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全球免疫分析市场 - 2024-2031

Global Immunoassay Market - 2024-2031

出版日期: 2024年06月18日 | 出版商:

DataM Intelligence | 英文 181 Pages | 商品交期: 最快1-2个工作天内

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简介目录

市场动态

司机

免疫分析仪器的技术进步

全球免疫分析市场的需求是由多种因素所驱动的。推动市场的关键因素是免疫分析仪器的技术进步，因为它能够识别和测量生物样本中存在的特定分子，免疫分析工具对于医疗诊断程序至关重要。

抗体、抗原、蛋白质、荷尔蒙或药物是这些化合物的例子。由于医疗保健领域对快速、精确的诊断工具的需求不断增长，免疫分析行业近年来显着增长并见证了技术发展。

此外，该行业的主要参与者在免疫分析市场推出的技术系统有助于推动该市场的成长。例如，2023 年 7 月，西门子 Healthineers 推出了用于临床化学和免疫分析测试的 Atellica CI 分析仪。

此外，2023 年 8 月，Fapon 最新的化学发光免疫分析系统 Shine i8000/9000 在 2023 年临床实验室博览会和美国临床化学协会 (AACC) 会议上推出。这款全自动高速分析仪具有每小时 900 次测试的令人难以置信的高吞吐量，以及具有一致性能量的整合紧凑设计。

同样，2022 年 11 月，Gethin Biotech 在 MEDICA 推出了新型 MAGICAL 6000 化学发光免疫分析仪。它是一款紧凑且创新的化学发光免疫分析仪，非常适合需要一步式化学发光解决方案的中高级工作流程实验室。该仪器生产力高且结构紧凑，可实现全自动操作，并且在同尺寸的任何设备中具有最快的测试速度。

限制

仪器和试剂的高成本、复杂的检测程序、免疫检测审批的严格监管框架以及有限的报销政策等因素预计将阻碍市场的发展。

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The demand for the global immunoassay market is driven by multiple factors. Key factors driving the market are the technological advancements in the immunoassay instruments owing to the capability of identifying and measuring particular molecules present in biological samples, immunoassay tools are essential to medical diagnostic procedures.

Antibodies, antigens, proteins, hormones, or medications are examples of these compounds. Due to the growing need in healthcare for quick and precise diagnostic tools, the immunoassay industry has grown significantly and witnessed technical developments over the years.

Moreover, key players in the industry launch technological systems in the immunoassay market help to drive this market growth. For instance, in July 2023- Siemens Healthineers introduced the Atellica CI Analyzer for clinical chemistry and immunoassay testing.

Also, in August 2023- Shine i8000/9000, Fapon's newest chemiluminescence immunoassay system, was introduced at the 2023 Clinical Lab Expo and Meeting of the American Association of Clinical Chemistry (AACC). The fully automated, high-speed analyzer has an incredibly high throughput of 900 tests per hour and an integrated, compact design with consistent performance.

Similarly in November 2022, Gethin Biotech launched the new MAGICAL 6000 chemiluminescence immunoassay Analyzer at MEDICA. It is a compact and innovative chemiluminescence immunoassay analyzer that is ideal for mid to high-workflow laboratories that require a one-step chemiluminescence solution. The instrument is highly productive and compact, allowing for fully automated operation and the fastest testing speed of any device of its size.

Restraints

Factors such as the high cost of instruments and reagents, complex assay procedures, the stringent regulatory framework for the approval of immunoassays, and limited reimbursement policies, are expected to hamper the market.

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Segment Analysis

The global immunoassay market is segmented based on product type, technology, specimen, application, end-user, and region.

The ELISA segment accounted for approximately 45.1% of the global immunoassay market share

The ELISA segment is expected to hold the largest market share over the forecast period. ELISA is an immunological assay commonly used to measure antibodies, antigens, proteins, and glycoproteins in biological samples. Some examples include diagnosis of HIV infection, pregnancy tests, and measurement of cytokines or soluble receptors in cell supernatant or serum.

In addition, major players in the industry's innovative new launches drive this market growth. For instance, in February 2023, Charles River Laboratories International, Inc. announced the launch of its first Enzyme-Linked Immunosorbent Assay (ELISA) Kit for the detection and quantitation of residual host cell proteins (HCP) in CHO-based biotherapeutics.

Also, in September 2022, Neogen launched an immunoassay (Veratox VIP) to detect cashew allergens. The Veratox VIP for Cashew allergen test is the second in Neogen's Veratox VIP series of enhanced quantitative enzyme-linked immunoassay (ELISA) products. It has a high level of specificity to deficient levels of cashew protein.

Geographical Analysis

North America accounted for approximately 41.3% of the global immunoassay market share

North America region is expected to hold the largest market share over the forecast period. The rise in demand for diagnostics related to chronic diseases and the availability of technologically advanced diagnostic techniques are expected to propel market growth over the forecast period.

Furthermore, in the U.S., there were 55.7 million people aged over 65 years in 2022 (~17% of the population in the country). Nearly 25% of this senior population suffers from cancer of which 30% are obese, creating an opportunity for local market players to boost their sales of diagnostic products for cancer, cardiology, endocrinology, infectious diseases, and other tests.

Moreover, key players in the industry launch new products, and mergers & acquisitions, would drive this market growth. For instance, in April 2022, GeneProof, a prominent molecular diagnostics firm based in Brno, Czech Republic, merged with American Laboratory Products Company, Ltd. (ALPCO), a specialty in vitro diagnostics company.

The merger made them a global market leader in diagnostic products with extensive capabilities covering innovative immunoassay testing kits, real-time PCR testing products, and automated laboratory instrumentation systems.

Also, in February 2022, Agilent Technologies, Inc. introduced Dako SARS-CoV-2 lgG linked immunosorbent assay in the U.S. with plans to launch in other regions, such as Canada, Europe, Latin America, and some parts of Asia Pacific shortly.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global Immunoassay market. The sudden increase in COVID-19 cases increased efforts in R&D in the diagnostics process aided by government funding. The increasing number of COVID-19 instances in 2020 and 2021 fueled the demand for immunoassay kits. The government is working on expanding the market for COVID-19 diagnostics to prevent further disease spread, vaccine supply, and a rise in demand for timely diagnostics.

The emphasis on critical patients has also shifted to developing time-efficient and accurate COVID-19 diagnostic kits. For instance, the FDA approved approximately 88 antibody-based and 256 molecular tests, totaling over 350 diagnostic test kits in 2021.

Market Segmentation

By Product Type

Reagents & kits
- ELISA Reagents & Kits
- Rapid Test Reagents & Kits
- ELISPOT Reagents & Kits
- Western Blot Reagents & Kits
- Other Reagents & Kits
Analyzers
- Open-ended Systems
- Closed-ended Systems
Software & Services

By Technology

Radioimmunoassay (RIA)
Enzyme Immunoassay (EIA)
- Fluorescence Immunoassays (FIA)
- Chemiluminescence Immunoassays (CLIA)
Rapid Assays
Others

By Specimen

Blood
Saliva
Urine
Other Specimens

By Application

Therapeutic Drug Monitoring
Drug Discovery
Disease Diagnosis
- Infectious Disease
- Cancer
- Endocrinology
- Autoimmune Disorders
- Cardiology
- Hematology
- Clinical Chemistry
Others

By End-Users

Hospitals
Blood Banks
Clinical Laboratories
Pharmaceutical and Biotech Companies
Academic Research Centers
Others

By Region

North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- U.K.
- France
- Spain
- Italy
- Rest of Europe
South America
- Brazil
- Argentina
- Rest of South America
Asia-Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Middle East and Africa

Competitive Landscape

The major global players in the immunoassay market include Abbott, Beckman Coulter, Inc, F. Hoffmann-La Roche Ltd, Siemens Healthcare Private Limited, bioMerieux SA, Bio-Rad Laboratories, Inc., DiaSorin S.p.A., BD, Thermo Fisher Scientific Inc., Merck KGaA among others.

Key Developments

In July 2023, Sysmex Corporation introduced a novel fully automated, and high-speed chemiluminescence immunoassay system at the 2023 AACC exhibition.
In July 2023, SEKISUI Diagnostics, introduced the OSOM COVID-19 Antigen Home Test, a lateral flow immunoassay for diagnosis of SARS-CoV-2 virus.
In March 2023, F. Hoffmann-La Roche Ltd. collaborated with Eli Lily and Company to support the development of Roche's Elecsys Amyloid Plasma Panel (EAPP).
In February 2023, bioMerieux company received 510(k) clearance and the CLIA waiver for their BIOFIRE SPOTFIRE system and BIOFIRE SPOTFIRE respiratory panel.
In February 2022, bioMerieux launched VIDAS KUBE, a next-generation system for automated immunoassay testing. At the beginning of 2023, it was planned in selected countries and the rest of the world, extending gradually as of Q2.
In April 2022, The Simple Plex HEK 293 HCP 3G assay for automated process impurity detection on the Ella immunoassay platform was launched by Bio-Techne Corporation and Cygnus Technologies, a division of Maravai LifeSciences. In Gene and Cell Therapy applications, purifying viral particles to reduce host cell protein (HCP) contamination is an important part of the viral production workflow. Impurity clearance is performed according to regulatory criteria to guarantee HCP and accurate quantification throughout process phases is required.
In November 2022, LumiraDx launched a rapid microfluidic immunoassay HbA1c test in Europe, parts of the Middle East, Asia, Latin America, and Africa.
In February 2022, NOVEOS Immunoassay Analyzer gained additional FDA 510(k) clearance from Hycor Biomedical Inc., a medical device firm that makes and supplies in-vitro diagnostic equipment. The NOVEOS Immunoassay Analyzer is a chemiluminescent immunoassay analyzer that can diagnose allergies. It's made to assist with analyte concentration measurements in human samples.

Why Purchase the Report?

To visualize the global immunoassay market segmentation based on product type, technology, specimen, application, end-user and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development
Excel data sheet with numerous data points of global immunoassay market level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping is available in excel consisting of key products of all the major players.

The global immunoassay market report would provide approximately 78 tables, 94 figures, and 181 Pages.

Target Audience 2024

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Technology
3.3. Snippet by Specimen
3.4. Snippet by Application
3.5. Snippet by End-User
3.6. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Technological Advancements in Immunoassay Instruments
  - 4.1.1.2. Rising Prevalence of Chronic & Infectious Diseases
  - 4.1.1.3. Increasing Demand for Point-of-Care Diagnostics
- 4.1.2. Restraints
  - 4.1.2.1. The High Cost of Instruments & Reagents
  - 4.1.2.2. Complex Assay Procedures
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Unmet Needs
5.6. PESTEL Analysis
5.7. Patent Analysis
5.8. SWOT Analysis

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID
- 6.1.2. Scenario During COVID
- 6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Product Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 7.1.2. Market Attractiveness Index, By Product Type
7.2. Reagents & kits*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 7.2.3. Portable Immunoassay
- 7.2.4. ELISA Reagents & Kits
- 7.2.5. Rapid Test Reagents & Kits
- 7.2.6. ELISPOT Reagents & Kits
- 7.2.7. Western Blot Reagents & Kits
- 7.2.8. Other Reagents & Kits
7.3. Analyzers
- 7.3.1. Open-ended Systems
- 7.3.2. Closed-ended Systems
7.4. Software & Services

8. By Technology

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 8.1.2. Market Attractiveness Index, By Technology
8.2. Radioimmunoassay (RIA) *
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Enzyme Immunoassay (EIA)
8.4. Fluorescence Immunoassays (FIA)
8.5. Chemiluminescence Immunoassays (CLIA)
8.6. Rapid Assays
8.7. Others

9. By Specimen

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 9.1.2. Market Attractiveness Index, By Specimen
9.2. Blood*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Saliva
9.4. Urine
9.5. Other Specimen

10. By Application

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.1.2. Market Attractiveness Index, By Application
10.2. Therapeutic Drug Monitoring *
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Drug Discovery
10.4. Disease Diagnosis
- 10.4.1. Infectious Disease
- 10.4.2. Cancer
- 10.4.3. Endocrinology
- 10.4.4. Autoimmune Disorders
- 10.4.5. Cardiology
- 10.4.6. Hematology
- 10.4.7. Clinical Chemistry
- 10.4.8. Others

11. By End-User

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.1.2. Market Attractiveness Index, By End-User
11.2. Hospitals*
- 11.2.1. Introduction
- 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
11.3. Blood Banks
11.4. Clinical Laboratories
11.5. Pharmaceutical and Biotech Companies
11.6. Academic Research Centers
11.7. Others

12. By Region

12.1. Introduction
- 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 12.1.2. Market Attractiveness Index, By Region
12.2. North America
- 12.2.1. Introduction
- 12.2.2. Key Region-Specific Dynamics
- 12.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.2.8.1. U.S.
  - 12.2.8.2. Canada
  - 12.2.8.3. Mexico
12.3. Europe
- 12.3.1. Introduction
- 12.3.2. Key Region-Specific Dynamics
- 12.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.3.8.1. Germany
  - 12.3.8.2. UK
  - 12.3.8.3. France
  - 12.3.8.4. Italy
  - 12.3.8.5. Spain
  - 12.3.8.6. Rest of Europe
12.4. South America
- 12.4.1. Introduction
- 12.4.2. Key Region-Specific Dynamics
- 12.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.4.8.1. Brazil
  - 12.4.8.2. Argentina
  - 12.4.8.3. Rest of South America
12.5. Asia-Pacific
- 12.5.1. Introduction
- 12.5.2. Key Region-Specific Dynamics
- 12.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.5.8.1. China
  - 12.5.8.2. India
  - 12.5.8.3. Japan
  - 12.5.8.4. South Korea
  - 12.5.8.5. Rest of Asia-Pacific
12.6. Middle East and Africa
- 12.6.1. Introduction
- 12.6.2. Key Region-Specific Dynamics
- 12.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 12.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 12.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 12.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

13. Competitive Landscape

13.1. Competitive Scenario
13.2. Market Positioning/Share Analysis
13.3. Mergers and Acquisitions Analysis

14. Company Profiles

14.1. Abbott *
- 14.1.1. Company Overview
- 14.1.2. Product Portfolio & Description
- 14.1.3. Financial Overview
- 14.1.4. Key Developments
14.2. Beckman Coulter, Inc
14.3. F. Hoffmann-La Roche Ltd
14.4. Siemens Healthcare Private Limited
14.5. bioMerieux SA
14.6. Bio-Rad Laboratories, Inc
14.7. DiaSorin S.p.A.
14.8. BD
14.9. Thermo Fisher Scientific Inc
14.10. Merck KGaA

LIST NOT EXHAUSTIVE