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頭部・頚部がん:市場予測・分析 (2024年まで)

Head and Neck Cancer Disease Coverage Forecast and Market Analysis to 2024

発行 Datamonitor Healthcare 商品コード 939971
出版日 ページ情報 英文 83 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=106.61円で換算しております。
頭部・頚部がん:市場予測・分析 (2024年まで) Head and Neck Cancer Disease Coverage Forecast and Market Analysis to 2024
出版日: 2020年06月19日 ページ情報: 英文 83 Pages
概要

当レポートでは、世界の頭部・頚部がん向け治療薬の治験情勢と市場動向見通しについて分析し、疾患の概要や疫学的予測、現在の主な治療薬 (上市済み/パイプライン製品) や治験の進行状況、現在のアンメットニーズと将来的な市場機会、治験/市場の先行きに関する専門家の見解、といった情報を取りまとめてお届けいたします。

目次

第1章 概要

第2章 疾患の背景

  • 定義
  • 患者の分類
  • リスク要因
  • 症状
  • 診断

第3章 治療法

  • 紹介パターン
  • 標準的治療法:疾患の進行段階別
  • 局所進行性疾患に対する好ましい全身療法レジメン
  • 非常に進行した疾患に対する好ましい全身療法レジメン
  • 承認済みの市販薬

第4章 疫学

  • 発症例の分析手法

第5章 市販薬

第6章 パイプライン医薬品

第7章 主な規制イベント:地域別

第8章 成功の可能性

第9章 ライセンス契約/資産買収取引

第10章 治験環境

  • 治験依頼者の分類:状況別
  • 治験依頼者の分類:相 (フェーズ) 別
  • 昨今の動向

第11章 医薬品の評価モデル

第12章 市場のダイナミクス

第13章 将来の動向

  • 標準的な治療法:免疫療法への移行
  • Keytrudaの支配的地位:ラベル拡張により強化
  • HNSCC診断薬としての承認を巡る競争
  • 転移性・再発性HNSCC向けの組み合わせ型免疫療法に対する関心増大
  • その他の新たなアプローチ:免疫チェックポイント阻害薬に後れを取る

第14章 コンセンサスの予測

第15章 近年の市場動向とアナリストの見解

第16章 今後の市場の主な動き

第17章 KOL (専門家) の見解

第18章 参考文献

  • 処方薬の情報

第19章 付録

図表

LIST OF FIGURES

  • Figure 1: TNM classifications for HNSCCs
  • Figure 2: Trends in incident cases of head and neck cancer, 2018-27
  • Figure 3: Overview of pipeline drugs for head and neck cancer in the US
  • Figure 4: Pipeline drugs for head and neck cancer, by company
  • Figure 5: Pipeline drugs for head and neck cancer, by drug type
  • Figure 6: Pipeline drugs for head and neck cancer, by classification
  • Figure 7: Probability of success in the head and neck cancer pipeline
  • Figure 8: Clinical trials in head and neck cancer
  • Figure 9: Top 10 drugs for clinical trials in head and neck cancer
  • Figure 10: Top 10 companies for clinical trials in head and neck cancer
  • Figure 11: Trial locations in head and neck cancer
  • Figure 12: Head and neck cancer trials status
  • Figure 13: Head and neck cancer trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for head and neck cancer
  • Figure 15: Market dynamics in head and neck cancer
  • Figure 16: Future trends in head and neck cancer
  • Figure 17: Debio 1143 for Head and Neck Cancer: Phase I/II - LA-SCCHN (September 30, 2019)
  • Figure 18: Monalizumab for Head and Neck Cancer: Phase Ib/II - w/Cetuximab (US and EU) (September 30, 2019)
  • Figure 19: ASP-1929 for Head and Neck Cancer: Phase I/IIa - w/PIT (June 1, 2019)
  • Figure 20: Keytruda for Head and Neck Cancer: Phase III - KEYNOTE-048 (May 31, 2019)
  • Figure 21: Imfinzi for Head and Neck Cancer: Phase III - EAGLE (+/- Tremelimumab) (May 15, 2019)
  • Figure 22: Ibrance for Head and Neck Cancer: Phase II - PALATINUS (w/Cetuximab) (May 15, 2019)
  • Figure 23: Opdivo for Head and Neck Cancer: Phase II - CheckMate-714 (April 25, 2019)
  • Figure 24: Imfinzi for Head and Neck Cancer: Phase III - EAGLE (+/- Tremelimumab) (December 7, 2018)
  • Figure 25: Enoblituzumab for Head and Neck Cancer: Phase I - w/Pembrolizumab or MGA012 (Solid Tumors) (November 9, 2018)
  • Figure 26: Keytruda for Head and Neck Cancer: Phase III - KEYNOTE-048 (October 22, 2018)
  • Figure 27: Key upcoming events in head and neck cancer

LIST OF TABLES

  • Table 1: Head and neck cancer: ICD-10 diagnosis codes
  • Table 2: Recommended (category 1) chemotherapy regimens for locally advanced disease, by origin of primary tumor
  • Table 3: Preferred systemic therapy regimens for very advanced disease, by origin of primary tumor
  • Table 4: Approved marketed drugs for head and neck cancer
  • Table 5: Incident cases of head and neck cancer, 2018-27
  • Table 6: Incident cases of head and neck cancer, by gender, 2018
  • Table 7: Marketed drugs for head and neck cancer
  • Table 8: Pipeline drugs for head and neck cancer in the US
  • Table 9: Historical global sales, by drug ($m), 2015-19
  • Table 10: Forecasted global sales, by drug ($m), 2020-24
  • Table 11: Bavencio for Head and Neck Cancer (March 13, 2020)
  • Table 12: Debio 1143 for Head and Neck Cancer (September 30, 2019)
  • Table 13: Monalizumab for Head and Neck Cancer (September 30, 2019)
  • Table 14: ABBV-368 for Head and Neck Cancer (September 4, 2019)
  • Table 15: Enoblituzumab for Head and Neck Cancer (July 10, 2019)
  • Table 16: SD-101 for Head and Neck Cancer (June 1, 2019)
  • Table 17: ASP-1929 for Head and Neck Cancer (June 1, 2019)
  • Table 18: Keytruda for Head and Neck Cancer (May 31, 2019)
  • Table 19: Imfinzi for Head and Neck Cancer (May 15, 2019)
  • Table 20: Ibrance for Head and Neck Cancer (May 15, 2019)
  • Table 21: Sacituzumab Govitecan for Head and Neck Cancer (April 29, 2019)
  • Table 22: Opdivo for Head and Neck Cancer (April 25, 2019)
  • Table 23: Imfinzi for Head and Neck Cancer (December 7, 2018)
  • Table 24: Enoblituzumab for Head and Neck Cancer (November 9, 2018)
  • Table 25: Tipifarnib for Head and Neck Cancer (October 22, 2018)
  • Table 26: Keytruda for Head and Neck Cancer (October 22, 2018)
目次
Product Code: DMKC0214483

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 880,700 incident cases of head and neck cancer (HNC) worldwide, and expects that number to increase to 967,000 incident cases by 2027. The majority of HNC diagnoses (75.2%) worldwide are in males, ranging from 64.9% to 76.3% across regions.

Though a heterogenous group of diseases, the overwhelming majority (90%) of HNCs are comprised of squamous cell carcinomas of the head and neck (HNSCCs).

Most HNC patients are treated with surgery, radiotherapy, and/or platinum-based chemotherapy.

Erbitux, once among the dominant branded systemic therapies for HNC, is being eclipsed by newer checkpoint inhibitors. Erbitux is approved for use in combination with radiation therapy to treat patients with unresectable SCCHN and both first- and subsequent-line recurrent/metastatic SCCHN as monotherapy and in combination with chemotherapy.

HNSCC tumors are highly immunogenic and have elevated expression of immune checkpoint modulators. As such, there has been much interest in the development of immunotherapies to allow for a more targeted treatment program.

The first immunotherapies approved for recurrent/metastatic HNSCCs are the checkpoint inhibitors Keytruda (for first and second line) and Opdivo (second line only). They have quickly established themselves as the most successful marketed drugs in this treatment setting. Keytruda is approved for second-line patients with a tumor proportion score (TPS) of >50%, while Opdivo has no such restrictions.

Setbacks in the pipeline for treatments being developed for recurrent/metastatic HNSCCs, such as Imfinzi and Gilotrif, and, most recently, the suspension of JAVELIN 100 (which tested Bavencio combined with chemoradiotherapy for non-resectable HNSCC), have allowed Keytruda and Opdivo to consolidate their leading positions in this setting.

Keytruda is favored by American physicians, and unlike Opdivo, is available for first- as well as second-line intervention for recurrent/metastatic HNSCC. However, Keytruda is not broadly available in the UK in the first-line setting due to a recent rejection by NICE, and Opdivo is typically favored by British physicians in the second-line setting.

The ongoing Phase III CheckMate-651 trial seeks to gain approval for Opdivo for first-line recurrent/metastatic HNSCC, and challenge Keytruda in this setting.

Keytruda is in Phase III trials in the lucrative, newly diagnosed, locally advanced HNSCC setting. KEYNOTE-412 is evaluating Keytruda combined with chemoradiation and as maintenance therapy for non-resectable HNSCC, while KEYNOTE-689 is evaluating Keytruda as neoadjuvant therapy and in combination with standard-of-care adjuvant therapy for resectable HNSCC. Keytruda is also seeking its first approval for nasopharyngeal cancer. KEYNOTE-122 is evaluating Keytruda versus standard-of-care chemotherapy for recurrent/metastatic nasopharyngeal cancer. Success in these areas would result in unrivaled availability for Keytruda across the HNC treatment landscape.

The other checkpoint inhibitor in Phase III development for newly diagnosed, locally advanced HNSCCs is Tecentriq. IMvoke010 is evaluating Tecentriq as single-agent adjuvant therapy for resectable, locally advanced HNSCC. IMvoke010 may offer an attractive alternative by using checkpoint inhibition as a monotherapy in locally advanced HNSCC, thereby avoiding the toxicity of platinum-based chemotherapy.

Immunotherapy approaches outside of checkpoint inhibitors, such as targeted T-cell therapy (TT10-EB-VST for EBV-positive nasopharyngeal cancer) and ICOS agonists (GSK3359609), are also in development for HNCs. Such advances look set to ensure the dominance of immunotherapy sales in HNC for the foreseeable future.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation
  • Risk factors
  • Symptoms
  • Diagnosis

TREATMENT

  • Referral patterns
  • Standard of care by disease progression
  • Preferred systemic therapy regimens for locally advanced disease
  • Preferred systemic therapy regimens for very advanced disease
  • Approved marketed drugs

EPIDEMIOLOGY

  • Incidence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • NICE Draft Guidance: Rejects Keytruda In Head And Neck Cancer
  • EU Approvals: Keytruda Cleared For First-Line Head And Neck Cancer
  • Keytruda Swells In Head And Neck Cancer With First-Line Claim, Full Approval

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Tech Transfer Roundup: MD Anderson Inks Set of IO Deals Covering US, UK, Japan, China
  • Idera Pharmaceuticals Inc. and AbbVie Inc. Forged a Trial Collaboration to Study Combinations of ABBV368, Tilsotolimod, Nab-Paclitaxel, and/or ABBV181
  • Well-Funded I-Mab Gains Chinese Rights to MacroGenics' Enoblituzumab
  • Immuno-Oncology Firm Elicio Launches, Raises $30m in First Round
  • Immunomedics Inc. Granted Everest Medicines Ltd. Exclusive Rights to Develop, Register, and Sell Sacituzumab Govitecan in Asia

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Standard of care shifting to immunotherapies
  • Keytruda's dominant position bolstered by label expansions
  • Immunotherapies compete for approval in newly diagnosed HNSCC
  • Growing interest in combination immunotherapies in recurrent/metastatic HNSCC
  • Other novel approaches lag behind checkpoint inhibitors

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Bavencio for Head and Neck Cancer (March 13, 2020)
  • Debio 1143 for Head and Neck Cancer (September 30, 2019)
  • Monalizumab for Head and Neck Cancer (September 30, 2019)
  • ABBV-368 for Head and Neck Cancer (September 4, 2019)
  • Enoblituzumab for Head and Neck Cancer (July 10, 2019)
  • SD-101 for Head and Neck Cancer (June 1, 2019)
  • ASP-1929 for Head and Neck Cancer (June 1, 2019)
  • Keytruda for Head and Neck Cancer (May 31, 2019)
  • Imfinzi for Head and Neck Cancer (May 15, 2019)
  • Ibrance for Head and Neck Cancer (May 15, 2019)
  • Sacituzumab Govitecan for Head and Neck Cancer (April 29, 2019)
  • Opdivo for Head and Neck Cancer (April 25, 2019)
  • Imfinzi for Head and Neck Cancer (December 7, 2018)
  • Enoblituzumab for Head and Neck Cancer (November 9, 2018)
  • Tipifarnib for Head and Neck Cancer (October 22, 2018)
  • Keytruda for Head and Neck Cancer (October 22, 2018)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY

  • Prescription information

APPENDIX