Consolidated Donor Funded Procurement of HIV Diagnostics

Transcription

1 Consolidated Donor Funded Procurement of HIV Diagnostics Meeting on HIV Diagnostic Global Demand Forecast Geneva, 9 April 2015 Mercedes Perez Gonzalez Prequalification Team Diagnostics Assessment Department of Essential Medicines & Health Products

2 WHO annual data analysis Since 2000, WHO/PQT has analysed the volume of IVDs procured in the donor-funded public sector market Using data sets from Global Fund, SCMS, UNICEF, WHO,CHAI Data is cleaned and aggregated Duplicates and obvious errors removed Most complete data sets for HIV RDTs Less complete data sets for HIV EID, HIV VL, CD4 2

3 Quality of data reported Delays in reporting Challenges for data analysis GFATM Entry for RDT/EIA only mandated since 2008 Entry for CD4/VL/EID only mandated since 2013 WHO is not strictly a major procurer, UNICEF acts as for UN family Different identifiers Different regulatory versions Price implications Duplication between sources UNICEF, GFATM, etc. 3

4 Major limitations of the data set GFATM, SCMS data analysed on actual delivery date while WHO and UNICEF data on purchase order date Limited to key reagents Data for CD4, VL and EID restricted to 2013 and 2014 Data set for GFATM 2014 likely incomplete No data on direct procurement from countries 4

5 Procurement of HIV RDTs CHAI WHO UNICEF SCMS GFTAM CHAI WHO UNICEF SCMS GFTAM 73,136,872 89,942,637 81,687,704 5

6 HIV S/R Assays VWAP(US$), Ex-Works GFATM SCMS UNICEF WHO data from WHO excludes data from Vietnam 6

7 Manufacturer market share (2013, 2014) by volume HIV S/R assays 6% 4% % Alere 2% 2% 1% Trinity Biotech Premier Medical Corporation Ltd. 0% 4% 4% 2% 6% 0% 0% 1% 2013 Alere Shanghai Kehua Bioengineering Co., Ltd. Orgenics Ltd Orgenics Ltd. Chembio Diagnostic Systems, Inc. Shanghai Kehua Bioengineering Co., Ltd. Standard Diagnostics 12% 12% 59% Chembio Diagnostic Systems, Inc. Premier Medical Corporation Ltd. Trinity Biotech Standard Diagnostics InTec Products Orasure Technologies Orasure Technologies InTec Products Fujirebio Inc. Other ACON Biotech (Hangzhou) Co., Ltd Excludes data from CHAI 7

8 Trends up to 2014 HIV RDT market has always been highly consolidated Dominated by Determine HIV-1/2 (Alere Medical) with 83% market share in 2014 Despite 12 HIV RDTs WHO prequalified, just 5-6 other RDTs make up the rest of market Alere owns Abon, Standard Diagnostics, Alere Medical 8

9 Expected trends up to 2018 National validated testing algorithms usually reviewed every 5 years Maximum of 3 assays required Most public sector procurement goes to high prevalence settings Therefore likely to only require 2 assays mostly So some predictability of what assays will be used in which order 1 st line, 2 nd line, 3 rd line assays 9

10 HIV Virological Technologies Use of specific reagents as tracer reagents to estimate consumption of VL, and of EID assays Relatively few data points available as scale-up it yet to happen Will be increasingly hard to do this in the future as the same platform with same or different reagents might be used for the two different objectives E.g. Use of Alere Q HIV-1/2 Detect for both resolution of adult HIV diagnosis (from inconclusive results) and for infant diagnosis 10

11 Viral load tracer reagents procurement UNICEF SCMS GFTAM UNICEF SCMS GFTAM , ,112 11

12 HIV VL Market Share 2013, 2014 (volume) Tracer reagents 2014 Abbott RealTime HIV % 7% 0% 50% artus HI Virus-1 RG RT- PCR Kit 3% 5% 0% 20% Abbott RealTime HIV-1 Biocentric Generic Charge Virale artus HI Virus-1 RG RT-PCR Kit 38% 3% 1% COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 Exavir Load Version 3 HIV Quantitative REAL- TIME PCR Kit 72% Biocentric Generic Charge Virale COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version

13 Expected trends up to 2018 Expansion of COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 due to Roche Global Access Programme As platforms are multi-analyte Likely to be used for purposes other than HIV VL such as EID, HCV, etc. Important to forecast the facility needs to ensure platforms is well-utilised 13

14 Qualitative tracer reagents procurement CHAI UNICEF SCMS GFTAM CHAI UNICEF SCMS GFTAM , ,528 14

15 Qualitative (tracer reagents) market share by volume (2013, 2014) 0% 2% 2013 Abbott RealTime HIV-1 Qualitative 2014 Abbott RealTime HIV-1 Qualitative 32% Alere q HIV-1/2 Detect 20% Alere q HIV-1/2 Detect 2% 66% AMPLICOR HIV-1 DNA Test v1.5 68% 10% AMPLICOR HIV-1 DNA Test v1.5 COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0 COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0 15

16 Added Costs for virological technologies Extraction Reagents Calibrators Controls Service maintenance contract (around 20 % instrument price) WHO establishes LTAs with manufacturers (not volume dependent) 16

17 CD4 tracer reagents procurement CHAI WHO UNICEF SCMS GFTAM CHAI WHO UNICEF SCMS GFTAM ,466,005 7,758,430 17

18 CD4 Trends FASCount (BD) had dominated the market for some years Diffusion of CD4 technologies for POCT PIMA CD4 (Alere Technologies GmbH) was first to PQ, first to market Maturation of regulatory approval processes in some countries Therefore, hesitant to implement without their own evaluation FACSPresto (BD) may be suited to higher through-put facilities Role for CD4 to initiate ART will continue as CD4 threshold recommendations still in place And in settings where viral load scale-up proceeds slowly, CD4 may still be used for monitoring ART 18

19 Trends up to 2018 Likely continued expansion of CD4 technologies for POCT Laboratory-based, high through-put instruments will continue to be used outside of sub-saharan Africa where CD4 is used for testing objectives other than for ART initiation Total volume of CD4 likely to decrease reflecting scale up of HIV viral load for monitoring ART 19

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