Pipeline/Commercial Insight: Supportive Care in Oncology - Significant growth opportunities exist in new supportive care indications : Market Research Report

Pipeline/Commercial Insight: Supportive Care in Oncology - Significant growth opportunities exist in new supportive care indications

Published by: Datamonitor

Published: Jun. 15, 2007 - 241 Pages

ABOUT DATAMONITOR HEALTHCARE: 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 Datamonitor; About Datamonitor Healthcare; About the Oncology analysis team; Disclaimer

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Pipeline/Commercial Insight: Supportive Care in Oncology - Significant growth opportunities exist in new supportive care indications

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