体外诊断

是指将样本(血液、体液、组织)从人体中取出后进行检测而进行诊断,是相对于体内诊断而言。检测过程中需要相应的仪器和试剂,而这些仪器和试剂就组成了体外诊断系统,从事这些仪器和试剂研发、生产和营销的企业就形成了体外诊断产业,汇集了生物、医学、电子、机械等相关技术。

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首页 » 体外诊断 » 2020年全球伴随诊断(CD)市场将达35亿美元

2020年全球伴随诊断(CD)市场将达35亿美元

来源:生物谷 2014-06-11 09:44

2014年6月10讯 /生物谷BIOON/ --伴随诊断(companion diagnostic,CD)是一种体外诊断技术,能够提供有关患者针对特定治疗药物的治疗反应的信息,有助于确定能够从某一治疗产品中获益的患者群体,从而改善治疗预后并降低保健开支。此外,伴随诊断还有助于确定最有可能针对治疗药物产生响应的患者群体。目前,伴随诊断市场还处于初期阶段。

联合市场调研(Allied Market Research,AMR)近日发布一份最新报告指出,2013年全球伴随诊断(CD)市场价值11亿美元,在未来7年内,该市场将以20%的年度复合增长率(CAGR)增长,并在2020年达到35亿美元。从地理上划分,全球伴随诊断市场可细分为北美、欧洲、亚太、LAMEA(拉丁美洲,中东,非洲)。在2013年中,北美占有最大的市场份额(43.97%),其次是欧洲(38%),这2个地区是伴随诊断创收最高的地区,将继续保持其主导地位至2020年,其原因主要是由于这些地区癌症和其他疾病发病率的升高,以及更高的医疗保健意识。LAMEA预计将成为增长最快的市场,在预测期间内的CAGR达22.7%。驱动全球伴随诊断市场增长的因素,包括越来越多的生物标志物被发现以及药物及相应诊断试剂盒的联合开发。然而,不断增加的药物研发相关成本可能会阻碍该市场的增长。

从适应症划分,伴随诊断市场可细分为肿瘤学、心血管疾病、中枢神经系统、炎症及病毒学。其中,肿瘤学是伴随诊断市场创收最高的疾病领域,目前已开发了多种伴随诊断试剂盒用于各类癌症生物标志物的检测,该细分市场的主要驱动力是靶向性药物研发的增长,需要相应的伴随诊断试剂盒的开发。

从技术层面划分,伴随诊断市场可细分为免疫组化和分子诊断。其中,分子诊断将成为增长最快、创收最高的领域,主要是由于实时PCR、原位杂交、新一代测序技术的广泛使用。推动市场增长的其他因素,包括分子诊断技术的进步,带来了准确性和精确度更高的诊断结果,同时这些方法的应用也降低了检测成本。

伴随诊断是一个新兴市场,调查显示,目前该领域中大多数企业正与制药公司合作,为其管线药物开发伴随诊断试剂盒。该市场中,主要的参与者包括Dako(安捷伦科技)、Qiagen公司、罗氏、雅培、Ventana医疗、生物梅里埃(bioMerieux)、Myriad Genetics、Resonance Health、Leica Microsystems及生命技术(Life Technologies)。

伴随诊断是个性化治疗的一个重要方面,对于预测患者针对特定药物的治疗反应至关重要。随着民众不断提高的警觉意识及不断升高的癌症发病率,伴随诊断将成为靶向性治疗方法的一个重要因素。目前,越来越多的公司正在开发靶向性治疗产品,相应地,伴随诊断试剂盒的开发已成为其新药研发战略的重要组成部分。(生物谷Bioon.com)

英文原文:Global Companion Diagnostic (CD) Market is Expected to Reach $3.5 Billion by 2020 - Allied Market Research

Companion diagnostics are in-vitro diagnostics that provide information about therapeutic responses of patients for a specific treatment. Companion diagnostics market is still nascent, and it is projected to reach $3.5 billion by 2020 from a base value of $1.1 billion in 2013, growing at a CAGR of 20% during 2014 to 2020. The global companion diagnostic market is segmented based on indication, technology and geography (North America, Europe, Asia Pacific and LAMEA). Geographically, LAMEA is the fastest growing region. The key drivers for this market are the increase in the discovery of biomarkers and co-development of drug and corresponding diagnostic. However, cost associated with developing drugs could impede the growth of this market. Opportunities for this market lie in developing companion diagnostics for various central nervous system conditions and hereditary conditions.

Companion Diagnostics Indication Market Analysis

Companion diagnostics is segmented on the basis of its use for indications such as oncology, cardiovascular conditions, central nervous system indications, inflammation and virology. Oncology is the highest revenue generating segment, as majority of the companion diagnostics have been developed for detection of various cancer biomarkers. The key driver for this market is an increase in research and development of targeted drugs, which require a corresponding companion diagnostic.

Companion Diagnostics Technology Market Analysis

Companion diagnostics technology market is segmented into Immunohistochemistry and Molecular diagnostics. Molecular diagnostics would be the fastest growing and highest revenue generator, mainly due to the use of techniques such as real time PCR, In Situ Hybridization and next generation sequencing. Other factors contributing to the growth is technological advancements in molecular diagnostics, which has resulted in increased accuracy and precision and also reduced cost of testing using these methods.

Companion Diagnostics Geography Market Analysis

Companion Diagnostics market has been segmented geographically into North America, Europe, Asia Pacific and LAMEA. North America has the major market share of 43.97% followed by Europe, which accounted for about 38% of the overall CD market in 2013. North America and Europe together accounted for over 82% in the global CD market in 2013 and they would continue to be the major markets through 2020. This is mainly due to the increasing incidence of cancer and other diseases and higher health care awareness in these regions.

Competitive Analysis

A study of some of the key players has showed that majority of the companies in this market are focusing on collaborations with drug companies. Companion diagnostics is a emerging market and companies are collaborating with drug companies to develop companion diagnostics for their pipeline drugs, which are in developing phase. Approvals for companion diagnostics are the second most popular strategy. Companies profiled in this report include Dako (Agilent Technologies), Qiagen, Roche, Abbott Laboratories, Inc., Ventana Medical Systems, bioMerieux, Myriad Genetics, Inc., Resonance Health Ltd., Leica Microsystems, and Life Technologies.

High Level Analysis

The report is focusing on the trends in technology and diagnosis of various indications, which are driving the growth of the companion diagnostics market. Analysis of the market based on porters five force model shows that the bargaining power of the suppliers is high as the products produced are highly differentiated. The threat of new entrants is low as significant research and development is required for developing diagnostic tests. Apart from the R&D requirements, the investment required is also high. These factors make it difficult for new companies to enter the market. The threat of substitutes is low in this market as companion diagnostics are developed for specific biomarkers and the products are highly differentiated. Competition in this market is moderate as the market is still emerging and there are a few companies in the market. Government regulations are favoring use of companion diagnostics for determining a particular treatment. Companies are focusing on collaborations with pharmaceutical companies as a key strategy to gain competitive advantage.

Reason for doing the study

Companion diagnostics are an important aspect of the personalized treatment approach and are essential for predicting the therapeutic response to a particular drug. With increasing awareness among the population and rising incidences of cancer, companion diagnostics would become an essential factor for targeted therapeutic approach. More and more companies are developing targeted therapeutics products and companion diagnostics is an integral part of their strategy.

KEY BENEFITS

In-depth analysis of the companion diagnostic market by technology and indications give a clear idea of the scope of this market
Analysis of the market by geography would help in making region specific plans
Estimations for period of 2013 to 2020 have been given, taking into consideration the current market scenario and future trends, which would give a clearer picture of the potential of the market
Porter’s five force model and SWOT analysis would help in a deeper understanding of the market and help in making strategic decisions
Top factors impacting the market would help in making decisions for business development

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