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The Pharmaceutical Industry in Figures Key Data 2021

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The Pharmaceutical Industry in Figures Key Data 2021 The Pharmaceutical Industry in Figures Key Data 2021 www.efpia.eu EFPIA Key Data | 2021 THE PHARMACEUTICAL INDUSTRY: A KEY ASSET TO SCIENTIFIC AND MEDICAL PROGRESS Thanks to advances in science and technology, the targeted treatments. European citizens can expect research-based pharmaceutical industry is entering not only to live longer, but to live better quality lives. an exciting new era in medicines development. Yet major hurdles remain, including Alzheimer’s, Research methods are evolving and we have many Multiple Sclerosis, many cancers, and rare diseases. promising prospects on the horizon, with ground- breaking cell and gene therapies being increasingly available*. The innovative pharmaceutical industry is driven by, and drives, medical progress. It aims to turn fundamental research into innovative treatments that are widely available and accessible to patients. Already, the industry has contributed to significant improvements in patient well-being. Today’s European citizens can expect to live up to 30 years longer than they did a century ago. Some major steps in biopharmaceutical research, complimented by many smaller steps, have allowed for reductions in mortality, for instance from HIV/AIDS-related causes and a number of cancers. High blood pressure and cardiovascular diseases can be controlled with antihypertensive and cholesterol-lowering medicines; knee or hip replacements prevent patients from immobility; and some cancers can be controlled – or even cured – with the help of new TOTAL NUMBER OF DEATHS AMONG AIDS CASES IN EUROPE (TOTAL EU/EEA) 4000 Source: HIV/ AIDS surveillance in Europe 2020 3000 2587 2516 (2019 data), WHO 2316 2297 Regional Office for 2052 Europe & European 2000 1789 1769 1621 Centre for Disease Prevention and 1055 1000 774 Control (ECDC), 26 November 2020 0 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 *https://www.efpia.eu/publications/downloads/efpia/iqviaefpia-pipeline-review-2021 2 THE PHARMACEUTICAL INDUSTRY: A KEY ASSET TO THE EUROPEAN ECONOMY As well as driving medical progress by researching, world, the research-based pharmaceutical industry developing and bringing new medicines that improve is a key asset of the European economy. It is one of health and quality of life for patients around the Europe’s top performing high-technology sectors. INDUSTRY (EFPIA total) 2000 2010 2019 2020 Production 127,504 199,730 293,213 310,000 (e) Exports (1) (2) 90,935 276,357 473,753 515,000 (e) Imports 68,841 204,824 333,626 360,000 (e) Trade balance 22,094 71,533 140,127 155,000 (e) R&D expenditure 17,849 27,920 37,754 39,000 (e) Employment (units) 556,506 701,059 823,882 830,000 (e) R&D employment (units) 88,397 116,253 121,594 125,000 (e) Total pharmaceutical market value 89,449 153,684 227,404 240,500 (e) at ex-factory prices Payment for pharmaceuticals by statutory health insurance systems 76,909 129,464 140,374 149,500 (e) (ambulatory care only) Values in € million unless otherwise stated (1) Data relate to EU-28, Norway and Switzerland since 2005 (EU-15 before 2005); Croatia and Serbia included since 2010; Turkey included since 2011; Russia included since 2013 (2) Data relating to total exports and total imports include EU-28 intra-trade (double counting in some cases) Source: EFPIA member associations (official figures) - (e): EFPIA estimate; Eurostat (EU-28 trade data 2000-2020) 3 EFPIA Key Data | 2021 MAIN TRENDS The research-based pharmaceutical industry can the period 2015-2020 the Brazilian, Chinese and play a critical role in restoring Europe to growth and Indian markets grew by 11.3%, 4.8% and 10.0% ensuring future competitiveness in an advancing respectively compared to an average market global economy. In 2020 it invested an estimated € growth of 5.0% for the top 5 European Union 39,000 million in R&D in Europe. It directly employs markets and 4.9% for the US market (source: IQVIA some 830,000 people and generates about three MIDAS, April 2021). times more employment indirectly – upstream and In 2020 North America accounted for 49.0% of downstream – than it does directly (PwC, Economic world pharmaceutical sales compared with 23.9% and societal footprint of the pharmaceutical industry for Europe. According to IQVIA (MIDAS April in Europe, June 2019). However, the sector faces real 2021), 63.7% of sales of new medicines launched challenges. Besides the additional regulatory hurdles during the period 2015-2020 were on the US mar- and escalating R&D costs, the sector has been ket, compared with 17.4% on the European mar- severely hit by the impact of fiscal austerity measures ket (top 5 markets). introduced by governments across much of Europe since 2010. The fragmentation of the EU pharmaceutical market has resulted in a lucrative parallel trade. There is rapid growth in the market and research This benefits neither social security nor patients environment in emerging economies such as and deprives the industry of additional resources Brazil, China and India, leading to a gradual to fund R&D. Parallel trade was estimated to migration of economic and research activities from amount to € 5,758 million (value at ex-factory Europe to these fast-growing markets. During prices) in 2019. GEOGRAPHICAL BREAKDOWN (BY MAIN MARKETS) OF SALES OF NEW MEDICINES LAUNCHED DURING THE PERIOD 2015-2020 Note: New medicines cover all new active ingredients marketed for the first time on the world market during the period 63.7% 2015-2020 USA 17.4 % Europe Europe (Top 5) comprises (Top 5) Germany, France, Italy, Spain 6.9% and United Kingdom Japan Pharmerging comprises 21 10.2% Rest of countries ranked by IQVIA as the World high-growth pharmaceutical markets (Algeria, Argentina, Bangladesh, Brazil, Colombia, 1.8% Pharmerging Chile, China, Egypt, India, Indonesia, Kazakhstan, Mexico, Nigeria, Pakistan, Philippines, Poland, Russia, Saudi Arabia, South Africa, Turkey and Vietnam) Source: IQVIA (MIDAS April 2021) 4 PHARMACEUTICAL R&D EXPENDITURE IN EUROPE, USA AND JAPAN (MILLION OF NATIONAL CURRENCY UNITS*), 1990-2019 70,000 64,357 62,220 60,000 Japan 50,000 USA 40,688 37,754 40,000 36,275 Europe 27,920 30,000 21,364 17,849 20,000 12,760 14,047 13,392 7,766 7,462 10,000 6,803 5,161 0,000 1990 2000 2010 2018 2019 * Note: Europe: € million; USA: $ million; Japan: ¥ million x 100 Europe USA Japan Source: EFPIA member associations, PhRMA, JPMA SHARE OF PARALLEL IMPORTS IN PHARMACY MARKET SALES (%) – 2019 26 25,0 24 22 20 18 16 14 12 10 9,8 8,7 8,6 8 7,3 6,3 6 4 3,0 2,5 2,6 2 2,0 0 Austria Belgium Denmark Finland Germany Ireland Netherlands Poland Sweden U.K. Note: U.K.: in % of pharmacy market sales at reimbursement prices Source: EFPIA member associations (estimate) 5 EFPIA Key Data | 2021 PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPE All new medicines introduced into the market are The cost of researching and developing a new the result of lengthy, costly and risky research and chemical or biological entity was estimated development (R&D) conducted by pharmaceutical at € 1,926 million ($ 2,558 million in year 2013 companies: dollars) in 2014 (DiMasi et al, Journal of Health Economics, January 2016); By the time a medicinal product reaches the market, an average of 12-13 years will have elapsed since On average, only one to two of every 10,000 the first synthesis of the new active substance; substances synthesised in laboratories will successfully pass all stages of development required to become a marketable medicine. PHASES OF THE RESEARCH AND DEVELOPMENT PROCESS Pre–clinical development Patent application Clinical trials Acute toxicity Pharmacology Chronic toxicity Phase I Phase II Phase III Registration / Marketing authorisation Price Reimbursement Pharmacovigilance Screening (10,000 molecules) Screening 1 medicinal product 0 5 years 10 years 15 years 20 years 25 years patent expiry SPC (supplementary protection certificate) max. + 5 years 10 years of R&D 2 to 3 years of administrative procedures 6 PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPE EFPIA 2019 € million € million Austria 311 Latvia n.a Belgium 3,846 Lithuania n.a Bulgaria 91 Malta n.a Croatia 40 Netherlands 642 Cyprus 85 Norway 126 Czech Rep. 62 Poland 339 Denmark 1,543 Portugal 117 Estonia n.a Romania 75 Finland 182 Russia 727 France 4,451 Slovakia n.a Germany 8,466 Slovenia 180 Greece 51 Spain 1,212 Hungary 242 Sweden 1,104 Iceland n.a Switzerland 6,383 Ireland 305 Turkey 137 Italy 1,600 U.K. 5,437 TOTAL 37,754 Note: The figures relate to the R&D carried out in each country. Hungary, Portugal: 2018 data; Bulgaria, France, Greece: 2017 data; Slovenia: 2016 data; Norway, Sweden: 2015 data; Cyprus, Ireland: 2013 data; Croatia, Netherlands: 2011 data Belgium, Croatia, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway (LMI members), Poland, Romania, Slovenia, Sweden (LIF members), Switzerland (Interpharma members), Turkey: estimate Source: EFPIA member associations (official figures) 7 EFPIA Key Data | 2021 AllocationALLOCATION OF of R&D R&D INVESTMENTS investments BY FUNCTION by function (%) (%) 15.7 Pre-human/Pre-clinical 8.8 Phase I 9.7 Phase II 47.4 Clinical Trials 28.9 Phase III 4.3 Approval 11.2 Pharmacovigilance (Phase IV) Source: PhRMA, Annual Membership 21.4 Uncategorized Survey 2020 (percentages calculated from 2019 data; total values may be affected by rounding) NUMBER OF NEW CHEMICAL AND BIOLOGICAL ENTITIES (2001-2020) Europe USA Japan Others 140 138 120 Others 100 89 Japan 80 75 72 USA 64 61 60 51 Europe 49 48 38 40 31 31 23 20 19 14 11 0 2000-2005 2006-2010 2011-2015 2016-2020 Source: SCRIP – EFPIA calculations (according to nationality of mother company) 8 2,600 IMPORTANCE OF 2,558 2,500 PHARMACEUTICAL R&D 2,400 2,300 In 2019 the pharmaceutical industry invested more 2,200 than € 37,700 million in R&D in Europe.
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