マルチプレックスアッセイの世界市場規模：技術別、エンドユーザー別、用途別、地域別、範囲および予測

マルチプレックスアッセイの世界市場規模および予測

マルチプレックスアッセイの市場規模は、2024年に430万米ドルと評価され、2024年～2031年の間に7.66％のCAGRで成長する見込みで、2031年には736万米ドルに達すると予測されます。マルチプレックスアッセイは、生物医学研究と診断における画期的なアプローチであり、1つのサンプル内で多くの分析物を同時に検出・定量することができます。これらのアッセイは、プロセスを迅速化し、貴重なサンプル量を節約し、複雑な生物学的システムに対する完全な洞察を提供する能力があるため、多くの注目を集め、採用されています。マルチプレックスアッセイでは、マイクロアレイ、ビーズベースアッセイ、マイクロフルイディクスなどの最新技術を用いて、タンパク質、核酸、代謝物など様々なバイオマーカーを同時に分析します。

これらのアッセイは、炎症、免疫細胞の活性化、宿主と病原体の相互作用に関与するサイトカイン、ケモカイン、その他の免疫メディエーターの研究に一般的に用いられています。ビーズベースのイムノアッセイやフローサイトメトリーベースのアッセイなどのマルチプレックスサイトカインアッセイでは、生体試料中の多数のサイトカインやケモカインを同時に検出することができ、免疫系の機能、疾患の病態生理、治療反応に関する重要な知見を得ることができます。これらのアッセイは、自己免疫疾患や感染症、がん免疫学、ワクチン開発などの研究開発に有用です。

マルチプレックスアッセイの世界市場力学

主な市場促進要因

慢性疾患の有病率の増加：

慢性疾患、特にがんや自己免疫疾患の有病率の増加は、マルチプレックスアッセイ市場の主要促進要因です。世界保健機関（WHO）によると、がんは世界最大の死因であり、2020年には約1,000万人が死亡します。国際がん研究機関（IARC）は、2040年までに世界のがん罹患数が2020年比47%増の2,840万人に達すると予測しています。罹患数の増加により、マルチプレックス検査などの効果的な診断方法の必要性が高まっています。米国がん協会は、がんリスク評価のためのマルチプレックス遺伝子パネル検査が2019年から2023年の間に30％増加したとしており、これらの技術がより広く使用されるようになっていることを示しています。

プロテオミクスとゲノミクス研究の進歩：

プロテオミクスとゲノミクス研究の著しい進歩が、マルチプレックスアッセイの需要を促進しています。National Human Genome Research Instituteによると、ヒトゲノムの塩基配列決定コストは2001年の1億米ドルから2023年には1,000ドル以下にまで下がり、ゲノム研究がより身近なものになりました。これにより、多重検査を必要とする研究活動が活発化しています。Global Genomics Market Report 2023によると、ゲノム市場は2023年から2030年にかけて13.6％のCAGRで開拓され、2030年には629億米ドルに達すると予測されています。また、マルチプレックスアッセイがゲノミクス市場の約18%を占めており、大きな成長の可能性を示しています。

創薬・開発活動の増加：

製薬業界が個別化医療や標的医薬品を重視するようになったことで、医薬品の研究開発プロセスにおけるマルチプレックス検査の利用が加速しています。PhRMAによると、開発中の個別化医薬品の数は2015年から2023年の間に145%急増しました。2023年には、米国食品医薬品局（FDA）は25の個別化医薬品を認可し、新薬承認全体の35％を占める。この動向は、バイオマーカーの発見や複雑な生物学的経路の理解に不可欠なマルチプレックス検査の必要性を高めています。

主な課題

交差反応性と特異性

：マルチプレックス・アッセイで最も難しいことの一つは、異なるターゲット間の交差反応性を制限しながら、各分析物に対する特異性を維持することです。交差反応性は、アッセイで使用される抗体やプローブが不要なターゲットに非特異的に結合し、偽陽性の結果をもたらす場合に生じる。これは、濃度の異なる多くの分析対象物を含む複雑な生物学的サンプルでは特に課題となります。高い特異性を得るためには、交差反応性を最小限に抑えた抗体やプローブを注意深く選択し、非特異的結合を減らすために試験条件を徹底的に最適化する必要があります。

ダイナミックレンジと感度：

マルチプレックスアッセイにおけるもう一つの問題は、分析値の広いダイナミックレンジにわたって適切な感度を確立することです。生物学的サンプルには数桁の濃度の分析対象物が含まれることが多く、低存在量ターゲットと高存在量ターゲットの両方を正確に検出できるアッセイが必要となります。しかしながら、親和性、検出効率、マトリックス成分による干渉のばらつきのために、マルチプレックスアッセイにおいてすべての分析対象物に対して一貫した感度を維持することは困難です。

データ解析と解釈

マルチプレックスアッセイデータの解析と解釈は、特に複数のサンプルで検出された複数の分析対象物から得られる膨大なデータセットを扱う場合に、新たな困難をもたらします。データ解析の手法は、分析対象物間の複雑な相互作用に加え、起こりうるバッチ効果、正規化に関する懸念、統計的考察を考慮しなければならないです。さらに、マルチプレックスアッセイデータをゲノミクスやプロテオミクスのような他のオミックスデータセットと組み合わせることで、有用な知見を引き出し、生理学的に重要なパターンや相関関係を見出すためには、高度なバイオインフォマティクスツールや計算手法が必要となります。

主要動向

技術の進歩：

技術の進歩は、マルチプレックス検査の進歩を促進する重要な動向の一つです。アッセイプラットフォーム、検出方法、アッセイフォーマットは、マルチプレックスアッセイの感度、特異性、スループットを向上させるために、時代とともに大きく進歩しています。マイクロアレイベースのアッセイ、ビーズベースのアッセイ、マイクロ流体プラットフォームは、タンパク質、核酸、微小分子を含む幅広い分析対象物の非常に正確で効率的な検出を可能にしています。

個別化医療への応用：

マルチプレックスアッセイの採用を促進するもう一つの重要な動向は、個別化医療における利用の拡大です。マルチプレックスアッセイは、患者固有の分子プロファイルを同定し、疾患の不均一性と個別化治療法の必要性が広く認識されるようになった現在、個別化治療の指針となる有用なツールを提供します。腫瘍学では、マルチプレックス検査は悪性腫瘍の分子プロファイルを解析し、治療反応や予後と関連する特定のバイオマーカーを見つけるために用いられています。

マルチオミクスアプローチの統合

：マルチオミクス手法の統合は、マルチプレックス検査分野に影響を与えるもう一つの注目すべき動向です。マルチオミクスとは、ゲノム、トランスクリプトミクス、プロテオミクス、メタボロミクス、エピゲノミクスといった複数の分子層を完全に調査し、生物学的システムの全体的な理解を達成することです。様々なオミックスデータを同時に測定できるマルチプレックスアッセイは、複雑な生物学的プロセスや疾患の理解を助けるために急速に開発されています。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 マルチプレックスアッセイ市場：技術別

• タンパク質ベースのマルチプレックスアッセイ
• 核酸ベースのマルチプレックスアッセイ

第5章 マルチプレックスアッセイ市場：用途別

• 臨床診断
• 創薬・医薬品開発
• 研究用途

第6章 マルチプレックスアッセイ市場：エンドユーザー別

• 病院および診断研究所
• 製薬・バイオテクノロジー企業
• 学術・研究機関

第7章 地域別分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• Thermo Fisher Scientific
• Bio-Rad Laboratories, Inc.
• Luminex Corporation
• QIAGEN N.V.
• Agilent Technologies, Inc.
• Illumina, Inc.
• Abcam plc
• Randox Laboratories Ltd.
• Merck KGaA
• BD（Becton, Dickinson and Company）

第11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

Global Multiplex Assays Market Size and Forecast

Multiplex Assays Market size was valued at USD 4.3 Million in 2024 and is projected to reach USD 7.36 Million by 2031 , growing at a CAGR of 7.66% from 2024 to 2031. Multiplex assays are a groundbreaking approach in biomedical research and diagnostics, allowing for the simultaneous detection and quantification of many analytes inside a single sample. These assays have received a lot of attention and adoption because of their capacity to expedite processes, save valuable sample volumes, and provide complete insights into complicated biological systems. Multiplex assays use modern technologies like microarrays, bead-based assays, and microfluidics to analyze a variety of biomarkers simultaneously including proteins, nucleic acids, and metabolites.

These assays are commonly used to study cytokines, chemokines, and other immune mediators involved in inflammation, immune cell activation, and host-pathogen interactions. Multiplex cytokine assays such as bead-based immunoassays and flow cytometry-based assays allow for the simultaneous detection of numerous cytokines and chemokines in biological samples yielding crucial insights into immune system function, disease pathophysiology, and treatment responses. These assays are useful in the research of autoimmune and infectious disorders, cancer immunology, and vaccine development, all of which involve dysregulated immune responses.

Global Multiplex Assays Market Dynamics

The key market dynamics that are shaping the multiplex assays market include:

Key Market Drivers:

Increasing Prevalence of Chronic Diseases:

The increased prevalence of chronic diseases, particularly cancer and autoimmune disorders, is a key driver of the multiplex assays market. According to the World Health Organization (WHO), cancer is the biggest cause of death worldwide, accounting for approximately 10 million deaths in 2020. The International Agency for Research on Cancer (IARC) predicts that the worldwide cancer burden will reach 28.4 million cases by 2040, up 47% from 2020. The rising illness load raises the need for effective diagnostic methods such as multiplex tests. The American Cancer Society states that multiplex gene panel testing for cancer risk assessment grew by 30% between 2019 and 2023, indicating that these technologies are becoming more widely used.

Advancements in Proteomics and Genomics Research:

The tremendous advancement in proteomics and genomics research is driving the demand for multiplex assays. The National Human Genome Research Institute claims that the cost of sequencing a human genome has dropped from USD 100 Million in 2001 to less than $1,000 in 2023, making genomic research more accessible. This has increased research activities needing multiplex tests. According to the Global Genomics Market Report 2023, the genomics market is predicted to develop at a 13.6% CAGR between 2023 and 2030, reaching USD 62.9 Billion by 2030. The research also mentions that multiplex assays account for roughly 18% of the genomics market, indicating a huge growth potential.

Increasing Drug Discovery and Development Activities:

The pharmaceutical industry's rising emphasis on personalized medicine and targeted medicines is accelerating the use of multiplex tests in drug research and development processes. According to PhRMA, the number of personalized medications in development surged by 145% between 2015 and 2023. In 2023, the US Food and Drug Administration (FDA) authorized 25 customized medicines, accounting for 35% of all new drug approvals. This trend is driving up the need for multiplex tests, which are critical for discovering biomarkers and comprehending complex biological pathways.

Key Challenges:

Cross-Reactivity and Specificity

: One of the most difficult aspects of multiplex assays is maintaining acceptable specificity for each analyte while limiting cross-reactivity between distinct targets. Cross-reactivity occurs when antibodies or probes employed in an assay bind non-specifically to unwanted targets resulting in false positive results. This can be especially challenging in complicated biological samples containing many analytes at different concentrations. To achieve high specificity, carefully choose antibodies or probes with minimum cross-reactivity and thoroughly optimize test conditions to reduce non-specific binding.

Dynamic Range and Sensitivity:

Another problem in multiplex assays is establishing adequate sensitivity over a wide dynamic range of analytic values. Biological samples frequently contain analytes with concentrations ranging several orders of magnitude necessitating assays capable of accurately detecting both low and high abundance targets. However, maintaining consistent sensitivity for all analytes in a multiplex assay can be difficult because of variances in affinity, detection efficiency, and interference from matrix components.

Data Analysis and Interpretation:

Analyzing and interpreting multiplex assay data poses a new difficulty especially when dealing with huge datasets derived from several analytes detected across multiple samples. Data analysis methods must take into account the intricate interactions between analytes as well as possible batch effects normalization concerns, and statistical considerations. Furthermore, combining multiplex assay data with other omics datasets such as genomics or proteomics necessitates advanced bioinformatics tools and computational methodologies to extract useful insights and find physiologically significant patterns or correlations.

Key Trends:

Advancements in Technology:

Technological advancements are one of the key trends driving the progress of multiplex tests. Assay platforms, detection methods, and assay formats have advanced significantly over time increasing the sensitivity, specificity, and throughput of multiplex assays. Microarray-based assays, bead-based assays, and microfluidic platforms have allowed for the very precise and efficient detection of a wide range of analytes including proteins, nucleic acids, and tiny molecules.

Application in Personalized Medicine:

Another important trend driving the adoption of multiplex assays is their growing use in personalized medicine. Multiplex assays provide a useful tool for identifying patient-specific molecular profiles and guiding tailored treatments as illness heterogeneity and the need for individualized treatment methods are becoming more widely recognized. In oncology, multiplex tests are used to molecularly profile malignancies to find particular biomarkers linked with therapy response and prognosis.

Integration of Multi-Omics Approaches

: The incorporation of multi-omics techniques is another notable trend impacting the field of multiplex tests. Multi-omics is the complete investigation of several molecular layers such as genomes, transcriptomics, proteomics, metabolomics, and epigenomics to achieve a holistic understanding of biological systems. Multiplex assays which allow for the simultaneous measurement of various omics data types are rapidly being created to help understand the complexities of biological processes and diseases.

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Global Multiplex Assays Market Regional Analysis

Here is a more detailed regional analysis of the multiplex assays market:

North America:

According to Verified Market Research, North America is expected to dominate the multiplex assays market during the forecast period. North America, particularly the United States, has a high prevalence of chronic diseases, which drives the demand for multiplex assays in diagnostics and research. According to the Centers for Disease Control and Prevention (CDC), six out of every ten persons in the United States have a chronic disease, with four out of ten having two or more. The American Cancer Society predicts that there will be 1.9 million new cancer cases identified in the United States by 2024. According to the National Cancer Institute, the usage of multiplex gene panel testing in cancer diagnosis grew by 35% from 2020 to 2023, with over 1.2 million tests performed in 2023 alone. High illness burden and rising usage of modern diagnostic technologies contribute considerably to the region's dominance in the multiplex assays market.

Furthermore, North America leads in life sciences research and development, which drives demand for advanced research tools such as multiplex assays. The National Institutes of Health's (NIH) budget for fiscal year 2024 is USD 47.5 Billion, up USD 2.5 Billion from 2023. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the US biopharmaceutical industry invested USD 102.3 Billion in R&D in 2023, with a large chunk going into genomics and proteomics research, which significantly relies on multiplex assays.

Asia Pacific:

The Asia Pacific region is expected to experience a significant increase in revenue growth within the global multiplex assays market during the forecast period. The Asia Pacific region is experiencing a large increase in chronic diseases, which is increasing demand for improved diagnostic tools such as multiplex assays. According to the World Health Organization (WHO), non-communicable illnesses account for 71% of all fatalities in Southeast Asia. According to the International Diabetes Federation, the number of adults with diabetes in the Asia-Pacific region is anticipated to rise by 30%, from 163 million in 2019 to 212 million in 2045. In China alone, the National Cancer Center reported 4.5 million new cancer cases in 2023, representing a 5% rise over the previous year. The increased illness burden is driving the use of multiplex tests for early detection and monitoring of numerous disorders at the same time.

Furthermore, the Asia Pacific region is experiencing rapid expansion of healthcare infrastructure and increased healthcare spending, which is driving up the usage of modern diagnostic technology. According to the World Bank, health expenditure as a proportion of GDP in East Asia and the Pacific has risen from 6.6% in 2010 to 7.2% in 2022. In India, the government allotted ₹89,155 crore (about USD 11 Billion) for the healthcare sector in the 2023-2024 budget, up 13% from the previous year.

Global Multiplex Assays Market: Segmentation Analysis

The Multiplex Assays Market is segmented based on Technology, End-User, Application and Geography.

Multiplex Assays Market, By Technology

• Protein-based Multiplex Assays
• Nucleic Acid-based Multiplex Assays

Based on Technology, the Multiplex Assays Market is divided into Protein-based Multiplex Assays and Nucleic Acid-based Multiplex Assays. The nucleic acid-based multiplex assay segment is estimated to hold a prominent position within the market. This is primarily due to the versatility and sensitivity of nucleic acid detection methods such as polymerase chain reaction (PCR), reverse transcription PCR (RT-PCR), and nucleic acid microarrays.

Multiplex Assays Market, By End-User

• Hospitals and Diagnostic Laboratories
• Pharmaceutical and Biotechnology Companies
• Academic and Research Institutes

Based on End-User, the Multiplex Assays Market is divided into Hospitals & Diagnostic Laboratories, Pharmaceutical & Biotechnology Companies, and Academic & Research Institutes. The pharmaceutical & biotechnology companies segment is estimated to dominate the multiplex assays market. These companies heavily rely on multiplex assays for various stages of drug discovery, preclinical and clinical development as well as biomarker validation. The demand from pharmaceutical and biotechnology companies stems from the imperative to conduct comprehensive and high-throughput screening of potential drug candidates, evaluate their efficacy and safety profiles, and identify relevant biomarkers for patient stratification and therapeutic response monitoring.

Multiplex Assays Market, By Application

• Clinical Diagnostics
• Drug Discovery and Development
• Research Applications

Based on Application, the Multiplex Assays Market is divided into Clinical Diagnostics, Drug Discovery & Development, and Research Applications. The clinical diagnostics segment is estimated to dominate the market due to the growing demand for accurate and quick diagnostic procedures that can assess several biomarkers from a single sample. Clinical diagnostics applications are essential for disease identification and monitoring, especially in chronic and infectious disorders. Multiplex assays' capacity to efficiently give comprehensive results makes them indispensable instruments in modern healthcare, consolidating their market leadership.

Multiplex Assays Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the Multiplex Assays Market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America is estimated to dominate the multiplex assays market. The presence of key industry players, continuous technical advancements, and substantial healthcare expenditures collectively contribute to its prominence. North America's robust healthcare infrastructure coupled with a well-established regulatory framework fosters innovation and facilitates market penetration for multiplex assays. Additionally, the region's proactive approach to healthcare delivery emphasis on precision medicine, and strong research and development ecosystem further bolster its market dominance.

Key Players

• The Multiplex Assays study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Thermo Fisher Scientific, Bio-Rad Laboratories, Inc., Luminex Corporation, QIAGEN N.V., Agilent Technologies, Inc., Illumina, Inc., Abcam plc, Randox Laboratories Ltd., Merck KGaA, BD (Becton, Dickinson and Company)

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Multiplex Assays Market Recent Developments
• In May 2022, CellCarta, a global precision medicine laboratory services provider, acquired the commercial rights to Precision tests' antibody panels and tests. Precision Assays is a leader in next-generation targeted proteomics testing. Precision tests provides pharmaceutical and biotech companies with advanced multiplex quantitative immuno-MRM mass spectrometry-based tests.
• In June 2023, Bio-Techne Corporation, a worldwide life sciences business, acquired Lunaphore, Inc, a leading provider of fully automated spatial biology solutions. The acquisition will support the development of diagnostic tools, streamline clinical trials, and eventually enhance patient outcomes.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Multiplex Assays Market, By Technology

• Protein-based Multiplex Assays
• Nucleic Acid-based Multiplex Assays

5. Multiplex Assays Market, By Application

• Clinical Diagnostics
• Drug Discovery and Development
• Research Applications

6. Multiplex Assays Market, By End User

• Hospitals and Diagnostic Laboratories
• Pharmaceutical and Biotechnology Companies
• Academic and Research Institutes

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Thermo Fisher Scientific
• Bio-Rad Laboratories, Inc.
• Luminex Corporation
• QIAGEN N.V.
• Agilent Technologies, Inc.
• Illumina, Inc.
• Abcam plc
• Randox Laboratories Ltd.
• Merck KGaA
• BD (Becton, Dickinson and Company)

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References