Global vaccine market - PDF Free Download

Global vaccine market Global Vaccine and Immunization Research Forum Amie Batson Chief Strategy Officer, PATH March 2016 PATH/Eric Becker

Agenda Overview of global vaccine market Demand Supply Financing Vaccine development and vaccine markets Product life cycle

Demand critical factors Epidemiology: Global and local; Individual and community Perceived safety vaccine hesitancy Perceived value for money Fit with delivery system PATH/Gabe Bienczycki

Demand growing market $ (Billions) 40 Perceived Safety 35vaccine hesitancy 30 Perceived value for 25 money 20 Epidemiology: Global 15 and local 10 6 17 28 33 Fit with delivery system 5 0 Vaccine Market Growth Vaccine Market Share 2014 (US$ Approximate Value) HICs 65% UMICS 23% LMICs 8% LICs 4% Source: Global Vaccine Market Model preliminary routine immunization market value analysis, March 2016

Global vaccine markets GAVI/UN MIC/LMIC PUBLIC US/EUROPE/JAPAN MIC/LMIC PRIVATE Note: Only non PAHO countries with >250,000 annual birth cohort included. Source: World Bank GNI 2013, UNPD Population Prospects 2012 Edition, GAVI Website, September 2014

Global vaccine markets GAVI/UN POOLED PROCUREMENT Characteristics to fit in delivery system Value for money MIC/LMIC PUBLIC US/EUROPE/JAPAN Vaccine hesitancy MIC/LMIC PRIVATE Note: Only non PAHO countries with >250,000 annual birth cohort included. Source: World Bank GNI 2013, UNPD Population Prospects 2012 Edition, GAVI Website, September 2014

Supply Regulatory requirements: national and WHO PQ Predictability of demand Reliability and scale of production PATH/Satvir Malhotra

Vaccine manufacturers 100% Developing country vaccine manufacturers 90% 80% 70% 60% 50% 40% 30% 20% 10% 21 4 12 13 17 33 Other Sanofi Pasteur MSD Merck Pfizer Sanofi Pasteur GlaxoSmithKline /Novartis National Global export Razi Parastatal global actors Institute Pasteur de Dakar Birmex Local CNBG BioFarma Butantan BioM Emerging actors Walvax Incepta Arabio LGLS SK Chemicals Niche Biovac Serum Institute of India Panacea BioE Innovax BBIL 0% State-owned Share of market value Source: Miloud Kaddar, WHO, Global Vaccines Market Features and Trends Presentation. Geneva, 2012; GAVI website, October 2014; PATH analysis Privately held

Scale matters in vaccine manufacturing: larger production can help drive down unit costs. Indicative cost per dose manufactured OECD 12M doses Gavi 57M doses Illustrative only *Assuming 80% coverage Manufacturing volume Source: United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, custom data acquired via website.

Financing Perceived value for money by market Tiered pricing Perceived reliability and timeliness of payor PATH/Jolene Beitz

The GAVI/UNICEF procurement has doubled in value in the last 5 years alone. UNICEF contracts (2001 14) Source: UNICEF public data

As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets. Gavi transitions 2015 2030 Demand (number of doses) Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only.

Vaccine Development why markets matter Demand and financing depends on characteristics of vaccine Fit with delivery system and schedule Value for money Significant investment PATH/Amy MacIver

Investments in vaccine development and production are significant. The expected market size is a critical factor. Investment $ million Decision Gate Decision Gate Phase III Licensure and production capital Preclinical Phase I & II Time (years) *All costs sourced from Light, Donald W., Jon Kim Andrus, and Rebecca N. Warburton. "Estimated research and development costs of rotavirus vaccines." Vaccine 27.47 (2009): 6627 6633, updated to 2016 USD

Product life cycle Product launch Early market penetration Maturity Number of products 1 1 2 Several Product capacity Low Medium High Cost/unit High Relatively high Yield and learning curve gains Tiers (High/middle income) Competitive Multiple tiers Lowest tier for the poorest Price PATH/Amy MacIver High

Changing landscape 2006 Source: UNICEF public data

Changing landscape 2007 Source: UNICEF public data

Changing landscape 2008 Source: UNICEF public data

Changing landscape 2009 Source: UNICEF public data

Changing landscape 2010 Source: UNICEF public data

Changing landscape 2011 Source: UNICEF public data

Changing landscape 2012 Source: UNICEF public data

This image cannot currently be displayed. Changing landscape 2013 Source: UNICEF public data

This image cannot currently be displayed. Changing landscape 2014 Source: UNICEF public data

Hib vaccine introduction: high and low income markets 100% Percentage of countries that have universally introduced vaccine 90% 80% 70% 60% 50% 40% 30% 20% 10% High income markets ~10+ years Low income markets 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Years since first introduction Source: International Vaccine Access Center (IVAC), Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015. Johns Hopkins Bloomberg School of Public Health.

PCV vaccine introduction: high and low income markets 100% Percentage of countries that have universally introduced vaccine 90% 80% 70% 60% 50% 40% 30% 20% 10% High income markets ~5 years Low income markets 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Years since first introduction Note: Limited projections are available for PCV introduction in high income countries Source: International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015.

New vaccines are reaching children in developing countries much more rapidly. 100% Percentage of countries that have universally introduced vaccine 90% 80% 70% 60% 50% 40% 30% 20% 10% Hib HIC Hib LIC PCV HIC PCV LIC 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Years since first introduction Note: Limited projections are available for PCV introduction in high income countries Source: International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015.

Tiered pricing enabled GAVI countries to access PCV earlier in the products lifecycles $120.00 PCV price and volume by Market 2015 $100.00 $80.00 $60.00 $40.00 USA Other HICs UMICs LMICs Gavi $20.00 $ 1M 7M 13M 19M 25M 31M 37M 43M 49M 55M 61M 67M 73M 79M 85M 91M 97M 103M 109M 115M 121M 127M 133M 139M 145M 151M 157M 163M 169M 175M 181M 187M 193M 199M 205M 211M 217M 223M 229M 2015 AVERAGE PRICE PER DOSE SHARE OF DEMAND Source: Global Vaccines Market Model, March 2016

Price tiering has also been critical in accelerating access to rotavirus vaccines. Rotavirus vaccine price and volume by Market 2015 $60.00 2015 AVERAGE PRICE PER DOSE $50.00 $40.00 $30.00 $20.00 USA Other HICs UMICs LMICs Gavi $10.00 $ 1M 4M 7M 10M 13M 16M 19M 22M 25M 28M 31M 34M 37M 40M 43M 46M 49M 52M 55M 58M 61M 64M 67M 70M 73M 76M 79M 82M 85M 88M 91M 94M 97M 100M 103M 106M 109M SHARE OF WASTAGE ADJUSTED DEMAND Source: Global Vaccines Market Model, March 2016

This image cannot currently be displayed. Vaccines without a dual market face other challenges. Meningitis A vaccine was developed through a public private partnership. DEMAND: African MOHs request conjugate Men A vaccine available at ~$0.50/dose DEVELOPMENT AND SUPPLY: PATH WHO partnership with Serum Institute of India, FDA, NIH, and others FINANCING: BMGF invest $75 million; gov ts and donors purchase doses Vaccine available on market in 2010; TODAY 235 million people protected By 2020, expect to protect ~ 400 million

The challenges managing the vicious cycle: Uncertainty about demand leads to limited investments in capacity Higher prices raise questions about value for money and increase uncertainty about demand and financing Demand Financing Supply Low capacity results in limited supply which creates shortages and keeps prices relatively high

The challenges creating a virtuous cycle: Lower costs translate into affordable prices for different markets stimulating demand Financing Supply Appropriately sized capacity increases efficiency of production benefit from economies of scale and supply all markets Demand Reliable demand leads to investment in adequate capacity and efficiently managed production

ot currently be displayed. This image cannot currently be displayed. Thank you! www.path.org PATH/Gabe Bienczycki