# Bioprocess Market Watch. October 2026 edition for European suppliers

In September 2026, 10 industry biologics trials started in Europe, 4 more than in August, according to ClinicalTrials.gov. This edition looks at open data up to 30 September 2026 on EMA authorisations, FDA approvals, clinical trials, equipment imports into the EU and registrations in Brazil and Japan. It is written for the people who run marketing or sales at a European bioprocess supplier.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-10/)

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

## What the open data say about September 2026

In September 2026, 10 industry biologics trials started in Europe, 24 in the United States and 16 in Asia. Worldwide there were 62, the highest figure since March. The EMA authorised 7 medicines and the FDA approved 10 across CDER and CBER. The FDA issued 13 CGMP warning letters. In the EU, July 2026 is the latest month with import data for all 27 member states.

The table compares each indicator with August 2026. These are counts of official records, not equipment orders or sales. September is the last month in this edition and its trial count may still rise, because many studies are registered weeks after they start. With numbers this small, a jump from one month to the next is not a trend.

Indicators for September 2026 compared with August 2026, counts of official records downloaded on 1 November 2026.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 10 | 6 | +4 |
| Biologics trials started worldwide | 62 | 46 | +16 |
| Biologics trials started in the United States | 24 | 18 | +6 |
| Biologics trials started in Asia | 16 | 12 | +4 |
| Medicines authorised by the EMA | 7 | 4 | +3 |
| FDA approvals, CDER and CBER | 10 | 10 | 0 |
| FDA CGMP warning letters | 13 | 11 | +2 |

## How many medicines the EMA and the FDA approved from April to September 2026

In September 2026, the EMA authorised 7 human medicines through the centralised procedure, 1 of them a biosimilar. The FDA approved 10, made up of 9 novel drugs from CDER and 1 biologics license from CBER. Over the six months in the chart, the EMA ranges from a high of 12 in April to a low of 4 in August.

EMA authorisations come in batches. The twelve-month series has 14 in November 2025 and 1 in December, so a quiet month does not mean anything has changed. CDER only counts new molecular entities and new therapeutic biologics. CBER counts vaccines, blood products and gene therapies, plus some diagnostic tests licensed as BLAs.

![Grouped bar chart of EMA authorisations and FDA approvals by month, from 12 and 3 in April to 7 and 10 in September 2026.](https://www.crida.studio/recursos/assets/ema-authorisations-and-fda-approvals-to-september-2026-october-edition.899f1e9ceeee.svg)

EMA authorisations and FDA approvals to September 2026, October edition

| Month | EMA | FDA |
| --- | --- | --- |
| Apr 2026 | 12 | 3 |
| May 2026 | 6 | 8 |
| Jun 2026 | 5 | 4 |
| Jul 2026 | 8 | 8 |
| Aug 2026 | 4 | 10 |
| Sep 2026 | 7 | 10 |

Medicines authorised by the EMA and approved by the FDA, across CDER and CBER, each month from April to September 2026.

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 September 2026

In September 2026, 24 industry biologics trials started in the United States, 16 in Asia, 10 in Europe and 3 in Latin America. These are interventional studies sponsored by companies, with at least one biological intervention, counted by start month on ClinicalTrials.gov. A study with sites in several countries counts in each country and once in the territory.

Within Europe, the United Kingdom had 5 new trials and France 4. Germany, Spain, Italy and Poland had 2 each, Belgium 1, and the Netherlands and Switzerland none. Because one study can appear in more than one country, the countries add up to more than the European total. Spain had 2, the same as in August.

A new trial usually needs batches of clinical material made under GMP, in pilot plants or at CDMOs. The count does not say how many systems will be bought or where each batch will be made, but it does show where new clinical activity is happening.

![Bar chart of industry biologics trials started in September 2026, with 24 in the United States, 16 in Asia, 10 in Europe and 3 in Latin America.](https://www.crida.studio/recursos/assets/biologics-trials-started-in-september-2026-by-territory-october-editio.8c60697887ad.svg)

Biologics trials started in September 2026 by territory, October edition

| Territory | Trials started |
| --- | --- |
| Europe | 10 |
| United States | 24 |
| Asia | 16 |
| Latin America | 3 |

Interventional industry trials with at least one biological intervention started in September 2026, by territory. A study counts once in each territory where it has sites.

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


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

According to ClinicalTrials.gov, 2 industry trials with at least one biological intervention, the same as in August. A study with sites in Spain and other countries counts in each country. September is the last month in this edition, so the figure may rise once studies that have already started are registered.

## How much the 27 member states imported under 8419.89 in July 2026

July 2026 is the latest month with Eurostat data for all 27 member states, which is why this section stops short of September. That month, the 27 states imported a total of 192,247 thousand euros under subheading 8419.89, down 21,235 thousand on June (-9.9%). Germany imported 54,060 thousand euros, the Netherlands 23,288 and Spain 14,961, third on the list.

This subheading covers other equipment for treating materials through a change of temperature, and includes much equipment that is neither a bioreactor nor a fermenter. The figures are each state's imports from any country, including other EU states, in current euros. June 2026, at 213,482 thousand euros, was the highest of the twelve months in the series.

![Bar chart of imports under subheading 8419.89 in July 2026, from Germany with 54,060 thousand euros to Austria with 8,248, with Spain third at 14,961.](https://www.crida.studio/recursos/assets/imports-under-8419-89-by-member-state-in-july-2026-october-edition.1cba0fc140e5.svg)

Imports under 8419.89 by member state in July 2026, October edition

| Member state | Thousand euros |
| --- | --- |
| Germany | 54,060 |
| Netherlands | 23,288 |
| Spain | 14,961 |
| France | 14,659 |
| Italy | 12,126 |
| Hungary | 8,924 |
| Poland | 8,564 |
| Austria | 8,248 |

Imports under subheading 8419.89 for the eight member states with the highest value in July 2026, the latest month with data for all 27, in thousand euros.

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

## Trials and registrations in Asia and Latin America in September 2026

In Asia, 16 biologics trials started in September 2026. China had 9, Japan 6, South Korea 5 and India none. In Latin America, 3 started, with 2 in Mexico, 1 in Brazil, 1 in Argentina and none in Colombia or Chile. As in Europe, a study with sites in several countries counts in each one.

In Brazil, ANVISA registered 6 biological medicines in September, the same as in August. The highest of the twelve months was April 2026, with 20. In Japan, the PMDA recorded 135 new drug entries in FY2024, from April 2024 to March 2025. FY2025 is still partial, with 119 entries from April 2025 to February 2026.

These figures have three limits. Only studies registered on ClinicalTrials.gov count, not those that appear only in a national registry. The ANVISA file has no registration date, so the process completion date is used. PMDA entries include new indications and doses, and they serve as context, not for month-by-month comparison.


### Do these counts measure demand for bioprocess equipment?

No. They are counts of official records, such as trials starting or medicines authorised, plus import values published by Eurostat. They show where there is activity and help decide where to look first, but they do not say how many bioreactors, filters or consumables will be bought, or by whom. That is why this watch gives no market size.

## What a European bioprocess supplier can do with these figures

For the coming quarter, put your effort where new trials appear month after month, not where there is a one-off spike. In September, the United Kingdom and France were the European countries with the most new trials, and the United States was the territory with the most. Before moving budget, look at each country's twelve months in this edition's CSV file and compare them with your current customers and distributors.

A trial count is a good reason to talk to clinical development teams and CDMOs. If you are targeting the United Kingdom or the United States, your content needs to be in English and speak to clinical manufacturing and scale-up. For France, Germany or Italy, a page in the local language and a local contact help.

To prepare, make sure your website and datasheets answer the usual questions on GMP and scale-up, and that your distributors have the same material. If you are heading to a trade show, bring these figures to open conversations. crida studio does marketing for bioprocess equipment makers and life science companies, and its founder led marketing at a European manufacturer for four and a half years.

## What went up and what went down compared with August 2026

Compared with August, most September counts are higher. Biologics trials rose from 46 to 62 worldwide (+34.8%), from 18 to 24 in the United States (+33.3%), from 12 to 16 in Asia (+33.3%), from 6 to 10 in Europe and from 1 to 3 in Latin America. Spain stays at 2.

The EMA goes from 4 to 7 authorisations and the FDA holds at 10, with CDER up from 7 to 9 and CBER down from 3 to 1. CGMP warning letters rise from 11 to 13 (+18.2%) and imports under subheading 8419.89 fall 9.9% from June to July. No one-month change is a trend, and in the chart worldwide trials range from 39 to 74 a month.

![Line chart of biologics trials started worldwide each month, from 47 in October 2025 to 62 in September 2026, with a high of 74 in March and a low of 39 in July.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-to-september-2026-october-edition.2598d8bf4bf5.svg)

Biologics trials started worldwide to September 2026, October edition

| Month | Trials |
| --- | --- |
| 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 |
| Jul 2026 | 39 |
| Aug 2026 | 46 |
| Sep 2026 | 62 |

Interventional industry trials with at least one biological intervention started worldwide each month, October 2025 to September 2026. The last month may still rise.

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


### How was each figure calculated?

With scripts that download the official sources and always apply the same filters, without estimates. The eight sources are the EMA, the FDA's CDER and CBER, FDA warning letters, ClinicalTrials.gov, Eurostat, ANVISA and the PMDA. The exact query for each one is in the method section at the end of the page.

## Where the figures come from and what they cannot tell you

Edition prepared in November 2026 with the data for its period. All sources were downloaded on 1 November 2026 and the data run to 30 September 2026, except Eurostat, which runs to July, and the PMDA, to February. These are counts of official records, not equipment sales, and recent months may still rise. The list below gives the exact query, download date and limits for 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[2026-09-01,2026-09-30] 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 July 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-2026-10.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-10.csv)
- [observatori-bioproces-2026-10.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-10.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 analysis applied to your own products?

This edition only uses public data. If you want the same analysis for your products or target markets, get in touch and we will work through it with you in a thirty-minute session.

[Book the session](https://www.crida.studio/en/#contact)

## More on web design

- [Bioprocess Market Watch. September 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-09/)
- [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 run a market analysis before launching new lab equipment](https://www.crida.studio/en/insights/guides/market-analysis-new-lab-equipment/)