
Competitive Landscape Assessment
Market share analysis for the North America and Europe region, which provides market shares of the top 3–5 key players in the IVD Contract Manufacturing Industry
- Competitive leadership mapping for established players in the US
Growth opportunities and latent adjacency in IVD Contract Manufacturing Market