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Key points
Policy recommendations
Quad countries should:
The biotechnology revolution and biotechnology market
Biotechnology is an interdisciplinary science that combines biology, technological innovation, and engineering to create outcomes ranging from human health, plant and ecology enhancement and environmental impact. The field delineates three areas of focus.[1] The first is the cognitive revolution, highlighting genes and their relationship with observable behaviour. The second, neuropharmacology, is the use and influence of chemicals and drugs on the nervous system for cognitive enhancement and its implications on society. The third area highlighted is the scope for prolonging life using biotechnology, its innovations, and the implications of this. Alongside these areas, the 21st century has also brought forward synthetic biology, genetic editing, and engineering as technologies with immense social consequences. In the last decade, biotechnology has garnered the attention of most innovators and technologists in a few key areas, including:
The intuitive first use in biotechnology is data collection, storage, use and sharing. Bioinformatics refers to biological data and information ranging from DNA to fingerprint scans, while biocuration is the organising, using and sharing of this data.[2] These two have drastically influenced medical research in biodata and biosafety labs.[3]
Genetic engineering and synthetic biology became significant with iterations in cancer research, medical innovation, health augmentation and a greater awareness and control in all disease prevention and life enhancement.[4]
Biotechnology also has applications in agriculture that encompass a wide range of areas to enhance and safeguard plants and animals. This includes the development of animal vaccines, techniques for modifying plants through genetic marker-assisted breeding, and genetic engineering of agricultural species, both plants and animals.[5] This field offers diverse benefits, including the ability to manufacture new products previously unattainable or delivered at a limited scale, improvements in traditional industrial processes, and advancements in sustainability with reduced environmental impact.
Finally, the last primary sector in biotechnology is biosafety and biosecurity. Biosafety involves efforts and studies to contain biological hazards to prevent accidental exposure of laboratory workers, local communities, and the environment, particularly concerning infectious pathogens. Biosecurity is a large-scale effort to ensure use in good faith for all biotechnology developments and prevention and deterrence against the use of any biological agents for harm. With the Biological Weapons Convention (BWC) holding its ninth review conference and recent conversations around biosafety labs and their security measures, this area, too, has assumed global importance.[6] Biotechnology strategies are yet to include these four areas that remain the most significant regarding application areas, scope, and impact.
Global biotechnology evolution
While the term biotechnology revolution has been popularised in the past three decades, the actual growth of the sector has maintained its predicted outcome in market size and growth, specifically in medical research and innovation.[7]
In the contemporary world, popular biotechnology has been deeply rooted in its genetic perspective of disease. Biotechnology already includes other sectors, even if they are derivative of gene engineering with large-scale impacts.[8] One of the biggest contenders in the biotechnology revolution is the European Union (EU), which has been the third-largest market in the biotechnology sector since 2012.[9] From 2012 till 2018, the EU was responsible for approximately 13 per cent of global medicine production.[10]
Countries such as South Korea, Singapore, and especially China, have significantly invested in their biotechnology sectors. China’s rapid growth and large-scale investment in biotechnology have influenced its position as the second most influential global leader in biotechnology.[11] Estimates suggest that Chinese governments have invested over US$100 billion in life sciences research and development.[12]
Quad countries and their strategies
Globally, specific guidelines apply to the biotechnology industry and impact all four Quad[i] countries — Australia, the US, Japan, and India. These include the BWC and the Cartagena Protocol for biosecurity.[13] The Convention on Biological Diversity (CBD) and the Nagoya Protocol overlook biodiversity and trade.[14] Further, the World Health Organisation (WHO) has highlighted guidelines on global biobanking, and biological lab safety post the COVID-19 pandemic.[15] Aside from these overarching guidelines, each Quad country has its regulatory approach to the biotechnology revolution.
The principal regulations in the field of biotechnology in Australia begin from the need to govern bioprospecting,[ii] and oversee gene technologies and environmental impact. Like Australia, India has also established good governance in the fields of genetic enhancement and engineering, environmental impact and pharmaceutical production.[16] In 2022, India also established its first mobile biosafety lab.[17] Japan, similarly, has well-established governance for its pharmaceutical sectors, and the US has led the global biotechnology industry consistently for the last decade.[18]
Overall, each Quad nation plays a distinct role in biotechnology. Australia excels in agricultural biotechnology and regenerative medicine, but requires help in commercialisation. Japan has a national bioeconomy strategy and aims to become a global leader, while the US is already a dominant force in biotech across various sectors. India is rapidly expanding its biotech sector, focusing on healthcare and agricultural challenges, and becoming a bio-manufacturing hub.[19]
Recommendations for enhancing the biotechnology revolution
The Quad countries are well-established in biotechnology and have comprehensive regulations. Specific areas can use more attention to enhance this status and achieve more significant growth in the biotechnology revolution, these include:
The first recommendation is in the fundamentals of the biotechnology sector, that is, data use and sharing. While the Quad countries are all undersigned in the CBD and the Nagoya Protocol, they can establish data-sharing guidelines that ensure equitable representation of the global South in the sharing of biological data, the fair use of this data and the return of research outcomes or sharing of profits with the sources of biological data.[20]
Data sharing — which will help foster research, development, and bioproduction data — requires increased investment. Increasing the capacity for bioproduction can directly influence the bioeconomy of each country.
Bioproduction is also heavily inclusive of genetic engineering, including modified crops and animals to increase the longevity of life and resistance to disease for the two. Bioproduction and agriculture involve the application of biotechnology in enhancing agricultural practices and improving industrial processes. Genetic modification of crops plays a substantial role in increasing agricultural productivity. The global agricultural biotechnology market size in 2022 stood at US$32.1 billion and is set to reach US$77.4 billion by 2032, nearly doubling in under a decade. [21]
Data sharing is very closely linked to bioproduction and agriculture, and enhancing this field through the Quad’s platform will help grow the vertical beyond its current trajectory. Government incentives, industry-academia collaboration, and intellectual property protection can help achieve this goal. Creating scope for international trade, knowledge-sharing, and cooperation can further enhance this.
In the last decade, with the introduction of automation, artificial intelligence (AI), and machine learning (ML), genetic engineering has advanced to include rapidly generated chemical compounds that save on workforce and work hours, data storage solutions such as DNA storage, organoid intelligence, and even manufactured organisms like Xenobots.[22]
In 2018, the WHO established an Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing and, in 2021, launched a governance framework for genome editing.[23] The Quad can leverage its alliance to represent common interests to the WHO and create guidelines in genome editing to make a foundation for global genome editing norms, and ethical guidelines that allow for equitable benefit sharing and research in medical applications and innovation.
Finally, there is a need to include biosecurity and biosafety more explicitly in global norms and guidelines. The Australia Group already represents all four Quad countries, and many others undersigned in the BWC, Cartagena Protocol, and Nagoya Protocol. The same group can also add to its focus a need for global biosafety standards in biosafety labs, especially level 3 and level 4 for biosafety labs (BSL3 and BSL4). Additionally, the Australia Group can grow to include other Indo-Pacific countries, including Indonesia, Vietnam, South Korea and others. This will help address a significant global gap faced by the biotechnology research sector due to the non-participation of countries leading in the biotechnology field, like China, giving smaller countries in the Quad a more significant platform, enhancing existing standards set by the WHO and ISO for the private sector.[24]
This article was first published in early December as part of the Quad Tech Network Series of the Australian National University’s (ANU) National Security College. The original article can be found here: The Quad’s contribution to revolutionising biotechnology strategies | National Security College (anu.edu.au)
Endnotes
[i] The Quadrilateral Strategic Alliance
[ii] Bioprospecting is commercialising new products based on biological resources, such as medicines and agrichemicals.
[1] Carnegie Endowment for International Peace, “Lecture series: The biotechnology revolution: Political Implications and Governance,” Carnegie Endowment for International Peace, 21 July, 2001, accessed 27 November 2023, https://carnegieendowment.org/2001/06/21/lecture-seriesbiotechnology-revolution-political-implications-and-governance-event-354.
[2] International Society for Biocuration, “Biocuration: Distilling data into knowledge,” PLoS Biology,
16 April 2018, accessed 27 November 2023, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5919672/ .
[3] L Annaratone et al., “Basic principles of biobanking: from biological samples to precision medicine for patients,” Virchows Archive, 13 July 2021, accessed 27 November 2023, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275637/.
[4] Ran et al., “Genome engineering using the CRISPR-Cas9 system,” Nature Protocol 8, 2281–2308
(2013) , accessed 27 November 2023, https://www.nature.com/articles/nprot.2013.143
Kevin Cook, “The Biotech Revolution: Profiting from the Future of Science”, Nasdaq, 7 February 2020, accessed 27 November 2023, https://www.nasdaq.com/articles/the-biotech-revolution:profiting-from-the-future-of-science-2020-02-07
[5]US Security Commission, “China’s Biotechnology Development: The Role of US and Other Foreign Engagement,” US Security Commission, 14 February 2019, accessed 27 November 2023, https://www.uscc.gov/research/chinas-biotechnology-development-role-us-and-other-foreignengagement
[6] Biological Weapons Convention, “Ninth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction,” Biological Weapons Convention, UN Office of Disarmament Affairs, 22 December 2022, accessed 27 November 2023, https://unodaweb-meetings.unoda.org/public/2022-12/20221221%20BWC_CONF_IX_9%20adv%20vers.pdf
World Health Organization, “Laboratory Biosafety Manual, 4th Edition,” World Health Organization, 21 December 2020, accessed 27 November 2023, https://www.who.int/publications/i/item/9789240011311
[7] Paul Nightingale et al., “The myth of the biotech revolution,” TRENDS in Biotechnology 22, no. 11 (2004): 564-569, November 2004, accessed 27 November 2023, https://www.cell.com/trends/biotechnology/fulltext/S0167-7799(04)00265-
3?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS01677799040 02653%3Fshowall%3Dtrue.
[8] Paul Nightingale et al., “The myth of the biotech revolution”.
[9] Deu et al., “Biotech in Europe: A Strong Foundation for Growth and Innovation” McKinsey & Company, 23 August 2019, accessed 27 November 2023,
https://www.mckinsey.com/industries/life-sciences/our-insights/biotech-in-europe-a-strongfoundation-for-growth-and-innovation
[10] Deu et al., “Biotech in Europe: A Strong Foundation for Growth and Innovation”.
[11] Deu et al., “Biotech in Europe: A Strong Foundation for Growth and Innovation”.
[12] Scott Moore, “China’s Role in the Global Biotechnology Sector and Implications for US Policy,” Brookings, April 2020, accessed 27 November 2023, https://www.brookings.edu/wpcontent/uploads/2020/04/FP_20200427_china_biotechnology_moore.pdf
[13] Convention on Biological Diversity, “The Cartagena Protocol on Biosafety,” Convention on Biological Diversity, 29 June 2023, accessed 27 November 2023,
https://bch.cbd.int/protocol?_gl=1%2A3uspor%2A_ga%2ANjc5NTI0MTkwLjE2ODYzODY1NjY.%2 A_ga_7S1TPRE7F5%2AMTY4OTY3MjQyNC4zLjEuMTY4OTY3MzQ3MS4xNi4wLjA
[14] Convention on Biological Diversity, “The Convention on Biological Diversity,” Convention on Biological Diversity, 13 May 2016, accessed 27 November 2023, https://www.cbd.int/convention/text/
Convention on Biological Diversity, “Nagoya Protocol,” Convention on Biological Diversity. 14 October 2014, accessed 27 November 2023, https://www.cbd.int/abs/
[15] World Health Organization, “Laboratory Biosafety Manual, 4th Edition”.
[16] Government of Australia, “Environment Protection and Biodiversity Conservation Regulations 2000”, Government of Australia, 3 January 2023, accessed 27 November 2023,
https://www.legislation.gov.au/Details/F2016C00914
Government of Australia, “Gene Technology Act, 2000,” Government of Australia, 1 July 2016 , accessed 27 November 2023, https://www.legislation.gov.au/Details/C2016C00792
[17] “India’s First Biosafety Level-3 Mobile Laboratory Launched in Maharashtra,” Livemint, 19 February 2022, accessed 27 November 2023, https://www.livemint.com/science/news/indiasfirst-biosafety-level-3-mobile-laboratory-launched-in-maharashtra-11645240585451.html
[18] “Biotechnological Transformation (BX) Strategy (2023-03-14),” Keidanren, 14 March 2023, accessed 27 November 2023,
https://www.keidanren.or.jp/en/policy/2023/015_proposal.html#:~:text=In%20Japan%2C%20the %20government%20started,advanced%20bioeconomy%20society%20by%202030
Japan Pharmaceuticals Manufacturing Association, “Pharmaceutical regulations in Japan 2020”, Japan Pharmaceuticals Manufacturing Association (2020), accessed 27 November 2023, https://www.jpma.or.jp/english/about/parj/eki4g600000078c0-att/2020.pdf
US Department of State, “Biosafety and Biosecurity.” US Department of State, accessed 27 November 2023, https://www.state.gov/biosafety-and-biosecurity/
[19] Dirk van der Kley, “Shaping the Quad’s DNA: How Can Quad Countries Manage Biotech’s Opportunities and Risks?” Quad Tech Network Series, Australian National University, November 2021, accessed 27 November 2023,
https://nsc.crawford.anu.edu.au/sites/default/files/publication/nsc_crawford_anu_edu_au/202111/shaping_the_quads_dna_how_can_quad_countries_manage_biotechs_opportunities_and_risk s_0.pdf
[20] Shravishtha Ajaykumar, “India’s Potential Influence on the Need for Global Governance of Biobanks,” Observer Research Foundation, 4 July 2023, accessed 27 November 2023, https://www.orfonline.org/expert-speak/indias-potential-influence-on-the-need-for-globalgovernance-of-biobanks/
[21] Acumen Research and Consulting, “Agricultural Biotechnology Market Size,” Acumen Research and Consulting, 16 March 2023, accessed 27 November 2023,
https://www.globenewswire.com/news-release/2023/03/16/2628847/0/en/Agricultural-
Biotechnology-Market-Size-Growing-at-9-4-CAGR-Set-to-Reach-USD-77-4-Billion-By2032.html#:~:text=The%20Global%20Agricultural%20Biotechnology%20Market%20Size%20in %202022%20stood%20at,and%20consumed%20around%20the%20world.
[22] Filip Miljković et al., “Impact of Artificial Intelligence on Compound Discovery, Design, and Synthesis,” ACS Omega 6 (49), 33293-33299, 29 November 2021, accessed 27 November 2023, https://pubs.acs.org/doi/10.1021/acsomega.1c05512
Latchesar Ionkov, “DNA: The Ultimate Data-Storage Solution,” Scientific American, 28 May 2021, accessed 27 November 2023, https://www.scientificamerican.com/article/dna-the-ultimatedata-storage-solution/
Lena Smirnova et al., “Organoid intelligence (OI) - The ultimate functionality of a brain microphysiological system,” ALTEX vol. 40,2 (2023): 191-203, 29 March 2023,
https://www.altex.org/index.php/altex/article/view/2630
Nilay Solanki et al., “Xenobots: Applications in Drug Discovery”, Current pharmaceutical biotechnology vol. 23, (2022), 29 August 2022, accessed 27 November 2023, https://www.eurekaselect.com/article/123115
[23] World Health Organization, “Human Genome Editing: A Framework for Governance”, World Health Organization, https://www.who.int/publications/i/item/9789240030060
[24] International Standards Organisation, “General Requirements for Biobanking”, International Standards Organisation, 15 July 2023, accessed 27 November 2023, https://www.iso.org/standard/67888.html
Ms Shravishtha Ajaykumar is an Associate Fellow at Observer Research Foundation. Her work includes the intersection of emerging technology, security, and society.
The ANU National Security College (NSC) is a joint initiative of The Australian National University and the Commonwealth Government. NSC is independent in its activities, research and editorial judgment and does not take institutional positions on policy issues. Accordingly, the authors are solely responsible for the views expressed in this publication, which should not be taken as reflecting the views of any government or organisation. NSC’s publications comprise peer-reviewed research and analysis concerning national security issues at the forefront of academic and policy inquiry. This paper has been written for the Quad Tech Network Dialogue, held in September 2023 as part of the Quad Tech Network initiative.
The Quad Tech Network (QTN) is an initiative of the NSC, delivered with support from the Australian Government. It aims to establish and deepen academic and official networks linking the Quad nations – Australia, India, Japan, and the United States – in relation to the most pressing technology issues affecting the future security and prosperity of the Indo-Pacific.
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Shravishtha Ajaykumar is Associate Fellow at the Centre for Security, Strategy and Technology. Her fields of research include geospatial technology, data privacy, cybersecurity, and strategic ...
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