January 15, 2025
Biopower
Securing American Leadership in Biotechnology
Executive Summary
The biorevolution is upon us. Converging breakthroughs in biological sequencing, engineering biology, and machine learning are ushering in an almost science fiction–like world in which humans can manipulate and even design the building blocks of life with increasing sophistication—for good or ill. In this world, cutting-edge biotechnologies will create organs, capture carbon emissions, restore polluted environments, tailor medicines to a person’s genes, and replace vulnerable supply chains for food, fuel, fabrics, and firepower with domestic biobased alternatives. According to one estimate, existing biotechnologies could have a direct economic impact of $4 trillion a year for the next 20 years.1 As innovation continues, the ceiling could be far higher.
If next-generation biotechnologies hold great promise, they also come with gathering perils from new bioweapons, intrusive biosurveillance, and the race for biotechnology breakthroughs without adequate safeguards for public health, the environment, and democratic values. For policymakers, the question is not whether the biorevolution has transformative power, but which nation will responsibly harness that power to unlock new tools for defense, health, manufacturing, food security, environmental remediation, and the fight against climate change. No country is better positioned to lead the biorevolution than the United States, but it requires that policymakers act now with swift, ambitious, and far-sighted steps to secure America’s place as the global biopower.
The United States enters the biorevolution with formidable tailwinds—an unrivaled innovation ecosystem, world-leading research institutes, unmatched private investment, talent, and a global network of democratic partners and allies. Recent federal investments and an emerging policy framework have fortified U.S. leadership. But in this fast-moving field, settling for gradual progress will guarantee falling behind as competitors like China race to eclipse the United States with ambitions to scale up their biotechnology research, innovation, talent, and infrastructure.
To secure America’s place as the global biopower, the Trump administration and Congress should accelerate U.S. tailwinds through greater investment in biotechnology research and infrastructure, especially in sectors beyond health and medicine; expand the pipeline of biotalent; and lead globally to drive biotechnology norms, standards-setting, and responsible adoption. At the same time, policymakers must navigate headwinds that could imperil further progress—specifically, an underdeveloped national biomanufacturing infrastructure; insufficient public and private investment that flows overwhelmingly to biotechnology research and development (R&D) in the health and medical sectors; a lack of uniform federal standards, definitions, and codes; a morass of conflicting policies and regulations; inaccessible and insecure biodata; and low public awareness and trust in emerging and ethically fraught biotechnology applications. This report outlines several recommendations to shore up America’s position as the preeminent biopower, including an investment of $20 billion in new federal funding. Policymakers should view this level of investment as the floor of what it will require to secure U.S. biotechnology leadership.
Cutting-edge biotechnologies will create organs, capture carbon emissions, restore polluted environments, tailor medicines to a person’s genes, and replace vulnerable supply chains for food, fuel, fabrics, and firepower with domestic biobased alternatives.
Regardless of what U.S. policymakers do, countries around the world are moving swiftly to embrace the biorevolution. The United Kingdom (UK) is driving innovation by concentrating and sharing its biodata through the UK Biobank, which houses the fully sequenced genetic codes of 500,000 people.2 France has invested roughly $9.5 billion through Innovation Santé 2030 to drive biomedical research.3 Japan has committed $3 billion to promote its biotechnology ecosystem.4 South Korea is carving out a niche in digital biotechnology and aims to transition 30 percent of its manufacturing industry to biomanufacturing within a decade.5
If any nation can surpass the United States as the global biopower, it will be China. In its most recent five-year plans, Beijing made explicit its ambition to become a biotechnology “superpower.” It is well on its way. China’s biotechnology leadership has surged on the back of significant public investment, long-term policy prioritization, a massive domestic market, decades of largely unrestricted capital flows, and the amassing of biodata through licit and illicit means.6 China’s concerted biotechnology push has already paid dividends: its scholars rank second in the world for authoring biomedical papers, and the country leads high-impact research in biofuels and biomanufacturing. China’s high-impact research in synthetic biology is more than triple that of the United States, posing a high risk of monopolization.7 Today, China is a global biomanufacturing powerhouse that exports roughly 40 percent of the world’s active pharmaceutical ingredients.8 Now, China aspires to move up the biotechnology value chain with a renewed push to support start-ups, integrate its vast biodata with cutting-edge machine learning tools, and dominate emerging markets for biotechnology with “national champions” such as BGI Group and WuXi Biologics, as it did with Huawei and 5G.
China’s ambition to close the gap with the United States should inspire action from policymakers to secure and extend America’s lead. To that end, this report outlines a series of immediate and longer-term recommendations in six key areas for leaders in policymaking and industry:
Invest in Research and Infrastructure
While the private sector largely drives biotechnology innovation, federal support is vital to general biotechnology R&D—especially in applications beyond health and medicine. To level up American biopower, policymakers should significantly expand public investment in biotechnology-related research, development, and infrastructure through the Department of Defense, Department of Energy, National Science Foundation, National Institutes of Health, and National Institute of Standards and Technology and support agency-led efforts to realize the March 2023 Bold Goals for Biotechnology and Biomanufacturing. Wherever possible, investments should seek to close the gap between the biomedical and biopharmaceutical sectors—which receive the lion’s share of public and private investment—and other promising biotechnology applications in areas such as defense, energy, and manufacturing. At the same time, the federal government should better coordinate and strategically target existing and future investments in general and applied biotechnology research. Finally, policymakers should consider financial and tax incentives to attract private capital to sustain biotechnology ventures across the Valley of Death, with a focus on biotechnology ventures in defense, manufacturing, energy, and agriculture.
Expand Biotalent
American biopower hinges on world-class biotalent in government, academia, and industry. Although the United States has a relative advantage in access to top STEM talent, it still faces a shortage that impedes progress. Industry should intensify engagement with secondary and postsecondary educational institutions to build early interest in biotechnology careers, expand internship and apprenticeship opportunities, and align curricula with anticipated biotechnology jobs. Policymakers should also pursue targeted immigration reform to supercharge the flow of top biotalent to U.S. research institutions and companies—paired with efforts to shore up research security—while acting to broaden biotalent and bioliteracy across government by leveraging initiatives such as the Presidential Innovation Fellowship and the U.S. Digital Service.
Unlock Biodata
Biotech leadership hinges on secure, quality biodata. However, biodata is too often segmented and sequestered in public and private labs according to different protocols with incompatible systems. Policymakers should clarify and modernize regulations for the use of artificial intelligence–ready health and genomic data for biotechnology research; invest in privacy-preserving and privacy-enhancing technology to promote large-scale biodata analysis while respecting privacy; establish a new American Biobank modeled on the successful UK Biobank; and fortify the cybersecurity of biodata repositories in government and private hospitals and clinics.
Strengthen and Streamline Policy
To the extent they exist, biotechnology standards, definitions, and regulations are outdated, inconsistent, and incoherent—sapping innovation. Policymakers should require a government-wide survey to identify regulatory gaps and develop uniform federal definitions, standards, and codes for biotechnology and the bioeconomy to improve tracking, measurement, and coordination. They should also establish a consolidated federal office to provide a single point of entry for biotechnology regulations and direct most federal agencies to develop strategies for aligning their various programs, investments, and outreach to drive responsible biotechnology innovation and broader biotechnology competitiveness.
Lead Globally
The United States should fully exercise its global leadership to shape the future of biotechnology. As with artificial intelligence (AI), Washington’s decisions in the next few years could determine whether next-generation biotechnologies will reflect democratic values or techno-authoritarianism. To that end, policymakers should convene a global Biotechnology Safety and Opportunity Summit modeled after the success of the UK’s 2023 Bletchley AI Safety Summit; set a global example by declaring red lines for unacceptable biotechnology research and applications; and develop a strategy for biotechnology standards-setting and joint research through existing partnerships such as the North Atlantic Treaty Organization (NATO); the Australia, United Kingdom, and United States trilateral security partnership (AUKUS); and the Quadrilateral Security Dialogue (the Quad).
Build Public Trust
Strong and sustained U.S. biotechnology leadership requires enduring support from policymakers and the public. However, both groups remain broadly unaware of the looming biorevolution and its consequences for America’s economy, security, and values. To elevate and broaden the debate, industry should hold a national summit on the bioeconomy to make the case for why biotechnology leadership is essential to U.S. national, health, and economic security, and highlight biotechnology’s positive applications. Senior executive branch leaders should crisscross the country and make the case for U.S. biotechnology leadership. For its part, Congress should hold regular biotechnology hearings and engage constituents to boost awareness among public and elected officials.
Chapter 1: The Biorevolution
If the 20th century saw the Information Revolution, the 21st is witnessing the biorevolution—a dizzying future in which humanity can design and manipulate the building blocks of life with greater precision, for good or ill. Propelled by converging breakthroughs in synthetic biology, biological engineering, biocomputing, and more, the biorevolution will have far-reaching consequences for the global economic and security landscape, even if those impacts remain poorly understood by policymakers and the public.
With emerging biotechnologies and techniques, humans can now shape life for our ends with increasing sophistication.
The biorevolution rests on a powerful and unsettling truth: the building blocks of life, such as DNA and RNA, are programmable. With emerging biotechnologies and techniques, humans can now shape life for our ends with increasing sophistication—with the potential for better crops, livestock, materials, medicines, and manufacturing, along with powerful new tools to promote food and energy security, power the economy, safeguard the environment, and protect Americans from future pandemics and biothreats. Biology is transitioning from a longtime scientific discipline of observation and measurement to a domain of human design.9
The United States has pushed the frontier of biotechnology for decades. In the 1970s, American scientists developed recombinant DNA technology, unlocking medical advances such as monoclonal antibodies and insulin treatments for diabetes.10 In the 1980s, American biochemist Kary Mullis developed the polymerase chain reaction (PCR)—a foundational tool in modern genetics that allows researchers to reproduce DNA sequences.11 Between 1990 and 2003, America spearheaded the Human Genome Project, a landmark scientific collaboration that generated the first nearly complete sequence of all three billion base pairs of the human genome.12 A decade later, Jennifer Doudna earned a Nobel Prize for helping to pioneer gene editing technology with CRISPR-Cas9.13 More recently, Drew Weissman helped lay the groundwork for the mRNA (messenger RNA) COVID-19 vaccine, which saved millions of lives.14
In its simplest form, biotechnology is the manipulation of biology to create services and products.
Although the United States led the world in biotechnology in the 20th century, there is no guarantee it will remain the global biopower in the 21st. America’s competitors, especially China, grasp biotechnology’s potential to enhance economic and military power and have moved proactively to realize it. In fact, China has already surpassed the United States in trials for CAR T-cell therapy—a promising cancer treatment.15 As the world’s current biotechnology leader, the United States still enjoys the strongest hand to become the 21st century biopower, propelled by natural tailwinds from its innovative private sector, premier research institutions, and dynamic capital markets. These advantages are no reason for the United States to rest on its laurels. Ambitious competitors and gathering domestic headwinds risk seriously eroding U.S. biotechnology leadership without significant changes to policies and investments today.
At a time when many emerging technologies compete for limited attention and resources, there is value in clarifying the benefits of U.S. biotechnology leadership and the dangers of ceding it to competitors. This report will make the national and economic security case for U.S. biotechnology leadership; review the history, recent developments, and priority issues in U.S. biotechnology policy; identify tailwinds and headwinds to U.S. biotechnology leadership; and assess biotechnology-leading nations abroad, from close partners to strategic competitors such as China. Finally, the report will outline recommendations in six key areas to secure America’s place as the 21st century biopower.
Biotechnology, Biomanufacturing, and the Bioeconomy
Biotechnology’s cross-cutting breadth, rapid advancements, and technical complexity can make it hard for policymakers and the public to grasp. In its simplest form, biotechnology is the manipulation of biology to create services and products. These range from precision medicine tailored to an individual’s DNA to genetically engineered crops that better resist drought and disease to alternative proteins; mRNA vaccines; and biobased armor, resins, fabrics, and fuel. If “biotechnology” captures the range of technology-based techniques and tools, then “biomanufacturing” is its application to create specific products.16 By extension, the term “bioeconomy” captures the economic activity generated from every product, service, and process derived from biological resources, even if they do not use biotechnologies.17 According the National Academies of Science, Engineering, and Medicine (NASEM), in 2016, the bioeconomy accounted for more than 5 percent of the U.S. gross domestic product (GDP)—nearly $1 trillion.18 An estimate from McKinsey & Company predicts that biological processes could generate up to 60 percent of all physical inputs in the global economy, with a direct economic impact of up to $4 trillion annually between 2030 and 2040.19
Historically, discussion of biotechnology and the bioeconomy tends to focus on research, development, and applications in the health, medical, and pharmaceutical sectors—reflecting biotechnology’s overwhelming share of public and private investment and activity. This report, however, will embrace a broader conception of biotechnology and the bioeconomy to reference the full spectrum of applications in health, energy, agriculture, and defense.
The world has already reaped many benefits from the biorevolution, from genetically engineered crops that are hardier and more nutritious to stem cell treatments for leukemia and sickle cell anemia to advanced biofuels that have boosted energy security and reduced carbon emissions. It took the Human Genome Project 13 years and $2.7 billion to sequence the human genome.20 Today, cutting-edge machines can do this in less than a day, for less than $1,000—and by the end of the decade, perhaps, for less than $100.21 The COVID-19 pandemic exacted a terrible toll—more than 1.5 million American lives lost and $5 trillion in federal spending—but it is worth imagining how much worse it would have been without biotechnology-enabled vaccines and the biotechnology-powered ability to sequence the virus within weeks.22 The pandemic was a painful but powerful demonstration of biotechnology’s power to save millions of lives and trillions of dollars.
Key Trends and Technologies
Although the biorevolution has gathered momentum for years, several converging trends will continue its acceleration: the collapsing cost of computing power, gene sequencing, and gene synthesis; the increasing sophistication and digitization of medical testing and records, which will dramatically expand biodata; and the rise of powerful artificial intelligence (AI) and machine learning tools. These trends have combined to give scientists and industries more biodata to analyze at lower cost and with greater power and precision.
These converging trends have powered biotechnology breakthroughs in several areas. Although detailing each breakthrough is beyond the scope of this report, policymakers should pay particular attention to developments in three key, often overlapping, areas: biological sequencing, engineering biology/synthetic biology, and human-machine interfaces.23
Biological sequencing. This field includes efforts to map, measure, and analyze biological molecules and pathways. The most consequential subset is the sequencing of genes, the instructions for building and maintaining the cells in living organisms. When arranged in a sequence, genes form strands of DNA, one of the building blocks of life. Advances in biological sequencing therefore bestow greater insights into the design and function of life, with far-reaching applications, from understanding novel biothreats, such as the COVID-19 virus, to developing personalized medicine to designing new biobased materials and manufacturing processes. Other promising subfields include the sequencing of proteins, metabolites, the microbiome, and RNA transcripts—the molecules that help regulate the flow of genetic information within cells.
Engineering biology/synthetic biology. These terms are often used interchangeably, but they have important distinctions. Whereas engineering biology is the application of engineering principles to existing biological systems to develop products, synthetic biology uses modern biotechnologies and techniques to create entirely novel biological systems. For example, manipulating the DNA of a cotton plant would fall under engineering biology, while synthetic biology would entail designing the DNA of a new and improved cotton plant de novo.
Biological engineering spans revolutionary gene editing technologies from CRISPR and TALEN to the Pfizer-BioNTech and Moderna COVID-19 vaccines, which use mRNA technology.24 Applications include lab-grown meat and bioengineered materials such as plant-based fibers, polymers, and coatings.
The pandemic was a painful but powerful demonstration of biotechnology’s power to save millions of lives and trillions of dollars.
Engineering biology techniques are also increasingly used to enhance regenerative medicine, which involves repairing, replacing, or regenerating damaged cells, tissues, and organs.25 Among the most promising advances in regenerative medicine is stem cell research, in which scientists use stem cells to 3-D print organic tissue and biobased materials.26 In a decade or more, some experts envision a world of 3-D printed organs for human transplant.27 In fact, British doctors have already successfully implanted a 3-D printed eye in a patient and 3-D printed bladders that saved the lives of three children.28
Biological engineering and synthetic biology hold immense potential. Future breakthroughs could allow societies to complement chemical- and petroleum-based materials with bioengineered materials with a lower environmental impact, just as they could complement conventional, carbon-intensive meats with lab-grown alternatives. They could provide healthy lungs, livers, kidneys, eyes, and other organs to any patient who needs them, and replace or regenerate diseased cells to treat sickle cell anemia and cardiovascular disease.29 None of these breakthroughs are imminent; indeed, some may be decades away. But given their potential, companies and countries would be unwise to ignore them.
Human-machine interfaces. This field sits at the intersection of organic biosystems (such as human organs) and inorganic systems (such as software and hardware). The most common applications are in the medical field, in which devices can create one- or two-way communications with parts of the body. For example, doctors can now place sensors on the scalp or implant them on the brain (“brain-computer interface”) to read a patient’s neural signals and control a robotic arm or a device cursor.30 Other biomachines can send electronic signals to the brain (“deep brain stimulation”) to modulate unusual neural activity and help manage the symptoms of Parkinson’s disease, or to help treat attention deficit disorder, obsessive compulsive disorder, and severe depression.31 Similarly, a cochlear implant in the ear sends electronic signals to stimulate the auditory nerve and improve hearing.32 Although this field has seen less progress than biological sequencing and biological engineering, there is growing potential for medical applications. These include neuroprosthetics to restore lost senses through technologies such as bionic vision, or technologies to direct a prosthetic limb with signals from the brain.33 Last year, Elon Musk’s company Neuralink made headlines for successfully implanting a chip onto a patient’s brain, reportedly restoring some mobility.34 Neuralink was not the first successful implantation of a neural chip, and it won’t be the last.35 In September 2024, the U.S. Food and Drug Administration (FDA) cleared Neuralink’s Blindsight device, which Musk claims could one day restore limited vision to certain people who are blind, for accelerated development.36 In time, biotechnology may be able to restore sight, hearing, and movement for millions—improving quality of life and productivity.
Developments in these three areas—biological sequencing, biological engineering/synthetic biology, and human-machine interfaces—will converge with other technology trends, especially the rapid expansion of advanced computing power and advanced AI tools and automation. According to AI research organization Epoch AI, from 1950 to 2010, it took almost two years to double computing power. But since 2010, it now takes only six months.37 Today, computing costs are up to 1,000 times cheaper than they were two decades ago.38 New machine learning techniques combined with the proliferation of biodata could allow researchers to extract transformative insights in health, medicine, agriculture, energy, and more.
The National Security Case for U.S. Biotechnology Leadership
As with any technological breakthrough, bad actors will seize on the biorevolution’s new tools and capabilities for their own nefarious ends. The same techniques that can sequence a deadly virus to develop a vaccine could also reveal how to make that virus even deadlier. The techniques to genetically manipulate staple crops to make them more resilient could yield insights about how to destroy them. The power to manipulate life inevitably unlocks the power to destroy it. Beyond direct threats to human security lie more fundamental questions about the dangers and ethics of “playing God” by treating DNA and RNA—the building blocks of life itself—as little more than computer code to manipulate for human ends.
Any qualms about the biorevolution should be tempered with the reality of its arrival. It is not a question of whether the biorevolution will happen, but which nations will lead it, shape it, and reap its benefits. The United States continues to lead the world in biotechnology, but China races to close the gap. Beijing has named biotechnology a strategic emerging industry, and it has already hit its 10-year targets. According to some estimates, China has invested up to $100 billion in life sciences research and development (R&D) at the local, provincial, and national levels.39 Leading Chinese biotechnology companies are also amassing vast genomic and health data, and the government’s prioritization of the sector has offered a strong signal for research and market investment.40
It is not realistic for the United States to out-compete China in every sector. Federal actions to protect and support certain sectors require a clear-eyed assessment of their importance to national security. The national security case for U.S. biotechnology leadership rests on five core arguments.
First, a strong biotechnology sector will better protect the nation’s citizens and economy from new pandemics and biothreats—both natural and human created. The COVID-19 pandemic painfully underscored the danger of unchecked viruses to the safety of America’s citizens and economy. A robust biotechnology sector will put the United States in a stronger position to anticipate, prevent, and mitigate future outbreaks and biothreats with the latest tools for virus detection, sequencing, and vaccine development. To weigh the value of a robust domestic biotechnology sector, consider a world in which the United States must rely on China for lifesaving vaccines for the next pandemic or a neglected U.S. biotechnology sector can only produce those vaccines months—or even years—later than foreign competitors. Beyond this, biotechnology has the potential to deliver breakthroughs to restore vision, sight, and movement through neuroprosthetics; tailored wellness and dieting regimes through personalized medicine; and precision treatments for sickle cell anemia and cardiovascular disease to improve the longevity, health, and productivity of Americans. Embracing the biorevolution could also avoid a future in which the United States must rely on competitors such as China for mission-critical materials for the U.S. military, clean energy breakthroughs, or cutting-edge tools to protect its population from novel pandemics and biothreats.41
The power to manipulate life inevitably unlocks the power to destroy it.
Second, ceding the biorevolution to competitors risks depriving the United States of potentially transformative defense applications. Breakthroughs in biotechnology could provide renewable sources of jet fuel.42 They could promote the physical and mental health of service members through products that help balance their microbiomes, enable self-repairing airfields with “living concrete” full of bacteria that regenerate to fill cracks as they emerge, and better protect soldiers with armor made of “dragon silk”—a genetically engineered spider silk that is not only lighter but up to three times tougher than traditional Kevlar.43 The U.S. Department of Defense (DoD) could employ new, lighter, and flame-retardant biological resins to improve the designs of drones, ships, and aircraft.44 Biological sensors could provide real-time alerts to hazardous biological or chemical agents.45 Researchers have manipulated the E. coli bacteria into a biosensor that can detect unexploded ordnance, reducing risks to both service members and civilians.46 Biotechnology’s defense applications are as far ranging as the field itself.47
Third, the biorevolution will bestow significant economic benefits to nations that harness it. Like AI, biotechnology could level up major sectors of the economy—from agriculture and pharmaceuticals to textiles, energy, and manufacturing. If the United States fails to invest in biotechnology, it risks missing out on the new tools, processes, and productivity it could unlock—and the billions, even trillions, of dollars in economic benefit. McKinsey & Company forecasts that existing biotechnology applications could have up to $4 trillion in annual, direct economic impact over the next 20 years.48 In addition, the World BioEconomy Forum estimates that the broad adoption of synthetic biology techniques in manufacturing could account for more than one-third of all global output—or nearly $30 trillion.49
Biotechnology can also strengthen domestic supply chains, for example, through biologically engineered crops that increase food security, a robust bioproduction capacity to strengthen national security supply chains, and a strong biopharmaceutical sector to ensure access to breakthrough vaccines and treatments in the event of new pandemics and biothreats.50 The biorevolution could also enable more resilient supply chains that promote broad-based economic growth. Today, manufacturing processes often rely on imported chemical inputs, exposing them to external supply chain shocks. By contrast, biomanufacturing relies on organic biomass ranging from agricultural byproducts such as animal waste to forestry byproducts like bark and wood chips. Unlike imported chemical inputs, these bio-inputs are renewable, domestically sourced, and broadly distributed across the country. As such, biomanufacturing facilities could be colocated with farms, forests, and municipal waste sites across the country, driving new jobs and investments in more remote and rural communities.
Fourth, biotechnology could unlock powerful tools to fight climate change and promote energy security. Climate change threatens U.S. national security in myriad ways, from direct harm to citizens from extreme weather to increased geopolitical instability from persistent drought and extreme heat.51 As Secretary of Defense Lloyd Austin has said, “No nation can find lasting security without addressing the climate crisis.”52 Fortunately, experts predict biotechnologies could someday yield advanced biofuels to significantly reduce emissions in transport, industry, and agriculture.53 Organic biomass—everything from fallen trees to food waste to farm products—is an abundant, renewable energy source. However, converting biomass to fuel still requires an expensive process of breaking down the cell walls into sugars and converting those sugars into fuel. Biofuel proponents hope advances in synthetic biology can streamline this process and make biofuels a more compelling alternative. Biotechnology also holds promise for carbon reduction and sequestration—from carbon-absorbing microalgae to genetically modified trees that pull more carbon dioxide from the air to genetically modified crops that require less energy-intensive fertilizers.54 As the urgency of tackling climate change and achieving energy security grows, so does the case for developing biotechnology-powered tools to advance these goals.
Biotechnology can also transform industrial processes to become less carbon intensive. For example, BDO (1,4-Butanediol) is a widely used chemical for manufacturing plastics and fibers. Companies such as Genomatica are developing biobased alternatives to BDO that use the fermentation of renewable feedstocks, such as sugarcane, instead of conventional chemical inputs. According to Boston Consulting Group, if the world’s 30 BDO manufacturers adopted bio-BDO, it would prevent the production of more than 15 million tons of carbon emissions annually—equivalent to the emissions of a million Americans.55
Fifth, the United States has a strategic opportunity and moral responsibility to set global norms and standards for biotechnology consistent with democratic values. The biorevolution raises difficult questions related to privacy, ethics, safety, and responsible biotechnology research, development, and deployment. The United States and China have fundamentally divergent views and practices surrounding the privacy of health data and the ethics of biological engineering more broadly. Infamously, Chinese scientist He Jiankui used CRISPR to alter three human embryos, two of whom were born in 2018 as Lulu and Nana, and a third who was born in 2019—the first genetically modified humans in history.56 Although China has since established stronger ethics rules for human studies, they completely exempted the private sector—a troubling omission.57
Securing the United States’ position as the 21st-century biopower warrants greater attention and action from policymakers to reinforce existing advantages, shore up vulnerabilities, and seize opportunities.
Just as troubling, the Chinese government has shown few qualms about using biotechnology for population control and repression of its ethnic and religious minorities, such as the Uyghurs. In the Xinjiang region, Chinese scientists are reportedly trying to use DNA samples to create an image of a person’s face, with which it could presumably use to track and target them.58 The government also appears to have embraced a troubling vision for offensive biotechnology capabilities.59 In December 2021, the U.S. Department of Commerce (DOC) placed several Chinese research institutes and biotechnology firms on the entity list for helping the Chinese military develop purported “brain control” weapons.60 In the past, Chinese military leaders have openly speculated about biotechnology’s potential offensive uses, for example, by enabling “specific ethnic genetic attacks.”61 China’s troubling biotechnology record makes it especially urgent for the United States to proactively shape global biotechnology norms and standards.
Given the stakes, securing the United States’ position as the 21st-century biopower warrants greater attention and action from policymakers to reinforce existing advantages, shore up vulnerabilities, and seize opportunities. To that end, chapter two of this report surveys the current state of U.S. biotechnology leadership, focusing on private sector strengths and weaknesses, along with a deeper dive into federal government policies, investments, and initiatives. It identifies financial, policy, regulatory, workforce, and other headwinds to U.S. biotechnology leadership. In chapter three, this report looks abroad to survey leading biotechnology allies, partners, and competitors to identify their relative strengths and weaknesses. Drawing on these assessments, the authors outline immediate and longer-term recommendations for leaders in policymaking and industry in six key areas:
- Invest in research and infrastructure
- Expand biotalent
- Unlock biodata
- Strengthen and streamline policy
- Lead globally
- Build public trust
Read the Full Report
- Michael Chui et al., “The Bio Revolution: Innovations Transforming Economies, Societies, and Our Lives,” McKinsey & Company, May 13, 2020, https://www.mckinsey.com/industries/life-sciences/our-insights/the-bio-revolution-innovations-transforming-economies-societies-and-our-lives. ↩
- “Learn More About UK Biobank,” UK Biobank, August 13, 2024, https://www.ukbiobank.ac.uk/learn-more-about-uk-biobank. ↩
- Alex Keown, “France Aims to Become European Leader in Life Sciences Innovation,” BioSpace, June 20, 2022, https://www.biospace.com/france-eyes-growth-in-life-sciences-industry-aims-to-become-top-ecosystem-in-europe. ↩
- Jules Adam, “Japan’s Ten Hottest Biotech Companies in Healthcare,” Labiotech, February 27, 2024, https://www.labiotech.eu/best-biotech/japan-hottest-biotech-healthcare. ↩
- “Leap to Global Top 3 in AI—Semiconductor, Advanced Biotechnology & Quantum Technology,” Office of the President, Republic of Korea, April 26, 2024, https://eng.president.go.kr/briefing/yKPaTKzX. ↩
- Anna B. Puglisi and Chryssa Rask, China, Biotechnology, and BGI: How China’s Hybrid Economy Skews Competition (Center for Security and Emerging Technology, May 2024), https://cset.georgetown.edu/publication/china-biotechnology-and-bgi. ↩
- Jamie Gaida et al., ASPI’s Critical Technology Tracker: The Global Race for Future Power (Australian Strategic Policy Institute, February 2023), https://ad-aspi.s3.ap-southeast-2.amazonaws.com/2023-08/ASPIs%20Critical%20Technology%20Tracker.pdf. ↩
- Aaron Dudley, “The Chinese API Market,” Mantell Associates, accessed July 28, 2024, https://www.mantellassociates.com/the-chinese-api-market. ↩
- Carol Kuntz, “Biotech Matters: Problems with Life Science Databases in the United States,” May 1, 2024, Center for a New American Security, https://www.cnas.org/publications/reports/biotech-matters-problems-with-life-science-databases-in-the-united-states. ↩
- “Recombinant DNA in the Lab,” Smithsonian Institution, accessed July 28, 2024, https://www.si.edu/spotlight/birth-of-biotech/recombinant-dna-in-the-lab; Komaljeet Gill et al., “RDT and Genetic Engineering: Basic of RDT Method, PCR, and Application,” chap. 13 in Basic Biotechniques for Bioprocess and Bioentrepreneurship, eds. Arvind Kumar Bhatt, Ravi Kant Bhatia, and Tek Chand Bhalla (Academic Press, 2023), https://doi.org/10.1016/B978-0-12-816109-8.00013-1. ↩
- Gill et al., “RDT and Genetic Engineering: Basic of RDT Method, PCR, and Application.” ↩
- Priya Duggal et al., “The Evolving Field of Genetic Epidemiology: From Familial Aggregation to Genomic Sequencing,” American Journal of Epidemiology 188, no. 12 (2019): 2069–2077, https://academic.oup.com/aje/article/188/12/2069/5566320; Diana Cano Bordajandi, “How the Human Genome Project Shook the World of Cancer Research,” The Institute of Cancer Research, February 15, 2021, https://www.icr.ac.uk/news-features/latest-features/how-the-human-genome-project-shook-the-world-of-cancer-research. ↩
- “The Nobel Prize in Chemistry 2020,” The Nobel Prize, accessed July 28, 2024, https://www.nobelprize.org/prizes/chemistry/2020/popular-information. ↩
- “The Nobel Prize in Physiology or Medicine 2023,” The Nobel Prize, accessed July 28, 2024, https://www.nobelprize.org/prizes/medicine/2023/press-release. ↩
- “China’s CAR T Market Comes of Age,” BioWorld, October 9, 2024, https://www.bioworld.com/China_CAR_T. ↩
- Joseph R. Biden, “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” The White House, September 22, 2022, https://www.whitehouse.gov/briefing-room/presidential-actions/2022/09/12/executive-order-on-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy. ↩
- Marcy E. Gallo, The Bioeconomy: A Primer, CRS Report No. R46881 (Congressional Research Service, September 19, 2022), https://crsreports.congress.gov/product/pdf/R/R46881. ↩
- Safeguarding the Bioeconomy (National Academies Press, 2020), 73, https://doi.org/10.17226/25525; Gallo, The Bioeconomy: A Primer. ↩
- Chui et al., “The Bio Revolution: Innovations Transforming Economies, Societies, and Our Lives.” ↩
- Kris A. Wetterstrand, “The Cost of Sequencing a Human Genome,” National Human Genome Research Institute, November 1, 2021, https://www.genome.gov/about-genomics/fact-sheets/Sequencing-Human-Genome-cost. ↩
- Tara O’Toole, The Biorevolution: Its Implications for U.S. National Security, Economic Competitiveness, and National Power (In-Q-Tel, Inc., February 2023), https://assets.iqt.org/pdfs/The_Biorevolution_Feb_2023.pdf/web/viewer.html; Kris A. Wetterstrand, “DNA Sequencing Costs: Data,” National Human Genome Research Institute, May 16, 2023, https://www.genome.gov/about-genomics/fact-sheets/DNA-Sequencing-Costs-Data; Jeremy Preston, Ashley VanZeeland, and Daniel A. Peiffer, “Innovation at Illumina: The Road to the $600 Human Genome,” Nature, accessed July 8, 2024, https://www.nature.com/articles/d42473-021-00030-9. ↩
- “The Pandemic’s True Death Toll,” The Economist, October 25, 2022, https://www.economist.com/graphic-detail/coronavirus-excess-deaths-estimates; “Funding Overview,” Pandemic Oversight, accessed July 8, 2024, https://www.pandemicoversight.gov/data-interactive-tools/funding-overview. ↩
- Chui et al., “The Bio Revolution: Innovations Transforming Economies, Societies, and Our Lives.” ↩
- “Understanding COVID-19 mRNA Vaccines,” National Human Genome Research Institute, August 30, 2021, https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-mRNA-Vaccines; Thomas Gaj, Charles A. Gersbach, and Carlos F. Barbas, III, “ZFN, TALEN, and CRISPR/Cas-Based Methods for Genome Engineering,” Trends in Biotechnology 31, no. 7 (July 2013): 397–405, https://doi.org/10.1016/j.tibtech.2013.04.004; Chui et al., “The Bio Revolution: Innovations Transforming Economies, Societies, and Our Lives.” ↩
- “Tissue Engineering and Regenerative Medicine,” National Institute of Biomedical Imaging and Bioengineering, accessed July 9, 2024, https://www.nibib.nih.gov/science-education/science-topics/tissue-engineering-and-regenerative-medicine; Ivana Pajcin et al., “Bioengineering Outlook on Cultivated Meat Production,” Micromachines 13, no. 3 (February 28, 2022): 402, https://doi.org/10.3390/mi13030402; Ruma Rani et al., “Bioengineered Polymer/Composites as Advanced Biological Detection of Sorbitol: An Application in Healthcare Sector,” Current Topics in Medicinal Chemistry 20, no. 11 (2020): 963–981, https://doi.org/10.2174/1568026620666200306131416; Daniela Matias de C. Bittencourt et al., “Bioengineering of Spider Silks for the Production of Biomedical Materials,” Frontiers in Bioengineering and Biotechnology 10 (August 8, 2022), https://doi.org/10.3389/fbioe.2022.958486; Barabadi, Hamed, et al. “Bioengineered Metal-Based Antimicrobial Nanomaterials for Surface Coatings,” chap. 17 in Antiviral and Antimicrobial Smart Coatings: Fundamentals and Applications, eds. Aditya Kumar et al. (Elsevier, 2023), 489–539, https://doi.org/10.1016/B978-0-323-99291-6.00012-8. ↩
- “Stem Cell Basics,” National Institutes of Health, accessed July 9, 2024, https://stemcells.nih.gov/info/basics/stc-basics; Lan Zhao et al., “Neural Stem Cell Therapy for Brain Disease,” World Journal of Stem Cells 13, no. 9 (September 26, 2021): 1278–1292, https://doi.org/10.4252/wjsc.v13.i9.1278; “UW Study Finds Photoreceptor Cells From Retinal Organoids Can Replicate Key Functions of Vision,” University of Wisconsin–Madison School of Medicine and Public Health, February 2, 2022, https://www.med.wisc.edu/news/photoreceptor-cells-replicate-key-vision-function; Chin Siang Ong et al., “3D Bioprinting Using Stem Cells,” Pediatric Research 83, no. 1 (January 2018): 223–231, https://doi.org/10.1038/pr.2017.252. ↩
- Kristen Rogers, “When We’ll Be Able to 3D-Print Organs and Who Will Be Able to Afford Them,” CNN, March 10, 2023, https://www.cnn.com/2022/06/10/health/3d-printed-organs-bioprinting-life-itself-wellness-scn/index.html. ↩
- Sara Spary, “British Man Given 3D Printed Eye in World First, Hospital Says,” CNN, November 25, 2021, https://www.cnn.com/2021/11/25/health/3d-printed-eye-scli-intl-gbr-scn/index.html; Rogers, “When We’ll Be Able to 3D-Print Organs and Who Will Be Able to Afford Them.” ↩
- Sébastien Levesque and Daniel E. Bauer, “Gene Correction for Sickle Cell Disease Hits Its Prime,” Nature Biomedical Engineering 7 (2023): 605–606, https://doi.org/10.1038/s41551-023-01040-2; Moran Yadid et al., “Bioengineering Approaches to Treat the Failing Heart: From Cell Biology to 3D Printing,” Nature Reviews Cardiology 19 (2022): 83–99, https://doi.org/10.1038/s41569-021-00603-7. ↩
- Janis Peksa and Dmytro Mamchur, “State-of-the-Art on Brain-Computer Interface Technology,” Sensors 23, no. 13 (June 28, 2023): 6001, https://doi.org/10.3390/s23136001. ↩
- Lorea Mar-Barrutia et al., “Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Systematic Review of Worldwide Experience After 20 Years,” World Journal of Psychiatry 11, no. 9 (September 19, 2021): 659–680, https://doi.org/10.5498/wjp.v11.i9.659; “Brain Stimulation Therapies,” National Institute of Mental Health, accessed July 12, 2024, https://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies; Katherine W. Scangos et al., “Closed-Loop Neuromodulation in an Individual with Treatment-Resistant Depression,” Nature Medicine 27, no. 10 (October 2021): 1696–1700, https://doi.org/10.1038/s41591-021-01480-w. ↩
- “Cochlear Implants,” National Institute on Deafness and Other Communication Disorders, June 13, 2024, https://www.nidcd.nih.gov/health/cochlear-implants. ↩
- Stephen Baak, “Neuroprosthetics and the Bionic Human,” Temple University, December 20, 2021, https://greymattersjournaltu.org/issue-2/neuroprosthetics-and-the-bionic-human. ↩
- “Neuralink’s First Human Patient Able to Control Mouse Through Thinking, Musk Says,” Reuters, February 20, 2024, https://www.reuters.com/business/healthcare-pharmaceuticals/neuralinks-first-human-patient-able-control-mouse-through-thinking-musk-says-2024-02-20. ↩
- “First Successful Implantation of Revolutionary Wireless Visual Prosthesis Brain Implant,” Illinois Tech, February 16, 2022, https://www.iit.edu/news/first-successful-implantation-revolutionary-wireless-visual-prosthesis-brain-implant. ↩
- “Musk’s Neuralink Gets FDA’s Breakthrough Device Tag for ‘Blindsight’ Implant,” Reuters, September 18, 2024, https://www.reuters.com/business/healthcare-pharmaceuticals/musks-neuralink-receives-fdas-breakthrough-device-tag-brain-implant-2024-09-17. ↩
- “Notable A.I. Models,” Epoch AI, updated October 9, 2024, https://epochai.org/data/notable-ai-models. ↩
- Lucy Hampton, “The Cost of Computing and the Productivity Puzzle,” Bennett Institute for Public Policy, Cambridge University, blog, July 17, 2023, https://www.bennettinstitute.cam.ac.uk/blog/cost-of-computing. ↩
- Scott Moore, China’s Role in the Global Biotechnology Sector and Implications for US Policy (Brookings Institution, April 2020), https://www.brookings.edu/articles/chinas-role-in-the-global-biotechnology-sector-and-implications-for-us-policy. ↩
- Moore, China’s Role in the Global Biotechnology Sector and Implications for US Policy. ↩
- “New Biotechnology Executive Order Will Advance DoD Biotechnology Initiatives for America’s Economic and National Security,” U.S. Department of Defense, September 14, 2022, https://www.defense.gov/News/Releases/Release/Article/3157504/new-biotechnology-executive-order-will-advance-DoD-biotechnology-initiatives-fo. ↩
- “Biofuels,” Defense Advanced Research Projects Agency, accessed July 22, 2024, https://www.darpa.mil/program/biofuels. ↩
- Timothy Marler and Daniel M. Gerstein, “Biotechnology and Today’s Warfighter,” RAND Corporation, October 25, 2022, https://www.rand.org/pubs/commentary/2022/10/biotechnology-and-todays-warfighter.html; Alexander McNamara, “Environmentally Friendly ‘Living Concrete’ Capable of Self-Healing,” BBC, January 15, 2020, https://www.sciencefocus.com/news/environmentally-friendly-living-concrete-capable-of-self-healing; “Spider Silk,” Kraig Biocraft Laboratories, October 13, 2014, https://www.kraiglabs.com/spider-silk.
↩ - Clara Rodríguez Fernández, “Airbus Will Use Recombinant Spider Silk to Build Lightweight Planes,” Labiotech, September 12, 2018, https://www.labiotech.eu/trends-news/airbus-amsilk-spider-silk-planes; Diane Dieuliis, “Biotechnology for the Battlefield: In Need of a Strategy,” War on the Rocks, November 27, 2018, https://warontherocks.com/2018/11/biotechnology-for-the-battlefield-in-need-of-a-strategy; Andrew Stewart, “The ‘Living Concrete’ That Can Heal Itself,” CNN, March 7, 2016, https://www.cnn.com/2015/05/14/tech/bioconcrete-delft-jonkers/index.html. ↩
- National Security Commission on Emerging Biotechnology: Interim Report (National Security Commission on Emerging Biotechnology, December 2023), https://www.biotech.senate.gov/press-releases/interim-report. ↩
- Josh Luckenbaugh, “New Biosensor Uses E. Coli to Detect Landmines,” National Defense, November 17, 2023, https://www.nationaldefensemagazine.org/articles/2023/11/17/new-biosensor-uses-e-coli-to-detect-landmines. ↩
- “New Biotechnology Executive Order Will Advance DoD Biotechnology Initiatives for America’s Economic and National Security.” ↩
- Chui et al., “The Bio Revolution: Innovations Transforming Economies, Societies, and Our Lives.” ↩
- “Declaration 2023,” World Bioeconomy Forum, December 12, 2023, https://wcbef.com/about-us/declarations/declaration-2023; Chui et al., “The Bio Revolution: Innovations Transforming Economies, Societies, and Our Lives.” ↩
- O’Toole, The Biorevolution: Its Implications for U.S. National Security, Economic Competitiveness, and National Power. ↩
- “Spotlight: Tackling the Climate Crisis,” U.S. Department of Defense, accessed September 20, 2024, https://www.defense.gov/Spotlights/Tackling-the-Climate-Crisis. ↩
- David Vergun, “Defense Secretary Calls Climate Change an Existential Threat,” U.S. Department of Defense, accessed September 20, 2024, https://www.defense.gov/news/news-stories/article/article/2582051/defense-secretary-calls-climate-change-an-existential-threat. ↩
- “Harnessing Biotechnology to Accelerate Advanced Biofuels Production,” Office of Energy Efficiency & Renewable Energy, April 12, 2016, https://www.energy.gov/eere/articles/harnessing-biotechnology-accelerate-advanced-biofuels-production. ↩
- John Fialka and E&E News, “Start-Up Hopes ‘Super’ Poplar Trees Will Suck Up More CO2,” Scientific American, February 9, 2023, https://www.scientificamerican.com/article/start-up-hopes-super-poplar-trees-will-suck-up-more-co2; Helen Onyeaka, et. al,” Minimizing Carbon Footprint via Microalgae as a Biological Capture,” Carbon Capture Science & Technology 1 (December 2021), https://www.sciencedirect.com/science/article/pii/S2772656821000075. ↩
- François Candelon et al., “Synthetic Biology Is About to Disrupt Your Industry,” Boston Consulting Group, February 10, 2022, https://www.bcg.com/publications/2022/synthetic-biology-is-about-to-disrupt-your-industry. ↩
- Dana Goodyear, “Dangerous Designs,” The New Yorker, September 2, 2023, https://www.newyorker.com/magazine/2023/09/11/the-transformative-alarming-power-of-gene-editing; “CRISPR,” National Human Genome Research Institute, October 9, 2024, https://www.genome.gov/genetics-glossary/CRISPR. ↩
- Dennis Normile, “In Wake of Gene-Edited Baby Scandal, China Sets New Ethics Rules for Human Studies,” Science, March 7, 2023, https://www.science.org/content/article/wake-gene-edited-baby-scandal-china-sets-new-ethics-rules-human-studies. ↩
- Sui-Lee Wee and Paul Mozur, “China Uses DNA to Map Faces, with Help From the West,” The New York Times, December 3, 2019, https://www.nytimes.com/2019/12/03/business/china-dna-uighurs-xinjiang.html. ↩
- U.S. Department of Commerce, “Commerce Acts to Deter Misuse of Biotechnology, Other U.S. Technologies by the People’s Republic of China to Support Surveillance and Military Modernization that Threaten National Security,” press release, December 16, 2021, https://www.commerce.gov/news/press-releases/2021/12/commerce-acts-deter-misuse-biotechnology-other-us-technologies-peoples. ↩
- Matthew S. Borman, “Addition of Certain Entities to the Entity List and Revision of an Entry on the Entity List,” Federal Register, December 17, 2021, https://www.federalregister.gov/documents/2021/12/17/2021-27406/addition-of-certain-entities-to-the-entity-list-and-revision-of-an-entry-on-the-entity-list. ↩
- Elsa B. Kania and Wilson Vorndick, “Weaponizing Biotech: How China’s Military Is Preparing for a ‘New Domain of Warfare,’” Defense One, August 14, 2019, https://www.defenseone.com/ideas/2019/08/chinas-military-pursuing-biotech/159167. ↩
More from CNAS
-
Biotech Matters
Operation Warp Speed showed the power of the U.S. government to direct national biotech capabilities around a shared goal—in this case, a novel vaccine. But there are many oth...
By Hannah Kelley
-
Biotech Matters: Innovation in Agricultural Biotechnology
In 1986, the United States established a “Coordinated Framework for the Regulation of Biotechnology.” In the decades since, this policy helped to enable the rapid development ...
By Dr. L. Val Giddings
-
Biotech Matters: Public-Private Coordination of Biotechnology
An appreciation of biotechnology’s great opportunities is, for many commentators, intimately joined with regret about a disconnect between the U.S. government and the private ...
By Richard Danzig
-
Biotech Matters: Automated Scientists Will Power Tomorrow’s Bioeconomy
Twenty years ago, it was barely plausible that soon every person on Earth would have a supercomputer in their pocket with ready access to the world’s information. Even though ...
By Dr. David A. Markowitz
-
AI and the Evolution of Biological National Security Risks
New AI capabilities may reshape the risk landscape for biothreats in several ways. AI is enabling new capabilities that might, in theory, allow advanced actors to optimize bio...
By Bill Drexel & Caleb Withers