Bioprocess Market Watch. March 2026 edition for European suppliers

What the open data say for February 2026

In February 2026, 55 industry biologics trials started worldwide, and 13 had at least one site in Europe. The United States also had 13, Asia 26 and Latin America 4. The EMA authorised 7 medicines, 2 of them biosimilars, while the FDA approved 4 and issued 6 CGMP warning letters.

According to Eurostat, the 27 EU member states imported 158,349 thousand euros under subheading 8419.89 that month, with Germany accounting for 38,846 thousand. Trials and approvals are small counts of official records, not equipment demand, and a single month does not make a trend.

How many medicines did the EMA and the FDA approve?

In February 2026 the EMA authorised 7 human medicines through the centralised procedure, 2 of them biosimilars. The FDA approved 4, all novel drugs from CDER, and CBER granted no new biologics license. The chart compares both agencies over the last six months.

The EMA authorises in batches. It authorised 1 medicine in October 2025 and 1 in December 2025, but 14 in November. So one weak month does not make a trend. For a supplier, each authorisation is a product that can now be sold in the EU and that someone will have to make. The EMA table flags biosimilars but does not single out other biologics.

Where did February's biologics trials start?

In February 2026, Europe and the United States had 13 trials each, Asia 26 and Latin America 4. These are interventional studies sponsored by companies, with at least one biological intervention, counted by start month on ClinicalTrials.gov. Each one needs clinical batches made under GMP.

By European country, France and Spain had 6 each, Italy 5 and the United Kingdom 3. Germany, Belgium and Poland had 2 each, the Netherlands 1 and Switzerland none. A study with sites in several countries counts in each one, which is why the countries add up to more than the European total.

This count does not tell you where manufacturing will happen. A trial's country is where the sites and patients are, and the clinical batch may be made elsewhere. For a supplier, the figure shows where there is clinical activity with biologics and where it makes sense to look for contacts, but not how much equipment will be bought.

Which member states imported most under subheading 8419.89?

February 2026 is the latest month with data for all 27 member states in Eurostat within this edition's period. That month the 27 imported 158,349 thousand euros under subheading 8419.89. Germany imported 38,846 thousand, followed by the Netherlands with 16,114, Sweden with 14,998 and France with 13,540. Spain imported 8,269 thousand.

Subheading 8419.89 covers other machinery, plant and laboratory equipment for treating materials through a change of temperature. It includes bioreactors and fermenters, but also plenty of equipment that is neither. It also counts goods arriving from other EU states. Over the last twelve months, the lowest month was August 2025, with 152,702,945 euros, and the highest was December 2025, with 207,864,244 euros.

What can open data tell us about Asia and Latin America?

In Asia, 26 biologics trials started in February 2026. Of these, 21 had a site in China, 4 in Japan, 4 in South Korea and none in India. China had more trials than each of the other three countries in every month of the series. Japan and South Korea see few trials a month, so a change from one month to the next says little.

In Latin America, 4 trials started in February 2026, 2 of them with sites in Brazil. That month the Brazilian agency ANVISA registered no biologics, after 1 in January. Over the last twelve months, the peak was 10 registrations, in March 2025. The ANVISA open file has no registration date, so the count uses the date the process was completed.

In Japan we count PMDA approvals by fiscal year, from April to March. Between FY2020 and FY2024 there were between 123 and 146 a year. FY2025 has 119 from April 2025 to February 2026, a partial figure. These entries include new indications and doses, not only new active ingredients, so they are context rather than a monthly gauge.

What does this month mean for a European supplier?

For the April to June 2026 quarter, February offers two leads in Europe. Of the European countries broken out here, France, Spain and Italy had the most trial starts. Germany, the Netherlands and Sweden imported the most under subheading 8419.89. France had both 6 trials and 13,540 thousand euros of imports. Before moving budget, check the twelve-month series in the CSV, because one month is not a trend.

If you sell to teams making clinical batches, talk about scale-up from lab to pilot plant, single-use and GMP documentation such as URS, FAT, SAT, IQ, OQ and PQ. Do it in English for the whole of Europe and add French, German, Italian or Spanish where you really want to win business. If you are looking at Asia, where China had 21 trials in February, prepare English material built for distributors.

Get your website ready with language versions and hreflang, downloadable datasheets and a kit for distributors in each country. If you are weighing up a trade show, work out the cost per contact first. At crida studio we do marketing for bioprocess equipment makers and life science companies, and the studio's founder led marketing at a European manufacturer for four and a half years.

What went up and what went down since the last edition?

Compared with the February edition, which covered January 2026, trials in Europe went from 6 to 13 and in Spain from 5 to 6. FDA approvals rose from 1 to 4, all from CDER. CGMP warning letters went from 5 to 6. EMA biosimilars stayed at 2 and CBER licenses at 0.

In the United States, trials fell from 18 to 13, and in Latin America from 6 to 4. Worldwide they went from 57 to 55 and in Asia from 27 to 26. EMA authorisations went from 11 to 7 and ANVISA registrations from 1 to 0. Imports under subheading 8419.89 fell from 159,894 to 158,349 thousand euros, down 1.0%.

The chart shows biologics trials started worldwide each month from March 2025 to February 2026. The low was 42 in November 2025 and the high 65 in June 2025. February had 55. With numbers this small, no one-month move is a trend.

How was this edition made and what does it not tell you?

Edition prepared in November 2026 with the data for its period. The data run to 28 February 2026 and were downloaded on 1 November 2026. Apart from the Eurostat imports, which are in euros, everything is a count of official records, not equipment demand or market size. A trial with sites in several countries counts in each one. Some records are filled in late, so the latest months may still rise slightly.