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Chronic Myeloid Leukemia (CML) - Global Drug Forecast and Market Analysis to 2030

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    Report

  • 141 Pages
  • December 2021
  • Region: Global
  • GlobalData
  • ID: 5530784
Chronic myeloid leukemia (CML) is a myeloproliferative cancer resulting from the formation of an abnormal gene; BCR-ABL1. Although CML is now highly survivable due to the availability of multiple effective BCR-ABL1 inhibitors, the patient population is increasing as a result of longer life expectancies and an aging population. CML is almost exclusively treated with BCR-ABL1 inhibitors. Patients are likely to receive Novartis’ first-generation inhibitor Gleevec (or a generic version of imatinib) in the first line. However, high-risk patients, and those progressing receive second- or third-generation inhibitors, including Novartis’ Tasigna, BMS’ Sprycel, Pfizer’s Bosulif or Takeda/Incyte’s Iclusig.

The global market is expected to experience negative growth during the forecast period. Just four agents are forecast to either launch or expand in the forecast period in the 8MM; three BCR-ABL1 inhibitors and one stem cell transplant cell therapy product. Growth will be driven by the launch and expansion of these products, along with an increase in prevalent cases. However, this growth will not offset the significant negative effect on branded sales the introduction of generic alternatives to the currently available second- and third-generation inhibitors is expected to have on the market.

Key Highlights


  • The main drivers of growth include the anticipated approval and launch of 3 pipeline therapies, and the label expansion of one currently marketed therapy across the 8MM during the forecast period, as well as an increase in prevalent cases.
  • The main barriers to growth in the 8MM are key patent expiries of all but one of the currently marketed BCR-ABL1 inhibitors
  • Among the late-stage pipeline products and marketed agents, BCR-ABL1 TKIs are expected to continue to dominate sales
  • The most important unmet needs in the CML market include: wider therapeutic options for patients who progress to advanced disease, a wider range of options for patients intolerant or resistant to currently available therapies, to increase the proportion of patients successfully discontinuing therapy in the long-term, and a need to improve compliance.

Key Questions Answered


  • 4 late-stage pipeline agents are expected to enter the CML market from 2021 onwards. What impact will these agents have on the market? Which of these drugs will have the highest peak sales, and why?
  • What are the current unmet needs in CML, which pipeline agents are positioned to counter these unmet needs?
  • What are the opportunities for R&D?
  • What is the market outlook in the 8MM from 2020-2030? Considering major patent expiries, launch of new premium priced agents and expected label expansions.
  • What are the main corporate trends?
  • Who are the current and future players?

Scope


  • Overview of CML including epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline CML market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting CML therapeutics sales in the 8MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase II - III).
  • Analysis of the current and future market competition in the global CML therapeutics market. Insightful review of the key industry drivers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy


The report will enable you to:
  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global CML therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CML market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global CML therapeutics market from 2019-2029.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 CML: Executive Summary
1.1 The CML Market Will Decline from $4.25B to $3.35B by 2030
1.2 Novartis Expected to Take Market-Leading Position
1.3 The Level of Unmet Need in the CML Market Is Relatively Low
1.4 The CML Space Is Crowded with Safe and Effective BCR-ABL1 TKIs, Leaving Little Room for New Market Entrants
1.5 Scemblix Is Expected to Become the Market-Leading Brand by 2030
1.6 What Do Physicians Think?
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging Systems
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global and Historical Trends
4.4 Forecast Methodology
4.4.1 Sources
4.4.2 Forecast Assumptions and Methods
4.4.3 Diagnosed Incident Cases of CML
4.4.4 Diagnosed Incident Cases of CML by Staging
4.4.5 Diagnosed Incident Cases of CML by Risk Status
4.4.6 Diagnosed Incident Cases of CML by T315I Mutation
4.4.7 Five-, 10-, 15-, 20-Year Diagnosed Prevalent Cases of CML
4.5 Epidemiological Forecast for CML (2020-2030)
4.5.1 Diagnosed Incident Cases of CML
4.5.2 Age-Specific Diagnosed Incident Cases of CML
4.5.3 Sex-Specific Diagnosed Incident Cases of CML
4.5.4 Diagnosed Incident Cases of CML by Staging
4.5.5 Diagnosed Incident Cases of CML by Risk Status
4.5.6 Diagnosed Incident Cases of CML by T315I Mutation
4.5.7 20-Year Diagnosed Prevalent Cases of CML
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 Impact
4.6.3 Limitations of the Analysis
4.6.4 Strengths of the Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview Including KOL Insights
5.1.1 US
5.1.2 EU
5.1.3 Japan
5.1.4 Canada
6 Competitive Assessment
6.1 Overview
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Lack of Options for Patients with BP Disease
7.3 Need for Greater Options for Patients Refractory or Intolerant to TKIs
7.4 Need to Increase the Number of Patients Who Can Safely Discontinue Therapy and Remain Treatment-Free
7.5 Need to Improve Compliance
8 R&D Strategies
8.1 Overview
8.1.1 Development of More Potent Versions of Existing BCR-ABL1 Inhibitors
8.1.2 Development of BCR-ABL1 Inhibitors Against Common Resistance Mutations
8.1.3 Development of BCR-ABL1 Inhibitors with Improved Side-Effect Profiles and Fewer Toxicity Concerns
8.2 Clinical Trials Design
8.2.1 Preferred Endpoints in CP Disease
8.2.2 Advanced-Disease Trials May Require Different Design
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive Assessment
11 Current and Future Players
11.1 Overview
11.2 Deal-Making Trends
12 Market Outlook13 Appendix
List of Tables
Table 1: CML: Key Metrics in the 8MM
Table 2: Staging of CML as Defined by Commonly Used Staging Systems
Table 3: Prognostic Scoring Systems for CML
Table 4: Risk Factors and Comorbid Conditions Associated with CML
Table 5: Treatment Guidelines for CML
Table 6: Top Deals by Value, 2016-2020
Table 7: CML Market - Global Drivers and Barriers, 2020-2030
Table 8: Key Events Impacting Sales for CML in the US, 2020-2030
Table 9: CML Market - Drivers and Barriers in the US, 2020-2030
Table 10: Key Events Impacting Sales for CML in the 5EU, 2020-2030
Table 11: CML Market - Drivers and Barriers in the 5EU, 2020-2030
Table 12: Key Events Impacting Sales for CML in Japan, 2020-2030
Table 13: CML Market - Drivers and Barriers in Japan, 2020-2030
Table 14: Key Events Impacting Sales for CML in Canada, 2020-2030
Table 15: CML Market - Drivers and Barriers in Canada, 2020-2030
Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for CML in 2020 and 2030
Figure 2: Analysis of the Company Portfolio Gap in CML During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of CP CML Patients During the Forecast Period
Figure 4: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of Advanced-Phase CML Patients During the Forecast Period
Figure 5: Diagram of the Translocation Event that Occurs Between Chromosomes Nine and 22 in CML
Figure 6: 8MM, Diagnosed Incidence of CML, Men, Cases Per 100,000 Population, All Ages, 2010-2030
Figure 7: 8MM, Diagnosed Incidence of CML, Women, Cases Per 100,000 Population, All Ages, 2010-2030
Figure 8: 8MM, Sources Used to Forecast Diagnosed Incident Cases of CML (ICD-10 = C92.1)
Figure 9: 8MM, Sources Used to Forecast the Five-, 10-, 15-, and 20-Year Diagnosed Prevalent Cases of CML (ICD-10 = C92.1)
Figure 10: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of CML (ICD-10 = C92.1) by Staging
Figure 11: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of CML (ICD-10 = C92.1) by Risk Status
Figure 12: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of CML (ICD-10 = C92.1) by T315I Mutation
Figure 13: 8MM, Diagnosed Incident Cases of CML, N, Both Sexes, All Ages, 2020
Figure 14: 8MM, Diagnosed Incident Cases of CML by Age, N, All Ages, 2020
Figure 15: 8MM, Diagnosed Incident Cases of CML by Sex, N, All Ages, 2020
Figure 16: 8MM, Diagnosed Prevalent Cases of CML by Staging, N, All Ages, 2020
Figure 17: 8MM, Diagnosed Incident Cases of CML by Risk Status, N, All Ages, 2020
Figure 18: 8MM, Diagnosed Incident Cases of CML by T315I Mutation, N, Both Sexes, All Ages, 2020
Figure 19: 8MM, 20-Year Diagnosed Prevalent Cases of CML, N, Both Sexes, All Ages, 2020
Figure 20: Overview of the Treatment Algorithm in CML
Figure 21: Unmet Needs and Opportunities in CML
Figure 22: Overview of the Development Pipeline in CML
Figure 23: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for CML in the 8MM During the Forecast Period
Figure 24: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against Sprycel in CP Disease
Figure 25: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against Iclusig in Advanced Disease
Figure 26: Analysis of the Company Portfolio Gap in CML During the Forecast Period
Figure 27: Global (8MM) Sales Forecast by Country for CML in 2020 and 2030
Figure 28: Sales Forecast by TKI for CML in the US in 2020 and 2030
Figure 29: Sales Forecast by TKI for CML in the 5EU in 2020 and 2030
Figure 30: Sales Forecast by TKI for CML in Japan in 2020 and 2030
Figure 31: Sales Forecast by TKI for CML in Canada in 2020 and 2030

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Ascentage Pharma
  • Bristol Myers Squibb
  • Gamida Cell
  • Incyte
  • Novartis
  • Otsuka
  • Pfizer
  • Sun Pharma Advanced Research Group
  • Takeda
  • Teva