Si prevede che il mercato dei test sviluppati in laboratorio raggiungerà i 7.269,3 milioni di dollari entro il 2028 rispetto ai 4.524,75 milioni di dollari del 2021; si prevede che crescerà a un CAGR del 7,0% nel periodo 2021-2028.
Un test sviluppato in laboratorio (LDT) è un tipo di test diagnostico in vitro progettato e utilizzato all'interno di un singolo laboratorio. Questi test possono essere utilizzati per stimare o distinguere analiti come proteine, biomolecole/composti (glucosio, colesterolo, ecc.) e DNA estratto da campioni raccolti da soggetti umani. L’espansione dei metodi di diagnostica in vitro automatizzata (IVD) per laboratori e dispensari per eseguire analisi precise e prive di errori sta alimentando la crescita del mercato dei test sviluppati in laboratorio.
La crescita del mercato dei test sviluppati in laboratorio è principalmente attribuita a fattori quali l’aumento dei casi di cancro e malattie genetiche e il gran numero di lanci di prodotti. Tuttavia, il cambiamento del panorama normativo sta ostacolando la crescita del mercato. Ad esempio, in Europa, la conformità al regolamento sui dispositivi in vitro (IVDR) sarà obbligatoria per tutti i test diagnostici in vitro a partire da maggio 2022; il regolamento mira a garantire l’efficacia clinica e la sicurezza dei test medici, trasformando così l’industria diagnostica, che rappresenta una grande preoccupazione per gli operatori del mercato.
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Mercato dei test sviluppati in laboratorio: approfondimenti strategici
CAGR (2021 - 2028)7,0%- Dimensione del mercato nel 2021:
4,52 miliardi di dollari - Dimensione del mercato nel 2028:
7,27 miliardi di dollari
Dinamiche di mercato
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Giocatori chiave
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD.,
- QIAGEN
- Illumina, Inc.,
- Eurofins Scientifico
- Biodesix
- Biotecnologie adattive
- Bioteranostica
- Rosetta Genomics Ltd.,
Panoramica regionale
- Nord America
- Europa
- Asia-Pacifico
- America meridionale e centrale
- Medio Oriente e Africa
Segmentazione del mercato
Tipo- Biochimica clinica
- Terapia intensiva
- Ematologia
- Microbiologia
- Diagnostica molecolare
- Immunologia
- Altri
Applicazione- Istituti accademici
- Organizzazioni di ricerca clinica
- Laboratorio degli ospedali
- Centri diagnostici specializzati
- Altri
- Il PDF di esempio mostra la struttura del contenuto e la natura delle informazioni con analisi qualitative e quantitative.
Approfondimenti di mercato
La ricerca continua sui farmaci personalizzati offre opportunità di crescita agli attori del mercato dei test sviluppati in laboratorio
Gli LDT svolgono un ruolo vitale nello sviluppo di farmaci personalizzati che probabilmente si riveleranno un mezzo promettente per affrontare le malattie attraverso trattamenti o cure efficaci finora sfuggiti. Secondo la Personalized Medicine Coalition, i farmaci personalizzati rappresentavano solo il 5% delle nuove entità molecolari approvate dalla FDA nel 2005; tuttavia, nel 2016, questo numero è salito a oltre il 25%. Inoltre, il 42% di tutti i composti e il 73% dei composti oncologici in cantiere hanno il potenziale per fungere da farmaci personalizzati. Le aziende biofarmaceutiche hanno quasi raddoppiato i loro investimenti in ricerca e sviluppo in farmaci personalizzati negli ultimi cinque anni e si prevede che aumenteranno ulteriormente i loro investimenti del 33% nei prossimi cinque anni. I ricercatori biofarmaceutici prevedono inoltre un aumento del 69% nello sviluppo di farmaci personalizzati nei prossimi cinque anni. I test di laboratorio vengono utilizzati per diagnosticare malattie e prevedere e monitorare la risposta ai farmaci, nonché per ottenere i dati informatici necessari per algoritmi predittivi complessi.
Le medicine personalizzate stanno diventando il marchio di fabbrica del trattamento del cancro; è un approccio in continua evoluzione che si basa sulla personalizzazione dei trattamenti in base al corredo genetico individuale. Nel 2019, la FDA ha approvato 12 farmaci personalizzati per indagare e affrontare le cause profonde delle malattie, combinando così la medicina di precisione con l’assistenza clinica. La crescente domanda di medicina personalizzata offre significative opportunità di crescita per gli attori che operano nel mercato dei test sviluppati in laboratorio.
Approfondimenti basati sul tipo
Il mercato dei test sviluppati in laboratorio, per tipologia, è segmentato in biochimica clinica, terapia intensiva, ematologia, microbiologia, diagnostica molecolare, immunologia e altri. Si prevede che il segmento della diagnostica molecolare deterrà la quota maggiore del mercato nel 2021. Tuttavia, si prevede che il segmento dell’ematologia registrerà il CAGR più elevato sul mercato durante il periodo di previsione.
Approfondimenti basati sulle applicazioni
Per applicazione, il laboratorio ha sviluppato applicazioni di mercato per test in istituti accademici, organizzazioni di ricerca clinica, laboratori ospedalieri, centri diagnostici specializzati e altri. Si stima che il segmento dei laboratori ospedalieri rappresenterà la quota di mercato maggiore nel 2021. Tuttavia, si prevede che il segmento dei centri diagnostici specialistici registrerà il CAGR più elevato sul mercato durante il periodo di previsione.
Il lancio e l’approvazione dei prodotti sono strategie comunemente adottate dalle aziende per espandere la propria presenza globale e i portafogli di prodotti. Inoltre, gli operatori del mercato di prova sviluppato in laboratorio si concentrano sulla strategia di partnership per ampliare la propria clientela, che, a sua volta, consente loro di mantenere il proprio marchio a livello globale.
Il rapporto segmenta il mercato dei test sviluppati in laboratorio come segue
In base alla tipologia, il mercato dei test sviluppati in laboratorio è segmentato in biochimica clinica, terapia intensiva, ematologia, microbiologia, diagnostica molecolare, immunologia e altri. In base all'applicazione, il mercato dei test sviluppati in laboratorio è segmentato in istituti accademici, organizzazioni di ricerca clinica, laboratori ospedalieri, centri diagnostici specializzati e altri. Sulla base della geografia, il mercato dei test sviluppati in laboratorio è segmentato in Nord America (Stati Uniti, Canada e Messico), Europa (Regno Unito, Germania, Francia, Italia, Spagna e resto d’Europa), Asia Pacifico (Cina, Giappone, India, Australia, Corea del Sud e resto dell'Asia Pacifico), Medio Oriente e Africa (EAU, Arabia Saudita, Sud Africa e resto del Medio Oriente e Africa) e America meridionale e centrale (Brasile, Argentina , e il resto dell'America meridionale e centrale).
Ambito del rapporto di mercato dei test sviluppati in laboratorio
| Attributo del rapporto | Dettagli |
|---|---|
| Dimensioni del mercato nel 2021 | 4,52 miliardi di dollari |
| Dimensioni del mercato entro il 2028 | 7,27 miliardi di dollari |
| CAGR globale (2021-2028) | 7,0% |
| Dati storici | 2019-2020 |
| Periodo di previsione | 2022-2028 |
| Segmenti coperti | Per tipo
|
| Regioni e paesi coperti | Nord America
|
| Leader di mercato e profili aziendali chiave |
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- Il PDF di esempio mostra la struttura del contenuto e la natura delle informazioni con analisi qualitative e quantitative.
Profili aziendali
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD.,
- QIAGEN
- Illumina, Inc.,
- Eurofins Scientifico
- Biodesix
- Biotecnologie adattive
- Bioteranostica
- Rosetta Genomics Ltd.,
- Guardante Salute
- Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
- PEST and SWOT Analysis
- Market Size Value / Volume - Global, Regional, Country
- Industry and Competitive Landscape
- Excel Dataset
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
The laboratory developed test market is led by type molecular diagnostics segment is growing significantly due to the increasing attention to the development of genetic therapeutics. The growing research in human genomics is playing a vital role in developing laboratory developed tests. The technological advantages of molecular tests make them compelling diagnostic tools, and they have become valuable for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS).
The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under huge pressure to manage increasing test volumes and conduct more complex diagnostic assays, which further underlines the need for flexible automation systems. Many MedTech companies are offering automation solutions to help streamline clinical laboratory processes. For instance, Roche Cobas Omni–Utility Channel is beneficial for both IVD assays and high-volume LDTs. It is designed to meet the growing needs of efficient workflows in laboratories, as it can assist in different stages ranging from sample processing to quick data interpretation. It can run up to 96 results in about 3 hours and up to 864 results in 8 hours, thereby boosting the efficiency of laboratories.
The growth of the region is attributed to factors such as rising public–private partnerships, and increasing funding activities are widely enhancing the performance of medical devices. Moreover, presence of well-developed healthcare infrastructure and government support are some of the prominent factors propelling the market growth in Asia Pacific. In Asia Pacific, India is the largest market for laboratory developed test. The market growth in Asia Pacific is mainly attributed to factors such as the growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, large number of product launches. However concerns high capital investment for setting up advanced labs hinders the market growth in Asia Pacific.
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.
The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, large number of product launches. However, changing regulatory landscape for instance, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry is a great concern to hinder the market growth. In August 2021, eMed, a telehealth company democratizing healthcare through digital-point-of-care solutions, and Quest Diagnostics the world's leading provider of diagnostic information services, are collaborated to bring clinician-guided rapid antigen testing for COVID-19 to employers seeking to foster safer environments by decreasing the risk of COVID-19 exposure in their workplaces which is contributing to the growth of the target market. Such strategic steps are also projected to drive the market growth.
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The List of Companies - Laboratory Developed Test Market
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD.,
- QIAGEN
- Illumina, Inc.,
- Eurofins Scientific
- Biodesix
- Adaptive Biotechnologies
- Biotheranostics
- Rosetta Genomics Ltd.,
- Guardant Health
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Below is the breakup of our primary respondents by company, designation, and region:
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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.
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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.
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