2021年全球单克隆抗体诊断试剂市场价值76.5406亿美元;预计 2022 年至 2028 年复合年增长率为 13.5%。
单克隆抗体 (mAb) 是生物医学研究中使用的重要诊断试剂;微生物研究;肝炎、艾滋病、流感、单纯疱疹、衣原体感染的诊断;以及治疗感染和癌症。针对单一表位的单克隆抗体具有高度特异性、同质性,并且可以无限量生产。杂交瘤衍生的或细菌克隆的单克隆抗体技术使得能够大规模生产针对抗原位点的高度特异性探针,无论是激素、酶、受体还是微生物产品。推动该市场增长的主要因素包括癌症和其他慢性疾病患病率的上升、正在试验的强大药物管道的存在以及开发新疗法的广泛研发工作。
该报告提供对全球单克隆抗体诊断试剂市场的洞察和深入分析,强调各种参数,包括市场趋势、技术进步、市场动态以及全球领先市场参与者的竞争格局分析。它还包括COVID-19大流行对所有地区市场的影响。
COVID-19大流行对单克隆抗体诊断试剂市场的总体影响是积极的;因此,该市场继续受到关注,预计未来几年将会增长。 Celltrion 集团宣布,韩国食品药品安全部 (MFDS) 已批准 regdanvimab (CT-P59),这是一种用于治疗 COVID-19 的单克隆抗体,可供 50 岁及以上老年患者长期使用,或至少一种潜在的疾病,如肥胖、心血管疾病、慢性肺病、糖尿病、慢性肾病、慢性肝病、服用免疫抑制剂且出现轻度 COVID-19 症状的患者、以及出现中度 COVID-19 症状的成年患者。此外,单克隆抗体疗法已在其他国家成功用于治疗轻度或中度症状的 COVID-19 患者,现已获得印度药品监管总局 (DCGI) 批准在印度使用。
< h3>战略洞察基于地理位置的洞察
按地理位置划分,全球单克隆抗体诊断试剂市场分为北美(美国、加拿大和墨西哥)、欧洲(法国) 、德国、英国、西班牙、俄罗斯、意大利和欧洲其他地区)、亚太地区(中国、印度、日本、澳大利亚、韩国、哈萨克斯坦和亚太地区其他地区)、中东和非洲非洲(沙特阿拉伯、阿联酋、南非以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。
单克隆抗体诊断试剂市场利润丰厚的地区
市场洞察< /h3>广泛的研发工作开发新疗法
单克隆抗体的众多应用涉及疾病的预防、诊断和治疗。单克隆抗体在诊断中的应用是最先进的,特别是对尿液和血液等体液进行的测试。此外,mAb 诊断应用包括 ELISA、蛋白质印迹、免疫印迹、流式细胞术、免疫组织化学、放射免疫学测定和电子显微镜等技术。此外,用于诊断应用的单克隆抗体可以检测针对牲畜病毒和真菌疾病以及寄生虫病的抗原和抗体。
此外,单克隆抗体由于其选择性、高结合亲和力和亲和力,是一种有价值的试剂,具有丰富的应用前景。免疫原性/低毒性;单克隆抗体最适合临床、环境和元素研究。 mAb 的诊断应用还包括医疗设备、体外测试和医学成像。
此外,mAb 的用途通过促进开发新的免疫疗法而扩大了对一系列疾病的了解。例如,癌症疗法受益于单克隆抗体的研究,最有可能是利妥昔单克隆抗体的开发,证明它是许多癌症的有效治疗方法。此外,许多单克隆抗体现已被美国食品和药物管理局 (FDA) 认可,可安全用于商业治疗。上述因素预计将有助于预测期内单克隆抗体诊断试剂市场的增长。
基于测试的见解
基于测试,全球单克隆抗体诊断试剂市场分为双抗原夹心化学发光法、酶联免疫吸附法、重组免疫印迹法和点免疫金过滤法。 2021 年,酶联免疫吸附检测领域占据最大的市场份额,预计 2022 年至 2028 年复合年增长率最高。
全球单克隆抗体诊断试剂市场(按测试) 2021年和2028年
基于应用的洞察
基于应用,全球单克隆抗体诊断试剂市场分为激素诊断、肿瘤监测、病毒检测和其他应用。肿瘤监测领域在2021年占据最大的市场份额,预计在预测期内复合年增长率最高。
全球单克隆抗体诊断试剂市场参与者正在采取有机策略,包括产品推出和研发扩张,以扩大其在全球的足迹和产品组合,并满足不断增长的产品需求。市场上的一些主要参与者包括 BioGenex; Bio-Rad 实验室有限公司;生物护理医疗有限责任公司;赛尔群医疗保健有限公司;创造性诊断;正威生物科技;赛默飞世尔科技公司; AB克隆公司; Apto-Gen;和 Abcam plc。
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
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.
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.
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.
The CAGR value of the monoclonal antibody diagnostic reagent market during the forecasted period of 2022-2028 is 13.5%
The monoclonal antibody diagnostic reagent market is estimated to be valued at US$ 8,642.00 million in 2022.
The monoclonal antibody diagnostic reagent market is expected to be valued at US$ 18,507.20 million in 2028.
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.
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
- BioGenex
- Bio-Rad Laboratories, Inc.
- Biocare Medical, LLC
- Celltrion Healthcare Co., Ltd.
- Creative Diagnostics
- GenWay Biotech
- Thermo Fisher Scientific Inc.
- ABclonal, Inc.
- Apto-Gen
- Abcam plc.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- 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.
- 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:
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.
- 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.
- 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.
Related Reports
Sep 2022
Colonoscopes Market
Forecast to 2028 - COVID-19 Impact and Global Analysis By Product Type (Fiber Optic Colonoscopy Devices, Video Colonoscopy Devices); Application (Colorectal Cancer, Lynch Syndrome, Ulcerative Colitis, Crohn's Disease, Polyp); End User (Hospitals, Ambulatory Surgery Center, Others), and Geography
Sep 2022
Noninvasive Fat Reduction Market
Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Technology (Cryolipolysis, Laser Lipolysis, Ultrasound, and Others), End User (Hospitals, Dermatology Clinics & Cosmetic Clinics, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Sep 2022
Medical Ultrasound Flow Meter Market
Size and Forecast (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Implementation Type (Clamp-On, Inline, and Others), Technology (Doppler, Transit Time, and Hybrid), Application (Heart and Lung Machines, Extracorporeal Membrane Oxygenation, Perfusion, Organ Transportation Systems, and Others), End User (Hospitals and Clinics, Ambulatory Surgical Centers, Research Laboratories, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Sep 2022
Rapid Test Kits Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Type (Rapid Antigen Testing, Rapid Antibody Testing, and Others), Product (Over-the-Counter Rapid Testing Kit and Professional Rapid Testing Kit), Technology (Lateral Flow Assay, Solid Phase, Agglutination, Immunospot Assay, and Cellular Component-Based), Application (Blood Glucose Testing, Infectious Disease Testing, Pregnancy and Fertility, Cardiometabolic Testing, and Others), End User (Hospital and Clinics, Home Care, Diagnostics Centers, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Sep 2022
Osteoarthritis Therapy Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Therapy Type [Transcutaneous Electrical Nerve Stimulation (TENS), Occupational Therapy, Physical Therapy, Platelet-Rich Plasma Therapy and Stromal Vascular Fraction, Prolotherapy, and Others], Disease Indication (Knee Osteoarthritis, Spine Osteoarthritis, Foot and Ankle Osteoarthritis, Shoulder Osteoarthritis, Hand Osteoarthritis, and Others), End User (Hospitals & Clinics, Specialty Clinics, Ambulatory Surgical Centers, Homecare, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Sep 2022
Bariatric Surgeries Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type [Adjustable Gastric Bands (AGB), Sleeve Gastrectomy, Gastric Bypass, Biliopancreatic Diversion with Duodenal Switch (BPD-DS), and Others], End User (Hospitals and Ambulatory Surgical Centers), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Sep 2022
Post-Acute Care Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Service Type (Skilled Nursing Facilities, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Home Health Agency, and Others), Age (Elderly, Adult, and Others), Disease Conditions (Amputations, Wound Management, Brain Injury and Spinal Cord Injury, Neurological Disorders, and Others), and Geography
Sep 2022
Lung Cancer Therapy Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Therapy Type (Noninvasive and Minimally Invasive), Indication (Non-Small Cell Lung Cancer and Small Cell Lung Cancer), End User (Hospitals, Oncology Clinics, Research Centers, and Others), and Geography (North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa)