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市場調查報告書
商品編碼
1624414
全球多重檢測市場規模(按技術、最終用戶、應用、地區、範圍和預測)Global Multiplex Assays Market Size By Technology, By End-User, By Application, By Geographic Scope and Forecast |
多重檢測市場預計在 2024 年價值為 430 萬美元,預計到 2031 年將達到 736 萬美元,2024 年至 2031 年的複合年增長率為 7.66%。多重分析是生物醫學研究和診斷領域的一種革命性方法,可以同時檢測和量化單一樣本中的多種分析物。這些檢測方法因其能夠加快處理速度、節省寶貴的樣本量並提供對複雜生物系統的完整洞察而吸引了廣泛關注和採用。多重分析使用微陣列、基於珠子的分析和微流體等現代技術同時分析各種生物標記物,包括蛋白質、核酸和代謝物。
這些檢測通常用於研究參與發炎、免疫細胞活化和宿主-病原體相互作用的細胞激素、趨化因子和其他免疫介質。多重細胞激素檢測,例如基於珠子的免疫檢測和基於流式細胞儀的檢測,可以同時檢測生物樣本中的多種細胞因子和趨化因子,為免疫系統功能、疾病病理生理學和治療反應提供重要見解。這些檢測方法對於自體免疫和傳染病、癌症免疫學以及疫苗開發的研究和開發很有用。
主要市場驅動因子
慢性病發生率不斷上升:
慢性病,尤其是癌症和自體免疫疾病的日益流行,是多重檢測市場發展的主要驅動力。根據世界衛生組織 (WHO) 的數據,癌症是世界第一大死亡原因,2020 年約有 1,000 萬人死於癌症。國際癌症研究機構(IARC)預測,到2040年,全球癌症病例數將達到2,840萬,比2020年增加47%。此疾病發生率的不斷增加使得對有效診斷方法(例如多重檢測)的需求不斷增加。美國癌症協會報告稱,用於評估癌症風險的多重基因組檢測在 2019 年至 2023 年間將增加 30%,這表明這些技術正得到越來越廣泛的應用。
蛋白質體學與基因體學研究的進展:
蛋白質體學和基因組學研究的重大進展推動了對多重檢測的需求。據美國國家人類基因組研究所稱,人類基因組定序成本已從 2001 年的 1 億美元降至 2023 年的 1,000 美元以下,使基因組研究更加經濟實惠。這導致需要多重測試的研究活動增加。根據2023年全球基因組學市場報告,基因組學市場預計從2023年到2030年將以13.6%的複合年增長率成長,到2030年達到629億美元。此外,多重檢測約佔基因組學市場的 18%,顯示具有巨大的成長潛力。
藥物研發活動增加:
製藥業對個人化醫療和標靶藥物的日益重視,加速了多重測試在藥物研發過程中的使用。據美國藥物研究和製造商協會 (PhRMA) 稱,2015 年至 2023 年間,正在開發的個人化藥物數量將增加 145%。 2023年,美國食品藥物管理局(FDA)將核准25種個人化藥物,佔所有新藥核准的35%。這一趨勢推動了多重測試的需求,這對於發現生物標記和理解複雜的生物途徑至關重要。
主要問題
交叉反應性與特異性
:多重分析中最大的課題之一是保持每種分析物的特異性,同時限制不同目標之間的交叉反應。當檢測中使用的抗體或探針非特異性地與不需要的標靶結合時,就會發生交叉反應,導致假陽性結果。對於含有許多不同濃度分析物的複雜生物樣整體說,這尤其具有課題性。為了實現高特異性,必須仔細選擇交叉反應性最小的抗體和探針,並且必須徹底優化測試條件以減少非特異性結合。
動態範圍與靈敏度:
多重分析中的另一個課題是在較寬的動態分析範圍內建立足夠的靈敏度。生物樣本中通常含有濃度跨越幾個數量級的分析物,因此需要能夠準確檢測低丰度和高丰度目標的檢測方法。然而,由於親和力、檢測效率和基質成分的干擾等因素的變化,在多重分析中保持所有分析物的一致靈敏度非常困難。
資料分析與解釋
多重檢測資料的分析和解釋帶來了新的課題,特別是在處理多個樣本中檢測到的多種分析物產生的大型資料集時。資料分析方法必須考慮分析物之間的複雜交互作用以及可能的批次效應、標準化問題和統計考量。此外,將多重檢測數據與基因組學和蛋白質組學等其他組學數據集相結合將獲得有用的見解並揭示與生理相關的模式和相關性,這需要先進的生物資訊工具和計算方法。
主要趨勢
技術進步:
技術進步是推動多重測試進步的主要趨勢之一。隨著時間的推移,檢測平台、檢測方法和檢測形式已經取得了顯著的進步,從而提高了多重檢測的靈敏度、特異性和通量。基於微陣列的分析、基於珠子的分析和微流體平台能夠高度準確且有效地檢測各種分析物,包括蛋白質、核酸和小分子。
個人化醫療的應用:
推動多重檢測應用的另一個重要趨勢是其在個人化醫療中的應用日益廣泛。在疾病異質性和個人化治療的必要性被廣泛認可的時代,多重檢測提供了一種有用的工具來識別患者特定的分子譜並指導個性化治療。在腫瘤學中,多重測試用於分析惡性腫瘤的分子特徵並找到與治療反應和預後相關的特定生物標記。
整合多組學方法
:多組學方法的整合是影響多重測試領域的另一個顯著趨勢。多組學是對基因組學、轉錄組學、蛋白質組學、代謝組學和表觀基因組學等多個分子層的全面探究,以全面瞭解生物系統。可以同時測量多個組學數據的多重檢測方法正在迅速開發,以幫助理解複雜的生物過程和疾病。
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.
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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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.
The Multiplex Assays Market is segmented based on Technology, End-User, Application and Geography.
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.
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.
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.
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.
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.