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ADC (抗体-薬物複合体) への注目

Spotlight on Antibody-Drug Conjugates

発行 Datamonitor Healthcare 商品コード 912157
出版日 ページ情報 英文 71 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=109.67円で換算しております。
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ADC (抗体-薬物複合体) への注目 Spotlight on Antibody-Drug Conjugates
出版日: 2019年09月20日 ページ情報: 英文 71 Pages
概要

当レポートでは、ADC (抗体-薬物複合体) 市場について調査し、市場の概要、主要企業、主な承認済みADC、パイプライン動向、および戦略などについて分析しています。

概要

主な調査結果

ADCのイントロダクション

  • ADCの個別に標的化された性質により毒性の削減と同時に大きな効果をもたらす
  • 参考資料

ADC分野における主要企業

  • ImmunoGen や Seattle Genetics などの企業がADC領域をけん引
  • ImmunoGen
  • Seattle Genetics
  • 第一三共
  • 参考資料

現在、承認済みのADC

  • 現在承認済みのADCの6つのうち5つが血液悪性腫瘍に適応
  • Mylotarg
  • Adcetris
  • Kadcyla
  • Besponsa
  • Lumoxiti
  • Polivy

パイプライン動向

  • ADCの適応
  • ADC標的の情勢
  • 併用研究
  • 成功率
  • ADCの後期段階パイプラインは固形腫瘍にのみ焦点を当てる
  • サシツズマブゴビテカン
  • トラスツズマブデルクステカン
  • エンフォルツマブベドチン
  • 参考資料

戦略考察

  • 正しい標的に当てる
  • 幅広い適用性を求める
  • ニッチな疾患/適応症をターゲットに
  • 慎重なADC設計
  • バイオマーカードリブンADCの開発
  • 毒性の管理
  • 多勢の中で目立つ
  • 併用戦略の採用
  • 癌以外の疾病領域をターゲットに
  • 価格と効果、安全性およびQoLのバランスを取る
目次
Product Code: DMKC0208374

Overview

The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.

ADC development has historically not been without its setbacks. While the concept of delivering a potent cytotoxic payload directly to tumor cells and causing minimum damage to non-tumor cells was viewed as a significant advance towards precision medicine, the concept has proved difficult to translate into the clinic. Despite the obvious conceptual advantages to ADCs, toxicity, including accumulation during long treatment durations, can still be challenging. Arguably the greatest setback related to toxicity for the ADC class was Mylotarg's withdrawal from the US market in

2010. Although US approval was reinstated in 2017, at a reduced dose and a revised fractionated dosing schedule, the withdrawal has up until relatively recently cast a shadow over the class. However, based on recent approvals and the robust pipeline, it is clear that the clouds are lifting for the ADC class.

The recent resurgence in ADC development coincides with improvements in ADC platforms, linker technologies, and new applications such as combination approaches with immunotherapy and chemotherapy to treat cancer. There is also a small but emerging trend to evaluate ADCs beyond the realm of oncology. The late-stage ADC pipeline is still, however, solely focused on oncology, specifically solid tumor indications.

TABLE OF CONTENTS

OVERVIEW

KEY FINDINGS

INTRODUCTION TO ANTIBODY-DRUG CONJUGATES

  • The specific targeted nature of ADCs confers greater efficacy while also reducing toxicity
  • Bibliography

KEY PLAYERS IN THE ANTIBODY-DRUG CONJUGATE FIELD

  • Companies like ImmunoGen and Seattle Genetics are leaders in the field of ADCs
  • ImmunoGen
  • Seattle Genetics
  • Daiichi Sankyo
  • Bibliography

CURRENTLY APPROVED ANTIBODY-DRUG CONJUGATES

  • Five of the six currently approved ADCs are indicated for hematological malignancies
  • Mylotarg
  • Adcetris
  • Kadcyla
  • Besponsa
  • Lumoxiti
  • Polivy
  • Bibliography

PIPELINE TRENDS

  • Indications for ADCs
  • ADC target landscape
  • Combination studies
  • Success rates
  • The ADC late-stage pipeline is focused solely on solid tumors
  • Sacituzumab govitecan
  • Trastuzumab deruxtecan
  • Enfortumab vedotin
  • Bibliography

STRATEGIC INSIGHTS

  • Hitting the right target
  • Going for broad applicability
  • Targeting a niche disease/indication
  • Careful ADC design
  • Developing a biomarker-driven ADC
  • Managing toxicity
  • Standing out from the crowd
  • Adopting a combination strategy
  • Targeting disease areas beyond cancer
  • Balancing price with efficacy, safety, and QoL

LIST OF FIGURES

  • Figure 1: ADC design
  • Figure 2: Top 20 ADC companies by pipeline size, 2019
  • Figure 3: SWOT analysis of Mylotarg
  • Figure 4: SWOT analysis of Adcetris
  • Figure 5: SWOT analysis of Kadcyla
  • Figure 6: SWOT analysis of Besponsa
  • Figure 7: SWOT analysis of Lumoxiti
  • Figure 8: SWOT analysis of Polivy
  • Figure 9: ADC pipeline activity, preclinical phase through launch, 2019
  • Figure 10: ADC development by disease area, 2019
  • Figure 11: ADC pipeline activity by indication and phase, 2019
  • Figure 12: Top 10 ADC targets, by phase, 2019
  • Figure 13: Completed ADC trials by outcome
  • Figure 14: Reasons for ADC trial terminations

LIST OF TABLES

  • Table 1: Currently approved ADCs
  • Table 2: ImmunoGen's ADC pipeline
  • Table 3: Select ImmunoGen deals
  • Table 4: Seattle Genetics' ADC pipeline
  • Table 5: Seattle Genetics' ADC collaborator pipeline
  • Table 6: Select Seattle Genetics deals
  • Table 7: Daiichi Sankyo's ADC pipeline
  • Table 8: Select Daiichi Sankyo deals
  • Table 9: Key efficacy data for Mylotarg
  • Table 10: Adcetris - approved indications
  • Table 11: Key efficacy data for Adcetris
  • Table 12: Key efficacy data for Kadcyla
  • Table 13: Key efficacy data for Besponsa
  • Table 14: Key efficacy data for Lumoxiti
  • Table 15: Key efficacy data for Polivy
  • Table 16: Combination trials of ADCs and approved immune checkpoint inhibitors
  • Table 17: ADC candidates in Phase III development
  • Table 18: Key efficacy and safety data for sacituzumab govitecan
  • Table 19: Key efficacy and safety data for trastuzumab deruxtecan
  • Table 20: Key efficacy and safety data for enfortumab vedotin
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