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2023年HER2阳性乳腺癌市场将达到126亿美元

  1. HER2阳性
  2. Kadcyla
  3. Perjeta
  4. 乳腺癌
  5. 赫赛汀

来源:生物谷 2014-10-14 10:13

乳腺癌市场,罗氏霸主地位无法撼动!未来10年,罗氏仍将继续统治HER2阳性乳腺癌市场,市场份额继续保持95%以上。

2014年10月14日讯 /生物谷BIOON/ --导读:乳腺癌是女性中最常见的恶性肿瘤,其中HER2阳性乳腺癌最为凶险,约占20-30%。罗氏赫赛汀(Herceptin)1998年上市,为HER2阳性乳腺癌临床治疗带来了一场革命,目前已成为临床金标准,市场份额高达95%。GlobalData发布报告,未来10年,HER2阳性乳腺癌市场将高速发展,在2023年市值达到126亿美元,而罗氏新推出的2种乳腺癌药物Perjeta和Kadcyla,将帮助维持其市场霸主地位,使其市场份额维持在95%以上。

在全球范围内,乳腺癌是女性群体中最常见的恶性肿瘤,在所有病例中,约有20-30%为“最凶险的乳腺癌”——HER2阳性乳腺癌。相对于其他类型的乳腺癌,HER2阳性乳腺癌的疾病进展速度更快,恶性程度更高,更容易复发和转移,预后也较差。

罗氏霸主地位无法撼动

罗氏赫赛汀(Herceptin)于1998年上市,该药的问世,彻底改变了HER2阳性乳腺癌的临床治疗,该药显著提高了患者的无病生存期(DFS),目前已成为HER2阳性乳腺癌临床治疗的金标准。目前,赫赛汀(Herceptin)的市场份额高达95%,随着该药欧洲专利的到期,罗氏分别于2012年和2013年推出的乳腺癌新药Perjeta和Kadcyla,将帮助其继续保持霸主地位。与赫赛汀(Herceptin)一样,这2种单抗新药也靶向于HER2受体,业界预测,到2023年,这些药物仍可确保罗氏占据市场份额的95%以上。

而市场中,其他制药公司面临的挑战是寻找治疗不足的患者群体。另外,HER2阳性新药研发管线单薄,仍存在一些尚待满足的医疗需求。

2023年HER2阳性乳腺癌市场高达126亿美元

据全球知名市场调研公司GlobalData发布的报告,未来10年,HER2阳性乳腺癌市场将以9.82%的年度复合增长率(CAGR)增长,在2023年达到126.3亿美元。高昂生物制剂的迅速市场接纳、人口老龄化的加剧,是推动全球HER2阳性乳腺癌市场高速增长的主要驱动力。其中,获批用于癌症初期阶段(非转移阶段)的生物制剂,以及品牌药物的联合治疗,对市场的影响最大。

赫赛汀专利到期,Perjeta和Kadcyla接棒

到2023年,辅助治疗(adjuvant setting)是最大的细分市场,年度复合增长率(CAGR)高达12.3%,该细分市场约占HER2阳性乳腺癌市场的63%。届时,赫赛汀(Herceptin)将不再是市场的领导者,取而代之的是罗氏的乳腺癌新药Perjeta和Kadcyla,这2种药物的市场份额将分别达到37%和39%。

赫赛汀(Herceptin)的欧洲专利将于2014年到期,美国专利到2019年到期,这将导致赫赛汀销售显著减少;不过,更便利的皮下注射剂型赫赛汀(Herceptin)将部分降低专利到期的冲击。

新药研发进程缓慢,市场机会有限

新的HER2阳性靶向性药物的研发进程缓慢,目前仅有1种药物进入III期临床,即Puma生物技术公司的抗癌药物neratinib(来那替尼),该药在III期临床试验中,用于HER2阳性乳腺癌治疗时,疗效优于罗氏赫赛汀(Herceptin)。此前,勃林格殷格翰(BI)首个肿瘤学药物Gilotrif(afatinib,阿法替尼)治疗HER2阳性乳腺癌临床试验失败,最近,葛兰素史克(GSK)乳腺癌药物Tykerb(lapatinib,拉帕替尼)在III期试验用于HER2阳性乳腺癌辅助治疗也惨遭失败,这些研究表明,酪氨酸激酶抑制剂(TKIs)类药物最适合转移性疾病的较后期阶段。

HER2阳性乳腺癌市场,罗氏的霸主地位无法撼动,该市场的新玩家,需要找到具有不同作用机制(MOA,mechanism of action)的药物,用于缺医少药的患者群体。不过,接受采访的行业领袖人物表示,HER2阳性乳腺癌中尚未满足的医疗需求,仍存在着商业机会。

新的靶向药物和具独特作用机制新药的开发,为HER2阳性乳腺癌市场提供了激动人心的机会,而未来的药物开发,将开始朝将HER2阳性和HER2阴性乳腺癌群体合并为一体的趋势发展。(生物谷Bioon.com)

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英文原文:PharmaPoint: HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023

HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the HER2-positive breast cancer market, with coverage of multiple settings of the disease including neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic.

Since its introduction in 1998, Roche’s gold standard therapy, Herceptin (trastuzumab), a monoclonal antibody, revolutionized the treatment of the disease. The realization that targeting the HER2 receptor could significantly improve disease-free survival (DFS) has created a large market for HER2-directed therapies. In 2013, Roche dominated the HER2-positive market, with a share of 95%. With Herceptin’s patent expiry looming in Europe Roche launched Perjeta and Kadcyla in 2012 and 2013 to maintain its leadership. GlobalData forecasts that the two monoclonal antibodies that also target the HER2 receptor will ensure Roche still occupies over 95% of the market in 2023.

The challenge for new entrants into the HER2-positive market is to find patient populations that are currently underserved, and can work cooperatively with Roche’s targeted therapies. The HER2-positive pipeline is weak, and there are still unmet needs that have yet to be suitably addressed. GlobalData expects that the HER2-positive market will grow due to the premium pricing of new agents, and an increasing aging population in the US, 5EU, Japan, and China.

Key Findings

The HER2-positive breast cancer market will increase by 2.5-fold, reaching $12.63bn by 2023, at a CAGR of 9.82%, driven by the rapid uptake of the latest premium-priced biologics. Approval of these agents in the early (non-metastatic) stages will have the greatest impact on the market, along with combinations of branded therapies.

By 2023, the largest market segment will be the adjuvant setting, with rapid growth at a CAGR of 12.3%, and representing 63% of the total HER2-positive market. Herceptin will no longer be the market leader, with new agents Perjeta and Kadcyla taking 37% and 39% market share respectively.

The patent expiry of Herceptin in the 5EU in 2014, and in the US in 2019, will significantly reduce Herceptin sales, however, its introduction of a more convenient subcutaneous reformulation of Herceptin will limit this impact.

Development of new HER2-targeting therapies is slow, with only one agent, Puma Biotechnology’s neratinib, in Phase III, following the failure of BI’s gilotrif. The recent failure of GSK’s Tykerb in the adjuvant setting shows that TKIs are best suited to later stages of metastatic disease.

Entry into the Roche-dominated HER2-positive market is challenging, with new players needing to find alternative MOAs in underserved patient populations. KOLs identified areas of important unmet need that can still provide opportunities in the HER2-positive space.

Future drug development will begin to merge the HER2-positive and HER2-negative populations, as new targets and MOAs are developed, providing exciting opportunities.

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