Projected Demand for HIV Diagnostic Tests

Projected Demand for HIV Diagnostic Tests John Stover, Yu Teng, Adebiyi Adesina, Eline Korenromp On behalf of the Diagnostics Forecasting Technical Working Group (CDC, CHAI, GFATM, PfSCM, UNAIDS, UNICEF, USAID, WHO) GLOBAL FORECASTS OF DIAGNOSTIC DEMAND FOR 2014-2018, WHO MEETING WITH DIAGNOSTIC MANUFACTURERS AND STAKEHOLDERS Geneva, 9-10 April 2015

Purpose Project future demand for HIV diagnostic tests. These projections are intended to: Support advocacy for the scale-up of access to HIV-related diagnostics; Inform producers so that they can plan for adequate supply.

Data Sources WHO Survey: Data about actual test utilization, provided by countries in response to an annual survey conducted by WHO. CHAI: Utilization data from 25 countries supported by CHAI. PfSCM: Procurements for 2011-2013 for countries covered by the PfSCM project. Procurement: Procurement data reported to WHO through the Global Price Reporting Mechanism (GPRM), including by Global Fund. GARPR: Country reports on number of tests performed as provided to the Global AIDS Response Progress Reporting system. Projected ART and PMTCT patients: Projections to 2018 of the number of ART and PMTCT patients by country prepared by Avenir Health based on UNAIDS estimates.

Seven Projection Scenarios Extrapolation: Linear extrapolation of past trends of actual use, reported through the WHO surveys. 90-90-90: Achievement of UNAIDS treatment targets for 2020. Guidelines: All countries implement WHO testing guidelines. Country Targets: Achievement of country-defined targets, stated by countries in the WHO surveys. CHAI: Country-specific forecasts for 25 key countries, scaled up to global level. PfSCM: Linear extrapolation of past procurement trends by PfSCM. Procurement: Linear extrapolation of procurement trends reported to GPRM. GARPR: Linear extrapolation of country reports through GARPR.

Methods: Extrapolate past trends, based on WHO Survey For countries reporting data for 2 or 3 years, use linear extrapolation. For countries with data for one year, apply the ratio of tests to ART patients in that year. For EID apply the ratio to HIV+ women receiving PMTCT. For countries with no data, apply the average ratio of tests to ART or PMTCT patients from countries with data. Constrain the EID forecast by the total need for PMTCT (95% of HIV-infected pregnant women) in each country, plus 10% to account for re-tests. 80 60 40 20 0 Number of Countries Responding CD4 VL EID 2011 2012 2013

Methods: 90-90-90 Targets / Projections Ambitious Treatment Targets: Writing the Final Chapter of the AIDS Epidemic UNAIDS Reference Discussion Paper By 2020: 90% of HIV+ people know their status 90% of those diagnosed are sustained on antiretroviral therapy 90% on treatment with durable viral suppression. Achieving these goals would mean 60% more people on treatment in 2018 than 2015 CD4 tests: 14% higher than a linear extrapolation of past trends. VL: WHO guidelines achieved by 2018 EID: 95% PMTCT coverage, + 10% re-tests for infants HIV-positive.

Methods: Other scenarios (I) Guidelines scenario: This scenario characterizes the need for diagnostic tests. It uses a linear extrapolation of the number of people on ART by country, and assumes that all countries will fully implement WHO guidelines which call for: 2 CD4 tests at treatment initiation, and one annually while on ART; 2 VL tests in the first year of treatment, and one annually after the first year; One EID test for each child born to an HIV+ mother, plus confirmatory tests for those (~10%) found HIV+. Country Targets scenario: This scenario uses targets for 2017, submitted by national programs, as part of the 2014 WHO survey: CD4 tests: Average 29% increase from 2013 to 2017. EID: 184% increase from 2013 to 2017 (Kenya).

Methods: Other scenarios (II) CHAI: Market forecasts prepared by CHAI, based on detailed analyses in 25 supported countries, scaled up to all low- and middle-income countries. SCMS: Actual procurements for 2011-2013 for countries covered by SCMS, linearly extrapolated to 2014-2018. Procurement: Procurement data (RDT, etc.) reported through the Global Price Reporting Mechanism (GPRM), including Global Fund, linearly extrapolated to 2014-2018. GARPR: Country reports on number of tests (RDT) performed, as provided to the Global AIDS Response Progress Reporting system, linearly extrapolated to 2014-2018.

CD4 Tests: Top 10 countries 6 000 000 Data Projection (linear extrapolation, from WHO survey) 5 000 000 4 000 000 3 000 000 2 000 000 1 000 000 0 2011 2012 2013 2014 2015 2016 2017 2018 South Africa India Uganda Kenya China Thailand Zimbabwe Zambia Ukraine Côte d'ivoire

Demand for CD4 Tests: all LMIC 40 000 000 35 000 000 30 000 000 Data Projection 25 000 000 20 000 000 15 000 000 10 000 000 Linear Extrapolation 90/90/90 goal Country targets CHAI High CHAI Low PFSCM Guidelines 5 000 000 0 2011 2012 2013 2014 2015 2016 2017 2018 Note that the PfSCM forecast is for a limited number of countries.

Indexes of Total Demand for CD4 Tests (2013=1.0) 2.4 2.2 2.2 2.0 1.8 1.6 1.4 1.2 1.9 1.8 1.7 1.6 1.6 1.4 Linear Extrapolation 90/90/90 goal Country targets CHAI High CHAI Low PFSCM Guidelines 1.0 2013 2014 2015 2016 2017 2018 Note: PfSCM forecast is for a limited number of countries.

CD4 Tests by Region 20 000 000 16 000 000 Data Projection (linear extrapolation, from WHO survey) 12 000 000 8 000 000 4 000 000 Africa Asia & EE LAC 0 2011 2012 2013 2014 2015 2016 2017 2018 Africa includes both SSA and North Africa; Asia and EE includes all of Asia and Eastern Europe; LAC includes all of Latin America and the Caribbean

Viral Load Tests: Top 10 Countries 6 000 000 5 000 000 4 000 000 3 000 000 2 000 000 1 000 000 Data Projection South Africa Brazil Thailand Uganda United Republic of Tanzania Zambia China Mozambique Ukraine Kenya 0 2011 2012 2013 2014 2015 2016 2017 2018 South Africa accounts for 1/3 of total market. Uganda, Tanzania, Zambia and Mozambique should be in the top 10 on the basis of numbers of ART patients, but they have not provided any data on VL testing.

Demand for Viral Load Tests 35 000 000 30 000 000 Data Projection 25 000 000 20 000 000 15 000 000 10 000 000 Linear Extrapolation 90/90/90 goal Country targets CHAI Guideline 5 000 000 0 2011 2012 2013 2014 2015 2016 2017 2018

Indexes of Demand for Viral Load Tests (2013=1.0) 4.5 4.0 4.40 4.35 4.00 3.5 3.0 2.5 2.0 1.5 2.08 1.71 Linear Extrapolation 90-90-90 Goal Country targets CHAI Guideline 1.0 2013 2014 2015 2016 2017 2018

Demand for Viral Load Tests by Region 12 000 000 10 000 000 Data Projection (linear extrapolation, from WHO survey) 8 000 000 6 000 000 4 000 000 Africa Asia & EE LAC 2 000 000 0 2011 2012 2013 2014 2015 2016 2017 2018 Africa includes both SSA and North Africa; Asia and EE includes all of Asia and Eastern Europe; LAC includes all of Latin America and the Caribbean

Early Infant Diagnosis: Top 10 Countries 350 000 Data Projection (linear extrapolation, from WHO survey) 300 000 250 000 200 000 150 000 100 000 50 000 South Africa Uganda Botswana Zimbabwe Kenya Nigeria Zambia United Republic of Tanzania Mozambique India 0 2011 2012 2013 2014 2015 2016 2017 2018

Demand for EID Tests 3 500 000 3 000 000 Data Projection 2 500 000 2 000 000 1 500 000 1 000 000 Extrapolation 90/90/90 Country targets CHAI SCMS Procurement Guidelines 500 000 0 2011 2012 2013 2014 2015 2016 2017 2018 Note: SCMS forecast is for a limited number of countries.

Index of Demand for EID Tests (2013=1.0) 3.5 3.0 3.26 2.5 2.0 1.5 1.0 1.95 1.71 1.25 0.95 0.89 Extrapolation 90/90/90 Country targets CHAI SCMS Guidelines 0.5 2013 2014 2015 2016 2017 2018 Note: SCMS forecast is for a limited number of countries.

Demand for EID by Region 800 000 Data Projection (linear extrapolation, from WHO survey) 600 000 400 000 Africa Asia & EE LAC 200 000 0 2011 2012 2013 2014 2015 2016 2017 2018 Africa includes both SSA and North Africa; Asia and EE includes all of Asia and Eastern Europe; LAC includes all of Latin America and the Caribbean

Demand for Rapid HIV Tests 180 000 000 160 000 000 Data Projection 162 million 140 000 000 120 000 000 GARPR Procurement 100 000 000 80 000 000 81 million 60 000 000 40 000 000 20 000 000 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Indexes of Demand for Rapid HIV Tests (2013=1.0) 1.5 1.45 1.4 1.35 1.3 1.2 Procurement GARPR 1.1 1.0 2013 2014 2015 2016 2017 2018

Resource need, to reach targeted coverage (US $) Resource need, to reach targeted coverage (US $) Resource need, to reach targeted coverage (US $) Need for HIV testing: country projections $12,000,000 $9,000,000 $6,000,000 $3,000,000 $- Mozambique Nigeria $100,000,000 Family Planning ANC attendants / Pregnant women Out- & $80,000,000 in-patients w. AIDS symptoms TB patients Partners $60,000,000 of PLWH newly identified STI patients Other $40,000,000 outpatients & in-patients FSW MSM$20,000,000 IDU Other women $- 15-49 years Other men 15-49 years Family Planning ANC attendants / Pregnant women Out- & in-patients w. AIDS symptoms TB patients Partners of PLWH newly identified STI patients Other outpatients & in-patients FSW MSM IDU Other women 15-49 years Other men 15-49 years $6,000,000 $4,000,000 $2,000,000 $- Senegal Family Planning ANC attendants / Pregnant women Out- & in-patients w. AIDS symptoms TB patients Partners of PLWH newly identified STI patients Other outpatients & in-patients FSW MSM IDU Other women 15-49 years Other men 15-49 years Increase in test & budget needed, from 2015 to 2016-2020: Mozambique: 35% Nigeria: 267% Senegal: 169% Avenir Health projection for UNAIDS HCT consultation, March 2015

Summary Demand for CD4 tests is expected to continue to increase substantially, reaching 23-36 million by 2018. Demand for viral load tests will likely reach 15-30 million by 2018. Most scenarios however remain below the need (per 90-90-90 scenario) for reaching the 90% viral suppression target. Demand for EID tests will likely grow. But, decreasing HIV prevalence among pregnant women will likely limit 2018 demand to less than twice the volume used in 2013. The demand for RDTs is projected to increase by up to 45% by 2018. This is less than required to reach the 90-90-90 targets. In view of resource constraints, advocacy for the uptake of HIV testing and Viral Load testing will be critical to reach the 90/90/90 targets.