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Safeguarding the Bioeconomy (2020)

Chapter: 4 Areas of Leadership in the Global Economy

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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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Suggested Citation:"4 Areas of Leadership in the Global Economy." National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press. doi: 10.17226/25525.
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4 Areas of Leadership in the Global Economy Summary of Key Findings • Internationally, the United States is the leader in the commercialization of advances in synthetic biology and continues to hold an advantage in terms of the education of new Ph.D.’s in the life sciences. This position provides the basis for but no guarantee of future leadership in bioeconomy innovation. This chapter identifies metrics commonly used to determine strategic leadership positions in the global economy and provides an overview of those areas of the bioeconomy in which the United States currently maintains a leadership position. In particular, U.S. investments and outputs in science, innovation, and entrepreneurship are compared with those of other countries investing heavily in the bioeconomy. Although the United States has maintained leadership in many domains of science and innovation since World War II, the set of leading innovator nations has expanded substantially over the past few decades as such countries as Germany, Israel, Singapore, South Korea, and, increasingly, China have increasingly invested in education and innovative capacity (Furman et al., 2002; Furman and Hayes, 2004). Concerns about the future leadership of the United States in key segments of science and innovation have been raised in numerous forums (see, e.g., NRC, 2007; NASEM, 2010; American Academy of Arts and Sciences, 2014, McNutt, 2019). Many of the foundational scientific and technical advances that enable the bioeconomy were pioneered in the United States. These advances include Herbert Boyer and Stanley Cohen’s invention of recombinant-DNA technology in 1973, which arguably launched the biotechnology industry. They also include subsequent advances in genome editing enabled by CRISPR/Cas-9 technology, initially demonstrated for potential use as a tool by Jennifer Doudna and Emmanuelle Charpentier in 2012 (Jinek et al., 2012; Doudna and Charpentier, 2014) and further developed by a number of research teams (Cho et al., 2013; Cong et al., 2013; Mali et al., 2013; Slaymaker et al., 2016; Suzuki et al., 2016; Qi et al., 2013). Leadership in initial scientific discovery does not, however, guarantee subsequent leadership in science or innovation. This observation is dramatically illustrated by the case of Great Britain’s early leadership in the chemistry of aniline dyes, the impetus having been provided by the early discoveries of William Henry Perkin in the mid-1850s. Britain’s leadership was subsequently eclipsed by the industrial scientific and technological leadership of the German chemical and dye industries in the 1860s and German leadership in biology, pharmaceuticals, and medicine in the subsequent decades of the 1870s and 1880s (Murmann, 2003). LEADERSHIP IN SCIENCE IN THE BIOECONOMY Paul Krugman (1991) famously stated that knowledge flows are exceptionally difficult to measure because, unlike physical goods, they do not leave a clear trace. This fundamental measurement problem has frustrated the study of knowledge creation, knowledge spillovers, and innovation despite the 104 Prepublication Copy

Areas of Leadership in the Global Economy best efforts of researchers and policy makers. The measurement problems are even greater in the context of international studies of knowledge creation, leadership, and competitiveness, as such advances have different meanings in different contexts. For example, shop floor workers may achieve new-to-the-world innovations in manufacturing in mechanized factories with no immediate relevance to factories that rely on manual labor, whereas new-to-the-world innovations may be achieved in countries that rely on manual labor for manufacturing that may be of limited or no relevance in locations characterized by a high degree of factory automation. Adding to the difficulty of measuring knowledge creation across nations is the problem that countries, particularly those not at the frontier of knowledge generation, have typically underinvested in the collection of data. The measurement problem is particularly acute in the context of industry sectors, such as the bioeconomy, whose definition varies across countries and whose output is not measured in a systematic way, even within most individual countries. The following outline of the metrics for identifying strategic leadership positions in the global bioeconomy thus relies on a range of measures. Comparisons of Government R&D Expenditures on the Bioeconomy One valuable measure of scientific leadership in the bioeconomy would involve comparing time- series data on total government expenditures on R&D in the bioeconomy. These data would ideally be converted into real rather than nominal dollars to capture the impact of inflation and would include measures of both the flows of expenditures (i.e., annual expenditures in each year) and the stock of expenditures (i.e., accumulated expenditures, adjusted to reflect the depreciation of knowledge over time). The committee was unable to find a historical data series of government expenditures on biotechnology or other aspects of the bioeconomy from either NSF or the OECD that compares the United States with a wide range of other countries. The OECD does report a data series for a set of countries not including the United States (Figure 4-1). This series compares intramural biotechnology R&D expenditures in the government and higher education sectors as a fraction of total government and higher education sector R&D expenditures. It is difficult to compare these data effectively across nations, however, because of differences in the mode of data collection. One point that does appear clear, however, is that relative to historical investment, South Korea and, to some degree, Spain and the Czech Republic, have begun to accelerate investments in biotechnology. The data suggest that South Korea devoted nearly $3.4 billion to government and higher education spending on biotechnology in 2016. A related though not directly comparable figure for the United States is that in fiscal year 2015, agencies of the U.S. federal government, principally the Department of Health and Human Services, obligated $30.5 billion to the life sciences (Figure 4-2). Of this amount, $14.8 billion was targeted to general biological sciences, $10.9 billion to medical sciences, $1.3 billion to agricultural sciences, $0.8 billion to environmental sciences, and $2.6 billion to other life sciences (National Science Board and National Science Foundation, 2018, Appendix Table 4-25). While not all of the bioeconomy is based on life sciences, these data suggest that the United States remains among the world’s leaders in government-led investment in the biological sciences. Prepublication Copy 105

Safeguarding the Bioeconomy FIGURE 4-1 Intramural biotechnology R&D expenditures in the government and higher education sectors, selected Organisation for Economic Co-operation and Development (OECD) countries, 2005–2016 ($US millions Purchasing Power Parity [PPP]). NOTES: For Germany, total public federal bioeconomy R&D expenditures exclude the higher education sector. For Poland, they include the private nonprofit sector. For the Russian Federation, a proxy indicator is used: R&D expenditure in life sciences (before 2011, “living systems”), which includes bioengineering, biocatalysis, biosynthesis and biosensor technologies, biomedical and veterinary technologies, genomics and pharmacogenetics, living cell technologies. SOURCE: OECD, Key Biotechnology Indicators, http://oe.cd/kbi, October 2018. FIGURE 4-2 Federal obligations for research, across all agencies and by major science and engineering field, fiscal year 2015. SOURCE: National Science Foundation and National Science Board, 2018, Figure 4-12. 106 Prepublication Copy

Areas of Leadership in the Global Economy Comparisons of Scientific Output in the Bioeconomy A second, valuable indicator of scientific leadership in the bioeconomy can be gleaned from measures of scientific output, that is, academic publications. Numerous sources, including Thompson Reuters Web of Knowledge, Elsevier’s Scopus database, and Microsoft Academic, provide primary information on numbers of academic publications. Categorizing publications according to scientific fields is a challenge, but data agencies, including the OECD and NSF, compile indicators using these primary data. Individual researchers can do the same. Figure 4-3 reports counts of science and engineering publications in Scopus, by selected region and field, for 2016, based on an analysis performed by NSF for the Science and Engineering Indicators. 1 These data show that the United States leads the world in the production of publications in the biological and medical sciences (although the collective publication output of the countries of the European Union exceeds that of the United States). The output of publications in the biological and medical sciences with author addresses based in China is, however, quite striking, particularly compared with historical levels. The rise of Chinese biotechnology is documented in Figure 4-4, which reports annual biotechnology publications in the United States and China based on an analysis by Gryphon Scientific & Rhodium Group in its 2019 report China’s Biotechnology Development. The data shown in Figure 4-4 document a substantial rise in biotechnology research output over the past decade, with acceleration beginning around 2011 across a number of regions. While the biotechnology publication output for both the European Union and China has risen substantially, these data do not suggest that either region is on a trajectory to eclipse the output of the United States in the short-term. Comparisons of Scientific Training for the Bioeconomy A third important measure that can be used to compare global bioeconomy leadership is the training of scientific and technical personnel. As is true for both government investment and scientific output, there are limitations to the data on the bioeconomy workforce. In particular, it is easier to measure the output of recently trained graduates in particular scientific disciplines than to track the total count of employees in the bioeconomy workforce. This is due, in part, to the complexities of measuring the bioeconomy workforce. Whereas it is relatively straightforward to classify individuals with Ph.D.’s in biology as potential contributors to the bioeconomy, it is more difficult to count the number of individuals trained in areas that are complementary contributors to the bioeconomy, including, for example, those with specific training in data analytics, computer science, automation, the marketing of biologic medicines, or logistics for the transportation of biofuels. 2 1 The use of academic publications and citations as indicators of scientific output and leadership has become the subject of a large body of research, including studies in the field of scientometrics (Garfield and Schoenbach, 1956; Garfield, 1979; Derek de Solla Price, 1976; Loet Leydesdorff, 2001). Research has noted the limitations of this approach, including the potential for strategic and reputation-based citation (Simkin and Roychowdhury, 2003). Nonetheless, country-level counts of publications have proven useful in understanding broad trends in scientific progress and as a result, are regularly included among the statistics gathered and reported by NSF’s Science and Engineering Indicators. 2 It is important to note that counts of doctorate recipients may not be fully consistent across countries, as countries do vary in their expectations for doctoral student work. Prepublication Copy 107

Safeguarding the Bioeconomy FIGURE 4-3 Counts of science and engineering publications in Scopus, by selected region and field, 2016. NOTES: Data callouts indicate the number of publications in the biological sciences. EU = European Union. Article counts are from a selection of journals in science and engineering from Scopus. Articles are classified by their year of publication and are assigned to a region, country, or economy on the basis of the institutional address(es) listed in the article. Articles are credited on a fractional-count basis in which, for example, if two authors of different nationalities co-wrote a paper, each of their countries would be credited with one-half of a paper. See Appendix Table 5-26 in Science and Engineering Indicators 2018 for regions, countries, and economies included in the EU. Percentages may not add to 100 percent because of rounding. SOURCE: National Science Foundation, National Center for Science and Engineering Statistics, Science and Engineering Indicators 2018 (Table 5-23), based on SRI International; Science-Metrix; Elsevier, Scopus abstract and citation database (accessed July 2017). FIGURE 4-4 Annual biotechnology publications, United States versus China, 2000–2017. SOURCE: Computed by Gryphon Scientific and Rhodium Group (2019, Figure 1-2) based on Scopus data, using English-language publication search on keywords, “CAR-T” OR (“therapeutic antibodies”) OR (CRISPR AND editing OR engineering) OR (synthetic biology) OR “metabolic engineering” OR (genomics AND “precision medicine” OR “personalized medicine”) OR agrobacterium OR (CRISPR AND plants). 108 Prepublication Copy

Areas of Leadership in the Global Economy Cross-country comparisons of the count of doctoral graduates by field are available from the OECD for 2016. Figure 4-5 reports these data for students identified as having completed degrees in “biological and related sciences.” In concordance with the publication and investment measures reported above, these data provide evidence of U.S. bioeconomy leadership. The United States awarded more than twice as many doctorates in 2016 as Germany, the next most prolific country for which data are available. Note, however, that the OECD is not able to report either the total number of doctorates awarded in China or the number granted in biological and related sciences. Note, as well, that the OECD data represent both imprecise estimates and underestimates of the total number of doctoral recipients in fields related to the bioeconomy. For example, NSF reports for 2016 that the United States produced 12,568 doctorate recipients in life sciences (which includes (1) agricultural and natural sciences, (2) biological and biomedical sciences, and (3) health sciences), plus another 1,089 doctorate recipients in bioengineering and biomedical engineering. 3 Data that track over time the number of recipients of doctoral degrees in the biosciences by country of citizenship are not publicly available in a curated dataset. The closest estimates come from the Science and Engineering Indicators, which collates data from a number of different country sources on the number of degrees awarded in a country by broad academic field. Figure 4-6 shows an increase in the number of doctoral degrees in the combined category of physical and biological sciences, mathematics, and statistics for selected countries in the years 2000, 2007, and 2014. These data exclude some degrees that apply to the bioeconomy, such as bioengineering, yet because the data include degrees in mathematics, statistics, and physical sciences, they likely include doctoral students beyond those trained for specific work in the bioeconomy. These limitations notwithstanding, the key features of the data are that the United States leads in the number of doctoral degrees in fields pertinent to the bioeconomy granted throughout the period (though the number of degrees from China saw the greatest growth over the period). If the current rates of growth persist, China will soon surpass the United States in the awarding of such degrees. FIGURE 4-5 Doctoral graduates in biological and related sciences, 2016. SOURCE: The committee’s calculations based on data extracted from https://stats.oecd.org (July 2019). 3 See https://www.nsf.gov/statistics/2018/nsf18304/data/tab12.pdf. Prepublication Copy 109

Safeguarding the Bioeconomy 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 United China Germany United France India Spain Italy South Japan States Kingdom Korea 2000 2007 2014 FIGURE 4-6 Number of doctoral degrees in physical and biological sciences, mathematics, and statistics, selected countries and selected years, 2000–2014. NOTES: Data for China exclude computer sciences, as these are counted under engineering rather than physical and biological sciences, mathematics, and statistics. Data for Japan include thesis doctorates, called ronbun hakase, earned by employees in industry. In data on higher education for Japan, mathematics is included in natural sciences (included in this chart), and computer sciences are included in engineering (not included). Data for doctoral degrees use International Standard Classification of Education (ISCED 2011) level 8. Science degree data do not include health fields. Data for India are for 2006 rather than 2007. SOURCES: Compiled by authors based on National Science Board and National Science Foundation (2018, Appendix 2-38 and 2-39). Given that doctoral trainees are the engine powering the advances in basic research at academic institutions, being able to supplement the United States’ bioeconomy workforce with talented students from around the world is a benefit. Among the roughly 45,000 recipients of doctoral degrees within the United States, about 30–34 percent are students on temporary visas, the largest fraction of whom are of Chinese origin. Table 4-1 reports a number of key facts about Ph.D. graduates of U.S. institutions between 2011 and 2017 who did not hold U.S. citizenship. Several facts are notable. First, citizens from China, India, and South Korea constitute the largest number of non-U.S. citizens who completed doctoral degrees at U.S. academic institutions in 2011 and 2017. Further, among Asian countries, China experienced the greatest increase in the number of citizens completing U.S.-based doctorates, a boost of approximately 40 percent in 2017 relative to the nearly 4,000 Chinese citizen students who completed their degree in 2011. Interestingly, however, the fraction of doctoral students staying in the United States remained relatively constant across countries, including China, during the period 2011–2017. For selected countries, Science and Engineering Indicators reports the total number of doctoral degrees awarded by U.S. institutions, by scientific field and citizenship of recipient, for the period 1995– 2015. Data for China, India, South Korea, and Taiwan are presented in Table 4-2. Nearly 70,000 students with Chinese citizenship received doctoral degrees in science and engineering fields from U.S. institutions during this time. Of these individuals, 12,002 earned degrees in biological sciences, and 10,816 earned degrees in physical sciences. 110 Prepublication Copy

Areas of Leadership in the Global Economy Taken together, these indicators suggest that the United States continues to lead the world in government investments and outputs as well as the production of doctoral recipients in sciences related to the bioeconomy. This leadership does not, however, appear to be as secure as it once was. China, in particular, has begun to increase its investments at a rapid rate and appears poised to overtake the United States at least in the production of doctoral recipients in these bioeconomy-related sciences in the medium term (see Gryphon Scientific and Rhodium Group, 2019). NATIONAL COMPARISONS OF PRIVATE INNOVATION INPUTS Whereas the prior chapter highlighted government expenditures on R&D investments relevant to the bioeconomy, this section of this chapter transitions to focus on overall national investments and investments from the private sector. These data tell a story similar to that in prior sections of this chapter. While the United States maintains leadership in bioeconomy investments, questions arise about the nation’s ability to maintain its historical leadership position across science and engineering sectors. TABLE 4-1 Doctorate Recipients with Temporary Visas, by Year of Degree and Intent to Stay in the United States after Receiving Degree (All Degrees), by Country of Citizenship, 2011–2017 Total, all years, Percentage Point Change, 2011 2017 2011–2017 2011–2017 Country of Citizenship Number % Staying Number % Staying Number % Staying Number % Staying All temp. visa holders 14,235 70.1 16,323 74.2 109,476 71.5 15 6 Americas 1,449 57.3 1,443 56.6 10,370 56.4 0 -1 Asia 9,568 74.5 10,659 80.0 73,431 76.4 11 7 China 3,988 82.1 5,564 83.2 34,458 81.9 40 1 India 2,165 84.6 1,974 88.6 15,335 85.8 -9 5 South Korea 1,445 60.0 1,126 68.5 9,173 62.4 -22 14 Europe 1,962 64.3 1,788 67.4 12,994 63.8 -9 5 France 125 64.8 107 69.2 790 63.7 -14 7 Germany 203 65.5 154 68.2 1,340 58.1 -24 4 Italy 137 60.6 161 70.8 1,069 64.8 18 17 Turkey 493 61.9 498 61.0 3,275 61.0 1 -1 Middle East 600 61.3 1,509 62.1 7,052 64.4 152 1 Iran 198 88.9 771 92.6 3,472 90.1 289 4 Saudi Arabia 49 14.3 340 10.3 996 11.9 594 -28 NOTE: Percentages based on all doctorate recipients on temporary visas who indicated where they intended to stay after graduation (United States versus foreign location), not just those with definite commitments for employment or postdoctoral study. SOURCE: National Science Foundation, National Center for Science and Engineering Statistics, Survey of Earned Doctorates (2018). Prepublication Copy 111

Safeguarding the Bioeconomy TABLE 4-2 Asian Recipients of U.S. Science and Engineering Doctorates on Temporary Visas, by Field and Country or Economy of Origin, 1995–2015 Field Asia China India South Korea Taiwan All fields 166,920 68,379 32,737 26,630 16,619 Science & engineering 146,258 63,576 30,251 20,626 13,001 Engineering 55,215 23,101 13,208 8,274 5,045 Science 91,043 40,475 17,043 12,352 7,956 Agricultural sciences 4,927 1,745 823 720 441 Biological sciences 25,149 12,202 5,654 2,459 2,374 Computer sciences 9,287 4,229 2,477 1,015 597 Earth, atmospheric, & ocean sciences 2,803 1,563 357 338 228 Mathematics 7,494 4,493 805 967 503 Medical & other health sciences 5,298 1,368 1,371 672 878 Physical sciences 20,528 10,816 3,516 2,216 1,305 Psychology 2,053 530 277 481 320 Social sciences 13,504 3,529 1,763 3,484 1,310 Non–science and engineering 20,662 4,803 2,486 6,004 3,618 NOTES: Asia includes Afghanistan, Bangladesh, Bhutan, Brunei, Burma, Cambodia, China, Christmas Island, Hong Kong, India, Indonesia, Japan, Kazakhstan, Kyrgyzstan, Laos, Macau, Malaysia, Maldives, Mongolia, Nepal, North Korea, Pakistan, Papua New Guinea, Paracel Islands, Philippines, Singapore, South Korea, Spratly Islands, Sri Lanka, Taiwan, Tajikistan, Thailand, Timor-Leste, Turkmenistan, Uzbekistan, and Vietnam. Data include temporary visa holders and non-U.S. citizens with unknown visa status who are assumed to be on temporary status. SOURCE: Science and Engineering Indicators 2018, National Science Foundation, National Center for Science and Engineering Statistics, 2015 Survey of Earned Doctorates (SED). Figures 4-7 and 4-8, respectively, report total national expenditures on R&D and the percentage of GDP devoted to R&D for countries allocating the most resources to R&D for the year 2015. Figure 4-7 shows that the United States continues to lead the world in total investment in innovation, with nearly $500 billion invested in R&D in 2015. China, however, is now investing an amount that is increasingly close to that of the United States, with more than $400 billion having been invested in 2015. Both countries invest more than the total invested by the European Union, which was $386.5 billion in that same year. Indeed, no country other than China invests even half as much in innovation as does the United States. It is not the case, however, that the United States leads the world in investment relative to the size of its economy. Figure 4-8 shows that numerous countries, including Israel, South Korea, Switzerland, Japan, Sweden, Austria, Taiwan, Denmark, Germany, and Finland, invest a higher fraction of GDP in R&D relative to the United States, while Figure 4-9 demonstrates that U.S. R&D investment as a share of GPD has remained stable even as that of other countries, such as South Korea and Japan, has continued to rise. NATIONAL COMPARISONS OF INNOVATION IN BIOTECHNOLOGY AND OTHER AREAS OF THE BIOECONOMY Ideal data on country-level investment in the bioeconomy are difficult to obtain. Indeed, it is difficult to obtain even reliable data on R&D investment for even the largest bioeconomy segments, including one of the oldest, biotechnology. OECD compiles data on the number of firms active in biotechnology (Figure 4-10). The presented data do not include China, for which information on aggregate R&D investment in biotechnology does not appear to be available in a reliable way (see Gryphon Scientific and Rhodium Group, 2019, pp. 13 and 36). The data in Figure 4-10 suggest, however, that the United States contains the largest number of biotechnology firms of any country in the world— more than 3,000 in 2015. Furthermore, U.S. private-sector firms invest an order of magnitude more heavily in biotechnology relative to firms in other countries. According to the OECD, U.S. firms invested approximately $40 billion in biotechnology R&D in 2015, an amount that exceeded the combined 112 Prepublication Copy

Areas of Leadership in the Global Economy investments of other leading countries in biotechnology (i.e., Switzerland, France, South Korea, Belgium, Germany, and Denmark) (Figure 4-11). The United States is also a clear leader in the OECD’s counts of firms active in biotechnology R&D (Figure 4-10), although these data are particularly difficult to compare across countries. FIGURE 4-7 Purchasing Power Parity (PPP)-adjusted gross domestic expenditures on R&D (GERD), selected countries, 2015. NOTE: Data shown here reflect international standards for calculating GERD, which vary slightly from the National Science Foundation's methodology for tallying total U.S. R&D. SOURCES: National Science Foundation, Science and Engineering Indicators 2018, based on National Center for Science and Engineering Statistics, National Patterns of R&D Resources (annual series); OECD, Main Science and Technology Indicators (2017/1); United Nations Educational, Scientific and Cultural Organization Institute for Statistics Data Centre, http://data.uis.unesco.org (accessed October 13, 2017). FIGURE 4-8 Percentage of gross domestic product devoted to gross expenditure on R&D (GERD/GDP %), selected countries, 2015. NOTE: Data here reflect international standards for calculating GERD, which vary slightly from the National Science Foundation's methodology for tallying U.S. total R&D. SOUCES: National Science Foundation, Science and Engineering Indicators 2018, based on National Center for Science and Engineering Statistics, National Patterns of R&D Resources (annual series); OECD, Main Science and Technology Indicators (2017/1); United Nations Educational, Scientific and Cultural Organization Institute for Statistics Data Centre, http://data.uis.unesco.org (accessed October 13, 2017). Prepublication Copy 113

Safeguarding the Bioeconomy FIGURE 4-9 Gross domestic expenditures on R&D as a share of gross domestic product by the United States, the European Union (EU), China, and selected other countries, 1985–2015. SOURCE: National Science Board and National Science Foundation, 2018. FIGURE 4-10 Number of firms active in biotechnology, 2015. NOTES: Data include biotechnology R&D firms, unless otherwise noted. Data not available for China or Japan. ^ Data for these countries include biotechnology companies, not just biotechnology R&D firms. + For Sweden, data include only firms with 10 or more employees. * For the United States, the number of firms includes only those that actually responded to the survey. The data are adjusted to the weight to account for missing responses. The survey was administered only to firms with five or more employees. SOURCE: OECD, Key Biotechnology Indicators, http://oe.cd/kbi, October 2018. 114 Prepublication Copy

Areas of Leadership in the Global Economy Denmark^ Germany Belgium South Korea France Switzerland United States 0 5 10 15 20 25 30 35 40 45 $US billions, PPP FIGURE 4-11 Biotechnology R&D expenditures in the business sector, 2015. NOTES: Denmark data are from 2013; U.S. data include firms with five or more employees only. SOURCE: OECD, Key Biotechnology Indicators, http://oe.cd/kbi; and OECD, Main Science and Technology Indicators Database, www.oecd.org/sti/msti.htm, October 2018. Data on international patenting suggest that U.S. leadership in biotechnology R&D remains substantial (see Figure 4-12). The OECD compiles data on the fraction of biotechnology patents originating from inventors in each country, counting patents based on the fraction of inventors that come from that country. For example, a patent that lists three total inventors, one each from the United States, Canada, and Germany, would be measured as contributing one-third of a patent in each of those countries. The data refer to patent families filed under the Patent Cooperation Treaty within the Five IP Offices (IP5, which includes the European Patent Office [EPO]; Japan Patent Office; Korean Intellectual Property Office; National Intellectual Property Administration, PRC; U.S. Patent and Trademark Office [USPTO]), with members filed at the EPO or at the USPTO, by the first filing date. These data document the United States’ leadership in biotechnology innovation over the past 20 years, but also the relative erosion of that leadership position. The United States contributed more than 40 percent of patents in 2001, but only slightly more than 35 percent in 2007 and less than 35 percent in 2014. The U.S. percentage is, however, more than twice the fraction contributed by any other country. Japan represents the next-highest fraction of patents at less than 15 percent of the overall total. South Korea and China experienced the greatest increase in the fraction of international biotechnology patents during 2001–2014, with South Korea increasing its fraction from 2 percent to 10 percent and China increasing its fraction from 1 percent to 5 percent. A different story emerges based on World Intellectual Property data, which compare annual biotechnology patents issued in the United States and China (see Figure 4-13). Unlike the OECD data, these data do not reflect international patents (i.e., patents registered in multiple domains), but rather just patents filed in the United States and China, respectively. These data suggest a substantial increase in biotechnology patenting in China. It is not clear, however, whether these patents reflect innovation at the world’s technological frontier, but they might signal China’s potential to begin innovating at the world frontier of biotechnology. Prepublication Copy 115

Safeguarding the Bioeconomy FIGURE 4-12 Fraction of world biotechnology patents, selected countries and years. NOTES: Data: The new list of International Patent Classification (IPC) codes for defining biotechnology patents was used to extract these data. The definition is outlined in OECD (Forthcoming). Data refer to patent families filed within the Five IP Offices (IP5) with members filed at the European Patent Office (EPO) or at the U.S. Patent and Trademark Office (USPTO), by first filing date and the inventor’s residence, using fractional counts. Data for 2014 are estimates. FIGURE 4-13 Annual biotechnology patents granted in the United States and China, 1996–2016. SOURCE: Gryphon Scientific and Rhodium Group (2019) from World Intellectual Property Organization. More broadly, the extent of commitment by foreign countries to their overall innovation infrastructure and the increasing investments in biosciences by countries, particularly by countries with defined R&D strategies, like China and South Korea, suggest that U.S. leadership in biosciences and bioeconomy innovation, is unlikely to be maintained in the future at the same level as it has been in the recent past. 116 Prepublication Copy

Areas of Leadership in the Global Economy In terms of the deployment of agricultural biotechnology, the United States leads the world in acreage planted with bioengineered crops, with 40 percent (75.0 million hectares) of the world total in 2017 of 189.8 million hectares. The next four largest shares are in Brazil (26 percent, 50.2 million hectares), Argentina (12 percent, 23.6 million hectares), Canada (7 percent, 13.1 million hectares), and India (6 percent, 11.4 million hectares). Over the first 21 years of the commercialization of bioengineered crops, from 1996 to 2016, the United States captured the largest cumulative economic benefits from the technology (ISAAA, 2017). NATIONAL COMPARISONS OF ENTREPRENEURSHIP/VENTURE CAPITAL FUNDING The entrepreneurial culture of the United States has long been considered an important feature of the national institutional environment, an aspect that has contributed to the nation’s technological leadership and economic dynamism. Economists have, however, pointed out that the historical dynamism—such as rate of entrepreneurship, fraction of workers in small and growing firms, and rate of new job creation—that historically characterized the U.S. economy has been showing signs of decline (Decker et al., 2014; Haltiwanger, 2015). While declining dynamism may be an issue in the U.S. economy overall, however, it does not appear to affect the bioeconomy in particular. There are a number of sources for information on international entrepreneurship and venture funding, but none of them appear to provide consistent, historical data across the full set of sectors encompassed by the bioeconomy. As a result, we surveyed results for several principal bioeconomy sectors and sources, beginning with one of the economically largest sectors of the bioeconomy, biotechnology. The EY Biotechnology Report 2017 compiles and reports on financing, initial public offerings (IPOs), and venture capital investments based on Capital IQ and VentureSource. These data suggest that the scale of biotechnology venture financing in the United States continues to greatly exceed that of Europe and leading Asian countries. Figure 4-14 tracks financing for biotechnology firms in the United States between 2001 and 2016 and demonstrates how venture funding, follow-on funding, and debt funding rose, on average, throughout the 15-year period, while IPO proceeds fluctuated. These patterns are similar to those occurring in the European biotechnology sector during the same period, although of a substantially greater magnitude. Whereas total U.S. biotechnology financing had reached $10 billion by 2003, it did not achieve this level in Europe until 2015 (Figure 4-15). And although biotechnology ventures in China and South Korea have received substantial investment in the past few years, the data as of 2016 suggest that biotechnology ventures in China, Japan, South Korea, and Taiwan lag substantially behind those in the United States and Europe, having not reached $4 billion in financing in any year prior to or including 2016, the last year of the Ernst and Young (EY) data (Figure 4-16). These comparisons rely mainly on venture investment data. Other valuable indicators of competitiveness and leadership in this area would include measures of business dynamics, such as measures of entry (e.g., counts of new firms) and exit (e.g., initial public offerings, acquisitions, and firm failings). Prepublication Copy 117

Safeguarding the Bioeconomy FIGURE 4-14 U.S. biotechnology financings by year, 2001–2016. SOURCE: EY Biotechnology Report 2017, citing Capital IQ, and VentureSource. Reprinted with permission; copyright 2017, Ernst & Young LLP. FIGURE 4-15 European biotechnology financings by year, 2001–2016. SOURCE: EY Biotechnology Report 2017, citing Capital IQ, and VentureSource. Reprinted with permission; copyright 2017, Ernst & Young LLP. 118 Prepublication Copy

Areas of Leadership in the Global Economy FIGURE 4-16 Biotechnology financings, total across China, Japan, South Korea, and Taiwan, 2011–2016. SOURCE: EY Biotechnology Report 2017, citing Capital IQ, and VentureSource. Reprinted with permission; copyright 2017, Ernst & Young LLP. U.S. LEADERSHIP CASE STUDY: SYNTHETIC BIOLOGY Synthetic biology is one of the most dynamic areas of biological science and one of the most interesting emerging subsectors of the bioeconomy. It is also an area in which evidence of U.S. leadership exists in innovation, entrepreneurship, and scientific and economic success. Figure 4-17 reports counts of academic publications in synthetic biology published in journals indexed by the Web of Science from 2000 to 2015, showing the world wide total and the numbers for leading countries by author affiliation. During this period, the number of such publications annually grew from fewer than 200 to more than 1,000. In each year since 2000, the United States has produced more than half of the total global publications in this area. A University of Manchester and Georgia Tech study by Philip Shapira, Seokbeom Kwon, and Jan Youtie classifies synthetic biology papers indexed by Web of Science that were sponsored by the top 15 synthetic biology funding agencies worldwide based on the agency that originally provided their funding, and derives a series of measures related to these publications (Figure 4-18) (Shapira and Kwon, 2018). Their analyses document that NIH and NSF fund the largest fraction of synthetic biology publications worldwide and that these publications garner more citations than those funded by other agencies. Along with papers funded by the U.S. Office of Naval Research, the Defense Advanced Research Projects Agency, and the U.S. Department of Energy, these government-funded papers also receive the highest average number of citations per paper. China’s National Natural Science Foundation (NNSFC) funds the third-largest number of synthetic biology papers, but as of 2018, those papers were receiving substantially fewer citations on average relative to those funded by the other agencies tracked by the coauthors. These findings suggest substantial leadership by the United States in the science of synthetic biology. More generally, they suggest the fact that this leadership may be driven, to a significant degree, by investments made by the U.S. federal government. Prepublication Copy 119

Safeguarding the Bioeconomy FIGURE 4-17 Synthetic biology publications, worldwide and by leading countries by author affiliation, 2000–2015. NOTE: Line graph depicts worldwide annual publications. Bar chart depicts annual publications for the six leading countries by total publication output. SOURCE: Shapira et al., 2017. FIGURE 4-18 Citations to publications sponsored by the top 15 synthetic biology funding agencies, 2000–2015. NOTE: Based on analysis of Web of Science publication records (2000 to mid-July 2018. Shapira et al. (2017) synthetic biology search strategy. N = 11,369 (67% of which report funding acknowledgment information). VantagePoint used for list cleaning of funding agency organizational names. SOURCE: Shapira and Kwon, 2018. In further work, Shapira and Kwon (2018) demonstrate the relationship between synthetic biology publications and patents for the 10 countries that generate the largest number of synthetic biology patents (see Figure 4-19). These data, too, document U.S. leadership. Between 2003 and 2017, the authors link more than 4,000 synthetic biology patents to inventors in the United States. The closest country to the United States in the count of patents included in the PATSTAT database (of international patent families) is Japan, which recorded fewer than 1,000 patents during the same period. Authors with affiliations in the 120 Prepublication Copy

Areas of Leadership in the Global Economy United States also published more than 4,000 articles, while the closest country, Great Britain, generated fewer than 1,500. Because these data are based on a longer time period, they may underestimate the recent progress made by countries like South Korea and China; however, the data do make clear the historical leadership of the United States, both in science and intent to commercialize synthetic biology. Although the United States maintains a substantial advantage overall in synthetic biology science and innovation, this advantage is not hegemonic. Indeed, the two firms that patent the most in this area are a Danish firm, Novozymes AS, and a Swiss firm, Hoffmann LaRoche (see Figure 4-20). Headquartered outside of Copenhagen, Novozymes is one the world’s leading producers of industrial enzymes and microorganisms. Headquartered in Basel, Switzerland, Hoffmann-La Roche is a global pharmaceutical conglomerate that encompasses multiple R&D centers in the United States, including the main location of initially U.S.-based biotechnology firm Genentech, which has the fourth-highest number of synthetic biology patents identified by Shapira and Kwon (2018) over the period of their study. While 5 of the 6 organizations with the most synthetic biology patents are not based in the United States, 17 of the next 18 are. Overall, more than 60 percent of the 40 organizations with the most synthetic biology patents are based in the United States. U.S. leadership in synthetic biology is not limited to academia, but appears to extend to entrepreneurship as well. As of early 2019, SynBioBeta had identified more than 350 U.S.-based firms in this subsector, while the countries with the second- and third-most firms, the United Kingdom and France, had only 87 and 27 such firms, respectively (see Figure 4-21). Among the entrepreneurial ventures leveraging synthetic biology in the United States are such firms as Ginkgo Bioworks, which designs microorganisms for commercial use, and two firms funded in 2018—Impossible Foods, which develops plant-based meat substitutes, and Moderna Therapeutics, which develops drug therapies based on messenger RNA. FIGURE 4-19 Synthetic biology publications and patents, 2003–2017. NOTE: Publications: analysis of Web of Science publication records (2000 to mid-July 2018). Shapira et al. (2017) synthetic biology search strategy, N = 11,369. Patents: analysis of PATSTAT patent records (2003 to August 3, 2018), Kwon et al. (2016) synthetic biology patent search strategy, N = 8,460. VantagePoint used for data cleaning and analysis. SOURCE: Shapira and Kwon, 2018. Prepublication Copy 121

Safeguarding the Bioeconomy FIGURE 4-20 Top patent assignees in the synthetic biology domain, worldwide, by organization and country of origin, 2003–2018. NOTE: Analysis of PATSTAT patent records (2003 to August 3, 2018), Kwon et al. (2016) synthetic biology patent search strategy, N = 8,460 (7,847 with identified assignee country locations). Note that a patent “assignee” is the entity to whom the property right over the patent has been granted. SOURCE: Shapira and Kwon, 2018. FIGURE 4-21 Global locations of synthetic biology firms. SOURCE: Cumbers, 2019. Presentation to the committee January 2019. U.S. LEADERSHIP IN THE BIOECONOMY: SYNTHESIS Taken together, the data the committee reviewed suggest that the United States is a clear leader in developing research that leads to bioeconomy innovation. The data suggest, however, that other countries, particularly South Korea and China, are increasing their investments in science and innovation. 122 Prepublication Copy

Areas of Leadership in the Global Economy As is true for other areas of science and innovation, the United States has historically attracted and to a great extent retained the best and the brightest scientific talent to attend its graduate schools, enroll in postdoctoral training, and serve as researchers and faculty. While the data up until 2017 suggest that the United States has continued to attract and retain talented individuals from around the world, scientists and policy makers are beginning to raise questions about the nation’s ability to continue to do so, both because of the increasing investments in science by other countries and because of the threats to the historical consensus regarding the national priority of investing in science and innovation in the United States, as discussed in Chapter 7 of this report (Peri et al., 2014; Kerr, 2019; Alberts and Narayanamurti, 2019). While the overall innovation ecosystem and historical stock of investments protect U.S. leadership in the bioeconomy, a series of other policies and choices that are relevant to future competitive success in this sector deserve consideration both on their merits and with regard to their impact on the bioeconomy. For example, the Information Technology and Innovation Foundation (ITIF) estimated in 2012 that the United States offered R&D tax incentives that were only 27th among the 42 countries it had studied (Stewart et al., 2012). Economists studying tax credits have found evidence that such policies can stimulate R&D investment, and it is possible that greater support 4 for such policies in the United States could contribute to greater bioeconomy competitiveness (Agrawal et al., 2019; Rao, 2016). Given that work characterizing bioeconomies is in a relatively early stage, however, it is likely too soon to make definitive statements about which policy levers have the most influence on bioeconomy leadership. This is particularly true considering the multiple industrial applications for the science and innovation underlying the bioeconomy. The committee hopes that research efforts will engage with these topics. CONCLUSIONS This chapter has examined the available data to assess the status of U.S. leadership within the global bioeconomy, providing a discussion of the strengths and caveats of each metric. Conclusion 4-1: The United States is a clear leader in the global landscape in multiple areas related to the bioeconomy, including federal funding for biological sciences; the production of science, innovation, and entrepreneurship in synthetic biology; and the generation and adoption of bioengineered crops. This leadership has been based to a substantial degree on the country’s historical edge in science and the production of new-to-the-world knowledge. Conclusion 4-2: The current U.S. international position is one of general leadership in those areas built on research and development in the life sciences—leadership that has been built as a result, and not despite, of open scientific borders. Continued leadership will involve (1) careful analysis of the policies and ecosystem features that undergird the bioeconomy, and (2) continued commitment from the federal government to world-leading investment in sciences. REFERENCES Agrawal, A., C. Rosell, and T. S. Simcoe. 2019. Tax credits and small firm R&D spending. NBER working paper 20615. https://www.nber.org/papers/w20615 (accessed September 7, 2019). Alberts, B., and V. Narayanamurti. 2019. Two threats to U.S. science. Science 364(6441):613. American Academy of Arts and Sciences. 2014. Restoring the foundation: The vital role of research in preserving the American dream. https://www.amacad.org/publication/restoring-foundation-vital-role-research-preserving- american-dream (accessed September 7, 2019). 4 It should be noted that the U.S. R&D tax credit was made permanent in 2015. However, it was not changed in magnitude (https://www.eidebailly.com/insights/articles/rd-tax-credit-enhanced-and-becomes-permanent). Prepublication Copy 123

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Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to drive economic growth. While the United States has been a leader in advancements in the biological sciences, other countries are also actively investing in and expanding their capabilities in this area. Maintaining competitiveness in the bioeconomy is key to maintaining the economic health and security of the United States and other nations.

Safeguarding the Bioeconomy evaluates preexisting and potential approaches for assessing the value of the bioeconomy and identifies intangible assets not sufficiently captured or that are missing from U.S. assessments. This study considers strategies for safeguarding and sustaining the economic activity driven by research and innovation in the life sciences. It also presents ideas for horizon scanning mechanisms to identify new technologies, markets, and data sources that have the potential to drive future development of the bioeconomy.

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