단일클론 항체 진단 시약 시장 조사 – 규모, 점유율, 개발 및 미래 범위 2031

  • Report Code : TIPRE00027682
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 168
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2021년 전 세계 단클론항체 진단시약 시장 규모는 76억5406만 달러였다. 2022년부터 2028년까지 연평균 13.5% 성장할 것으로 추정됩니다.



단클론항체(mAb)는 생의학 연구에 사용되는 중요한 진단 시약입니다. 미생물 연구; 간염, AID, 인플루엔자, 단순 헤르페스, 클라미디아 감염의 진단; 감염 및 암 치료에 사용됩니다. 단일 에피토프에 대한 단클론 항체는 매우 특이적이고 균질하며 무제한으로 생산될 수 있습니다. 하이브리도마 유래 또는 박테리아 복제 단일클론 항체 기술은 호르몬, 효소, 수용체 또는 미생물 제품에 관계없이 항원 부위에 대한 고도로 특이적인 프로브의 대량 생산을 가능하게 했습니다. 이 시장의 성장을 주도하는 주요 요인으로는 암 및 기타 만성 질환의 유병률 증가, 시험 중인 약물의 강력한 파이프라인 존재, 새로운 치료법을 개발하기 위한 광범위한 R&D 노력 등이 있습니다.



보고서는 통찰력과 -시장 동향, 기술 발전, 시장 역학 및 글로벌 주요 시장 참여자의 경쟁 구도 분석을 포함한 다양한 매개 변수를 강조하는 글로벌 단일 클론 항체 진단 시약 시장에 대한 심층 분석. 또한 COVID-19 팬데믹이 모든 지역의 시장에 미치는 영향도 포함합니다.



COVID-19 팬데믹이 단일 클론 항체 진단 시약 시장에 미치는 전반적인 영향은 긍정적이었습니다. 따라서 시장은 계속해서 견인력을 얻고 있으며 향후 몇 년 동안 성장할 것으로 예상됩니다. 셀트리온그룹은 코로나19 치료용 단일클론항체 레그단비맙(CT-P59)을 식품의약품안전처로부터 만 50세 이상 고령자, 비만, 심혈관 질환, 만성 폐 질환, 당뇨병, 만성 신장 질환, 만성 간 질환, COVID-19 경미한 증상이 있는 면역억제제 환자 및 COVID-19 중등도 증상이 있는 성인 환자와 같은 적어도 하나의 기저 질환 . 또한, 경증 또는 중등도의 증상을 보이는 COVID-19 환자를 치료하기 위해 다른 국가에서 성공적으로 사용된 단클론 항체 요법이 현재 인도에서 사용하도록 인도 의약품 통제국(Drugs Controller General of India, DCGI)의 승인을 받았습니다.



< h3>전략적 인사이트

지리 기반 인사이트



글로벌 단클론항체 진단시약 시장은 지역별로 북미(미국, 캐나다, 멕시코), 유럽(프랑스)으로 구분됩니다. , 독일, 영국, 스페인, 러시아, 이탈리아 및 기타 유럽), 아시아 태평양(중국, 인도, 일본, 호주, 한국, 카자흐스탄 및 기타 APAC), 중동 및 아프리카(사우디아라비아) , UAE, 남아프리카, 기타 중동 및 아프리카), 중남미(브라질, 아르헨티나, 나머지 중남미).



단클론 항체 진단에 유리한 지역 시약 시장



시장 통찰력



새로운 치료법 개발을 위한 광범위한 R&D 노력



단클론항체의 수많은 적용에는 질병의 예방, 진단 및 치료가 포함됩니다. 진단에서 mAb의 적용은 특히 소변 및 혈액과 같은 체액에 대해 수행되는 테스트에서 가장 발전된 것입니다. 또한 mAbs 진단 응용 프로그램에는 ELISA, 웨스턴 블롯, 면역 블롯 블롯, 유동 세포 계측법, 면역 조직 화학, 방사선 면역학 분석 및 전자 현미경 검사와 같은 기술이 포함됩니다. 또한 진단용 mAb는 가축의 바이러스 및 진균성 질병과 기생충 질병에 대한 항원 및 항체를 검출할 수 있습니다.



또한 mAb는 선택성, 높은 결합 친화성 및 면역원성/낮은 독성; mAb는 임상, 환경 및 원소 연구에 가장 적합합니다. mAb의 진단 응용 분야에는 의료 기기, 체외 검사 및 의료 영상도 포함됩니다.



또한 mAb의 활용도는 새로운 면역 요법 개발에 기여하여 다양한 질병을 이해하는 데 확장되었습니다. 예를 들어, 암 치료법은 mAb를 사용한 연구에서 이익을 얻었으며, 대부분의 경우 RituximAb의 개발을 통해 많은 암에 대한 효과적인 치료법을 입증했습니다. 또한 많은 mAb는 현재 미국 식품의약국(FDA)에서 상업적 치료제로 사용하기에 안전한 것으로 인정하고 있습니다. 위에서 언급한 이러한 요인들은 예측 기간 동안 단클론 항체 진단 시약 시장 성장에 기여할 것으로 예상됩니다.



테스트 기반 통찰력



테스트를 기반으로 한 글로벌 단일 클론 항체 진단 시약 시장 이중항원샌드위치화학발광법, 효소결합면역흡착법, 재조합면역블롯법, 도트면역금여과법으로 나뉜다. 2021년에는 효소 결합 면역 흡착 분석 부문이 가장 큰 시장 점유율을 차지했으며 2022년부터 2028년까지 가장 높은 CAGR을 기록할 것으로 예상됩니다. 2028(image)

응용 기반 통찰력



응용 프로그램을 기준으로 전 세계 단일 클론 항체 진단 시약 시장은 호르몬 진단, 종양 모니터링, 바이러스 탐지 및 기타 응용 프로그램으로 분류됩니다. 종양 모니터링 부문은 2021년에 가장 큰 시장 점유율을 차지했으며 예측 기간 동안 가장 높은 CAGR을 기록할 것으로 예상됩니다.



글로벌 단일 클론 항체 진단 시약 시장 플레이어는 제품 출시 및 확장, 전 세계적으로 발자국과 제품 포트폴리오를 확장하고 증가하는 제품 수요를 충족합니다. 시장에서 활동하는 주요 업체 중 일부는 BioGenex입니다. Bio-Rad Laboratories, Inc.; 바이오케어 메디컬, LLC; (주)셀트리온헬스케어 창의적 진단; GenWay 생명 공학; Thermo Fisher Scientific Inc.; ABclonal, Inc.; 앱토젠; 및 Abcam plc.



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

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to country scope.

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.

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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