IVD Contract Research Organization Market Size and Growth 2031

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

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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 Regional Insights

The regional trends and factors influencing the IVD Contract Research Organization Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses IVD Contract Research Organization Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

IVD Contract Research Organization Market Report Scope

IVD Contract Research Organization Market Players Density: Understanding Its Impact on Business Dynamics

The IVD Contract Research Organization Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

Major Companies operating in the IVD Contract Research Organization Market are:

1. Proxima Clinical Research, Inc.
2. Clinexa
3. ResearchDx
4. NAMSA
5. Nexelis
6. ICON PLC

Disclaimer: The companies listed above are not ranked in any particular order.

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