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WORKING DOCUMENT November 2017 | 1 V3P: Global Fact Sheet In 2014, the V3P initiative was launched to provide all countries with a platform for greater vaccine price, procurement, and product transparency. It provides non-Gavi-funded MICs an opportunity to learn about vaccine purchase in other countries, whether through UNICEF or the PAHO Revolving Fund (pooled procurement), or directly (self-procurement). This 2017 V3P pricing report highlights the analyses on vaccine price and procurement data, acquired up to August 2017. This global fact sheet is intended for use by global and regional vaccine policy makers. It provides information on availability of data for vaccine procurement and price, on global volume and value of the vaccine market, and of relationship of price with time, procurement method, income, presentation, and volume. Caution should be exercised when comparing vaccine prices between countries as there may be multiple explanations for variability. The V3P data are sourced from voluntary reports from countries, and the country composition may vary from one year to the next. Historical data are limited to a maximum of four years (2013–2016) and EUR is overrepresented in the data set. Therefore, extrapolation of price trends from one region to another may not be possible. The database collects limited information on procurement systems, which may limit any interpretation of the factors that influence vaccine prices. The latest data reported on in the 2017 V3P Pricing Report is for the 2016 calendar year. Additional information can be accessed here: www.who.int/immunization/v3p. GLOBAL 1 Each dot represents a vaccine purchase by one country. Map created using the Global Vaccine Market Model (GVMM) Demand Module (Linksbridge SPC, a Bill & Melinda Gates Foundation funded project) which leverages the V3P to enhance the data inputs and refine outputs. Information shared by UNICEF SD, Gavi, and PAHO Revolving Fund are key inputs to the GVMM. The WHO/UNICEF Joint Reporting Form (JRF) also aids in determining routine vaccines used by country. Background The world vaccine market consists of four segments: Gavi, the Vaccine Alliance, UNICEF, PAHO Revolving Fund (RF), and rest of the world (ROW) (see Chart 1). About 70 of the lowest-income countries in the world rely on Gavi for funding of some key vaccines. UNICEF Supply Division (SD) is the procurement agent for most of these countries and for an additional approximately 30 MICs (totalling about 100 countries). The PAHO RF provides financial and procurement support to about 40 countries and territories in the Americas. The ROW consists of self-funding and self-procuring countries spanning all income levels, and receiving only marginal, mostly indirect, financial, procurement, market shaping, or other related support. Within this group of countries, self-procuring MICs have been most challenged to secure a sustainable and affordable supply of vaccines. Non-Gavi-funded MICs tend to have less ability to collect and use market intelligence, have weaker procurement skills, and have more limited budgets to draw upon for vaccine purchase. Chart 1. Classification of country vaccine purchase by funding and procurement method 1 increasing GNI per capita

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Page 1: Background - WHO...WORKING DOCUMENT • November 2017 | 1 V3P: Global Fact Sheet In 2014, the V3P initiative was launched to provide all countries with a platform for greater vaccine

WORKING DOCUMENT • November 2017 | 1

V3P: Global Fact Sheet

In 2014, the V3P initiative was launched to provide all countries with a platform for greater vaccine price, procurement, and product transparency. It provides non-Gavi-funded MICs an opportunity to learn about vaccine purchase in other countries, whether through UNICEF or the PAHO Revolving Fund (pooled procurement), or directly (self-procurement). This 2017 V3P pricing report highlights the analyses on vaccine price and procurement data, acquired up to August 2017.

This global fact sheet is intended for use by global and regional vaccine policy makers. It provides information on availability of data for vaccine procurement and price, on global volume and value of the vaccine market, and of relationship of price with time, procurement method, income, presentation, and volume.

Caution should be exercised when comparing vaccine prices between countries as there may be multiple explanations for variability. The V3P data are sourced from voluntary reports from countries, and the country composition may vary from one year to the next. Historical data are limited to a maximum of four years (2013–2016) and EUR is overrepresented in the data set. Therefore, extrapolation of price trends from one region to another may not be possible. The database collects limited information on procurement systems, which may limit any interpretation of the factors that influence vaccine prices.

The latest data reported on in the 2017 V3P Pricing Report is for the 2016 calendar year. Additional information can be accessed here: www.who.int/immunization/v3p.

GLOBAL

1Each dot represents a vaccine purchase by one country. Map created using the Global Vaccine Market Model (GVMM) Demand Module (Linksbridge SPC, a Bill & Melinda Gates Foundation funded project) which leverages the V3P to enhance the data inputs and refine outputs. Information shared by UNICEF SD, Gavi, and PAHO Revolving Fund are key inputs to the GVMM. The WHO/UNICEF Joint Reporting Form (JRF) also aids in determining routine vaccines used by country.

BackgroundThe world vaccine market consists of four segments: Gavi, the Vaccine Alliance, UNICEF, PAHO Revolving Fund (RF), and rest of the world (ROW) (see Chart 1).

About 70 of the lowest-income countries in the world rely on Gavi for funding of some key vaccines. UNICEF Supply Division (SD) is the procurement agent for most of these countries and for an additional approximately 30 MICs (totalling about 100 countries). The PAHO RF provides financial and procurement support to about 40 countries and territories in the Americas. The ROW consists of self-funding and self-procuring countries spanning all income levels, and receiving only marginal, mostly indirect, financial, procurement, market shaping, or other related support. Within this group of countries, self-procuring MICs have been most challenged to secure a sustainable and affordable supply of vaccines. Non-Gavi-funded MICs tend to have less ability to collect and use market intelligence, have weaker procurement skills, and have more limited budgets to draw upon for vaccine purchase.

Chart 1. Classification of country vaccine purchase by funding and procurement method1

increasing GNI per capita

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Data Availability

As of August 2017, the V3P contained vaccine price information from 84% of countries in the world from all regions and covering 95% of the global birth cohort. This includes data directly shared by 144 countries from six regions for 2016 (see Chart 2).

Chart 3 shows the proportion of countries for which price data is available from the V3P database, whether shared by countries directly, or by UNICEF SD2 and the PAHO Revolving Fund3.

Chart 2. Number of countries reporting vaccine price data directly to V3P for 2016.

How the V3P Data can be used

The main uses of the V3P data are to provide information on:• procurement options, including available products,

suppliers, presentation forms and sizes, and procurement methods;

• vaccine price ranges, for budgeting, planning, and decision-making;

• vaccine price dynamics, including how prices evolve with time and correlate with income level, volume, and procurement method;

• vaccine market dynamics, including market size and share, and evolution over time, to understand the value of a product within a market and help better inform security of supply strategies.

2UNICEF SD data available at: https://www.unicef.org/supply/index_57476.html3PAHO Revolving Fund data available at: http://www.paho.org/hq/index.php?option=com_content&view=article&id=9561%3A2014-revolving-fund-prices&catid=839%3Arevolving-fund&Itemid=40714&lang=en

Chart 3. Coverage of the V3P database (2016), including data shared by individual countries, PAHO RF, and UNICEF SD

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Key Takeaways for 2016• The reported data for 2016 represents a total value

of $9.3 billion for a total volume of 3.2 billion doses purchased from 73 manufacturers.

• For the 2016 data, market segments with the highest value were HICs (by income group), AMR (by region), and PCV (by vaccine type).

• Prices of the majority of vaccines are declining in self-procuring countries. There are proportionally more vaccines with increasing price in pool-procuring countries, but these increases are predominantly for mature vaccines selling at relatively low prices.

• Pool-procurement results in lower weighted average price (WAP) for 78 to 90% of vaccines.

• There is an association between prices and income level for 60% of vaccines.

• The range between lowest and highest price for the same vaccine type increases substantially with income level (from as much as 14-fold in non-Gavi MICs to 29-fold in HICs).

• 82 to 86% of vaccines have a lower WAP in 10- or 20-dose presentations than in single-dose.

• No correlation can be observed between volume and price based on data available, and further statistical analysis is needed to explore this relationship.

All the data and many additional analyses are available on the V3P website: www.who.int/immunization/v3p.

4Note: V3P market data is for 54% of AMR countries (including the US market) and 64% of EUR countries. The absence of data from these two sizeable regions limits interpretation of the global market analysis.

Chart 4. Global distribution of vaccines by volume and value.

Analysis of the 2016 Data | Global Vaccine MarketBy Vaccine TypeVaccine “types” in the V3P database refers to the diseases, single or multiple, which the vaccines prevent, in conjunction with the nature of antigens contained within the vaccines. Thus DTP and DTaP constitute two separate vaccines types although they both prevent the same diseases.

In all, 58 vaccine types were reported to the V3P in 2016, in 3.15 billion doses, purchased for a reported total of $9.29 billion4.

The breakdown of the market by vaccine type is shown in Chart 4.

The top 10 vaccines by value account for 70% of the value of the global market, but only 26% of the volume. Chart 5 (see page 4) shows that some of the highest volume vaccines (DTP-HepB-Hib) have equivalent or lesser value to much lower volume vaccines (HPV, Rota, Varicella).

VOLUME VALUE

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Chart 5. Market size by volume (number of doses) and value (USD), for 10 highest value vaccines globally

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By Presentation Type“Presentation type” in the V3P database refers to the form of the final container (ampoule, vial, pre-filled syringe, etc). “Presentation size” refers to the number of doses contained in the final container (single dose, or multiple doses).

The breakdown of the market by presentation size and presentation type are shown in Chart 6.

Half of all doses procured are in single-dose presentations. Vials constitute the vast majority of presentation forms.

By RegionThe frequency of use and value of vaccine types varies by region, but six (BCG, bOPV1,3, DTP-HepB-Hib, IPV, MMR, Td) of the 10 most frequently used vaccines globally are in the top 10 in five of the six regions. The largest vaccine market by value was AMR, which accounted for about 63% of the global market5. The relative value of the markets in other regions is more evenly distributed, ranging from about 5% in WPR to 11% in AFR.

By Income GroupThe value of the vaccine markets by income groups is shown in Chart 7 (see page 6). The highest value market is the HIC market, accounting for 50% of the global market, followed by the non-Gavi, non-PAHO MIC market (17%), the Gavi market (19%), and the PAHO Revolving Fund (RF) MIC market (13%).

Chart 6. Distribution of vaccines by presentation sizes and presentation types (amp = ampoule; appl = applicator; pt = plastic tube; pfs = pre-filled syringe).

5AMR data includes only data reported directly to V3P by 19 countries. Data from the US accounts for 72% of the AMR market value.

Global Distribution of Presentation Sizes Global Distribution of Presentation Types

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Prices Over Time

A full analysis of price change over time is presented in Chart 8. The increase or decrease in average vaccine price (P) was compared to the inflation rate to determine how both nominal and real prices have evolved over time.6

On the whole, the majority of vaccines are decreasing in price for self-procuring countries. The proportion of vaccines with increasing price is higher in pool-procuring countries, but these are predominantly mature vaccines at relatively low prices.

Because of the relatively small number of data points for each product, price trends were assessed without distinction between manufacturers. Thus, a product switch in any given year that results in a price change may distort (positively or negatively) any observed price trend.

The WAP price for single-dose new vaccines (HPV, PCV, and Rota) in non-Gavi, non-PAHO MICs is studied further here, showing progressive declines over the last three years, in spite of the limited participants in the market (see Chart 9, page 7).

Chart 7. The size of the market of all vaccines directly reported to the V3P, by income group (showing from top to bottom: number of doses, number of countries, and value of market in USD), for 2016.

6Of note is that the analysis is based on the global inflation rate but does not take into consideration the fact that inflation may vary by region or income group.7The analysis includes 24 vaccine types for which at least three records were registered by countries between 2013/14 and 2016 (representing 19 vaccine types for HICs and 11 for MICs). The analyses for PAHO and Gavi are based on 24 and 14 vaccine types purchased respectively, in both 2010 and 2017.

Chart 8. Average vaccine price evolution over time according to procurement mechanism and vaccine type7

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Prices and Procurement MethodIn most cases, pooled procurement provides access to the most favourable prices, within the same income group, compared to self-procurement (see Chart 10). For the 2016 V3P data set, pool-procurement resulted in lower WAP than self-procurement for 78 to 90% of vaccines, depending on income group.

Chart 9. WAP (circle) and price range (max and min) of single-dose new vaccines – HPV, PCV, and Rota – in non-Gavi, non-PAHO MICs, between 2014 and 2016.

Chart 10. Proportion of vaccines with lower WAP, by procurement method, for non-Gavi countries, in 2016. (d = dose)

For very mature vaccines at low prices, the difference in WAP between self- and pool-procurement may be less consequential, but, as can be noted for DT 10-dose in non-Gavi countries, prices can be up to ten-fold higher for self-procuring MICs, compared to pool-procurement (see Chart 11, page 8). For newer vaccines, the price differences can be significant for MICs. The relative difference in WAP of MMR single-dose to self-procuring, non-Gavi UMICs is nearly double the price to pool-procuring, non-Gavi UMICs.

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Chart 11. Impact of procurement method on WAP of DT 10-dose and MMR 1-dose, in non-GAVI MICs, in 2016.

Prices and IncomeAlthough vaccine characteristics are often differentiated between markets (acellular pertussis versus whole-cell pertussis combinations, etc.), prices also tend to be differentiated across income groups for the same product.

An analysis of correlation between GNI per capita and vaccine price for 30 vaccine types and 61 non-PAHO and non-Gavi countries is presented in Chart 12.

The analysis does not take into consideration other important elements such as the manufacturer, product characteristics, presentation size, and form or procurement mechanism. Note that the analysis only includes non-Gavi countries and non-PAHO countries.

Note that the spread in price differentiation between the lowest-income groups may be small for the most mature vaccines, where prices are already at their lowest (see Chart 13, page 9).

Chart 12. Pearson correlation between GNI per capita and vaccine price in non-Gavi and non-PAHO countries, in 2016.

The correlation analysis was only conducted when a minimum of 10 observations (N ≥ 10) were available and the result considered statistically significant when returning a p-value less than or equal to 0.05 (p ≤ 0.05).

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The 2016 data show that for most vaccines, in addition to an increase in unit price by income group, the price range widens for higher-income groups. This is particularly visible for the highest price vaccines, where the price range can be substantial within and across income groups (see Chart 14).

Table 1 shows the average multiplier for prices by income groups, for 32 vaccine types, independent of any factors which may affect prices, such as the manufacturer, product characteristics, presentation size and form, or procurement mechanism.

GLOBAL

Chart 13. Tiered pricing (WAP) of HepB (ped) 1-dose and bOPV1,3 20-dose, by income groups, in self-procuring, non-Gavi countries, in 2016.

Chart 14. Price range, per quartile, of single-dose PCV, by income category, showing widening price range with increasing income level, in 2016.

Table 1. Average multiplier factor between the lowest and highest price of a vaccine type, by country category, in 2016.

Category Average multiplier between lowest and highest price across vaccine types

Gavi countries 6.2

All non-Gavi MICs (incl. PAHO countries) 13.9

All HICs (incl. PAHO countries) 29.1

Across all income levels 15.9

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Chart 15. Proportion of vaccines with lower WAP, by presentation size, for non-Gavi countries, in 2016.

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Prices and ProductsAn analysis of 11 vaccine types with presentations in both single- and 10- or higher dose (see Chart 15) shows that a majority of vaccines have lower WAPs when purchased in 10- or 20-dose presentations. Although the differentiation between smaller presentation sizes, e.g., 2-dose and 5-dose, is not always observed, the tendency for lower price with much larger presentation sizes (e.g., 10-dose, 20-dose) than with single-dose generally holds across vaccine types.

However, it should be cautioned that price should not be the only consideration for presentation size, and both

logistical and programmatic needs should be carefully considered when selecting presentation size. Product characteristics, such as composition and presentation sizes, tend to differentiate prices of products between income groups. Higher-income countries tend to use single-dose presentations whereas lower income groups may more often use multi-dose presentations (e.g., 2-, 5-, and 10-dose presentations). Chart 16 shows the difference between the proportions of countries using single-dose MMR by income group, as well as the price differentiation by presentation size, within each income group.

Chart 16. WAP differentiation between single-dose and 10-dose MMR within income groups, and proportion of countries using single-dose MMR across income groups, in 2016.

8Excludes prices from USA for DTaP-Hib-IPV, Hib, Influenza (seasonal - Adult), Influenza (seasonal - ped) and PCV single-dose, which were not available for the analyses.

Prices and VolumesTo better understand the relationship between vaccine price and volume purchased, an analysis of linear correlation between volume and price was conducted on 102 products, differentiated by presentation sizes (e.g., BCG 10-dose, BCG 20-dose)8.

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Chart 17. Number of manufacturers, number of products, showing proportion of self-procuring countries by vaccine type, for vaccines recommended for routine use by WHO, in 2016.

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These were analysed separately by country category (Gavi-countries, non-Gavi, non-PAHO MIC, and HIC). Of these 102 products, only seven showed a statistically significant correlation between volume purchased and price9.• Negative correlation10 was found in the “Non-Gavi,

non-PAHO MICs” category for four vaccines: DT 10-dose; Td 10-dose; IPV 1-dose; PCV1.

• Positive correlation was found in the “HIC” category for three vaccines: HepB (ped) 1-dose; HPV 1-dose; Tdap 1-dose.

This analysis shows inconclusive evidence about the relationship between volume and price.

General Information on Supply and Price Changes

Chart 17 shows the number of manufacturers for vaccines recommended by WHO for routine immunization11, along with the number of available products for each, and the proportion of countries self-procuring each vaccine type. Products are defined as the unique combination of vaccine type, manufacturer, presentation form, and presentation size.

Chart 18 shows the price ranges for the same vaccine types (all presentation forms and sizes, all procurement methods, and all income groups combined).

9Only vaccines purchased at the national level through self-procurement and self-funding were included in the analysis. The correlation analysis was only conducted when a minimum of 10 observations (N ≥ 10) were available and the result considered statistically significant when returning a p-value less than or equal to 0.05 (p ≤ 0.05).10The correlation is considered negative when the correlation coefficient r associated with the number of observation N is lower than the threshold of -0.3, such as: r(N) ≤ -0.3. The correlation is considered positive when r(N) is higher than the threshold of +0.3, such as: r(N) ≥ 0.3. When -0.3 ≤r(N) ≤0.3, it is considered that there is little to no association (no value in this analysis was found in this range).11Vaccines recommended by WHO for routine immunization, as presented in the Summary of WHO Position Papers as of March 2017. Cholera, MMRV, MenA, MenB, and TBE could not be included in the analysis for lack of sufficient data.

Chart 18. Maximum, median, and minimum prices for vaccines recommended for routine use by WHO, in 2016 (median price labeled).

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