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市场调查报告书
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1297778
全球分子诊断市场 - 2023-2030年Global Molecular Diagnostics Market - 2023-2030 |
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全球分子诊断市场在2022年达到228亿美元,预计到2030年将出现有利可图的增长,达到357亿美元。在预测期内(2023-2030),全球分子诊断市场预计将呈现5.9%的复合增长率。肿瘤学的日益盛行和各种应用的研究与开发的不断发展,推动了分子诊断市场的需求趋势。
分子诊断学,也被称为基因变异的鉴定,其目标是使检测、诊断、分类、预测结果和跟踪治疗反应更加容易。分子诊断学科是实验室医学、基因组学专业知识和技术成功互动的结果,特别是鉴于分子基因组技术的实质性进展。
所有这些因素都有助于识别和精确描述遗传性疾病的遗传基础,这对提供准确的诊断至关重要。高通量技术,如全基因组关联分析和下一代测序,提供了对疾病原因的关键洞察力。
分子诊断市场范围包括肿瘤学、心血管疾病、传染病和其他应用,这增加了分子诊断的市场份额。全球分子诊断市场正在扩大,因为包括诊断技术的不断进步和各国即将进行的医疗审批等因素,也为分子诊断市场的增长创造了积极的前景。
这些分子诊断法提供了各种好处,例如特异性、敏感性、应用和周转时间。扩增技术有利于提高方法学的灵敏度,定位只存在于不足浓度的重要目标分子。分子技术通过专注于感兴趣的特定分子,减少假阳性测试结果的可能性。
与传统的培养程序相比,分子方法通常提供更快的从接收到结果报告的周转时间。分子技术的应用范围更广,包括识别和监测肿瘤标志物、耐药性、法医学、基因测试和传染性疾病。因此,不断增长的新型产品的优势推动了分子诊断市场的发展。
主要企业正在开发和推出各种技术先进的产品。目前在分子诊断技术和产品类型方面正在取得众多的进步。
此外,2023年5月,A型噬菌体是导致结核病的细菌的天敌,它已经进化到可以躲避身体的免疫系统,现在正被用来在早期阶段识别疾病。英国第一个噬菌体研究中心将于5月16日正式揭幕,并在创新英国Actiphage中强调,基于噬菌体的结核病分子诊断将在KTN上的英国噬菌体创新展示中亮相。
结核分枝杆菌(Mtb)是一种具有厚厚细胞壁的细菌,可以阻止其DNA的释放,已被证明在检测方面具有挑战性,并且在培养中生长缓慢。Actiphage利用一种噬菌体(一种只感染Mtb的病毒)搜索血液中的活Mtb细胞。根据位于莱斯特的NIHR呼吸系统生物医学研究中心的研究,使用Actiphage在血液中发现的Mtb是活动性结核病的一个标志;这代表了终结结核病斗争中的一个可能的进展。
依靠病原体的核酸而不是其表型的诊断方法受到一些问题的阻碍。一个重要的促成因素是大量的假阳性和假阴性结果。由于环境、实验室、甚至准备反应混合物的工具中的DNA污染,一种疾病可能被错误地识别。与活细胞污染相比,DNA污染更难从表面或实验室设备上清除,而活细胞污染很容易做到。
一个假阳性的结果可能来自于识别导致死亡的病原生物,而其全基因组的DNA仍然留在样本中。由于在这些情况下,RNA不如DNA持久,基于RNA的程序如NASBA或RT-PCR提供了一个分子备份。因此,上述这些因素限制了分子诊断市场的增长。
由于COVID-19大流行和全球众多国家的封锁,所有行业的公司的财务健康都受到了影响。因此,在COVID-19公共卫生紧急情况期间,美国食品和药物管理局(FDA)发布了指导方针,其中包括帮助赞助商和研究人员的一般注意事项,确保试验参与者的安全,遵守良好的临床实践(GCP),并将试验完整性的风险降到最低。
实时RT-PCR是识别COVID-19病毒最常用的实验室技术之一。尽管许多国家已经采用实时RT-PCR技术来诊断其他疾病,如埃博拉和寨卡病毒,但许多国家仍然希望得到援助,将这种技术用于COVID-19病毒并扩大其国家诊断能力。
估计俄乌冲突对全球分子诊断市场的影响不大,因为这一地区的主要市场参与者数量不多。然而,在预测期内,原材料进出口的影响预计对全球分子诊断市场的增长影响不大。
The Global Molecular Diagnostics Market reached US$ 22.8 billion in 2022 and is projected to witness lucrative growth by reaching up to US$ 35.7 billion by 2030. The Global Molecular Diagnostics Market is expected to exhibit a CAGR of 5.9% during the forecast period (2023-2030). The increasing prevalence of oncology and the growing research and development for various applications drive demand for molecular diagnostics market trends.
The goal of molecular diagnostics, also known as the identification of genetic variations, is to make it easier to detect, diagnose, classify, predict outcomes, and track therapeutic response. The discipline of molecular diagnostics results from the successful interaction of laboratory medicine, genomics expertise, and technology, particularly in light of substantial advancements in molecular genomic technologies.
All these elements help identify and precisely characterize the genetic underpinnings of hereditary disorders, which is essential for providing an accurate diagnosis. High-throughput techniques, such as genome-wide association analyses and next-generation sequencing, offer crucial insights into disease causes.
The Molecular Diagnostics Market scope comprises applications as oncology, cardiovascular disorders, infectious diseases and others, which has increased the molecular diagnostics market share. The global market for molecular diagnostics is expanding as a result of factors including the increasing advances in diagnostics technology and their upcoming medical approvals across countries are also creating a positive outlook for the molecular diagnostics market growth.
These molecular diagnostics provide various benefits for instance, specificity, sensitivity, applications and turnaround time. Amplification techniques are beneficial for raising a methodology's sensitivity and locating target molecules of significance that only exist at deficient concentrations. Molecular techniques reduce the likelihood of false positive test findings by focusing on the particular molecule of interest.
Molecular approaches typically offer faster turnaround times from receiving to result reporting than traditional culture procedures. Molecular techniques have a wider range of applications, including in identifying and monitoring tumor markers, medication resistance, forensics, genetic testing, and infectious disorders. Hence, the growing novel products' advantages drives the molecular diagnostics market.
A variety of technologically advanced products are being developed and launched by the major players. Numerous advancements are currently being made in molecular diagnostic technology and product type.
Furthermore, in May 2023, A phage, a natural enemy of the bacteria that causes tuberculosis and which has evolved to elude the body's immune system, is now being used to identify the illness at an early stage. The first Center for Phage Research in the UK will be formally unveiled on May 16 and highlighted in the Innovate UK Actiphage, a molecular diagnostic for tuberculosis based on phages will be featured in the UK Phage Innovation Showcase on KTN.
Mycobacterium tuberculosis (Mtb), a bacterium with a thick cell wall that blocks the release of its DNA, has proven challenging to detect and is slow to grow in culture. Actiphage searches the blood for live Mtb cells using a phage, a virus that only infects Mtb. Mtb discovered in the blood using Actiphage is a sign of active TB disease, according to research from the NIHR Respiratory Biomedical Research Centre in Leicester; this represents a possible advance in the fight to End TB.
Diagnostic assays that depend on the nucleic acids of the pathogen instead of on its phenotype are hampered by a few issues. A significant contributing factor is the high number of false positive and false negative outcomes. A disease may be mistakenly identified due to DNA contamination in the environment, the lab, and even the tools for preparing the reaction mix. DNA contamination is more difficult to remove from surfaces or lab equipment than living cell contamination, which can be easily done.
A false positive outcome could come from identifying pathogenic organisms that cause death and whose genome-wide DNA remains in the sample. Since RNA is less durable than DNA in these circumstances, RNA-based procedures like NASBA or RT-PCR provide a molecular backup. Hence these above-mentioned factors are limiting the molecular diagnostics market's growth.
The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations worldwide. Therefore, for the period of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.
Real-time RT-PCR is one of the most used laboratory techniques to identify the COVID-19 virus. Although many nations have employed real-time RT-PCR to diagnose other illnesses like the Ebola and Zika viruses, many still want assistance in adapting this technique for the COVID-19 virus and expanding their national diagnostic capacities.
The Russia-Ukraine conflict is estimated to have a low impact on the global molecular diagnostics market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global molecular diagnostics market growth over the forecast period.
Instruments from the product type segment account for 37.3% of the market share owing to rising novel product launches.
Sample-to-answer instruments are designed to accept single-use cartridges with integrated Reagents and Kits that allow the detection of single or multiple targets in a patient's sample. The ideal option for mobile laboratories are diagnostic devices utilizing hermetically sealed cartridges that can withstand travel and extended storage in various climatic conditions without requiring a cold chain.
Various instruments are being launched with advanced technology. For instance, molecular biology, genomics, proteomics, and pharmacology techniques can all be accommodated by the Liquid Handling workstation known as EXTRAlab. It is distinguished by its great degree of adaptability. The workstation enables the creation of a fully automated lab to carry out sample preparation, dilution, and dispensing.
The modular design allows for simple reconfiguration to fit the customer's unique needs. For example, the liquid handling system can be modified to handle a variety of volumes and can have additional devices integrated on the basic platform.
Manufacturers have chances to expand their operations in this region because of the rising demand for molecular diagnostics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of molecular diagnostics, increasing demand.
North America has a large number of producers and suppliers. As a result of the swift economic development of the area, industrial production has increased, fueling the demand of molecular diagnostics.
Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals and novel product launches. Researchers are becoming more aware of various diagnostic approaches for cancer or other disorders, leading to expanding the market in this region. These factors shows the dominance of North America.
The major global players in the molecular diagnostics market include: Illumina, Inc., F Hoffmann-la Roche Ltd, Abbott, Bio-Rad Laboratories, Inc., BD, Hologic Inc., Myriad Genetics, Inc., Agilent Technologies Inc., Thermo Fisher Scientific Inc. and Danaher among others.
The Global Molecular Diagnostics Market Report Would Provide Approximately 53 Tables, 54 Figures And 195 Pages.
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