首頁 > 市場調查報告書 > 製藥

市場調查報告書

商品編碼

1825282

RUO免疫測量市場：2025-2030 年預測

RUO Immunoassay Market - Forecasts from 2025 to 2030

出版日期: 2025年08月15日 | 出版商:

Knowledge Sourcing Intelligence | 英文 145 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

僅供研究使用 (RUO)免疫測量市場預計將從 2025 年的 57.08 億美元成長到 2030 年的 107.71 億美元，複合年成長率為 13.54%。

全球RUO免疫測量市場正經歷強勁成長，這得益於生物醫學研究的活性化、生物標記檢測技術的進步以及自動化和可客製化檢測套件的日益普及。 RUO免疫測量僅用於研究目的，不用於診斷，但它們在臨床前和非臨床環境中對生物標記、藥物動力學和宿主細胞蛋白質污染物的評估中發揮著重要作用。慢性病和感染疾病的日益普及需要先進的生物分析工具，但挑戰仍然存在，例如試劑干擾導致的數據不可靠。

市場促進因素

生物醫學研究和日益成長的生物分析需求

生物製藥研發 (R&D) 的激增是 RUO免疫測量市場的主要驅動力。在先導化合物發現、臨床前試驗和生物製程開發中，對數據主導決策的需求加速了對高效生物分析方法的需求，這些方法需要以最少的樣品和試劑使用量提供準確可靠的結果。 RUO免疫測量支持多種應用，例如評估病毒載體的免疫抗原性以及開發重組蛋白和奈米抗體等新型治療方法。例如，Grail 於 2023 年 1 月推出了一款僅供研究使用的解決方案，該解決方案利用靶向甲基化技術分析外周血中的遊離 DNA，從而實現預後預測、微小殘留病檢測以及跨癌症類型的複發追蹤。

自動化和客製化的進步

自動化和高通量平台的技術進步正在提高RUO免疫測量的效率，減少手動流程和操作員疲勞。可客製化的檢測試劑套件因其能夠滿足專業研究需求（尤其是在藥物開發領域）而日益普及。這些創新提高了生物標記檢測的準確性並簡化了工作流程，使RUO免疫測量在基礎科學和生物製藥研發等領域至關重要。像Almac Diagnostic Services這樣的公司，其2021年的收益成長了8.6%，他們正在利用這項需求，提供用於研究的檢測設計和過渡服務。

市場限制

數據可靠性的挑戰

交叉反應抗體試劑的干擾是一項重大挑戰，它降低了RUO免疫測量數據的可靠性。透過平行性、測定類型和樣本大小等參數及早識別干擾，對於緩解藥物-標靶複合物解離等問題至關重要。雖然最佳化試劑濃度和孵育時間也是有效的，但這些挑戰使開發準確且可重複的測定方法變得複雜，從而限制了市場的成長。

市場區隔分析

免疫測量（RIA）的發展

RUO免疫測量市場依產品細分為免疫測量(RIA)、酵素結合免疫吸附檢測法(ELISA)、計數免疫檢測(CIA)、免疫測量(FIA) 和化學冷光免疫檢測(CLIA)。 RIA細分市場預計將顯著成長，因為它能夠測量抗體、荷爾蒙和藥物等微量物質。根據美國癌症協會的數據，預計2024年美國將新增2,041,910例癌症病例。癌症等慢性疾病的發生率不斷上升，推動了對基於RIA的技術的需求，以支持高級研究並改善臨床療效。

地理視角

北美市場優勢

以美國為首的北美佔據了RUO免疫測量市場的最大佔有率，這得益於慢性病的高發病率以及政府對生物製藥研發的大量投入。 2022年9月，美國衛生與公眾服務部撥款4000萬美元，用於擴大抗生素和原料藥的生物製造。此外，2022年6月，美國疾病管制與預防中心向「癌症登月計畫」投資2.15億美元，以促進癌症治療研究，從而推動了臨床前試驗對RUO免疫測量的需求。

亞太地區快速成長

由於人口老化、感染疾病高發生率以及先進檢測技術的日益普及，亞太地區預計將以最快的速度成長。該地區對快速檢測和診斷的重視推動了對RUO免疫測量的需求，尤其是在慢性病和感染疾病的監測方面。

活性化、日益提升的自動化程度以及對可客製化高通量檢測解決方案日益成長的需求將推動該市場顯著成長。北美市場投資強勁，疾病流行率高，亞太地區預計將快速擴張。 RIA 領域是一個關鍵的成長領域，但資料可靠性仍然是一個挑戰。近期的合作和收購凸顯了市場對技術創新的關注，使 RUO免疫測量在預測期內成為生物製藥和疾病研究的關鍵工具。

本報告的主要優點

深入分析：深入了解主要和新興地區的市場洞察，重點關注客戶群、政府政策和社會經濟因素、消費者偏好、垂直行業和其他細分市場。
競爭格局：了解主要企業所採用的策略策略，並了解採用正確的策略的市場滲透潛力。
市場趨勢和促進因素：探索動態因素和關鍵市場趨勢以及它們將如何影響未來的市場發展。
可行的建議：利用洞察力來制定策略決策，在動態環境中開闢新的業務流和收益。
受眾廣泛：對於新興企業、研究機構、顧問、中小企業和大型企業來說，既有利又划算。

它有什麼用途？

產業與市場考量、商業機會評估、產品需求預測、打入市場策略、地理擴張、資本支出決策、法律規範與影響、新產品開發、競爭影響

調查範圍

2022 年至 2024 年的歷史數據和 2025 年至 2030 年的預測數據
成長機會、挑戰、供應鏈前景、法律規範與趨勢分析
競爭定位、策略和市場佔有率分析
收益成長和預測細分市場和區域分析（包括國家）
公司概況（尤其是財務狀況和關鍵發展）

The global Research Use Only (RUO) immunoassay market is experiencing robust growth, driven by rising biomedical research, advancements in biomarker detection, and the increasing adoption of automation and customizable assay kits. RUO immunoassays, designed exclusively for research purposes and not for diagnostic use, are critical in preclinical and nonclinical settings for evaluating biomarkers, pharmacokinetics, and host cell protein contaminants. The market is propelled by the growing prevalence of chronic and infectious diseases, necessitating advanced bioanalytical tools, though challenges like data reliability due to reagent interference persist.

Market Drivers

Rising Biomedical Research and Bioanalytical Needs

The surge in biopharmaceutical research and development (R&D) is a primary driver of the RUO immunoassay market. The demand for effective bioanalytical methods that deliver precise, reliable results with minimal sample and reagent use is accelerating, driven by the need for data-driven decision-making in lead discovery, preclinical trials, and bioprocess development. RUO immunoassays support applications such as assessing the immunogenicity of viral vectors and developing novel therapies like recombinant proteins and nanobodies. For instance, in January 2023, Grail introduced a research-use-only solution using targeted methylation technology to analyze cell-free DNA from peripheral blood, enabling prognosis, minimal residual disease detection, and recurrence tracking across cancer types.

Advancements in Automation and Customization

Technological advancements in automation and high-throughput platforms are enhancing the efficiency of RUO immunoassays, reducing manual processes and operator fatigue. Customizable assay kits are gaining traction for their ability to address specialized research needs, particularly in pharmaceutical development. These innovations improve precision in biomarker detection and streamline workflows, making RUO immunoassays indispensable in fields like basic science and biopharmaceutical R&D. Companies like Almac Diagnostic Services, which reported an 8.6% revenue growth in 2021, are capitalizing on this demand by offering assay design and migration services for research purposes.

Market Restraint

Challenges in Data Reliability

Interference from cross-reacting antibody reagents poses a significant challenge, reducing the reliability of RUO immunoassay data. Early identification of interference through parameters like parallelism, assay type, and sample size is critical to mitigate issues like drug-target complex dissociation. Optimizing reagent concentrations and incubation periods can help, but these challenges limit market growth by complicating the development of accurate and reproducible assays.

Market Segmentation Analysis

Growth in Radioimmunoassay (RIA)

The RUO immunoassay market is segmented by product into Radioimmunoassay (RIA), Enzyme-Linked Immunosorbent Assay (ELISA), Counting Immunoassay (CIA), Fluoroimmunoassay (FIA), and Chemiluminescence Immunoassay (CLIA). The RIA segment is expected to grow significantly due to its ability to measure minute quantities of substances like antibodies, hormones, and drugs. The rising prevalence of chronic diseases, such as cancer, with an estimated 2,041,910 new cases in the U.S. in 2024 according to the American Cancer Society, is driving demand for RIA-based techniques to support advanced research and improve clinical treatment outcomes.

Geographical Outlook

North America's Market Dominance

North America, led by the United States, holds the largest share of the RUO immunoassay market, driven by the high prevalence of chronic diseases and significant government investments in biopharmaceutical R&D. In September 2022, the U.S. Department of Health and Human Services allocated $40 million to expand biomanufacturing for antibiotics and active pharmaceutical ingredients. Additionally, the Centers for Disease Control and Prevention invested $215 million in June 2022 in the Cancer Moonshot program to advance cancer treatment research, boosting demand for RUO immunoassays in preclinical testing.

Asia-Pacific's Rapid Growth

The Asia-Pacific region is expected to grow at the fastest rate, fueled by a large aging population, high infectious disease prevalence, and increasing adoption of advanced laboratory techniques. The region's focus on rapid examination and diagnosis is driving demand for RUO immunoassays in research settings, particularly for chronic and infectious disease studies.

Key Developments

In October 2024, ADx NeuroSciences partnered with Alamar Biosciences to develop customized biomarker assays using Alamar's NULISA platform and ARGO HT System, enhancing neurodegenerative disease research for pharmaceutical companies. In August 2024, VION Biosciences acquired Ansh Labs, integrating custom manufacturing and contract development to strengthen RUO immunoassay capabilities for underserved markets.

The RUO immunoassay market is poised for significant growth, driven by rising biomedical research, advancements in automation, and the increasing need for customizable, high-throughput assay solutions. North America dominates due to robust investments and disease prevalence, while Asia-Pacific is set for rapid expansion. The RIA segment is a key growth area, though challenges in data reliability persist. Recent collaborations and acquisitions highlight the market's focus on innovation, positioning RUO immunoassays as critical tools in biopharmaceutical and disease research during the forecast period.

Key Benefits of this Report:

Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, and other sub-segments.
Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape future market developments.
Actionable Recommendations: Utilize the insights to exercise strategic decisions to uncover new business streams and revenues in a dynamic environment.
Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

What do businesses use our reports for?

Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

Historical data from 2022 to 2024 & forecast data from 2025 to 2030
Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
Competitive Positioning, Strategies, and Market Share Analysis
Revenue Growth and Forecast Assessment of segments and regions including countries
Company Profiling (Strategies, Products, Financial Information, and Key Developments among others.

Market Segmentation:

By Product

Radioimmunoassay (RIA)
Enzyme Immunoassay or Enzyme-linked Immunosorbent Assays (ELISA)
Counting Immunoassay (CIA)
Fluoroimmunoassay (FIA)
Chemiluminescence Immunoassay (CLIA)

By Application

Infectious Disease
Oncology
Blood Screening and Toxicology
Cardiology
Others

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
Germany
France
United Kingdom
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Others
Asia Pacific
China
India
Japan
South Korea
Indonesia
Thailand
Others

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

2.1. Market Overview
2.2. Market Definition
2.3. Scope of the Study
2.4. Market Segmentation

3. BUSINESS LANDSCAPE

3.1. Market Drivers
3.2. Market Restraints
3.3. Market Opportunities
3.4. Porter's Five Forces Analysis
3.5. Industry Value Chain Analysis
3.6. Policies and Regulations
3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. RUO IMMUNOASSAY MARKET BY PRODUCT

5.1. Introduction
5.2. Radioimmunoassay (RIA)
5.3. Enzyme Immunoassay or Enzyme-linked Immunosorbent Assays (ELISA)
5.4. Counting Immunoassay (CIA)
5.5. Fluoroimmunoassay (FIA)
5.6. Chemiluminescence Immunoassay (CLIA)

6. RUO IMMUNOASSAY MARKET BY APPLICATION

6.1. Introduction
6.2. Infectious Disease
6.3. Oncology
6.4. Blood Screening and Toxicology
6.5. Cardiology
6.6. Others

7. RUO IMMUNOASSAY MARKET BY GEOGRAPHY

7.1. Introduction
7.2. North America
- 7.2.1. USA
- 7.2.2. Canada
- 7.2.3. Mexico
7.3. South America
- 7.3.1. Brazil
- 7.3.2. Argentina
- 7.3.3. Others
7.4. Europe
- 7.4.1. Germany
- 7.4.2. France
- 7.4.3. United Kingdom
- 7.4.4. Spain
- 7.4.5. Others
7.5. Middle East and Africa
- 7.5.1. Saudi Arabia
- 7.5.2. UAE
- 7.5.3. Others
7.6. Asia Pacific
- 7.6.1. China
- 7.6.2. India
- 7.6.3. Japan
- 7.6.4. South Korea
- 7.6.5. Indonesia
- 7.6.6. Thailand
- 7.6.7. Others