# Bioprocess Market Watch. January 2026 edition for European suppliers

According to ClinicalTrials.gov, 17 industry-sponsored biologics trials with sites in Europe got under way in December 2025, 9 more than in November. This first edition of the Market Watch reads open data from the EMA, the FDA, Eurostat and other registries up to 31 December 2025. It is written for marketing and sales leads at European makers of bioprocess equipment, consumables and services.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-01/)

By David Monje, crida studio · Published 2026-11-02 · Updated 2026-11-02

## 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.

Indicators for December 2025 compared with November 2025. All figures are counts of official records.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 17 | 8 | +9 |
| Biologics trials started worldwide | 62 | 42 | +20 |
| Biologics trials started in the United States | 31 | 13 | +18 |
| Biologics trials started in Asia | 32 | 18 | +14 |
| Medicines authorised by the EMA | 1 | 14 | -13 |
| FDA approvals, CDER and CBER | 10 | 14 | -4 |
| FDA CGMP warning letters | 13 | 8 | +5 |

## 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.

![Grouped bar chart by month. From July to December 2025 the EMA authorised 11, 13, 11, 1, 14 and 1 medicines, and the FDA approved 6, 6, 6, 2, 14 and 10.](https://www.crida.studio/recursos/assets/ema-authorisations-and-fda-approvals-by-month-to-december-2025.0b00a7242a38.svg)

EMA authorisations and FDA approvals by month to December 2025

| Month | EMA | FDA |
| --- | --- | --- |
| Jul 2025 | 11 | 6 |
| Aug 2025 | 13 | 6 |
| Sep 2025 | 11 | 6 |
| Oct 2025 | 1 | 2 |
| Nov 2025 | 14 | 14 |
| Dec 2025 | 1 | 10 |

Human medicines authorised by the EMA and FDA approvals, CDER novel drugs and CBER licenses, by month from July to December 2025.

Source: [EMA medicines table and FDA, CDER and CBER approvals](https://www.ema.europa.eu/en/medicines/download-medicine-data)

## 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.

![Bar chart of industry biologics trials started in December 2025 by territory. Europe 17, United States 31, Asia 32 and Latin America 9.](https://www.crida.studio/recursos/assets/industry-biologics-trials-started-in-december-2025-by-territory.7abc82361671.svg)

Industry biologics trials started in December 2025 by territory

| Territory | Trials started |
| --- | --- |
| Europe | 17 |
| United States | 31 |
| Asia | 32 |
| Latin America | 9 |

Industry-sponsored interventional trials with at least one biological intervention that started in December 2025. A trial with sites in several territories counts in each.

Source: [ClinicalTrials.gov, API v2](https://clinicaltrials.gov/api/v2/studies)


### How many biologics trials started in Spain in December 2025?

13, according to ClinicalTrials.gov. These are industry-sponsored interventional trials with at least one biological intervention and at least one site in Spain. November had 3. A trial with sites in several countries counts in each one, and a single month is not a trend. The latest month may also still rise.

## 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.

![Bar chart of imports under subheading 8419.89 in December 2025, in thousand euros. Germany 41,479, Netherlands 24,585, France 22,691, Belgium 22,453 and Spain 10,420.](https://www.crida.studio/recursos/assets/imports-of-subheading-8419-89-by-member-state-in-december-2025.54ec171d657f.svg)

Imports of subheading 8419.89 by member state in December 2025

| Member state | Thousand euros |
| --- | --- |
| Germany | 41,479 |
| Netherlands | 24,585 |
| France | 22,691 |
| Belgium | 22,453 |
| Austria | 12,451 |
| Spain | 10,420 |
| Sweden | 9,607 |
| Poland | 9,413 |

The eight member states with the highest imports under subheading 8419.89 in December 2025, the latest month of the edition's period with data for all 27 states, in thousand euros.

Source: [Eurostat, Comext DS-045409](https://ec.europa.eu/eurostat/web/international-trade-in-goods/database)

## 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.


### Are these counts a measure of equipment demand?

No. They are counts of official records, such as trials, authorisations or FDA letters, and they do not say how much equipment will be bought or for what value. They show where the activity is and which sponsors to follow. The Eurostat imports are in euros, but subheading 8419.89 includes plenty of apparatus that is not a bioreactor.

## 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.

![Line chart of industry biologics trials started worldwide in each month of 2025. The low is 37 in January, the high 65 in June, and December has 62.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-by-month-to-december-2025.38386ae3dee2.svg)

Biologics trials started worldwide by month to December 2025

| Month | Trials |
| --- | --- |
| Jan 2025 | 37 |
| Feb 2025 | 38 |
| Mar 2025 | 63 |
| Apr 2025 | 44 |
| May 2025 | 61 |
| Jun 2025 | 65 |
| Jul 2025 | 57 |
| Aug 2025 | 46 |
| Sep 2025 | 47 |
| Oct 2025 | 47 |
| Nov 2025 | 42 |
| Dec 2025 | 62 |

Industry-sponsored interventional trials with at least one biological intervention, by start month, from January to December 2025.

Source: [ClinicalTrials.gov, API v2](https://clinicaltrials.gov/api/v2/studies)


### How was each figure calculated?

From public data published by the EMA, the FDA, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA, downloaded on 1 November 2026. Every figure comes straight from its source, with no estimates. The method section gives the exact query and the limits of each source, and the data can be downloaded as CSV and JSON to repeat the calculations.

## 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.


- [EMA, medicines table](https://www.ema.europa.eu/en/medicines/download-medicine-data). File medicines-output-medicines_json-report_en.json of the medicines table on the Download medicine data page, with the keys category, marketing_authorisation_date and biosimilar. Rows with category equal to Human and marketing_authorisation_date within the month. Biosimilars are the subset with biosimilar equal to Yes. Downloaded on 2026-11-01. Centralised procedure medicines only. Counted by marketing authorisation date, including medicines later withdrawn. Includes generics and biosimilars. The table flags biosimilars but does not single out other biologics. The EMA updates the file twice a day and figures may shift slightly.
- [FDA, CDER novel drug approvals](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025). Table on the Novel Drug Approvals page for 2025, one row per approval, counted by the month in the Approval Date column. Downloaded on 2026-11-01. New molecular entities and new therapeutic biological products approved by CDER only. Excludes generics, biosimilars and new indications for products already approved.
- [FDA, CBER biologics license approvals](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2025-biological-license-application-approvals). Table on the Biological License Application Approvals page for 2025, one row per license, counted by the month in the Approval Date column. Downloaded on 2026-11-01. New CBER licenses, such as vaccines, blood products and gene therapies, plus some diagnostic reagents and tests licensed as BLAs. Excludes supplements to licenses already approved. Approvals from the last few weeks may not be on the page yet.
- [FDA, warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters). Full table on the Warning Letters page, 3,779 letters on the download date, read through the table's own data endpoint with the same columns as the XLSX export. Rows with Issuing Office CDER or CBER and CGMP in Subject, counted by the month of Letter Issue Date. Downloaded on 2026-11-01. The FDA posts each letter days or weeks after issuing it, so recent months may still rise. Only CDER and CBER letters count, not those from other FDA centers and offices such as foods, medical devices, veterinary medicine or inspections. The subject is set by the FDA and mixes finished drugs, active ingredients and biologics. The page's XLSX export returns at most 1,000 rows, so it was not used.
- [ClinicalTrials.gov, API v2](https://clinicaltrials.gov/api/v2/studies). ClinicalTrials.gov API v2, /api/v2/studies with countTotal=true, pageSize=1 and fields=NCTId, reading totalCount. For each month, filter.advanced equal to AREA[StartDate]RANGE[2025-12-01,2025-12-31] AND AREA[StudyType]INTERVENTIONAL AND AREA[LeadSponsorClass]INDUSTRY AND AREA[InterventionType]BIOLOGICAL AND AREA[LocationCountry]COVERAGE[FullMatch]"Spain", where the last term is replaced by the territory's country or an OR of its countries, and dropped for the world. Europe is the 27 EU member states plus the United Kingdom, Switzerland, Norway and Iceland. Asia is Japan, China, India and South Korea. Latin America is Brazil, Mexico, Argentina, Colombia and Chile. Downloaded on 2026-11-01. A count of study records, not of equipment demand. Each study falls in the month of its start date, which in some records is still an estimate. A study with sites in several countries counts in each country, so the countries add up to more than the territory total. Many studies are registered weeks after they start, so recent months may rise. The intervention type is chosen by whoever registers the study and many antibodies are registered as DRUG, so the count falls short. Database updated on 30 October 2026.
- [Eurostat, Comext DS-045409](https://ec.europa.eu/eurostat/web/international-trade-in-goods/database). Comext dissemination API, ec.europa.eu/eurostat/api/comext/dissemination/statistics/1.0/data/DS-045409 with freq=M, reporter set to each of the 27 member states, partner=WORLD, product=841989, flow=1 (imports), indicators=VALUE_IN_EUROS and sinceTimePeriod=2023-01. The EU27 total is the sum of the 27 states and is only computed for months with data for all 27. Downloaded on 2026-11-01. Subheading 8419.89 covers other machinery, plant and laboratory equipment for treating materials through a change of temperature, and includes much equipment that is neither a bioreactor nor a fermenter. These are each state's imports from any country, including other EU states, in current euros. The latest month with data for all 27 states within the edition period is December 2025, and Eurostat may revise the figures. Data updated on 16 October 2026.
- [ANVISA, open medicines data](https://dados.anvisa.gov.br/dados/). File DADOS_ABERTOS_MEDICAMENTOS.csv in the ANVISA open data directory, Latin-1 encoded and semicolon separated. Rows with CATEGORIA_REGULATORIA equal to Biológico, counted once per NUMERO_REGISTRO_PRODUTO, by the month of DATA_FINALIZACAO_PROCESSO. Downloaded on 2026-11-01. The file has no registration date column, so the process completion date is used. The file repeats rows for the same registration and each registration number is counted once. It includes registrations now inactive and drops dates with impossible years. File updated on 13 October 2026, and the months since then are not given because they are not complete yet.
- [PMDA, list of approved drugs](https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html). PDF «April 2004 to February 2026 [3.06 MB]» linked from the List of Approved Products page, converted to text with pdftotext. One entry per number in each New Drugs Approved section, assigned to a fiscal year by approval date. Downloaded on 2026-11-01. Counts new approvals and partial changes, such as new indications or doses, not only new active ingredients. One entry may group several presentations. The PDF runs to February 2026 and the current fiscal year is partial. It is context and is not compared month by month.

## Open data

- [observatori-bioproces-2026-01.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-01.csv)
- [observatori-bioproces-2026-01.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-01.json)

## References

- [EMA, medicines table (Download medicine data)](https://www.ema.europa.eu/en/medicines/download-medicine-data)
- [FDA, CDER novel drug approvals for 2025](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025)
- [FDA, CBER biological license application approvals for 2025](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2025-biological-license-application-approvals)
- [FDA, warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)
- [ClinicalTrials.gov, API v2](https://clinicaltrials.gov/api/v2/studies)
- [Eurostat, international trade in goods database](https://ec.europa.eu/eurostat/web/international-trade-in-goods/database)
- [ANVISA, open medicines data](https://dados.anvisa.gov.br/dados/)
- [PMDA, list of approved products](https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html)

## The crida perspective

We are a marketing, brand and technology studio based in Girona. We bring identity, content and development together so a digital experience makes sense from beginning to end.

crida studio, Caldes de Malavella (Girona, Spain). David Monje, founder and director.

## Is your market or segment missing from this edition?

Tell us which one and we will consider adding it to the next edition or preparing it just for you. We reply within two working days, with no obligation.

[Get in touch](https://www.crida.studio/en/#contact)

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