# Bioprocess Market Watch. May 2026 edition for European suppliers

In April 2026, 11 industry-sponsored biologics trials started in Europe, 3 more than in March, according to ClinicalTrials.gov. This edition looks at open data up to 30 April 2026 on EMA and FDA approvals, clinical trials by territory and EU equipment imports. It is written for European suppliers of bioprocess equipment, consumables and services who need to decide where to focus their sales effort.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-05/)

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

## What the April 2026 open data says

In April 2026, 11 industry biologics trials started in Europe, 3 more than in March. Worldwide, 54 started, 20 fewer, with Asia down from 45 to 17 and the United States up from 11 to 17. The EMA authorised 12 medicines, 5 of them biosimilars, and the FDA approved 3 across CDER and CBER.

The FDA also issued 12 CGMP warning letters from CDER and CBER, 3 more than in March. These are counts of official records with small numbers, and one month on its own does not make a trend.

Indicators for April 2026 compared with March 2026. All are counts of official records.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 11 | 8 | +3 |
| Biologics trials started worldwide | 54 | 74 | -20 |
| Biologics trials started in the United States | 17 | 11 | +6 |
| Biologics trials started in Asia | 17 | 45 | -28 |
| Medicines authorised by the EMA | 12 | 6 | +6 |
| FDA approvals, CDER and CBER | 3 | 7 | -4 |
| FDA CGMP warning letters | 12 | 9 | +3 |

## EMA authorisations and FDA approvals over six months

In April 2026 the EMA authorised 12 human medicines through the centralised procedure, 6 more than in March, and 5 were biosimilars. The FDA approved 3, 2 novel drugs from CDER and 1 biologics license from CBER, against 7 in March.

The six-month chart shows that the EMA authorises in batches, with 14 medicines in November 2025 and 1 in December. A quiet month like December does not mean the pace has dropped. FDA numbers swing too, with 14 approvals in November 2025 and 1 in January 2026.

For a supplier, each authorisation is a product that can now be sold and so has to be made at commercial scale. The EMA table flags biosimilars and names each marketing authorisation holder. CDER counts new molecules and new therapeutic biologics, while CBER licenses products such as vaccines, blood products and gene therapies.

![Grouped bar chart of EMA authorisations and FDA approvals by month, from 14 and 14 in November 2025 to 12 and 3 in April 2026.](https://www.crida.studio/recursos/assets/medicines-authorised-by-the-ema-and-approved-by-the-fda-to-april-2026.4ed5b1543879.svg)

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

| Month | EMA | FDA |
| --- | --- | --- |
| Nov 2025 | 14 | 14 |
| Dec 2025 | 1 | 10 |
| Jan 2026 | 11 | 1 |
| Feb 2026 | 7 | 4 |
| Mar 2026 | 6 | 7 |
| Apr 2026 | 12 | 3 |

Human medicines authorised by the EMA through the centralised procedure and FDA approvals from CDER and CBER, month by month from November 2025 to April 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 April 2026

In April 2026, 17 industry biologics trials started with sites in the United States, 17 in Asia, 11 in Europe and 2 in Latin America. A study with sites in several territories counts in each one, so the bars cannot be added up.

Within Europe, Spain had 6, Germany and Poland 4 each, France and Italy 3, the United Kingdom and the Netherlands 2, Belgium 1 and Switzerland none. With numbers this small, one or two studies can reshuffle the countries from one month to the next.

Behind many of these trials are batches of clinical material made in pilot plants or at a CDMO, using small bioreactors, filtration and single-use consumables. Knowing where trials start helps you decide where to visit and which distributors to support, but it says nothing about how much equipment will be bought.

![Bar chart of biologics trials started in April 2026, with 17 in the United States, 17 in Asia, 11 in Europe and 2 in Latin America.](https://www.crida.studio/recursos/assets/biologics-trials-started-by-territory-in-april-2026.9b3f16eb3b46.svg)

Biologics trials started by territory in April 2026

| Territory | Trials started |
| --- | --- |
| Europe | 11 |
| United States | 17 |
| Asia | 17 |
| Latin America | 2 |

Industry-sponsored interventional trials with at least one biological intervention and a start date in April 2026, by where they have sites. One study 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 April 2026?

ClinicalTrials.gov shows 6, against 4 in March. These are industry-sponsored trials with at least one biological intervention and at least one site in Spain. A study with sites in several countries counts in each of them, which is why the European countries add up to more than the 11 trials for Europe.

## How much EU member states imported under subheading 8419.89

April 2026 is the latest month with data for all 27 member states. Together they imported 204,612 thousand euros under subheading 8419.89, which is 22,144 thousand or 12.1% more than in March. Germany imported 43,571 thousand euros, Belgium 29,453 and the Netherlands 20,634. Spain is eighth in the chart, with 8,508.

Besides reactors and fermenters, the subheading covers many other kinds of apparatus for treating materials through a change of temperature, and it includes what one member state buys from another. So these figures are not the size of the bioreactor market. Over twelve months, the lowest total was in August 2025, at 152,702,945 euros, and the highest in December 2025, at 207,864,244 euros.

![Bar chart of imports under subheading 8419.89 for the eight member states with the highest value in April 2026, from Germany with 43,571 thousand euros to Spain with 8,508.](https://www.crida.studio/recursos/assets/imports-under-subheading-8419-89-by-member-state-april-2026.42a0f5dbe777.svg)

Imports under subheading 8419.89 by member state, April 2026

| Member state | Thousand euros |
| --- | --- |
| Germany | 43,571 |
| Belgium | 29,453 |
| Netherlands | 20,634 |
| France | 16,786 |
| Sweden | 12,833 |
| Italy | 11,601 |
| Hungary | 10,769 |
| Spain | 8,508 |

Each member state's imports from any country in April 2026, the latest month with data for all 27 states, in thousand euros. The subheading 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, 17 biologics trials started in April 2026, against 45 in March. China had 12, Japan and South Korea 3 each and India 1. China had 45 in March, its highest figure in the twelve months, and a peak like that, in one country and one month, should be read with care.

In Latin America, 2 trials started, with sites in Brazil, Argentina and Chile and none in Mexico or Colombia. ANVISA, Brazil's regulator, completed 20 biologics registrations in April, against 6 in March. That is its highest monthly figure in the twelve months.

In Japan, where the fiscal year runs from April to March, the PMDA list shows 135 approval entries in fiscal year 2024 and 119 in fiscal year 2025 up to February 2026, a year that is still partial. These entries include new indications and doses. For China, India and South Korea, this edition only uses trial data.


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

No. They are counts of official records, such as trials starting, medicines authorised or imports declared. They show where there is activity, but not how many bioreactors, filters or consumables will be bought, or at what price. That is why this edition gives no sales figures and no forecasts.

## What this month means for a European bioprocess supplier

With these figures, sales effort for the following quarter makes more sense where trials keep coming month after month than where there is a one-off peak. In April, Spain, Germany and Poland had the most trials among the nine European countries we track. Before moving budget, check each country against the twelve-month series in the data file.

On messaging, in April the EMA authorised 5 biosimilars and the FDA issued 12 CGMP warning letters. If you sell to biosimilar makers, talk about scale-up and cost per batch. If you sell to plants that face inspections, talk about documentation and validation support. Do it in English and also in the language of the countries where you want to grow, such as Spanish or German.

To get ready, check that your website has datasheets in those languages, that distributors in Asia and Latin America have up-to-date material and that your trade show calendar takes into account where trials start. 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 previous edition

Compared with the previous edition, which ran to March, biologics trials rose in Europe from 8 to 11, in the United States from 11 to 17 and in Spain from 4 to 6. They fell worldwide from 74 to 54, down 27.0%, in Asia from 45 to 17 and in Latin America from 4 to 2.

EMA authorisations went from 6 to 12 and biosimilars from 0 to 5, while FDA approvals fell from 7 to 3. CGMP warning letters rose from 9 to 12, ANVISA biologics registrations from 6 to 20 and imports under subheading 8419.89 from 182,468 to 204,612 thousand euros.

The twelve-month line puts April in context. Worldwide, biologics trials started ranged from 42 in November 2025 to 74 in March 2026, and April, at 54, sits between the two. It takes several months in a row to call it a trend.

![Line chart of biologics trials started each month worldwide, from 61 in May 2025 to 54 in April 2026, with a low of 42 in November 2025 and a high of 74 in March 2026.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-may-2025-to-april-2026.a208c8b79ff8.svg)

Biologics trials started worldwide, May 2025 to April 2026

| Month | Trials |
| --- | --- |
| 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 |
| Apr 2026 | 54 |

Industry-sponsored interventional trials with at least one biological intervention started each month worldwide, from May 2025 to April 2026.

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


### How was each figure calculated?

With data downloaded on 1 November 2026 from eight open sources, including the EMA, the FDA, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA. The edition was prepared in November 2026 with the data for its period. The method section gives the exact query and the limits of each source, and the data can be downloaded as CSV and JSON.

## How this edition was made and what the data does not say

Edition prepared in November 2026 with the data for its period. The data runs to 30 April 2026 and was downloaded on 1 November 2026 from eight open sources. These are counts of official records and import values, and they do not measure equipment demand or market size. Recent months may still rise because many records arrive late. The list below gives the exact query and the limits of each source.


- [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[2026-04-01,2026-04-30] 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 April 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-2026-05.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-05.csv)
- [observatori-bioproces-2026-05.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-05.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 country or segment missing here?

Tell us which country or segment matters to you and we will consider adding it to a future edition or preparing it just for you, with the same open sources and method.

[Tell us what you need](https://www.crida.studio/en/#contact)

## More on web design

- [Bioprocess Market Watch. April 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-04/)
- [Bioprocess Market Watch. June 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-06/)
- [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/)