Mercado de pruebas desarrolladas en laboratorio: mapeo competitivo y perspectivas estratégicas para 2028

  • Report Code : TIPRE00019603
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 183
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Laboratory Developed Test Market to Grow at a CAGR of 7.0% to reach US$ 7,269.3 million from 2021 to 2028

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Se espera que el mercado de pruebas desarrolladas en laboratorio alcance los 7.269,3 millones de dólares en 2028 desde los 4.524,75 millones de dólares en 2021; Se espera que crezca a una tasa compuesta anual del 7,0% durante 2021-2028.

 

Una prueba desarrollada en laboratorio (LDT) es un tipo de prueba de diagnóstico in vitro diseñada y utilizada en un solo laboratorio. Estas pruebas se pueden utilizar para estimar o distinguir analitos como proteínas, biomoléculas/compuestos (glucosa, colesterol, etc.) y ADN extraído de muestras recolectadas de sujetos humanos. La expansión de los métodos automatizados de diagnóstico in vitro (IVD) para laboratorios y dispensarios para realizar análisis precisos y sin errores está impulsando el crecimiento del mercado de pruebas desarrolladas en laboratorio.    

El crecimiento del mercado de pruebas desarrolladas en laboratorio se atribuye principalmente a factores como los crecientes incidentes de cáncer y trastornos genéticos, y el gran número de lanzamientos de productos. Sin embargo, el cambiante panorama regulatorio está obstaculizando el crecimiento del mercado. Por ejemplo, en Europa, el cumplimiento del Reglamento de dispositivos in vitro (IVDR) será obligatorio para todas las pruebas de diagnóstico in vitro a partir de mayo de 2022; El reglamento tiene como objetivo garantizar la eficacia clínica y la seguridad de las pruebas médicas, transformando así la industria del diagnóstico, que es una gran preocupación para los actores del mercado.

 

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Mercado de pruebas desarrolladas en laboratorio: ideas estratégicas

Mercado de pruebas desarrolladas en laboratorio

  • CAGR (2021 - 2028)
    7,0%
  • Tamaño del mercado 2021
    US$ 4,52 mil millones
  • Tamaño del mercado 2028
    US$ 7,27 mil millones

Dinámica del mercado

CONTROLADORES DE CRECIMIENTO
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FUTURAS TENDENCIAS
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OPORTUNIDADES
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Jugadores claves . Jugadores principales

  •  
  • Quest Diagnóstico incorporado
  • F. HOFFMANN-LA ROCHE LTD.,
  • QIAGEN
  • ilumina, inc.,
  • Eurofins Científico
  • biodesix
  • Biotecnologías adaptativas
  • Bioteranostica
  • Rosetta Genomics Ltd.,

Panorama regional

  • América del norte
  • Europa
  • Asia-Pacífico
  • América del Sur y Central
  • Medio Oriente y África

Segmentación de mercado

Tipo
  • Bioquímica clínica
  • Cuidado crítico
  • Hematología
  • Microbiología
  • Diagnóstico molecular
  • Inmunología
  • Otros
Solicitud
  • Institutos Académicos
  • Organizaciones de investigación clínica
  • Laboratorio de hospitales
  • Centros de diagnóstico especializados
  • Otros
  • El PDF de muestra muestra la estructura del contenido y la naturaleza de la información con análisis cualitativo y cuantitativo.

 

 

Perspectivas del mercado

 

 

La investigación continua sobre medicamentos personalizados brinda oportunidades de crecimiento a los actores del mercado de pruebas desarrolladas en laboratorio

 

Los LDT desempeñan un papel vital en el desarrollo de medicamentos personalizados que probablemente resulten ser medios prometedores para abordar enfermedades mediante tratamientos o curas eficaces hasta ahora eludidos. Según la Coalición de Medicina Personalizada, los medicamentos personalizados representaron sólo el 5% de las nuevas entidades moleculares aprobadas por la FDA en 2005; sin embargo, en 2016, esta cifra aumentó a más del 25%. Además, el 42% de todos los compuestos y el 73% de los compuestos oncológicos en proceso tienen potencial para servir como medicamentos personalizados. Las empresas biofarmacéuticas casi han duplicado sus inversiones en I+D en medicamentos personalizados en los últimos cinco años, y se espera que aumenten aún más sus inversiones en un 33% en los próximos cinco años. Los investigadores biofarmacéuticos también predicen un aumento del 69% en el desarrollo de medicamentos personalizados en los próximos cinco años. Las pruebas de laboratorio se utilizan para diagnosticar enfermedades y predecir y monitorear la respuesta a los medicamentos, así como para obtener datos informáticos necesarios para algoritmos predictivos complejos.

Las medicinas personalizadas se están convirtiendo en la marca registrada del tratamiento del cáncer; es un enfoque en constante evolución que se basa en la personalización de tratamientos según la composición genética individual. En 2019, la FDA aprobó 12 medicamentos personalizados para investigar y abordar las causas fundamentales de las enfermedades, combinando así la medicina de precisión en la atención clínica. La creciente demanda de medicina personalizada ofrece importantes oportunidades de crecimiento para los actores que operan en el mercado de pruebas desarrolladas en laboratorio.

 

 

Información basada en tipos

 

El mercado de pruebas desarrolladas en laboratorio, por tipo, se segmenta en bioquímica clínica, cuidados críticos, hematología, microbiología, diagnóstico molecular, inmunología y otros. Se espera que el segmento de diagnóstico molecular tenga la mayor participación del mercado en 2021. Sin embargo, se prevé que el segmento de hematología registre la CAGR más alta del mercado durante el período de pronóstico.

 

Información basada en aplicaciones

 

Por aplicación, el laboratorio desarrolló aplicaciones de mercado de pruebas en institutos académicos, organizaciones de investigación clínica, laboratorios de hospitales, centros de diagnóstico especializados y otros. Se estima que el segmento de laboratorios de hospitales representará la mayor participación de mercado en 2021. Sin embargo, se prevé que el segmento de centros de diagnóstico especializados registre la CAGR más alta del mercado durante el período de pronóstico.

Los lanzamientos y aprobaciones de productos son estrategias comúnmente adoptadas por las empresas para expandir su huella global y sus carteras de productos. Además, los actores del mercado de pruebas desarrollados por el laboratorio se centran en la estrategia de asociación para ampliar su clientela, lo que, a su vez, les permite mantener su marca a nivel mundial.

 

El informe segmenta el mercado de pruebas desarrolladas en laboratorio de la siguiente manera

 

Según el tipo, el mercado de pruebas desarrolladas en laboratorio se segmenta en bioquímica clínica, cuidados críticos, hematología, microbiología, diagnóstico molecular, inmunología y otros. Según la aplicación, el mercado de pruebas desarrolladas en laboratorio se segmenta en institutos académicos, organizaciones de investigación clínica, laboratorios de hospitales, centros de diagnóstico especializados y otros. Según la geografía, el mercado de pruebas desarrolladas en laboratorio está segmentado en América del Norte (EE. UU., Canadá y México), Europa (Reino Unido, Alemania, Francia, Italia, España y el resto de Europa), Asia Pacífico (China, Japón, India, Australia, Corea del Sur y resto de Asia Pacífico), Medio Oriente y África (EAU, Arabia Saudita, Sudáfrica y resto de Medio Oriente y África) y América del Sur y Central (Brasil, Argentina , y Resto de América del Sur y Central).

 

 

Alcance del informe de mercado de pruebas desarrolladas en laboratorio

Atributo del informeDetalles
Tamaño del mercado en 20214,52 mil millones de dólares
Tamaño del mercado para 20287,27 mil millones de dólares
CAGR global (2021 - 2028)7,0%
Información histórica2019-2020
Período de pronóstico2022-2028
Segmentos cubiertosPor tipo
  • Bioquímica clínica
  • Cuidado crítico
  • Hematología
  • Microbiología
  • Diagnóstico molecular
  • Inmunología
  • Otros
Por aplicación
  • Institutos Académicos
  • Organizaciones de investigación clínica
  • Laboratorio de hospitales
  • Centros de diagnóstico especializados
  • Otros
Regiones y países cubiertosAmérica del norte
  • A NOSOTROS
  • Canadá
  • México
Europa
  • Reino Unido
  • Alemania
  • Francia
  • Rusia
  • Italia
  • El resto de Europa
Asia-Pacífico
  • Porcelana
  • India
  • Japón
  • Australia
  • Resto de Asia-Pacífico
América del Sur y Central
  • Brasil
  • Argentina
  • Resto de América del Sur y Central
Medio Oriente y África
  • Sudáfrica
  • Arabia Saudita
  • Emiratos Árabes Unidos
  • Resto de Medio Oriente y África
Líderes del mercado y perfiles clave de empresas
  •  
  • Quest Diagnóstico incorporado
  • F. HOFFMANN-LA ROCHE LTD.,
  • QIAGEN
  • ilumina, inc.,
  • Eurofins Científico
  • biodesix
  • Biotecnologías adaptativas
  • Bioteranostica
  • Rosetta Genomics Ltd.,
  • El PDF de muestra muestra la estructura del contenido y la naturaleza de la información con análisis cualitativo y cuantitativo.

 

 

Perfiles de empresa

 

  • Quest Diagnóstico incorporado
  • F. HOFFMANN-LA ROCHE LTD.,
  • QIAGEN
  • ilumina, inc.,
  • Eurofins Científico
  • biodesix
  • Biotecnologías adaptativas
  • Bioteranostica
  • Rosetta Genomics Ltd.,
  • Salud guardián

Laboratory Developed Test Market Report Scope

Report Attribute Details
Market size in US$ 4.52 Billion
Market Size by US$ 7.27 Billion
Global CAGR 7.0%
Historical Data 2019-2020
Forecast period 2022-2028
Segments Covered By Tipo
  • Bioquímica Clínica
  • Cuidados Críticos
  • Hematología
  • Microbiología
  • Diagnóstico Molecular
  • Inmunología y Otros
By Aplicación
  • Institutos Académicos
  • Organizaciones de Investigación Clínica
  • Laboratorios de Hospitales
  • Centros de Diagnóstico de Especialidades y Otros
Regions and Countries Covered América del Norte
  • EE. UU.
  • Canadá
  • México
Europa
  • Reino Unido
  • Alemania
  • Francia
  • Rusia
  • Italia
  • resto de Europa
Asia-Pacífico
  • China
  • India
  • Japón
  • Australia
  • resto de Asia-Pacífico
América del Sur y Central
  • Brasil
  • Argentina
  • Resto de América del Sur y Central
Medio Oriente y África
  • Sudáfrica
  • Arabia Saudita
  • Emiratos Árabes Unidos
  • Resto de Medio Oriente y África
Market leaders and key company profiles
  • Quest Diagnostics Incorporated
  • F HOFFMANN LA ROCHE LTD
  • QIAGEN
  • Illumina Inc
  • Eurofins Scientific
  • Biodesix
  • Adaptive Biotechnologies
  • Biotheranostics
  • Rosetta Genomics Ltd
  • Report Coverage
    Report Coverage

    Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

    Segment Covered
    Segment Covered

    This text is related
    to segments covered.

    Regional Scope
    Regional Scope

    North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

    Country Scope
    Country Scope

    This text is related
    to country scope.

    Frequently Asked Questions


    Which type is expected to dominate the market in the forecast period?

    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).

    What are future trends of Laboratory Developed Test Market?

    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.

    What is the regional analysis in terms of laboratory developed test market?

    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.

    What is laboratory developed test mean?

    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.

    What are the driving factors for the laboratory developed test market across the globe?

    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.

    The List of Companies - Laboratory Developed Test Market

     

    1. Quest Diagnostics Incorporated
    2. F. HOFFMANN-LA ROCHE LTD.,
    3. QIAGEN
    4. Illumina, Inc.,
    5. Eurofins Scientific
    6. Biodesix
    7. Adaptive Biotechnologies
    8. Biotheranostics
    9. Rosetta Genomics Ltd.,
    10. Guardant Health

    The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

    1. 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.

    1. 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:

    Research Methodology

    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.

    1. 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.

    1. 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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