The IVD contract research organization market size is projected to reach US$ 10.04 billion by 2031 from US$ 5.51 billion in 2023. The market is expected to register a CAGR of 7.80% during 2023–2031. Technological advancements and increased research & development activities will likely remain a key trend in the market.
IVD Contract Research Organization Market Analysis
Due to the rise in clinical studies, the market for diagnostic contract research organizations is predicted to expand more quickly. The main driver of the market's growth is the rising need for sophisticated diagnostic tools. The Asia Pacific region is expected to grow fastest because of the high adoption rate of outsourcing activities and the growing number of clinical studies. Businesses worldwide in the IVD contract research organization market, like NAMSA, Proxima Clinical Research, Inc., and ICON PLC, have used organic and inorganic growth strategies. These strategies have aided both the market's expansion and the players' commercial growth, including product launches, partnerships, and acquisitions.
IVD Contract Research Organization Market Overview
The increased incidence of several diseases, including autoimmune disorders, cancer, and bacterial infections, is the cause of the growing need for in-vitro diagnostics. As a result, there is an increasing need for sophisticated and efficient in-vitro diagnostics to identify illnesses and aid in monitoring and treating patients' conditions. To meet market demand, several industry participants concentrate on providing superior in-vitro diagnostics products, resulting in a rise in IVD product launches. Due to the need for IVD clinical research organizations to conduct preclinical studies to guarantee the efficacy and precision of products, the market for these organizations is expanding. For example, Invitae announced in February 2022 that FusionPlex Dx and LiquidPlex Dx were now available in Europe. It offers the best CE-IVD products, enabling oncologists and pathologists in Europe to effectively and promptly provide patients with critical information directing their cancer treatment. To combat cancer, it offers crucial, superior innovation for precision oncology.
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IVD Contract Research Organization Market: Strategic Insights
Market Size Value in US$ 4,738.79 Million in 2021 Market Size Value by US$ 8,019.53 Million by 2028 Growth rate CAGR of 7.8% from 2021 to 2028 Forecast Period 2021-2028 Base Year 2021
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IVD Contract Research Organization Market: Strategic Insights
| Market Size Value in | US$ 4,738.79 Million in 2021 |
| Market Size Value by | US$ 8,019.53 Million by 2028 |
| Growth rate | CAGR of 7.8% from 2021 to 2028 |
| Forecast Period | 2021-2028 |
| Base Year | 2021 |
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IVD Contract Research Organization Market Drivers and Opportunities
Increasing demand for In-Vitro Diagnostics and Increase in Clinical Trials Favor the Market Growth
The need for sophisticated and effective in-vitro diagnostics and monitoring of disorders that aid in treatment has arisen from the rising prevalence of diseases like cancer, cardiovascular disorders, autoimmune disorders, and health problems. According to the National Stem Cell Foundation (NSCF) 2022 report, autoimmune diseases afflict approximately 4% of the global population; in the US, they affect 5-8% of the total population. There are over 80 different types of autoimmune diseases. The market for IVD contract research organizations is expanding due to this. Clinical trials are essential when assessing a medication or device's safety and efficacy in the marketplace. These studies contribute to our understanding of the most effective methods in therapy and diagnosis. The need for sophisticated IVD diagnostics has arisen due to the rising prevalence of disorders, which has stimulated clinical trials and grown the IVD contract research organization market.
Moreover, the adoption of outsourcing activities has grown due to increased R&D and rising investments in IVD diagnostic development. Outsourcing is becoming increasingly popular in drug and device development services because it saves money and time. As a result, more contract research firms are now available to assist manufacturers in creating cutting-edge IVD diagnostics. For example, 4250 contract research organizations are estimated to be operating in the United States in 2022.
Therefore, the market for IVD contract research organizations is expanding due to increased R&D investments, the prevalence of disorders and clinical trials, and contract research organizations themselves.
Increase in Point-of-Care Testing and Potential Opportunities from Developing Economies Creates Significant Opportunities in the Market
The infrastructure and healthcare facilities have improved, raising the preference for cutting-edge and successful treatment methods over conventional ones. Compared to traditional testing services, point-of-care testing (POCT) has seen a rise in demand due to its quick results and ability to treat patients. The demand for IVD has increased due to the rise in point-of-care testing, which has given the IVD contract research organization market numerous opportunities. Asia Pacific is anticipated to grow considerably due to emerging economies like China and India. APAC nations are becoming increasingly popular as outsourcing hubs for multinational diagnostics and medical equipment producers. The market for IVD contract research organizations is anticipated to expand due to the low cost of manufacturing and operation and the growing demand for IVD products worldwide.
Additionally, Asia's scientific base and capabilities are constantly expanding due to the increasing contribution of clinical research, centralized healthcare institutions, highly qualified and motivated investigators, and first-rate clinical trial facilities. Given that APAC is home to about 60% of the world's population, it provides a diverse patient pool. Therefore, the IVD contract research organizations market is anticipated to see new opportunities due to the factors above.
IVD Contract Research Organization Market Report Segmentation Analysis
Key segments that contributed to the derivation of the IVD contract research organization market analysis are type and services.
- Based on type, the IVD contract research organization market is segmented into clinical chemistry, molecular diagnostics, companion diagnostics, immunochemistry, microbiology, hematology, histology & cytology, and others. The clinical chemistry segment held the most significant market share in 2023.
- By services, the market is categorized into clinical research, biostatistics & data management services, therapeutic expertise, regulatory services, reimbursement support services, assay development services, and others. The biostatistics & data management services segment held the largest share of the market in 2023.
IVD Contract Research Organization Market Share Analysis by Geography
The geographic scope of the IVD contract research organization market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.
The North America IVD contract research organization market is segmented into the US, Canada, and Mexico. The growing innovations in medical devices and diagnostics, increasing R&D activities, presence of well-established marketing hubs, and growing demand for various monitoring and therapeutic medical devices for IVD resulted in the introduction of novel products likely to account for the market growth in the region. Increasing emphasis on preventive care coupled with enhanced access to healthcare facilities is expected to boost the development of the in-vitro diagnostics market in the US. The market players focus on developing advanced diagnostic systems for the exponentially increasing patient pool, enabling rapid disease detection. For instance, in February 2019, Grail, a U.S.-based diagnostic services player, received an estimated USD 1.5 billion in financial aid from Microsoft and Amazon to develop new technology for rapid cancer detection. Furthermore, the ease of efforts concerning regulatory compliance taken care of by the CROs further aids in the market growth
IVD Contract Research Organization Market Report Scope
IVD Contract Research Organization Market News and Recent Developments
The IVD contract research organization market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the IVD contract research organization market are listed below:
- Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, announced that it has been named “Best Contract Research Organization” in the Full-Service Provider category at the 19th Annual Scrip Awards. The Best CRO ranking from Scrip follows the company’s recognition earlier in the year as Top CRO to Work With in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey, and winner of the 2023 Society for Clinical Research Sites (SCRS) Eagle Award recognizing the CRO committed to advancing the clinical research profession through strong site partnerships. (Source: Parexel, Press Release, November 2023)
IVD Contract Research Organization Market Report Coverage and Deliverables
The “IVD Contract Research Organization Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:
- IVD contract research organization market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- IVD contract research organization market trends as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST/Porter’s Five Forces and SWOT analysis
- IVD contract research organization market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments.
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the IVD contract research organization market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Type, Services, and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
North America dominated the IVD contract research organization market in 2023
Key factors driving the market are increasing demand for in-vitro diagnostics, increased clinical trials, and new product launches by market players.
The market is expected to register a CAGR of 7.80% during 2023–2031.
Proxima Clinical Research, Inc., Toolbox Medical Innovations, Clinexa, ResearchDx, NAMSA, Nexelis, ICON PLC, DCN Dx, CMIC HOLDINGS Co., LTD, AKRN Scientific Consulting SL.
Technological advancements and increased research & development activities will likely remain a key trend in the market.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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