Mercado de reactivos de diagnóstico de anticuerpos monoclonales: mapeo competitivo y perspectivas estratégicas para 2031

  • Report Code : TIPRE00027682
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 168
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El mercado mundial de reactivos de diagnóstico de anticuerpos monoclonales se valoró en 7.654,06 millones de dólares en 2021; se estima que crecerá a una tasa compuesta anual del 13,5 % entre 2022 y 2028.

Los anticuerpos monoclonales (mAb) son importantes reactivos de diagnóstico que se utilizan en la investigación biomédica; investigación microbiológica; en el diagnóstico de hepatitis, SIDA, influenza, herpes simple, infecciones por clamidia; y en el tratamiento de infecciones y cáncer. Los anticuerpos monoclonales dirigidos a epítopos individuales son muy específicos, homogéneos y pueden producirse en cantidades ilimitadas. La tecnología de anticuerpos monoclonales derivados de hibridomas o clonados bacterianos ha permitido la producción en masa de sondas altamente específicas para sitios antigénicos, ya sea en hormonas, enzimas, receptores o productos microbianos. Los principales factores que impulsan el crecimiento de este mercado incluyen la creciente prevalencia del cáncer y otras enfermedades crónicas, la presencia de una sólida cartera de medicamentos en fase de prueba y amplios esfuerzos de I+D para desarrollar terapias novedosas.

El informe ofrece conocimientos y análisis en profundidad del mercado global de reactivos de diagnóstico de anticuerpos monoclonales, enfatizando varios parámetros, incluidas las tendencias del mercado, los avances tecnológicos, la dinámica del mercado y el análisis del panorama competitivo de los principales actores del mercado global. También incluye el impacto de la pandemia de COVID-19 en el mercado de todas las regiones.

El impacto general de la pandemia de COVID-19 en el mercado de reactivos de diagnóstico de anticuerpos monoclonales fue positivo; por lo tanto, el mercado continúa ganando terreno y se espera que crezca en los próximos años. Celltrion Group ha anunciado que el Ministerio de Seguridad de Alimentos y Medicamentos de Corea (MFDS) ha aprobado regdanvimab (CT-P59), un anticuerpo monoclonal para el tratamiento de la COVID-19 para uso prolongado en pacientes de edad avanzada de 50 años o más, o con al menos una afección médica subyacente, como obesidad, enfermedad cardiovascular, enfermedad pulmonar crónica, diabetes, enfermedad renal crónica, enfermedad hepática crónica y pacientes con agentes inmunosupresores con síntomas leves de COVID-19 y pacientes adultos con síntomas moderados de COVID-19 . Además, la terapia con anticuerpos monoclonales, que se ha utilizado con éxito en otros países para tratar a pacientes de COVID-19 con síntomas leves o moderados, ahora ha sido aprobada por el Contralor General de Medicamentos de la India (DCGI) para su uso en la India.

< h3>Información estratégica

Información basada en geografía

Por geografía, el mercado mundial de reactivos de diagnóstico de anticuerpos monoclonales está segmentado en América del Norte (EE. UU., Canadá y México), Europa (Francia , Alemania, Reino Unido, España, Rusia, Italia y el resto de Europa), Asia Pacífico (China, India, Japón, Australia, Corea del Sur, Kazajstán y el resto de APAC), Oriente Medio y Asia. África (Arabia Saudita, Emiratos Árabes Unidos, Sudáfrica y el resto de Oriente Medio y África) y Sudáfrica y África. Centroamérica (Brasil, Argentina y el resto de América Central y del Sur).

regiones lucrativas para el mercado de reactivos de diagnóstico de anticuerpos monoclonales

Perspectivas del mercado< /h3>

Amplios esfuerzos de I+D para desarrollar nuevas terapias

Las numerosas aplicaciones de los mAb implican la prevención, el diagnóstico y el tratamiento de enfermedades. La aplicación de mAbs en el diagnóstico es la más avanzada, particularmente para pruebas realizadas en fluidos corporales como orina y sangre. Además, la aplicación de diagnóstico de mAb incluye técnicas como ELISA, Western blot, inmunotransferencia, citometría de flujo, inmunohistoquímica, ensayo de radioinmunología y microscopía electrónica. Además, los mAb destinados a aplicaciones de diagnóstico pueden detectar antígenos y anticuerpos contra enfermedades virales y fúngicas del ganado y enfermedades parasitarias.

Además, los mAb son reactivos valiosos destinados a abundantes aplicaciones debido a su selectividad, alta afinidad de unión y inmunogenicidad/baja toxicidad; Los mAb son los más adecuados para la investigación clínica, ambiental y elemental. Las aplicaciones de diagnóstico de los mAb también incluyen dispositivos médicos, pruebas in vitro e imágenes médicas.

Además, la utilidad de los mAb se amplió para comprender una variedad de enfermedades al contribuir al desarrollo de nuevos tratamientos de inmunoterapia. Por ejemplo, las terapias contra el cáncer se beneficiaron de la investigación con mAb, muy probablemente para el desarrollo de RituximAb, que demostró ser un tratamiento eficaz para muchos cánceres. Además, la Administración de Alimentos y Medicamentos de EE. UU. (FDA) reconoce ahora que muchos mAb son seguros para su utilización en terapias comerciales. Se espera que los factores mencionados anteriormente contribuyan al crecimiento del mercado de reactivos de diagnóstico de anticuerpos monoclonales durante el período de pronóstico.

Información basada en pruebas

Basado en las pruebas, el mercado global de reactivos de diagnóstico de anticuerpos monoclonales se segmenta en método de quimioluminiscencia tipo sándwich de doble antígeno, ensayo inmunoabsorbente ligado a enzimas, ensayo de inmunotransferencia recombinante y ensayo de filtración dot-inmunogold. En 2021, el segmento de ensayo inmunoabsorbente ligado a enzimas representó la mayor participación de mercado y se prevé que registre la CAGR más alta de 2022 a 2028.

Mercado global de reactivos de diagnóstico de anticuerpos monoclonales, por pruebas: 2021 y 2028

Información basada en aplicaciones

Según la aplicación, el mercado global de reactivos de diagnóstico de anticuerpos monoclonales se segmenta en diagnóstico de hormonas, monitoreo de tumores, detección de virus y otras aplicaciones. El segmento de monitoreo de tumores tuvo la mayor participación de mercado en 2021 y se espera que registre la CAGR más alta durante el período de pronóstico.

Los actores del mercado global de reactivos de diagnóstico de anticuerpos monoclonales están adoptando estrategias orgánicas, incluido el lanzamiento de productos y expansión, para expandir su presencia y cartera de productos en todo el mundo y satisfacer la creciente demanda de productos. Algunos de los actores clave que operan en el mercado son BioGenex; Laboratorios Bio-Rad, Inc.; Biocare médico, LLC; Celltrion Healthcare Co., Ltd.; Diagnóstico Creativo; GenWay Biotecnología; Termo Fisher Scientific Inc.; ABclonal, Inc.; Apto-Gen; y Abcam plc.

Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

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

Country Scope
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Frequently Asked Questions


What are monoclonal antibody diagnostic reagent?

Monoclonal antibodies (mAb) are important diagnostic reagents that are being used in biomedical research, microbiological research in diagnosis of Hepatitis, AIDs, influenza, herpes simplex, chlamydia infections and in treatment of infections and cancer. The monoclonal antibodies being directed against single epitopes are highly specific, homogeneous and can be produced in unlimited quantities. The hybridoma-derived or bacterially cloned monoclonal antibody technology has enabled the mass production of highly specific probes for antigenic sites, whether on hormones, enzymes, receptors, or microbial products.

What are the driving factors for the global monoclonal antibody diagnostic reagent market across the world?

Rising prevalence of cancer and other chronic diseases, extensive R&D efforts to develop novel therapies, and presence of strong pipeline of drugs under trial are the major factors contributing to the growth of the monoclonal antibody diagnostic reagent industry.

Who are the major players in the monoclonal antibody diagnostic reagent market across the globe?

The monoclonal antibody diagnostic reagent market majorly consists of the players, such as BioGenex; Bio-Rad Laboratories, Inc.; Biocare Medical, LLC; Celltrion Healthcare Co., Ltd.; Creative Diagnostics; GenWay Biotech; Thermo Fisher Scientific Inc.; ABclonal, Inc.; Apto-Gen; and Abcam plc.

What is the market CAGR value of the monoclonal antibody diagnostic reagent market during the forecast period?

The CAGR value of the monoclonal antibody diagnostic reagent market during the forecasted period of 2022-2028 is 13.5%

What is the estimated monoclonal antibody diagnostic reagent market size in 2022?

The monoclonal antibody diagnostic reagent market is estimated to be valued at US$ 8,642.00 million in 2022.

What are the growth estimates for the monoclonal antibody diagnostic reagent market till 2028?

The monoclonal antibody diagnostic reagent market is expected to be valued at US$ 18,507.20 million in 2028.

Which segment by tests led the monoclonal antibody diagnostic reagent market?

The enzyme-linked immunosorbent assay segment held the largest share of the market in the global monoclonal antibody diagnostic reagent market contributing a market share of 37.89% in 2021.

Which region is projected to be the fastest-growing region in the global monoclonal antibody diagnostic reagent market?

The Asia Pacific is expected to be the fastest-growing region in the monoclonal antibody diagnostic reagent market over the forecast period due to growing investments from international players in China and India, increasing disposable income, and chronic diseases in these regions will show promising growth in the monoclonal antibody diagnostic reagent market.

The List of Companies - Monoclonal Antibody Diagnostic Reagent Market

  1. BioGenex
  2. Bio-Rad Laboratories, Inc.
  3. Biocare Medical, LLC
  4. Celltrion Healthcare Co., Ltd.
  5. Creative Diagnostics
  6. GenWay Biotech
  7. Thermo Fisher Scientific Inc.
  8. ABclonal, Inc.
  9. Apto-Gen
  10. Abcam plc.

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.

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  • Validates and strengthens in-house secondary research findings
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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
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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.

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  • 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:

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  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.

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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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