Las organizaciones de investigación por contrato de IVD brindan servicios de apoyo a las empresas de biotecnología durante todo el desarrollo y comercialización del producto. Las empresas de instrumentos/equipos de diagnóstico requieren diversos servicios regulatorios y de prueba para implementar el ciclo de vida del producto. Los CRO están diseñados específicamente para realizar estos servicios para reducir el costo y el tiempo internos de las empresas. El desarrollo continuo en instalaciones sanitarias y productos IVD y el lanzamiento de nuevos productos impulsan el crecimiento del mercado. Además, la creciente demanda de avances tecnológicos y DIV basado en biomarcadores debido a las diversas ventajas que ofrecen promueve el crecimiento del mercado.
Información estratégica
El mercado de organizaciones de investigación por contrato de DIV está segmentado según el tipo, los servicios y la geografía. Por geografía, el mercado está ampliamente segmentado en América del Norte, Europa, Asia Pacífico, Medio Oriente y Asia. África y el Sur y el Sur. Centroamérica. El informe de mercado ofrece información y un análisis en profundidad del mercado, enfatizando parámetros como las tendencias del mercado, los avances tecnológicos, la dinámica del mercado y el análisis competitivo de los principales actores del mercado a nivel mundial.
Regiones lucrativas para el mercado de organizaciones de investigación por contrato de IVD
Perspectivas del mercado
Lanzamientos de nuevos productos por parte de los actores del mercado para impulsar el mercado de organizaciones de investigación por contrato de IVD durante el período de pronóstico
< p>La creciente demanda de diagnósticos in vitro se debe a la creciente prevalencia de diversas enfermedades, como el cáncer, los trastornos autoinmunes y las infecciones bacterianas. Por lo tanto, la demanda de diagnósticos in vitro efectivos y avanzados para detectar enfermedades que ayuden a tratar y monitorear a los pacientes es cada vez mayor. las condiciones han aumentado. Varios actores del mercado se centran en ofrecer mejores productos de diagnóstico in vitro para satisfacer la demanda del mercado, lo que llevó al aumento de los lanzamientos de productos IVD. Esto ha creado la demanda de que las organizaciones de investigación clínica de IVD realicen estudios preclínicos para garantizar la efectividad y precisión de los productos, impulsando así el crecimiento del mercado de organizaciones de investigación por contrato de IVD.A continuación se muestran algunos ejemplos de empresas que lanzaron Nuevos productos y desarrollos de IVD:
- En febrero de 2022, Invitae anunció la disponibilidad de FusionPlex Dx y LiquidPlex Dx en Europa. Proporciona productos CE-IVD de la más alta calidad para permitir a los patólogos y oncólogos europeos proporcionar de manera eficiente información vital a tiempo para guiar la terapia contra el cáncer para los pacientes. Ofrece una innovación esencial de alta calidad para la oncología de precisión en la lucha contra el cáncer.
- En abril de 2021, Illumina anunció la puesta en marcha de sus esfuerzos de detección del cáncer mediante el lanzamiento de una nueva prueba de diagnóstico in vitro (IVD) para impulsar sus colaboraciones de diagnóstico complementario (CDx) centradas en la oncología. También planea lanzar una nueva plataforma de datos bioinformáticos basada en la nube.
Estos desarrollos por parte de los actores del mercado están impulsando el mercado de organizaciones de investigación por contrato IVD.
Type Insights
Según el tipo, el mercado global de organizaciones de investigación por contrato de IVD se segmenta en química clínica, diagnóstico molecular, inmunoquímica, diagnóstico complementario, hematología, histología y citología, microbiología y otros. En 2021, el segmento de química clínica tuvo la mayor participación del mercado. Además, se espera que el segmento de hematología registre la CAGR más alta del mercado durante 2021-2028. El crecimiento del mercado para el segmento de hematología se atribuye a la mayor concienciación de los pacientes, las autopruebas de los pacientes, el rápido envejecimiento de la población mundial y las pruebas automatizadas debido a los avances tecnológicos. Además, la creciente demanda de IVD impulsaría el crecimiento del mercado en los próximos años.
Mercado de organización de investigación por contrato de IVD, por tipo: 2021 y 2028
Información sobre servicios
Basado en los servicios, el mercado global de organizaciones de investigación por contrato de IVD se segmenta en investigación clínica, bioestadística y servicios de gestión de datos, terapéuticos. experiencia, servicios regulatorios, servicios de apoyo al reembolso, servicios de desarrollo de ensayos y otros. En 2021, el segmento de servicios de gestión de datos y bioestadística tuvo la mayor cuota de mercado. Sin embargo, se espera que el segmento de servicios de apoyo a los reembolsos registre la CAGR más alta durante 2021-2028. El crecimiento del mercado para el segmento de servicios de bioestadística y gestión de datos se atribuye al aumento de ensayos clínicos, estudios científicos básicos e investigaciones poblacionales, así como a su diseño, realización, análisis e interpretación. Las herramientas de gestión de datos de investigación clínica ayudan en todas las partes del estudio, desde la configuración hasta la implementación y el envío. Ya sea que los servicios de gestión de datos clínicos se requieran como un servicio independiente, como parte de una oferta de servicios completa o como subcontratación funcional completa, los proveedores de servicios adaptan los servicios de gestión de datos clínicos para satisfacer las necesidades. Por lo tanto, todos estos factores impulsan el crecimiento del mercado de organizaciones de investigación por contrato de IVD.
Los lanzamientos de productos y las colaboraciones son estrategias muy adoptadas por los actores del mercado global de organizaciones de investigación por contrato de IVD. A continuación se enumeran algunos de los recientes desarrollos clave del mercado:
- En marzo de 2022, NAMSA, una organización de investigación por contrato (CRO) de tecnología médica líder en el mundo que ofrece servicios de desarrollo globales de extremo a extremo, anunció la adquisición de ÅKRN Scientific Consulting, una destacada CRO europea de dispositivos médicos con sede en Madrid, España.
- En febrero de 2022, Proxima Clinical Research, una empresa que guía a las empresas farmacéuticas y de dispositivos médicos emergentes desde las primeras etapas del desarrollo de productos a través de la comercialización, anunció que ha sido honrado con dos premios de oro y una mención honorífica de los AVA Digital Awards, una competencia creativa internacional que honra el genio creativo.
- En febrero de 2021, Icon Plc adquirió PRA Health Sciences , Inc. Ambas empresas pueden brindar valor a sus pacientes, clientes, personal y accionistas como resultado de estas adquisiciones.
La pandemia de COVID-19 ha impactado en gran medida a las organizaciones de investigación por contrato de DIV a nivel mundial y afectó los ensayos clínicos de varios productos. Las constantes mutaciones en el nuevo coronavirus existente y su gravedad han sido la causa de pérdidas catastróficas de vidas y han impactado la economía global. La pandemia de COVID-19 está desconcertando a las instituciones sanitarias con desafíos operativos y clínicos sin precedentes. La pandemia ha tenido un impacto crítico en el mundo, pero también ha brindado una oportunidad para el mercado de organizaciones de investigación por contrato de IVD. Las organizaciones de investigación por contrato estaban dando prioridad al desarrollo de kits de prueba, tratamientos y vacunas para la COVID-19, lo que detuvo otros ensayos clínicos y actividades de I+D. Además, las iniciativas gubernamentales de apoyo y las inversiones de los principales actores del mercado en el desarrollo de kits de prueba COVID-19 basados en IVD aumentaron los ensayos clínicos para kits de prueba IVD COVID-19. Una vez controlada la pandemia, se espera que los ensayos clínicos para otros diagnósticos junto con los kits de prueba COVID-19 y su producción promuevan el crecimiento del mercado de organizaciones de investigación por contrato de IVD. Sin embargo, la pandemia de COVID-19 llevó a la implementación de nuevas prácticas y enfoques con políticas regulatorias revisadas para los ensayos clínicos, que se espera que tengan un impacto moderadamente positivo en el mercado de organizaciones de investigación por contrato de IVD en los próximos años.
Organización de investigación por contrato de IVD– Segmentación del mercado
El mercado global de organizaciones de investigación por contrato IVD está segmentado según el tipo, los servicios y la geografía. En términos de tipo, el mercado se segmenta en química clínica, diagnóstico molecular, inmunoquímica, diagnóstico complementario, hematología, histología y citología, microbiología y otros. Según los servicios, el mercado de organizaciones de investigación por contrato de DIV se segmenta en investigación clínica, bioestadística y servicios de gestión de datos, experiencia terapéutica, servicios regulatorios, servicios de apoyo a reembolsos, servicios de desarrollo de ensayos y otros. Geográficamente, el mercado está segmentado en América del Norte, Europa, Asia Pacífico, Medio Oriente y Asia. África y América del Sur y Central.
Perfiles de la empresa
- Proxima Clinical Research, Inc.
- Clinexa, ResearchDx
- NAMSA < li>Nexelis, una Q² Empresa de soluciones
- ICON PLC
- Caja de herramientas Innovaciones médicas
- DCN Dx
- CMIC HOLDINGS Co., LTD
- AKRN Consultoría Científica SL
- ResearchDx
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
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 and advised several client 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 organization 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 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/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.
- 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.
- 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.
- 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.
- 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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