# Bioprocess Market Watch. July 2026 edition for European suppliers

In June 2026 industry sponsors started 10 biologics trials with sites in Europe, the same as in May. This July edition looks at open data up to 30 June 2026 from the EMA, the FDA, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA. It is written for the marketing director or CEO of a European bioprocess manufacturer or supplier who has to decide where to sell next.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-07/)

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

## What the open data says about June 2026

In June 2026 industry sponsors started 10 biologics trials with sites in Europe, the same as in May. Worldwide they started 59 and in the United States 23, more than the month before. The EMA authorised 5 medicines and the FDA approved 4, across CDER and CBER.

The FDA also issued 15 CGMP warning letters to drug and biologics manufacturers, and Eurostat puts EU imports under subheading 8419.89 at 213,482 thousand euros. Trials and approvals are counts of official records, not equipment demand, and with numbers this small one month up or down is not a trend.

Indicators for June 2026 compared with May 2026. These are counts of official records from the EMA, the FDA and ClinicalTrials.gov.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 10 | 10 | 0 |
| Biologics trials started worldwide | 59 | 49 | +10 |
| Biologics trials started in the United States | 23 | 14 | +9 |
| Biologics trials started in Asia | 25 | 26 | -1 |
| Medicines authorised by the EMA | 5 | 6 | -1 |
| FDA approvals, CDER and CBER | 4 | 8 | -4 |
| FDA CGMP warning letters | 15 | 10 | +5 |

## How many medicines the EMA and the FDA approved up to June

In June 2026 the EMA authorised 5 medicines through the centralised procedure, and 1 of them was a biosimilar. The FDA approved 4, made up of 3 novel drugs from CDER and 1 biologics license from CBER. Over the six months in the chart, the EMA peaks in April with 12 and the FDA in May with 8.

The EMA authorises in batches, so the series jumps a lot. Across the twelve months of data there are months with a single authorisation, such as October and December 2025, and one month with 14, November. A low month means nothing on its own. The EMA table includes generics and flags biosimilars, but does not single out other biologics.

For a supplier, each approval is a product moving into commercial manufacturing. CDER approvals are new molecular entities and new therapeutic biologics, while CBER approvals are licenses for products such as vaccines, blood products and gene therapies, plus some diagnostic reagents. These counts do not say who makes each product or where.

![Grouped bar chart of EMA authorisations and FDA approvals by month. January 11 and 1, February 7 and 4, March 6 and 7, April 12 and 3, May 6 and 8, June 5 and 4.](https://www.crida.studio/recursos/assets/ema-authorisations-and-fda-approvals-january-to-june-2026.4f1d56146912.svg)

EMA authorisations and FDA approvals, January to June 2026

| Month | EMA | FDA |
| --- | --- | --- |
| Jan 2026 | 11 | 1 |
| Feb 2026 | 7 | 4 |
| Mar 2026 | 6 | 7 |
| Apr 2026 | 12 | 3 |
| May 2026 | 6 | 8 |
| Jun 2026 | 5 | 4 |

Human medicines authorised by the EMA and approved by the FDA, CDER and CBER, each month from January to June 2026, taken from both agencies' public tables.

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

## Where industry biologics trials started in June 2026

In June 2026 industry sponsors started 25 biologics trials with sites in Asia, 23 in the United States, 10 in Europe and 4 in Latin America. These are interventional studies with at least one biological intervention, counted by start month. One study can count in more than one territory, so the territories cannot be added up.

Of the nine European countries we track, Spain had the most trial starts in June, with 7. Italy and Poland follow with 6, and Germany, France and the United Kingdom with 5. Belgium has 2, the Netherlands 1 and Switzerland none. Because one study can have sites in several countries, the countries add up to more than the European total of 10.

A biologics trial needs batches of the product, made in the sponsor's own plant or at a CDMO. The site country does not say where those batches are made, but it does show where sponsors with products in trials are active. For a supplier of pilot-scale equipment or consumables, it is a pointer to potential customers, bearing in mind how small the numbers are.

![Bar chart of biologics trials started in June 2026 by territory. Europe 10, United States 23, Asia 25 and Latin America 4.](https://www.crida.studio/recursos/assets/biologics-trials-started-by-industry-in-june-2026-by-territory.18308038515a.svg)

Biologics trials started by industry in June 2026, by territory

| Territory | Trials started |
| --- | --- |
| Europe | 10 |
| United States | 23 |
| Asia | 25 |
| Latin America | 4 |

Industry-sponsored interventional studies with at least one biological intervention that started in June 2026, by territory of their 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 June 2026?

According to ClinicalTrials.gov, industry sponsors started 7 biologics trials with at least one site in Spain in June 2026, 2 more than in May. A study with sites in several countries counts in each one, so the countries add up to more than the European total, which was 10. The latest month may still rise.

## Which EU states import the most under subheading 8419.89

In June 2026, the latest month with data for all 27 member states, EU imports under subheading 8419.89 came to 213,482 thousand euros. Germany imported 42,653 thousand euros and the Netherlands 34,871. France, Italy, Belgium and Sweden follow, between 15,616 and 12,284. Spain ranks ninth, with 8,804,245 euros.

Subheading 8419.89 covers other equipment for treating materials through a change of temperature, and includes much equipment that is neither a bioreactor nor a fermenter. These are imports from any country, including other EU states, in current euros. The figure shows where this family of equipment is bought, not how many bioreactors are sold.

In the twelve-month series of the EU27 total, June 2026 is the highest month and August 2025 the lowest. A rise over a single month is not a trend, and Eurostat may revise these figures in later releases.

![Bar chart of imports under subheading 8419.89 in June 2026 in thousand euros. Germany 42,653, Netherlands 34,871, France 15,616, Italy 13,936, Belgium 13,522, Sweden 12,284, Poland 9,356 and Austria 8,970.](https://www.crida.studio/recursos/assets/imports-under-subheading-8419-89-in-the-top-eight-member-states-june-2.36d331093a4b.svg)

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

| Member state | Thousand euros |
| --- | --- |
| Germany | 42,653 |
| Netherlands | 34,871 |
| France | 15,616 |
| Italy | 13,936 |
| Belgium | 13,522 |
| Sweden | 12,284 |
| Poland | 9,356 |
| Austria | 8,970 |

Imports from any country in thousand euros in June 2026, the latest month with data for all 27 member states. The subheading also covers 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 industry sponsors started 25 biologics trials in June 2026. China has 18, Japan 9, South Korea 4 and India 1. ClinicalTrials.gov is a US registry, and trials registered only in the national registries of these countries do not appear in it. That is why the Asian count falls short.

In Latin America 4 trials started, 3 with sites in Brazil, 2 in Argentina and 1 in Chile. Mexico and Colombia had none. The open data file of ANVISA, the Brazilian regulator, shows 14 biologics registrations with the process completed in June, 12 in May and 20 in April. The file has no registration date, so each registration is counted by the date its process was completed.

In Japan, the PMDA lists approved drugs by fiscal year, from April to March. FY2024 has 135 entries and FY2023 had 123. FY2025 only has data up to February 2026, with 119 entries, so it is partial. Each entry can be a new drug or a new indication. It is context and is not compared month by month.


### Do these counts measure demand for equipment?

No. They are counts of official records, such as trials started or medicines authorised, and they do not say how much equipment is bought or what it is worth. Eurostat imports are in euros, but subheading 8419.89 mixes bioreactors and fermenters with other heat treatment equipment. The counts show where there is activity and how it changes from month to month.

## What a European bioprocess supplier can do with this data

Where should sales effort go next quarter? In June, Germany and the Netherlands lead imports under subheading 8419.89, and Spain, Italy and Poland have the most trial starts of the nine European countries we track. One month is not enough to decide. Before moving budget, check whether the pattern holds across the twelve-month series.

What should you say, and in which language? A multinational sponsor may make purchasing decisions at headquarters or through its CDMO, and English is the way in. For a plant or a distributor in Germany, Italy or Poland, a datasheet and a page in the local language help. The message needs to be concrete, covering scale-up, GMP documentation and after-sales service.

What should you prepare? A website in the languages of the markets you choose, downloadable datasheets, a distributor kit and a trade show calendar that fits those countries. 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 has changed since the previous edition

Compared with the previous edition, with May 2026 data, Europe holds at 10 trials and Latin America at 4. Trials started worldwide rise from 49 to 59, in the United States from 14 to 23 and in Spain from 5 to 7. Asia goes from 26 to 25. The EMA goes from 6 to 5 authorisations and the FDA from 8 to 4.

CGMP warning letters from the FDA also rise, from 10 to 15, as do ANVISA biologics registrations, from 12 to 14, and imports under subheading 8419.89, from 184,970 to 213,482 thousand euros. In the chart, trials started worldwide move between 42 and 74 a month, with the high in March 2026. No single-month change is a trend.

![Line chart of biologics trials started worldwide each month from July 2025 to June 2026. The low is 42 in November 2025, the high 74 in March 2026, and June has 59.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-july-2025-to-june-2026.23055cd06b30.svg)

Biologics trials started worldwide, July 2025 to June 2026

| Month | Trials |
| --- | --- |
| 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 |
| Jun 2026 | 59 |

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

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


### How was this edition calculated?

From eight public sources downloaded on 1 November 2026, namely the EMA, the FDA's CDER and CBER, FDA warning letters, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA. Every figure comes from the official data, with no estimates. The method section gives the exact query for each source and the table can be downloaded as CSV and JSON.

## How this edition was made and where its limits are

Edition prepared in November 2026 with the data for its period. The data runs to 30 June 2026 and was downloaded on 1 November 2026 from eight public sources. Everything here is a count of official records or a trade value, not equipment demand. The latest month may be undercounted and rise later, because some records are added late. The full table can be downloaded as CSV and JSON.


- [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[2026-06-01,2026-06-30] 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 June 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-2026-07.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-07.csv)
- [observatori-bioproces-2026-07.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-07.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 portfolio?

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

[Request your analysis](https://www.crida.studio/en/#contact)

## More on web design

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- [Bioprocess Market Watch. August 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-08/)
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- [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/)
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- [How to market bioprocess equipment to German buyers](https://www.crida.studio/en/insights/guides/market-bioprocess-equipment-germany/)
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