Bioprocess Market Watch. January 2026 edition for European suppliers

What the December 2025 data say

In December 2025, 17 industry biologics trials started in Europe, 9 more than in November, and 62 worldwide. Spain had 13, more than any other European country we track. The EMA authorised 1 medicine and the FDA approved 10.

FDA CGMP warning letters came to 13, and imports of subheading 8419.89 stayed almost level with November. The table compares each indicator with the previous month, and its figures are counts of official records, not equipment demand.

EMA authorisations and FDA approvals, July to December

In December 2025 the EMA authorised 1 human medicine and the FDA approved 10, made up of 7 novel drugs from CDER and 3 biologics licenses from CBER. In November each agency had approved 14. From July to December, the EMA ranged between 1 and 14 authorisations a month and the FDA between 2 and 14.

The EMA authorises in batches, so a month with 1 authorisation does not mean the sector has stalled. In November, 9 of the 14 medicines authorised were biosimilars, and in December none. The EMA table flags biosimilars but does not single out other biologics. CBER approves vaccines, blood products, gene therapies and some diagnostic reagents.

Each authorisation is a product that can now be sold and will need manufacturing with qualified consumables, equipment and services. This edition only counts authorisations, and the individual products are listed in the EMA and FDA sources.

Where biologics trials started in December

In December 2025, 17 industry biologics trials started with sites in Europe, 31 in the United States, 32 in Asia and 9 in Latin America. Worldwide the figure was 62. The territories add up to more than the total because a trial with sites in several countries counts in each one.

Within Europe, Spain had 13, Italy 9 and Germany 8. France, the United Kingdom and Poland had 7 each, Belgium 6, the Netherlands 3 and Switzerland none. These are small numbers, and in November Spain had only 3. One month does not make a trend, and December may still rise because many studies are registered late.

A new trial means clinical batches that someone has to make, often a CDMO or a pilot plant. The site country tells you where patients are treated, not where the medicine is made. It shows where the activity is and which sponsors to follow.

Imports under subheading 8419.89, which includes reactors and fermenters

In December 2025, the latest month of the edition's period with data for all 27 states, EU member states imported goods under subheading 8419.89 worth 207,864 thousand euros, according to Eurostat. November stood at 207,414 thousand, 450 less, a change of 0.2%. Germany imported 41,479 thousand, the Netherlands 24,585, France 22,691 and Belgium 22,453.

Spain ranked sixth with 10,420 thousand euros, behind Austria with 12,451. Read this with care. The subheading includes other heat treatment apparatus that are neither reactors nor fermenters, and it counts purchases from any country, including within the EU.

The data files include the monthly 2025 series for the 27 states combined. The lowest month was August, at 152,702,945 euros, and the highest was December, at 207,864,244 euros. With such a broad subheading, there is no way to tell how much of it is bioreactors.

What open data can tell you about Asia and Latin America

In Asia, which here means Japan, China, India and South Korea, 32 industry biologics trials started in December 2025. China had 24, Japan 9, South Korea 7 and India 2. Latin America had 9, with 4 in Brazil, 4 in Chile, 3 in Argentina, 1 in Mexico and none in Colombia.

In Brazil, ANVISA completed 4 biologics registrations in December and none in November, by the date the process closed. In Japan, the PMDA gives 135 entries for fiscal year 2024, from April 2024 to March 2025. Fiscal year 2025 has 104 up to December and is still partial. These entries also include new indications and doses.

Many countries run their own trial registries, and not everything appears on ClinicalTrials.gov. ANVISA and the PMDA count different things from the EMA and the FDA and cannot be compared with each other. They show whether a country is moving.

What this means for a European bioprocess supplier

For the coming quarter, these data show where clinical and regulatory work is happening. Germany, Spain, France, Italy, Poland and the United Kingdom had industry biologics trials starting in every month of 2025. That makes a good list for checking whether your CRM covers the sponsors and CDMOs in those countries.

The message depends on who is buying. In November, 9 of the 14 medicines the EMA authorised were biosimilars, a field where cost per batch and capacity weigh heavily. Among the licenses CBER approves are gene therapies, made in small batches with tight traceability. English works across the sector, but buyers in Germany, Spain, Italy or France appreciate their own language.

Before the quarter starts, it pays to prepare a page for each type of customer, datasheets to download in English and in each country's language, a kit for distributors and a trade show calendar with the cost per contact. 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 changed since November and how to read the series

As this is the first edition, the comparison is with the previous month, November 2025. Trial starts rose in every territory, up 9 in Europe, 18 in the United States, 14 in Asia and 7 in Latin America. Approvals fell, down 13 at the EMA and 4 at the FDA, and CGMP warning letters went from 8 to 13.

The chart shows trials started worldwide in each month of 2025, between 37 in January and 65 in June, with 62 in December. Each point is a count of records, and the latest months can rise with late registrations. A real change shows up when it repeats over several months.

Method, sources and limits of this edition

Edition prepared in November 2026 with the data for its period. The data run to 31 December 2025 and were downloaded on 1 November 2026 from eight public sources. They are counts of official records, not equipment demand, and no figure is a market size. The latest month may still rise because some records arrive late. The list below sets out what each source counts, what it leaves out and the exact query.