CAR-T r/r CLL Global Market Forecast

  • ID: 4401813
  • Report
  • Region: Global
  • 130 Pages
  • iOnco-analytics
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FEATURED COMPANIES

  • Axi-Cel
  • Juno Therapeutics Inc.
  • Kite Pharma/Gilead
  • Novartis
  • MORE

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in western countries with an age-adjusted incidence of ~4.4 per 100,000 persons in the United States. In 2017, the US recorded ~20,000 diagnosed cases and ~4,600 deaths. Global estimates are ~36,000 diagnosed cases per year.

Symptomatic CLL disease remains incurable with standard therapies although HSCT can offer a cure, dependent on patient age; comorbidity and the potential for GvHD. Recent improvements in standard (chemo-immunotherapeutic) therapy have been achieved with small molecule inhibitors of B cell receptor signalling such as Ibrutinib (Imbruvica®, AbbVie, Janssen) (a Bruton’s Tyrosine Kinase (BTK) inhibitor) and Idelalisib (Zydelig®, Gilead) (a PI3Kd-isoform selective inhibitor) and the apoptosis regulation inhibitor Venetoclax (Venclexta®, Abbvie, Genentech Roche) (an inhibitor of B-cell lymphoma-2 (BCL-2)). Despite their benefits these agents require continuous administration and are not curative. BTK refractory CLL remains an issue. High risk patients with cytogenetic aberrations (e.g. del(17p), del(11q), TP53 mutation, unmutated IGHV) have a poor prognosis and unfavourable/short outcomes.

Novel immune-therapeutic approaches in development for CLL include monoclonal antibodies, bi-specific antibodies, anti-PD1/PDL-1 checkpoint inhibitors, and the CAR-T cell therapies including JCAR014/JCAR017 (Juno Therapeutics), KTE-C19 (Kite Pharma), and CTL019 (tisagenlecluecel-T)(Novartis Pharmaceuticals). These potential CAR-T therapies or their next generations e.g. ‘armoured’ CARs and humanized versions are in development.

This product consists of a detailed Executive presentation (~130 slides, .pdf) and MS-Excel workbook forecasting the commercial potential ($ 000s) of novel CAR-T therapies in r/r CLL across 9 major Western markets to 2030. A patientbased flow methodology has been devised where possible intervention scenarios for CAR-T introduction are visualised so that the optimum product positioning can be assessed. In addition, an up-to-date review of CLL disease background, epidemiology, current and future treatments is presented along with a comprehensive review of the CAR-T CLL competitive landscape. Pricing, cost effectiveness, manufacturing and logistical considerations are also discussed. All assumptions are clearly provided.

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FEATURED COMPANIES

  • Axi-Cel
  • Juno Therapeutics Inc.
  • Kite Pharma/Gilead
  • Novartis
  • MORE

1. Executive summary

2. CAR-T treatment for r/r CLL - Commercial model: key outputs

  • CAR-T eligible CLL patients/line of therapy 2017-2030 (Global)
  • CAR-T eligible CLL patients/line of therapy to 2030 (US)
  • CAR-T eligible CLL patients/line of therapy to 2030 (M5EU)
  • CAR-T treated CLL patients/line of therapy to 2030 (Global)
  • CAR-T treated CLL patients/line of therapy to 2030 (US)
  • CAR-T treated CLL patients/line of therapy to 2030 (M5EU)
  • CAR-T cell therapy: projected CLL revenue forecast per scenario ($000s) to 2030 (Global)
  • CAR-T cell therapy: projected CLL revenue forecast per scenario ($000s) to 2030 (US)
  • CAR-T cell therapy: projected CLL revenue forecast per scenario ($000s) to 2030 (M5EU)

3. Chronic lymphocytic leukaemia - Disease background

  • Chronic lymphocytic leukaemia (CLL) - Disease background
  • Chronic lymphocytic leukaemia (CLL) - Types of CLL
  • Chronic lymphocytic leukaemia (CLL) - Risk factors
  • Chronic lymphocytic leukaemia (CLL) – Symptoms
  • Chronic lymphocytic leukaemia (CLL) - diagnosis and prognosis
  • Chronic lymphocytic leukaemia (CLL) - Molecular genetics
  • Chronic lymphocytic leukaemia (CLL) - Molecular genetics and prognostic significance
  • Chronic lymphocytic leukaemia (CLL) - Common gene aberrations and prognostic significance
  • Chronic lymphocytic leukaemia (CLL) - Disease staging
  • Chronic lymphocytic leukaemia (CLL) - Prognostic Index

4. Chronic lymphocytic leukaemia – Epidemiology

  • Chronic lymphocytic leukaemia (CLL) - Leukaemia incidence (US)
  • Chronic lymphocytic leukaemia (CLL) - Incidence (US)
  • Chronic lymphocytic leukaemia (CLL) - Incidence, age distribution and mortality (US)
  • Chronic lymphocytic leukaemia (CLL) - Incidence, sex and race (US)
  • Chronic lymphocytic leukaemia (CLL) - Leukaemia incidence (UK)
  • Chronic lymphocytic leukaemia (CLL) - Incidence (UK)
  • Chronic lymphocytic leukaemia (CLL) - Incidence, sex and age (UK)
  • Chronic lymphocytic leukaemia (CLL) - Mortality and age (UK)
  • Chronic lymphocytic leukaemia (CLL) - Incidence, mortality and country (UK)
  • Chronic lymphocytic leukaemia (CLL) - Incidence and mortality in US, Canada, Europe, Australia, Japan
  • Chronic lymphocytic leukaemia (CLL) - Prevalence in US, Canada, Europe, Australia, Japan

5. Chronic lymphocytic leukaemia – Treatment

  • Chronic lymphocytic leukaemia (CLL) – Treatment requirements
  • Chronic lymphocytic leukaemia (CLL) - Treatment agents
  • Chronic lymphocytic leukaemia (CLL) - Treatment agents for relapsed/refractory CLL
  • Chronic lymphocytic leukaemia - Treatment regimens by disease stage and risk category
  • Chronic lymphocytic leukaemia - Treatment flow
  • Chronic lymphocytic leukaemia – Transplantation
  • Chronic lymphocytic leukaemia - Transplantation treatment scenarios
  • Chronic lymphocytic leukaemia - Treatment challenges

6. Novel treatments for CLL - Immunotherapy approaches

  • Chronic lymphocytic leukaemia - Immunotherapy approaches in development
  • Chimeric Antigen Receptor T cells (CAR-T) – overview
  • Chimeric Antigen Receptor T cells (CAR-T) - antigen selection
  • CAR-T cell therapy: potential issues and challenges
  • Steps in the manufacture of a CAR-T cell therapy
  • CAR-T cell therapy for CLL- Key published studies
  • CAR-T cell therapy for CLL- Key published studies - Studies in combination with ibrutinib
  • CAR-T cell therapy for CLL- Summary of key published studies
  • CAR-T cell therapy for CLL: pipeline analysis methodology
  • CAR-T cell therapy for CLL: pipeline analysis – key findings
  • Pipeline analysis table: Key ongoing CAR-T studies for CLL
  • Key CAR-T cell programmes - Juno Therapeutics Inc. – Background
  • Juno Therapeutics Inc. - Background: CAR and TCR R&D pipeline
  • Juno Therapeutics Inc. - Background: CAR-T manufacturing process (JCAR017)
  • Pipeline analysis: Key industry CAR-T studies for CLL - Juno Therapeutics
  • Pipeline analysis: Key industry CAR-T studies for CLL - Novartis and CTL019 background
  • Pipeline analysis: Key industry CAR-T studies for CLL - Novartis and CTL019 background: the path to commercialization
  • Pipeline analysis: Key industry CAR-T studies for CLL - Novartis and CTL019 background: manufacturing process
  • Pipeline analysis: Key industry CAR-T studies for CLL - Novartis and CTL019
  • Pipeline analysis: Key industry CAR-T studies for CLL - Novartis and CTL119 – background
  • Pipeline analysis: Key CAR-T studies for CLL - Novartis and CTL119
  • Pipeline analysis: Key CAR-T studies for CLL - Kite Pharma/Gilead and CAR-T cell therapy background
  • Kite Pharma/Gilead and CAR-T cell therapy - Axi-Cel (KTE-C19) manufacturing process
  • Kite Pharma/Gilead: CAR-T R&D pipeline, September 2017

7. Novel treatments for CLL - Modelling commercial potential of CAR-T cell therapies

  • CAR-T cell therapy for CLL: Target product profile
  • CAR-T cell therapy for CLL: International Workshop on Chronic Lymphocytic Leukaemia (iwCLL) guidelines
  • CLL modelling approach: patient flow/treatment scenarios
  • Modelling approach: markets modelled in this analysis
  • Pricing CAR-T cell therapy
  • Pricing CAR-T therapies for indications other than paediatric ALL
  • Price comparisons of existing therapies for first line and r/r CLL
  • US cost burden projection for CLL with oral therapies as first line treatment
  • Pricing comparisons with cell and novel immuno-oncology therapies
  • Pipeline summary/potential launch sequence
  • Model caveats and limitations

8. Bibliography

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  • Axi-Cel
  • Juno Therapeutics Inc.
  • Kite Pharma/Gilead
  • Novartis
Note: Product cover images may vary from those shown
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