Agarwal Amit, Ressler Dan, Snyder Glenn
Deloitte Consulting LLP, San Francisco, CA, USA.
Deloitte Consulting LLP, Philadelphia, PA, USA.
Pharmgenomics Pers Med. 2015 Mar 31;8:99-110. doi: 10.2147/PGPM.S49493. eCollection 2015.
Companion diagnostics are an indispensable part of personalized medicine and will likely continue to rapidly increase in number and application to disease areas. The first companion diagnostics were launched in the 1980s and in the face of significant initial skepticism from drug developers as to whether segmenting a drug's market through a diagnostic was advisable. The commercial success of drugs such as Herceptin® (trastuzumab) and Gleevec® (imatinib), which both require testing with companion diagnostics before they can be prescribed, has moved the entire companion diagnostic field forward. From an initial start of a handful of oncology drugs with corresponding diagnostics, the field has expanded to include multiple therapeutic areas, and the number of combinations has grown by 12-fold. Based on drugs in clinical trials, the rapid growth will likely continue for the foreseeable future. This expansion of companion diagnostics will also have a global component as markets in Europe will evolve in a similar but not identical pattern as the US. One of the greatest challenges to future growth in companion diagnostics is aligning the incentives of all stakeholders. A major driver of growth will continue to be the economic incentives for drug developers to pair their products with diagnostics. However, diagnostic companies are caught between the conflicting demands of two major stakeholders, pharmaceutical companies on one hand and payers/providers on the other. Regulators are also becoming more demanding in aligning development time lines between drugs and diagnostics. In order to survive and prosper, diagnostic companies will need to think more broadly about companion diagnostics than the historical match between a specific drug and a single diagnostic. They will also have to continue the process of consolidation and global expansion that the industry has already begun. Despite these potential obstacles, companion diagnostics have become one of the hottest areas of deal making in the diagnostic space in recent years, and the future trends continue to look bright.
伴随诊断是个性化医疗不可或缺的一部分,其数量和在疾病领域的应用可能会继续迅速增长。首批伴随诊断产品于20世纪80年代推出,最初遭到了药物开发商的严重质疑,他们怀疑通过诊断来细分药物市场是否明智。像赫赛汀(曲妥珠单抗)和格列卫(伊马替尼)这样的药物,在开处方前都需要进行伴随诊断检测,它们的商业成功推动了整个伴随诊断领域的发展。从最初仅有少数几种肿瘤药物及相应诊断产品起步,该领域已扩展到包括多个治疗领域,组合数量增长了12倍。基于临床试验中的药物,在可预见的未来,这种快速增长可能会持续。伴随诊断的这种扩张也将具有全球层面,因为欧洲市场的发展模式将与美国相似但不完全相同。伴随诊断未来增长面临的最大挑战之一是协调所有利益相关者的激励措施。增长的一个主要驱动力将继续是药物开发商将其产品与诊断相结合的经济激励。然而,诊断公司夹在两大利益相关者相互冲突的需求之间,一方是制药公司,另一方是付款方/供应商。监管机构在协调药物和诊断的开发时间表方面也要求越来越高。为了生存和繁荣,诊断公司需要比以往更广泛地思考伴随诊断,而不仅仅是特定药物与单一诊断之间的传统匹配。它们还必须继续行业已经开始的整合和全球扩张进程。尽管存在这些潜在障碍,但近年来伴随诊断已成为诊断领域最热门的交易领域之一,未来趋势依然看好。