高密度マルチプレックス診断検査の世界市場

高密度マルチプレックス診断検査の世界市場は2030年までに55億米ドルに達する見込み

2023年に21億米ドルと推定される高密度マルチプレックス診断検査の世界市場は、分析期間2023-2030年にCAGR 14.8%で成長し、2030年には55億米ドルに達すると予測されます。本レポートで分析したセグメントの1つである診断ラボの最終用途は、CAGR 15.1％を記録し、分析期間終了までに18億米ドルに達すると予測されます。病院・診療所エンドユーズ分野の成長率は、分析期間中CAGR 14.6%と推定されます。

米国市場は推定5億5,570万米ドル、中国はCAGR13.6％で成長すると予測

米国の高密度マルチプレックス診断検査市場は、2023年に5億5,570万米ドルと推定されます。世界第2位の経済大国である中国は、2030年までに8億1,910万米ドルの市場規模に達すると予測され、分析期間2023-2030年のCAGRは13.6%です。その他の注目すべき地域別市場としては、日本とカナダがあり、分析期間中のCAGRはそれぞれ13.4％と12.5％と予測されています。欧州では、ドイツがCAGR 10.4%で成長すると予測されています。

世界の高密度マルチプレックス診断検査市場- 主要動向と促進要因のまとめ

高密度マルチプレックス診断検査は精密医療の未来に革命をもたらすか？

高密度マルチプレックス診断検査は精密医療を推進する重要なツールとして台頭してきていますが、このような高度な診断プラットフォームが現代の医療に不可欠な理由は何でしょうか？高密度マルチプレックスアッセイは、1つのサンプルから複数のバイオマーカーを同時に検出・定量することを可能にし、病気の診断や患者の健康状態のモニタリングに比類ない効率を提供します。このようなアッセイは、マイクロアレイ、次世代シーケンシング（NGS）、ビーズベースのシステムなどの技術を用いて、タンパク質、核酸、代謝物など数百から数千の分析物を一度に検査することができます。複数のバイオマーカーを詳細に把握することが正確な診断や治療に不可欠な、腫瘍学、感染症、免疫学、個別化医療などの分野で広く利用されています。

高密度マルチプレックス診断検査の魅力は、複数のターゲットを包括的かつ同時に分析できる点にあり、従来の単一ターゲット検査に伴う時間、コスト、複雑さを軽減することができます。このようなアッセイによって、ヘルスケア・プロバイダーは、単に診断的な洞察を得ることができるだけではありません。ヘルスケアを取り巻く環境が、より個別化されたデータ主導のアプローチへとシフトする中、高密度マルチプレックス診断検査は、患者の予後を改善し、治療戦略を最適化し、医療イノベーションを推進する上で不可欠なツールとなりつつあります。

テクノロジーは高密度マルチプレックス診断検査をどのように進化させたか？

技術の進歩により、高密度マルチプレックス診断検査の性能、感度、スケーラビリティは大幅に向上し、臨床や研究への応用がよりパワフルで利用しやすくなりました。最も重要な技術革新の一つは、高スループットマイクロアレイプラットフォームの開発です。マイクロアレイは、1回の検査で何千もの遺伝子マーカーやタンパク質マーカーの同時測定を可能にし、疾患バイオマーカーの大規模なスクリーニングや発見を可能にします。これらのプラットフォームは、感度と特異性が向上し、低存在量のバイオマーカーでも検出できるように進化してきました。また、最新のマイクロアレイはコスト効率とスピードが向上しており、ルーチンの臨床診断や大規模な集団健康調査に最適です。

次世代シーケンシング（NGS）は、単一サンプルから膨大な量の遺伝子情報を解析することを可能にし、マルチプレックス診断に革命をもたらしました。NGSベースのアッセイは、ゲノム全体、エクソーム、または遺伝子の標的パネルを高密度フォーマットでシーケンスすることができ、広範な遺伝子変異、突然変異、および遺伝子発現プロファイルを同時に検出することが可能です。この技術はがん診断の進歩に役立っており、腫瘍内の複数の遺伝子変異を同定することで、個別化された治療計画を導くことができます。NGSプラットフォームは精度だけでなく、スピードとスケーラビリティの面でも向上しており、高密度多重遺伝子アッセイが臨床検査室や研究機関にとってより利用しやすくなっています。

ビーズベースの多重化技術も大きな進歩を遂げました。これらのプラットフォームは、色分けされたビーズを使用して異なる分析物を同時に捕捉・測定するもので、多重化への柔軟でスケーラブルなアプローチを提供します。ビーズベースアッセイは、生物学的サンプル中のタンパク質、サイトカイン、その他の可溶性バイオマーカーの測定に一般的に用いられています。ビーズベースシステムの進歩により感度が向上し、血液や血清のような複雑なサンプル中の低濃度バイオマーカーの検出が可能になりました。このため、複数のサイトカインや免疫マーカーの検出が疾患の進行や免疫応答の理解に不可欠な免疫学や炎症研究において、ビーズベースアッセイは特に有用です。

自動化と機械学習がマルチプレックス診断プラットフォームに統合されたことで、その効率と診断能力はさらに向上しました。自動化されたワークフローにより、高密度の多重アッセイを最小限の作業時間で実施することが可能となり、ヒューマンエラーが減少し、スループットが向上しています。機械学習アルゴリズムは、これらのアッセイによって生成された大規模なデータセットの解析に使用されており、手作業では検出が困難なバイオマーカー間のパターンや相関関係を同定しています。このような自動化と人工知能（AI）の組み合わせは、臨床医や研究者が多重化データからより意味のある洞察を引き出し、診断精度を向上させ、患者ケアにおいてより多くの情報に基づいた意思決定を可能にするのに役立っています。

デジタルPCR（dPCR）のようなデジタル多重化技術もまた、従来の技術と比較してより高い感度と精度を提供することで、高密度マルチプレックスアッセイを進歩させてきました。dPCRは、極めて低濃度の特定のDNAまたはRNA配列の定量を可能にするため、希少な遺伝子変異や循環腫瘍DNAの検出ががんの早期発見とモニタリングに不可欠なリキッドバイオプシーのようなアプリケーションに最適です。サンプルを何千もの個々の反応に分割することで、dPCRは高い精度を達成し、バックグラウンドノイズの影響を低減するため、最も微妙な遺伝的変化も検出することができます。

なぜ高密度マルチプレックス診断検査が現代のヘルスケアと調査に不可欠なのか？

高密度マルチプレックス診断検査が現代のヘルスケアや研究に不可欠な理由は、1つのサンプルから複数のバイオマーカーを包括的かつハイスループットで解析することで、より詳細で正確な疾患状態の理解を可能にするからです。例えば腫瘍学の分野では、これらのアッセイによって、臨床医は腫瘍サンプル中の複数の遺伝子変異、タンパク質発現、免疫マーカーのプロファイリングを行うことができ、各患者のがん特有の分子特性に合わせた個別化治療計画を立てることができます。複数のバイオマーカーを同時に同定することで、高密度マルチプレックスアッセイは標的療法、免疫療法、併用療法を導き、治療成績を向上させ、副作用のリスクを軽減することができます。

感染症診断において、高密度マルチプレックスアッセイは、1回の検査で複数の病原体やウイルスの変異体を検出するために特に有用です。例えば、COVID-19のパンデミックの際、マルチプレックスアッセイは、SARS-CoV-2ウイルスの異なる株や他の呼吸器病原体を1つのサンプルで検査するために使用されました。単一の検体から包括的な検査を行うこの能力は、共同感染の診断、ウイルスの進化のモニタリング、亜種の拡散の追跡に不可欠であり、これは公衆衛生の監視と対応努力に不可欠です。

免疫学や自己免疫疾患では、マルチプレックスアッセイによって、研究者や臨床医がサイトカイン、ケモカイン、抗体などの幅広い免疫マーカーを測定し、免疫反応や疾患の進行に関する洞察を得ることができます。これらのアッセイは、関節リウマチ、ループス、多発性硬化症などの複雑な免疫関連疾患の診断に使用され、基礎となる免疫調節異常を理解するためには複数のバイオマーカーの詳細な分析が必要となります。多重アッセイはワクチン開発や免疫療法においても重要な役割を担っており、複数の免疫応答を測定することは有効性と安全性を評価する上で極めて重要です。

個別化医療の台頭は、高密度マルチプレックス診断検査の重要性をさらに浮き彫りにしています。個別化医療は、個人の分子的・遺伝的体質を詳細に理解し、最も効果が期待できる治療をオーダーメイドすることに依存しています。マルチプレックスアッセイにより、複数の遺伝子変異、遺伝子発現、エピジェネティックマーカーの同時分析が可能となり、患者の疾患プロファイルをより包括的に把握することができます。これは、複数の遺伝子変異が腫瘍の成長を促進する可能性があり、腫瘍に存在する特定の変異に基づいて標的療法を選択しなければならないがん治療において特に重要です。高密度マルチプレックスアッセイは、このレベルの精度を可能にし、より効果的で個別化された治療戦略を可能にします。

ファーマコゲノミクスでは、高密度マルチプレックスアッセイを用いて、患者の薬物代謝に影響を与える遺伝子変異を同定します。この情報は、臨床医が個々の患者にとって最も効果的な薬剤と投与量を選択するのに役立ち、薬物有害反応のリスクを減らし、治療成績を向上させる。一度に複数の遺伝子変異を分析することで、これらのアッセイは患者の遺伝子プロファイルをより完全に理解し、より安全で効果的な投薬管理を可能にします。

学術研究および臨床研究において、高密度マルチプレックスアッセイは、大規模なバイオマーカー探索、集団研究、臨床試験において非常に有用です。研究者はこれらのアッセイを用いて、新たな疾患バイオマーカーの同定、疾患の遺伝的・分子的基盤の研究、新たな治療法の有効性の評価を行っています。数百から数千のバイオマーカーを同時に分析できるため、より包括的な研究や迅速なデータ作成が可能になり、科学的発見のペースが加速され、臨床試験の質が向上します。

高密度マルチプレックス診断検査市場の成長を促進する要因は？

高密度マルチプレックス診断検査市場の成長は、精密医療に対する需要の高まり、個別化治療や標的治療の台頭、バイオマーカー探索の進歩、ヘルスケアや研究におけるハイスループット診断の継続的なニーズなど、いくつかの重要な要因によってもたらされます。主な促進要因の1つは、個々の患者の生物学的特性を詳細に理解することで治療を個別化する精密医療への世界のシフトです。高密度マルチプレックスアッセイは、複数のバイオマーカーの同時分析を可能にし、特にがん、自己免疫疾患、希少遺伝子疾患において、個別化治療計画の策定に必要な分子的洞察を提供します。

特にがん領域では、バイオマーカーに基づく治療法の利用が増加していることも、高密度マルチプレックスアッセイの需要を後押ししています。特定の遺伝子変異やタンパク質マーカーを標的とするがん治療法が開発されるにつれ、臨床医は腫瘍サンプル中の複数のバイオマーカーをプロファイリングして最適な治療法を選択できるツールを必要としています。高密度マルチプレックスアッセイは、これらのバイオマーカーの包括的な解析を可能にし、臨床医が患者のがんの分子 促進要因を同定し、それに応じて治療を調整することを可能にします。このため、がん診断や薬剤開発において多重アッセイが広く採用されるようになった。

次世代シーケンサー（NGS）やその他のハイスループット技術の継続的な成長も、多重化診断アッセイ市場の拡大に寄与しています。NGSがより利用しやすくなり、費用対効果も高まるにつれて、遺伝子検査、がんスクリーニング、希少疾患診断などの臨床現場での利用が増加しています。NGSベースの多重アッセイは、幅広い遺伝子変異を解析できるため、従来の単一遺伝子検査よりも詳細で正確な診断が可能です。NGSプラットフォームの利用可能性が高まるにつれ、シーケンシング技術の力を活用して包括的な遺伝学的洞察を提供できる多重化アッセイに対する需要が高まっています。

バイオマーカーの発見と検証の進歩も、多重化診断アッセイの需要を促進しています。がんから心血管疾患まで幅広い疾患の新たなバイオマーカーを調査・同定する中で、1回の検査で複数のバイオマーカーを検出できる診断ツールに対するニーズが高まっています。高密度マルチプレックスアッセイは、複数の疾患関連バイオマーカーを同時に分析できるため、この目的に適しており、より包括的で正確な診断が可能です。このため、バイオマーカー探索やバリデーション研究、特に医薬品開発や臨床試験において、多重アッセイの採用が増加しています。

感染症検査におけるハイスループット診断の需要も、高密度マルチプレックス診断検査市場の成長を加速させています。COVID-19のパンデミックは、1回の検査で複数の病原体やウイルス変異体を検出できる迅速でスケーラブルな診断ソリューションの必要性を浮き彫りにしました。マルチプレックスアッセイは、同時感染の特定、SARS-CoV-2亜種の拡散モニタリング、公衆衛生介入の指針として重要な役割を果たしました。新興感染症の脅威が続く中、包括的で迅速な結果を提供できる多重化診断プラットフォームへのニーズは高まることが予想されます。

さらに、費用対効果の高い診断法への注目の高まりが、多重化アッセイの需要を促進しています。従来の診断検査では、異なるバイオマーカーを分析するために複数のサンプル、試薬、検査が必要となることが多く、コスト高と納期の長期化につながっていました。対照的に、高密度マルチプレックスアッセイでは、1つのサンプルから複数のバイオマーカーを同時に分析できるため、追加検査の必要性が減り、全体的なコストが削減されます。この費用対効果は、効率性と拡張性が重要な大規模臨床試験、集団健康調査、ルーチン診断において特に重要です。

テクノロジーの進歩、個別化医療への注目の高まり、ヘルスケアや研究におけるハイスループット診断の必要性により、高密度マルチプレックス診断検査市場は大きく成長する態勢を整えています。これらのアッセイが進化し続けるにつれて、診断精度の向上、治療戦略の最適化、精密医療分野の進展においてますます重要な役割を果たすようになると思われます。

調査対象企業の例（全12件）

• Abbott Laboratories
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Erba Diagnostics, Inc.
• F. Hoffmann-La Roche AG
• Gold Standard Diagnostics Corporation
• Hologic, Inc.
• Luminex Corporation
• Randox Laboratories Ltd.
• Thermo Fisher Scientific, Inc.

目次

第1章 調査手法

第2章 エグゼクティブサマリー

• 市場概要
• 主要企業
• 市場動向と促進要因
• 世界市場の見通し

第3章 市場分析

• 米国
• カナダ
• 日本
• 中国
• 欧州
• フランス
• ドイツ
• イタリア
• 英国
• その他欧州
• アジア太平洋
• その他の地域

第4章 競合

Global High-Density Multiplexed Diagnostic Assays Market to Reach US$5.5 Billion by 2030

The global market for High-Density Multiplexed Diagnostic Assays estimated at US$2.1 Billion in the year 2023, is expected to reach US$5.5 Billion by 2030, growing at a CAGR of 14.8% over the analysis period 2023-2030. Diagnostic Laboratories End-Use, one of the segments analyzed in the report, is expected to record a 15.1% CAGR and reach US$1.8 Billion by the end of the analysis period. Growth in the Hospitals & Clinics End-Use segment is estimated at 14.6% CAGR over the analysis period.

The U.S. Market is Estimated at US$555.7 Million While China is Forecast to Grow at 13.6% CAGR

The High-Density Multiplexed Diagnostic Assays market in the U.S. is estimated at US$555.7 Million in the year 2023. China, the world's second largest economy, is forecast to reach a projected market size of US$819.1 Million by the year 2030 trailing a CAGR of 13.6% over the analysis period 2023-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 13.4% and 12.5% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 10.4% CAGR.

Global High-Density Multiplexed Diagnostic Assays Market - Key Trends and Drivers Summarized

Are High-Density Multiplexed Diagnostic Assays Revolutionizing the Future of Precision Medicine?

High-density multiplexed diagnostic assays are emerging as a critical tool in advancing precision medicine, but what makes these sophisticated diagnostic platforms so essential for modern healthcare? High-density multiplexed assays allow for the simultaneous detection and quantification of multiple biomarkers from a single sample, offering unparalleled efficiency in diagnosing diseases and monitoring patient health. These assays can test for hundreds or even thousands of analytes—such as proteins, nucleic acids, or metabolites—at once, using technologies like microarrays, next-generation sequencing (NGS), or bead-based systems. They are extensively used in fields such as oncology, infectious diseases, immunology, and personalized medicine, where a detailed understanding of multiple biomarkers is essential for accurate diagnosis and treatment.

The appeal of high-density multiplexed diagnostic assays lies in their ability to provide comprehensive and simultaneous analysis of multiple targets, which reduces the time, cost, and complexity associated with traditional single-target tests. These assays offer more than just diagnostic insights—they enable healthcare providers to better understand the molecular mechanisms underlying diseases, tailor treatment plans to individual patients, and monitor treatment responses with greater precision. As the healthcare landscape shifts towards more personalized and data-driven approaches, high-density multiplexed diagnostic assays are becoming indispensable tools in improving patient outcomes, optimizing therapeutic strategies, and driving medical innovation.

How Has Technology Advanced High-Density Multiplexed Diagnostic Assays?

Technological advancements have significantly enhanced the performance, sensitivity, and scalability of high-density multiplexed diagnostic assays, making them more powerful and accessible for clinical and research applications. One of the most important innovations has been the development of high-throughput microarray platforms. Microarrays allow the simultaneous measurement of thousands of genetic or protein markers in a single test, enabling large-scale screening and discovery of disease biomarkers. These platforms have evolved to offer increased sensitivity and specificity, allowing for the detection of even low-abundance biomarkers. Modern microarrays are also more cost-effective and faster, making them ideal for routine clinical diagnostics and large-scale population health studies.

Next-generation sequencing (NGS) has revolutionized multiplexed diagnostics by enabling the analysis of vast amounts of genetic information from a single sample. NGS-based assays can sequence entire genomes, exomes, or targeted panels of genes in a high-density format, making it possible to detect a wide array of genetic variants, mutations, and gene expression profiles simultaneously. This technology has been instrumental in advancing cancer diagnostics, where identifying multiple genetic mutations in tumors can guide personalized treatment plans. NGS platforms have improved not only in terms of accuracy but also in terms of speed and scalability, making high-density multiplexed genetic assays more accessible to clinical laboratories and research institutions.

Bead-based multiplexing technologies have also made significant strides. These platforms use color-coded beads to simultaneously capture and measure different analytes, offering a flexible and scalable approach to multiplexing. Bead-based assays are commonly used for measuring proteins, cytokines, and other soluble biomarkers in biological samples. Advances in bead-based systems have increased their sensitivity, enabling the detection of low-abundance biomarkers in complex samples, such as blood or serum. This makes bead-based assays particularly useful for immunology and inflammation research, where detecting multiple cytokines or immune markers is essential for understanding disease progression and immune responses.

The integration of automation and machine learning into multiplexed diagnostic platforms has further enhanced their efficiency and diagnostic capabilities. Automated workflows enable high-density multiplexed assays to be performed with minimal hands-on time, reducing human error and increasing throughput. Machine learning algorithms are being used to analyze the large datasets generated by these assays, identifying patterns and correlations between biomarkers that might be difficult to detect manually. This combination of automation and artificial intelligence (AI) is helping clinicians and researchers extract more meaningful insights from multiplexed data, improving diagnostic accuracy and enabling more informed decision-making in patient care.

Digital multiplexing technologies, such as digital PCR (dPCR), have also advanced high-density multiplexed assays by offering higher sensitivity and precision compared to traditional techniques. dPCR enables the quantification of specific DNA or RNA sequences at extremely low concentrations, making it ideal for applications such as liquid biopsy, where detecting rare genetic mutations or circulating tumor DNA is critical for early cancer detection and monitoring. By partitioning the sample into thousands of individual reactions, dPCR achieves high accuracy and reduces the impact of background noise, allowing for the detection of even the most subtle genetic changes.

Why Are High-Density Multiplexed Diagnostic Assays Critical for Modern Healthcare and Research?

High-density multiplexed diagnostic assays are critical for modern healthcare and research because they offer comprehensive, high-throughput analysis of multiple biomarkers from a single sample, providing a more detailed and accurate understanding of disease states. In the field of oncology, for instance, these assays enable clinicians to profile multiple genetic mutations, protein expressions, and immune markers in tumor samples, allowing for personalized treatment plans tailored to the specific molecular characteristics of each patient's cancer. By identifying multiple biomarkers simultaneously, high-density multiplexed assays can guide the use of targeted therapies, immunotherapies, and combination treatments, improving treatment outcomes and reducing the risk of adverse effects.

In infectious disease diagnostics, high-density multiplexed assays are particularly valuable for detecting multiple pathogens or variants of a virus in a single test. During the COVID-19 pandemic, for example, multiplexed assays were used to test for different strains of the SARS-CoV-2 virus, as well as other respiratory pathogens, in a single sample. This ability to perform comprehensive testing from a single specimen is critical for diagnosing co-infections, monitoring viral evolution, and tracking the spread of variants, which is essential for public health surveillance and response efforts.

In immunology and autoimmune diseases, multiplexed assays allow researchers and clinicians to measure a wide range of immune markers, such as cytokines, chemokines, and antibodies, providing insights into the immune response and disease progression. These assays are used to diagnose complex immune-related conditions, such as rheumatoid arthritis, lupus, and multiple sclerosis, where a detailed analysis of multiple biomarkers is necessary to understand the underlying immune dysregulation. Multiplexed assays also play a key role in vaccine development and immunotherapy, where measuring multiple immune responses is critical for assessing efficacy and safety.

The rise of personalized medicine has further highlighted the importance of high-density multiplexed diagnostic assays. Personalized medicine relies on a detailed understanding of an individual's molecular and genetic makeup to tailor treatments that are most likely to be effective. Multiplexed assays enable the simultaneous analysis of multiple genetic mutations, gene expressions, and epigenetic markers, providing a more comprehensive picture of a patient's disease profile. This is especially important in cancer treatment, where multiple genetic mutations may drive tumor growth, and targeted therapies must be chosen based on the specific mutations present in the tumor. High-density multiplexed assays enable this level of precision, allowing for more effective and personalized treatment strategies.

In pharmacogenomics, high-density multiplexed assays are used to identify genetic variations that affect how patients metabolize drugs. This information helps clinicians choose the most effective medications and dosages for individual patients, reducing the risk of adverse drug reactions and improving therapeutic outcomes. By analyzing multiple genetic variants at once, these assays provide a more complete understanding of a patient's genetic profile, allowing for safer and more effective medication management.

In academic and clinical research, high-density multiplexed assays are invaluable for large-scale biomarker discovery, population studies, and clinical trials. Researchers use these assays to identify new disease biomarkers, study the genetic and molecular basis of diseases, and evaluate the efficacy of new treatments. The ability to analyze hundreds or thousands of biomarkers simultaneously allows for more comprehensive studies and faster data generation, accelerating the pace of scientific discovery and improving the quality of clinical trials.

What Factors Are Driving the Growth of the High-Density Multiplexed Diagnostic Assays Market?

The growth of the high-density multiplexed diagnostic assays market is driven by several key factors, including the increasing demand for precision medicine, the rise of personalized and targeted therapies, advancements in biomarker discovery, and the ongoing need for high-throughput diagnostics in healthcare and research. One of the primary drivers is the global shift towards precision medicine, which relies on a detailed understanding of individual patient biology to tailor treatments. High-density multiplexed assays enable the simultaneous analysis of multiple biomarkers, providing the molecular insights necessary for developing personalized treatment plans, particularly in cancer, autoimmune diseases, and rare genetic disorders.

The increasing use of biomarker-based therapies, particularly in oncology, is also driving demand for high-density multiplexed assays. As more cancer treatments are developed that target specific genetic mutations or protein markers, clinicians need tools that can profile multiple biomarkers in tumor samples to select the most appropriate therapy. High-density multiplexed assays allow for the comprehensive analysis of these biomarkers, enabling clinicians to identify the molecular drivers of a patient's cancer and tailor treatment accordingly. This has led to the widespread adoption of multiplexed assays in oncology diagnostics and drug development.

The ongoing growth of next-generation sequencing (NGS) and other high-throughput technologies is also contributing to the expansion of the multiplexed diagnostic assays market. As NGS becomes more accessible and cost-effective, it is increasingly being used in clinical settings for genetic testing, cancer screening, and rare disease diagnosis. NGS-based multiplexed assays can analyze a wide array of genetic variants, providing a more detailed and accurate diagnosis than traditional single-gene tests. The increasing availability of NGS platforms is driving demand for multiplexed assays that can leverage the power of sequencing technology to provide comprehensive genetic insights.

Advancements in biomarker discovery and validation are also fueling the demand for multiplexed diagnostic assays. As researchers identify new biomarkers for diseases ranging from cancer to cardiovascular disorders, there is a growing need for diagnostic tools that can detect multiple biomarkers in a single test. High-density multiplexed assays are well-suited for this purpose, as they can analyze multiple disease-related biomarkers simultaneously, providing a more comprehensive and accurate diagnosis. This has led to increased adoption of multiplexed assays in biomarker discovery and validation studies, particularly in the context of drug development and clinical trials.

The demand for high-throughput diagnostics in infectious disease testing has also accelerated the growth of the high-density multiplexed diagnostic assays market. The COVID-19 pandemic highlighted the need for rapid, scalable diagnostic solutions capable of detecting multiple pathogens or viral variants in a single test. Multiplexed assays played a crucial role in identifying co-infections, monitoring the spread of SARS-CoV-2 variants, and guiding public health interventions. As the threat of emerging infectious diseases continues, the need for multiplexed diagnostic platforms that can provide comprehensive and rapid results is expected to grow.

In addition, the growing focus on cost-effective diagnostics is driving demand for multiplexed assays. Traditional diagnostic tests often require multiple samples, reagents, and tests to analyze different biomarkers, leading to higher costs and longer turnaround times. High-density multiplexed assays, by contrast, allow for the simultaneous analysis of multiple biomarkers from a single sample, reducing the need for additional tests and lowering overall costs. This cost-effectiveness is particularly important in large-scale clinical trials, population health studies, and routine diagnostics, where efficiency and scalability are critical.

With advancements in technology, the increasing focus on personalized medicine, and the need for high-throughput diagnostics in healthcare and research, the high-density multiplexed diagnostic assays market is poised for significant growth. As these assays continue to evolve, they will play an increasingly important role in improving diagnostic accuracy, optimizing treatment strategies, and advancing the field of precision medicine.

Select Competitors (Total 12 Featured) -

• Abbott Laboratories
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Erba Diagnostics, Inc.
• F. Hoffmann-La Roche AG
• Gold Standard Diagnostics Corporation
• Hologic, Inc.
• Luminex Corporation
• Randox Laboratories Ltd.
• Thermo Fisher Scientific, Inc.

TABLE OF CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

• 1. MARKET OVERVIEW
  • Influencer Market Insights
  • Global Economic Update
  • High-Density Multiplexed Diagnostic Assays - Global Key Competitors Percentage Market Share in 2024 (E)
  • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E)
• 2. FOCUS ON SELECT PLAYERS
• 3. MARKET TRENDS & DRIVERS
  • Expansion of Genomics and Proteomics Research Spurs Adoption of Multiplexed Diagnostic Assays
  • Growth in Use of Multiplexed Assays in Infectious Disease Diagnostics Expands Market Opportunities
  • Role of Multiplexed Diagnostic Assays in Supporting Clinical Trials and Drug Development Expands Market Reach
  • Growth in Use of High-density Multiplexed Assays in Immuno-oncology and Liquid Biopsy Fuels Market Demand
  • Expansion of Multiplexed Diagnostic Assays in Veterinary and Agricultural Applications Strengthens Market
  • Increasing Use of High-density Multiplexed Assays in Neurodegenerative Disease Research Fuels Market Growth
• 4. GLOBAL MARKET PERSPECTIVE
  • TABLE 1: World High-Density Multiplexed Diagnostic Assays Market Analysis of Annual Sales in US$ Thousand for Years 2014 through 2030
  • TABLE 2: World Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • TABLE 3: World Historic Review for High-Density Multiplexed Diagnostic Assays by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 4: World 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets for Years 2014, 2024 & 2030
  • TABLE 5: World Recent Past, Current & Future Analysis for Diagnostic Laboratories by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • TABLE 6: World Historic Review for Diagnostic Laboratories by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 7: World 16-Year Perspective for Diagnostic Laboratories by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2014, 2024 & 2030
  • TABLE 8: World Recent Past, Current & Future Analysis for Hospitals & Clinics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • TABLE 9: World Historic Review for Hospitals & Clinics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 10: World 16-Year Perspective for Hospitals & Clinics by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2014, 2024 & 2030

III. MARKET ANALYSIS

• UNITED STATES
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2024 (E)
  • TABLE 11: USA Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 12: USA Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 13: USA 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• CANADA
  • TABLE 14: Canada Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 15: Canada Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 16: Canada 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• JAPAN
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2024 (E)
  • TABLE 17: Japan Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 18: Japan Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 19: Japan 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• CHINA
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2024 (E)
  • TABLE 20: China Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 21: China Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 22: China 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• EUROPE
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2024 (E)
  • TABLE 23: Europe Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2023 through 2030 and % CAGR
  • TABLE 24: Europe Historic Review for High-Density Multiplexed Diagnostic Assays by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 25: Europe 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK and Rest of Europe Markets for Years 2014, 2024 & 2030
  • TABLE 26: Europe Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 27: Europe Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 28: Europe 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• FRANCE
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2024 (E)
  • TABLE 29: France Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 30: France Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 31: France 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• GERMANY
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2024 (E)
  • TABLE 32: Germany Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 33: Germany Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 34: Germany 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• ITALY
  • TABLE 35: Italy Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 36: Italy Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 37: Italy 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• UNITED KINGDOM
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2024 (E)
  • TABLE 38: UK Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 39: UK Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 40: UK 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• REST OF EUROPE
  • TABLE 41: Rest of Europe Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 42: Rest of Europe Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 43: Rest of Europe 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• ASIA-PACIFIC
  • High-Density Multiplexed Diagnostic Assays Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2024 (E)
  • TABLE 44: Asia-Pacific Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 45: Asia-Pacific Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 46: Asia-Pacific 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030
• REST OF WORLD
  • TABLE 47: Rest of World Recent Past, Current & Future Analysis for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics - Independent Analysis of Annual Sales in US$ Thousand for the Years 2023 through 2030 and % CAGR
  • TABLE 48: Rest of World Historic Review for High-Density Multiplexed Diagnostic Assays by End-Use - Diagnostic Laboratories and Hospitals & Clinics Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2014 through 2022 and % CAGR
  • TABLE 49: Rest of World 16-Year Perspective for High-Density Multiplexed Diagnostic Assays by End-Use - Percentage Breakdown of Value Sales for Diagnostic Laboratories and Hospitals & Clinics for the Years 2014, 2024 & 2030

IV. COMPETITION