COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Merck KGaA (Germany)
It supports cell and gene therapy not by making the therapies but by selling the tools and processes used to make them. Its iPS cell work centres on organ models for drug discovery
There are two companies called Merck. One is Merck & Co. of the United States (known as MSD outside the U.S. and Canada), and the other is Merck KGaA of Germany, which operates in the U.S. and Canada under names such as MilliporeSigma and EMD. The Form 10-K of the U.S. company, Merck & Co., for the year to December 2025 says nothing about iPS cells, genome editing, cell therapy or gene therapy (the only related item is the personalised mRNA therapy V940, developed jointly with Moderna). By contrast, the 2025 annual report of Merck KGaA describes in concrete terms genome editing reagents, a manufacturing platform for AAV (gene therapy vectors), and drug-discovery models that use iPS cells and organoids. This article therefore covers Merck KGaA only. The company does not develop or sell cell therapy medicines itself. It sells the materials, equipment and contract manufacturing that support other companies' cell and gene therapies. This is not an introduction to or recommendation of any therapy, only an organisation of the company's disclosures.
- Merck KGaA in 30 seconds, and where it stands in iPS cells and regenerative medicine
- The logo and how the name is written
- Where the company sits in the iPS cell and regenerative medicine field
- Scale
- Resources committed to this field
- What it has done so far
- What comes next
- What the company is aiming for
- Map of partnerships
- Technologies, products and services on offer
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Merck KGaA in 30 seconds, and where it stands in iPS cells and regenerative medicine
(Merck Kommanditgesellschaft auf Aktien)Darmstadt, Germany. Founded in 1668
(supplier of materials, equipment and contract manufacturing)Does not develop or sell cell therapy medicines itself
(42% of the group)2025. Of which Process Solutions €3.785 billion
base editing reagentsLaunched July 2025. For research use
In cell and gene therapy, Merck KGaA is a company that sells picks and shovels Sourced. It does not sell therapies given to patients. It provides reagents for making vectors, purification filters, single-use equipment, contract manufacturing and quality testing to other companies that develop therapies. In the annual report, iPS cells appear in the context of organ models (organoids) for drug discovery, not in the context of making cells to transplant into patients. The same report also sets out the company's internal policies on human stem cells and genome editing (including a ban on germline interventions). For more, see our explainers on viral vectors, genome editing, organoids and spheroids, GMP and CDMOs.
2. The logo and how the name is written
A note on names: Merck KGaA (Germany) and Merck & Co., Inc. (United States, known as MSD elsewhere) are separate companies. Merck KGaA holds the worldwide rights to the Merck name and trademark except in Canada and the United States. In the U.S. and Canada it operates as MilliporeSigma (life science), EMD Serono (healthcare) and EMD Electronics (electronics) (annual report). The logo is the single-colour black version taken from the company's official website.
Official site: https://www.merckgroup.com/en3. Where the company sits in the iPS cell and regenerative medicine field
Merck KGaA is placed on the left of Fig. 1 (large pharma & strategic partners), but of that column's description (enters through deals and acquisitions, and has a sales network), the part about "selling therapies" does not apply to Merck KGaA. As a large operating company, it sits in the position of supporting other companies' therapy-making with materials and processes. Its mechanisms of treatment break down as follows Sourced.
| Mechanism | What Merck KGaA has | Status |
|---|---|---|
| Gene delivery such as AAV | AAV Express (contract manufacturing), AAViator (manufacturing platform), VirusGen (stabiliser), Pellicon Capsule (filtration device), Mirus Bio (transfection reagents) | Products and services launched in 2025. The therapies themselves belong to other companies |
| Genome editing | PURedit Cas9 base editing reagents, custom CRISPR-Cas enzymes, gene-modified cell lines | A supplier for research. Does not develop therapies |
| iPS cell-derived cells | Drug-discovery models that integrate iPS cells and organoids (developed with imec), the Hub Organoids acquisition | For drug discovery and toxicity assessment. No manufacture of cells for transplant is described |
| Autologous / allogeneic cell therapy, CAR-T | - | Not described in the annual report (it does supply equipment and consumables for cell and gene therapy) |
| mRNA and lipid nanoparticles | mRNA synthesis, LNP synthesis and formulation, and targeted-delivery capabilities used across business sectors | The report states an aim of developing smart LNPs |
4. Scale
Merck KGaA is a large operating company, so the whole-company picture is limited to one table. Amounts are in € million and the fiscal year ends in December Sourced.
| Measure (€ million) | 2024 | 2025 |
|---|---|---|
| Group sales | 21,156 | 21,102 (organic growth +3.1%) |
| Life Science sales | 8,916 | 8,980 (organic growth +4.0%, 42% of the group) |
| of which Process Solutions (for manufacturing) | 3,522 | 3,785 (organic growth +10.7%) |
| of which Science & Lab Solutions (for research) | 4,672 | 4,536 (organic growth +0.3%) |
| of which Life Science Services (contract development, manufacturing and testing) | 722 | 659 (organic growth -4.5%) |
| R&D expenses (group / Life Science) | about 2,300 / 388 | about 2,400 / 401 |
| Employees | 62,557 | 62,461 (of whom about 6,500 in R&D) |
The figures above are for the group and its business sectors. The annual report does not break out sales for cell and gene therapy Not yet confirmed. The description of the AAV Express Platform in the annual report cites a figure that about 70% of cell and gene therapy innovators outsource manufacturing, but no source is given and it is probably a market estimate, so this article does not use it. The rise in the Healthcare sector's R&D spending in 2025 is due to the acquisition of SpringWorks Therapeutics (rare-tumour medicines) and has no bearing on the subject of this article.
5. Resources committed to this field
| Resource | What it is | Category |
|---|---|---|
| People (sites and staff) | More than 1,700 people in Life Science R&D (12 sites worldwide). About 6,500 in R&D across the group. The number dedicated to cell and gene therapy is not disclosed | Sourced / dedicated headcount not confirmed |
| Money (R&D) | Life Science R&D expenses were €401 million (2025). The breakdown for cell and gene therapy is not disclosed | Sourced / breakdown not confirmed |
| Money (manufacturing capital expenditure) | A filter plant in Cork, Ireland (about €150 million, opened September 2025; €440 million across Ireland in total). Investment in Darmstadt as well. Capital expenditure dedicated to cell and gene therapy is not disclosed | Sourced / dedicated amount not confirmed |
| Outside investment and acquisitions | Mirus Bio (31 July 2024, US$617 million in cash); Hub Organoids (23 December 2024, total consideration of €104 million, with contingent consideration of up to €40 million); the chromatography business of JSR (agreed October 2025, completion expected in the first half of 2026) | Sourced |
| In-licensing and collaborations | imec (May 2025, a physiological model integrating iPS cells and organoids), Promega (October 2025, drug-discovery screening), Opentrons (laboratory automation), Siemens (digital) | Sourced |
| Universities, research institutions and public funding | A 90-year relationship with Washington University in St. Louis. A memorandum of understanding was signed in July 2025 (joint research and technology scouting) | Sourced (public funding not confirmed) |
The purpose of the Mirus Bio acquisition (US$617 million) was to provide solutions for every stage of viral vector manufacturing, and the large goodwill (€366 million at acquisition) reflects expectations of people and future innovation. Hub Organoids is a company that holds a core patent portfolio on organoids, and of the total consideration of €104 million, part of the contingent consideration (€15 million) was already paid in 2025 Sourced. Both were acquisitions of tool and platform-technology companies, not of therapy developers.
6. What it has done so far
| When | What happened | Why it matters |
|---|---|---|
| 31 July 2024 | Acquires Mirus Bio (U.S.) | Obtains reagents for the gene-introduction step of AAV manufacturing |
| 23 December 2024 | Acquires Hub Organoids (Netherlands), which holds a core organoid patent portfolio | Human-derived 3D models to reduce animal testing |
| January 2025 | Announces completion of the Hub Organoids acquisition (with a description of the business) | - |
| May 2025 | Collaboration with imec. Develops a physiological model that integrates iPS cells and patient-derived organoids with semiconductor sensors | Uses iPS cells in organ models for drug discovery |
| May 2025 | Launches Pellicon Capsule, a single-use filtration device for viral gene therapy | Equipment for purification in cell and gene therapy |
| June 2025 | Launches the AAV Express Platform, a contract service leading to GMP manufacture of cell and gene therapies | Expansion of contract manufacturing |
| July 2025 | Launches PURedit Cas9 Cytosine Base Editors, research reagents for base editing | Editing that avoids double-strand breaks, including in primary cultured cells |
| July 2025 | Memorandum of understanding with Washington University in St. Louis | Joint research and technology scouting |
| Autumn 2025 | Launches AAViator (an AAV manufacturing platform) and VirusGen (a stabiliser for the upstream stage of AAV manufacturing, October) | Support for scaling up AAV |
| 2025 | Expands testing with next-generation sequencing for viral clearance (confirming impurity removal) in AAV gene therapy. Sets up an organoid working group under the SCROC (the oversight committee for research on stem cells and similar technologies) | Quality testing and ethical governance |
| 1 January 2026 | Reorganises Life Science into three new business units (Process Solutions, Advanced Solutions and Discovery Solutions) | A sales structure matched to types of customer |
7. What comes next
in the first half of 2026Subject to regulatory approval and other conditions. For purifying antibody medicines
None of the following appears in the annual report Not yet confirmed.
A sales target for cell and gene therapy; manufacture of iPS cell-derived cells for transplant; the operating status and customer names for contract manufacturing such as AAV Express; the amount invested in the imec collaboration; and sales of genome editing reagents.
8. What the company is aiming for
This section goes beyond what the company says directly. It sets out inferences that can be drawn from primary sources, each with its basis.
| What can be read | Primary evidence behind it | Category |
|---|---|---|
| In cell and gene therapy it is aiming to offer the whole manufacturing process from start to finish from one company | The stated purpose of the Mirus Bio acquisition (solutions for every stage of viral vector manufacturing), AAViator, VirusGen, Pellicon Capsule, AAV Express and expanded quality testing | Inference (Sourced: the existence of the product range) |
| It will not move to the developer side of therapies | No in-house cell or gene therapy products are described. The Healthcare acquisition was for rare-tumour medicines (SpringWorks) | Inference |
| It uses iPS cells to speed up drug discovery and reduce animal testing | The stated aims of the imec collaboration: highly predictive preclinical models and a step-by-step reduction of animal testing | Sourced (the stated aim) |
| Its in-house research on pluripotent stem cells is small at present | The annual report says there are currently no in-house research projects requiring SCROC (the oversight committee for research on stem cells and similar technologies) approval | Sourced |
| On human stem cells and genome editing it is setting its ethical framework first | The ban on germline interventions, the human stem cell principles and the establishment of SCROC | Sourced (the existence of the policies) / Inference (the intent) |
In 2025 Life Science sales grew 10.7% in Process Solutions, which serves manufacturing, but only 0.3% in Science & Lab, which serves research, and fell 4.5% in contract services Sourced. The annual report explains the slowdown in research by lower spending at university and government laboratories after U.S. policy changes. From this, it appears that the company's growth is being steered away from laboratories and towards manufacturing (the materials needed once a therapy gets close to practical use) Not yet confirmed. How much cell and gene therapy contributes to that growth is not disclosed.
9. Map of partnerships
10. Technologies, products and services on offer
| Item | What the annual report says |
|---|---|
| PURedit Cas9 Cytosine Base Editors | Launched July 2025. Base editing with CRISPR Cas9 RNPs (protein-RNA complexes) that avoids double-strand DNA breaks and reduces off-target effects (editing at places other than the target). Can also be used in primary cultured cells. For research use |
| AAV Express Platform (Life Science Services) | Launched June 2025. A contract service to bridge cell and gene therapies to GMP commercial manufacturing |
| AAViator / VirusGen | AAViator is an integrated platform that shortens AAV manufacturing timelines. VirusGen (October 2025) is a stabiliser for the upstream stage of AAV manufacturing; it lengthens the time available for transfection complexes to form and helps scale-up while preserving titre and the share of full capsids |
| Pellicon Capsule | Launched May 2025. A single-use tangential flow filtration device for viral gene therapy. It reduces cross-contamination and operator exposure, and the processing of cell and gene therapies can be scaled at any size |
| Quality testing | Uses next-generation sequencing in viral clearance testing for AAV gene therapy |
| Hub Organoids / imec | A core organoid patent portfolio. Organ models integrating iPS cells and patient-derived organoids with semiconductor sensors |
| mConfig | An online entry point for custom design of cell culture media and process chemicals (updated May 2025). Manufacturability can be checked immediately |
In making cell and gene therapies, a change in any of the culture medium, transfection reagents, filtration and purification membranes, single-use flow paths, cryopreservation or quality testing changes yield and lot-to-lot variability. The products Merck KGaA launched in 2025 are concentrated in exactly this layer Sourced. (1) Transfection reagents (Mirus Bio, VirusGen): in making AAV, the quality of the complex that joins the plasmids to the cells determines the share of full capsids (see our explainer on viral vectors). (2) Filtration and purification (Pellicon Capsule, Natrix CH chromatography membranes): single-use formats reduce the risk of cross-contamination and the cleaning steps (see our explainers on GMP and bioreactors). (3) Custom media design (mConfig): animal-component-free formulations improve lot-to-lot reproducibility (see our explainer on cell manufacturing and cell banking). (4) Editing enzymes and guide RNA (PURedit): research reagents, not GMP-grade materials for therapy (see our explainers on genome editing and on off-target effects and safety assessment). However, sales of each product, and which therapy developers use them, are not disclosed Not yet confirmed.
11. The risks this company carries
| Risk | Substance | Category |
|---|---|---|
| Weaker demand from research | Organic growth of Science & Lab Solutions in 2025 was 0.3%. The company attributes this to lower spending at university and government laboratories after U.S. policy changes | Sourced |
| A drop in contract services | Organic growth of Life Science Services was -4.5%. The company explains this as a reaction to one-off projects in the previous year | Sourced |
| Tariffs and exchange rates | The company cites higher costs from increased U.S. tariffs, and an adverse currency effect (-3.4% in Life Science) | Sourced |
| Dependence on customers' therapies succeeding | Sales of materials depend on whether customers' cell and gene therapies succeed in the clinic and move on to commercial production | Inference |
| The scale in cell and gene therapy is invisible | No sales, customer count or utilisation is disclosed for this field | Sourced (the absence of disclosure) |
| Ethics and regulation | Internal policies on human stem cells and genome editing restrict uses (such as a ban on germline interventions). They may also affect supply for research | Sourced (the existence of the policies) / Inference (the effect) |
| Integrating acquisitions | Completion of the JSR chromatography business is expected in the first half of 2026 and is subject to regulatory approval | Sourced |
12. Glossary
- KGaA
- A German company form (Kommanditgesellschaft auf Aktien, a partnership limited by shares). It combines partners with unlimited liability (the founding family) and shareholders with limited liability.
- AAV
- Adeno-associated virus. Used in gene therapy as a vector to deliver genes into cells.
- Base editing
- A form of genome editing that rewrites one base into another without cutting both DNA strands.
- Organoid
- A three-dimensional cluster of cells grown from stem cells and the like that reproduces part of the structure and function of an organ.
- iPS cell
- A cell made pluripotent by introducing genes into an ordinary body cell. See our explainer on iPS cells.
- CDMO
- Contract development and manufacturing organisation. Life Science Services is of this kind.
- GMP
- Good manufacturing practice, the quality standard for making medicines.
- SCROC
- The oversight committee for research on stem cells, organoids and new modalities. It checks that in-house research follows company policy.
- Organic growth
- Sales growth excluding the effects of exchange rates and of acquisitions and disposals.
13. References
- Merck KGaA Annual Report 2025, Company profile and structure (founding, shareholder structure, employees and rights to the name). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/company-profile-and-structure.html
- Merck KGaA Annual Report 2025, Life Science (business structure, acquisitions and collaborations). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/company-profile-and-structure/life-science.html
- Merck KGaA Annual Report 2025, Research and development, Life Science (PURedit, AAV Express, AAViator, VirusGen, Pellicon Capsule). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/research-and-development/life-science.html
- Merck KGaA Annual Report 2025, Research and development (group R&D expenses, the collaboration with imec, LNP and mRNA capabilities). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/research-and-development.html
- Merck KGaA Annual Report 2025, The Group (group results: sales and organic growth). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/report-on-economic-position/course-of-business-and-economic-position/the-group.html
- Merck KGaA Annual Report 2025, Life Science (results by business unit: sales, organic growth and their drivers). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/report-on-economic-position/course-of-business-and-economic-position/life-science.html
- Merck KGaA Annual Report 2025, Bioethics (genome editing policy, human stem cell principles, SCROC and the organoid working group). https://www.reports.merckgroup.com/en/annualreport/2025/management-report/sustainability-statement/governance/bioethics.html
- Merck KGaA Annual Report 2025, notes to the consolidated financial statements: Acquisitions and divestments (Mirus Bio and Hub Organoids). https://www.reports.merckgroup.com/en/annualreport/2025/notes/group-structure/acquisitions-and-divestments.html
- Merck & Co., Inc. Form 10-K for the fiscal year ended December 31, 2025 (filed with the U.S. SEC on 24 February 2026). Used to confirm that iPS cells, cell therapy and gene therapy are not mentioned, and for the joint development of the personalised mRNA therapy V940 with Moderna. https://www.sec.gov/Archives/edgar/data/310158/000031015826000063/mrk-20251231.htm
- Merck KGaA Official website, used to check the company name and logo. https://www.merckgroup.com/en
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| History of Merck KGaA (1668), the founding family's holding, Frankfurt listing, 62,461 employees, rights to the name (the U.S. and Canada exception) | Sourced | Reference 1 https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/company-profile-and-structure.html |
| Structure of Life Science (three business units, 42% share of sales, new structure, list of acquisitions and collaborations) | Sourced | Reference 2 https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/company-profile-and-structure/life-science.html |
| PURedit, Pellicon Capsule, AAV Express, AAViator, VirusGen, mConfig, quality testing, and Life Science R&D (more than 1,700 people, 12 sites) | Sourced | Reference 3 https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/research-and-development/life-science.html |
| Group R&D (about €2.4 billion, about 6,500 people), the collaboration with imec (iPS cells and organoids), LNP and mRNA capabilities | Sourced | Reference 4 https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/research-and-development.html |
| Sales and organic growth for the group and business units (2024 and 2025) | Sourced | References 5 and 6 https://www.reports.merckgroup.com/en/annualreport/2025/management-report/report-on-economic-position/course-of-business-and-economic-position/life-science.html |
| The ban on germline interventions, the human stem cell principles, SCROC, the organoid working group, and that no in-house research currently requires approval | Sourced | Reference 7 https://www.reports.merckgroup.com/en/annualreport/2025/management-report/sustainability-statement/governance/bioethics.html |
| Terms of the Mirus Bio and Hub Organoids acquisitions | Sourced | Reference 8 https://www.reports.merckgroup.com/en/annualreport/2025/notes/group-structure/acquisitions-and-divestments.html |
| That the 10-K of Merck & Co. (U.S.) does not mention iPS cells, genome editing, cell therapy or gene therapy (the only related item is the joint development of the personalised mRNA therapy V940 with Moderna) | Sourced | Reference 9 https://www.sec.gov/Archives/edgar/data/310158/000031015826000063/mrk-20251231.htm |
| Confirmation of the logo and the way the name is written | Sourced | Reference 10 https://www.merckgroup.com/en |
| The three types of company in Fig. 1 | Our calculation | Our own classification. Companies shown are examples from those covered in this series |
| Sales for cell and gene therapy, sales of each product, customer names, the operating status of contract manufacturing, and capital expenditure | Not yet confirmed | Not in the annual report. This article makes no estimate https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/company-profile-and-structure/life-science.html |
| The figure in the AAV Express Platform description that about 70% of innovators outsource manufacturing | Not yet confirmed | No source is given and it is probably a market estimate, so it is not used https://www.reports.merckgroup.com/en/annualreport/2025/management-report/fundamental-information-about-the-group/research-and-development/life-science.html |
| The reading that it is aiming to offer the whole manufacturing process from start to finish | Inference | This article's interpretation of the purpose of the Mirus Bio acquisition and the products launched in 2025 |
| The reading that it will not move to the developer side of therapies | Inference | This article's interpretation of the absence of any in-house product |
| The reading that growth is being steered from research towards manufacturing | Inference | This article's interpretation of organic growth rates by business unit |
| The risk that sales depend on the success of customers' therapies | Inference | This article's interpretation of the business model |
Last updated 1 October 2026 / Troy Technical
Every figure in this article comes from Merck KGaA's 2025 annual report (the statutory combined management report and the notes to the consolidated financial statements) and from Merck & Co.'s filing with the U.S. SEC. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of primary sources, not statements made by the company. This article is not medical advice. It does not recommend any particular treatment or rank it against others.