IVD Contract Research Organization Market Analysis by 2021, 28

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IVD Contract Research Organization Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Clinical Chemistry, Molecular Diagnostics, Immunochemistry, Companion Diagnostics, Hematology, Histology & Cytology, Microbiology, and Others), Services (Clinical Research, Biostatistics & Data Management Services, Therapeutic Expertise, Regulatory Services, Reimbursement Support Services, Assay Development Services, and Others), and Geography

Publication Month: Mar 2022 | Report Code: TIPRE00028373 | No. of Pages: 155 | Category: Healthcare IT | Status: Published

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.

Strategic Insights

Report Coverage - IVD Contract Research Organization Market
Report CoverageDetails
Market Size Value inUS$ 4,738.79 Million in 2021
Market Size Value byUS$ 8,019.53 Million by 2028
Growth rateCAGR of 7.8% from 2021 to 2028
Forecast Period2021-2028
Base Year2021
No. of Pages155
No. of Tables57
No. of Charts & Figures78
Historical data availableYes
Segments coveredType, Services, and Geography
Regional scopeNorth America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country scopeUS, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina
Report coverageRevenue forecast, company ranking, competitive landscape, growth factors, and trends
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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

Lucrative Regions for IVD Contract Research Organization Market

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Market Insights
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

IVD Contract Research Organization Market, by Type – 2021 and 2028

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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

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

  1. Proxima Clinical Research, Inc.,
  2. Clinexa, ResearchDx
  3. NAMSA
  4. Nexelis, a Q² Solutions Company
  5. ICON PLC
  6. Toolbox Medical Innovations
  7. DCN Dx
  8. CMIC HOLDINGS Co., LTD
  9. AKRN Scientific Consulting S.L.
  10. ResearchDx
  • Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the global IVD contract research organization market.
  • Highlights key business priorities in order to assist companies to realign their business strategies.
  • The key findings and recommendations highlight crucial progressive industry trends in the global IVD contract research organization market, thereby allowing players across the value chain to develop effective long-term strategies.
  • Develop/modify business expansion plans by using substantial growth offering developed and emerging markets.
  • Scrutinize in-depth global market trends and outlook coupled with the factors driving the market, as well as those hindering it.
  • Enhance the decision-making process by understanding the strategies that underpin security interest with respect to client products, segmentation, pricing and distribution.
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