Frontier Pharma: Hematological Cancers - Highly Innovative Pipeline Continues Trend towards Targeted, Patient-Specific Therapies

  • ID: 3776324
  • Report
  • Region: Global
  • 73 Pages
  • GBI Research
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Leukemia Has Largest Pipeline and Most First-in-Class Innovation in Hematological Cancers Space
Hematological malignancies are a class of cancer that affect the blood, lymph nodes and bone marrow, and include numerous forms of leukemia, lymphoma and myeloma. Hematological malignancies constituted 9% of all newly diagnosed malignancies in the US in 2011, with data indicating that lymphomas are more prevalent than leukemia or myeloma.

Excluding acute lymphocytic leukemia and Hodgkin’s lymphoma, these types of malignancy are generally associated with increasing age. Therefore, considering the aging population globally, this class of malignancy is likely to become more prevalent.

The report assesses first-in-class innovation in the hematological cancer pipeline, highlighting key trends in first-in-class product distribution. Analysis reveals that the hematological cancer pipeline is among the most innovative in the industry, with 463 first-in-class products, representing 45.3% of the pipeline with a disclosed molecular target.

The first-in-class targets in the pipeline are numerous and varied in nature. Cancer immunotherapies are the most common, with a total of 128 across all stages of development, followed by the signal transduction group of targets. The most commercially successful targeted drugs in the market fall into these two categories, including Rituxan (a cancer immunotherapy) and Gleevec (a signal transducer). The other target families have much fewer first-in-class products, reflecting the strong interest in cancer immunotherapies and targets implicated in signal transduction.

Over the past 15 years, the treatment of hematological malignancies has changed significantly, with the development of targeted therapies. These developments have been based on the growing understanding of the signaling pathways involved in disease pathogenesis. A notable example is the approval of Rituxan in 1997, which is used to treat multiple types of hematological malignancies, including Non-Hodgkin’s lymphoma. Analysis indicates that the current pipeline is following this trend of focusing on innovative, targeted therapies.

Scope

The hematological cancers market is characterized by commercially successful therapies.
- Which classes of drug dominate the market?
- What additional benefits have newly approved therapies brought to the market?

The pipeline contains a range of molecule types and molecular targets, with a strong emphasis on targeted therapies, as opposed to chemotherapeutic agents.
- Which molecular targets appear most frequently in the pipeline?
- To what degree is the pipeline penetrated by first-in-class innovation?
- Which target families have the most first-in-class products?

First-in-class products differ substantially in their clinical potential, based on their alignment to disease-causing pathways.
- How well are first-in-class targets aligned to known disease-causing pathways?
- Which targets are specifically found in early-stage development?
- Which are the most promising first-in-class targets in early-stage development?

There have been 284 licensing deals and 238 co-development deals pertaining to hematological cancer products since 2006.
- Which territories show the most deal activity?
- What were the trends in deal completion by product stage of development?
- Which of the first-in-class products in development are not currently involved in a licensing or co-development deal, and therefore represent investment opportunities?

Reasons to buy

This report will allow you to:
- Understand the current clinical and commercial landscape. It includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
- Visualize the composition of the hematological cancers market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
- Analyze the hematological cancers pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating hematological cancers.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.
- Identify commercial opportunities in the hematological cancers deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of hematological cancer therapies that are not yet involved in deals, and may be potential investment opportunities.

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1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Executive Summary
2.1 Significant Unmet Needs Persist in Hematological Cancer Market
2.2 Large Hematological Cancer Pipeline Displays Strong Degree of Innovation
2.3 Leuekmia Displays Most Pipeline Activity among Hematological Cancer Indications
3 The Case for Innovation in Hematological Cancers
3.1 Growing Number of Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 Report Guidance

4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Epidemiology
4.2.1 Leukemia
4.2.2 Lymphoma
4.2.3 Myeloma
4.3 Pathophysiology
4.3.1 Leukemia
4.3.2 Lymphoma
4.3.3 Myeloma
4.4 Symptoms
4.5 Diagnosis
4.5.1 Leukemia
4.5.2 Lymphoma
4.5.3 Myeloma
4.6 Prognosis and Survival
4.6.1 Survival
4.7 Treatment
4.7.1 Surgery and Radiation Therapy
4.7.2 Stem-Cell Transplantation
4.7.3 Pharmacological
4.8 Overview of Marketed Products
4.8.1 Conclusion
4.8.2 Unmet Need

5 Assessment of Pipeline Product Innovation
5.1 Pipeline by Molecule Type, Phase and Therapeutic Target
5.2 Comparative Distribution of Programs between Hematological Cancer Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class Pipeline Programs

6 Hematological Cancer Pathophysiology and Innovation Alignment
6.1 The Complexity of Signaling Networks in the Oncology
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
6.3 First-in-Class Target Matrix Assessment

7 First-in-Class Target Evaluation
7.1 Pipeline Programs which Target Interleukin-7 Receptor
7.2 Pipeline Programs that Target Notch 2 and Notch 3
7.3 Pipeline Programs that Target Focal Adhesion Kinase
7.4 Pipeline Programs that Target Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1
7.5 Pipeline Programs that Target Interleukin-1 Receptor Accessory Protein
7.6 Pipeline Programs that Target HLA-DR
7.7 Pipeline Programs that Target L-Selectin
7.8 Pipeline Programs that Target Eukaryotic Translation Initiation Factor 4E

8 Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.2.1 Deal by Region, Year and Value
8.2.2 Deals by Stage of Development and Value
8.2.3 Deals by Molecule Type, Molecular Target and Value
8.2.4 Figure for Licensing Deals Valued Above $100m
8.3 Co-development Deals
8.3.1 Deals by Region, Year and Value
8.3.2 Deals by Stage of Development and Value
8.3.3 Deals by Molecule Type, Mechanism of Action and Value
8.3.4 Figure for Co-development Deals Valued above $100m
8.4 First-in-Class Programs Not Involved in Licensing or Co-Development Deals

9 Appendix
9.1 Abbreviations
9.2 Bibliography
9.3 Research Methodology
9.4 Secondary Research
9.4.1 Marketed Product Heatmaps and Treatment Algorithm
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-development Deals
9.5 Contact Us
9.6 Disclaimer

1.1 List of Tables
Table 1: Hematological Cancers Therapeutics Market, Global, Epidemiology of Hematological Disease Severity, 2016
Table 2: Hematological Cancers Therapeutics Market, Global, Lymphoma, Prognostic Factors, 2016
Table 3: Hematological Cancers Therapeutics Market, Global, Prognostic Factors, 2016
Table 4: Hematological Cancer Therapeutics Market, Global, Commonly Used Chemo-Regimens
Table 5: Hematological Cancers Therapeutics Market, Global, Data for IL-7R Alpha as a Therapeutic Target, 2016
Table 6: Hematological Cancers Therapeutics Market, Global, Data for Notch 2 and Notch 3 as a Therapeutic Target, 2016
Table 7: Hematological Cancers Therapeutics Market, Global, Focal Adhesion Kinase as a Therapeutic Target, 2016
Table 8: Hematological Cancers Therapeutics Market, Global, MALT1 as a Therapeutic Target, 2016
Table 9: Hematological Cancers Therapeutics Market, Global, IL1RAP as a Therapeutic Target, 2016
Table 10: Hematological Cancers Therapeutics Market, Global, HLA-DR as a Therapeutic Target, 2016
Table 11: Hematological Cancers Therapeutics Market, Global, L-Selectin as a Therapeutic Target, 2016
Table 12: Hematological Cancers Therapeutics Market, Global, EIF-4E as a Therapeutic Target, 2016

1.2 List of Figures
Figure 1: Hematological Cancers Therapeutics Market, Global, Innovation Trends in Product Approvals, 1987-2012
Figure 2: Hematological Cancers Therapeutics Market, Global, Sales Performance of First-in-Class and Non-First-in-Class Products after Marketing Approval, 2016
Figure 3: Hematological Cancers Therapeutics Market, Global, Marketed Product Overview, 2016
Figure 4: Hematological Cancers Therapeutics Market, Global, Pipeline for Hematological Cancers by Stage of Development and Molecule Type, 2016
Figure 5: Hematological Cancers Therapeutics Market, Global, Pipeline for Key Hematological Cancers by Stage of Development, 2016
Figure 6: Hematological Cancers Therapeutics Market, Global, Pipeline for Key Hematological Cancers by Molecule Type, 2016
Figure 7: Hematological Cancers Therapeutics Market, Global, Pipeline for Hematological Cancers by Molecular Target, 2016
Figure 8: Hematological Cancers Therapeutics Market, Global, Pipeline for Key Hematological Cancers by Molecular Target, 2016
Figure 9: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, 2016
Figure 10: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, Leukemia, 2016
Figure 11: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, Lymphoma, 2016
Figure 12: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, Myeloma, 2016
Figure 13: Hematological Cancers Therapeutics Market, Global, Pipeline Innovation by Indication and Stage of Development, 2016
Figure 14: Hematological Cancers Therapeutics Market, Global, Hematological Cancer Pipeline First-in-Class and Established Molecular Targets, 2016
Figure 15: Hematological Cancers Therapeutics Market, Global, Leukemia Pipeline First-in-Class and Established Molecular Targets, 2016
Figure 16: Hematological Cancers Therapeutics Market, Global, Lymphoma Pipeline First-in-Class and Established Molecular Targets, 2016
Figure 17: Hematological Cancers Therapeutics Market, Global, Myeloma Pipeline First-in-Class and Established Molecular Targets, 2016
Figure 18: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 1, 2016
Figure 19: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 2, 2016
Figure 20: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 3, 2016
Figure 21: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 4, 2016
Figure 22: Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, Part 1, 2016
Figure 23: Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, Part 2, 2016
Figure 24: Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, Part 3, 2016
Figure 25: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting IL-7R Alpha, 2016
Figure 26: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Notch 2 and Notch 3, 2016
Figure 27: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Focal Adhesion Kinase, 2016
Figure 28: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting MALT1, 2016
Figure 29: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting IL1RAP, 2016
Figure 30: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting HLA-DR, 2016
Figure 31: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting L-Selectin, 2016
Figure 32: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting EIF-4E, 2016
Figure 33: Hematological Cancers Therapeutics Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014
Figure 34: Hematological Cancers Therapeutics Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014
Figure 35: Hematological Cancers Therapeutics Market, Global, Licensing Deals by Region, Year and Value, 2006-2016
Figure 36: Hematological Cancers Therapeutics Market, Global, Licensing Deals by Indication and Value, 2006-2016
Figure 37: Hematological Cancers Therapeutic Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016
Figure 38: Hematological Cancers Therapeutics Market, Global, Licensing Deals by Molecule Type and Molecular Target, 2006-2016
Figure 39: Hematological Cancers Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2016
Figure 40: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Region, Year and Value, 2006-2016
Figure 41: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Indication, 2006-2016
Figure 42: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Stage of Development and Value, 2006-2016
Figure 43: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Molecule Type and Molecular Target, 2006-2016
Figure 44: Hematological Cancers Therapeutics Market, Global, Co-development Deals Valued above $100m, 2006-2016
Figure 45: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 1, 2016
Figure 46: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 2, 2016
Figure 47: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 3, 2016
Figure 48: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 4, 2016
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Of the three major indications within hematological cancer, namely leukemia, lymphoma and myeloma, leukemia has the largest pipeline, with 798 products in active development, while lymphoma has 552 and myeloma has 396, according to the report.

Our latest report states that there are currently 1,234 pipeline products in active development in the hematological cancer therapy area, and for each of the three key indications, the composition by stage of development is relatively similar, although leukemia and myeloma have more products in clinical development.

One of our analysts explains: “Leukemia has the most products in the hematological cancers pipeline, with 349 in clinical development and 446 in early-stage development, while three products had an undisclosed stage of development. In terms of individual stages, however, Preclinical is the largest across leukemia and lymphoma, while Phase II is the largest in myeloma. It is notable that Phase II also contains many products for leukemia and lymphoma, which is a promising trend for product development. The leukemia indication contains the most first-in-class products, with 195, while the lymphoma and myeloma pipelines contain 186 and 8 first-in-class products, respectively.”

The report also states that considerable unmet needs remain in hematological cancer, with acute myeloid leukemia (AML) particularly ill-served, as there is a need for more efficacious targeted therapies across all patient subtypes. The treatment of AML is still limited to conventional DNA-targeted chemotherapy regimens, which achieve long-term survival rates of 25-50% in patients below the age of 60, and only 5-15% in older patients, indicating a clear need for more efficacious treatments.

This report provides analysis of the hematological cancers treatment pipeline, stratified by stage of development, molecule type and molecular target. It includes information on the current clinical and commercial landscape, and the composition of the hematological market in terms of dominant molecule types and targets, as well as highlighting current unmet needs.
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