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市場調査レポート

注目市場の分析:骨髄異形成症候群 (MDS)

Market Spotlight: Myelodysplastic Syndrome (MDS)

発行 Datamonitor Healthcare 商品コード 573563
出版日 ページ情報 英文 62 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=107.98円で換算しております。
注目市場の分析:骨髄異形成症候群 (MDS) Market Spotlight: Myelodysplastic Syndrome (MDS)
出版日: 2020年01月31日 ページ情報: 英文 62 Pages
概要

当レポートでは、骨髄異形成症候群 (MDS) 市場について調査分析し、主要パイプライン・上市薬、臨床試験、規制動向、特許情報、罹患率の10ヶ年予測、ライセンス・買収取引、収益予測など、体系的な情報を提供しています。

要点

疾患の背景

  • サブタイプ

治療

  • 支持療法
  • 成長因子
  • 化学療法
  • 幹細胞移植

疫学

パイプライン薬

上市薬

  • 承認:国別

規制動向

ライセンス・資産買収取引

親特許

収益機会

臨床試験情勢

  • スポンサー:状況別
  • スポンサー:フェーズ別
  • 最近の出来事

参考文献

  • 処方箋情報

付録

図表

LIST OF FIGURES

  • Figure 1: Trends in incident cases of MDS, 2017-26
  • Figure 2: Overview of pipeline drugs for MDS in the US
  • Figure 3: Pipeline drugs for MDS, by company
  • Figure 4: Pipeline drugs for MDS, by drug type
  • Figure 5: Pipeline drugs for MDS, by classification
  • Figure 6: ASTX727 for MDS (December 9, 2019): Phase III - ASCERTAIN (vs. Decitabine)
  • Figure 7: Magrolimab for MDS (December 9, 2019): Phase Ib - w/Azacitidine (AML/MDS)
  • Figure 8: Vidaza for MDS (December 9, 2019): Phase II - w/Durvalumab
  • Figure 9: ASTX727 for MDS (June 6, 2019): Phase III - ASCERTAIN (vs. Decitabine)
  • Figure 10: Reblozyl for MDS (December 2, 2018): Phase III - MEDALIST
  • Figure 11: Key upcoming events in MDS
  • Figure 12: Probability of success in the MDS pipeline
  • Figure 13: Licensing and asset acquisition deals in MDS, 2015-20
  • Figure 14: Parent patents in MDS, 2020-28
  • Figure 15: Parent patents in MDS, 2028-34
  • Figure 16: Clinical trials in MDS
  • Figure 17: Top 10 drugs for clinical trials in MDS
  • Figure 18: Top 10 companies for clinical trials in MDS
  • Figure 19: Trial locations in MDS
  • Figure 20: MDS trials status
  • Figure 21: MDS trials sponsors, by phase

LIST OF TABLES

  • Table 1: Incident cases of MDS, 2017-26
  • Table 2: Marketed drugs for MDS
  • Table 3: Pipeline drugs for MDS in the US
  • Table 4: APR-246 for MDS (December 9, 2019)
  • Table 5: ASTX727 for MDS (December 9, 2019)
  • Table 6: Magrolimab for MDS (December 9, 2019)
  • Table 7: MBG453 for MDS (December 9, 2019)
  • Table 8: Venclexta for MDS (December 9, 2019)
  • Table 9: Vidaza for MDS (December 9, 2019)
  • Table 10: CX-01 for MDS (July 31, 2019)
  • Table 11: Pracinostat for MDS (July 31, 2019)
  • Table 12: Magrolimab for MDS (July 11, 2019)
  • Table 13: ASTX727 for MDS (June 6, 2019)
  • Table 14: Magrolimab for MDS (May 15, 2019)
  • Table 15: Multiple Drugs for MDS (May 13, 2019)
  • Table 16: Revilimid for MDS (February 27, 2019)
  • Table 17: Reblozyl for MDS (December 2, 2018)
  • Table 18: Historical global sales, by drug ($m), 2014-18
  • Table 19: Forecasted global sales, by drug ($m), 2020-24
目次
Product Code: DMKC0179850

This Market Spotlight report covers the myelodysplastic syndrome market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, probability of success, upcoming events, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways:

Datamonitor Healthcare estimates that in 2017, there were 367,200 incident cases of myelodysplastic syndrome (MDS) worldwide, and forecasts that number to increase to 401,700 incident cases by 2026.

Approved drugs in the MDS space target DNA methyltransferase, BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, erythropoietin receptor, angiogenesis, E3 ubiquitin ligase, the immune system, and DNA synthesis. These therapies are administered via the intravenous, oral, and subcutaneous routes.

The greatest proportion of industry-sponsored drugs in active clinical development for MDS are in Phase II, with only one drug in the NDA/BLA stage.

Therapies in development for MDS focus on a wide variety of targets. The majority of pipeline drugs in the MDS space are administered via the intravenous or oral routes, with the remainder being subcutaneous or intradermal formulations.

High-impact upcoming events for drugs in the MDS space comprise topline Phase II and Phase III trial results, Phase II/III and Phase III updated trial results, an expected CHMP opinion, and an estimated PDUFA date.

The overall likelihood of approval of a Phase I hematologic asset is 10%, and the average probability a drug advances from Phase III is 59.6%. Drugs, on average, take 8.9 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

There have been 17 licensing and asset acquisition deals involving MDS drugs during 2015-20. The $1.8bn exclusive global collaboration and license agreement made in December 2018 between Argenx and Cilag to evaluate cusatuzumab (ARGX-110), an anti-CD70 SIMPLE Antibody, in acute myeloid leukemia (AML), high-risk MDS, and other hematological malignancies was the largest deal.

The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for MDS have been in the early and mid-phases of development, with 89% of trials in Phase I-II, and only 11% in Phase III-IV.

The US has a substantial lead in the number of MDS clinical trials globally. France leads the major EU markets, while Japan has the top spot in Asia.

Clinical trial activity in the MDS space is dominated by completed trials. Bristol-Myers Squibb has the highest number of completed clinical trials for MDS, with 98 trials.

Bristol-Myers Squibb leads the industry sponsors with by far the highest overall number of clinical trials for MDS.

TABLE OF CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Subtypes

TREATMENT

  • Supportive therapy
  • Growth factors
  • Chemotherapy
  • Immune treatments
  • Stem cell transplant

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • APR-246 for MDS (December 9, 2019)
  • ASTX727 for MDS (December 9, 2019)
  • Magrolimab for MDS (December 9, 2019)
  • MBG453 for MDS (December 9, 2019)
  • Venclexta for MDS (December 9, 2019)
  • Vidaza for MDS (December 9, 2019)
  • CX-01 for MDS (July 31, 2019)
  • Pracinostat for MDS (July 31, 2019)
  • Magrolimab for MDS (July 11, 2019)
  • ASTX727 for MDS (June 6, 2019)
  • Magrolimab for MDS (May 15, 2019)
  • Multiple Drugs for MDS (May 13, 2019)
  • Revilimid for MDS (February 27, 2019)
  • Reblozyl for MDS (December 2, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Celgene Eyes Second Indication For Reblozyl
  • MAA Positive Opinions

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Onconova Grants Canadian Rigosertib Rights To Knight
  • Deals Shaping The Medical Industry, September 2019
  • HanX To Develop, Sell Onconova's Rigosertib In China

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY

  • Prescription information

APPENDIX