# Bioprocess Market Watch. April 2026 edition for European suppliers

In March 2026, 8 industry-sponsored biologics trials started in Europe, 5 fewer than in February, while 45 started in Asia. This April edition looks at open data from the EMA, the FDA, ClinicalTrials.gov and Eurostat up to 31 March 2026. It is written for people who sell bioprocess equipment, consumables or services in Europe and need to decide where to put their sales effort.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-04/)

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

## What the open data say about March 2026

In March 2026, 74 industry biologics trials started worldwide, the highest figure in the last twelve months. Asia had 45, the United States 11 and Europe 8, down 5 on February. With numbers this small, a single month does not make a trend.

The EMA authorised 6 medicines, none of them biosimilars, and the FDA approved 7 across CDER and CBER. The FDA also issued 9 CGMP warning letters, 3 more than in February, and the table below sets these figures against February's.

Indicators for March 2026 against February 2026, with the change between the two months. All of them are counts of official records.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 8 | 13 | -5 |
| Biologics trials started worldwide | 74 | 55 | +19 |
| Biologics trials started in the United States | 11 | 13 | -2 |
| Biologics trials started in Asia | 45 | 26 | +19 |
| Medicines authorised by the EMA | 6 | 7 | -1 |
| FDA approvals, CDER and CBER | 7 | 4 | +3 |
| FDA CGMP warning letters | 9 | 6 | +3 |

## How many medicines the EMA and the FDA approved in March 2026

The EMA authorised 6 human medicines in March 2026 and the FDA approved 7, made up of 5 CDER novel drugs and 2 CBER biologics licenses. The two figures do not measure the same thing. The EMA count includes generics and biosimilars, while the FDA count only covers CDER novel drugs and new CBER licenses.

The chart shows that the EMA authorises in batches. It authorised 14 in November 2025, 1 in December and 11 in January 2026, so a month with a single authorisation means little on its own. The FDA also swings widely, from 14 approvals in November 2025 to 1 in January 2026.

For a supplier, each authorisation is a product that can now be sold and that someone has to make at commercial scale. The EMA table does not say which ones are biologics and only flags biosimilars, none in March and 2 in February. CBER covers vaccines, blood products and gene therapies, but also some diagnostic reagents.

![Grouped bar chart of EMA authorisations and FDA approvals by month. The EMA goes from 14 in November 2025 to 1 in December, and in March 2026 it has 6 against 7 for the FDA.](https://www.crida.studio/recursos/assets/ema-authorisations-and-fda-approvals-per-month-through-march-2026.9f31c0fd46c9.svg)

EMA authorisations and FDA approvals per month through March 2026

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

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

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 March 2026

Asia was the territory with the most industry biologics trials started in March 2026, with 45. The United States had 11, Europe 8 and Latin America 4. The world total of 74 also counts countries not broken out here.

Within Europe, Spain led the nine countries we break out, with 4. Germany, Italy and the United Kingdom had 3 each, France and Poland 2, Switzerland 1, and the Netherlands and Belgium none. A trial with sites in several countries counts in each one, which is why the countries add up to more than Europe's 8.

A new trial usually means clinical batches that someone has to make, often in a pilot plant or at a CDMO. The count does not say where they are made or on what equipment, though. Many antibodies are also registered as drugs rather than biologics, so the figure falls short.

![Bar chart of industry biologics trials started in March 2026. Asia has 45, the United States 11, Europe 8 and Latin America 4.](https://www.crida.studio/recursos/assets/industry-biologics-trials-started-in-march-2026-by-territory.d33bdf63fc11.svg)

Industry biologics trials started in March 2026, by territory

| Territory | Trials started |
| --- | --- |
| Europe | 8 |
| United States | 11 |
| Asia | 45 |
| Latin America | 4 |

Industry-sponsored interventional trials with at least one biological intervention that started in March 2026, by territory. A trial can count in more than one territory.

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


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

According to ClinicalTrials.gov, 4 industry trials with at least one biological intervention and a site in Spain started in March 2026, 2 fewer than in February. Of the nine European countries we break out, Spain had the most. The figure may rise as late registrations arrive.

## Which EU states imported the most under subheading 8419.89

Germany was the member state that imported the most under subheading 8419.89 in March 2026, with 45,827 thousand euros. France followed with 17,787 and the Netherlands with 17,370, while Spain came seventh with 9,053. March 2026 is the latest month with data for all 27 states within this edition's period.

In total, the 27 states imported 182,468 thousand euros in March, 24,119 more than in February, a rise of 15.2%. Over the twelve-month series, the total ranges from a low of 152,702,945 euros in August 2025 to a high of 207,864,244 euros in December 2025.

Subheading 8419.89 includes bioreactors and fermenters, but also other apparatus for treating materials through a change of temperature. These are imports from any country, other EU states included, in current euros. The data show which countries import most of this kind of equipment, but not how many bioreactors are sold.

![Bar chart of imports under subheading 8419.89 in March 2026, in thousand euros. Germany has 45,827, France 17,787, the Netherlands 17,370 and Austria, in eighth place, 8,312.](https://www.crida.studio/recursos/assets/imports-under-subheading-8419-89-by-member-state-march-2026.3bb560d6c69a.svg)

Imports under subheading 8419.89 by member state, March 2026

| Member state | Thousand euros |
| --- | --- |
| Germany | 45,827 |
| France | 17,787 |
| Netherlands | 17,370 |
| Sweden | 12,797 |
| Poland | 10,158 |
| Italy | 9,981 |
| Spain | 9,053 |
| Austria | 8,312 |

Imports under subheading 8419.89 for the eight member states with the highest value in March 2026, the latest month with data for all 27, in thousand euros. Includes other heat treatment apparatus.

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, China had 45 trials started in March 2026, as many as the whole territory, up from 21 in February. Japan had 4, South Korea 3 and India none. This is a one-month jump, and ClinicalTrials.gov does not capture every trial in the region, so it is too early to call it a trend.

In Latin America, 4 trials started, the same number as in February. Brazil had 3, Chile 2, and Mexico, Argentina and Colombia 1 each. In Brazil, ANVISA has 6 biologic medicine registrations with the process completed in March and none in February. The file has no registration date, so we use the process completion date.

For Japan, we count PMDA approvals by fiscal year, which runs from April to March. There were 135 in FY2024 and 119 in FY2025, which is partial because the list runs to February 2026. These entries include new indications and doses, not only new drugs, and serve as context.


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

No. They are counts of official records, such as trials, authorisations, warning letters or medicine registrations, and they do not say how much equipment is bought or for what amount. The Eurostat imports are in euros, but subheading 8419.89 includes a lot of apparatus that is not a bioreactor. They show where there is activity and how it changes.

## What this means if you sell bioprocess equipment or services

To decide where to put your sales effort next quarter, look at the twelve-month series rather than March alone. Asia has had more trials than Europe every month, and more than the United States every month since August 2025. If you already have a distributor there, it may be worth giving them more support. If not, take the time to study it before entering.

What to say depends on who buys. Trials point to clinical manufacturing, and authorisations to commercial production. If you sell pilot or single-use equipment, talk about scale-up and clinical batches. If you sell to plants already in production, talk about GMP, validation and service. Do it in English and in the language of each key country, such as German for Germany, which led imports this month.

Before the next trade show, check that your website has technical datasheets in English, that distributors have the same material and that trade show contacts reach your CRM. At crida studio we do marketing for bioprocess equipment manufacturers 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 previous edition, which covered February 2026, trials rose worldwide, from 55 to 74 (+34.5%), and in Asia, from 26 to 45. FDA approvals also rose, from 4 to 7, as did CGMP warning letters, from 6 to 9, and ANVISA biologics registrations, from 0 to 6. EU27 imports rose by 15.2%.

Trials fell in Europe, from 13 to 8, in the United States, from 13 to 11, and in Spain, from 6 to 4. EMA authorisations went from 7 to 6 and biosimilars from 2 to 0. Latin America stayed at 4. These are small numbers, and none of these one-month moves makes a trend.

The line chart puts March in context. Over twelve months, trials started worldwide range from 42 in November 2025 to 74 in March 2026, and before this month the peak was 65, in June 2025. Bear in mind that the last month in the series can rise as late registrations come in.

![Line chart of industry biologics trials started worldwide each month. It goes from 44 in April 2025 to 74 in March 2026, with a low of 42 in November 2025.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-each-month-through-march-2026.eea26a1f84c7.svg)

Biologics trials started worldwide each month through March 2026

| Month | Trials |
| --- | --- |
| 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 |
| Mar 2026 | 74 |

Industry-sponsored interventional trials with at least one biological intervention, by start month, from April 2025 to March 2026. The last month may rise with late registrations.

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


### How was this edition calculated?

With open data from the EMA, the FDA, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA, downloaded on 1 November 2026 and counted with our own script, with no estimates. The method section gives the exact query, date and limits for each source, and the edition's data can be downloaded as CSV and JSON.

## How this edition was built and what the data do not show

Edition prepared in November 2026 with the data for its period, which run to 31 March 2026. All sources were downloaded on 1 November 2026. The indicators are counts of official records, plus Eurostat imports in euros, and they do not measure equipment demand or market size. Recent months may rise because many records arrive late. Below you will find each source with its exact query and 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[2026-03-01,2026-03-31] 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 March 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-2026-04.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-04.csv)
- [observatori-bioproces-2026-04.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-04.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.

## Want the same analysis for your own products?

This edition uses only public data, with sources and dates. For the same analysis on your products or target markets, write to us and we will prepare it with you in a thirty-minute session.

[Request a session](https://www.crida.studio/en/#contact)

## More on web design

- [Bioprocess Market Watch. March 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-03/)
- [Bioprocess Market Watch. May 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-05/)
- [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/)
- [Cell and gene therapy clinical trials in Spain in 2026](https://www.crida.studio/en/insights/guides/cell-gene-therapy-trials-spain-2026/)