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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 51 Pages
納期: 即日から翌営業日
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注目市場の分析:骨髄異形成症候群 (MDS) Market Spotlight: Myelodysplastic Syndrome (MDS)
出版日: 2019年10月25日 ページ情報: 英文 51 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

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, and the immune system. 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 9.6%, and the average probability a drug advances from Phase III is 58.3%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

There have been 20 licensing and asset acquisition deals involving MDS drugs during 2014-19. 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. Celgene has the highest number of completed clinical trials for MDS, with 93 trials.

Celgene 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

  • CX-01 for MDS (July 31, 2019)
  • Pracinostat for MDS (July 31, 2019)
  • 5F9 for MDS (July 11, 2019)
  • ASTX727 for MDS (June 6, 2019)
  • 5F9 for MDS (May 15, 2019)
  • Multiple Drugs for MDS (May 13, 2019)
  • Revilimid for MDS (February 27, 2019)
  • Luspatercept for MDS (December 2, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • MAA Positive Opinions

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Deals Shaping The Medical Industry, September 2019
  • HanX To Develop, Sell Onconova's Rigosertib In China
  • Impressive Clinical Results For Argenx's Oncology Candidate Seal The Deal for Janssen

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY

  • Prescription information

APPENDIX

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 (June 6, 2019): Phase III - ASCERTAIN (vs. Decitabine)
  • Figure 7: Luspatercept for MDS (December 2, 2018): Phase III - MEDALIST
  • Figure 8: Key upcoming events in MDS
  • Figure 9: Probability of success in the MDS pipeline
  • Figure 10: Licensing and asset acquisition deals in MDS, 2014-19
  • Figure 11: Parent patents in MDS, 2019-28
  • Figure 12: Parent patents in MDS, 2029-34
  • Figure 13: Clinical trials in MDS
  • Figure 14: Top 10 drugs for clinical trials in MDS
  • Figure 15: Top 10 companies for clinical trials in MDS
  • Figure 16: Trial locations in MDS
  • Figure 17: MDS trials status
  • Figure 18: 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: CX-01 for MDS (July 31, 2019)
  • Table 5: Pracinostat for MDS (July 31, 2019)
  • Table 6: 5F9 for MDS (July 11, 2019)
  • Table 7: ASTX727 for MDS (June 6, 2019)
  • Table 8: 5F9 for MDS (May 15, 2019)
  • Table 9: Multiple Drugs for MDS (May 13, 2019)
  • Table 10: Revilimid for MDS (February 27, 2019)
  • Table 11: Luspatercept for MDS (December 2, 2018)
  • Table 12: Historical global sales, by drug ($m), 2014-18
  • Table 13: Forecasted global sales, by drug ($m), 2019-23
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