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ANTIRETROVIRAL MEDICINES IN LOW- AND MIDDLE-INCOME COUNTRIES:

FORECASTS OF GLOBAL AND

REGIONAL DEMAND FOR 2012–2015

MAY 2013

AIDS MEDICINES AND DIAGNOSTICS SERVICE

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ANTIRETROVIRAL MEDICINES IN LOW- AND MIDDLE-INCOME COUNTRIES:

FORECASTS OF GLOBAL AND

REGIONAL DEMAND FOR 2012–2015

MAY 2013

AIDS MEDICINES AND DIAGNOSTICS SERVICE

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1.Anti-Retroviral agents – supply and distribution. 2.HIV infections – therapy. 3.Drug industry – trends. 4.Developing countries. I.World Health Organization.

ISBN 978 92 4 150546 8 (NLM classification: WC 503.2)

© World Health Organization 2013

All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264;

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Printed by the WHO Document Production Services, Geneva, Switzerland.

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CONTENTS

Acknowledgements . . . 2

Abbreviations . . . 3

List of figures . . . 4

List of tables . . . 5

Executive summary . . . 6

1. Objectives and overall methods . . . 8

2. Determining the key forecast variables . . . 9

2.1 Total number of people receiving treatment . . . 9

2.2 Number of people receiving first- and second-line therapy . . . 12

2.3 Proportion of people receiving treatment by antiretroviral drug . . . 13

2.4 Number of women receiving antiretroviral drugs for preventing mother-to-child transmission . . . 18

3. Forecasting the demand for active pharmaceutical ingredients . . . 20

3.1 Calculating the total volumes of APIs in metric tonnes required for each antiretroviral drug. . . 20

3.2 Forecast demand for APIs for 2012–2015 . . . 21

4. Discussion . . . 22

References . . . 23

Annex 1. . . . 24

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ACKNOWLEDGEMENTS

WHO expresses its gratitude to the Futures Institute, in particular to John Stover and Biyi Adenesina, for their technical contribution in producing this report on forecasts for global and regional demand for antiretroviral drugs.

WHO is grateful for the valuable inputs from the Technical Working Group members who met in Washington, DC on 22–23 October 2012 to harmonize the assumptions and forecasts for global demand for antiretroviral drugs: Biyi Adenisina (Futures Institute), Randy Allen (Clinton Health Access Initiative (CHAI)), Robert Burn (Partnership for Supply Chain Management (PFSCM)), Bill Coggin (Office of the United States Global AIDS Coordinator), John Crowley (United States Agency for International Development (USAID)), Gordon Cumstock (PFSCM), Vincent Habiyambere (WHO), David Jamieson (PFSCM), Joel Kuritsky (USAID), Chris Larson (PFSCM), Christine Malati (USAID), Ron Marrocco (PFSCM), Richard Owens (PFSCM), Jos Perriëns (WHO), Rohini Sen (CHAI), Hema Srinivasan (CHAI), Robert Staley (PFSCM) and Dominique Zwinkels (PFSCM).

WHO thanks everyone who contributed to this product, especially Boniface Dongmo Nguimfack (WHO), who produced the Global Price Reporting Mechanism (GPRM) data, and WHO staff and partners who participated in the joint WHO/UNAIDS consultation with pharmaceutical companies and stakeholders.

WHO expresses its special thanks to the technical review and editing committee: Biyi Adenisina (Futures Institute), Jessica Fast (CHAI), Vincent Habiyambere (WHO), Carlos Passarelli (UNAIDS), Jos Perriëns (WHO), Rohini Sen (CHAI), Robert Staley (PFSCM) and John Stover (Futures Institute).

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3TC lamivudine ABC abacavir

AMDS AIDS Medicines and Diagnostics Service API active pharmaceutical ingredient

ATV atazanavir

AZT zidovudine (also known as ZDV) CHAI Clinton Health Access Initiative

d4T stavudine

ddI didanosine

EFV efavirenz

FL first line (antiretroviral therapy) FTC emtricitabine

GPRM Global Price Reporting Mechanism IDV indinavir

LPV/r lopinavir boosted with ritonavir NFV nelfinavir

NNRTI non-nucleoside reverse-transcriptase inhibitor NRTI nucleoside reverse-transcriptase inhibitor NtRTI nucleotide reverse-transcriptase inhibitor

NVP nevirapine

PI protease inhibitor

SL second line (antiretroviral therapy) SQV saquinavir

TB tuberculosis TDF tenofovir

UNAIDS Joint United Nations Programme on HIV/AIDS UNICEF United Nations Children’s Fund

WHO World Health Organization

ABBREVIATIONS

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LIST OF FIGURES

Figure 1. Model for forecasting antiretroviral drug demand. . . .8

Figure 2. Comparison of projections of the number of people receiving antiretroviral therapy, 2012–2015 . . . . 11

Figure 3. Number of adults and children receiving first- and second-line antiretroviral therapy, 2012–2015, based on an average of three projections . . . . 12

Figure 4. Projected market share (%) of the average volume of primary NRTIs, 2012–2015 . . . . 14

Figure 5. Project market share (%) of d4T as a proportion of the total volume of primary NRTIs, 2012–2015 . . . . 14

Figure 6. Projected market share (%) of AZT as a proportion of the total volume of primary NRTIs, 2012–2015 . . . . 15

Figure 7. Projected market share (%) of TDF as a proportion of the total volume of primary NRTIs, 2012–2015 . . . . 15

Figure 8. Projected market share (%) of ABC and ddI as proportions of the total volume of primary NRTIs, 2012–2015 . . . . 16

Figure 9. Projected market share (%) of 3TC and FTC as proportions of the total volume of secondary NRTIs, 2012–2015 . . . . 16

Figure 10. Projected market share (%) of NVP and EFV as proportions of the total volume of NNRTIs, 2012–2015 . . . . 17

Figure 11. Projected market share (%) of LPV and ATV as proportions of the total volume of PIs, 2012–2015 . . . . 17

Figure 12. Number of people receiving first- and second-line antiretroviral therapy based on linear projection, 2011–2015 . . . . 25

Figure 13. Number of people receiving first- and second-line antiretroviral therapy based on country target projection, 2011–2015 . . . . 25

Figure 14. Number of people receiving first- and second-line antiretroviral therapy based on Clinton Health Access Initiative data, 2012–2015 . . . . 26

Figure 15. Average number of people receiving first- and second-line antiretroviral therapy in sub-Saharan Africa, based on linear and country target projections, 2012–2015 . . . . 26

Figure 16. Average number of people receiving first- and second-line antiretroviral therapy in Latin America and the Caribbean, based on linear and country target projections, 2012–2015 . . . . 27

Figure 17. Average number of people receiving first- and second-line antiretroviral therapy in the Eastern Mediterranean, based on linear and country target projections, 2012–2015. . . . . 27

Figure 18. Average number of people receiving first- and second-line antiretroviral therapy in Europe, based on linear and country target projections, 2012–2015 . . . . 28

Figure 19. Average number of people receiving first- and second-line antiretroviral therapy in South and South-East Asia, based on linear and country target projections, 2012–2015 . . . . 28

Figure 20. Average number of people receiving first- and second-line antiretroviral therapy in the Western Pacific, based on linear and country target projections, 2012–2015 . . . . 29

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LIST OF TABLES

Table 1. Summary of results . . . .7

Table 2. Summary of assumptions made in the forecast scenarios . . . .9

Table 3. Number of adults and children receiving treatment by scenario and average, 2012–2015 . . . . 10

Table 4. Proportion of people receiving second-line treatment, 2012–2015 . . . . 12

Table 5. Total and average number of women receiving antiretroviral drugs for preventing mother-to-child transmission, 2012–2015 . . . . 18

Table 6. Projected regimen mix for women receiving antiretroviral drugs for preventing mother-to-child transmission, 2011 and 2015 . . . . 18

Table 7. Daily doses for antiretroviral drugs based on WHO recommendations . . . . 20

Table 8. Volume of demand for APIs in metric tonnes, 2012–2015 . . . . 21

Table 9. Average projected number of people receiving treatment by region based on linear and country target projections, 2012–2015 . . . . 24

Table 10. Countries that provided country target data . . . . 24

Table 11. Average number of women receiving antiretroviral drugs for preventing mother-to-child transmission by region based on an average of linear and country target projections, 2012–2015 . . . . 29

Table 12. Volume of demand for APIs in metric tonnes – linear projection, 2012–2015 . . . . 30

Table 13. Volume of demand for APIs in metric tonnes – country target projection, 2012–2015 . . . . 30

Table 14. Volume of demand for APIs in metric tonnes – Clinton Health Access Initiative projection, 2012–2015 . . . . 31

Table 15. Volume of demand for APIs in metric tonnes in sub-Saharan Africa based on an average of linear and country target projections, 2012–2015 . . . . 31

Table 16. Volume of demand for APIs in metric tonnes in Latin America and the Caribbean based on an average of linear and country target projections, 2012–2015 . . . . 32

Table 17. Volume of demand for APIs in metric tonnes in the Eastern Mediterranean based on an average of linear and country target projections, 2012–2015 . . . . 32

Table 18. Volume of demand for APIs in metric tonnes in Europe based on an average of linear and country target projections, 2012–2015 . . . . 33

Table 19. Volume of demand for APIs in metric tonnes in South and South-East Asia based on an average of linear and country target projections, 2012–2015 . . . . 33

Table 20. Volume of demand for APIs in metric tonnes in the Western Pacific based on an average of linear and country target projections, 2012–2015 . . . . 20

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EXECUTIVE SUMMARY

The global effort to scale up HIV treatment in low- and middle-income countries continues to move closer towards achieving the goal of 15 million people receiving treatment by 2015. By the end of 2011, more than 8 million people in low- and middle-income countries were receiving antiretroviral therapy, which represents a 20-fold increase since 2003 (1).

The goal of this report is to provide countries and suppliers with a sense of how the global market for antiretroviral medicines in low- and middle-income countries is likely to evolve from 2012 to 2015. The report also aims to provide suppliers with a global forecast of the demand for active pharmaceutical ingredients (APIs) so that they can manage their manufacturing capacity accordingly.

Three forecasting approaches inform the consolidated results presented in this report. The linear regression forecast extrapolates from historical trends in the number of people receiving antiretroviral drugs; the country target model reflects the reported programme goals of national programmes; and the approach of the Clinton Health Access Initiative focuses on the experience of the countries with a high burden of HIV infection. The three approaches use data from the 2012 WHO survey on antiretroviral use, augmented in the Clinton Health Access Initiative model with data from the progress report towards universal access and country information.

The assumptions underlying the forecasts for demand for APIs for 2012–2015 were developed through the work of the Technical Working Group Meeting on Global Antiretroviral Demand Forecast, which included staff from the Clinton Health Access Initiative, WHO, the Office of the United States Global AIDS Coordinator, the United States Agency for International Development, the Partnership for Supply Chain Management and the Futures Institute. The technical working group coordinated several sources of data on antiretroviral drugs, including the WHO survey on antiretroviral use, the Global Price Reporting Mechanism (GPRM) data on procurement, Supply Chain Management System procurement, national guidelines and Clinton Health Access Initiative data on drug recipients to consolidate key assumptions and generate the projected demand for APIs. The key assumptions were based on historical data from WHO surveys for 2009 to 2011, GPRM procurement data from 2009 to the first quarter of 2012 and the forecast of the numbers of antiretroviral drug recipients of the Clinton Health Access Initiative.

The figures in this publication do not state what should be or will be accomplished by 2015. Rather, these estimates indicate the likely demand if current trends continue. The linear regression approach projects 15 million receiving treatment by 2015, the Clinton Health Access Initiative forecast is just under 14 million and the country target approach projects 16 million, exceeding the current universal access goal for 2015. Similarly, the three approaches generated varying outputs for two other key variables, the proportion of people receiving first-line and second-line therapy and the breakdown and trends in regimen use. The three approaches were therefore consolidated by averaging the key variables to generate a single forecast for 2012–2015. The average projection of the three approaches reaches 15 million by 2015. Table 1 shows the details of the results for the number of people receiving antiretroviral therapy and the market shares of the most frequently used APIs.

With regard to nucleoside reverse-transcriptase inhibitors (NRTIs), the consolidated forecast for demand for APIs during 2012–2015 indicates a continuing steep decline in demand for stavudine (d4T) as programmes continue making progress in phasing it out in accordance with WHO guidelines; a slowing of the increase in demand for zidovudine (AZT), but the forecast volume of which still increases by 50% from 2012 to 2015 (Table 8); and a more rapid expansion of tenofovir (TDF) market share (Fig. 4 and 7).

For nevirapine (NVP) and efavirenz (EFV), the forecast volumes in metric tonnes are very similar, although EFV, which initially lags slightly behind, overtakes NVP by 2015 (Fig. 10).

The demand for the two most frequently used protease inhibitors (PIs), lopinavir (LPV) and atazanavir (ATV), are forecast to double and quadruple respectively, although the demand for the former is significantly higher (Fig. 11).

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Table 1. Summary of results

Number of people receiving antiretroviral therapy or antiretroviral

drugs for preventing mother-to-child transmission 2012 2013 2014 2015 Average number of adults receiving treatment (millions) 9.3

[8.8–10.0] 10.9

[10.1–12.1] 12.4

[11.4–13.5] 13.8 [12.8–14.5]

Average number of children receiving treatment (millions) 0.72

[0.67–0.83] 0.89

[0.78–1.1] 1.0

[0.90–1.3] 1.2 [1.0–1.5]

Average number of people receiving treatment (millions) 10.0

[9.5–10.8] 11.8

[10.9–13.2] 13.4

[12.4–14.8] 15.0 [13.8–16.1]

Proportion of people receiving first-line treatment 96.0% 95.8% 95.2% 94.8%

Proportion of people receiving second-line treatment 4.0% 4.2% 4.8% 5.2%

Average number of women receiving antiretroviral drugs for preventing

mother-to-child transmission (based on two projections) 980 000 1 400 000 1 700 000 1 900 000 Projected average market share of primary NRTIs: d4T, TDF, AZT, ABC and ddI (percentage of all NRTIs) (Fig. 4)

d4T 20% 12% 10% 8.4%

AZT 42% 42% 41% 39%

TDF 37% 44% 48% 52%

ABC 1.8% 2.2% 2.2% 2.2%

ddI 0.4% 0.4% 0.3% 0.3%

Projected average market share of 3TC and FTC (percentage of the total of 3TC and FTC) (Fig. 9)

3TC 90% 88% 87% 85%

FTC 10% 11% 13% 15%

Projected average market share of NVP and EFV (percentage of the total of NVP and EFV) (Fig. 10)

NVP 61% 60% 58% 57%

EFV 39% 40% 42% 43%

Projected average market share of PIs (percentage of the total of PIs) (Fig. 11)

LPV 89% 86% 82% 79%

ATV 11% 14% 18% 21%

The numbers in [brackets] show the low and high estimates.

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1. OBJECTIVES AND OVERALL METHODS

The objectives of this report are:

• to improve information about the demand for antiretroviral therapy and antiretroviral medicines;

• to update the forecasts of demand for antiretroviral drugs prepared in 2011; and

• to forecast the global and regional demand for antiretroviral drugs from 2012 to 2015.

This report utilizes data compiled by the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative and the Supply Chain Management System Project to project the demand for antiretroviral drugs from 2012 to 2015. The numbers of people receiving antiretroviral therapy for the projected years are forecast using three approaches: linear projection of historical numbers of people receiving antiretroviral therapy by country;

country target projection (based on planning targets submitted by national programmes); and projections by the Clinton Health Access Initiative. In general, forecasting the number of people receiving treatment involved the following steps.

• Project the total number of people receiving antiretroviral therapy.

• Determine the number of people receiving first-line and second- line therapy, using the average of proportions from three sources of data: (1) linear regression based on the WHO surveys of antiretroviral drug use in 2009, 2010 and 2011 (1–5); (2) linear extrapolation of the relative market share of PIs for 2009–2011 from GPRM procurement data; and (3) the Clinton Health Access Initiative projection for second-line therapy by 2015.

• Determine the distribution of regimens for adults receiving first- and second-line therapy and children receiving treatment.

• Calculate the number of person-years of treatment for each regimen and thus for each antiretroviral drug.

• Calculate the total volume of APIs required to meet the forecast demand for each antiretroviral drug.

The averages of the results of the three approaches, in terms of numbers of people receiving antiretroviral drugs, the breakdown of first-line and second-line therapy and regimen use, were calculated and used as the basis to determine the final estimates of the demand for APIs for 2012–2015.

Figure 1. Model for forecasting antiretroviral drug demand

Adults and children receiving antiretroviral therapy Past ˙ Future

First-line therapy (%) Second-line therapy (%)

Adults and children receiving first- line therapy Adults and children receiving second-line therapy

Proportion of people by antiretroviral drug

Volume of demand for APIs in antiretroviral drugs

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2. DETERMINING THE KEY FORECAST VARIABLES

2.1 Total number of people receiving treatment

Table 2 summarizes the underlying assumptions and data sources of the three approaches to forecasting the number of people receiving antiretroviral therapy through 2015.

Table 2. Summary of assumptions made in the forecast scenarios

Linear Country target Clinton Health Access

Initiative

Data sources WHO AMDS surveys,

2009–2011 Country targets for

2012 to 2015 Progress report towards

universal access, based on WHO AMDS surveys; data from the Clinton Health Access Initiative country teams Number of countries for which

data are used 135 (2011) 43 21 low- and middle-income

countries with a high burden of HIV infection

Proportion of people in low- and middle-income countries receiving treatment represented in the data set

99% 53%

Extrapolated to the remaining 47% of the low- and middle- income countries

86%Extrapolated to the remaining 14% of the low- and middle- income countries

Underlying assumption The number of people receiving antiretroviral drugs will increase linearly at the same rate as the linear trend observed in 2009–2011, with no limitations on the rate of increase

National programme planning targets will be achieved

The scaling up of the number of people receiving treatment will increase linearly at the same rate as the linear trend observed in 2010–2011, with the rate of increase limited by UNAIDS estimates of the number of people who need antiretroviral therapy based on the 2010 WHO eligibility criteria

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results were summed to get the total for all low- and middle- income countries. Table 3 and Fig. 2 show the results and average of the three methods used to estimate the total number of adults and children. Annex 1 provides the average number of people receiving treatment by region for the linear and country target projections.1

2.1.1 Linear projection

This forecast estimates the annual increase in the number of people receiving treatment for 154 countries from a linear regression line fitted to the number of adults and children receiving antiretroviral therapy from the past three years (2009, 2010 and 2011), as reported in the WHO/UNICEF/UNAIDS reports on universal access to HIV prevention, treatment, care and support (3–5). The regression fit uses the actual month and year of each report.

In previous years, the results of applying linear regression were constrained by the estimated total need for antiretroviral therapy (from Spectrum projections for each country prepared in cooperation with UNAIDS). The total demand for antiretroviral drugs is defined as everyone currently receiving antiretroviral therapy plus those who meet the eligibility criteria but are not receiving antiretroviral therapy. With the CD4 threshold trending upwards, the likely introduction of treatment for prevention and option B+ for preventing mother-to-child transmission, the total number who need treatment will probably increase beyond the current Spectrum projections. Thus, the linear approach was not constrained by the upper limit of the estimated number of people who need antiretroviral therapy projected for 2015 based on the WHO 2010 recommendations on the use of antiretroviral drugs.

Since option B+ for preventing mother-to-child transmission is a new approach in which pregnant women living with HIV initiate

1 For details of the composition of the geographical regions, see the explanatory notes for classification of low- and middle-income countries by income level, epidemic level and geographical, UNAIDS, UNICEF and WHO regions on page 152 in Global HIV/AIDS response: epidemic update and health sector progress towards universal access. Progress report 2011 (5).

the number of women initiating antiretroviral therapy through option B+ to the linear projection of the number of adults receiving antiretroviral therapy. Table 6 provides the number and proportion of pregnant women receiving various options for preventing mother-to-child transmission, including lifelong antiretroviral therapy (option B+).

2.1.2 Country targets

Most countries now have their own targets for the number of people they expect to be receiving antiretroviral therapy during the next three to five years. These targets consider the realities in each country and their goals for increasing coverage. For the 2012–2015 country targets, 43 countries2 provided projections, accounting for about half the people receiving antiretroviral therapy in low- and middle-income countries. For countries that did not define targets, it is assumed that the total number of people receiving antiretroviral therapy will grow at the same rate as the aggregate projected for these 43 countries. This equates to average annual growth of nearly 2 million people per year.

We assume that the number of people receiving antiretroviral therapy and the country target projections account for the pregnant women who initiate antiretroviral therapy for life through option B+.

2.1.3 Clinton Health Access Initiative projection

The Clinton Health Access Initiative forecast uses the progress reports towards universal access, published annually by WHO, UNAIDS and UNICEF, for the baseline numbers of people receiving treatment, as this is the only public source of these data. The Clinton Health Access Initiative uses the top 21 high-volume countries,3 which represent 86% of all the people receiving treatment in low- and middle-income countries, as

2 Table 10 lists the countries that provided country target data.

3 The countries are Botswana, Brazil, Cameroon, China, Côte d’Ivoire, Ethiopia, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Russian Federation, Rwanda, South Africa, Swaziland, Thailand, Uganda, United Republic of Tanzania, Zambia and Zimbabwe.

2012 2013 2014 2015

Linear projection Adults 8 900 000 10 400 000 12 100 000 14 000 000

Children 670 000 780 000 890 000 1 000 000

Total 9 600 000 11 200 000 13 000 000 15 000 000

Country target Adults 10 000 000 12 100 000 13 500 000 14 500 000

Children 830 000 1 100 000 1 300 000 1 500 000

Total 10 900 000 13 200 000 14 800 000 16 000 000

Clinton Health Access Initiative Adults 8 800 000 10 100 000 11 500 000 12 800 000

Children 670 000 780 000 880 000 990 000

Total 9 500 000 10 900 000 12 400 000 13 800 000

Average Adults 9 200 000 10 900 000 12 400 000 13 800 000

Children 720 000 880 000 1 000 000 1 200 000

Total 10 000 000 11 800 000 13 400 000 15 000 000

Table 3. Number of adults and children receiving treatment by scenario and

average, 2012–2015

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the basis for its forecast and then extrapolates these results to the remaining 14%. To forecast the number of people receiving treatment, the rates of scaling up by country for these top 21 high-volume countries are assumed to remain constant for the next five years.

Table 3 and Fig. 2 present the three projection scenarios of the estimated number of people receiving antiretroviral therapy from 2012 to 2015 and the average of the three projections.

Figure 2. Comparison of projections of the number of people receiving antiretroviral therapy, 2012–2015

The linear projection is similar to the Clinton Health Access Initiative projection, except for the addition of women starting on antiretroviral therapy through option B+ for preventing mother-to-child transmission. The country target scenario varies from these two scenarios because the estimates are informed by the aspirations of each reporting country to reach the goal of universal access to treatment by 2015.

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Millions

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 0

16 14 12 10

6 4 2 8

13.8 15.0 16.0

Observred trend Country target Linear CHAI Average

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2012 2013 2014 2015

WHO AMDS Survey 4.5% 4.7% 5.3% 6.0%

GPRM 3.6% 3.9% 4.2% 4.5%

Clinton Health Access Initiative 4.2% 4.4% 4.7% 4.9%

Average 4.0% 4.2% 4.8% 5.2%

Table 4. Proportion of people receiving second-line treatment, 2012–2015

Three data sources were used to determine the proportion of people receiving second-line treatment.

• Linear regression of the total number of people receiving second-line therapy reported in the 2009, 2010 and 2011 WHO surveys. We assumed that the percentage of people receiving second-line therapy would not exceed 6% by 2015 because, unless viral load testing is expanded, identifying everyone needing to transition to second-line in this time frame is unlikely.

• Linear regression of the proportion of the people receiving protease inhibitors (PIs) reported in the GPRM for 2009, 2010 and 2011 (6). The projection for each year is calculated by adding the annual increment determined by the regression analysis to the proportion of people receiving second-line treatment in the previous year.

• The Clinton Health Access Initiative forecast uses the current proportion of people receiving second-line treatment as the baseline. It scales up the number of people receiving treatment

2.2 Number of people receiving first- and second-line therapy

by country based on national guidelines for treatment and diagnostic testing, attrition rates, treatment failure rates and loss to follow-up for the top 21 high-volume countries. This proportion of people receiving second-line treatment is then extrapolated to the other low- and middle-income countries (14% of the total people receiving treatment in low- and middle-income countries).

Table 4 shows the projected proportion of people receiving second-line treatment for each of the three data sources, which are within 1.5 percentage points of each other, as well as the average, which was used in estimating the demand for APIs.

The average proportions of people receiving second-line antiretroviral therapy are then applied to the average number of adults and children receiving treatment as forecast for 2012–

2015 (Table 3). Fig. 3 shows the number of adults and children receiving first- and second-line treatment.

Figure 3. Number of adults and children receiving first- and second-line antiretroviral therapy, 2012–2015, based on an average of three projections

14 12 10 8 16

6 4 2

Millions

2012 2013 2014 2015

Child SL 30 000 40 000 40 000 50 000

Child FL 690 000 850 000 980 000 1 120 000

Adult SL 440 000 510 000 590 000 690 000

Adult FL 8 810 000 10 370 000 11 770 000 13 090 000 0

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The distribution of people receiving treatment by antiretroviral drug was calculated using an average of three forecast scenarios as follows.

2.3.1 Observed trend in regimens based on a survey of antiretroviral drug use

The first projection method was based on observed trends in regimen use as reported in the WHO surveys of antiretroviral drug use from 2009 through 2011. For the countries that responded, the reported proportions of adults and children receiving each regimen were disaggregated into the percentage of people receiving each individual antiretroviral drug. For countries that did not respond to the survey, the average regional distribution was used. To forecast the antiretroviral drug distribution from 2012 to 2015 by country, a linear regression line was fit to the reported antiretroviral drug distribution from 2009 through 2011 projected to 2015 but constrained to be between 0% and 100%.

Note that the PIs, indinavir (IDV), saquinavir (SQV) and nelfinavir (NFV), were calculated differently. It was assumed that, since NFV will no longer be marketed, no one will receive this API from 2013 and that people formerly using NFV will be transitioned to lopinavir (LPV/r) and atazanavir (ATV) in a ratio of 9:1 (based on current GPRM data): 90% are transitioned to LPV and 10% to ATV. In addition, it was assumed that virtually everyone receiving SQV and IDV will be transitioned off in the same proportions to LPV (90%) and ATV (10%) by 2015, since demand is low and declining and the newer products are clinically preferable. We assume that, by 2015, the ratio of LPV to ATV will become 80%

to 20%.

2.3.2 Observed procurement trend from the Global Price Reporting Mechanism database

Global procurement data reported in the GPRM database were available for 2009, 2010 and 2011 and the first three quarters of 2012. Individual antiretroviral drugs were categorized by the following market categories: (1) primary NRTIs and NtRTIs – stavudine (d4T), zidovudine (AZT), tenofovir (TDF), abacavir (ABC) and didanosine (ddI); (2) secondary NRTIs: lamivudine (3TC) and emtricitabine (FTC); (3) NNRTIs – nevirapine (NVP) and efavirenz (EFV); and (4) PIs (primarily LPV and ATV). The total volume procured for each category was aggregated from the annual procurement quantity for all antiretroviral drugs in the group. Then the annual market share for each antiretroviral drug was calculated as its procurement volume proportional to the total annual volume for all antiretroviral drugs in the same

2.3 Proportion of people receiving treatment by antiretroviral drug

category. The annual antiretroviral drug market share was then lagged for a year, with the assumption that countries were procuring about one year ahead of actual consumption. The GPRM-derived estimated market share for each API for 2012 to 2015 was then calculated using the observed trend line from 2009 to the first three quarters of 2012.

In some cases, assumptions were made about the procurement pattern. For example, although the trend analysis showed that d4T would no longer be in demand by 2014, countries reported that a small percentage of people would still be receiving d4T by 2015. The trend curve for d4T was then fitted to show a 7%

market share of d4T in 2014 and a 5% market share in 2015. With respect to ATV, there were not enough recent data to establish a trend pattern. As such, the market share was assumed to be about 10% in 2011.

2.3.3 Regimen distribution forecast by the Clinton Health Access Initiative

The Clinton Health Access Initiative evaluates patient data, national guidelines, historical uptake rates by country,

epidemiological data and attrition and failure rates by country to forecast regimen distribution by country. Data on the distribution of regimens are collected from Clinton Health Access Initiative country teams for the most recent calendar year and serve as the baseline of the forecast. From these figures, the Clinton Health Access Initiative monitors how national guideline changes by country will influence the uptake of each antiretroviral drug.

For example, with the phasing out of d4T, many countries have changed their guidelines to make AZT- or TDF-based regimens the preferred NRTI; countries are proactively switching people from d4T to TDF or AZT and initiating new people onto these two preferred NRTIs. The proactive switching and uptake rates will differ by country, as will the preferred NRTI (AZT versus TDF).

The Clinton Health Access Initiative model uses individualized assumptions by country to forecast the uptake of each drug based on each country’s national guidelines and historical uptake rates. The model also splits out people receiving therapy by country based on epidemiological concerns: for example, TB coinfection, anaemia or percentage of the population that is of child-bearing age. The resulting forecast provides insight into trends by regimen, antiretroviral drug and country for the next five years.

Fig. 4 shows the projected market share of the primary NRTI using the average of the three different approaches. Fig. 5–11 show the trends for all three approaches plus the average for each antiretroviral drug.

(18)

Figure 4. Projected market share (%) of the average volume of primary NRTIs, 2012–2015

Figure 5. Projected market share (%) of d4T as a proportion of the total volume of primary NRTIs, 2011–2015

20 30 25 35

2011 2012 2013 2014 2015

GPRM-d4T 32% 20% 10% 7% 5%

CHAI-d4T 29% 19% 10% 9% 8%

WHO survey-d4T 33% 22% 17% 14% 12%

Average 31% 20% 12% 10% 8%

0

Percentage (%) 10

15

8%

12%

5 5%

30 50 40 60

2012 2013 2014 2015

d4T 20% 12% 10% 8.4%

TDF 37% 44% 48% 52%

AZT 42% 42% 41% 39%

ABC 1.8% 2.2% 2.2% 2.2%

ddl 0.4% 0.4% 0.3% 0.3%

0

Percentage (%)

10 20

52%

8.4%

39%

2.2%0.3%

42%

37%

20%

0.4%1.8%

44%

42%

12%

2.2%0.4%

48%

41%

2.2%

10%

0.4%

(19)

Figure 6. Projected market share (%) of AZT as a proportion of the total volume of primary NRTIs, 2011–2015

Figure 7. Projected market share (%) of TDF as a proportion of the total volume of primary NRTIs, 2011–2015

30 50 40 60

2011 2012 2013 2014 2015

GPRM-TDF 23% 34% 40% 46% 53%

CHAI-TDF 29% 41% 50% 52% 53%

WHO survey-TDF 24% 35% 42% 46% 49%

Average 26% 37% 44% 48% 52%

0

Percentage (%)

10 20

53%

49%

30 50 40 60

2011 2012 2013 2014 2015

GPRM-AZT 42% 45% 49% 46% 42%

CHAI-AZT 39% 38% 37% 36% 36%

WHO survey-AZT 43% 43% 41% 40% 39%

Average 41% 42% 42% 41% 39%

0

Percentage (%)

10 20

39%42%

36%

52%

(20)

Figure 8. Projected market share (%) of ABC and ddI as proportions of the total volume of primary NRTIs, 2011–2015

Figure 9. Projected market share (%) of 3TC and FTC as proportions of the total volume of secondary NRTIs, 2011–2015

70

30 90

50 60 40 100

2011 2012 2013 2014 2015

GPRM-3TC 88% 84% 81% 78% 74%

CHAI-3TC 94% 94% 94% 94% 94%

WHO survey-3TC 93% 91% 90% 89% 88%

Average-3TC 92% 90% 88% 87% 85%

GPRM-FTC 11% 16% 18% 22% 26%

CHAI-FTC 6% 6% 6% 6% 6%

WHO survey-FTC 7% 9% 10% 11% 12%

Average-FTC 8% 10% 11% 13% 15%

80

0

Percentage (%)

10 20

94%88%

74%

26%

12%

6%

2.2%

2.5 3.5

1.5 2.0 4.0

2011 2012 2013 2014 2015

GPRM-ABC 1.2% 1.0% 1.0% 1.0% 0.5%

CHAI-ABC 1.9% 2.3% 2.6% 2.7% 2.8%

WHO survey-ABC 2.0% 2.2% 3.2% 3.4% 3.4%

Average-ABC 1.8% 1.8% 2.2% 2.2% 2.2%

GPRM-ddl 0.4% 0.2% 0.1% 0.1% 0.1%

CHAI-ddl 0.4% 0.5% 0.4% 0.3% 0.3%

WHO survey-ddl 0.8% 0.6% 0.6% 0.6% 0.7%

Average-ddl 0.5% 0.4% 0.4% 0.3% 0.3%

3.0

0.0

Percentage (%)

0.5 1.0

3.4%

2.8%

0.7%

0.3%0.1%

0.5%

(21)

Figure 10. Projected market share (%) of NVP and EFV as proportions of the total volume of NNRTIs, 2011–2015

Figure 11. Projected market share (%) of LPV and ATV as proportions of the total volume of PIs, 2011–2015

70

30 90

50 60 40 100

2011 2012 2013 2014 2015

GPRM-LPV 87% 88% 85% 82% 80%

CHAI-LPV 87% 84% 77% 70% 64%

WHO survey-LPV 93% 94% 94% 94% 93%

Average-LPV 91% 89% 86% 82% 79%

GPRM-ATV 11% 12% 15% 18% 20%

CHAI-ATV 13% 16% 23% 30% 36%

WHO survey-ATV 3% 4% 5% 6% 7%

Average-ATV 9% 11% 14% 18% 21%

80

0

Percentage (%)

10 20

93%

80%

64%

36%

20%

7%

70

30 50 60

40 80

0 10 20

2011 2012 2013 2014 2015

GPRM-NVP 67% 63% 59% 55% 52%

CHAI-NVP 62% 61% 59% 58% 57%

WHO survey-NPV 60% 60% 61% 61% 62%

Average-NPV 63% 61% 60% 58% 57%

GPRM-EFV 67% 63% 59% 55% 52%

CHAI-EFV 62% 61% 59% 58% 57%

WHO survey-EFV 60% 60% 61% 61% 62%

Average-EFV 37% 39% 40% 42% 43%

Percentage (%)

62%57%

52%48%

43%38%

(22)

for certain antiretroviral drugs: that is, within a 10% margin.

However, there is noticeable variation. The market shares for 3TC and FTC projected by the Clinton Health Access Initiative differs from those projected by the GPRM and WHO antiretroviral drug survey projections. The Clinton Health Access Initiative assumes that the proportion of both antiretroviral drugs will remain constant, whereas the trends identified from GPRM procurement and the WHO antiretroviral drug use survey suggest increasing market share for FTC. Trends in manufacturing that could result

probably influence the demand for FTC.

The variation between the three projections for the PI market results from the limited consumption and procurement data available for atazanavir, which has only been on the market for just over 12 months. For projections based on the WHO antiretroviral drug survey data, assumptions about phasing out NFV, SQV and IDV also informed the projected market share of LPV/r and ATV.

2.4 Number of women receiving antiretroviral drugs for preventing mother-to- child transmission

The number of women receiving antiretroviral drugs for preventing mother-to-child transmission was based on two projection scenarios – linear and country target. The linear projection is based on linear regression of data on preventing mother-to-child transmission from 2009 through 2011, whereas the country targets are based on the goals set by 43 countries.

Table 5 shows the projected number of women receiving antiretroviral drugs for preventing mother-to-child transmission for each scenario as well as the average of the two scenarios.

Table 11 shows the estimated average number of women receiving antiretroviral drugs for preventing mother-to-child transmission by region, based on linear and country target projections.

As the average of the two projections shows, the number of women receiving antiretroviral drugs for preventing mother- to-child transmission is expected to increase mostly because of expanded coverage of services for preventing mother-to-child transmission.

To project the demand for antiretroviral drugs for women receiving antiretroviral drugs for preventing mother-to-child transmission, the total number of women receiving current

2012 2013 2014 2015

Linear 1 000 000 1 200 000 1 300 000 1 400 000

Country targets 1 100 000 1 700 000 2 200 000 2 500 000

Average 1 100 000 1 400 000 1 800 000 2 000 000

Annual rate of increase — 35% 24% 11%

Table 5. Total and average number of women receiving antiretroviral drugs for preventing mother-to-child transmission, 2012–2015

WHO-recommended regimens (Table 6) – single-dose NVP, WHO 2006 AZT, option A, option B and option B+ (all pregnant women living with HIV starting on lifelong antiretroviral therapy regardless of CD4 count) – was determined through the WHO antiretroviral drug use survey (7). Most country programmes are rapidly moving away from single-dose NVP and WHO 2006 AZT in favour of option A or B. Malawi and Uganda are now using option B+, and other countries are considering it. As a result, we expect the distribution of regimens for preventing mother- to-child transmission to change dramatically in the next few years. We have assumed that single-dose NVP and WHO 2006 AZT regimens would be discontinued by 2015 and that the use of antiretroviral therapy would rise substantially, as shown in Table 6.

The number of women receiving each regimen is determined by multiplying the number of women receiving services for preventing mother-to-child transmission by the regimen mix in that year. The volume of antiretroviral drugs required is calculated by multiplying the number of women receiving each regimen by the recommended doses.

(23)

Single-dose NVP. One or two courses of single-dose NVP during and after labour. WHO is discouraging this treatment regimen in place of option A, option B or triple antiretroviral therapy.

WHO 2006 AZT. Starting at 28 weeks of pregnancy, this treatment recommends a regimen of twice-daily ZDV, single-dose NVP at the onset of labour and AZT + 3TC during delivery and one week postpartum.

Option A. Starting at 14 weeks of pregnancy or soon thereafter, recommending twice-daily ZDV for the mother and infant

prophylaxis with either ZDV or NVP for six weeks after birth for infants not breastfeeding.

Option B. Triple-therapy regimen, usually AZT + 3TC + NVP during pregnancy and breastfeeding.

Triple antiretroviral therapy. Lifelong triple therapy for the mother’s health based on each country’s eligibility criteria. This includes option B+, including treatment for mothers with CD4 counts exceeding 350 cells/mm3.

2011 2015

Single-dose NVP 13% 0%

WHO 2006 AZT 19% 0%

Option A 28% 10%

Option B 11% 20%

Triple antiretroviral therapy 30% 70%

Table 6. Projected regimen mix for women receiving antiretroviral drugs for

preventing mother-to-child transmission, 2011 and 2015

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3. FORECASTING THE DEMAND FOR ACTIVE PHARMACEUTICAL INGREDIENTS

3.1 Calculating the total volumes of APIs in metric tonnes required for each antiretroviral drug

This section provides details of the forecast API volumes in metric tonnes. Its objective is to assist suppliers in ensuring that adequate manufacturing capacity is available to meet the demand for antiretroviral drugs.

Drug Daily dose

(mg/day per person)

d4T 60

ZDV 600

TDF 300

3TC 300

FTC 200

ABC 600

ddI 300

NVP 400

EFV 600

LPV 800

ATV 300

LPV/r 200

ATV/r 100

Table 7. Daily doses for antiretroviral drugs based on WHO recommendations

The volumes required for each antiretroviral drug are calculated as the product of the number of person-years of use, the recommended daily dose and 365 days per year. The number of person-years is estimated as the number of people who continue on that antiretroviral drug from the previous year plus one half the number of people who start on that antiretroviral drug during

the year. This assumes that the starting dates for those initiating antiretroviral therapy use that year are evenly distributed throughout the year. These calculations are summed across all countries and types of treatment (first-line and second-line therapy for adults and children) to calculate the total demand in person-years. Table 7 shows the recommended daily doses.

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3.2 Forecast demand for APIs for 2012–2015

Table 8 shows the volume of API in metric tonnes required for each antiretroviral drug based on the average of the three projections of numbers of people receiving the drugs (Table 3), the proportion receiving first- and second-line therapy (Table 4) and the distribution of antiretroviral drug regimens (Fig. 4–11).

(Tables 11–13 in Annex 1 show the detailed volume demand for each of the three projections individually). The API need in metric tonnes was calculated using the average number of

Drug 2012 2013 2014 2015

d4T 44 28 22 18

ZDV 930 1 300 1 400 1 400

TDF 400 520 700 920

ABC 40 20 18 16

ddI 5 1 1 1

3TC 940 1 100 1 200 1 300

FTC 70 90 120 150

NVP 830 950 1 000 1 100

EFV 790 980 1 100 1 300

LPV 140 170 210 270

ATV 6 11 18 27

RTV 42 59 77 98

Table 8. Volume of demand for APIs in metric tonnes, 2012–2015

people receiving treatment (including pregnant women receiving lifelong antiretroviral therapy through option B+) converted into person-years and then multiplied by the API distribution and finally multiplied by the recommended dosage for each API. The volume of demand for AZT, 3TC, NVP and LPV also includes the antiretroviral drugs needed for prophylaxis for the women in the programmes for preventing mother-to-child transmission: single- dose nevirapine, dual antiretroviral drugs, option A and option B.

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4. DISCUSSION

This report projects continued rapid increases in the number of people receiving antiretroviral drugs in low- and middle- income countries and changes in the market share of each antiretroviral drug. This forecasting exercise has been repeated annually since 2007. The projections have generally matched the actually experience in the short term reasonably well, with some tendency to underestimate the actual growth rate. This report uses three approaches to provide a range around the forecast.

The major strength of this approach is its grounding in historical trends, which should provide reasonably accurate projections, at least for the next few years. The projections for any individual country are subject to greater error, but the global trends have proven to be remarkably consistent over time.

However, this approach does not adequately capture factors that could affect future trends. In recent years, there has been much concern about how the global economic crisis is affecting the expansion of antiretroviral therapy coverage. Nevertheless, antiretroviral therapy programmes have been somewhat protected from cuts, and reductions in the cost per person have allowed programmes to expand without commensurate increases in resources. For the next few years, there continue to be concerns about funding and capacity constraints that might

limit market growth, but there are also forces that could lead to even more rapid increases. WHO is updating its treatment guidelines in 2013 and may recommend expanding eligibility criteria to include people with higher CD4 counts and most young children living with HIV. Recent studies have demonstrated that antiretroviral therapy is effective in preventing the onward transmission of HIV, strengthening the case for earlier treatment and eligibility for all discordant couples. In addition, option B+ is likely to be widely adopted for pregnant women living with HIV, leading to even more people receiving antiretroviral therapy. The overall prospects for continued rapid growth seem more likely than any slowing of the growth rate. The market share for some antiretroviral drugs has also shifted dramatically, most notably a rapid decline for d4T and a substantial increase for TDF.

The market for antiretroviral drugs seems likely to grow

substantially during the next several years. The number of people receiving antiretroviral drugs will probably increase by 13–14%

per year. Demand for individual antiretroviral drugs could increase substantially more. Sustaining this increase will require increasing production by manufacturers, continuing the funding from national programmes and major donors and expanding national capacity for providing services.

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REFERENCES

1. UNAIDS report on the global AIDS epidemic 2012. Geneva, UNAIDS, 2012 (http://www.unaids.org/en/media/unaids/contentassets/

documents/epidemiology/2012/gr2012/20121120_UNAIDS_Global_Report_2012_with_annexes_en.pdf, accessed 1 May 2013).

2. WHO, UNAIDS and Futures Institute. Antiretroviral medicines in low- and middle-income countries: usage in 2010 with global and regional demand forecast for 2011–2012. Geneva, World Health Organization, 2011.

3. WHO, UNAIDS and UNICEF. Towards universal access: scaling up priority interventions in the health sector: progress report 2009.

Geneva, World Health Organization, 2009 (http://www.who.int/hiv/pub/2009progressreport, accessed 1 May 2013).

4. WHO, UNAIDS and UNICEF. Towards universal access: scaling up priority interventions in the health sector: progress report 2010.

Geneva, World Health Organization, 2010 (http://www.who.int/hiv/pub/2010progressreport, accessed 1 May 2013).

5. WHO, UNAIDS and UNICEF. Global HIV/AIDS response: epidemic update and health sector progress towards universal access.

Progress report 2011. Geneva, World Health Organization, 2011 (http://whqlibdoc.who.int/publications/2011/9789241502986_eng.

pdf, accessed 1 May 2013).

6. Global Price Reporting Mechanism database [online database]. Geneva, World Health Organization, 2013 (http://www.who.int/

hiv/amds/gprm/en, accessed 1 May 2013).

7. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: recommendations for a public health approach. 2010 version. Geneva, World Health Organization, 2010 (http://whqlibdoc.who.int/publications/2010/9789241599818_

eng.pdf, accessed 1 May 2013).

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ANNEX 1.

2012 2013 2014 2015

Sub-Saharan Africa Adults 7 300 000 8 500 000 9 700 000 10 700 000

Children 670 000 840 000 980 000 1 000 000

Latin America and Caribbean Adults 700 000 900 000 1 000 000 1 100 000

Children 20 000 24 000 27 000 28 000

Eastern Mediterranean Adults 30 000 35 000 39 000 44 000

Children 1 400 1 800 2 200 2 300

Europe Adults 210 000 240 000 260 000 290 000

Children 28 000 33 000 40 000 41 000

South and South-East Asia Adults 960 000 1 200 000 1 400 000 1 500 000

Children 39 000 46 000 51 000 53 000

Western Pacific Adults 310 000 380 000 430 000 480 000

Children 13 000 14 000 16 000 16 000

Table 9. Average projected number of people receiving treatment by region based on linear and country target projections, 2012–2015

Benin Myanmar

Belarus Namibia

Bhutan Nepal

Botswana Niger

Burkina Faso Oman

Burundi Republic of Moldova

Cameroon Romania

Cape Verde Rwanda

China Saudi Arabia

Côte d’Ivoire Senegal

Cuba South Africa

Democratic Republic of the Congo South Sudan

Eritrea Sri Lanka

Ethiopia Syrian Arab Republic

Ghana Thailand

Iran (Islamic Republic of) Timor-Leste

Lebanon Togo

Madagascar United Republic of Tanzania

Malaysia Viet Nam

Malawi Zambia

Maldives Zimbabwe

Mauritius

Table 10. Countries that provided country target data

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Figure 12. Number of people receiving first- and second-line antiretroviral therapy based on linear projection, 2011–2015

Figure 13. Number of people receiving first- and second-line antiretroviral therapy based on country target projection, 2011–2015

10

2 14

6 8 4 18

Millions

2011 2012 2013 2014 2015

Child SL 24 799 29 811 37 245 47 385 59 738

Child FL 541 357 796 279 1 054 838 1 261 048 1 471 589

Adult SL 384 832 447 749 535 640 646 571 771 007

Adult FL 7 098 916 9 590 545 11 548 382 12 870 896 13 781 556 0

12 16 10

2 14

6 8 4 16

Millions

2011 2012 2013 2014 2015

Child SL 24 799 29 117 34 361 40 502 47 521

Child FL 541 357 644 681 747 079 848 580 949 203

Adult SL 384 889 439 115 505 179 583 990 676 586

Adult FL 7 098 859 8 447 658 9 914 271 11 523 149 13 298 615 0

12

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Figure 14. Number of people receiving first- and second-line antiretroviral therapy, Clinton Health Access Initiative data, 2011–2015

Figure 15. Average number of people receiving first- and second-line

antiretroviral therapy in sub-Saharan Africa based on linear and country target projections, 2012–2015

10

2 14 12

6 8

4

Millions

2012 2013 2014 2015

Child SL 20 527 26 421 33 942 37 217

Child FL 644 589 810 150 950 860 997 556

Adult SL 231 091 295 644 371 598 410 626

Adult FL 7 029 079 8 173 292 9 292 539 10 308 878 0

10

2 16

12

6 8

4 14

Millions

2011 2012 2013 2014 2015

Child SL 24 799 28 862 34 245 40 302 47 329

Child FL 541 357 639 039 744 570 844 380 945 377

Adult SL 384 832 435 740 492 059 553 808 620 314

Adult FL 7 098 916 8 382 739 9 656 797 10 927 602 12 192 561 0

(31)

Figure 16. Average number of people receiving first- and second-line

antiretroviral therapy in Latin America and the Caribbean based on linear and country target projections, 2012–2015

Figure 17. Average number of people receiving first- and second-line

antiretroviral therapy in the Eastern Mediterranean based on linear and country target projections, 2012–2015

40

20 15 10 50 45

5 30 35 Millions 25

2012 2013 2014 2015

Child SL 292 305 324 331

Child FL 1 144 1 519 1 856 1 945

Adult SL 2 273 2 642 3 084 3 269

Adult FL 27 760 32 037 36 412 41 160

0 1.0

0.2 1.4 1.2

0.6 0.8

0.4

Millions

2012 2013 2014 2015

Child SL 4 303 4 279 4 311 4 288

Child FL 15 944 19 624 23 082 23 580

Adult SL 131 252 131 780 135 409 135 789

Adult FL 565 525 772 553 883 613 983 506

0

(32)

Figure 18. Average number of people receiving first- and second-line

antiretroviral therapy in Europe based on linear and country target projections, 2012–2015

Figure 19. Average number of people receiving first- and second-line

antiretroviral therapy in South and South-East Asia based on linear and country target projections, 2012–2015

1.4 1.2 1.0 0.8 1.8 1.6

0.6 0.4 0.2

Millions

2012 2013 2014 2015

Child SL 2 065 2 301 2 591 2 721

Child FL 36 524 43 354 48 765 50 410

Adult SL 33 207 40 483 49 829 54 331

Adult FL 929 688 1 185 013 1 340 818 1 486 173

0.0 250 200 150 100 350 300

50

Millions

2012 2013 2014 2015

Child SL 1 229 1 397 1 611 1 702

Child FL 10 477 13 019 15 656 16 457

Adult SL 21 580 24 526 28 065 29 235

Adult FL 183 558 211 825 236 633 263 852

0

(33)

Figure 20. Average number of people receiving first- and second-line

antiretroviral therapy in the Western Pacific based on linear and country target projections, 2012–2015

2012 2013 2014 2015

Sub-Saharan Africa 990 000 1 400 000 1 700 000 1 900 000

Latin America and Caribbean 17 000 19 000 22 000 24 000

Eastern Mediterranean 1 400 1 900 2 200 2.600

Europe 18 000 20 000 25 000 27 000

South and South-East Asia 20 000 23 000 26 000 29 000

Western Pacific 6 900 10 000 11 000 12 000

Global 1 100 000 1 400 000 1 800 000 2 000 000

Table 11. Average number of women receiving antiretroviral drugs for preventing mother-to-child transmission by region based on average of linear and country target projections, 2012–2015

Millions

0.4 0.3 0.2 0.1 0.6

2012 2013 2014 2015

Child SL 1 049 1 101 1 164 1 194

Child FL 11 803 13 293 14 596 15 177

Adult SL 24 029 25 335 27 295 28 328

Adult FL 283 492 356 605 407 007 456 517

0.0 0.5

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Drug 2012 2013 2014 2015

d4T 40 36 37 39

ZDV 838 992 1 167 1 366

TDF 311 463 616 781

ABC 41 73 94 114

ddI 4.0 1.1 0.7 0.8

3TC 825 996 1 148 1 315

FTC 52 72 95 120

NVP 700 866 1 022 1 185

EFV 675 822 954 1 094

LPV 158 212 271 341

ATV 1.6 2.6 3.7 4.9

Table 12. Volume of demand for APIs in metric tonnes – linear projection, 2012–2015

Drug 2012 2013 2014 2015

d4T 39.0 27.8 22.6 18.5

ZDV 921.9 1 423.9 1 665.0 1 728.6

TDF 362.1 531.9 741.6 981.8

ABC 36.6 19.9 19.3 16.7

ddI 4.3 1.3 0.8 0.9

3TC 873.7 1 131.2 1 300.8 1 407.7

FTC 65.0 93.2 125.3 157.1

NVP 770.8 996.9 1 150.3 1 246.3

EFV 712.1 990.2 1 208.7 1 380.5

LPV 166.7 227.9 311.2 396.5

ATV 5.5 11.1 19.0 28.8

Table 13. Volume of demand for APIs in metric tonnes – country target projection,

2012–2015

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Drug 2012 2013 2014 2015

d4T 40.5 22.5 20.4 19.4

AZT 724.0 821.0 911.0 1 002.0

TDF 390.0 573.0 680.0 782.0

ABC 53.2 71.5 86.8 101.6

ddI 6.3 7.2 7.9 8.0

3TC 913.7 1 054.1 1 193.6 1 333.7

FTC 39.8 45.7 52.2 58.7

NVP 749.0 826.0 894.0 965.0

EFV 750.0 908.0 1 079.0 1 245.0

LPV 125.3 160.2 191.8 218.1

ATV 3.2 6.3 10.7 17.3

Table 14. Volume of demand for APIs in metric tonnes – Clinton Health Access Initiative projection, 2012–2015

Drug 2012 2013 2014 2015

d4T 28 24 24 25

AZT 633 807 958 1 111

3TC 659 829 953 1 066

NVP 552 702 816 921

EFV 570 721 834 936

ABC 34 71 100 125

ddI 4 5 6 9

LPV 128 184 255 334

TDF 292 444 581 709

FTC 45 62 80 99

RTV 33 50 71 94

ATV 0.1 0.2 0.3 0.5

Table 15. Volume of demand for APIs in metric tonnes for sub-Saharan Africa

based on an average of linear and country target projections, 2012–2015

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Drug 2012 2013 2014 2015

d4T 2.2 2.0 1.6 1.3

AZT 76.3 91.5 104.6 105.2

TDF 22.9 37.0 51.1 66.0

ABC 2.7 1.4 1.3 1.1

ddI 0.4 0.1 0.1 0.1

3TC 57.3 71.8 83.3 89.3

FTC 5.8 8.4 11.9 15.2

NVP 50.4 72.7 95.7 110.9

EFV 55.8 81.5 108.8 129.6

LPV 8.4 10.1 11.9 13.6

ATV 0.4 0.6 0.9 1.2

Table 16. Volume of demand for APIs in metric tonnes Latin America and Caribbean based on an average of linear and country target projections, 2012–2015

Drug 2012 2013 2014 2015

d4T 0.0 0.0 0.0 0.0

AZT 12.2 13.1 13.5 13.8

3TC 2.1 2.6 2.7 2.8

NVP 0.5 0.5 0.6 0.7

EFV 3.5 5.0 5.9 6.9

ABC 0.2 0.4 0.5 0.7

ddI 0.1 0.1 0.2 0.3

LPV 1.1 1.5 2.0 2.5

TDF 0.6 1.0 1.3 1.8

FTC 0.3 0.5 0.7 1.0

RTV 0.3 0.4 0.6 0.7

ATV 0.1 0.1 0.2 0.3

Table 17. Volume of demand for APIs in metric tonnes in the Eastern

Mediterranean based on an average of linear and country target projections,

2012–2015

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Drug 2012 2013 2014 2015

d4T 0.0 0.0 0.0 0.0

AZT 34 40 43 44

3TC 16 21 23 25

NVP 3 3 2 2

EFV 18 23 25 28

ABC 5 8 11 14

ddI 0 0 1 1

LPV 17 23 28 34

TDF 4 6 8 10

FTC 1 2 3 4

RTV 6 9 12 16

ATV 0.2 0.4 0.6 0.8

Table 18. Volume of demand for APIs in metric tonnes in Europe based on an average of linear and country target projections, 2012–2015

Drug 2012 2013 2014 2015

d4T 8 9 11 11

AZT 105 122 140 152

3TC 94 117 140 157

NVP 106 136 166 187

EFV 26 28 28 30

ABC 0 1 1 1

ddI 1 1 1 1

LPV 7 7 7 7

TDF 10 15 22 30

FTC 0 0 0 0

RTV 2 2 3 3

ATV 0.6 1.2 2.0 2.9

Table 19. Volume of demand for APIs in metric tonnes in South and South-East

Asia based on average of linear and country target projections, 2012–2015

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Drug 2012 2013 2014 2015

d4T 2 2 2 1

AZT 43 57 72 85

3TC 30 37 44 49

NVP 22 26 29 30

EFV 23 33 44 55

ABC 0 0 1 1

ddI 0 0 0 0

LPV 4 4 3 3

TDF 3 4 5 6

FTC 0 0 0 0

RTV 1 1 1 1

ATV 0.0 0.0 0.0 0.0

Table 20. Volume of demand for APIs in metric tonnes in the Western Pacific

based on an average of linear and country target projections, 2012–2015

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