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市場調查報告書
商品編碼
1722443
2025 年至 2033 年分子診斷市場報告(按產品、技術(聚合酶鍊式反應、雜交、DNA 定序、微陣列、等溫核酸擴增技術等)、應用、最終用戶和地區分類)Molecular Diagnostics Market Report by Product, Technology (Polymerase Chain Reactions, Hybridization, DNA Sequencing, Microarray, Isothermal Nucleic Acid Amplification Technology, and Others), Application, End Users, and Region 2025-2033 |
2024年全球分子診斷市場規模達209億美元。展望未來, IMARC Group預計到2033年市場規模將達到354億美元,2025-2033年期間的成長率(CAGR)為5.75%。傳染病和遺傳疾病的日益流行、聚合酶鏈反應(PCR)技術的進步、老齡化人口的不斷成長、早期疾病檢測意識的不斷增強以及政府的支持舉措都是影響市場發展軌蹟的因素。
主要市場促進因素:分子診斷市場正在擴大,主要是由於慢性病和傳染病的增加,這反過來又導致對準確診斷方法的需求不斷成長。此外,基因組學和個人化醫療的不斷進步也促進了分子診斷市場的成長。
主要市場趨勢:實質趨勢包括對 PCR 的需求(因為它準確且快速)以及由於新方法和診斷技術導致的試劑和試劑盒的增加。此外,非侵入性、早期診斷方法的發展也支持了這項需求。
地理趨勢:北美由於擁有先進的醫療基礎設施、更多的研發投資以及對個人化醫療的高度重視而處於世界領先地位。此外,亞太地區透過增加資源使用量以及增加與健康相關的知識和支出,面臨快速發展。
競爭格局:持續為市場做出貢獻的主要競爭公司包括羅氏診斷、雅培實驗室、凱傑、Bio-Rad 實驗室、西門子醫療、賽默飛世爾科技等。這些企業大力投資新技術和合作夥伴關係,以保持分子診斷市場佔有率並佔領新領域。
挑戰與機會:障礙在於分子診斷的監管複雜性與資金。伴隨著挑戰,新興市場日益成長的醫療保健需求以及持續的技術進步也為醫療保健提供者帶來了新的機會,這些進步有望提供更好的診斷並擴大市場。
慢性病和傳染病症率不斷上升
市場呈現出驚人的成長率,這主要是由於急性和慢性疾病病例的增加。癌症、心臟病和感染等疾病發生率的增加凸顯了分子診斷在快速正確診斷疾病方面的重要作用。這個屬性可以帶來更好的患者治療效果,並制定個人化治療計劃,從而增加了市場對分子診斷的需求。隨著世界各地健康狀況的日益複雜,對新型分子診斷設備的需求也不斷增加,這反過來又推動了市場的成長。根據衛生部報告,2016年非傳染性疾病佔全國死亡人數的61%,佔殘疾人數的55%。
基因組學和個人化醫療的技術進步
該行業正在經歷基因組學和個人化醫療的發展,這對全球分子診斷市場趨勢至關重要。 DNA 定序、基因表現和 RNA 等下一代 DNA 定序的基因分析創新至關重要,它們改變了診斷方式並允許識別特定的疾病標記和遺傳傾向。個人化醫療的利用,即根據個人的基因特徵制定治療方案,需要能夠準確解讀複雜基因資訊的複雜診斷技術。先進技術與個人化治療之間的持續合作正在擴大市場佔有率。
根據個人化醫療報道,2015年,美國總統歐巴馬啟動了精準醫療計畫(PMI)。該計劃為研究人員提供了安全存取大量基因組資料的機會,這些數據從數千個開始,可能擴展到一百萬個基因組序列,以進行深入的科學研究。
人口老化加劇,對針對性診斷的需求
由於老年族群中神經退化性疾病和心血管疾病等疾病的增多,對有效診斷方法的需求也在增加。分子診斷具有早期檢測健康狀況的寶貴功能,從而為便捷且改善療效的治療提供了清晰的途徑。這一人口結構的成長趨勢顯著增加了對晶片實驗室(LOA)技術等非侵入性和精確工具的需求,這表明越來越多的細分市場傾向於適應這一新的健康需求。這種人口轉變對分子診斷市場分析有重大貢獻。
試劑和試劑盒佔據市場主導地位
由於分子診斷擴展到各個專業醫療領域,市場正在經歷顯著成長,特別是在試劑和試劑盒領域。研究的新範式和新發明產生了新的分析和測試方法,這些分析和測試方法需要適當的試劑和試劑盒才能實現。慢性病數量的不斷增加使得對快速可靠的診斷工具的需求變得更加重要,從而推動了慢性病數量的成長。大型公司與研究機構的合作也對新試劑和試劑盒的開發產生了影響,因此在增加分子診斷市場收入方面發揮了重要作用。
聚合酶鍊式反應(PCR)佔據市場主導地位
PCR 領域在分子診斷市場前景中佔據主導地位。 PCR技術改進的出現,包括qPCR和dPCR的設計和構建,推動了擴增的生化過程,從而提高了靈敏度、準確性和速度。 PCR 的進步使其成為分子診斷中不可或缺的工具。精確分析基因圖譜對於個人化醫療和標靶治療至關重要。此外,即時診斷技術的進步和 PCR 平台的引入使醫療專業人員和患者能夠更輕鬆地進行分子檢測,從而擴大其在醫療環境中的整合。
傳染病診斷佔市場主導地位
分子診斷市場概況解釋說,市場動態與傳染病的快速傳播一致,包括病毒、細菌和真菌感染。疾病的迅速傳播,特別是那些有可能使世界陷入大流行病的疾病,迫切需要早期檢測機制和使用可行的遏制策略。分子生物學和免疫測定技術在診斷領域的出現徹底改變了這一領域,提高了病原體檢測和抗藥性分類的準確性和速度。這項突破為分子診斷創造了一個有前景的市場,並預示著預防性保健和監測項目成長的強勁趨勢。這些措施對醫療介入、阻止疫情蔓延發揮了重要作用。
北美佔據明顯優勢,佔最大的分子診斷市場佔有率
市場研究報告也對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。根據報告,北美是分子診斷最大的區域市場。
根據分子診斷市場預測期,北美市場因持續研發創新的強大文化而不斷成長。隨著癌症、心血管疾病、糖尿病等慢性疾病的發生率不斷上升,需要快速且可靠的檢測方法。醫療專業人員和患者對個人化醫療理解程度的提高以及其他因素正在推動市場成長。政府對醫療保健現代化的援助以及分子診斷技術的建立是業務成長的主要經濟驅動力。此外,DTC基因檢測也是提高消費者互動程度和支持分子診斷市場近期機會的重要組成部分。
(請注意,這只是關鍵參與者的部分列表,完整列表在報告中提供。)
主要的分子診斷公司正在參與該行業的最新趨勢,例如雅培實驗室和安捷倫科技公司。領先的生物製藥公司透過推出更新、更精確、經過更好測試的產品來推動診斷技術的改進。此外,全球巨頭正透過收購、合併和不同的合作方式繼續擴大其在各個地區的影響力,以增加其市場佔有率並促進進入新市場。這些策略舉措擴大了他們的產品線並提高了他們的活動質量,滿足了客製化和即時診斷的持續需求。分子診斷的最新發展包括人工智慧和機器學習技術的融合,可以更好地促進資料分析並提高診斷的準確性。
2023年5月,美國碧迪醫療公司宣布投資8,000萬美元在華雷斯城興建第三家工廠。
2023 年 1 月,安捷倫科技與 Akoya Biosciences 合作開發用於組織分析的多重免疫組織化學診斷產品。兩家公司也同意在臨床研究市場推廣多重檢測的端到端工作流程解決方案。
2023 年 4 月,雅培宣布收購心血管系統公司 (CSI),這是一家醫療器材公司,擁有用於治療周邊和冠狀動脈疾病的創新動脈粥狀硬化切除系統。
The global molecular diagnostics market size reached USD 20.9 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 35.4 Billion by 2033, exhibiting a growth rate (CAGR) of 5.75% during 2025-2033. The increasing prevalence of infectious diseases and genetic disorders, technological advancements in polymerase chain reaction (PCR), growing aging population, surging awareness of early disease detection, and supportive government initiatives are factors shaping the market's trajectory.
Major Market Drivers: The market for molecular diagnostics is expanding primarily due to rise in chronic and infectious illnesses which in turn is leading to growing demand for accurate diagnostics methods. In addition, the continual advancements in genomic and personalized medicine are contributing to the molecular diagnostics market growth.
Key Market Trends: Substantial trends include the demand for PCR as it is accurate and fast and the increase in reagents and kits due to the new methodologies and diagnostic technologies. Besides, the movement towards non-invasive, early diagnosis approaches is also supporting the demand.
Geographical Trends: North America is the leader in the world, due to the presence of advanced medical infrastructure, more investments in R&D and a great emphasis on personalized medicine. In addition, Asia-Pacific faces a fast development through increasing resource usage and more health-related knowledge and spendings.
Competitive Landscape: The key competitive companies that are constantly contributing to the market are Roche Diagnostics, Abbott Laboratories, QIAGEN, Bio-Rad Laboratories, Siemens Healthineers, and Thermo Fisher Scientific and others. These enterprises invest heavily in the new technologies and partnerships to maintain the molecular diagnostics market share and occupy new territories.
Challenges and Opportunities: The barriers are regulatory intricacies and finances of the molecular diagnostics. Along with the challenges, new opportunities emerge for healthcare providers from the growing healthcare needs in the emerging markets and from the constant technological advances which promise better diagnostics and expand the market.
Increasing prevalence of chronic and infectious diseases
The market is exhibiting an outstanding growth rate which is mainly due to the increasing cases of acute and chronic illnesses. This increase in disease occurrence, including cancer, heart diseases, and infection focuses on the significant role of the molecular diagnostics in giving fast and proper diagnosis of the disease. This attribute enables the better patient outcomes and also constitutes individual response personalized treatment plans, which increases the molecular diagnostics demand in the market. Along with the expanding complexities of health conditions all over the world, the demand for newfangled molecular diagnostic equipment is rising, which in turn perpetuates the market growth. According to a report by the ministry of health, in 2016, non-communicable diseases (NCDs) accounted for 61% of all mortalities and 55% of disability cases.
Technological advancements in genomics and personalized medicine
The sector is experiencing developments in genomics and personalized medicine that are crucial for the global molecular diagnostics market trends. Genetic profiling innovations for DNA sequencing, gene expression, and next-generation DNA sequencing such as RNA are essential and changing the ways of diagnosis and allowing the identification of specific disease markers and genetic predispositions. The utilization of personalized medicine, which entails to tailoring treatment based on the individual's genetic profile, is creating a need for sophisticated diagnostic technologies, that is able to decipher complex genetic information accurately. The rising cooperation between sophisticated technologies and tailored treatments is expanding the market share.
According to the personalized medicine report, in 2015, U.S. President Barack Obama launched the precision medicine initiative (PMI). This initiative offers researchers secure access to an extensive array of genomic data, starting with thousands and potentially expanding to one million genome sequences, for in-depth scientific research.
Rising aging population and demand for targeted diagnostics
The demand for efficient diagnostic method is rising due to rising illnesses, such as neurodegenerative disorders and cardiovascular problems in geriatric populations. Molecular diagnostics offer a valuable functionality of early detection of health conditions, thus providing a clear path for treatment at convenient and improved outcomes. The growing trend of this demographic is significantly increasing demand for non-invasive and accurate tools such as lab-on-a-chip (LOA) technology which is indicative of an increasing market segment's inclination to adapt to this new health requirement. This population shift is a significant contributing to the molecular diagnostics market analysis.
Reagents and kits dominate the market
The market is experiencing a significant increase, particularly in the reagents and kits segment, due to the expansion of molecular diagnostics reach into various medical areas of specialization. Fresh paradigms in research and novel inventions generate novel assays and testing methods that require the appropriate reagents and kits to be feasible. The growing number of chronic diseases make the need for fast and dependable diagnostic tools more crucial, driving the increase. Involvement of the major companies with research institutions also has an impact on the development of new reagents and kits, and hence plays a significant part in increasing the molecular diagnostics market revenue.
Polymerase chain reactions (PCR) dominate the market
The PCR segment is dominating the molecular diagnostics market outlook. The advent of PCR technology refinements, including the designing and constructing of qPCR and dPCR, propel the amplification's biochemical process, thereby improves the sensitivity, accuracy, and speed. Such advancement of PCR has made it an indispensable instrument in molecular diagnostics. Precise analysis of genetic profiles which can be used in personalized medicine and targeted therapies is now essential to these treatments. Besides, the point-of-care diagnostics advancement and PCR platform introduction into both of the healthcare professionals and patients make molecular testing more available this leads broaden its integration among healthcare environments.
Infectious diseases diagnostics dominate the market
The molecular diagnostics market overview explains that the market dynamics are in line with rapid spread of infectious diseases, encompassing viral, bacterial, and fungal infections. The rapid spread of diseases, especially those which have the potential to plunge the world into pandemics, has caused an urgent need for early detection mechanism and the use of viable containment strategies. The advent of molecular biology and immunoassay technologies in diagnostics revolutionized this landscape by enhancing the accuracy and speed of pathogen detection and typing for their resistances. This breakthrough has led to the creation of a promising market for molecular diagnostics and indicates a strong trend of the growth of preventive health and surveillance projects. These measures play an important role in the medical involvement and stopping the spread of infections.
North America exhibits a clear dominance, accounting for the largest molecular diagnostics market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for molecular diagnostics.
North America market is growing due to the strong culture of perpetual research and development innovation, as per the molecular diagnostics market forecast period. With the increase in the development of chronic diseases, such as cancer, cardiovascular diseases and diabetes, the rapid and reliable detection methods are required. The increased level of personalized medicine understanding in healthcare professionals and patients alongside other factors is propelling the market growth. Development of government aid in the healthcare modernization and the establishment of molecular diagnostics techniques are the major economies drivers in the business growth. Furthermore, DTC genetic testing is also a significant part which improves the level of consumer interaction and supports the molecular diagnostics market recent opportunities.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
Key molecular diagnostics companies are getting involved in the latest trends in the industry, such as Abbott Laboratories and Agilent Technologies Inc. Leading bio-pharmaceutical firms drive the improvements in diagnostic technology through introduction of newer, more precise, and better tested products. Besides, global giants are continuing to grow their presence across various regions with acquisitions, mergers, and different partnerships in order to increase their market share and facilitating the access to new markets. These strategic moves expand their product lines and improve the quality of their activity, catering to the all-time demand for a customized and point-of-care diagnoses. Molecular diagnostics recent developments include a merger of AI and machine learning technologies that better facilitate data analysis and enhance the accuracy of diagnostics.
In May 2023, Becton Dickinson and Company announced to invest US$ 80 million in the construction of its third plant in Ciudad Juarez.
In January 2023, Agilent Technologies and Akoya Biosciences collaborated to develop multiplex-immunohistochemistry diagnostic products for tissue analysis. The companies also agreed to market end-to-end workflow solutions for multiplex assays in the clinical research market.
In April 2023, Abbott announced the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company with an innovative atherectomy system used in treating peripheral and coronary artery disease.