# Bioprocess Market Watch. February 2026 edition for European suppliers

In January 2026, 6 industry biologics trials with at least one site in Europe got under way, down from 17 in December. This edition reads open official data from February 2025 through 31 January 2026. It is written for European makers and suppliers of bioprocess equipment, consumables and services who want to see where the activity is.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-02/)

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

## 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.

Indicators for January 2026 compared with December 2025, based on counts of official records from ClinicalTrials.gov, the EMA and the FDA.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 6 | 17 | -11 |
| Biologics trials started worldwide | 57 | 62 | -5 |
| Biologics trials started in the United States | 18 | 31 | -13 |
| Biologics trials started in Asia | 27 | 32 | -5 |
| Medicines authorised by the EMA | 11 | 1 | +10 |
| FDA approvals, CDER and CBER | 1 | 10 | -9 |
| FDA CGMP warning letters | 5 | 13 | -8 |

## 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.

![Grouped bar chart of EMA authorisations and FDA approvals by month, from 13 and 6 in August 2025 to 11 and 1 in January 2026, with 14 each in November.](https://www.crida.studio/recursos/assets/medicines-authorised-by-the-ema-and-approved-by-the-fda-to-january-202.82074def2d00.svg)

Medicines authorised by the EMA and approved by the FDA to January 2026

| Month | EMA | FDA |
| --- | --- | --- |
| Aug 2025 | 13 | 6 |
| Sep 2025 | 11 | 6 |
| Oct 2025 | 1 | 2 |
| Nov 2025 | 14 | 14 |
| Dec 2025 | 1 | 10 |
| Jan 2026 | 11 | 1 |

Human medicines authorised by the EMA and FDA approvals, CDER novel drugs plus CBER biologics licenses, by month from August 2025 to January 2026.

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

## 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.

![Bar chart of industry biologics trials started in January 2026, 27 in Asia, 18 in the United States, 6 in Europe and 6 in Latin America.](https://www.crida.studio/recursos/assets/new-biologics-trials-by-territory-in-january-2026.f33a755fb246.svg)

New biologics trials by territory in January 2026

| Territory | Trials started |
| --- | --- |
| Europe | 6 |
| United States | 18 |
| Asia | 27 |
| Latin America | 6 |

Industry-sponsored interventional trials with at least one biological intervention starting in January 2026, by territory. A trial with sites in several territories counts in each one.

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


### How many biologics trials started in Spain in January 2026?

According to ClinicalTrials.gov, 5 industry trials with at least one biological intervention started in January 2026 with a site in Spain, against 13 in December 2025. A trial with sites in several countries counts in each country. The figure may still rise as late registrations come in.

## 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.

![Bar chart of imports under subheading 8419.89 in January 2026, in thousand euros, from Germany at 33,924 and the Netherlands at 25,844 down to Poland at 7,160.](https://www.crida.studio/recursos/assets/imports-under-subheading-8419-89-in-the-top-eight-member-states-januar.c9e386440e5e.svg)

Imports under subheading 8419.89 in the top eight member states, January 2026

| Member state | Thousand euros |
| --- | --- |
| Germany | 33,924 |
| Netherlands | 25,844 |
| France | 14,348 |
| Sweden | 13,334 |
| Italy | 11,176 |
| Spain | 8,601 |
| Austria | 7,674 |
| Poland | 7,160 |

The eight member states with the highest imports under subheading 8419.89 in January 2026, the latest month with data for all 27, in thousand euros. Includes other heat treatment equipment.

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, 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.


### Are these counts equipment demand?

No. They are counts of official records, such as registered trials and authorised medicines, plus trade statistics for a customs subheading that also covers other equipment. They show where and when there is activity, but not how many units will be bought or for how much. To decide where to sell, combine them with what you know about your customers and distributors.

## 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.

![Line chart of industry biologics trials started worldwide each month, from 38 in February 2025 to 57 in January 2026, with a high of 65 in June 2025.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-each-month-to-january-2026.0aae91f395a4.svg)

Biologics trials started worldwide each month to January 2026

| Month | Trials |
| --- | --- |
| 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 |
| Jan 2026 | 57 |

Industry interventional trials with at least one biological intervention started worldwide each month, from February 2025 to January 2026. The latest month may still rise.

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


### How was this edition calculated?

With fixed queries to eight open sources from the EMA, the FDA, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA. The data was downloaded on 1 November 2026. The numbers are copied as they come, with no estimates. The method section gives each query and its limits, and the table can be downloaded as CSV and JSON.

## 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.


- [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-2026). Table on the Novel Drug Approvals page for 2025 and 2026, 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/2026-biological-license-application-approvals). Table on the Biological License Application Approvals page for 2025 and 2026, 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[2026-01-01,2026-01-31] 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=2024-01. 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 January 2026, 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-2026-02.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-02.csv)
- [observatori-bioproces-2026-02.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-02.json)

## References

- [EMA, medicines table (Download medicine data)](https://www.ema.europa.eu/en/medicines/download-medicine-data)
- [FDA, CDER novel drug approvals for 2026](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026)
- [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 2026](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2026-biological-license-application-approvals)
- [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 drugs](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.

## Want this reading applied to your markets?

This edition uses only public data. If you want the same reading for your product portfolio or target markets, write to us and we will prepare it with you in a thirty-minute session.

[Ask for the session](https://www.crida.studio/en/#contact)

## More on web design

- [Bioprocess Market Watch. January 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-01/)
- [Bioprocess Market Watch. March 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-03/)
- [Marketing for biotech, bioprocess and pharma companies](https://www.crida.studio/en/insights/services/biotech-bioprocess-pharma-marketing/)
- [What European bioprocess equipment makers’ websites look like in 2026](https://www.crida.studio/en/insights/guides/european-bioprocess-manufacturer-websites-2026/)
- [Trade show cost calculator for bioprocess equipment makers](https://www.crida.studio/en/insights/guides/trade-show-cost-calculator-bioprocess/)
- [Scandinavia, Germany or Asia, how to pick your next export market](https://www.crida.studio/en/insights/guides/choose-export-market-equipment/)
- [How to run a market analysis before launching new lab equipment](https://www.crida.studio/en/insights/guides/market-analysis-new-lab-equipment/)