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Nipro
A ¥660 billion medical device maker waits for full approval of Stemirac, its cell product for spinal cord injury

Nipro is a major medical device maker, producing dialysis equipment, syringes, pharmaceuticals and medical glass, and it is a slightly unexpected name in cell culture. Yet together with Sapporo Medical University it developed Stemirac, a regenerative medicine product in which stem cells from the patient's own bone marrow are grown outside the body and returned by intravenous drip, and on 28 December 2018 it obtained conditional and time-limited approval in Japan. With the seven-year time limit approaching, it applied for full approval on 14 November 2025. It also sells serum-free, chemically defined media and culture vessels for research. This profile keeps the medical device business to a minimum and uses primary sources to set out what the company is putting into its cell culture-related regenerative medicine business, and how far it has got.

Sources: Nipro's annual securities report for the year to March 2026 (filed 25 June 2026), financial results summaries and IR materials (12 May 2026, and for the first quarter in August 2026), its Medium-Term Management Plan (May 2025), company news releases, PMDA lists of approved products, and minutes of the Central Social Insurance Medical Council, used as primary material. Last updated September 2026.

What this article covers
  1. Nipro in 30 seconds, and where it stands in cell culture
  2. The logo and how the name is written
  3. Where the company sits in the cell culture landscape
  4. Scale (the medical device business in brief)
  5. Resources committed to cell culture
  6. What it has done so far
  7. What comes next
  8. What the company is aiming for in cell culture
  9. Map of cell culture partnerships
  10. Technologies, products and services
  11. The risks this company carries
  12. Glossary, references and claim-to-source audit

1. Nipro in 30 seconds, and where it stands in cell culture

LEGAL NAMENIPRO CORPORATIONThe company's official English name
HEADQUARTERSSettsu, Osaka, Japan3-26 Senrioka-Shinmachi
LISTINGTokyo Stock Exchange
Prime 8086
Listed on the TSE First Section in December 1996
CATEGORY IN THIS FIELDRegenerative medicine products (main)
Media and vessels (secondary)
The company as a whole is a medical device and pharmaceutical maker
MAIN CELL PRODUCTStemiracAutologous bone marrow-derived mesenchymal stem cells, for spinal cord injury
TYPE OF APPROVALConditional and time-limited
(28 December 2018)
Confirmed in the PMDA's list of approved products
FILING FOR FULL APPROVAL14 November 2025No announcement of approval found as of September 2026
SALES OF REGENERATIVE MEDICINE PRODUCTS¥850 millionYear to March 2026. About 0.13% of consolidated sales
The one thing to grasp first

Companies involved in cell culture can be divided into three types: contract development and manufacturing organisations (CDMOs), suppliers of equipment, consumables and media, and developers of cell and regenerative therapies. In cell culture, Nipro's main type is cell and regenerative therapy (it makes and sells an approved product under its own name, Stemirac), and its secondary type is supplier (research media, culture vessels and cryopreservation containers) Sourced. Of the two meanings of "cell culture", the company's work is concentrated on (2) regenerative medicine in which the cells themselves are the product, and the research culture materials for it. As for (1), producing biopharmaceuticals such as antibodies, it has obtained Japanese approval for biosimilars through a partnership with Samsung Bioepis of South Korea, but this is the commercialisation of in-licensed products; primary sources say nothing about Nipro carrying out the production culture.

2. The logo and how the name is written

The Nipro logo is a trademark of the company. We have not recreated it with generated imagery; the logo image (SVG) used on the official website is placed here as img/nipro_logo.svg.

A note on names: the legal entity's English name is NIPRO CORPORATION. The regenerative medicine product is marketed as "Stemirac for Injection" (a registered trademark); its non-proprietary name is "human (autologous) bone marrow-derived mesenchymal stem cells". The research media are made by a consolidated subsidiary, Cell Science & Technology Institute, Inc. (Sendai), and sold by Nipro. It is a separate company from Nipro Pharma, the group's pharmaceutical manufacturing subsidiary.

Official site: https://www.nipro.co.jp/

3. Where the company sits in the cell culture landscape

Three types of company involved in cell culture All of them "culture cells", yet what they actually sell is completely different CDMO (contract manufacturing) Tools, consumables & media Cell & regenerative therapy Makes others' drugs under contract Sells culture tools and materials Turns cells into the product Lonza / Samsung Biologics AGC Biologics / WuXi and others Thermo Fisher / Cytiva / Sartorius Merck / Ajinomoto / Corning, others Sumitomo Pharma / Takara Bio Allogene / ReproCELL and others Capacity and record win orders Sells whichever drug succeeds Approval brings a unique product Loses money if plants sit idle Falls when client spending cools High approval and cost hurdles Nipro: mainly on the right (makes and sells Stemirac), also in the middle (research media, vessels) But Nipro is mostly devices and drugs; regenerative medicine products are only about 0.13% of sales
Fig. 1 The three types of company involved in cell culture, and where Nipro sits. The classification is our own, and the companies shown are examples drawn from the 20 covered in this series Our calculation. Stemirac's approval is from the PMDA's list of products approved in FY2018; the ¥850 million in regenerative medicine product sales is from the IR materials for the year to March 2026; the ratio (¥850 million divided by consolidated sales of ¥660.5 billion) is our calculation.

4. Scale (the medical device business in brief)

The medical device and pharmaceutical businesses themselves are not the subject here, so only their size is noted Sourced.

Measure (consolidated)Year to March 2025Year to March 2026Year to March 2027 (company forecast)
Revenue (¥ million)644,586660,538700,000
Operating profit (¥ million)26,59837,62440,000
R&D expenses (¥ million)-26,817-
Employees39,16838,593-

Scale of the cell culture-related business (regenerative medicine)

MeasureValueSource and definition
Sales of regenerative medicine products (year to March 2025)¥540 millionSales by product in the IR materials for the year to March 2026
Sales of regenerative medicine products (year to March 2026)¥850 million (up 58.6%)As above
Regenerative medicine business sales (first quarter of the year to March 2027)¥258 million (¥160 million a year earlier)Segment note in the first-quarter results summary. Since April 2026 the regenerative medicine products business has been disclosed within "adjustments"
Regenerative medicine business profit (same period)−¥1,551 million (−¥1,749 million a year earlier)As above
Regenerative medicine facility (Tokyo CPF, Hamura, Tokyo)Book value ¥18,058 million / 115 employees"Major facilities" section of the annual securities report (31 March 2026)
A caution

In the annual securities report for the year to March 2026, regenerative medicine is included in the "Medical-related" segment, and no separate segment figures are disclosed. From April 2026, sales and profit of the regenerative medicine business have been shown in a note within "adjustments"; in the first quarter of the year to March 2027 there was a loss of ¥1.55 billion on sales of ¥258 million Sourced. This is defined differently from the "regenerative medicine products" figure in the sales-by-product data in the IR materials (¥220 million in the same quarter), so the two should not be added together or compared. The company also notes that "part of the manufacturing cost of regenerative medicine has been transferred to R&D expenses".

5. Resources committed to cell culture

ResourceWhat primary sources confirmConfirmed?
People (organisation, sites, headcount)An in-house Regenerative Medicine Division (headed by a managing director). 115 employees at the regenerative medicine manufacturing and research facilities of the Tokyo CPF (Hamura). The Regenerative Medicine Research Laboratories (Kusatsu, Shiga) have 578 staff together with the General Research Laboratories and the Pharmaceutical Research Laboratories; the number for regenerative medicine alone is not disclosed. A regenerative medicine R&D centre was opened in December 2016Partly confirmed
Money (R&D, capital expenditure)Of consolidated R&D expenses of ¥26,817 million, ¥17,649 million was for the Medical-related and other businesses. R&D and capital expenditure for regenerative medicine alone are not disclosed. The book value of the Tokyo CPF is ¥18,058 million (including leased assets of ¥10,923 million)Partly confirmed
Outside investments and acquisitionsThe research media are made by the consolidated subsidiary Cell Science & Technology Institute (Sendai). When it became a subsidiary, and at what cost, could not be confirmed in primary sourcesPartly confirmed
Universities and research institutesCo-developed Stemirac and STR03 with Sapporo Medical University. The human hematopoietic stem cell medium "HemEx®-TypeH" builds on technology from Professor Satoshi Yamazaki and colleagues at the Institute of Medical Science, University of TokyoConfirmed
A materials engineer's view: chemically defined media are "a fight against lot variation"

"CiMS®-U", launched by Nipro in April 2026, is a chemically defined medium free of biologically derived components for mesenchymal stem cells; the company says it supports stable culture of umbilical cord-derived as well as adipose-derived mesenchymal stem cells Sourced. In cell culture, the fact that biologically derived components such as fetal bovine serum vary in composition from lot to lot is a major obstacle to reproducibility and quality control. Chemically defined media reduce that variation, and the risk of unknown contaminants, by defining every component chemically. "HemEx®-TypeH", for hematopoietic stem cells, is likewise said to use a polymer developed as a pharmaceutical excipient so that it can do without albumin and keep lot-to-lot differences down. A company that has long made syringes and infusion bags to pharmaceutical quality now says its media, too, are "made to the same quality as pharmaceuticals and medical devices"; that is a very medical-device-maker way of thinking. Our explainer on cell culture media covers the basics.

6. What it has done so far

WhenWhat happenedWhy it matters
December 2016Opened a regenerative medicine R&D centreA research base for regenerative medicine
March 2018Launched "CiMS", a medium for human mesenchymal stem cellsThe starting point of the research media business
28 December 2018Stemirac received conditional and time-limited approval (as a regenerative medicine product with SAKIGAKE designation, a Japanese fast-track scheme). Indication: improvement of neurological symptoms and functional impairment associated with traumatic spinal cord injury (ASIA Impairment Scale A, B or C)The company describes it as the "world's first" regenerative medicine product for spinal cord injury
20 February 2019The calculated price was reported to the Central Social Insurance Medical Council (Chuikyo), the body that advises the health ministry on insurance prices: ¥14,957,755 per treatment (cost-based method, with a 10% premium for SAKIGAKE designation)Covered by Japan's public health insurance
FY2020 to FY2024The company's review of its previous medium-term plan found that the COVID-19 pandemic made treatment difficult, and the number of treating facilities and cases fell behind plan, so targets were missedThe company itself admits slow uptake
December 2023Announced "HemEx®-TypeH", a chemically defined medium for human hematopoietic stem cells (launched January 2024)Commercialised technology from the University of Tokyo's Institute of Medical Science
October 2024Started a Phase II trial of "STR03", autologous bone marrow-derived mesenchymal stem cells, in ALS (106 patients planned, double-blind; announced on 24 July 2025 together with completion of the first patient's dosing)Aims to widen indications with the same type of cell as Stemirac
May 2025The medium-term plan set out expectations of refiling by December 2025 and full approval in 2026Full approval built into the plan's assumptions
14 November 2025Applied for full approval of Stemirac. The company says it verified efficacy and safety internally through a comparative use-results survey within the seven-year approval periodThe procedure for moving on from conditional and time-limited approval
April 2026Launched the chemically defined medium "CiMS®-U". Changed how the regenerative medicine products business is disclosedA better medium, and more visibility of regenerative medicine's profit and loss

7. What comes next

STEMIRACUnder review for
full approval
Filed 14 November 2025. No announcement of approval found as of September 2026
MEDIUM-TERM SALES TARGETRegenerative medicine
+¥5.6 billion
Increase from FY2024 to FY2027, of which Stemirac accounts for +¥4.9 billion
NEW INDICATIONSALS and chronic
spinal cord injury
Advancing the STR03 Phase II trial and a company-sponsored trial of repeat dosing
TREATING FACILITIESNationwide expansionA medium-term plan policy. No target number of facilities is given

The May 2025 medium-term plan says it "expects to obtain full (formal) approval in 2026". The same document's timeline, however, also shows "full approval obtained: January 2027", so the timing varies even within the document Not yet confirmed. Full approval of Stemirac did not appear in the PMDA's list of products approved in FY2026 (which, when we checked, covered approvals up to 17 July 2026). On the other hand, Stemirac is still included in the Ministry of Health, Labour and Welfare's list of products under the NHI price standard (applicable from 20 May 2026) Sourced.

What could not be confirmed

None of the following appears in primary sources Not yet confirmed.

The timing of full approval of Stemirac; how it is treated after the time limit of the conditional and time-limited approval (December 2025) passed; the cumulative number of patients treated and treating facilities; the numerical results of the comparative use-results survey; capital expenditure and R&D spending in the regenerative medicine business; and when Cell Science & Technology Institute became a subsidiary.

8. What the company is aiming for in cell culture

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 readPrimary evidence behind itCategory
The immediate goal is full approval of Stemirac, and almost all the planned growth in regenerative medicine sales depends on itOf the planned +¥5.6 billion increase in regenerative medicine sales in the medium-term plan, +¥4.9 billion is from StemiracSourced
Reusing one cell manufacturing system across several diseasesIt is running an ALS trial with STR03, the same autologous bone marrow-derived mesenchymal stem cells as Stemirac, and also lists expansion into chronic spinal cord injuryInference
Media are being developed as components for standardisation and quality control in regenerative medicineThe annual securities report describes "developing solutions that accelerate the industrialisation of regenerative medicine, centred on this media technology that supports a stable supply of high-quality cells"Sourced
Regenerative medicine is treated as a small, loss-making, upfront-investment business within the companyThe regenerative medicine business had sales of ¥258 million and a loss of ¥1,551 million in the first quarter. Its disclosure was moved into adjustmentsInference
One inference, explained in full

Stemirac and STR03 are both products in which mesenchymal stem cells are taken from the patient's own bone marrow fluid, grown outside the body and returned into a vein by drip Sourced. The only differences are the target disease (spinal cord injury or ALS) and the number of doses, so the manufacturing system (collection kits, culture process, cryopreservation and transport to hospitals) can very probably be shared. Because autologous cell products are made one lot per patient, running a single process and adding target diseases is almost the only way to improve facility utilisation and cost per case. Our reading is that Nipro's explicit inclusion of ALS and chronic spinal cord injury in its medium-term plan is consistent with this Not yet confirmed.

9. Map of cell culture partnerships

Cell culture partnerships centred on Nipro Only ties stated in the annual securities report or company news releases; press-reported ties excluded Nipro Regen. med. unit Sapporo Medical University Co-developed Stemirac and STR03 IMS, University of Tokyo HSC expansion tech in a medium Cell Science & Tech. Inst. Subsidiary; makes research media Samsung Bioepis (Korea) Biosimilars sold in Japan Co-dev or tech transfer In-licensed (partner produces) Group company Few outside partners in cell culture appear in primary sources; no CDMO or equipment-maker ties were found
Fig. 2 Cell culture partnerships centred on Nipro. Sources: company news releases (14 December 2023; 24 July and 17 November 2025; 28 April and 3 September 2026). The partnership with Samsung Bioepis concerns commercialising antibody drugs (biosimilars), and production by cell culture is not described as Nipro's role, so it is shown distinctly from the others.

10. Technologies, products and services

CategoryProductWhat primary sources say
Regenerative medicine productStemirac (human (autologous) bone marrow-derived mesenchymal stem cells)Mesenchymal stem cells from bone marrow fluid collected from the patient, grown and expanded outside the body and cryopreserved. Includes, as sub-components, blood collection and bone marrow collection kits used at hospitals to collect peripheral blood and bone marrow fluid and send them to the manufacturing site. Given intravenously by drip (PMDA list of approved products)
Cell product in developmentSTR03 (human autologous bone marrow-derived mesenchymal stem cells)Phase II trial in ALS (repeat intravenous dosing, double-blind randomised controlled, 106 patients planned)
Research mediaCiMS®-U (for mesenchymal stem/stromal cells, chemically defined), CiMS (launched 2018), HemEx®-TypeH (for human hematopoietic stem cells, albumin-free)Made by Cell Science & Technology Institute and sold by Nipro. All are for research, not clinical use
Culture and storage containersCulture-related products, cell storage-related products (cryopreservation containers and reagents)Described as "made to the same quality as pharmaceuticals and medical devices". Not medical devices or pharmaceuticals themselves
A materials engineer's view: why a "collection kit" is part of the product

According to the PMDA's list of approved products, Stemirac includes as sub-components not only the cultured cells themselves but also kits for collecting bone marrow fluid and peripheral blood at the hospital Sourced. With autologous cell products, the conditions under which the raw material (the patient's cells) is collected and transported affect the quality of the final product, so the design manages even the raw-material devices as part of the product. For Nipro, which has long mass-produced devices for blood collection, infusion and dialysis, these "devices for collecting the raw material" are an extension of its core business. Our reading is that what a medical device maker brings to regenerative medicine is not just cell culture technology but the ability to supply its own devices for every step, from collection and transport through culture and freezing to administration Not yet confirmed.

11. The risks this company carries

RiskSubstanceCategory
Outcome of the full approval reviewThe company applied for full approval in November 2025, but whether and when approval will come is uncertain. The medium-term plan's growth in regenerative medicine sales assumes full approvalNot yet confirmed
Securing patientsIn its own review of the previous medium-term plan (FY2020 to FY2024), the company put sales growth in the Regenerative Medicine Division at 16.3% a year against a target of 249.8%, writing that "securing treating facilities and cases ... fell behind plan, and the targets were not met"Sourced
Losses in regenerative medicineIn the first quarter of the year to March 2027, the business lost ¥1,551 million on sales of ¥258 millionSourced
Priority within the companyRegenerative medicine products account for about 0.13% of consolidated sales. If losses continue, the business could be reconsidered when resources are allocatedInference
Results of the ALS trialDepending on the results of the STR03 Phase II trial (106 patients planned), expansion of the same cell technology to new indications could stallNot yet confirmed

12. Glossary

Regenerative medicine products
Products made by processing human cells or tissues, and gene therapy products. Japan's Pharmaceuticals and Medical Devices Act defines them as a category separate from drugs and medical devices.
Conditional and time-limited approval
A Japanese system that grants early approval to a regenerative medicine product, with conditions and a time limit of no more than seven years, when efficacy is presumed and safety is confirmed. A fresh application for approval is required within the time limit.
Full approval
Ordinary approval, as opposed to conditional and time-limited approval. Nipro applied afresh for Stemirac as a "new regenerative medicine product".
Comparative use-results survey
A post-marketing survey that assesses efficacy and safety by comparing information on patients who did and did not receive the product.
Mesenchymal stem cells (MSCs)
Stem cells obtained from bone marrow, fat, umbilical cord and other tissues. Their release of anti-inflammatory substances and similar actions are used therapeutically.
Chemically defined medium
A medium made entirely of chemically defined components, without serum or other biologically derived ingredients. See our explainer on cell culture media.
SAKIGAKE designation
A Japanese scheme that gives priority review and other support to bring innovative medicines and similar products to patients early. Stemirac is a designated product.
ASIA Impairment Scale
A scale that grades the severity of spinal cord injury from A (complete paralysis) to E (normal). Stemirac is indicated for grades A, B and C.
CPF
Cell Processing Facility: a facility for processing and culturing cells. Nipro has the "Tokyo CPF" in Hamura, Tokyo.
Concept diagram: an autologous cell product chain linked by devices, from collection kit through culture and freezing to drip administration
Fig. 3 Concept diagram of the flow of Nipro's autologous cell product. This is an AI-generated concept image and does not depict actual equipment or products.

13. References

  1. Nipro Annual securities report for the 73rd fiscal period (1 April 2025 to 31 March 2026; in Japanese, filed 25 June 2026): history, revenue, headcount, R&D activities (cell therapy products), capital expenditure, major facilities (Tokyo CPF) and segment information. https://www.nipro.co.jp/assets/document/ir_library/73rd/securities_report.pdf
  2. Nipro Consolidated financial results summary for the year to March 2026 [Japanese GAAP] (in Japanese, 12 May 2026): revenue, operating profit and the forecast for the year to March 2027. https://www.nipro.co.jp/assets/document/ir_library/73rd/financial_results.pdf
  3. Nipro IR materials for the year to March 2026 (in Japanese, May 2026): sales by product (regenerative medicine products) and the transfer of regenerative medicine manufacturing costs to R&D expenses. https://www.nipro.co.jp/assets/document/ir_library/73rd/ir_materials.pdf
  4. Nipro Medium-Term Management Plan (in Japanese, May 2025): review of the previous plan (regenerative medicine targets missed), planned change in regenerative medicine sales, the schedule for full approval of Stemirac and the policy on new indications. https://www.nipro.co.jp/assets/document/ir_library/72nd/midtermplan.pdf
  5. Nipro Consolidated financial results summary for the first quarter of the year to March 2027 [Japanese GAAP] (in Japanese, August 2026): segment change and regenerative medicine business sales and profit. https://www.nipro.co.jp/assets/document/ir_library/74th_first/financial_results.pdf
  6. Nipro IR materials for the first quarter of the year to March 2027 (in Japanese, August 2026): sales by product (regenerative medicine products). https://www.nipro.co.jp/assets/document/ir_library/74th_first/ir_materials.pdf
  7. Nipro Notice of application for full approval of the regenerative medicine product "Stemirac® for Injection" (in Japanese, 17 November 2025). https://www.nipro.co.jp/assets/document/newsrelease/251117.pdf
  8. Nipro Notice of the start of a Phase II clinical trial of human autologous bone marrow-derived mesenchymal stem cells "STR03" for ALS (in Japanese, 24 July 2025). https://www.nipro.co.jp/assets/document/newsrelease/250724.pdf
  9. Nipro Notice of the launch of "CiMS®-U", a chemically defined medium for human mesenchymal stem/stromal cells (in Japanese, 28 April 2026). https://www.nipro.co.jp/assets/document/newsrelease/260428_2.pdf
  10. Nipro Notice of the launch of "HemEx®-TypeH", a chemically defined medium for human hematopoietic stem cells (in Japanese, 14 December 2023). https://www.nipro.co.jp/assets/document/newsrelease/231214_1.pdf
  11. Nipro Marketing approval obtained for the biosimilar ustekinumab BS 130 mg for intravenous infusion "Nipro" (in Japanese, 3 September 2026). https://www.nipro.co.jp/assets/document/newsrelease/260903.pdf
  12. Pharmaceuticals and Medical Devices Agency (PMDA) List of products approved in FY2018 (regenerative medicine products; in Japanese): Stemirac's approval date, type of approval, components and indication. https://www.pmda.go.jp/files/000231456.pdf
  13. Pharmaceuticals and Medical Devices Agency (PMDA) List of products approved in FY2026 (regenerative medicine products; in Japanese). https://www.pmda.go.jp/files/000282058.pdf
  14. Ministry of Health, Labour and Welfare Minutes of the 409th general meeting of the Central Social Insurance Medical Council (in Japanese, 20 February 2019): pricing method and calculated price for Stemirac. https://www.mhlw.go.jp/stf/shingi2/0000205879_00054.html
  15. Ministry of Health, Labour and Welfare List of products under the NHI price standard (injectables, applicable from 20 May 2026; in Japanese): listing of Stemirac. https://www.mhlw.go.jp/topics/2026/04/dl/tp20260520-01_05.pdf
  16. Nipro Regenerative medicine business page (culture-related and cell storage-related products; in Japanese). https://www.nipro.co.jp/business/regenerativemedicine/
  17. Nipro Official website (in Japanese; used to check the logo). https://www.nipro.co.jp/

14. Claim-to-source audit

Claim in the articleCategorySource
Legal name, English name, head office address, listing history and the opening of the regenerative medicine R&D centreSourcedReference 1 https://www.nipro.co.jp/assets/document/ir_library/73rd/securities_report.pdf
Revenue, headcount, R&D expenses and capital expenditure; the Tokyo CPF's book value and headcountSourcedReference 1 https://www.nipro.co.jp/assets/document/ir_library/73rd/securities_report.pdf
Operating profit for the year to March 2026 and the forecast for the year to March 2027SourcedReference 2 https://www.nipro.co.jp/assets/document/ir_library/73rd/financial_results.pdf
Sales of regenerative medicine products (¥540 million to ¥850 million) and the transfer of manufacturing costs to R&D expensesSourcedReference 3 https://www.nipro.co.jp/assets/document/ir_library/73rd/ir_materials.pdf
Regenerative medicine products at about 0.13% of consolidated salesOur calculationOur calculation from figures in references 1 and 3
First-quarter regenerative medicine sales of ¥258 million and loss of ¥1,551 million, and the change in disclosureSourcedReference 5 https://www.nipro.co.jp/assets/document/ir_library/74th_first/financial_results.pdf
First-quarter sales by product (regenerative medicine products ¥220 million)SourcedReference 6 https://www.nipro.co.jp/assets/document/ir_library/74th_first/ir_materials.pdf
Stemirac's conditional and time-limited approval (28 December 2018), SAKIGAKE designation, components and indicationSourcedReference 12 https://www.pmda.go.jp/files/000231456.pdf
Calculated price of ¥14,957,755 per treatment (cost-based method, 10% SAKIGAKE premium)SourcedReference 14 https://www.mhlw.go.jp/stf/shingi2/0000205879_00054.html
Application for full approval (14 November 2025) and verification through the comparative use-results surveySourcedReference 7 https://www.nipro.co.jp/assets/document/newsrelease/251117.pdf
Full approval of Stemirac is absent from the PMDA's FY2026 list of approved products (covering approvals to 17 July)SourcedReference 13 https://www.pmda.go.jp/files/000282058.pdf
Stemirac is included in the NHI price standard list applicable from 20 May 2026SourcedReference 15 https://www.mhlw.go.jp/topics/2026/04/dl/tp20260520-01_05.pdf
Timing of full approval, treatment after the time limit, and cumulative cases and facilitiesNot yet confirmedCould not be confirmed in primary sources https://www.nipro.co.jp/assets/document/newsrelease/251117.pdf
The medium-term plan's expectation of full approval, planned regenerative medicine sales growth, policy on new indications, and the missed targets of the previous planSourcedReference 4 https://www.nipro.co.jp/assets/document/ir_library/72nd/midtermplan.pdf
The STR03 Phase II trial in ALS (started October 2024, 106 patients planned) and co-development with Sapporo Medical UniversitySourcedReference 8 https://www.nipro.co.jp/assets/document/newsrelease/250724.pdf
Features of CiMS®-U, manufacture by Cell Science & Technology Institute and sale by Nipro, and the March 2018 launch of CiMSSourcedReference 9 https://www.nipro.co.jp/assets/document/newsrelease/260428_2.pdf
Features of HemEx®-TypeH and the technology from the Institute of Medical Science, University of TokyoSourcedReference 10 https://www.nipro.co.jp/assets/document/newsrelease/231214_1.pdf
Biosimilar approval through the partnership with Samsung BioepisSourcedReference 11 https://www.nipro.co.jp/assets/document/newsrelease/260903.pdf
Culture-related and cell storage-related products made to the same quality as pharmaceuticals and medical devices, and the company's description of Stemirac as the "world's first" approved regenerative medicine product for spinal cord injurySourcedReference 16 https://www.nipro.co.jp/business/regenerativemedicine/
Headcount, R&D spending and capital expenditure for regenerative medicine alone, and when Cell Science & Technology Institute became a subsidiaryNot yet confirmedNot in primary sources. This article makes no estimate https://www.nipro.co.jp/assets/document/ir_library/73rd/securities_report.pdf
The three types of cell culture company, and Nipro's main and secondary typesOur calculationOur own classification. Companies shown are examples from the 20 in this series
The reading that one cell manufacturing system is being reused across several diseasesInferenceThis article's interpretation of what Stemirac and STR03 have in common
The reading that regenerative medicine is treated as a loss-making upfront investment, and the risk around its priority within the companyInferenceThis article's interpretation of first-quarter results and the change in disclosure
The reading that supplying devices for every step from collection to administration is a medical device maker's strengthInferenceThis article's interpretation of the product components in the PMDA list

Last updated 23 September 2026 / Troy Technical
Every figure in this article comes from Nipro's annual securities report, financial results summaries, IR materials, medium-term management plan and news releases, from the PMDA's lists of approved products, and from the minutes of the Ministry of Health, Labour and Welfare's Central Social Insurance Medical Council. 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.

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