Le organizzazioni di ricerca a contratto IVD forniscono servizi di supporto alle aziende biotecnologiche durante lo sviluppo e la commercializzazione del prodotto. Le aziende produttrici di strumenti/apparecchiature diagnostiche necessitano di vari servizi normativi e di test per implementare il ciclo di vita del prodotto. Le CRO sono specificamente progettate per eseguire questi servizi per ridurre i costi e i tempi interni delle aziende. Il continuo sviluppo delle strutture sanitarie e dei prodotti IVD e il lancio di nuovi prodotti stimolano la crescita del mercato. Inoltre, la crescente domanda di progressi tecnologici e IVD basati su biomarcatori a causa dei numerosi vantaggi da essi offerti promuove la crescita del mercato.
Approfondimenti strategici
Il mercato delle organizzazioni di ricerca a contratto IVD è segmentato sulla base della tipologia, dei servizi e della geografia. In base alla geografia, il mercato è ampiamente segmentato in Nord America, Europa, Asia Pacifico, Medio Oriente e Asia. Africa e Sud & America Centrale. Il rapporto di mercato offre approfondimenti e analisi approfondite del mercato, sottolineando parametri quali tendenze di mercato, progressi tecnologici, dinamiche di mercato e analisi competitiva dei principali attori del mercato a livello globale.
Regioni redditizie per il mercato delle organizzazioni di ricerca a contratto IVD
Approfondimenti di mercato
Lanci di nuovi prodotti da parte degli operatori del mercato per guidare il mercato delle organizzazioni di ricerca a contratto IVD durante il periodo di previsione
< p>La crescente domanda di diagnostica in vitro è dovuta alla crescente prevalenza di varie malattie, come il cancro, le malattie autoimmuni e le infezioni batteriche. Pertanto, la richiesta di una diagnostica in vitro efficace e avanzata per rilevare malattie che aiutino a curare e monitorare i pazienti’ le condizioni sono aumentate. Vari attori del mercato si concentrano sull’offerta di migliori prodotti diagnostici in vitro per soddisfare la domanda del mercato, il che ha portato all’aumento dei lanci di prodotti IVD. Ciò ha creato la domanda da parte delle organizzazioni di ricerca clinica IVD per studi preclinici per garantire l'efficacia e l'accuratezza dei prodotti, guidando così la crescita del mercato delle organizzazioni di ricerca clinica IVD.Di seguito sono riportati alcuni esempi di aziende che hanno lanciato nuovi prodotti e sviluppi IVD:
- Nel febbraio 2022, Invitae ha annunciato la disponibilità di FusionPlex Dx e LiquidPlex Dx in Europa. Fornisce prodotti CE-IVD della massima qualità per consentire ai patologi e agli oncologi europei di fornire in modo efficiente e tempestivo informazioni vitali per guidare la terapia antitumorale per i pazienti. Fornisce un'innovazione essenziale di alta qualità per l'oncologia di precisione nella lotta contro il cancro.
- Nell'aprile 2021, Illumina ha annunciato l'avvio delle sue attività di rilevamento del cancro lanciando un nuovo test diagnostico in vitro (IVD) per potenziare le sue collaborazioni diagnostiche complementari incentrate sull'oncologia (CDx). Prevede inoltre di lanciare una nuova piattaforma di dati bioinformatici basata su cloud.
Tali sviluppi da parte degli operatori del mercato stanno guidando il mercato delle organizzazioni di ricerca a contratto IVD.
Type Insights
In base al tipo, il mercato globale delle organizzazioni di ricerca a contratto IVD è segmentato in chimica clinica, diagnostica molecolare, immunochimica, diagnostica complementare, ematologia, istologia e citologia, microbiologia e altri. Nel 2021, il segmento della chimica clinica deteneva la quota maggiore del mercato. Inoltre, si prevede che il segmento ematologia registrerà il CAGR più elevato del mercato nel periodo 2021-2028. La crescita del mercato per il segmento ematologico è attribuita alla maggiore consapevolezza dei pazienti, agli autotest dei pazienti, al rapido invecchiamento della popolazione globale e ai test automatizzati dovuti ai progressi tecnologici. Inoltre, la crescente domanda di IVD stimolerebbe la crescita del mercato nei prossimi anni.
Mercato delle organizzazioni di ricerca a contratto IVD, per tipo: 2021 e 2028
Services Insights
Sulla base dei servizi, il mercato globale delle organizzazioni di ricerca a contratto IVD è segmentato in ricerca clinica, biostatistica e servizi di gestione dei dati, servizi terapeutici competenza, servizi di regolamentazione, servizi di supporto al rimborso, servizi di sviluppo di test e altri. Nel 2021, il segmento dei servizi di biostatistica e gestione dei dati deteneva la quota di mercato maggiore. Tuttavia, si prevede che il segmento dei servizi di supporto al rimborso registrerà il CAGR più elevato nel periodo 2021-2028. La crescita del mercato per il segmento dei servizi di biostatistica e gestione dei dati è attribuita all’aumento degli studi clinici, degli studi scientifici di base e della ricerca basata sulla popolazione, nonché alla loro progettazione, conduzione, analisi e interpretazione. Gli strumenti di gestione dei dati della ricerca clinica assistono in tutte le parti dello studio, dall'impostazione all'implementazione e alla presentazione. Sia che i servizi di gestione dei dati clinici siano richiesti come servizio autonomo, come parte di un'offerta di servizi completa o come outsourcing funzionale completo, i fornitori di servizi hanno personalizzato i servizi di gestione dei dati clinici per soddisfare le esigenze. Pertanto, tutti questi fattori guidano la crescita del mercato delle organizzazioni di ricerca a contratto IVD.
I lanci di prodotti e le collaborazioni sono strategie altamente adottate dagli attori globali del mercato delle organizzazioni di ricerca a contratto IVD. Di seguito sono elencati alcuni dei recenti sviluppi chiave del mercato:
- Nel marzo 2022, NAMSA, un'organizzazione di ricerca a contratto (CRO) leader a livello mondiale che offre servizi di sviluppo end-to-end globali, ha annunciato l'acquisizione di ÅKRN Scientific Consulting, un'importante CRO europea di dispositivi medici con sede a Madrid, Spagna.
- Nel febbraio 2022, Proxima Clinical Research, una società che guida le aziende farmaceutiche e di dispositivi medici emergenti fin dalle prime fasi dello sviluppo del prodotto attraverso la commercializzazione, ha annunciato di essere stato insignito di due premi d'oro e una menzione d'onore da AVA Digital Awards, un concorso creativo internazionale che premia il genio creativo.
- Nel febbraio 2021, Icon Plc ha acquisito PRA Health Sciences , Inc. Entrambe le aziende possono fornire valore ai propri pazienti, clienti, personale e azionisti a seguito di queste acquisizioni.
La pandemia di COVID-19 ha avuto un forte impatto sulle organizzazioni di ricerca a contratto IVD a livello globale e influenzato gli studi clinici per vari prodotti. Le costanti mutazioni del nuovo coronavirus esistente e la sua gravità sono state la causa di perdite catastrofiche di vite umane e hanno avuto un impatto sull’economia globale. La pandemia di COVID-19 sta lasciando perplesse le istituzioni sanitarie con sfide operative e cliniche senza precedenti. La pandemia ha avuto un impatto critico sul mondo, ma ha anche offerto un’opportunità per il mercato delle organizzazioni di ricerca a contratto IVD. Le organizzazioni di ricerca a contratto stavano dando priorità allo sviluppo di kit di test, trattamenti e vaccini per il COVID-19, il che ha interrotto altri studi clinici e attività di ricerca e sviluppo. Inoltre, le iniziative governative di sostegno e gli investimenti da parte dei principali attori del mercato nello sviluppo di kit di test COVID-19 basati su IVD hanno aumentato gli studi clinici per i kit di test COVID-19 IVD. Una volta controllata la pandemia, si prevede che gli studi clinici per altri strumenti diagnostici insieme ai kit di test COVID-19 e alla loro produzione promuoveranno la crescita del mercato delle organizzazioni di ricerca a contratto IVD. Tuttavia, la pandemia di COVID-19 ha portato all’implementazione di nuove pratiche e approcci con politiche normative riviste per gli studi clinici, che si prevede avranno un impatto moderatamente positivo sul mercato delle organizzazioni di ricerca a contratto IVD nei prossimi anni.
Organizzazione di ricerca a contratto IVD: Segmentazione del mercato
Il mercato globale delle organizzazioni di ricerca a contratto IVD è segmentato in base al tipo, ai servizi e alla geografia. In termini di tipologia, il mercato è segmentato in chimica clinica, diagnostica molecolare, immunochimica, diagnostica complementare, ematologia, istologia e citologia, microbiologia e altri. Sulla base dei servizi, il mercato delle organizzazioni di ricerca a contratto IVD è segmentato in servizi di ricerca clinica, biostatistica e gestione dei dati, competenze terapeutiche, servizi di regolamentazione, servizi di supporto al rimborso, servizi di sviluppo di test e altri. Geograficamente, il mercato è segmentato in Nord America, Europa, Asia Pacifico, Medio Oriente e Asia. Africa e America meridionale e centrale.
Profili aziendali
- Proxima Clinical Research, Inc.
- Clinexa, ResearchDx
- NAMSA < li>Nexelis, una domanda² Società di soluzioni
- ICON PLC
- Toolbox Medical Innovations
- DCN Dx
- CMIC HOLDINGS Co., LTD
- AKRN Scientific Consulting 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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