# Bioprocess Market Watch. June 2026 edition for European suppliers

In Europe, 10 industry-sponsored biologics trials started in May 2026, one fewer than in April. This edition gathers open data up to 31 May 2026 on EMA authorisations and FDA approvals, clinical trials, EU imports under subheading 8419.89, registrations in Brazil and approvals in Japan. It is written for marketing and management teams at European bioprocess equipment and service suppliers.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-06/)

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

## What the May 2026 data says

In May 2026, 49 industry biologics trials started worldwide, 5 fewer than in April. Europe had 10, down 1, and the United States 14, down 3. Asia, by contrast, went from 17 to 26. The EMA authorised 6 medicines, while the FDA approved 8 and issued 10 CGMP warning letters. With numbers this small, no single month's move is a trend.

Seven indicators for May 2026 compared with April. All are counts of official records.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 10 | 11 | -1 |
| Biologics trials started worldwide | 49 | 54 | -5 |
| Biologics trials started in the United States | 14 | 17 | -3 |
| Biologics trials started in Asia | 26 | 17 | +9 |
| Medicines authorised by the EMA | 6 | 12 | -6 |
| FDA approvals, CDER and CBER | 8 | 3 | +5 |
| FDA CGMP warning letters | 10 | 12 | -2 |

## EMA authorisations and FDA approvals over six months

In May 2026 the EMA authorised 6 human medicines, including 1 biosimilar. The FDA approved 8, all from CDER, which approves novel drugs and therapeutic biologics. CBER, which licenses vaccines, blood products and gene therapies, approved none. April had been the other way round, with 12 at the EMA and 3 at the FDA.

EMA authorisations arrive in batches. The single one in December 2025 does not mean the EMA slowed down, since January brought 11. The FDA went the opposite way, with 10 in December and 1 in January. The EMA table flags biosimilars but does not single out other biologics, so we cannot say how many are antibodies or vaccines.

![Grouped bar chart of EMA authorisations and FDA approvals by month. The EMA goes from 1 in December 2025 to 6 in May 2026, with 12 in April. The FDA goes from 10 to 8, with 1 in January.](https://www.crida.studio/recursos/assets/ema-and-fda-authorisations-and-approvals-by-month-to-may-2026.e7c2bfe9d4f4.svg)

EMA and FDA, authorisations and approvals by month to May 2026

| Month | EMA | FDA |
| --- | --- | --- |
| Dec 2025 | 1 | 10 |
| Jan 2026 | 11 | 1 |
| Feb 2026 | 7 | 4 |
| Mar 2026 | 6 | 7 |
| Apr 2026 | 12 | 3 |
| May 2026 | 6 | 8 |

Human medicines authorised by the EMA and FDA approvals, CDER plus CBER, by month from December 2025 to May 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 Spain in May 2026?

There were 5, according to ClinicalTrials.gov, against 6 in April. These are industry trials with at least one biological intervention and at least one site in Spain. A trial with sites in several countries counts in each of them. The May figure may still rise, because many studies are registered weeks after they start.

## Where biologics trials started in May 2026

In May 2026, 26 industry biologics trials started in Asia, 14 in the United States, 10 in Europe and 4 in Latin America. These are interventional trials with at least one biological intervention, counted by the country of their sites. A trial with sites in several territories counts in each one, so the territory figures cannot be added together.

Within Europe, France had 6 and Germany, Spain, Italy and the United Kingdom 5 each. Poland had 3, the Netherlands and Belgium 2 and Switzerland none. The numbers are so small that one trial more or less reshuffles the order from month to month, so the series is what counts.

Every new trial 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, but it does show in which countries biologics trials are starting and how steadily.

![Bar chart of trials started in May 2026 by territory, 26 in Asia, 14 in the United States, 10 in Europe and 4 in Latin America.](https://www.crida.studio/recursos/assets/industry-biologics-trials-started-by-territory-in-may-2026.b1d03c22b979.svg)

Industry biologics trials started by territory in May 2026

| Territory | Trials started |
| --- | --- |
| Europe | 10 |
| United States | 14 |
| Asia | 26 |
| Latin America | 4 |

Industry-sponsored interventional trials with at least one biological intervention that started in May 2026. A trial with sites in several territories counts in each.

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

## EU imports under subheading 8419.89 in May 2026

In May 2026 the 27 EU member states imported goods worth 184,970 thousand euros under subheading 8419.89, which includes reactors and fermenters. In April the figure was 204,612. Germany comes first with 38,827 thousand euros, followed by Sweden and the Netherlands. Spain is tenth with 7,129,758 euros. May is the latest month in the edition period with data for all 27 states.

These figures are not the size of any market. The subheading also covers other machinery that treats materials through a change of temperature, and many of these machines are not bioreactors. These are imports from any country, including other EU states, in current euros. Over twelve months the EU27 total ranged from 152,702,945 euros in August 2025 to 207,864,244 euros in December.

![Bar chart of imports under subheading 8419.89 in May 2026, in thousand euros. Germany has 38,827, Sweden 20,430 and Ireland, eighth, 9,555.](https://www.crida.studio/recursos/assets/the-eight-member-states-importing-most-under-subheading-8419-89-in-may.7e7268831559.svg)

The eight member states importing most under subheading 8419.89 in May 2026

| Member state | Thousand euros |
| --- | --- |
| Germany | 38,827 |
| Sweden | 20,430 |
| Netherlands | 18,754 |
| France | 12,106 |
| Italy | 11,956 |
| Poland | 9,957 |
| Hungary | 9,851 |
| Ireland | 9,555 |

Each state's imports from any country, in thousand euros. May 2026 is the latest month in the period with data for all 27 states. The subheading includes other heat treatment equipment.

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


### Do these counts measure equipment demand?

No. They are counts of official records, such as trials or authorisations, and import values for a customs subheading. A new trial means someone will make clinical batches, but the count does not say how much equipment they will use or how much they will spend. Use them to see where activity moves and how steadily, not to estimate sales.

## What open data says about Asia and Latin America

In Asia, 26 industry biologics trials started in May 2026, 9 more than in April. China had 21, Japan 7, South Korea 3 and India 1. March brought 45, the highest of the twelve months, and that level has not been reached since.

In Latin America 4 started, with 3 in Brazil, 2 in Argentina, 2 in Chile, 1 in Colombia and none in Mexico. ANVISA, Brazil's regulator, lists 12 biologics registrations dated May and 20 dated April, the highest of the twelve months. They are counted by the date the process was completed.

In Japan, the PMDA list is counted by fiscal year, April to March. FY2024 has 135 entries and FY2025, still partial, 119 up to February 2026. It includes new indications and doses, so it is context only. The trial counts also miss studies that appear only in national registries and not on ClinicalTrials.gov.


### How was each figure calculated?

From eight public sources downloaded on 1 November 2026. Trials come from the ClinicalTrials.gov API, authorisations from the EMA and the FDA, warning letters from the FDA, imports from Eurostat Comext, registrations from ANVISA and approvals from the PMDA list. No figure is an estimate, and the method section gives the exact query for every source.

## What this month means for a European supplier

Where should sales effort go next quarter? These figures give no reason to change plans. Europe moves between 6 and 17 trials a month, and in May France, Germany, Spain, Italy and the United Kingdom had 5 or 6 each. If you already have customers or distributors there, that is where it pays to keep pushing. Asia has more, mostly because of China, but open data says little beyond that.

What to say depends on who buys. Teams making clinical batches need equipment that is fit for GMP and scales from the lab to the pilot plant, and that is what your website and datasheets need to show with data. English works across Europe. German and French are worth adding if you sell in Germany or France, two of the countries with most trials in May.

What should you prepare? Your website and datasheets in English, an up-to-date kit for distributors and a trade show calendar that reflects where most 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 has gone up and down since the previous edition

Compared with the previous edition, which ran to April, biologics trials fell in Europe from 11 to 10, worldwide from 54 to 49 and in the United States from 17 to 14. They rose in Asia from 17 to 26 and in Latin America from 2 to 4. Spain went from 6 to 5. None of these moves is a trend.

EMA authorisations went from 12 to 6 and biosimilars from 5 to 1. FDA approvals rose from 3 to 8, with CDER up from 2 to 8 and CBER down from 1 to 0. CGMP warning letters fell from 12 to 10, ANVISA biologics registrations from 20 to 12 and imports under subheading 8419.89 from 204,612 to 184,970 thousand euros.

The line shows biologics trials started worldwide over twelve months. They range from 42 in November 2025 to 74 in March 2026, and May stands at 49. That figure may still rise as late registrations for May come in.

![Line chart of trials started worldwide each month, from 65 in June 2025 to 49 in May 2026, with a low of 42 in November and a high of 74 in March.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-each-month-june-2025-to-may-2026.8312aeb74e28.svg)

Biologics trials started worldwide each month, June 2025 to May 2026

| Month | Trials |
| --- | --- |
| 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 |
| May 2026 | 49 |

Industry-sponsored interventional trials with at least one biological intervention, by start month, worldwide. The May figure may still rise with late registrations.

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


### Why does the June edition show May data?

Each edition is named after a month and uses data up to the last day of the previous month. The June edition covers June 2025 to May 2026. It was prepared in November 2026 with the data for its period, and the figures are the ones available on 1 November.

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

Edition prepared in November 2026 with the data for its period. The figures run to 31 May 2026 and were downloaded on 1 November 2026 from eight public sources. They are counts and values from official records, with no estimates. The latest month may fall short because some registries fill in late, and EMA authorisations arrive in batches. The list gives each source's 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[2026-05-01,2026-05-31] 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 May 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-2026-06.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-06.csv)
- [observatori-bioproces-2026-06.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-06.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 this reading applied to your products?

This edition only uses public data. If you want the same reading for your product range or your target countries, 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. May 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-05/)
- [Bioprocess Market Watch. July 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-07/)
- [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/)