在过去的十年中,医疗保健行业见证了体外诊断(IVD)必威手机APP领域的显着增长和发展。IVD市场仍然是全球医疗设备行业中最大的细分市场,尽管存在更广泛扩展的机会,但在各个地区和细分市场之间仍存在挑战和范围。监管障碍,报销压力,医疗保健预算限制以及较低成本提供商的持续进步代表了面对IVD景观的一必威手机APP些逆风。
In lieu of regulations followed for other medical devices, regulators have started demanding an evidencebased approval process and are keen on measuring the demonstrable value delivered by high-end diagnostics throughout patient treatment. In light of this opportunity, a vast majority of companies are now eyeing companion diagnostics (CDx) and molecular diagnostics (MDx) as potential new offerings, especially given their high-growth potential.
肿瘤学has been the major area of focus in the field of CDx, and until now only a few companies are going “beyond oncology” in the CDx space. Other CDx focus areas include endocrinology, infectious diseases and neurodegenerative disorders, all of which are in dire need of breakthrough offerings to enable easy diagnosis and monitoring in follow up care setup.
Advancements in sequencing techniques and molecular biology have dramatically improved treatment outcomes in recent years. Since a majority of drugs tend to fail in clinical trials due to inadequate efficacy, drug manufacturers are currently focusing on exploring treatment options at the molecular level. This has led to deeper partnerships between pharmaceutical and CDx companies.
Regionally, the United States (U.S.) and Europe remain the biggest IVD markets, but recent and pending reimbursement cuts in these regions have resulted in sluggish growth and has dampened the outlook across the developed markets. Leading diagnostic companies are turning toward emerging regions to drive organic gains and to help offset the mature geographies. Citing the importance of these markets, the World Health Organization (WHO) recently stressed the need to improve access to diagnosis facilities in the developing world through technology transfer and local production. In addition to sales and marketing efforts, companies have already begun expanding their R&D infrastructure, technology frameworks and manufacturing in developing markets. The level of R&D efforts as a percent of sales, remain more or less similar across large and small IVD companies, yet larger firms are more aggressive on the Mergers and Acquisitions (M&A) front.
世卫组织最近发布了一份提案草案,该草案着重于制定一系列必需品清单,以改善对药物合理使用的IVD访问。这符合全球监管统一的努力,以消除管辖权差异。有针对性的结果是降低法规依从性的成本,并允许患者早期获得新技术和治疗,尤其是在新兴市场和发展中国家中。必威官方在线发展中市场的本地生产是资源密集的;因此,中小型公司应着眼于技术转让和许可,以在此类高增长市场中获得竞争优势。
尽管面临所有与市场相关的挑战,但由于疾病负担的增加,人口老龄化,对医疗保健的认识以及整个新兴地区的基础设施的改善,IVD市场将继续扩大。必威手机APP为了使IVD竞争对手实现健康的有机扩展,他们需要加强自己在高增长市场中的地位,同必威手机APP时利用他们在行业内部更成熟的地区和细分市场中的地位。
Introduction
IVD专注于分析从人体中得出的血液,尿液和其他标本,以提供诊断结果。它们是现代医疗保健行业的重要方面,其影响范围从医院和诊所到自我测试的消费者和复杂的研究必威手机APP中心。
根据美国食品药品监督管理局(FDA)的说法,“ IVD产品是用于诊断疾病或其他疾病的试剂,仪器和系统,包括确定健康状况,以治愈,减轻,治疗,治疗必威手机APP,或预防疾病或其后遗症。此类产品旨在用于收集,制备和检查从人体中取的标本。”
IVD test products are useful to diagnose, monitor, screen and assess susceptibilities to diseases, which aids physician decision-making throughout the patient journey. IVD remains pivotal in facilitating early, targeted treatments, reducing hospitals stays, improving healthcare outcomes, and minimizing treatment costs.
IVD市场继续以稳定的速度扩展,这证明了其在医疗保健行业中的重要作用。必威手机APP但是,在某些主要市场(如西欧)中,增长放缓,在某些国家,由于经济低迷和预算限制,市场签约了。尽管发达市场放缓,但由于新兴市场的需求不断增长,如拉丁美洲(LATAM),亚太地区(APAC)以及东欧,非洲和东欧,非洲和东欧,非洲和部分地区,全球IVD市场可能会维持其健康的扩张。必威手机APP中东(EEMEA)。IQVIA通过对医学,商业和公司文献进行详尽的审查来利用其深入的行业知识来撰写本文,该论文旨在成为一种全球资源,可以使市场观察者对业务趋势进行清晰和事实的了解。