THE Kennedy Moonshot speech on Sept. 22, 1962 is considered a symbolic date for American science supremacy. In that speech, Kennedy recommitted the nation to the Moon landing goal he proposed to Congress in May 1961, rallying the people to land astronauts on the Moon and back safely before the end of the decade. The Apollo landing in 1969 squarely put American science at the pinnacle of the world.
The executive order announced steps to bolster the “bioeconomy” in the United States. This classification covers research and development across a broad swath of products, including medical supplies, sustainable new fuels and food, and technologies meant to fight climate change.
The order committed the US government to help create domestic manufacturing facilities for biotechnology products and the supply chains of raw materials needed to run them. In addition, measures such as pushing more funding into research and development, providing innovators support in the form of federal data that helps identify unmet needs, streamlining regulatory approval of new products, and cooperative programs with international partners are included. Finally, the US government will mandate federal agencies increase mandatory purchasing requirements for domestic biotechnology products.
In a briefing on the executive order, the US government clarified that the administration is bringing more US-based biotechnology manufacturing home in response to other countries, particularly China, which is speeding up investment in the sector.
Bioscience is put on the same sanction level as others:
Under the Director of National Intelligence government, the US National Counterintelligence and Security Center (NCSC) has identified five technologies that the country must be a leader if it wants to remain a superpower in October 2021. They are artificial intelligence, quantum computing, bioscience, semiconductors and autonomous systems. China is identified as the peer competitor of the Americans in these five spaces. The CHIPS Act and the sanctions imposed on Chinese companies reflected the American desire to slow down or stop the Chinese progress in these cutting-edge technology domains in the 4th Industrial Revolution.
Out of the five areas, many pundits hoped that the US government would not subject bioscience to the same decoupling measures as the other four. They posited that bioscience touches people’s health and is not likely associated with military activities like the other four. However, the executive order issued by Biden dashed the hope that bioscience might not be a decoupling target.
Slow down Chinese Contract Research Organization(CRO) and Contract Development and Manufacturing Organizations (CDMOs):
The Contract Research Organization (CRO) is a subdivision of the pharmaceutical industry. It supports the pharmaceutical, biotechnology and medical device industries through research services outsourced on a contract basis. For example, a CRO may provide biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research and real-world surveillance.
The CRO started its current business model in the late 1970s and early 1980s when the pharmaceutical industry began to experience a continuing cost escalation. As a result, the 1990s saw explosive growth in the market for CRO services. They had successfully reduced costs and more speedily navigated the myriad testing and regulatory requirements in the drug development process.
The CRO industry has an estimated business volume of $70 billion in 2022, and the R&D spending of the top 15 pharmaceutical companies R&D budget in 2022 is estimated at $130 billion. The comparison demonstrated the importance of CRO to the pharmaceutical industry today,
The CRO industry started in China around the mid-2020s by multinational drug companies and returning overseas scientists. The country enjoyed a great competitive edge over the developed countries in pharmaceutical R&D in terms of a huge pool of high-quality local health science talents, a favorable regulatory environment, and the huge patient base, particularly in cancer.
In a 2021 Center for Security and Emerging Technology of Georgetown University report, it is estimated that China produced 1,520 health science PhDs in 2000 as against the US number of 894 in the same year. The comparative number was 9,668 vs 3,150 in 2019. As a result, the Chinese share of CRO increased from 1.3 percent of the global market to 4.4 percent in 2020 and will likely increase to 7.5 percent by 2025.
There are more than 1,100 CRO companies around the world, but the trend of consolidation is accelerating as technological sophistication increases. In recent years, the large CRO has expanded vertically into manufacturing and become CDMO. As a result, the largest 10 companies, led by IQVIA, Covance and LabCorp, hold a combined 50 percent market share. The Chinese company, Wuxi Biologics, with sales of $800 million in 2021, was the only Chinese company in the top 10 CRO list and ranked number 10.
Wuxi Biologics is a quick mover into the CDMO model. It had purchased Bayer’s manufacturing plant in Germany, Pfizer’s manufacturing plant in China and building manufacturing facilities in Massachusetts and Ireland. The company is acknowledged as an industry peer in pharmaceutical scale manufacturing, and Edward You, an officer at the NCSC, voiced public concern about the potential dependence of the US drug industry on Chinese manufacturers last year.
Humanity or national industrial policy first:
With Biden’s executive order, America essentially shows that no area is off limits in its pursuit to maintain its hegemony and is even willing to politicize the bioscience industry by placing it under its national industrial policy. This will force other countries to react. How effective the move will be is uncertain, but it already raises an issue of humanity vs national industrial policy. One hopes that the implementation rules of ARPA-H will still leave room for cooperation between the US and China to work together on critical drugs that can save human lives.
Editor’s note: For developing nations like the Philippines, we had better prepare and equip ourselves to navigate the impending storms when superpowers collide in unprecedented dimensions, as the US removes traditional norms of competition.
Dr. Henry Chan is an internationally recognized development economist based in Singapore. He is also a senior visiting research fellow at the Cambodia Institute for Cooperation and Peace and adjunct research fellow at the Integrated Development Studies Institute (IDSI). His primary research interest includes global economic development, Asean-China relations and the Fourth Industrial Revolution.
A similar version was published in Manila Times on September 18 2022. We welcome logical feedback and possibly working together with compatible frameworks. (idsicenter@gmail.com)
