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

Published: Jun 1, 2016 | Pages: 73 | Publisher: GBI Research | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

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

Summary

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.
 Table of Contents

1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 5
2.1 Significant Unmet Needs Persist in Hematological Cancer Market 5
2.2 Large Hematological Cancer Pipeline Displays Strong Degree of Innovation 5
2.3 Leuekmia Displays Most Pipeline Activity among Hematological Cancer Indications 5

3 The Case for Innovation in Hematological Cancers 6
3.1 Growing Number of Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 9

4 Clinical and Commercial Landscape 10
4.1 Disease Overview 10
4.2 Epidemiology 10
4.2.1 Leukemia 10
4.2.2 Lymphoma 11
4.2.3 Myeloma 11
4.3 Pathophysiology 12
4.3.1 Leukemia 12
4.3.2 Lymphoma 13
4.3.3 Myeloma 15
4.4 Symptoms 16
4.5 Diagnosis 16
4.5.1 Leukemia 16
4.5.2 Lymphoma 16
4.5.3 Myeloma 17
4.6 Prognosis and Survival 17
4.6.1 Survival 19
4.7 Treatment 19
4.7.1 Surgery and Radiation Therapy 20
4.7.2 Stem-Cell Transplantation 20
4.7.3 Pharmacological 21
4.8 Overview of Marketed Products 22
4.8.1 Conclusion 24
4.8.2 Unmet Need 24

5 Assessment of Pipeline Product Innovation 25
5.1 Pipeline by Molecule Type, Phase and Therapeutic Target 25
5.2 Comparative Distribution of Programs between Hematological Cancer Market and Pipeline by Therapeutic Target Family 29
5.3 First-in-Class Pipeline Programs 31

6 Hematological Cancer Pathophysiology and Innovation Alignment 42
6.1 The Complexity of Signaling Networks in the Oncology 42
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 42
6.3 First-in-Class Target Matrix Assessment 43

7 First-in-Class Target Evaluation 47
7.1 Pipeline Programs which Target Interleukin-7 Receptor 47
7.2 Pipeline Programs that Target Notch 2 and Notch 3 47
7.3 Pipeline Programs that Target Focal Adhesion Kinase 49
7.4 Pipeline Programs that Target Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1 49
7.5 Pipeline Programs that Target Interleukin-1 Receptor Accessory Protein 50
7.6 Pipeline Programs that Target HLA-DR 51
7.7 Pipeline Programs that Target L-Selectin 52
7.8 Pipeline Programs that Target Eukaryotic Translation Initiation Factor 4E 52

8 Strategic Consolidations 54
8.1 Industry-Wide First-in-Class Deals 54
8.2 Licensing Deals 55
8.2.1 Deal by Region, Year and Value 55
8.2.2 Deals by Stage of Development and Value 57
8.2.3 Deals by Molecule Type, Molecular Target and Value 57
8.2.4 Figure for Licensing Deals Valued Above $100m 59
8.3 Co-development Deals 60
8.3.1 Deals by Region, Year and Value 60
8.3.2 Deals by Stage of Development and Value 61
8.3.3 Deals by Molecule Type, Mechanism of Action and Value 61
8.3.4 Figure for Co-development Deals Valued above $100m 63
8.4 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 63

9 Appendix 68
9.1 Abbreviations 68
9.2 Bibliography 68
9.3 Research Methodology 71
9.4 Secondary Research 72
9.4.1 Marketed Product Heatmaps and Treatment Algorithm 72
9.4.2 Pipeline Analysis 72
9.4.3 First-in-Class Matrix Assessment 72
9.4.4 First-in-Class Target Profiles 73
9.4.5 Licensing and Co-development Deals 73
9.5 Contact Us 73
9.6 Disclaimer 73
List of Table

Table 1: Hematological Cancers Therapeutics Market, Global, Epidemiology of Hematological Disease Severity, 2016 10
Table 2: Hematological Cancers Therapeutics Market, Global, Lymphoma, Prognostic Factors, 2016 18
Table 3: Hematological Cancers Therapeutics Market, Global, Prognostic Factors, 2016 19
Table 4: Hematological Cancer Therapeutics Market, Global, Commonly Used Chemo-Regimens 21
Table 5: Hematological Cancers Therapeutics Market, Global, Data for IL-7R Alpha as a Therapeutic Target, 2016 47
Table 6: Hematological Cancers Therapeutics Market, Global, Data for Notch 2 and Notch 3 as a Therapeutic Target, 2016 48
Table 7: Hematological Cancers Therapeutics Market, Global, Focal Adhesion Kinase as a Therapeutic Target, 2016 49
Table 8: Hematological Cancers Therapeutics Market, Global, MALT1 as a Therapeutic Target, 2016 50
Table 9: Hematological Cancers Therapeutics Market, Global, IL1RAP as a Therapeutic Target, 2016 51
Table 10: Hematological Cancers Therapeutics Market, Global, HLA-DR as a Therapeutic Target, 2016 51
Table 11: Hematological Cancers Therapeutics Market, Global, L-Selectin as a Therapeutic Target, 2016 52
Table 12: Hematological Cancers Therapeutics Market, Global, EIF-4E as a Therapeutic Target, 2016 53 


List of Chart

Figure 1: Hematological Cancers Therapeutics Market, Global, Innovation Trends in Product Approvals, 1987-2012 6
Figure 2: Hematological Cancers Therapeutics Market, Global, Sales Performance of First-in-Class and Non-First-in-Class Products after Marketing Approval, 2016 8
Figure 3: Hematological Cancers Therapeutics Market, Global, Marketed Product Overview, 2016 23
Figure 4: Hematological Cancers Therapeutics Market, Global, Pipeline for Hematological Cancers by Stage of Development and Molecule Type, 2016 25
Figure 5: Hematological Cancers Therapeutics Market, Global, Pipeline for Key Hematological Cancers by Stage of Development, 2016 26
Figure 6: Hematological Cancers Therapeutics Market, Global, Pipeline for Key Hematological Cancers by Molecule Type, 2016 27
Figure 7: Hematological Cancers Therapeutics Market, Global, Pipeline for Hematological Cancers by Molecular Target, 2016 28
Figure 8: Hematological Cancers Therapeutics Market, Global, Pipeline for Key Hematological Cancers by Molecular Target, 2016 29
Figure 9: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, 2016 30
Figure 10: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, Leukemia, 2016 30
Figure 11: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, Lymphoma, 2016 30
Figure 12: Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, Myeloma, 2016 30
Figure 13: Hematological Cancers Therapeutics Market, Global, Pipeline Innovation by Indication and Stage of Development, 2016 32
Figure 14: Hematological Cancers Therapeutics Market, Global, Hematological Cancer Pipeline First-in-Class and Established Molecular Targets, 2016 33
Figure 15: Hematological Cancers Therapeutics Market, Global, Leukemia Pipeline First-in-Class and Established Molecular Targets, 2016 34
Figure 16: Hematological Cancers Therapeutics Market, Global, Lymphoma Pipeline First-in-Class and Established Molecular Targets, 2016 35
Figure 17: Hematological Cancers Therapeutics Market, Global, Myeloma Pipeline First-in-Class and Established Molecular Targets, 2016 36
Figure 18: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 1, 2016 38
Figure 19: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 2, 2016 39
Figure 20: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 3, 2016 40
Figure 21: Hematological Cancers Therapeutics Market, Global, First-in-Class Products in Clinical Development, Part 4, 2016 41
Figure 22: Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, Part 1, 2016 44
Figure 23: Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, Part 2, 2016 45
Figure 24: Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, Part 3, 2016 46
Figure 25: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting IL-7R Alpha, 2016 47
Figure 26: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Notch 2 and Notch 3, 2016 48
Figure 27: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Focal Adhesion Kinase, 2016 49
Figure 28: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting MALT1, 2016 50
Figure 29: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting  IL1RAP, 2016 51
Figure 30: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting HLA-DR, 2016 52
Figure 31: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting L-Selectin, 2016 52
Figure 32: Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting EIF-4E, 2016 53
Figure 33: Hematological Cancers Therapeutics Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 54
Figure 34: Hematological Cancers Therapeutics Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 55
Figure 35: Hematological Cancers Therapeutics Market, Global, Licensing Deals by Region, Year and Value, 2006-2016 56
Figure 36: Hematological Cancers Therapeutics Market, Global, Licensing Deals by Indication and Value, 2006-2016 56
Figure 37: Hematological Cancers Therapeutic Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016 57
Figure 38: Hematological Cancers Therapeutics Market, Global, Licensing Deals by Molecule Type and Molecular Target, 2006-2016 58
Figure 39: Hematological Cancers Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2016 59
Figure 40: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Region, Year and Value, 2006-2016 60
Figure 41: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Indication, 2006-2016 61
Figure 42: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Stage of Development and Value, 2006-2016 61
Figure 43: Hematological Cancers Therapeutics Market, Global, Co-development Deals by Molecule Type and Molecular Target, 2006-2016 62
Figure 44: Hematological Cancers Therapeutics Market, Global, Co-development Deals Valued above $100m, 2006-2016 63
Figure 45: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 1, 2016 64
Figure 46: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 2, 2016 65
Figure 47: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 3, 2016 66
Figure 48: Hematological Cancers Therapeutics Market, Global, First-in-Class Targets Not Involved in Deals, Part 4, 2016 67

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