#1CURRENT MARKET LANDSCAPE FOR PLASMA AND IMMUNOGLOBULINS Matthew Hotchko, PhD IPFA-EBA Symposium March 14, 2022 Marketing Research Bureau MRB#2METHODOLOGY AND DISCLAIMER The data used to develop the charts and tables shown in this presentation have been compiled from surveys conducted by the Marketing Research Bureau in over 90 countries and published in various syndicated reports. All the data and information originate from sources generally available to the public. Their accuracy is not guaranteed, and the Marketing Research Bureau assumes no liability for their use. © 2022 Sharing, posting, or reproducing this material, in whole or in part, is forbidden, unless granted explicit authorization from the Marketing Research Bureau. (MRB)#3Overview 1. 2. 3. 2020 Plasma protein usage and growth trends Immunoglobulin demand versus COVID19 reduced plasma collections Comparison of the trends in IG usage and the supply of plasma for fractionation in 2019 and 2020 3 (MRB#424 Years of worldwide plasma proteins market growth (without recombinant products) 1996 7.4% annual growth Hyperimmunes All Others 15% 7% Factor IX 5% IVIG/SCIG 24% Albumin 31% Factor VIII 18% 1996 Market: $4.8 billion Hyperimmunes Factor IX Factor VIII Note: Pie charts are drawn to scale All Others Albumin 2020 IVIG/SCIG 2020 Market: $26.6 billion (MRB)#5Market trends in past 5+ years • ● • · Immunoglobulin sales have grown among the fastest for all plasma proteins • Strong volume and price growth - supply capped by plasma collections Albumin has also grown, but more slowly • Volume growth has been steady, driven by China, but pricing has declined Plasma derived factor VIII and IX demand has been declining due to recombinant and non-factor competition • Pricing has been negatively affected by increased competition Decline in usage in high income countries, but growing in emerging markets Other Protein Trends: • • Those with recombinant or non-plasma competition have declined (C1-INH) Those without competition have grown (AAT) • Those prescribed for acute blood loss situations have grown (PCC and fibrinogen) 5 (MRB#6North America consumes the most IG, but Europe is over 25% total 2020 IG Usage by Region North America ■Europe Asia-Pacific Latin America Middle East-Africa 6 (MRB)#7Immunoglobulin has become ever more dominant in terms of plasma economics for the entire industry. 1. 2. 3. 4. IG is the global plasma market driver since the 1990s. The IG manufacturers base their plasma collections on their immunoglobulin sales forecasts. Albumin is also a last liter product today. 5. 6. 7. Since both products are made from practically every liter of plasma fractionated, the only way to increase (or decrease) the supply is to collect and fractionate more (or less) plasma. Albumin demand growth has been slower than plasma collections (and thus supply), resulting in flat to declining prices IG demand growth has been among the fastest compared to all plasma proteins As a result, companies have collected plasma to meet the expected IG demand in the 2010s, with growth at rates averaging 8-9% per year. But then..... COVID19 Pandemic happened, severely affecting plasma collections 7 (MRB)#8Globally, Source (Apheresis) plasma is providing all the volume growth for fractionation Global Plasma for Fractionation Recovered Source Total 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 Global plasma volume for fractionation fell 14% in 2020 from 2019 due to COVID19 pandemic Globally, the growth has come from Source (Apheresis) plasma (mainly commercial) despite the COVID-19 pandemic The volume of Recovered plasma (all public) has declined in recent years, including during the COVID-19 pandemic 80 (MRB#9Pre-pandemic plasma collection for fractionation was dominated by United States Origin of Plasma for Fractionation - 2019 18% 1% 0% North America * ■Europe 14% I Asia & Pacific ** 67% *United States represented over 99% of the North America total Latin America Middle East & Africa ** China represented almost 75% of Asia & Pacific total Total Plasma Collection volume 2019: 69 M liters 6 (MRB#10How did the pandemic change plasma collection? Origin of Plasma for Fractionation - 2020 2020 vs. 2019 2021 est. vs. 2019 North America * Down 18% Down 5-8% ■Europe Down 9% Down 0-3% I Asia & Pacific ** Down 7% Down 0-2% Latin America Middle East & Africa Total Plasma Collection volume 2019: 69 M liters 2020: 59 M liters (-14.5% vs. 2019) 10 10 (MRB#11Plasma is still dominated by United States after the pandemic, so countries. still rely on US plasma for some immunoglobulin products Origin of Plasma for Fractionation - 2020 1% 19% 0% North America ■Europe * Asia & Pacific ** 15% Latin America 65% Middle East & Africa Total Plasma Collection volume 2020: 59 million liters *United States represents over 99% of the North America total ** China represents 72% of Asia & Pacific total 11 (MRB#12North America and Asia-Pacific produce enough plasma for their internal use, but other regions must import IG made from US plasma Origin of Plasma for Fractionation - 2020 1% 19% 0% North America * ■Europe Asia & Pacific ** 15% Latin America 65% Middle East & Africa 2020 IG Usage by Region Since Europe consumes 25% of the worldwide IG supply but collects only 15% of the global plasma for fractionation, there is an imbalance that requires Europe to import IG produced from US plasma. 25% 12 (MRB)#13How has the industry responded to the pandemic challenge? • Due to the challenge created by COVID-19 to the plasma supply, companies in the United States have responded aggressively to increase collections • Over 100 new plasma collection centers gained FDA licenses in 2020, and almost 110 more in 2021 By end of 2021, nearly 1050 FDA licensed centers in US, up 24% from 2 years earlier • Donor fees were raised significantly, offering up to $1100-$1200 for 8 donations in first month. • Average donor fees went from under $60 a donation pre-pandemic to around $80 a donation in 2021 • At the same time, Europe has also made some moves to increase the regional plasma supply: • • • The United Kingdom has begun to use plasma (including source) for fractionation Poland has acquired thousands of plasmapheresis machines, hoping to double or triple its volume of plasma for fractionation Several countries have launched new programs to collect more source plasma Private companies in Germany, Austria, Czech Republic and Hungary continue to add more plasma collection centers 13 (MRB#14European Plasma Collections by Type European Plasma Collections 2019 vs. 2020 4.500 Down 13.0% 4.000 3.500 3.000 2.500 2.000 1.500 1.000 500 0 Public Recovered Down 4.0% Public Source 2019 2020 Down 7.5% Private Source Overall European collections declined by 9.4% in 2020 vs. 2019 due to the pandemic. In 2020, a total of 8.3 million liters of plasma were collected (source and recovered) in Europe. 14 MRE#15European IG Usage vs. Plasma Collection in 2019 vs. 2020 IG Usage (Tons) Plasma Collected (M Liters) +4.2% -9.4% 2019 2020 2019 2020 As a result of the drop in collections, due to the pandemic and the continued rise in IG demand, the imbalance of collections and IG product need grew in 2020. 15 (MRB)#162019 and 2020 Imbalance of Plasma Collections and Need for IG in Europe Plasma (Million liters) 14 2019 14 2020 112 12 12 32% 40% deficit deficit 10 10 8 9 4 2 0 Plasma Collected IG Needed 6 4 2 Plasma Collected IG Needed *Assume average blended yield of 4.5 grams IG per liter of plasma The self-sufficiency of Europe, dropped 8 percentage points from 2019 to 2020. 16 (MRB)#17Increase in Collections needed in 2019 and 2020 to meet needs of Patients in Europe Plasma (Million liters) 14 2019 14 2020 1122 12 47% 12 67% increase increase 10 10 8 9 4 2 0 Plasma Collected IG Needed 6 4 2 Plasma Collected IG Needed *Assume average blended yield of 4.5 grams IG per liter of plasma Increase in plasma collections required to meet the IG needs of all patients: 2019: 4.3 million liters 2020: 5.6 million liters 17 (MRB#18Conclusions • The COVID-19 pandemic has caused plasma collections to decrease in the United States, Europe and worldwide. At the same time, the IG demand has continued to increase in Europe between 2019 and 2020. • As a result of these opposite trends, the self-sufficiency rate for Europe dropped in 2020 vs 2019, covering only 60% of the plasma needed by patients for the production of immunoglobulins. Europe would need to increase plasma collections by 5.6 million liters, or 67%, which is two thirds, to provide enough plasma for fractionation to meet the IG needs of all its patients in 2020. 18 (MRB)#19Thank you! MRB MARKETING RESEARCH BUREAU, Office Phone: +1-425-502-6265 Email: info@marketing researchbureau.com mhotchko@marketing researchbureau.com www.marketing researchbureau.com 19 (MRB