モノクローナル抗体診断試薬市場 - 2031年の成長予測、統計および事実

  • Report Code : TIPRE00027682
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 168
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世界のモノクローナル抗体診断試薬市場は、2021 年に 76 億 5,406 万米ドルと評価されました。 2022 年から 2028 年にかけて CAGR 13.5% で成長すると推定されています。



モノクローナル抗体 (mAb) は、生物医学研究で使用されている重要な診断試薬です。微生物学的研究;肝炎、エイズ、インフルエンザ、単純ヘルペス、クラミジア感染症の診断;感染症やがんの治療にも。単一のエピトープに向けられたモノクローナル抗体は、非常に特異的で均質であり、無制限の量で生産することができます。ハイブリドーマ由来または細菌クローンのモノクローナル抗体技術により、ホルモン、酵素、受容体、微生物産物など、抗原部位に対する特異性の高いプローブの大量生産が可能になりました。この市場の成長を牽引する主な要因には、がんやその他の慢性疾患の有病率の上昇、治験中の強力な医薬品パイプラインの存在、新しい治療法を開発するための広範な研究開発努力が含まれます。



レポートは洞察を提供し、 -市場動向、技術の進歩、市場ダイナミクス、世界の主要な市場プレーヤーの競争状況分析など、さまざまなパラメーターを強調する、世界のモノクローナル抗体診断試薬市場の詳細な分析。また、COVID-19 パンデミックがすべての地域の市場に与える影響も含まれています。



COVID-19 パンデミックがモノクローナル抗体診断試薬市場に与える全体的な影響はプラスでした。したがって、市場は引き続き勢いを増しており、今後数年間で成長すると予想されます。セルトリオン グループは、韓国食品医薬品安全処 (MFDS) が regdanvimab (CT-P59) を承認したことを発表しました。これは、50 歳以上の高齢患者、または肥満、心血管疾患、慢性肺疾患、糖尿病、慢性腎臓病、慢性肝疾患、COVID-19 の軽度の症状を伴う免疫抑制剤を服用している患者、COVID-19 の中等度の症状を伴う成人患者など、少なくとも 1 つの基礎疾患.さらに、軽度または中等度の症状を持つ COVID-19 患者を治療するために他の国で成功裏に使用されているモノクローナル抗体療法は、インドでの使用がインドの医薬品管理局 (DCGI) によって承認されました。



< h3>戦略的洞察

地理に基づく洞察



地理的に、世界のモノクローナル抗体診断試薬市場は、北米 (米国、カナダ、メキシコ)、ヨーロッパ (フランス、ドイツ、英国、スペイン、ロシア、イタリア、およびその他のヨーロッパ)、アジア太平洋 (中国、インド、日本、オーストラリア、韓国、カザフスタン、およびその他の APAC)、中東およびアフリカ (サウジアラビア) 、UAE、南アフリカ、中東およびアフリカの残りの地域)、および中南米 (ブラジル、アルゼンチン、および中南米のその他の地域)。



モノクローナル抗体診断の有利な地域試薬市場



市場の洞察



新しい治療法を開発するための広範な研究開発努力



mAb の多数のアプリケーションには、疾患の予防、診断、および治療が含まれます。診断における mAb の適用は最も進んでおり、特に尿や血液などの体液に対して実施される検査では顕著です。さらに、mAb 診断アプリケーションには、ELISA、ウエスタンブロット、イムノブロットブロット、フローサイトメトリー、免疫組織化学、放射免疫アッセイ、電子顕微鏡などの技術が含まれます。また、診断用途向けの mAb は、家畜のウイルス性および真菌性疾患および寄生虫疾患に対する抗原および抗体を検出できます。



さらに、mAb は、その選択性、高い結合親和性、および免疫原性/低毒性; mAb は、臨床、環境、元素研究に最適です。 mAb の診断用途には、医療機器、体外試験、医療画像処理も含まれます。



さらに、新しい免疫療法の開発に貢献することで、さまざまな疾患を理解するために mAb の有用性が拡大しました。たとえば、がん治療は、多くのがんの効果的な治療法を証明するリツキシマブの開発のために、おそらく mAb を使用した研究の恩恵を受けました。また、多くの mAb は現在、米国食品医薬品局 (FDA) によって、商業的治療に安全に利用できると認められています。上記のような要因は、予測期間中のモノクローナル抗体診断試薬市場の成長に貢献すると予想されます。



テストに基づく洞察



テストに基づくと、世界のモノクローナル抗体診断試薬市場二重抗原サンドイッチ化学発光法、酵素結合免疫吸着アッセイ、組換え免疫ブロットアッセイ、およびドット免疫金ろ過アッセイに分割されます。 2021 年には、酵素結合免疫吸着アッセイ セグメントが最大の市場シェアを占め、2022 年から 2028 年にかけて最高の CAGR を記録すると予想されています。 2028 年 (画像)

アプリケーション ベースの洞察



アプリケーションに基づいて、世界のモノクローナル抗体診断試薬市場は、ホルモン診断、腫瘍モニタリング、ウイルス検出、およびその他のアプリケーションに分割されます。腫瘍モニタリング セグメントは 2021 年に最大の市場シェアを保持し、予測期間中に最高の CAGR を登録すると予想されます。



グローバルなモノクローナル抗体診断試薬市場のプレーヤーは、製品の発売と拡大し、フットプリントと製品ポートフォリオを世界中に拡大し、高まる製品需要に応えます。市場で活動している主要なプレーヤーのいくつかはBioGenexです。 Bio-Rad Laboratories、Inc.; Biocare Medical、LLC;セルトリオンヘルスケア株式会社;創造的な診断; GenWayバイオテック;サーモフィッシャーサイエンティフィック社; ABclonal、Inc.;アプトジェン;および 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

This text is related
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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