Global Vaccine Market

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 • Perceived Safety – vaccine hesitancy • Perceived value for money • Epidemiology: Global and local • Fit with delivery system Source: Global Vaccine Market Model preliminary routine immunization market value analysis, March 2016 6 17 28 33 0 5 10 15 20 25 30 35 40 $ (Billions) Vaccine Market Growth UMICS 23% LMICs 8% LICs 4% HICs 65% Vaccine Market Share 2014 (US$ Approximate Value) Global vaccine markets 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 MIC/LMIC PRIVATE US/EUROPE/JAPAN GAVI/UN MIC/LMIC PUBLIC Global vaccine markets 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 MIC/LMIC PRIVATE US/EUROPE/JAPAN Vaccine hesitancy GAVI/UN POOLED PROCUREMENT • Characteristics to fit in delivery system • Value for money MIC/LMIC PUBLIC Supply PATH/Satvir Malhotra • Regulatory requirements: national and WHO PQ • Predictability of demand • Reliability and scale of production Vaccine manufacturers 33 17 13 12 4 21 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Share of market value Other Sanofi‐Pasteur MSD Merck Pfizer Sanofi‐Pasteur GlaxoSmithKline /Novartis Source: Miloud Kaddar, WHO, “Global Vaccines Market Features and Trends” Presentation. Geneva, 2012; GAVI website, October 2014; PATH analysis State-owned Privately held Developing country vaccine manufacturers BioE Innovax BBIL Parastatal global actors Local Emerging actors Niche National Global export Serum Institute of India LGLS CNBG BioFarma BioM Butantan Institute Pasteur de Dakar Birmex Biovac Walvax SK Chemicals Panacea Incepta Arabio Razi Scale matters in vaccine manufacturing: larger production can help drive down unit costs. Illustrative only Indicative cost per dose manufactured 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. Gavi 57M doses OECD 12M doses *Assuming 80% coverage Financing PATH/Jolene Beitz • Perceived value for money by market • Tiered pricing • Perceived reliability and timeliness of payor The GAVI/UNICEF procurement has doubled in value in the last 5 years alone. Source: UNICEF public data UNICEF contracts (2001‐14) Demand (number of doses) As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets. Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only. Gavi transitions 2015‐2030 Demand (number of doses) As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets. Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only. Gavi transitions 2015‐2030 Demand (number of doses) As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets. Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only. Gavi transitions 2015‐2030 Vaccine Development – why markets matter PATH/Amy MacIver • Demand and financing depends on characteristics of vaccine • Fit with delivery system and schedule • Value for money • Significant investment Investments in vaccine development and production are significant. The expected market size is a critical factor. *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 Time (years) Investment $ million Preclinical Phase I & II Phase III Licensure and production capital Decision Gate Decision Gate 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 Price High Tiers (High/middle income) Competitive ‐ Multiple tiers ‐ Lowest tier for the poorest PATH/Amy MacIver 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 Changing landscape ‐ 2013 This image cannot currently be displayed. Source: UNICEF public data Changing landscape ‐ 2014 This image cannot currently be displayed. Source: UNICEF public data Hib vaccine introduction: high‐ and low‐income markets Source: International Vaccine Access Center (IVAC), Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015. Johns Hopkins Bloomberg School of Public Health. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 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 Percentage of countries that have universally introduced vaccine Years since first introduction High‐income markets Low‐income markets ~10+ years PCV vaccine introduction: high‐ and low‐income markets Source: International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015. Note: Limited projections are available for PCV introduction in high‐income countries 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 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 Percentage of countries that have universally introduced vaccine Years since first introduction High‐income markets Low‐income markets ~5 years New vaccines are reaching children in developing countries much more rapidly. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 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 Percentage of countries that have universally introduced vaccine Years since first introduction Hib HIC Hib LIC PCV HIC PCV LIC 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 Source: Global Vaccines Market Model, March 2016 $‐ $20.00 $40.00 $60.00 $80.00 $100.00 $120.00 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 USA Other HICs UMICs LMICs Gavi PCV price and volume by Market 2015 Price tiering has also been critical in accelerating access to rotavirus vaccines. Source: Global Vaccines Market Model, March 2016 $‐ $10.00 $20.00 $30.00 $40.00 $50.00 $60.00 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 2015 AVERAGE PRICE PER DOSE SHARE OF WASTAGE‐ADJUSTED DEMAND USA Other HICs UMICs LMICs Gavi Rotavirus vaccine price and volume by Market 2015 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: Financing Demand Supply Uncertainty about demand leads to limited investments in capacity Low capacity results in limited supply which creates shortages and keeps prices relatively high Higher prices raise questions about value for money and increase uncertainty about demand and financing Financing Demand Supply The challenges – creating a virtuous cycle: Reliable demand leads to investment in adequate capacity and efficiently managed production Lower costs translate into affordable prices for different markets stimulating demand Appropriately sized capacity increases efficiency of production ‐ benefit from economies of scale and supply all markets ot currently be displayed. PATH/Gabe Bienczycki Thank you! www.path.org This image cannot currently be displayed. Global vaccine markets 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 MIC/LMIC PRIVATE US/EUROPE/JAPAN • Vaccine hesitancy GAVI/UN POOLED PROCUREMENT • Characteristics to fit in delivery system • Value for money MIC/LMIC PUBLIC