Il European pharmaceutical sector he holds his breath: the axe of the Trump's tariffs, with Saturday's edict bringing them overall to 30 %, he has, at least for now, spared Even though in recent days the tycoon's threats reached tariffs of 200%. For the European Union, this is a significant and constantly expanding sector, and the duties would represent a huge burden. This is especially true given that a new competitor is now emerging, bringing results beyond expectations: China.
For the EU, drug exports account for over 313 billion, over a third of which go to the USA.
Il pharmaceutical sector in the European Union In 2024, exports reached a record figure of 313,4 billion euros, with a growth of 13,5%, according to Eurostat data. The main destination, needless to say, is towards United States with 38,2%.
Specifically, the'Italy It recorded exports of 53,8 billion euros, "equal to over 90% of production, estimated at 56,1 billion euros," says Farmindustria, specifying that Italy is considered a European production hub, "among the main countries in terms of pharmaceutical production and the seventh largest pharmaceutical market in the world."
Last week Trump He shared his wishes for the sector on his social media platform Truth. “We will soon announce something on pharmaceutical products. We will give companies a year, a year and a half, to move here and after that we will apply duties "customs," the American president declared in a cabinet meeting, adding that the rate could reach around 200%.
Chinese drugs are changing the world landscape
While waiting to see if and how Trump wants to act on the sector, pharmaceutical companies in the Old Continent, but also in the United States, find themselves having to deal with a Partner become very respectable: the Chinese pharmaceutical companies have come a long way from the days when they simply imitated their predecessors. The remarkable turnaround of the China Biotech is changing the global pharmaceutical landscape, so much so that it is being compared to the revolution of artificial intelligence and electric vehicles, eclipsing the EU e reaching the United States, according to a report Bloomberg.
Il number of important new drugs, especially those to fight cancer e obesity, that have entered the development phase is increased dramatically topping 1.250 last year, far surpassing the European Union and nearly matching the number of approximately 1.440 in the United States. Drugs from a country once known for low-cost, quality-challenged imitations are now increasingly meeting the high required standards to gain recognition from both drug regulators and Western pharmaceutical giants.
The results, obtained from the analysis of a database managed by Norstella, a provider of pharmaceutical intelligence solutions, show a radical shift in the center of gravity of medical innovation, just at the time when Trump is considering tariffs on the sector.
This change occurred at a unprecedented paceWhen China began reviewing its drug regulatory system in 2015, the country had only 160 compounds to enter the global pipeline of innovative drugs, less than 6% of the total, behind Japan and the United Kingdom. reforms have helped simplify reviews, strengthen data quality standards and improve transparencyThe plan initiated by the Chinese government, the "Made in China 2025" to boost production in 10 sectors priority, has helped to stimulate a series of investments also in biotechnology, triggering a boom driven by scientists e entrepreneurs trained abroad.
"Not only is it now almost on par with the United States, but it's also on that growth trajectory," said Daniel Chancellor, vice president of intellectual leadership at Norstella. "It wouldn't be sensationalistic to say that China will surpass the United States in the coming years simply in terms of the number of drugs entering its manufacturing pipeline."
The world's most stringent regulatory agencies, including the U.S. Food and Drug Administration and the European Medicines Agency, are increasingly viewing Chinese drugs as promising enough to warrant spending additional resources to expedite their review, granting them coveted industry recognitions such as priority review, breakthrough therapy designation, or expedited status.
The connections between Big Pharma and Chinese industries
One of the first examples of Chinese innovation is a cell therapy that has shown promise for the potential treatment of an aggressive blood cancer. Initially developed in China by Legend Biotech Corp, it is now commercialized by Johnson & Johnson – after having obtained several designations along the way – and is considered superior to a competing therapy of origin USHowever, the absolute number of Chinese-origin drugs receiving these designations is significantly lower than that of their US counterparts.
A new cancer drug from Akeso Inc. found to be more effective than Keytruda Merck & Co Inc., has been compared to the phenomenon DeepSeek in the field of Artificial Intelligence: lower costs, greater speed of implementation, at least equal if not higher quality.
Even other multinationals such as Merck, AstraZeneca Plc and Roche Holding AG They acquired Chinese assets. In May, Pfizer Inc. set a new record by announcing an early $1,2 billion deal with 3SBio Inc. for a cancer drug similar to Akeso's. According to the biopharmaceutical deal database DealForma, These agreements are increasing both in value and frequency, demonstrating confidence in the international competitiveness of Chinese-origin drugs and their ability to generate substantial revenues.
Chinese clinical trials are one step ahead
One of the main advantages that fueled therise of Chinese biotech companies and their ability to conduct research so cheaper and faster at every stage of the process, from laboratory experiments and animal testing to human trials.
As we know, creating a new drug from scratch requires a huge commitment, both in terms of time and money. But the enormous patient catchment area and hospital network China's centralized research has become a significant accelerator. An analysis of the time required for various phases of drug trials shows that doctors in China can recruit patients for trials much more quickly: for early-stage trials of cancer and obesity drugs, they can complete patient enrollment in half the time compared to the United States.
La cost difference This means that Chinese companies can afford to conduct multiple trials simultaneously to find a winning solution, or quickly launch new projects once a scientific idea has been validated by other groups. Of course, clinical data in China are only the beginning. U.S. regulators have made it clear that the results of clinical trials conducted exclusively in China, no matter how positive, are not sufficient to support drug approval. Chinese biotech companies aiming to sell their drugs abroad must demonstrate that the treatment's benefits can be replicated in non-Chinese patients through complex and slower global trials.
The United States is preparing to thwart China
It may still take several years before a critical mass of Chinese drugs gains approval in the United States and the European Union (the gold standard for high-quality treatments) and becomes widely used in the Western world, but many in the industry believe this is inevitable. Of the 50 companies that generated the highest number of innovative drug candidates between 2020 and 2024, 20 were Chinese, compared to five in the previous five years.
A congressional committee has already sounded the alarm: the United States risks losing its leadership position in another crucial area for national security. The perception of a threat has pushed the U.S. government to ask for get in the way the biotechnological growth of China (through restrictions such as export controls on scientific equipment and barriers to investment) and at the same time stimulate the national biotechnology sector, including by modifying the regulatory environment to emulate countries where clinical trials are conducted more rapidly. Robert F. Kennedy, U.S. Secretary of Health and Human Services, recently pledged to “Accelerating American Biotechnology.”
