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Malaria Medicines Landscape

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Malaria Medicines Landscape 2015 Malaria Medicines Landscape MARCH 2015 UNITAID Secretariat World Health Organization Avenue Appia 20 CH-1211 Geneva 27 Switzerland T +41 22 791 55 03 F +41 22 791 48 90 [email protected] www.unitaid.org UNITAID is hosted and administered by the World Health Organization © 2015 World Health Organization (Acting as the host organization for the Secretariat of UNITAID) The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind either expressed or implied. The responsibility and use of the material lie with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This report was prepared by Katerina Galluzzo and Alexandra Cameron with support from UNITAID. All reasonable precautions have been taken by the author to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall UNITAID or the World Health Organization be liable for damages arising from its use. ii CONTENTS Abbreviations . vii Executive summary . 10 1. Introduction . 19 2. Methodology . 20 2.1 Literature review . 20 2.2 Data collection and analysis . 23 3. Public health problem . 27 3.1 Global malaria guidelines and policy recommendations for treatment . 30 3.2 Commodity access issues in treatment . 32 3.2.1 Child-friendly ACT formulations . 34 3.2.2 Severe malaria treatments . 35 3.2.3 Preventive chemotherapy . 35 4. Medicines technology landscape . 37 4.1 Overview of current products on the market . 37 4.2 Pipeline . 40 5. Market landscape . 45 5.1 Growth and evolution of the ACT market . .46 5.2 UNITAID and scaling up ACTs . 51 5.3 Current ACT market . 52 5.3.1 Market size . 52 5.3.2 Market share . 55 5.3.3 Prices . .64 5.4 Paediatric ACTs . 71 5.4.1 Market characteristics of donor-procured, child-pack ACT . 71 5.4.2 Characteristics of the market for dispersible AL. .76 5.4.3 Procurement prices of ACTs for children under 5 years old in the donor-funded market. .78 5.4.4 Retail availability and price of child-dose QAACTs . 82 Technical Report iii 2015 UNITAID Malaria Medicines Landscape 5.5 Severe malaria . .83 5.5.1 Injectable therapies for severe malaria market overview . 83 5.5.2 RAS market overview. .84 5.6 Overview of the antimalarial market in the WHO South-East Asia Region and Western Pacific Region. .85 5.6.1 Market size and share of malaria products procured for the WHO South-East Asia Region and Western Pacific Region . 85 5.6.2 Market share of ACTs and non-artemisinin monotherapies (oral therapies) procured in the donor-funded market for the WHO South-East Asia Region and Western Pacific Region . 88 5.6.3 Market share of antimalarials distributed at the facility level in Cambodia and Myanmar .....89 5.6.4 Trends in availability of antimalarials in private and public sector facilities in Cambodia and Myanmar. .91 5.6.5 Cambodia and Myanmar median price of available antimalarials in the private sector .......93 5.7 Artemisinin market overview . 95 5.7.1 Artemisinin supply chain . 96 5.7.2 Artemisinin production costs . 97 5.7.3 Artemisinin prices . 97 5.7.4 Artemisinin supply forecasts . 98 5.7.5 Market volatility . 100 6. Market shortcomings and their reasons . 101 6.1 Market shortcomings for malaria medicines . 101 6.2 Market shortcomings for paediatric antimalarial medicines . 104 7. Opportunities for market interventions . 105 7.1 Potential opportunities . .105 8. Appendices . 110 References . 113 Figures Figure 1. Flow chart illustrating the merging of data source and total results . 25 Figure 2. Malaria disease burden estimated deaths and estimated cases, 2000–2013 . 28 Figure 3. Malaria cases (estimated) by WHO region, 2012; malaria deaths (estimated) by WHO region, 2013 . 29 Figure 4. Global malaria deaths in the 10 highest burdened countries, 2012. .29 Figure 5. Global malaria cases in the 10 highest burdened countries, 2012. .30 Figure 6. Summary of WHO treatment guidelines for malaria . 32 Figure 7. Approximation of QAACT coverage compared to annual malaria cases, 2013 . 33 Figure 8: Proportion of ACTs among antimalarial treatments given to febrile children, by health sector, nine African countries with at least two household surveys, 2006–2012. .34 Figure 9. Global malaria medicines pipeline . 42 iv Table of Contents Figure 10. ACT deliveries, by health sector and initiative status, 2005–2013 . .47 Figure 11. Global Fund malaria programme grant allocations over time, by United Nations geographical regions (2004–2016) . 50 Figure 12. Number of ACTs procured for Africa compared to total donor procurement (world), 2009–2012 . 51 Figure 13. Value of the donor-funded prequalified ACT market over time, by ACT, 2007–2012 . 54 Figure 14. Value of donor-funded ACT market in 2012, by manufacturer ($US) . 55 Figure 15. ACT deliveries to the public and private sector, 2005–2013. .56 Figure 16. ACTs procured in the donor-funded market by United Nations geographical region, 2007–2013 . 57 Figure 17. Market share by volume of AL by manufacturer, 2007–2012 . 58 Figure 18. Market share by volume of ASAQ and AS+AQ by manufacturer, 2008–2012 . 59 Figure 19. Percentage of treatment courses that were FDCs, 2007–2013 . 61 Figure 20. Market share of antimalarials distributed in the public and private sectors, over time (DRC, Nigeria and Uganda) . 63 Figure 21. Market share of QAACT brands among all QAACTs sold/distributed within outlets in the past seven days, by sector (Nigeria and Uganda), 2011 and 2013 . .64 Figure 22. Median treatment course price of AL 6x4, ASAQ co-blister 12+12 and FDC 3x2 procured by international donors, 2006–2013 . 65 Figure 23. Median unit price, AL 6x4 treatment course, by manufacturer, procured by international donors, 2007–2013 . 67 Figure 24. Median unit price of ASAQ 3x2, by manufacturer, procured by international donors, 2007–2013 . 68 Figure 25. Price of QAACTs vs non-QAACTs AETD, among ACTs audited in the private, 2009–2013 . 69 Figure 26. Price of QAACTs, non-QAACTs and non-oAMTs, AETD among outlets stocking at least one antimalarial at the time of survey in the private sector, 2013. .70 Figure 27. Availability of antimalarials, among outlets stocking at least one antimalarial at the time of survey, by sector . 71 Figure 28. Market value of AL and ASAQ/AS+AQ procured in the donor market for children under 5 years old, 2007–2012 . .72 Figure 29. AL relative percentage of pack sizes procured in the donor market, 2007–2013 . 73 Figure 30. ASAQ and AS+AQ relative percentage of pack sizes procured in the donor market, 2007–2012 . .74 Figure 31. Volumes of ACT packs for children under 5 years old (ASAQ and AS+AQ) procured by international donors, 2007–2012. .75 Figure 32. Proportion of AS+AQ and ASAQ packs for children under 5 years old procured by international donors, by manufacturer, 2008–2013. .76 Figure 33. Volume of AL packs for children under 5 years old procured by international donors, 2007–2012, by dispersibility. ..
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