根据商业信息公司 GBI Research 近日发布的新研究报告，因美国药品定价结构及数个后期管线药物的预期获批所带来的有利市场环境，到2019年，胃癌和食道癌治疗性单克隆抗体（单抗）药物市场将翻一番。具体而言，胃癌单抗市场将以10%的年均复合增长率（CAGR）增长，从2012年的2.56亿美元增长至2019年的5.01亿美元；食管癌单抗市场将以9.9%的年均复合增长率增长，从2012年的1.37亿美元增长至2019年的2.65亿美元。
目前，仅有一种单抗药物获批可用于这2种适应症，即罗氏（Roche）重磅药物赫赛汀（Herceptin，通用名：trastuzumab，曲妥珠单抗），该药主要用于乳腺癌治疗。Herceptin于2010年获FDA批准用于胃癌和食道癌治疗，然而，该药专利将于2014年在欧盟到期，并于2019年在美国到期。
GBI Research分析师Dominic Trewartha指出，总体而言，对于人类细胞表皮生长因子受体2（HER2）阳性患者群体，与单用化疗相比，Herceptin能够显著改善患者的生存时间，而不会增加副作用或安全问题。然而，在大多数晚期疾病患者中，该药的疗效并不足以提供持续性的缓解，或在早期阶段完全取代常规化疗。
根据GBI Research报告，当前，胃癌和食管癌研发管线充裕度一般，有33种胃癌单抗和8种食道癌单抗药物在研。后期管线中也包括一些新颖的药物，这些药物已显示出了一定的临床和商业潜力。然而，没有一种产品预期能够提供超过现有疗法的显著改善。
目前，仍需要一些更强大的具有卓越疗效的产品，用于转移性和早期阶段胃癌和食道癌的治疗。此外，有众多HER2阴性患者群体不适于Herceptin治疗。因此，在这类患者群体及HER2过表达群体中，仍存在着巨大的未获满足的医疗需求。
英文原文：
Due to favorable market conditions in terms of US pricing structures and the anticipated approval of a number of late-stage pipeline drugs, the market value for monoclonal antibodies (MAbs) in gastric and esophageal cancer treatment is expected to double by 2019.
A new report from business intelligence provider GBI Research forecasts that the market for MAbs in gastric cancer will grow from $256 million in 2012 to $501 million by 2019, at a compound annual growth rate (CAGR) of 10%, while the MAbs market for esophageal cancer is expected to climb from $137 million in 2012 to $265 million by 2019, at a CAGR of 9.9%.
Currently, there is only one MAb - Swiss drug major Roche’s Herceptin (trastuzumab) - available for the two indications. Primarily marketed for breast cancer, Herceptin gained approval from the US Food and Drug Administration for the treatment of gastric and esophageal cancers in 2010. However, its patent is expected to expire in the European union in 2014 and in the USA by 2019.
GBI Research analyst Dominic Trewartha says: “Overall, Herceptin is able to improve survival times to a significant extent when compared with chemotherapy alone, without adding a substantial amount of side effects or safety concerns in Human Epidermal growth factor Receptor-2 (HER-2) positive patients. However, its efficacy is not sufficient to bring about a sustained remission in most cases of advanced disease, or to replace conventional chemotherapy completely in earlier stages.”
Moderate new drug pipeline
According to GBI Research, the pipeline for both indications is moderate, with 33 MAbs for gastric cancer and eight for esophageal cancer. The late-stage pipelines also include a number of novel drugs that have shown some clinical and commercial potential. However, none of these products are anticipated to offer significant improvements over existing therapies.
“There is still a need for stronger products with superior efficacy to treat both gastric and esophageal cancers in the metastatic and early settings periods. Also, with a large HER-2 negative patient population that is not eligible for treatment with Herceptin, there is a strong unmet need and opportunity for therapies that are effective in these patients, including those who overexpress HER-2,” Mr Trewartha concludes.
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