# Bioprocess Market Watch. September 2026 edition for European suppliers

Industry sponsors started 6 biologics trials in Europe in August 2026, one fewer than in July, according to ClinicalTrials.gov. This edition covers open data up to 31 August 2026 on clinical trials, EMA and FDA approvals, EU imports under subheading 8419.89 and registrations in Asia and Latin America. It is meant for anyone selling bioprocess equipment, consumables or services from Europe.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-09/)

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

## What the August 2026 data says

Industry sponsors started 6 biologics trials in Europe in August 2026, 1 fewer than in July. Worldwide the count was 46, up 7, and in the United States 18, up 4, while Asia stayed at 12. The EMA authorised 4 medicines and the FDA approved 10. The FDA also issued 11 CGMP warning letters. With numbers this small, no single month is a trend.

Seven indicators for August 2026 compared with July. All are counts of official records, and the August figures may still rise.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 6 | 7 | -1 |
| Biologics trials started worldwide | 46 | 39 | +7 |
| Biologics trials started in the United States | 18 | 14 | +4 |
| Biologics trials started in Asia | 12 | 12 | 0 |
| Medicines authorised by the EMA | 4 | 8 | -4 |
| FDA approvals, CDER and CBER | 10 | 8 | +2 |
| FDA CGMP warning letters | 11 | 11 | 0 |

## EMA authorisations and FDA approvals from March to August

In August 2026 the EMA authorised 4 human medicines, 1 of them a biosimilar, and the FDA approved 10. Of those 10, 7 were CDER novel drugs and 3 were CBER licences. CDER also approves therapeutic biologics, and CBER handles vaccines, blood products and gene therapies. In July the two agencies were level, with 8 each.

EMA authorisations come in batches. Over twelve months there were months with 1, such as October and December 2025, and months with 14, such as November. So the 4 in August do not signal any change of pace. The EMA table flags biosimilars but does not single out other biologics.

![Grouped bar chart of EMA and FDA counts by month in 2026. March 6 and 7, April 12 and 3, May 6 and 8, June 5 and 4, July 8 and 8 and August 4 and 10.](https://www.crida.studio/recursos/assets/ema-authorisations-and-fda-approvals-march-to-august-2026.8d2a78b8a6b2.svg)

EMA authorisations and FDA approvals, March to August 2026

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

Human medicines authorised by the EMA and FDA approvals, CDER novel drugs plus CBER licences, by month from March to August 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 August 2026?

The count is 2, according to ClinicalTrials.gov, against 4 in July. 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. The August figure may still rise, because many studies are registered weeks after they start.

## Where biologics trials started in August, by territory and country

In August 2026, industry sponsors started 18 biologics trials in the United States, 12 in Asia, 6 in Europe and 1 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, and the world total includes countries outside these four territories.

Within Europe, Germany and the United Kingdom had 3 each, Spain 2, and Italy and Switzerland 1 each. France, the Netherlands, Belgium and Poland had none. The countries add up to more than the European total of 6 for the same reason. With numbers this low, a single trial reshuffles the order from one month to the next.

Behind every trial are clinical batches that someone has to manufacture, often in a pilot plant or at a CDMO. The count does not say where they are made or on what equipment, but it does show where biologics trials start and how regularly.

![Bar chart of industry biologics trials started in August 2026. Europe 6, United States 18, Asia 12 and Latin America 1.](https://www.crida.studio/recursos/assets/biologics-trials-started-by-territory-in-august-2026.6bfafb3184b6.svg)

Biologics trials started by territory in August 2026

| Territory | Trials started |
| --- | --- |
| Europe | 6 |
| United States | 18 |
| Asia | 12 |
| Latin America | 1 |

Industry interventional trials with at least one biological intervention started in August 2026, by country of the sites. 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 with July data

July 2026 is the latest month with data for all 27 EU states. That month they imported a combined 192,247 thousand euros under subheading 8419.89, which includes reactors and fermenters. In June the figure was 213,482, the highest of the twelve months. Germany tops the list with 54,060 thousand euros, followed by the Netherlands with 23,288 and Spain, in third place, with 14,961.

This is not what the EU spends on bioreactors. The subheading also covers other heat treatment equipment, and it counts each state's imports from any country, including other EU states. Spain coming ahead of France, which has 14,659, is worth watching, but the data does not say what kind of equipment comes in.

![Bar chart of imports under subheading 8419.89 for the top eight states in July 2026, in thousand euros. Germany has 54,060, the Netherlands 23,288, Spain 14,961 and Austria, eighth, 8,248.](https://www.crida.studio/recursos/assets/imports-of-subheading-8419-89-in-july-2026-september-edition.6cacd258909c.svg)

Imports of subheading 8419.89 in July 2026, September 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 |

The eight EU states with the highest imports in July 2026, the latest month with data for all 27, in thousand euros. The subheading includes other heat treatment equipment.

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


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

No. They are counts of official records, such as trials starting or medicines authorised, plus the value of imports under a customs heading. A trial means clinical batches will be made, but the record does not say on what equipment or at what cost. The counts show where there is activity and how regular it is, not how much anyone will buy.

## What open data shows for Asia and Latin America

In Asia, industry sponsors started 12 biologics trials in August 2026, the same as in July. China had 9, South Korea 2, Japan 1 and India none. July and August are the lowest of the twelve months in Asia, but they are also the most recent, and late registrations may still lift them.

Latin America had 1 trial start, in Argentina, and none in Brazil, Mexico, Colombia or Chile. ANVISA, the Brazilian agency, shows 6 biologics registrations dated August and 10 dated July. They are counted by process completion date, because the open file has no registration date. April, with 20, is the highest of the twelve months.

In Japan, the PMDA list is counted by fiscal year, April to March. FY2024 has 135 entries and FY2025, still partial, has 119 up to February 2026. An entry can be a new drug or a new indication, so the list is context only. Nor do the counts include trials that appear only in national registries, because they are not on ClinicalTrials.gov.


### How was each figure calculated?

From eight public sources downloaded on 1 November 2026. Approvals come from the EMA and the FDA, trials from the ClinicalTrials.gov API and imports from Eurostat Comext. The rest comes from FDA warning letters, ANVISA and the PMDA. No figure is an estimate, and the method section gives the exact query for each source.

## What this month means for a European supplier

Where should sales effort go next quarter? The August data gives no reason to change plans. Europe has ranged between 6 and 17 trial starts a month since September 2025, and in August Germany and the United Kingdom had 3 each. Germany also led imports under subheading 8419.89 in July, with Spain third. If you already have customers or distributors there, that is where it makes sense to push.

What to say depends on who buys. Teams making clinical batches want to know whether equipment scales from lab to pilot plant and how it fits GMP, and that is best shown with data on the website and in datasheets. English works across Europe. German pays off if you sell in Germany, and Spanish if you sell in Spain.

What to prepare? Up-to-date datasheets and website in English, a kit for distributors and a trade show calendar that reflects where more trials start. Before booking a stand, it is worth working out what each contact will cost. 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 gone up and down since the previous edition

Compared with the previous edition, which covered July, biologics trial starts rose worldwide, from 39 to 46, and in the United States, from 14 to 18. They fell in Europe, from 7 to 6, and in Spain, from 4 to 2. Asia stayed at 12 and Latin America went from 0 to 1. None of these one-month moves is a trend.

The EMA went from 8 authorisations to 4, with biosimilars steady at 1. The FDA rose from 8 approvals to 10, with CDER up from 6 to 7 and CBER from 2 to 3. CGMP warning letters held at 11, and ANVISA biologics registrations fell from 10 to 6.

The import figures for subheading 8419.89 are the same as in the previous edition, because July is still the latest month with all 27 states. The line shows biologics trials started worldwide over twelve months, between 39 in July 2026 and 74 in March. August sits at 46 and, like July, may still rise as late registrations come in.

![Line chart of biologics trials started worldwide each month, from 47 in September 2025 to 46 in August 2026, with a low of 39 in July and a high of 74 in March.](https://www.crida.studio/recursos/assets/biologics-trials-started-worldwide-september-2025-to-august-2026.1fc74898a240.svg)

Biologics trials started worldwide, September 2025 to August 2026

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

Industry interventional trials with at least one biological intervention, by start month, worldwide. August may still rise as studies finish being registered.

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


### Why does the September edition show August data?

Each edition is named after a month and uses data up to the last day of the previous month, in this case 31 August 2026. Imports run to July because it is the latest month with data for all 27 states. The edition was prepared in November 2026 with the data for its period.

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

Edition prepared in November 2026 with the data for its period. The figures run to 31 August 2026 and were downloaded on 1 November from eight public sources. They are counts of records, with no estimates. The latest month usually comes in low, because many records are added late. EMA authorisations arrive in batches, and the latest Eurostat month with all 27 states is July.


- [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[2026-08-01,2026-08-31] 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 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-2026-09.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-09.csv)
- [observatori-bioproces-2026-09.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-09.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 company?

Download the table with sources and dates. For the same reading applied to your products or the countries where you sell, write to us and we will prepare it with you in a thirty-minute session.

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

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