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Malaria Diagnostics Technology and Market Landscape

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Malaria Diagnostics Technology and Market Landscape LANDSCAPE MALARIA DIAGNOSTICS TECHNOLOGY AND MARKET LANDSCAPE 3rd EDITION APRIL 2016 © 2016 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 lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This report was prepared by Jennifer Daily with support from UNITAID. All reasonable precautions have been taken by the authors 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. Design and layout: blossoming.it 2 | Malaria diagnostics technology and market landscape 2016 LANDSCAPE MALARIA DIAGNOSTICS TECHNOLOGY AND MARKET LANDSCAPE 3rd EDITION APRIL 2016 Malaria diagnostics technology and market landscape 2016 | 3 Table of Contents 7 Abbreviations 10 Executive summary 10 Introduction and methodology 10 Public health problem, commodity access and malaria policy 11 Quality and regulatory programmes 11 Technology landscape 13 Malaria RDT market 16 Market shortcomings 16 Opportunities for market intervention 17 1. Introduction 18 2. Methodology 18 Diagnostics technology landscape methods 19 Market landscape methods 22 Acknowledgements 23 3. Public health problem and commodity access 24 Role of diagnostics in managing fever/case management 24 Role of malaria diagnostics in surveillance and programme management 25 Changes in epidemiology 26 Global targets for malaria 27 Malaria diagnostics policies 28 Access to malaria diagnostics for case management 4 | Malaria diagnostics technology and market landscape 2016 33 4. Performance, quality and regulatory programmes 33 WHO Product Testing Programme (only for malaria RDTs) 34 WHO-FIND Lot Testing Programme (only for malaria RDTs) 34 WHO Prequalification of In Vitro Diagnostics Programme (PQ) 35 Global Fund/UNITAID Expert Review Panel for diagnostics 35 Other regulators 38 5. Malaria diagnostics technology landscape 38 Overview of approaches to malaria diagnosis 38 Antigen-detecting malaria RDTs 45 Microscopy 48 Nucleic acid detection 56 Hemozoin detection 59 Spectroscopy 60 Serology 61 Technology pipeline progress and the malaria R&D agenda 66 Diagnostics to support P. vivax management 71 Diagnostics for elimination and low-level transmission 72 Malaria diagnostics technology development challenges 76 6. Malaria RDT market landscape 76 Growth and evolution of the malaria RDT market 77 Public and private sector diagnostic test availability 79 Range of malaria RDT products and suppliers 80 Prices 83 Market share (by volume of RDTs) Malaria diagnostics technology and market landscape 2016 | 5 85 Malaria RDT quality 90 Malaria RDT demand 100 Malaria RDT supply 106 7. Market shortcomings 110 8. Opportunities for market interventions 110 Market interventions: works in progress 112 Market interventions: additional opportunities 120 Annex 1. Surveillance in low-transmission settings 121 Annex 2. WHO malaria diagnostics policies 125 Annex 3. R&D and programmatic stakeholders 125 R&D stakeholders 127 Programme donors 130 Annex 4. Technology developer and product profiles 155 Annex 5. Contribution of public and private sector outlets to malaria management 158 Annex 6. Additional information on quality and adaptability of RDTs 162 Annex 7. Procurement processes 165 Annex 8. RDT need compared to RDT financing 166 References 6 | Malaria diagnostics technology and market landscape 2016 Abbreviations ACT artemisinin-based combination therapy ALMA African Leaders Malaria Alliance °C degree Celsius CE Mark European Conformity (Conformité Européenne) mark CHAI Clinton Health Access Initiative cm centimetre DFID Department for International Development (United Kingdom) DNA deoxyribonucleic acid ELISA enzyme linked immunosorbant assay FIND Foundation for Innovative New Diagnostics Global Fund Global Fund to Fight AIDS, Tuberculosis and Malaria GMP Global Malaria Programme GPS global positioning system GTS Global Technical Strategy for Malaria 2016–2030 G6PD glucose-6-phosphate dehydrogenase Hb haemoglobin HRP-II histidine rich protein-II HWG Harmonization Working Group (Roll Back Malaria Partnership) IPTp intermittent preventive treatment in pregnancy ISO International Organization for Standardization ISTp intermittent screening and treatment in pregnancy kg kilogram LAMP loop-mediated isothermal amplification LED light-emitting diode Malaria diagnostics technology and market landscape 2016 | 7 LOD limit of detection MAb monoclonal antibody mL millilitre MPAC Malaria Policy Advisory Committee NAAT nucleic acid amplification test ng nanogram NGO nongovernmental organization PCR polymerase chain reaction PCW positive control well Pf Plasmodium falciparum/P. falciparum pLDH parasite lactate dehydrogenase PMI United States President’s Malaria Initiative POC point of care PPM Pooled Procurement Mechanism (Global Fund) PQ WHO Prequalification of In Vitro Diagnostics Programme PQR Price and Quality Reporting (Global Fund) PSI Population Services International Pv Plasmodium vivax/P. vivax Pvom Plasmodium vivax, ovale, malariae p/µL parasites per microlitre QA quality assurance QC quality control QMS quality management systems R&D research and development 8 | Malaria diagnostics technology and market landscape 2016 RBC red blood cells RDT rapid diagnostic test RNA ribonucleic acid TB tuberculosis TBD to be determined µL microlitre UMT Urine Malaria Test™ UNICEF United Nations Children’s Fund US United States USAID United States Agency for International Development USB universal serial bus US CDC United States Centers for Disease Control, Atlanta US FDA United States Food and Drug Administration UV ultraviolet VPP Voluntary Pooled Procurement WHO World Health Organization Malaria diagnostics technology and market landscape 2016 | 9 Executive summary Introduction and methodology This report is part of an ongoing initiative within UNITAID to describe and monitor the malaria diagnostics technology and market landscape. It includes a review of the current research and development (R&D) pipeline and the rapid diagnostic test (RDT) market, analysis of the markets overall health and discussion of potential opportunities for market-based interventions to address challenges. Information in this report was derived through a variety of methods, including desk research, procurement dataset analyses and consultation with experts. Public health problem, commodity access and malaria policy Globally, since 2000, there has been a 37% decrease in malaria incidence; however, progress is both uneven and fragile. Many countries have reduced transmission to very low levels and over one third of the 96 malaria-endemic countries have committed to elimination in the coming decades. At the same time, declines in incidence and mortality have been slower in the countries that have the highest burden of disease. To address these epidemiological shifts and ensuing challenges, in May 2015, the World Health Assembly adopted a new World Health Organization (WHO) Global Technical Strategy for Malaria 2016–2030 (GTS), a 15-year roadmap for malaria. The GTS sets out targets for control and for elimination. With respect to diagnosis, the GTS emphasizes the need to achieve universal coverage of core interventions, including diagnostic testing, as well as the need for innovative delivery and new diagnostic product development. Additionally, 10 | Malaria diagnostics technology and market landscape 2016 it stresses the importance of surveillance, and diagnostic testing underpins many surveillance activities. In 2010, WHO began recommending that all suspected cases of malaria be tested before treatment. Since then progress has been most pronounced in the public sector, especially in Africa where an estimated 65% of cases were tested in 2014, a 24% increase over testing rates in 2010. However, hundreds of millions of fevers remain undiagnosed, and presumptive treatment is still common, particularly in the private sector, as is seeking no form of treatment for fever. Quality and regulatory programmes For malaria RDTs, there are several quality programmes in place, including the WHO Product Testing Programme, the WHO-FIND Lot Testing Programme and the WHO Prequalification of In Vitro Diagnostics Programme (PQ). The Product Testing Programme has been most influential, although there are still gaps in the malaria RDT quality continuum (see Section 7 and 8). These programmes are currently only available for blood-based RDTs; the
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