# Bioprocess Market Watch. August 2026 edition for European suppliers

In July 2026, industry sponsors started 7 biologics trials in Europe, 3 fewer than in June, according to ClinicalTrials.gov. This edition looks at open data on trials, EMA and FDA approvals, EU imports and registrations in Asia and Latin America up to 31 July 2026. It is written for companies that sell bioprocess equipment, consumables or services from Europe.

[Web version](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-08/)

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

## What the July 2026 data says

In July 2026, industry sponsors started 7 biologics trials in Europe and 39 worldwide, fewer than in June. The United States saw 14 new trials and Asia 12. The EMA authorised 8 medicines, 3 more than in June, and the FDA approved 8, up 4. The FDA also issued 11 CGMP warning letters, 4 fewer. July is the latest month, so its trial count may still rise.

The table compares each indicator for July with its value in June. With numbers this small, a single month does not make a trend, which is why each section also looks at the months before. The data can be downloaded as CSV and JSON, with sources and download dates.

Indicators for July 2026 next to June 2026. These are counts of official records, and some July figures may still rise.

| Indicator | Month | Previous month | Change |
| --- | --- | --- | --- |
| Biologics trials started in Europe | 7 | 10 | -3 |
| Biologics trials started worldwide | 39 | 59 | -20 |
| Biologics trials started in the United States | 14 | 23 | -9 |
| Biologics trials started in Asia | 12 | 25 | -13 |
| Medicines authorised by the EMA | 8 | 5 | +3 |
| FDA approvals, CDER and CBER | 8 | 4 | +4 |
| FDA CGMP warning letters | 11 | 15 | -4 |

## EMA authorisations and FDA approvals over six months

The EMA authorised 8 human medicines in July 2026, 1 of them a biosimilar. The FDA approved 8, made up of 6 novel drugs from CDER and 2 biologics licences from CBER. The two agencies do not count the same thing. The EMA includes generics and biosimilars, while the FDA counts only novel drugs and new licences. To see which products they are and who holds the authorisation, look each one up on each agency's website.

Over the six months in the chart, the EMA ranges from 5 to 12 authorisations a month and the FDA from 3 to 8. EMA authorisations come in batches. The twelve-month series has months with 1, such as October and December 2025, and months with 13 or 14, so a quiet month is not a trend. The EMA table also flags biosimilars only and does not single out other biologics.

![Grouped bar chart of EMA authorisations and FDA approvals in 2026. February 7 and 4, March 6 and 7, April 12 and 3, May 6 and 8, June 5 and 4 and July 8 and 8.](https://www.crida.studio/recursos/assets/monthly-ema-authorisations-and-fda-approvals-february-to-july-2026.7e1bed718f2c.svg)

Monthly EMA authorisations and FDA approvals, February to July 2026

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

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

Industry sponsors started 4 trials with at least one biological intervention and sites in Spain, according to ClinicalTrials.gov. That is 4 of the 7 started in Europe. In June there were 7 in Spain. A study with sites in several countries counts in each, and July may still rise because many studies are registered late.

## Where biologics trials started in July

Of the 7 biologics trials that industry sponsors started in Europe in July 2026, 4 have sites in Spain. Germany, France, the United Kingdom, the Netherlands and Belgium have 1 each, and Italy, Poland and Switzerland none. A study with sites in several countries counts in each of them, so the country figures add up to more than the European total.

Outside Europe, 14 started in the United States, 12 in Asia and none in Latin America. Every trial needs clinical batches made under GMP, but the country of the sites does not say where they are made or on what equipment. The count shows where industry is running clinical work.

![Bar chart of industry biologics trials started in July 2026. Europe 7, United States 14, Asia 12 and Latin America 0.](https://www.crida.studio/recursos/assets/where-industry-biologics-trials-started-in-july-2026.83d5f1724dfb.svg)

Where industry biologics trials started in July 2026

| Territory | Trials started |
| --- | --- |
| Europe | 7 |
| United States | 14 |
| Asia | 12 |
| Latin America | 0 |

Interventional trials sponsored by industry with at least one biological intervention, started in July 2026, by country of the sites. A study with sites in several territories counts in each.

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

## Which EU states import most under subheading 8419.89

In July 2026, the member states imported 192,247 thousand euros under subheading 8419.89, 9.9% less than in June. It is the latest month in the period with data for all 27 states. Germany imported 54,060 thousand, well ahead of the Netherlands with 23,288. Spain is third with 14,961, just ahead of France with 14,659.

Subheading 8419.89 includes bioreactors and fermenters, but also other machinery, plant and laboratory equipment for treating materials through a change of temperature. These are imports from any country, including other EU states, and Eurostat may revise them. June 2026, at 213,482 thousand euros, is the highest of the twelve months in the series, and August 2025 the lowest.

![Bar chart of imports under subheading 8419.89 in July 2026, in thousand euros. Germany 54,060, Netherlands 23,288, Spain 14,961, France 14,659, Italy 12,126, Hungary 8,924, Poland 8,564 and Austria 8,248.](https://www.crida.studio/recursos/assets/top-eight-eu-importers-of-subheading-8419-89-in-july-2026.b9206e1cceec.svg)

Top eight EU importers of subheading 8419.89 in July 2026

| 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 by the eight EU states with the highest value in July 2026, the latest month in the period with data for all 27 states, in thousand euros.

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, medicines authorised or imports under a customs heading. They show where there is activity, but not how many units are bought, at what scale or by whom. That is why this edition gives no market sizes or forecasts, and every figure carries its source and date.

## What open data shows for Asia and Latin America

In Asia, industry sponsors started 12 biologics trials in July 2026, 13 fewer than in June. Of these, 8 have sites in China, 3 in South Korea, 1 in Japan and none in India. China has more than Japan, India and South Korea in every month of the series. Trials listed only in national registries are left out, so the count may fall short.

No trial started in Latin America in July, after 4 in June. ANVISA, Brazil's regulator, registered 10 biological medicines in July and 14 in June. Since April 2026 every month has had 10 or more, while from November 2025 to March 2026 no month went above 6. The date used is the process completion date, not a registration date.

In Japan, the PMDA counts approvals by fiscal year, from April to March. FY2024 had 135 and the four years before it between 123 and 146. The count includes new indications and doses, not only new active ingredients. FY2025 is partial, with 119 entries from April 2025 to February 2026, and cannot be compared yet.


### How was it calculated?

With repeatable queries to eight open 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, registrations from ANVISA and approvals from the PMDA. The method section gives each exact query, and the data can be downloaded.

## What this means for a European supplier

Where should sales effort go next quarter? One month does not change a plan, but the twelve-month series gives some pointers. Spain, Germany, France and the United Kingdom have new trials every month, and Spain reached 13 in December 2025. The United States has between 11 and 31 a month. It is worth checking which sponsors run trials in these countries and which CDMOs they work with.

What to say, and in which language? This data cannot tell you whether the sector is growing or slowing, so do not use it to claim either. Explain which stage each piece of equipment serves, from pilot plants for trials to production of an approved product. English is the base. Spanish covers Spain and Latin America, Portuguese covers Brazil and German covers Germany, July's top importer under 8419.89.

What to prepare? A page per market with datasheets, GMP documentation and a local contact, a kit for distributors in Asia and Latin America, and a trade show calendar chosen by cost per contact. At crida studio we do marketing for bioprocess equipment makers and life science companies, and the studio's founder ran marketing at a European manufacturer for four and a half years.

## What has changed since the previous edition

Compared with the previous edition, which had June data, trials fell in every territory, while EMA authorisations rose from 5 to 8 and FDA approvals from 4 to 8. Outside the table, Spain went from 7 trials to 4, Latin America from 4 to 0, ANVISA registrations from 14 to 10 and imports under 8419.89 from 213,482 to 192,247 thousand euros.

The line shows biologics trials started worldwide each month since August 2025. They range from 39 in July 2026 to 74 in March 2026. July is the lowest month in the series, but it is also the latest, and late registrations may still be added. It would take several months in a row moving the same way before calling it a trend.

![Line chart of biologics trials started worldwide each month from August 2025 to July 2026, between 39 in July 2026 and 74 in March 2026.](https://www.crida.studio/recursos/assets/twelve-months-of-biologics-trials-started-worldwide-to-july-2026.652e08e5fb58.svg)

Twelve months of biologics trials started worldwide, to July 2026

| Month | Trials |
| --- | --- |
| 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 |
| Jul 2026 | 39 |

Industry interventional trials with at least one biological intervention started worldwide each month, August 2025 to July 2026. The latest month may still rise.

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


### Why are there fewer trials in July than in June?

The data does not say why, but part of the drop may come from late registration. Many trials are registered weeks after they start, so the 39 worldwide and the 7 in Europe may still rise. With numbers this small, a one-month drop is not a trend, and the twelve-month series is the better guide.

## Method and limits of this edition

Edition prepared in November 2026 with the data for its period, which runs to 31 July 2026. All sources were downloaded on 1 November 2026, and the figures are counts of official records, not sales or equipment demand.

The latest month usually comes in low, because many trials are registered weeks after they start and the FDA posts warning letters late. Many antibodies are also registered as drugs rather than biologics. Below is each source with its exact query, download date 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[2026-07-01,2026-07-31] 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-2026-08.csv](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-08.csv)
- [observatori-bioproces-2026-08.json](https://www.crida.studio/recursos/dades/observatori-bioproces-2026-08.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 markets?

If you want the same analysis for your product range or for a market this edition does not cover, 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

- [Bioprocess Market Watch. July 2026 edition for European suppliers](https://www.crida.studio/en/insights/guides/bioprocess-market-watch-2026-07/)
- [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 plan a multilingual website to sell equipment across Europe](https://www.crida.studio/en/insights/guides/multilingual-website-sell-equipment-europe/)