The IVD contract research organization market is projected to reach US$ 8,019.53 million by 2028 from US$ 4,738.79 million in 2021; it is estimated to grow at a CAGR of 7.8% from 2021 to 2028.
IVD contract research organizations provide support services to the biotechnology companies throughout the development and commercialization of the product. Diagnostic instruments/equipment companies require various regulatory and testing services to implement product lifecycle. CROs are specifically designed to perform these services to reduce the in-house cost and time of the companies. The continuous development in healthcare facilities and IVD products and new products launches propel the growth of the market. Also, rising demand for technological advancements and biomarker-based IVD owing to several advantages offered by them promotes the growth of the market.
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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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The IVD contract research organization market is segmented on the basis of type, services, and geography. By geography, the market is broadly segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. The market report offers insights and in-depth analysis of the market, emphasizing parameters such as market trends, technological advancements, market dynamics, and the competitive analysis of the globally leading market players.
Lucrative Regions for IVD Contract Research Organization Market
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Market Insights
New Product Launches by Market Players to Drive IVD Contract Research Organization Market during Forecast Period
New Product Launches by Market Players to Drive IVD Contract Research Organization Market during Forecast Period
The rising demand for in-vitro diagnostics is due to the increasing prevalence of various diseases, such as cancer, autoimmune disorders, and bacterial infections. Thus, the demand for effective and advanced in-vitro diagnostics to detect diseases that help treat and monitor patients’ conditions has increased. Various market players focus on offering better in-vitro diagnostics products to fulfill the market demand, which led to the increase in IVD product launches. This has created the demand for IVD clinical research organizations for preclinical studies to ensure the effectiveness and accuracy of products, thus driving the growth of the IVD contract research organization market.
Following are a few examples of companies that launched new IVD products and developments:
- In February 2022, Invitae announced the availability of FusionPlex Dx and LiquidPlex Dx in Europe. It provides the highest quality CE-IVD products to enable European pathologists and oncologists to efficiently provide vital information on time to guide cancer therapy for patients. It delivers essential high-quality innovation for precision oncology in the fight against cancer.
- In April 2021, Illumina announced the setup of its cancer detection efforts by launching a new in-vitro diagnostic (IVD) test to boost its oncology-focused companion diagnostic (CDx) collaborations. It also plans to launch a new cloud-based bioinformatics data platform.
Such developments by market players are driving the IVD contract research organization market.
Type Insights
Based on type, the global IVD contract research organization market is segmented into clinical chemistry, molecular diagnostics, immunochemistry, companion diagnostics, hematology, histology and cytology, microbiology, and others. In 2021, the clinical chemistry segment held the largest share of the market. Moreover, the hematology segment is expected to register the highest CAGR in the market during 2021–2028. The market growth for the hematology segment is attributed to the increased patient awareness, patient self-testing, a rapidly ageing global population, and automated testing due to technological advancements. Also, the rising demand for IVD would propel the growth of the market in the coming years.
IVD Contract Research Organization Market, by Type – 2021 and 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Services Insights
Based on services, the global IVD contract research organization market is segmented into clinical research, biostatistics and data management services, therapeutic expertise, regulatory services, reimbursement support services, assay development services, and others. In 2021, the biostatistics and data management services segment held the largest market share. However, the reimbursement support services segment is expected to register the highest CAGR during 2021–2028. The market growth for the biostatistics and data management services segment is attributed to the increase in clinical trials, basic scientific studies, and population-based research, as well as their design, conduct, analysis, and interpretation. Clinical research data management tools assist with all parts of the study, from set-up to implementation and submission. Whether clinical data management services are required as a stand-alone service, as part of a complete-service offering, or as full functional outsourcing, service providers tailored clinical data management services to match the needs. Thus, all these factors drive the growth of the IVD contract research organization market.
Product launches and collaborations are highly adopted strategies by the global IVD contract research organization market players. A few of the recent key market developments are listed below:
- In March 2022, NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced the acquisition of ÅKRN Scientific Consulting, a prominent European Medical Device CRO based in Madrid, Spain.
- In February 2022, Proxima Clinical Research, a company guiding emerging medical device and pharmaceutical companies from the earliest stages of product development through commercialization, announced that it has been honored with two gold awards and one honorable mention by AVA Digital Awards, an international creative competition honoring creative genius.
- In February 2021, Icon Plc acquired PRA Health Sciences, Inc. Both businesses can provide value to their patients, clients, staff, and shareholders as a result of these acquisitions.
The COVID-19 pandemic has highly impacted IVD contract research organization globally and affected the clinical trials for various products. The constant mutations in the existing novel coronavirus and its severity have been the cause of catastrophic loss of life and impacted the global economy. The COVID-19 pandemic is perplexing healthcare institutions with unprecedented operational and clinical challenges. The pandemic has critically impacted the world, but it has also provided an opportunity for the IVD contract research organization market. The contract research organizations were prioritizing the development of COVID-19 testing kits, treatments, and vaccines, which halted other clinical trials and R&D activities. Furthermore, supportive government initiatives and investments by major market players in the development of IVD-based COVID-19 test kits increased the clinical trials for IVD COVID-19 test kits. Once the pandemic was controlled, the clinical trials for other diagnostics along with COVID-19 test kits and its production is expected to promote the growth of the IVD contract research organization market. However, the COVID-19 pandemic led to the implementation of new practices and approaches with revised regulatory policies for the clinical trials, which is expected to have a moderately positive impact on the IVD contract research organization market in the coming years.
IVD Contract Research Organization– Market Segmentation
The global IVD contract research organization market is segmented on the basis of type, services, and geography. In terms of type, the market is segmented into clinical chemistry, molecular diagnostics, immunochemistry, companion diagnostics, hematology, histology and cytology, microbiology, and others. Based on services, the IVD contract research organization market is segmented into clinical research, biostatistics and data management services, therapeutic expertise, regulatory services, reimbursement support services, assay development services, and others. Geographically, the market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South and Central America.
Company Profiles
- Proxima Clinical Research, Inc.
- Clinexa, ResearchDx
- NAMSA
- Nexelis, a Q² Solutions Company
- ICON PLC
- Toolbox Medical Innovations
- DCN Dx
- CMIC HOLDINGS Co., LTD
- AKRN Scientific Consulting S.L.
- ResearchDx
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
IVD Contract research organizations provide support services to the biotechnology, companies throughout the development and commercialization of the product. Diagnostic instruments/equipment companies require various regulatory as well as testing services to implement product lifecycle. CROs are specifically designed to perform these services in order to reduce the in-house cost and time of the companies.
Key factors that are driving the growth of this market are increasing demand for in-vitro diagnostics and clinical trials and new product launches by market players are expected to boost the market growth for the IVD contract research organizations over the years.
The CAGR value of the IVD contract research organizations market during the forecasted period of 2021-2028 is 7.8%.
The clinical chemistry segment held the largest share of the market in the global IVD contract research organizations market and held the largest market share of 23.99% in 2021.
The clinical research segment dominated the global IVD contract research organizations market and accounted for the largest market share of 19.21% in 2021.
The IVD contract research organizations market majorly consists of players such as Proxima Clinical Research, Inc.; Clinexa; ResearchDx; NAMSA; Nexelis, a Q² Solutions Company; ICON PLC; Toolbox Medical Innovations; DCN Dx; CMIC HOLDINGS Co., LTD and AKRN Scientific Consulting S.L. amongst others.
NAMSA and Proxima Clinical Research, Inc. are the top two companies that hold huge market shares in the IVD contract research organizations market.
North America IVD Contract Research Organizations market is segmented by country into US, Canada and Mexico. The US holds the largest share of the North American IVD contract research organization market. The growing innovations in the medical devices and diagnostics, increasing R&D activities, presence of well-established marketing hubs and increasing demand for various monitoring and therapeutic medical devices for IVD resulting in introduction of novel products likely to account for the growth of the market in the region.
The pandemic of coronavirus disease 2019 (COVID-19) has increased hospital resource use and necessitated the postponement of non-urgent heart surgical procedures. The market players have witnessed disruption in their business operations, slumped demand for products had marginal negative impact on the IVD contract research organizations market. Hence, the COVID 19 had somewhat negative impact on the IVD contract research organizations market before the introduction of COVID-19 vaccine. However, in the long run, as the vaccination schedule is established and the transmission rate decreases, healthcare systems will return to normal and is expected to experience increased demand for IVD contract research organizations.
The List of Companies - IVD Contract Reserach Organization Market
- Proxima Clinical Research, Inc.,
- Clinexa, ResearchDx
- NAMSA
- Nexelis, a Q² Solutions Company
- ICON PLC
- Toolbox Medical Innovations
- DCN Dx
- CMIC HOLDINGS Co., LTD
- AKRN Scientific Consulting S.L.
- ResearchDx
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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