Bioprocess Market Watch. February 2026 edition for European suppliers

January 2026 in numbers

Europe saw 6 new industry biologics trials in January 2026, 11 fewer than in December. Worldwide, 57 trials started, and Asia, with 27, had more than any other territory. The EMA authorised 11 medicines and the FDA approved 1, the reverse of December.

FDA CGMP warning letters fell from 13 to 5, and imports under subheading 8419.89 into the 27 EU member states went from 207,864 to 159,894 thousand euros. These are counts of official records and Eurostat trade statistics, and with counts this small a single month does not make a trend.

The EMA authorised 11 medicines in January and the FDA approved 1

The EMA authorised 11 human medicines through the centralised procedure in January 2026, 2 of them biosimilars. The FDA approved 1, a novel drug from CDER, and CBER approved no new biologics license. December had been the other way round, with 1 EMA authorisation and 10 FDA approvals, 7 from CDER and 3 from CBER.

EMA authorisations come in batches. A month with just 1, such as October or December 2025, does not mean anything has slowed down. The EMA table flags biosimilars but does not separate other biologics from small-molecule medicines, and it includes generics. CBER licenses vaccines, blood products, gene therapies and some diagnostic reagents. Neither count says where each product is made.

How many biologics trials started in each territory

In January 2026, 57 industry trials with at least one biological intervention started. Of these, 27 had a site in Asia, 18 in the United States, 6 in Europe and 6 in Latin America. A trial with sites in several territories counts in each one, and some countries fall outside the four territories, so these figures should not be added together.

In Europe, 5 of the 6 trials had a site in Spain, and 4 each in Germany, Italy and the United Kingdom. France and Poland had 3 each, the Netherlands and Belgium 1 each, and Switzerland none. Several trials run in more than one country, which is why the countries add up to more than the total.

The registry shows where patients are treated, not where the product is made or on what equipment. For a supplier of pilot plant or single-use equipment, it points to where clinical work is happening, which you then need to check with customers and distributors. Many antibodies are also registered as drugs rather than biologics, so the count falls short.

Which EU member states imported most under subheading 8419.89

January 2026 is the latest month with data for all 27 member states within this edition's period. That month, the 27 together imported 159,894 thousand euros under subheading 8419.89. Germany imported the most, at 33,924 thousand euros, followed by the Netherlands at 25,844 and France at 14,348. Spain came sixth, at 8,601.

Read this with care. Subheading 8419.89 covers other equipment for treating materials through a change of temperature, and much of it is neither a bioreactor nor a fermenter. It also counts trade between EU states. In the twelve-month series for the 27 combined, December 2025 is the highest month and August the lowest. January is 23.1% below December, and Eurostat may still revise these figures.

What open data can tell you about Asia and Latin America

In Asia, 21 of the 27 trials started in January 2026 had a site in China, 5 in South Korea, 4 in Japan and 2 in India. China has been the Asian country with the most trials every month, between 13 and 25 over the twelve months of the series. This edition reads only ClinicalTrials.gov, not the national trial registries of each Asian country.

In Latin America, all 6 January trials had a site in Brazil, 3 in Argentina and 1 each in Mexico, Colombia and Chile. ANVISA registered 1 medicine in the biological category in January and 4 in December, going by the process completion date. Over the series, ANVISA ranges from 0 to 10 registrations a month.

In Japan, PMDA approvals are counted by fiscal year, April to March. Between FY2020 and FY2024 they ranged from 123 to 146 entries a year. FY2025 is still partial, with 104 entries from April 2025 to January 2026, so it cannot be compared with complete years. The list also counts new indications and doses, not only new active ingredients.

What it means for a European bioprocess supplier

For the coming quarter, one month is no reason to move budget, but it is a reason to check where you are looking. Germany had sites in 4 of the 6 European trials in January and was the top importer under subheading 8419.89, while Spain appeared in 5 of the 6. Before deciding, open your country's records on ClinicalTrials.gov and see which companies sponsor them.

In your messaging, English is the base, because several trials run in more than one country at once. For Germany, datasheets and pages in German are worth having, and for Brazil, in Portuguese. The message that fits these figures is the step from the lab to clinical manufacturing, backed by IQ, OQ and PQ qualification documents and local service.

It is worth preparing a website with downloadable datasheets in each language, a kit for distributors in Asia and Brazil, and a trade show plan built on numbers, for example with the trade show cost calculator. 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 has changed since the January edition

Compared with the previous edition, which ran to December 2025, almost every January count is down. Europe goes from 17 to 6 trials, the United States from 31 to 18, Asia from 32 to 27 and Latin America from 9 to 6. Spain falls from 13 to 5. Worldwide the drop is smaller, from 62 to 57, down 8.1%.

EMA authorisations rise from 1 to 11, and authorised biosimilars from 0 to 2. FDA approvals fall from 10 to 1, CGMP warning letters from 13 to 5, ANVISA biologics registrations from 4 to 1, and imports under subheading 8419.89 from 207,864 to 159,894 thousand euros.

The line shows the worldwide total each month, from a low of 38 trials in February 2025 to a high of 65 in June, with January 2026 at 57. December 2025 was the busiest month for Europe in the whole series, with 17 trials, which is why the January drop looks so steep.

How this edition was built and what its limits are

Edition prepared in November 2026 with the data for its period, February 2025 to 31 January 2026, downloaded on 1 November 2026 from eight open sources. These are counts of official records, not equipment demand or market figures. The latest month may still rise, because some records arrive late. The list below gives each exact query and its limits.