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Pipeline/Commercial Insight: Supportive Care in Oncology

Significant growth opportunities exist in new supportive care indications

Publication Date   June 2007
Publisher   Datamonitor
Product Type   Report
Pages   241
ISBN Number   not applicable
Product Code   DAT872
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Price £7,600.00

approximately: $14,200 | €9,639

Summary


Introduction

Supportive care can be defined as those products used to prevent and/or treat the adverse side effects that arise as a result of the tumor itself or administration of anticancer therapies, in particular cytotoxic chemotherapy. While the antihormonal therapies and novel molecular targeted therapies do not exist without some toxicity, these are not as severe as those associated with chemotherapy.

Scope

  • Overview of the current oncology supportive care market, including profiles of key marketed products and events impacting each during 200616
  • Examination of the oncology supportive care pipeline with in-depth clinical and commercial profiles of Phase III and some key Phase II candidates
  • Seven-market sales forecasts from 2006 to 2016 for branded oncology supportive care products and key pipeline candidates
  • Detailed discussion of key strategic issues in the oncology supportive care market, including one commercial impact case study

Highlights

The oncology supportive care market is forecast to undergo slightly positive growth at a CAGR of 0.6%, from a seven-market sales total of $13,763m in 2006 to $14,679m in 2016. This low level of growth is largely due to an increasing level of patent expiry and generic competition, including the impending launch of biosimilars in the EU.

The erythropoietins class has come under increasing levels of scrutiny of late due to emerging doubts over safety of these products. As a result the FDA and EMEA are recommending more restrictive conditions for use and increased monitoring of patients. It is expected that sales of these products will suffer as a result of these restrictions.

Any significant future growth in the oncology supportive care market will likely come from product development in new indications, such as EGFR-inhibitor associated skin rash. However, given the early-phase of clinical development for such products, it will be some time before any impact is made and true future potential can be determined.

Reasons to Purchase

  • Understand market specific drivers and predict the future potential of key marketed and pipeline oncology supportive care products
  • Assess the impact of product launches and identify the opportunities and risks for key products within the oncology supportive care market
  • Adopt knowledge to drive strategic planning for marketed products and optimize the market penetration of new entrants

Content


  • About The Oncology Pharmaceutical Analysis Team
  • Andrew Paramore - Oncology Lead Analyst & Head Of Product Development
  • Chapter 1 Executive Summary
    • Objective Of The Analysis
    • Datamonitor Insight Into The Oncology Supportive Care Market
    • Related Reports
    • Upcoming Reports
  • Chapter 2 Pipeline Overview
    • Pipeline Overview
    • Pipeline By Developmental Phase And Indication
    • The Oncology Supportive Care Pipeline In Its Entirety Is Relatively Sparse
    • Pipeline Split By Phase
    • The Late-Phase Pipeline Will Flourish In The Future, As Early-Stage Agents Move Forward In Development
    • Pipeline Split By Indication
    • Chemotherapy-Induced Nausea And Vomiting Is The Most Popular Indication In Terms Of Pipeline Activity
    • Significant Unmet Needs In The Cancer-Related Mucositis Market Means The Early-Phase Pipeline Has Increased In Activity
    • A Greater Level Of Activity Would Have Been Expected In The Cancer-Related Thrombocytopenia Pipeline
    • Pipeline By Company
    • At Least 67 Companies Are Involved In The Oncology Supportive Care Pipeline
    • The High Involvement Of Smaller Companies In The Oncology Supportive Care Pipeline Is Not Surprising, Given That 82% Of Compounds Are In Early-Phase Development
    • The Top Three Companies In Terms Of Marketed And Pipeline Oncology Supportive Care Products Are Amgen, Glaxosmithkline And Roche
    • Amgen
    • Glaxosmithkline
    • Roche
    • Key Metrics
    • Datamonitor Pipeline Assessment Summary
  • Chapter 3 Market Definition And Pipeline Dynamics
    • Supportive Care Overview
    • Market Definition And Classification Of Products
    • A4a - Anti-Emetics And Anti-Nauseants
    • Playing A Key Role In The Prophylaxis And/Or Treatment Of Acute And Delayed Chemotherapy-Induced Nausea And Vomiting
    • Defining The Emetic Risk Of Various Cytotoxics Used To Treat Cancer
    • Anti-Emetic Mode Of Action Is Conferred By Blocking The Action Of Various Neuroreceptors
    • Classes Of Anti-Emetic/Anti-Nauseant
    • B3c - Erythropoiesis-Stimulating Products
    • Anemia May Severely Affect Patient Quality Of Life
    • Products Capable Of Stimulating The Production Of Red Blood Cells Can Be Used To Treat Cancer-Related Anemia
    • Key Erythropoiesis-Stimulating Products
    • L3a1 - Colony-Stimulating Factors
    • Neutropenia Was Potentially Fatal Before The Introduction Of Current Supportive Care Measures
    • Colony-Stimulating Factors Promote The Production Of White Blood Cells To Prevent Neutropenia
    • Key Colony-Stimulatings Factors
    • L3a9 - All Other Immunostimulating Agents Excluding Interferons
    • Thrombocytopenia Increases The Risk Of Severe Bleeding In Cancer Patients
    • Only One Formally Approved Agent Exists For The Prevention Of Thrombocytopenia To Date
    • M5b1/M5b2 - Bisphosphonate Bone Calcium Regulators
    • Bone Metastases And Tumor-Induced Hypercalcemia Can Cause Significant Morbidity In Cancer Patients
    • Bisphosphonates Are Used In The Prevention And/Or Treatment Of Cancer-Related Skeletal Events Due To Their Ability To Restore Normal Balance To Bone Activity
    • Key Bisphosphonates Approved For Oncology Indications
    • V3d0 - Detoxifying Agents For Antineoplastic Treatment
    • Mucositis Can Result In Significant Complications, Exacerbated By Further Cancer Treatment And Any Therapy-Related Nausea And Vomiting
    • Use Of The Only Growth Factor Approved For Mucositis To Date Is Restricted By Its Cost, Particularly In More Conservative Markets
    • Current Market Dynamics
    • A Top-Line View Of The Oncology Supportive Care Market
    • The Large Majority Of Drug Classes Underwent Significant Sales Growth Between 2005 And 2006
    • The Oncology Supportive Care Market By Drug Class
    • Epidemiology
    • Epidemiology Of Cancer
    • A Continuously Expanding Patient Base
    • Increased Incidence A Consequence Of Aging Populations And Lifestyle Modifications
    • Epidemiology Of Supportive Care Indications
  • Chapter 4 Marketed Products Forecast Analysis
    • Country-Specific Assumptions And Effects
    • Generic Pricing And Erosion Assumptions
    • Product Assumptions And Effects
    • A4a1 - 5-Ht3 Serotonin Receptor Antagonists
    • Drug Class Asumptions
    • Helsinn Pharma/Mgi Pharma's Aloxi (Palonosetron)
    • Sanofi-Aventis's Anzemet (Dolasetron)
    • Roche/Chugai's Kytril (Granisetron)
    • Astellas' Nasea (Ramosetron)
    • Novartis's Navoban (Tropisetron)
    • Welfide/Japan Tobacco's Serotone (Azasetron)
    • Nisshin Kyorin Pharmaceuticals' Sinseron (Indisetron)
    • Glaxosmithkline's Zofran (Ondansetron)
    • A4a9 - Other Anti-Emetics/Anti-Nauseants
    • Merck & Co's Emend (Aprepitant)
    • B3c0 - Erythropoiesis-Stimulating Products
    • Drug Class Assumptions
    • Controversy Affecting The Drug Class As A Whole
    • Amgen's Aranesp (Darbepoetin Alfa)
    • Amgen Epogen/Johnson & Johnson's Procrit/Kirin's Eprex (Epoetin Alfa)
    • Roche's Neorecormon (Epoetin Beta)
    • L3a1 - Colony-Stimulating Factors
    • Chugai's Granocyte (Lenograstim)
    • Bayer Schering/Berlex's Leukine (Sargramostim)
    • Amgen's Neulasta (Pegfilgrastim)
    • Amgen's Neupogen (Filgrastim)
    • Kyowa Hakko Kogyo's Neu-Up (Nartograstim)
    • L3a9 - Other Immunostimulating Agents
    • Wyeth's Neumega (Oprelvekin)
    • M5b1/M5b2 - Oral And Injectable Bisphosphonates
    • Drug Class Assumptions
    • Proctor & Gamble/Sanofi-Aventis's Actonel (Risedronic Acid)
    • Novartis's Aredia (Pamidronic Acid)
    • Astellas' Bisphonal (Incadronic Acid)
    • Roche/Glaxosmithkline's Bondronat/Boniva/Bonviva (Ibandronic Acid)
    • Bayer Schering's Bonefos (Clodronic Acid)
    • Novartis's Zometa (Zoledronic Acid)
    • V3d0 - Other Detoxifying Agents For Cancer
    • Amgen's Kepivance (Palifermin)
    • Forecasts
    • Forecast Methodology
  • Chapter 5 Pipeline Anti-Emetic Products Analysis And Forecasts
    • Pipeline Overview
    • Definition Of Current Comparator
    • Glaxosmithkline's Zofran (Ondansetron)
    • The Preferred 5-Ht3 Receptor Antagonist In The Seven Major Markets
    • Reckitt Benckiser Healthcare/Biodelivery Sciences' Emezine (Reformulated Prochlorperazine Maleate)
    • Drug Profile
    • Issue Of A Non-Approvable Letter By The Fda For Emezine May Not Bode Well For The Drug's Future
    • Clinical Trial Data
    • Pharmacokinetic Studies Indicate That Emezine's Route Of Administration May Result In A Higher Plasma Concentration Than Traditional Formulations
    • Datamonitor Comments
    • Biodelivery Sciences Believes Emezine To Confer Advantages By Virtue Of Its Formulation
    • The Widespread Availability Of Generic Prochlorperazine And More Efficacious Newer Anti-Emetics Means That Uptake Of Emezine May Be Limited
    • Hana Biosciences/Novadel Pharma's Zensana (Reformulated Ondansetron)
    • Drug Profile
    • Long-Term Stability Issues Means Reformulation Of Zensana Was Necessary, However, This Has Delayed Commercialization
    • Clinical Trial Data
    • Zensana Has Been Proven Bioequivalent To Zofran
    • Surveyed Members Of The Oncology Community Ranked Zensana Highly In Terms Of Potential Ease Of Use
    • Datamonitor Comments
    • Zensana Confers Administration Advantages Over Traditionally Formulated Ondansetron, However, The Drug's Price Point Should Be Set With Caution
    • Prostrakan's Sancuso (Reformulated Granisetron)
    • Drug Profile
    • Sancuso Allows For An Alternative Route Of Administration To Kytril
    • Clinical Trial Data
    • Phase Iii Data Show Sancuso To Confer Comparable Efficacy And Safety To Oral Kytril
    • Datamonitor Comments
    • Sancuso Must Be Priced Competitively In Order To Avoid Being Driven Out Of The Market By Generic Versions Of 5-Ht3 Anatagonists
    • Ap Pharma's Apf-530 (Reformulated Slow-Release Granisetron)
    • Drug Profile
    • Slow-Release Formulation Of Granisetron Should Provide Consisent Protection Against Chemotherapy-Induced Nausea And Vomiting
    • Clinical Trial Data
    • Clinical Data Support The Use Of A Single Injection Of Apf-530 Adminstered 30 Minutes Before Chemotherapy To Provide Continuous Protection
    • Datamonitor Comments
    • While Generic Versions Of Granisetron Will See Uptake, Apf-530 May Lose Out Somewhat To Sancuso Due To Its Formulation
    • Glaxosmithkline's Casopitant (Gw-679769)
    • Drug Profile
    • Casopitant Could Become The Second Nk-1 Antagonist To Reach The Market
    • Clinical Trial Data
    • Casopitant In Combination With Zofran Is Effective In Patients Receiving Moderately-Emetogenic Chemotherapy
    • Varying Doses Of Capositant Are Effective In Preventing Nausea And Vomiting Associated With Highly-Emetogenic Chemotherapy
    • Datamonitor Comments
    • Given The Youth Of The Nk-1 Antagonist Drug Class, Casopitant Could Represent A Valuable Addition To Treatment Options
    • Forecasts
    • Datamonitor Drug Assessment Summary
    • Future Potential Of Pipeline Anti-Emetic Products
    • The Pipeline Anti-Emetics Will Enjoy Reasonable Uptake And Sales, However, No Major Breakthroughs In The Prevention And/Or Treatment Of Chemotherapy-Induced Nausea And Vomiting Will Be Provided
  • Chapter 6 Pipeline Erythropoiesis-Stimulating Products Analysis And Forecasts
    • Pipeline Overview
    • Definition Of Current Comparator
    • Amgen's Aranesp (Darbepoetin Alfa)
    • Available Across Most Of The Seven Major Markets And A More Convenient Dosing Schedule For Patients
    • Shire's Dynepo (Epoetin Delta)
    • Drug Profile
    • The First Recombinant Erythropoietin To Be Produced In Human Cells
    • Clinical Trial Data
    • A Complete Dearth Of Information Relating To Dynepo's Development In Cancer-Related Anemia...
    • ...However, Equal Efficacy To Epogen/Procrit Has Been Demonstrated In Treatment Of Anemia Related To Chronic Kidney Disease
    • Datamonitor Comments
    • Ongoing Patent Litigation With Amgen Resulted In Delayed European Launch Of Dynepo, Plus A Ban On Us Launch Until Relevant Patents Have Expired
    • Dynepo's Pricing At A 30% Discount To Its Competitors In Germany Means That Some Off-Label Use In Oncology Indications Is Likely
    • Roche's Mircera (Continuous Erythropoietin Receptor Activator)
    • Drug Profile
    • A Novel Erythropoiesis-Stimulating Agent With Several Theoretical Advantages Over Competitors
    • Suspension Of Recruitment Into An Oncology Phase Ii Due To An Imbalance In Fatalities Across Treatment Arms
    • Clinical Trial Data
    • Mircera Appears To Have Dose-Dependent Clinical Activity In Anemic Nhl Patients Receiving Chemotherapy
    • Phase Ii Results In Nsclc Patients Support The Feasibility Of Extended Administration Of Mircera
    • Mircera Produces A Rapid And Sustained Hemoglobin Response In Multiple Myeloma Patients
    • Datamonitor Comments
    • Despite Potentially Negative Publicity Surrounding Suspension Of Enrollment Into The Nh19960 Study, Mircera's Reputation Should Remain Relatively Intact
    • Hurdles Put In Place By Amgen Need To Be Overcome
    • Entering The Eu Market Is Likely To Be Slightly Easier For Roche
    • The Entire Erythropoietin Drug Class Has Come Under Fire
    • Forecasts
    • Datamonitor Drug Assessment Summary
    • Future Potential Of Pipeline Erythropoeisis-Stimulating Products
    • Both Pipeline Erythropoietins Are Expected To See Some Off-Label Use Prior To Formal Approval In Oncology Indications
  • Chapter 7 Pipeline Anti-Neutropenia Products Analysis And Forecasts
    • Pipeline Overview
    • The Current Cancer-Related Neutropenia Pipeline
    • An Exceedingly Sparse Pipeline Means Any Threat To Currently Marketed Products Is Minimal
  • Chapter 8 Pipeline Anti-Thrombocytopenia Products Analysis And Forecasts
    • Pipeline Overview
    • Definition Of Current Comparator
    • Wyeth's Neumega (Oprelvekin)
    • Chosen Only Due To The Complete Lack Of Other Commercially Approved Products In This Indication
    • Glaxosmithkline/Ligand Pharmaceuticals' Promacta (Eltrombopag)
    • Drug Profile
    • Promacta's Oral Availability May Represent A Significant Advantage
    • Clinical Trial Data
    • Early Trial Data Demonstrates Promacta's Ability To Boost Platelet Levels In Cancer Patients Undergoing Chemotherapy, But Fails To Meet Primary Endpoint
    • Positive Phase Iii Data In Other Indications Mean That Theoretically, Promacta Should Confer Efficacy In Cancer-Related Thrombocytopenia
    • Datamonitor Comments
    • A Severe Lack Of Approved Agents For The Prevention And/Or Treatment Of Cancer-Related Thrombocytopenia Provides Opportunity
    • A Gap In The Market Exists For A Product Such As Promacta, Which Glaxosmithkline Should Take Full Advantage Of
    • Amgen's Amg-531
    • Drug Profile
    • A Novel Drug Designed To Specifically Target The Thrombopoietin Receptor
    • Clinical Trial Data
    • No Cancer-Specific Study Data Exist, Making It Difficult To Judge Amg-531's Potential In This Patient Population
    • Datamonitor Comments
    • Amgen's Leading Status In The Oncology Supportive Care Market Will Prove Invaluable For Amg-531
    • Forecasts
    • Datamonitor Drug Assessment Summary
    • Future Potential Of Pipeline Anti-Thrombocytopenia Products
    • Following Initial Off-Label Use In Oncology Indications, The Anti-Thrombocytopenia Pipeline Products Are Forecast To Enjoy Significant Sales
  • Chapter 9 Pipeline Anti-Mucositis Products Analysis And Forecasts
    • Pipeline Overview
    • Definition Of Current Comparator
    • Amgen's Kepivance (Palifermin)
    • Chosen Only Due To The Complete Lack Of Other Commercially Approved Products In This Indication
    • Mgi Pharma's Saforis (L-Glutamine)
    • Drug Profile
    • Increasing Availability Of L-Glutamine In The Oral Mucosa May Prevent The Onset Of Mucositis
    • Clinical Trial Data
    • Phase Iii Trial Results Showing Saforis Is Capable Of Significantly Reducing The Incidence Of Oral Mucositis Forms The Basis For Nda Submission
    • Earlier Phase Iii Results Show Saforis Appears To Reduce The Incidence Of Oral Mucositis
    • Datamonitor Comments
    • Cost And Route Of Administration Of Amgen's Kepivance Places Saforis At A Significant Advantage
    • Forecasts
    • Datamonitor Drug Assessment Summary
    • Future Potential Of Pipeline Anti-Mucositis Products
    • A Relatively Low Level Of Peak Sales Are Deceptive In The Face Of Reasonable Uptake Of Saforis In Cancer-Releated Mucositis
  • Chapter 10 Pipeline Cancer-Related Skeletal Events Products Analysis And Forecasts
    • Pipeline Overview
    • Definition Of Current Comparator
    • Novartis's Zometa (Zoledronate)
    • The Leading Bisphosphonate For The Prevention And/Or Treatment Of Cancer-Related Skeletal Events
    • Amgen's Denosumab (Amg-162)
    • Drug Profile
    • The First Targeted Therapy For Cancer-Related Skeletal Events
    • Clinical Trial Data
    • Interim Results Show Denosumab To Be At Least As Effective As Intravenous Bisphosphonates In Reducing The Risk Of Cancer-Related Skeletal Events
    • Interim Results Show Denosumab Normalizes Bone Turnover More Frequently Than Intravenous Bisphosphonates
    • Datamonitor Comments
    • By Virtue Of Its Monoclonal Antibody Formulation, Denosumab Is Likely To Be More Expensive Than Currently Marketed Bisphosphonates...
    • ...However, Its Lack Of Association With Osteonecrosis Of The Jaw May Work In Its Favor
    • Amgen's Experience Represents A Major Advantage For Denosumab
    • Forecasts
    • Datamonitor Drug Assessment Summary
    • Future Potential Of Pipeline Cancer-Related Skeletal Events Products
    • Denosumab Theoretically Confers Several Advantages Over Currently Available Bisphosphonates, Therefore Uptake And Accompanying Sales Are Forecast To Be Encouraging
  • Chapter 11 Commercial Impact And Lifecycle Management: Case Study
    • The Changing Oncology Supportive Care Market
    • Current Areas Of Commercial Opportunity
    • Several Areas Of Supportive Care Are Drastically Underserved At Present
    • Potentially Increasing Range Of Use For Current Products
    • Increasing Use Of Targeted Therapies
    • A Shift Towards Increased Use Of Molecular Targeted Therapies Will Introduce New Supportive Care Challenges
    • New Supportive Care Measures Need To Be Developed, Thereby Providing Significant Commercial Opportunity...
    • ...Yet, It Could Be That The High Cost Of The Targeted Therapies Will Result In Hampered Uptake Of Supportive Care Products
    • The Threat Of Biosimilars
    • The Biologic Supportive Care Products Will No Longer Be Protected From Generic Competition
    • Some Biosimilar Products Can Be Launched In The Eu Immediately...
    • ...However, The Us Is Lagging Behind
    • The High Cost Of Some Supportive Care Products Inhibits Their Use, Indicating A Great Desire For Cheaper Biosimilar Versions...
    • ...Although Biosimilar Drugs Bring With Them A New Set Of Issues
    • Increased Safety Concerns In Future
    • As Seen With The Erythropoeitins Class, Increased Vigilance With Respect To Safety May Be Enforced In The Future
    • How The Oncology Supportive Care Market Will Change
    • On The Whole, The Oncology Supportive Care Market Will Undergo Positive Growth...
    • ...Albeit At A Minimal Growth Rate, Due To A Lack Of Major Innovation
    • Future Growth Is Likely To Come From Those Early-Phase Products Targeting New Supportive Care Indications
  • Appendix A - Market Data And Major Brand Key Facts
    • A4a (Anti-Emetics And Anti-Nauseants) Class Market Data
    • B3c (Erythropoiesis-Stimulating Products) Class Market Data
    • L3a1 (Colony-Stimulating Factors) Class Market Data
    • L3a9 (Other Immunostimulating Agents) Class Market Data
    • M5b1/M5b2 (Oral And Injectable Bisphosphonates) Class Market Data
    • V3d0 (Other Detoxifying Agents For Cancer) Class Market Data
    • Sales Data And Forecasts
    • Powerpoint Executive Presentation
  • Appendix B - Sales Forecasts
    • Us Forecasts
    • Japan Forecasts
    • France Forecasts
    • Germany Forecasts
    • Italy Forecasts
    • Spain Forecasts
    • Uk Forecasts
    • Five Major European Markets (Eu5) Forecasts
    • Seven Major Market Forecasts
  • Appendix C
    • Bibliography
  • List Of Tables
  • List Of Figures
    • Methodology
    • Datamonitor Forecast Methodology
    • Forecasts For Marketed Drugs
    • Forecasts For Pipeline Drugs
    • Datamonitor Drug Assessment Methodology
    • About The Oncology Analysis Team
    • Disclaimer