市場調查報告書

肝細胞癌(HCC)疾病市場:到2038年的預測和市場分析

Hepatocellular carcinoma (HCC) Disease Coverage Forecast and Market Analysis to 2038

出版商 Datamonitor Healthcare 商品編碼 951319
出版日期 內容資訊 英文 79 Pages
商品交期: 最快1-2個工作天內
價格
肝細胞癌(HCC)疾病市場:到2038年的預測和市場分析 Hepatocellular carcinoma (HCC) Disease Coverage Forecast and Market Analysis to 2038
出版日期: 2020年06月30日內容資訊: 英文 79 Pages
簡介
肝臟的惡性腫瘤主要是腺癌,有兩種主要的細胞類型:肝細胞癌(HCC)和膽管癌。肝癌是與癌症相關的死亡的第三大主要原因,肝癌佔原發性肝癌的85%。據說它主要是由丙型肝炎感染引起的,通常是由乙型肝炎或酒精引起的。自2007年在美國獲批以來,Nexavar已確立了其作為晚期肝細胞癌標準治療方法的堅實地位。但是,隨著2020年(美國),2021年(歐洲)和2022年(日本)引入仿製藥,預計Nexavar的份額將穩步下降。 Nexavar還是Tecentriq和Avastin的有力競爭者,這是第一個在III期IMbrave 150試驗中顯示出比Nexavar更好的總體生存期(OS)和無進展生存期(PFS)的方案。有望面對。

該報告調查了肝細胞癌(HCC)疾病市場,並提供了有關疾病治療和流行病學,市場趨勢,臨床試驗前景,治療事件和分析師觀點的信息。

內容

概述

疾病背景

  • 定義
  • 風險因素
  • 症狀
  • 篩選
  • 診斷

治療

  • 參考模式
  • 患者細分
  • 非常早期和早期的肝癌(0-A期)
  • 中級肝癌(B期)
  • 晚期肝癌(C期)
  • 終端HCC(階段D)
  • 復發

流行病學

  • 代調查方法

非處方藥

管道藥物

主要監管事件

  • Roche:獲得TIGIT/Tecentriq批准
  • 間質性肺疾病:Opdivo + Yervoy權利獲取

成功的可能性

許可和資產收購交易

  • BeiGene和Celgene與Anti-PD-1合作
  • BeiGene,BioAtla,潛在的IO組合測試

臨床試驗狀態

  • 按狀態贊助
  • 每個階段的讚助商
  • 最近事件

藥物評估模型

市場動態

趨勢

  • 通過推出PD-1/PD-L1抑製劑組合促進預測期內的HCC市場增長
  • 通過將標籤擴展到以前的治療設置來擴大接受全身治療的HCC患者的數量
  • 管道藥品的激烈競爭
  • 主要品牌仿製藥或生物仿製藥侵蝕的增長影響

共識預測

最近發生的事件和分析師的觀點

  • Imfinzi(2020年5月29日)
  • 多種藥物(2020年5月29日)
  • Tecentriq(2019年11月22日)
  • Tecentriq(2019年10月21日)
  • Opdivo(2019年9月27日)
  • Tecentriq(2019年9月27日)
  • Opdivo(2019年6月24日)
  • Keytruda(2019年6月2日)
  • Namodenoson(2019年3月26日)
  • Keytruda(2019年2月19日)
  • Beleodaq(2019年1月17日)

即將發生的主要事件

主要意見領袖的見識

潛在需求

參考文獻

  • 處方信息

附錄

目錄
Product Code: DMKC0217075

DISEASE OVERVIEW

Malignant tumors of the liver are primarily adenocarcinomas, with two major cell types: hepatocellular carcinoma (HCC), and cholangiocarcinoma. Liver cancer is the third-leading cause of cancer-related deaths, and HCC accounts for 85% of all primary liver cancers. It occurs mainly due to hepatitis C infection, and to a lesser extent hepatitis B and alcohol. While surgical resection and liver transplantation are potentially curative therapies for early-stage HCC, the majority of diagnoses take place at a disease stage that is too advanced for these treatments.

Datamonitor Healthcare estimates that in 2018, there were 682,000 incident cases of hepatocellular carcinoma (HCC) worldwide in those aged 40 years and older, and forecasts that number to increase to 812,000 cases by 2027. The majority of HCC diagnoses (70.7%) worldwide are in males, ranging from 56.0-72.4% across regions.

Nexavar has been firmly established as the standard of care in advanced HCC since gaining approval in the US in 2007. However, Nexavar is forecast to steadily lose market share after the introduction of generics in 2020 (US), 2021 (EU), and 2022 (Japan). Additionally, Nexavar will face strong competition from the combination of Tecentriq and Avastin, which was the first regimen to demonstrate both superior overall survival (OS) and progression-free survival (PFS) over Nexavar in the Phase III IMbrave150 study.

Datamonitor Healthcare forecasts HCC sales in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK) to rise from $681m in 2018 to $2.5bn in 2027. Numerous PD-1/PD-L1 therapies are expected to be approved as monotherapies or as part of combination regimens for the first-line treatment of advanced HCC, and are expected to see significant uptake in this setting. Furthermore, the approval of expensive combination therapies in HCC will continue to drive market growth despite the generic erosion of key brands such as Nexavar.

After demonstrating a PFS benefit and non-inferior OS over Nexavar in the Phase III REFLECT study, Lenvima became the second systemic therapy approved as a first-line treatment for HCC in 2018. However, Lenvima is also expected to face significant competition from both the combination of Tecentriq and Avastin and from other immunotherapy regimens in development for the first-line setting. The loss of revenue to these therapies could be mitigated by approval of a Lenvima and Keytruda combination, which is currently being tested in the Phase III LEAP-002 trial.

Following positive results from the Phase III RESORCE trial, Stivarga was the first therapy to be approved for HCC patients previously treated with Nexavar, in 2017. However, Stivarga now faces strong competition for these previously treated patients from targeted therapies Cabometyx and Cyramza, and immune checkpoint inhibitor therapies Opdivo, Yervoy, and Keytruda.

Although Cyramza failed to meet its primary endpoint in the Phase III REACH trial, the subsequent Phase III REACH-2 trial confirmed Cyramza's efficacy in the subgroup of patients with high levels of alpha-fetoprotein (AFP), and supported a US approval for HCC patients who have been previously treated with Nexavar and have AFP levels ≥400ng/mL. Cyramza faces competition from Cabometyx and Stivarga, which are also approved for patients who have progressed on Nexavar, and from immunotherapies.

Cabometyx is approved in the US and EU for HCC patients who have progressed on Nexavar, where it faces competition from Stivarga, Cyramza, and the immunotherapies. Exelixis is also pursuing the combination of Cabometyx and Tecentriq for use in the first-line setting in the Phase III COSMIC-312 study, with topline results expected in the second half of 2020.

Imfinzi with tremelimumab, a PD-L1 inhibitor + CTLA-4 inhibitor combination, is being investigated for the first-line treatment of advanced HCC in the Phase III HIMALAYA trial. AstraZeneca is also investigating Imfinzi for the treatment of patients with locoregional HCC in the Phase III EMERALD-1 study and for the adjuvant treatment of patients with HCC who are at high risk of recurrence after hepatic resection or ablation in the Phase III EMERALD-2 study. Approval in these settings would help to differentiate Imfinzi from other PD-1/PD-L1 inhibitors in HCC.

In 2017, Opdivo became the first drug in the PD-1/PD-L1 inhibitor class approved in the US for the treatment of advanced HCC patients who have progressed on Nexavar. Additionally, the combination of Opdivo and Yervoy received an accelerated approval in March 2020 for the same treatment setting, becoming the first regimen containing a drug in the PD-1/PD-L1 inhibitor class combined with a CTLA-4 inhibitor approved for HCC in the US. However, Opdivo's commercial potential beyond this setting is limited because the Phase III CheckMate 459 trial testing its use in the first-line setting failed to show a statistically significant OS benefit in comparison to Nexavar.

Keytruda was approved shortly after Opdivo for patients who have progressed on Nexavar, in 2018. Both therapies were approved under accelerated pathways based on Phase II data. Although the confirmatory Phase III KEYNOTE-240 trial of Keytruda failed to meet its primary endpoint due to the statistical plan chosen for the study and the impact of post-study treatment on survival results, Keytruda remains an approved therapy for HCC.

Following the failure of Opdivo's CheckMate 459 trial, tislelizumab is the only PD-1/PD-L1 inhibitor being developed as a monotherapy for previously untreated HCC patients. Given the expected competition in the first-line setting, tislelizumab's commercial potential will be determined by its cost-benefit ratio compared to the combination regimens, as well as its efficacy in patients who are unable to tolerate combination therapy.

Key recent events include pivotal trial read-outs, such as positive results for Tecentriq and Avastin in the Phase III IMbrave150 trial in the first-line setting and Opdivo's failure to show an OS benefit over Nexavar as a first-line monotherapy in the Phase III CheckMate 459 trial.

Key upcoming catalysts for 2020 include the topline results from the Phase III HIMALAYA study of Imfinzi and tremelimumab, and topline results from the Phase III COSMIC-312 study of Cabometyx and Tecentriq.

The overall likelihood of approval of a Phase I HCC asset is 8.9%, and the average probability a drug advances from Phase III is 45.5%. HCC drugs, on average, take 10.5 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

DISEASE BACKGROUND

  • Definition
  • Risk factors
  • Symptoms
  • Screening
  • Diagnosis

TREATMENT

  • Referral patterns
  • Patient segmentation
  • Very early and early-stage HCC (Stages 0-A)
  • Intermediate HCC (Stage B)
  • Advanced-stage HCC (Stage C)
  • Terminal-stage HCC (Stage D)
  • Recurrence

EPIDEMIOLOGY

  • Incidence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • ASCO 2020: Roche Highlights TIGIT As Tecentriq Bags Another Approval
  • Keeping Track: A Good Week For Interstitial Lung Diseases; Opdivo+Yervoy Gains Liver Cancer Claim

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Asia Deal Watch: BeiGene And Celgene Exit Their Anti-PD-1 Collaboration
  • Asia Deal Watch: BeiGene, BioAtla To Test Potential IO Combination

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Launches of PD-1/PD-L1 inhibitor combinations will drive growth in the HCC market over the forecast period
  • Label expansions into earlier treatment settings could expand the number of HCC patients treated with systemic therapy
  • Pipeline drugs will face fierce competition in the first-line setting
  • Generic or biosimilar erosion of key brands will have minimal impact on growth

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Imfinzi for Hepatocellular Carcinoma (May 29, 2020)
  • Multiple Drugs for Hepatocellular Carcinoma (May 29, 2020)
  • Tecentriq for Hepatocellular Carcinoma (November 22, 2019)
  • Tecentriq for Hepatocellular Carcinoma (October 21, 2019)
  • Opdivo for Hepatocellular Carcinoma (September 27, 2019)
  • Tecentriq for Hepatocellular Carcinoma (September 27, 2019)
  • Opdivo for Hepatocellular Carcinoma (June 24, 2019)
  • Keytruda for Hepatocellular Carcinoma (June 2, 2019)
  • Namodenoson for Hepatocellular Carcinoma (March 26, 2019)
  • Keytruda for Hepatocellular Carcinoma (February 19, 2019)
  • Beleodaq for Hepatocellular Carcinoma (January 17, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Modified BLCL system
  • Figure 2: Trends in incident cases of HCC, 2018-27
  • Figure 3: Overview of pipeline drugs for HCC in the US
  • Figure 4: Pipeline drugs for HCC, by company
  • Figure 5: Pipeline drugs for HCC, by drug type
  • Figure 6: Pipeline drugs for HCC, by classification
  • Figure 7: Probability of success in the HCC pipeline
  • Figure 8: Clinical trials in HCC
  • Figure 9: Top 10 drugs for clinical trials in HCC
  • Figure 10: Top 10 companies for clinical trials in HCC
  • Figure 11: Trial locations in HCC
  • Figure 12: HCC trials status
  • Figure 13: HCC trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for HCC
  • Figure 15: Market dynamics in HCC
  • Figure 16: Future trends in HCC
  • Figure 17: Imfinzi for Hepatocellular Carcinoma (May 29, 2020): Phase II - w/Tremelimumab or Bevacizumab
  • Figure 18: Lenvima and Keytruda for Hepatocellular Carcinoma (May 29, 2020): Phase Ib - KEYNOTE-524/Study 116
  • Figure 19: Tecentriq for Hepatocellular Carcinoma (November 22, 2019): Phase III - IMbrave150
  • Figure 20: Tecentriq for Hepatocellular Carcinoma (October 21, 2019): Phase III - IMbrave150
  • Figure 21: Opdivo for Hepatocellular Carcinoma (September 27, 2019): Phase III - CheckMate 459 (vs. Sorafenib)
  • Figure 22: Tecentriq for Hepatocellular Carcinoma (September 27, 2019): Phase Ib - Multiple Combinations
  • Figure 23: Opdivo for Hepatocellular Carcinoma (June 24, 2019): Phase III - CheckMate 459 (vs. Sorafenib)
  • Figure 24: Keytruda for Hepatocellular Carcinoma (June 2, 2019): Phase III - KEYNOTE-240
  • Figure 25: Namdenoson for Hepatocellular Carcinoma (March 26, 2019): Phase II - Child-Pugh Class B Cirrhosis
  • Figure 26: Keytruda for Hepatocellular Carcinoma (February 19, 2019): Phase III - KEYNOTE-240
  • Figure 27: Key upcoming events in HCC

LIST OF TABLES

  • Table 1: Preferred branded treatments for patients with HCC
  • Table 2: Incident cases of HCC, 2018-27
  • Table 3: Incident cases of HCC, by gender, 2018
  • Table 4: Marketed drugs for HCC
  • Table 5: Pipeline drugs for HCC in the US
  • Table 6: Historical global sales, by drug ($m), 2015-19
  • Table 7: Forecasted global sales, by drug ($m), 2020-24
  • Table 8: Imfinzi for Hepatocellular Carcinoma (May 29, 2020)
  • Table 9: Multiple Drugs for Hepatocellular Carcinoma (May 29, 2020)
  • Table 10: Tecentriq for Hepatocellular Carcinoma (November 22, 2019)
  • Table 11: Tecentriq for Hepatocellular Carcinoma (October 21, 2019)
  • Table 12: Opdivo for Hepatocellular Carcinoma (September 27, 2019)
  • Table 13: Tecentriq for Hepatocellular Carcinoma (September 27, 2019)
  • Table 14: Opdivo for Hepatocellular Carcinoma (June 24, 2019)
  • Table 15: Keytruda for Hepatocellular Carcinoma (June 2, 2019)
  • Table 16: Namodenoson for Hepatocellular Carcinoma (March 26, 2019)
  • Table 17: Keytruda for Hepatocellular Carcinoma (February 19, 2019)
  • Table 18: Beleodaq for Hepatocellular Carcinoma (January 17, 2019)