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市場調查報告書

多發性骨髓瘤:疾病預測和市場分析

Multiple Myeloma Disease Coverage Forecast and Market Analysis

出版商 Datamonitor Healthcare 商品編碼 962431
出版日期 內容資訊 英文 144 Pages
商品交期: 最快1-2個工作天內
價格
多發性骨髓瘤:疾病預測和市場分析 Multiple Myeloma Disease Coverage Forecast and Market Analysis
出版日期: 2020年09月17日內容資訊: 英文 144 Pages
簡介

Datamonitor Healthcare估計,2018年全球40歲以上成年人多發性骨髓瘤(MM)暴發134,100起,預計到2027年將增至153,700起。

該報告調查並分析了多發性骨髓瘤市場,並分析了疾病的背景,主要治療指南,非處方藥/管線藥物,臨床試驗情況,預測,未滿足的需求等。

目錄

目錄

概述

  • 最新要點

疾病背景

  • 定義
  • 危險因素
  • 概述
  • 症狀
  • 診斷
  • 患者細分
  • 合併症
  • 子類型

治療

  • 悶燒多發性骨髓瘤
  • 活動性多發性骨髓瘤

流行病學

非處方藥

管道醫學

重大監管事件

  • GSK的Blenrep贏得BCMA競賽並警告眼毒性
  • EMA同意GSK的 Belantamab
  • GSK的骨髓瘤藥物已獲得AdComm的認可,但其局限性仍然很明顯
  • 對眼睛毒性的擔憂可能會限制GSK骨髓瘤藥物的潛力
  • 賽諾菲 "努力" 解決Sarclisa在英格蘭的資金問題
  • 新歐盟批准
  • 藍鳥/Bristol'Ide-Cel'CAR-T潛在的製造問題
  • 批准新的Darzalex管理
  • Xpovio迴避提交BOSTON的第二個下半週期
  • 英國授予多發性骨髓瘤患者使用賽諾菲的依沙妥昔單抗的早期使用權
  • GSK提交BCMA藥物治療多發性骨髓瘤
  • Celgene獲得另一種經歐洲藥品管理局(EMA)PRIME(優先醫學)批准的骨髓瘤CAR-T
  • 歐盟批准:J&J Darzalex的新適應症進展
  • Karyopharm多發性骨髓瘤的Xpovio價格為每4週週期$ 22,000

成功的可能性

許可和資產收購交易

  • Kiadis與Sanofi簽署《自然殺傷細胞療法協議》
  • Bluebird修改業務優先級,以確保從布里斯托爾獲得預付款
  • Harpoon和AbbVie簽署血液癌症
  • Amgen以27億美元的BeiGene參加中國腫瘤學市場競爭

臨床試驗情況

  • 贊助商:按狀態
  • 贊助商:分階段
  • 最近事件

藥物評估模型

市場動態

趨勢

  • 主要品牌Revlimid和Velcade的通用化大大減緩了市場增長
  • 在預測期內,針對BCMA的新療法有助於多發性骨髓瘤市場的增長
  • 擴大非處方藥的標籤有助於平衡市場衰退
  • 復發/難治性管道和新批准藥物的增長取決於將標籤擴展至治療的早期階段

共識預測

最近發生的事件和分析師的觀點

  • Darzalex
  • Blenrep
  • Blenrep
  • U CARTS1
  • Sarclisa
  • Kyprolis
  • CC-92480
  • OrvacabtageneAutoleucel
  • JNJ-64007957
  • Xpovio
  • Blenrep
  • Ide-cel
  • Ygalo
  • Ninlaro
  • Empliciti
  • Xpovio
  • Blenrep
  • Darzalex
  • C-CAR088
  • CC-93269
  • JNJ-4528
  • ide-cel
  • Ninlaro
  • Daratumumab-rHuPH20 (Subcutaneous)
  • Multiple
  • Blenrep
  • CERC-007
  • Darzalex
  • Xpovio
  • GEN3014
  • Sarclisa
  • AMG 420
  • Darzalex
  • Iberdomid
  • Darzalex
  • Iberdomide

即將發生的重大事件

KOL Insight

未滿足的需求

參考

  • 處方藥信息

附錄

數位列表

表列表

目錄
Product Code: DMKC0219422

Disease Overview

Multiple myeloma is characterized by the infiltration of malignant, antibody-producing plasma cells in the bone marrow. Almost all cases occur in individuals aged over 40 years, and age at diagnosis has an impact on patient outcome, especially in terms of the treatment options available. Most patients will receive at least three lines of treatment, and eligible patients will receive stem cell transplantation.

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 134,100 incident cases of multiple myeloma (MM) in adults aged 40 years and older worldwide, and expects that number to increase to 153,700 incident cases by 2027.

The launch of BCMA-targeted therapies will play a pivotal part in future market dynamics over the next decade. Key new product launches will include the antibody-drug conjugate (ADC) Blenrep and the CAR-T therapies ide-cel and JNJ-4528. Given the unmet need for effective therapies for heavily pretreated patients, uptake is expected to be rapid.

Revlimid, a thalidomide analog, and Velcade, a proteasome inhibitor (PI), are key therapies across patient segments, both as monotherapies and as backbones for combination regimens. These drugs have broad approvals across all markets, and the expected expiry of their patents will exert substantial downward pressure on the MM market.

Darzalex, the first monoclonal antibody (MAb) approved for MM, has experienced steady uptake and has become a new standard of care based on impressive trial results in the relapsed/refractory MM (RRMM) setting. The drug, a CD38-targeted MAb, will experience continual commercial success due to several label expansions in the newly diagnosed MM and RRMM settings, as well as the recent approval of a more convenient subcutaneous formulation.

Sarclisa, another CD38-directed MAb, is expected to face intense in-class competition from Darzalex, especially in the relapsed/refractory setting where Sarclisa gained its first approval as a treatment for RRMM patients who have received at least two prior therapies. Although Sarclisa is currently relegated to the highly competitive later lines of therapy, where it will also compete with Farydak, Empliciti, and Velcade, label expansions to earlier treatment settings will expand its commercial potential.

Bristol Myers Squibb, which also markets Revlimid, has positioned Pomalyst as a subsequent therapy option. Pomalyst, another thalidomide analog, adds a treatment option to Bristol Myers Squibb's MM portfolio, but faces increasing competition in the late-stage treatment setting from a number of approved and pipeline therapies.

Second-generation PI Kyprolis is approved for the treatment of RRMM as a monotherapy and in combination with either dexamethasone, Darzalex and dexamethasone, or Revlimid and dexamethasone. Kyprolis remains the favored PI in the RRMM setting as it demonstrated improved safety and efficacy over Velcade, another PI, in the Phase III ENDEAVOR trial. However, unlike Velcade, Kyprolis does not offer a subcutaneous formulation.

In combination with Revlimid and dexamethasone, Ninlaro, the first oral PI approved by the FDA, is part of an all-oral regimen approved for the treatment of patients with relapsed MM with one prior line of therapy. Ninlaro has seen consistent sales in the MM market due to its convenient administration, a competitive price, and the combination's relatively favorable safety profile.

Empliciti, the only SLAMF7-targeted MAb approved for MM, has seen moderate uptake since the combination of Empliciti, Revlimid, and dexamethasone (ERd) was approved for the treatment of MM patients who have received one to three prior lines of therapy. A label expansion in combination with Pomalyst and dexamethasone for the treatment of MM patients who have received at least two prior therapies provided expanded options for the use of Empliciti in the treatment of RRMM, but did not significantly improve the drug's commercial potential in this crowded treatment space.

The XPO1 inhibitor Xpovio represents the first novel mechanism approved for MM since the approval of the anti-SLAMF7 antibody Empliciti. Xpovio in combination with dexamethasone is approved in the US for patients with RRMM who have received at least four prior therapies and whose disease is refractory to at least two PIs, at least two immunomodulatory agents, and an anti-CD38 MAb. Given the small patient population, Xpovio has experienced only limited uptake, although label expansions to earlier treatment settings will expand the drug's commercial potential.

Ygalo is in the BLA phase as a treatment for patients with triple-refractory MM, but this novel dipeptide prodrug of melphalan has only a modest commercial outlook given it will face significant competition from both approved and late-phase competitors in an increasingly crowded market. Although Ygalo demonstrated a 26% overall response rate in the registrational Phase II HORIZON study, the BCMA-directed therapies have shown better efficacy results. Ygalo is also being developed for earlier lines of therapy, where it may find greater commercial success.

Venclexta is positioned to be approved for a limited subset of RRMM patients. The FDA placed a clinical hold on all Venclexta trials in MM after the Phase III BELLINI study showed a higher mortality rate in patients treated with the combination of Venclexta, Velcade, and dexamethasone than in patients treated with Velcade/dexamethasone. However, the FDA lifted the partial clinical hold exclusively for the Phase III CANOVA study of Venclexta in combination with dexamethasone for the treatment of patients with RRMM positive for the translocation (11;14) abnormality, and topline results from the trial are expected in 2021.

Key recent events include Blenrep's approval in the US and EU for heavily pretreated MM, approval of a subcutaneous formulation of Darzalex, and two Phase III failures: Ninlaro in the induction setting (TOURMALINE-MM2), and Kyprolis in an ECOG study comparing Kyprolis or Velcade combined with Revlimid and dexamethasone (KRd vs VRd) in front-line MM. Other key events include Ygalo's success in the pivotal Phase II HORIZON study as a treatment for triple-refractory MM, and two Phase III successes for second-line or later MM: Sarclisa's success in IKEMA in combination with Kyprolis and dexamethasone, and Xpovio's success in BOSTON in combination with Velcade and dexamethasone.

Key upcoming catalysts for the next year include the expected US approvals of ide-cel and Ygalo, and label expansions in the US for Xpovio.

The overall likelihood of approval of a Phase I MM asset is 6.9%, and the average probability a drug advances from Phase III is 58.3%. MM drugs, on average, take 8.6 years from Phase I to approval, compared to 9.4 years in the overall oncology space.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Risk factors
  • Presentation
  • Symptoms
  • Diagnosis
  • Patient segmentation
  • Co-morbidities
  • Subtypes

TREATMENT

  • Smoldering multiple myeloma
  • Active multiple myeloma

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • GSK's Blenrep Wins BCMA Race, Carries Ocular Toxicity Warning
  • EMA Says Yes To GSK's Belantamab
  • GSK's Myeloma Drug Gets AdComm Backing, But Limitations Remain Clear
  • Concerns About Eye Toxicity Could Limit GSK's Myeloma Drug Potential
  • Sanofi Is 'Working On' Resolving England's Sarclisa Funding Concerns
  • New EU Approvals
  • Manufacturing Issues Ground bluebird/Bristol 'Ide-Cel' CAR-T
  • Approval For New Darzalex Dosing
  • Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
  • UK Multiple Myeloma Patients Allowed Early Access To Sanofi's Isatuximab
  • GSK Files Its BCMA Drug In Multiple Myeloma
  • Celgene Gets Another Myeloma CAR-T Accepted Onto EMA's PRIME
  • EU Approvals: J&J's Darzalex Steps Ahead With New Indication
  • Karyopharm's Xpovio In Multiple Myeloma Priced At $22,000 Per Four-Week Cycle

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Kiadis And Sanofi Sign Natural Killer Cell Therapy Pact
  • Bluebird Revises Business Priorities And Secures Upfront Cash From Bristol
  • Harpoon Finds A Blood Cancer Partner In AbbVie
  • Amgen Joins China Oncology Market Race With $2.7bn BeiGene Stake

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Genericization of key brands Revlimid and Velcade will substantially slow market growth
  • New BCMA-targeted therapies will contribute to growth in the multiple myeloma market over the forecast period
  • Label expansions of marketed drugs will help balance out downturn in the market
  • The growth of pipeline and newly approved drugs in the relapsed/refractory setting will be dependent on label expansions

to earlier lines of therapy

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Darzalex for Multiple Myeloma (July 31, 2020)
  • Blenrep for Multiple Myeloma (July 14, 2020)
  • Blenrep for Multiple Myeloma (July 10, 2020)
  • UCARTS1 for Multiple Myeloma (July 6, 2020)
  • Sarclisa for Multiple Myeloma (June 2, 2020)
  • Kyprolis for Multiple Myeloma (May 31, 2020)
  • Sarclisa for Multiple Myeloma (May 31, 2020)
  • CC-92480 for Multiple Myeloma (May 31, 2020)
  • Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
  • JNJ-64007957 for Multiple Myeloma (May 29, 2020)
  • Xpovio for Multiple Myeloma (May 28, 2020)
  • Blenrep for Multiple Myeloma (May 27, 2020)
  • Ide-cel for Multiple Myeloma (May 13, 2020)
  • Sarclisa for Multiple Myeloma (May 12, 2020)
  • Ygalo for Multiple Myeloma (March 26, 2020)
  • Ninlaro for Multiple Myeloma (March 10, 2020)
  • Empliciti for Multiple Myeloma (March 9, 2020)
  • Xpovio for Multiple Myeloma (March 2, 2020)
  • Blenrep for Multiple Myeloma (December 16, 2019)
  • Darzalex for Multiple Myeloma (December 10, 2019)
  • C-CAR088 for Multiple Myeloma (December 7, 2019)
  • CC-93269 for Multiple Myeloma (December 7, 2019)
  • JNJ-4528 for Multiple Myeloma (December 7, 2019)
  • ide-cel for Multiple Myeloma (December 6, 2019)
  • Ninlaro for Multiple Myeloma (November 7, 2019)
  • Daratumumab-rHuPH20 (Subcutaneous) for Multiple Myeloma (September 15, 2019)
  • Multiple Drugs for Multiple Myeloma (September 13, 2019)
  • Blenrep for Multiple Myeloma (August 23, 2019)
  • CERC-007 for Multiple Myeloma (August 7, 2019)
  • Darzalex for Multiple Myeloma (July 8, 2019)
  • Xpovio for Multiple Myeloma (July 3, 2019)
  • GEN3014 for Multiple Myeloma (June 11, 2019)
  • Sarclisa for Multiple Myeloma (June 2, 2019)
  • AMG 420 for Multiple Myeloma (June 2, 2019)
  • Darzalex for Multiple Myeloma (June 2, 2019)
  • Iberdomide for Multiple Myeloma (June 2, 2019)
  • Darzalex for Multiple Myeloma (June 2, 2019)
  • Iberdomide for Multiple Myeloma (May 15, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Recommended treatment regimens for relapsed/refractory multiple myeloma
  • Figure 2: Trends in incident cases of multiple myeloma, 2018-27
  • Figure 3: Overview of pipeline drugs for multiple myeloma in the US
  • Figure 4: Pipeline drugs for multiple myeloma, by company
  • Figure 5: Pipeline drugs for multiple myeloma, by drug type
  • Figure 6: Pipeline drugs for multiple myeloma, by classification
  • Figure 7: Probability of success in the multiple myeloma pipeline
  • Figure 8: Clinical trials in multiple myeloma
  • Figure 9: Top 10 drugs for clinical trials in multiple myeloma
  • Figure 10: Top 10 companies for clinical trials in multiple myeloma
  • Figure 11: Trial locations in multiple myeloma
  • Figure 12: Multiple myeloma trials status
  • Figure 13: Multiple myeloma trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for multiple myeloma
  • Figure 15: Market dynamics in multiple myeloma
  • Figure 16: Future trends in multiple myeloma
  • Figure 17: Sarclisa for Multiple Myeloma (June 2, 2020): Phase III - IKEMA (w/Carfilzomib+Dex)
  • Figure 18: Kyprolis for Multiple Myeloma (May 31, 2020): Phase III - ECOG Study - w/Bortezomib/Lenalidomide/Dexamethasone (VRd)
  • Figure 19: Sarclisa for Multiple Myeloma (May 31, 2020): Phase II - GMMG-CONCEPT
  • Figure 20: Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020): Phase I/II - EVOLVE
  • Figure 21: JNJ-64007957 for Multiple Myeloma (May 29, 2020): Phase I - CR108206
  • Figure 22: Xpovio for Multiple Myeloma (May 28, 2020): Phase III - BOSTON
  • Figure 23: Blenrep for Multiple Myeloma (May 27, 2020): Phase II - DREAMM-6 (2L)
  • Figure 24: Sarclisa for Multiple Myeloma (May 12, 2020): Phase III - IKEMA (w/Carfilzomib+Dex)
  • Figure 25: Ygalo for Multiple Myeloma (March 26, 2020): Phase II - HORIZON
  • Figure 26: Ninlaro for Multiple Myeloma (March 10, 2020): Phase III - TOURMALINE-MM2 (w/Len/Dex (First Line))
  • Figure 27: Empliciti for Multiple Myeloma (March 9, 2020): Phase III - ELOQUENT-1
  • Figure 28: Xpovio for Multiple Myeloma (March 2, 2020): Phase III - BOSTON
  • Figure 29: Blenrep for Multiple Myeloma (December 16, 2019): Phase II - DREAMM 2 (4L)
  • Figure 30: Darzalex for Multiple Myeloma (December 10, 2019): Phase III - CANDOR (w/Kyprolis+Dex)
  • Figure 31: JNJ-4528 for Multiple Myeloma (December 7, 2019): Phase Ib/II - CARTITUDE-1 (Dose Finding)
  • Figure 32: ide-cel for Multiple Myeloma (December 6, 2019): Phase II - KarMMa
  • Figure 33: Ninlaro for Multiple Myeloma (November 7, 2019): Phase III - TOURMALINE-MM4
  • Figure 34: Daratumumab-rHuPH20 (Subcutaneous) for Multiple Myeloma (September 15, 2019): Phase II - PLEIADES
  • Figure 35: Darzalex and Kyprolis for Multiple Myeloma (September 13, 2019): Phase III - CANDOR (w/Darzalex+Dex)
  • Figure 36: Blenrep for Multiple Myeloma (August 23, 2019): Phase II - DREAMM 2 (4L)
  • Figure 37: Darzalex for Multiple Myeloma (July 8, 2019): Phase II - GRIFFIN (vs. RVd)
  • Figure 38: Sarclisa for Multiple Myeloma (June 2, 2019): Phase III - ICARIA-MM (w/PomDex)
  • Figure 39: AMG 420 for Multiple Myeloma (June 2, 2019): Phase I - PK/PD
  • Figure 40: Darzalex for Multiple Myeloma (June 2, 2019): Phase III - COLUMBA (vs. SC)
  • Figure 41: Iberdomide for Multiple Myeloma (June 2, 2019): Phase Ib/IIa - MM-001 (w/Dexamethasone)
  • Figure 42: Darzalex for Multiple Myeloma (June 2, 2019): Phase III - Cassiopeia - w/Bortezomib/Thalidomide/Dexamethasone (MMY3006)
  • Figure 43: Iberdomide for Multiple Myeloma (May 15, 2019): Phase Ib/IIa - MM-001 (w/Dexamethasone)
  • Figure 44: Key upcoming events in multiple myeloma

LIST OF TABLES

  • Table 1: Diagnostic criteria for MGUS and smoldering multiple myeloma
  • Table 2: Symptoms of advanced multiple myeloma
  • Table 3: ISS criteria for multiple myeloma
  • Table 4: R-ISS criteria for multiple myeloma
  • Table 5: Common co-morbidities associated with multiple myeloma
  • Table 6: Common cytogenetic abnormalities associated with multiple myeloma
  • Table 7: Incident cases of multiple myeloma, 2018-27
  • Table 8: Incident cases of multiple myeloma, by gender, 2018
  • Table 9: Marketed drugs for multiple myeloma
  • Table 10: Pipeline drugs for multiple myeloma
  • Table 11: Historical global sales, by drug ($m), 2015-19
  • Table 12: Forecasted global sales, by drug ($m), 2020-24
  • Table 13: Darzalex for Multiple Myeloma (July 31, 2020)
  • Table 14: Blenrep for Multiple Myeloma (July 14, 2020)
  • Table 15: Blenrep for Multiple Myeloma (July 10, 2020)
  • Table 16: UCARTS1 for Multiple Myeloma (July 6, 2020)
  • Table 17: Sarclisa for Multiple Myeloma (June 2, 2020)
  • Table 18: Kyprolis for Multiple Myeloma (May 31, 2020)
  • Table 19: Sarclisa for Multiple Myeloma (May 31, 2020)
  • Table 20: CC-92480 for Multiple Myeloma (May 31, 2020)
  • Table 21: Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
  • Table 22: JNJ-64007957 for Multiple Myeloma (May 29, 2020)
  • Table 23: Xpovio for Multiple Myeloma (May 28, 2020)
  • Table 24: Blenrep for Multiple Myeloma (May 27, 2020)
  • Table 25: Ide-cel for Multiple Myeloma (May 13, 2020)
  • Table 26: Sarclisa for Multiple Myeloma (May 12, 2020)
  • Table 27: Ygalo for Multiple Myeloma (March 26, 2020)
  • Table 28: Ninlaro for Multiple Myeloma (March 10, 2020)
  • Table 29: Empliciti for Multiple Myeloma (March 9, 2020)
  • Table 30: Xpovio for Multiple Myeloma (March 2, 2020)
  • Table 31: Blenrep for Multiple Myeloma (December 16, 2019)
  • Table 32: Darzalex for Multiple Myeloma (December 10, 2019)
  • Table 33: C-CAR088 for Multiple Myeloma (December 7, 2019)
  • Table 34: CC-93269 for Multiple Myeloma (December 7, 2019)
  • Table 35: JNJ-4528 for Multiple Myeloma (December 7, 2019)
  • Table 36: ide-cel for Multiple Myeloma (December 6, 2019)
  • Table 37: Ninlaro for Multiple Myeloma (November 7, 2019)
  • Table 38: Daratumumab-rHuPH20 (Subcutaneous) for Multiple Myeloma (September 15, 2019)
  • Table 39: Multiple Drugs for Multiple Myeloma (September 13, 2019)
  • Table 40: Blenrep for Multiple Myeloma (August 23, 2019)
  • Table 41: CERC-007 for Multiple Myeloma (August 7, 2019)
  • Table 42: Darzalex for Multiple Myeloma (July 8, 2019)
  • Table 43: Xpovio for Multiple Myeloma (July 3, 2019)
  • Table 44: GEN3014 for Multiple Myeloma (June 11, 2019)
  • Table 45: Sarclisa for Multiple Myeloma (June 2, 2019)
  • Table 46: AMG 420 for Multiple Myeloma (June 2, 2019)
  • Table 47: Darzalex for Multiple Myeloma (June 2, 2019)
  • Table 48: Iberdomide for Multiple Myeloma (June 2, 2019)
  • Table 49: Darzalex for Multiple Myeloma (June 2, 2019)
  • Table 50: Iberdomide for Multiple Myeloma (May 15, 2019)