# Bioprocess Market Watch. March 2026 edition for European suppliers

In February 2026, 13 industry biologics trials started in Europe, according to ClinicalTrials.gov. This March edition covers open data from the EMA, the FDA, Eurostat, ANVISA and the PMDA up to 28 February 2026. It is written for European makers and suppliers of bioprocess equipment, consumables and services who need to decide where to put their sales effort.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-03/)

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

## 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.

Indicators for February 2026 compared with January 2026. Counts of official records from ClinicalTrials.gov, the EMA and the FDA.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 13 | 6 | +7 |
| Biologics trials started worldwide | 55 | 57 | -2 |
| Biologics trials started in the United States | 13 | 18 | -5 |
| Biologics trials started in Asia | 26 | 27 | -1 |
| Medicines authorised by the EMA | 7 | 11 | -4 |
| FDA approvals, CDER and CBER | 4 | 1 | +3 |
| FDA CGMP warning letters | 6 | 5 | +1 |

## 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.

![Grouped bar chart of EMA authorisations and FDA approvals by month, from 11 and 6 in September 2025 to 7 and 4 in February 2026, with 14 and 14 in November.](https://www.crida.studio/recursos/assets/medicines-authorised-by-the-ema-and-approved-by-the-fda-to-february-20.c59898c483fd.svg)

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

| Month | EMA | FDA |
| --- | --- | --- |
| Sep 2025 | 11 | 6 |
| Oct 2025 | 1 | 2 |
| Nov 2025 | 14 | 14 |
| Dec 2025 | 1 | 10 |
| Jan 2026 | 11 | 1 |
| Feb 2026 | 7 | 4 |

Medicines authorised each month by the EMA and FDA approvals, adding CDER and CBER, from September 2025 to February 2026.

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

## 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.

![Bar chart of biologics trials started in February 2026, 13 in Europe, 13 in the United States, 26 in Asia and 4 in Latin America.](https://www.crida.studio/recursos/assets/biologics-trials-started-by-territory-in-february-2026.6e5b6132bf53.svg)

Biologics trials started by territory in February 2026

| Territory | Trials started |
| --- | --- |
| Europe | 13 |
| United States | 13 |
| Asia | 26 |
| Latin America | 4 |

Industry-sponsored interventional trials with at least one biological intervention, by territory, starting in February 2026. A study 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 February 2026?

There were 6, according to ClinicalTrials.gov, one more than in January 2026. These are industry-sponsored trials with at least one biological intervention and at least one site in Spain. A study that also has sites in other countries counts in each of them. Because many studies are registered late, the figure may still rise slightly.

## 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.

![Bar chart of imports under subheading 8419.89 in February 2026, in thousand euros, from 38,846 in Germany to 5,659 in Finland, with Spain at 8,269.](https://www.crida.studio/recursos/assets/imports-under-subheading-8419-89-by-member-state-february-2026.369d33dedca2.svg)

Imports under subheading 8419.89 by member state, February 2026

| Member state | Thousand euros |
| --- | --- |
| Germany | 38,846 |
| Netherlands | 16,114 |
| Sweden | 14,998 |
| France | 13,540 |
| Italy | 8,528 |
| Spain | 8,269 |
| Austria | 7,586 |
| Finland | 5,659 |

The eight member states with the most imports in February 2026, in thousand euros. It is the latest month with data for all 27. The subheading includes other heat treatment apparatus.

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

## 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.


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

No. They are counts of official records, such as trials, approvals, warning letters and registrations, and they do not say how much equipment will be bought. The Eurostat imports are in euros, but subheading 8419.89 mixes bioreactors and fermenters with plenty of other apparatus. They show where there is activity and how it moves each month.

## 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.

![Line chart of biologics trials started worldwide each month, from 63 in March 2025 to 55 in February 2026, between a low of 42 and a high of 65.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-march-2025-to-february-2026.84c8c227c41f.svg)

Biologics trials started worldwide, March 2025 to February 2026

| Month | Trials |
| --- | --- |
| 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 |
| Feb 2026 | 55 |

Industry-sponsored interventional trials with at least one biological intervention, by start month, from March 2025 to February 2026. The latest month may still rise.

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


### How was this edition calculated?

From downloads made on 1 November 2026 from eight public sources, the EMA, CDER and CBER at the FDA, FDA warning letters, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA. Nothing is estimated. The method section gives the exact query for each source, and the downloadable CSV has the full values.

## 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.


- [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[2026-02-01,2026-02-28] 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 February 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-2026-03.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-03.csv)
- [observatori-bioproces-2026-03.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-03.json)

## References

- [EMA, medicines table](https://www.ema.europa.eu/en/medicines/download-medicine-data)
- [FDA, CDER novel drug approvals](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026)
- [FDA, CBER biologics license approvals](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2026-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, Comext DS-045409](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.

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

Tell us which one it is and we will look at adding it to the next edition or preparing it just for you, with the same public sources and method.

[Tell us about it](https://www.crida.studio/en/#contact)

## More on web design

- [Bioprocess Market Watch. February 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-02/)
- [Bioprocess Market Watch. April 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-04/)
- [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 plan a multilingual website to sell equipment across Europe](https://www.crida.studio/en/insights/guides/multilingual-website-sell-equipment-europe/)