Astellas Pharma Inc

Performance in the 2026 Index

17th place. Astellas is among the lowest-performing companies overall across all three Technical Areas. Robust anti-corruption controls strengthen performance. However, the absence of priority disease research and development (R&D), lack of access planning and limited registration and coverage of access strategies remain significant gaps. 

Opportunities for Astellas

Ensure all late-stage R&D projects are covered by comprehensive access plans. Astellas does not provide evidence of access planning for any of its late-stage candidates. It can strengthen its approach to access planning by ensuring that all late-stage projects are covered by comprehensive access plans that address availability, affordability and sustainable supply in low- and middle-income countries (LMICs).  For example, it can develop access plans for the paediatric adaption of gilteritinib (Xospata®), currently in Phase III development for leukaemia. 

Expand access to its innovative oncology products. Astellas has access strategies in place for its oncology products. However, these strategies do not extend to low-income countries (LICs), and the products are supplied in an average of seven countries in scope. It can expand access strategies to more countries for key products such as enzalutamide (Xtandi®) for prostate cancer, enfortumab vedotin (Padcev®) for bladder cancer and gilteritinib (Xospata®) for leukaemia.  

 Publicly disclose the components of its patient reach approach. Astellas’ approach includes metrics but does not provide further evidence of other methodology components, including the equation, assumptions and limitations. It could further strengthen patient reach reporting by regularly publishing disaggregated patient reach numbers, including disaggregation by geographic region and/or country income level, and disclosing the outcomes of its product-specific access strategies. 

Changes since the 2024 Index

• Partnered with Direct Relief to provide donated tacrolimus (Prograf®) for patients who require an immunosuppressant in Tanzania, with more than 200 patients reached to date.  

• Through the Astellas Global Health Foundation, supported different health system strengthening and community health initiatives in LMICs. Recent grants supported child health services in Senegal through Amref Health Africa, HIV and tuberculosis (TB) service delivery in Kenya through PATH, essential health services in Yemen through International Medical Corps, emergency preparedness and community health resilience in Peru through Plan International, and mental health services for refugees in Uganda through the Office of the United Nations High Commissioner for Refugees.  

• Secured global rights to an Evopoint Biosciences antibody-drug conjugate that targets claudin 18.2, maintaining its investment in gut cancer. 

Sales and operations

Therapeutic areas: Oncology, ophthalmology, nephrology, transplantation, urology, women’s health

Product categories: Innovative medicines 

M&A news: None identified

Sample of pipeline and portfolio assessed by the Index

PIPELINE for diseases in scope

Astellas has 8 R&D projects in scope, none of which target priority diseases. All 8 projects target other diseases in scope, focusing on cancer (7) and kidney diseases (1). Of its 8 R&D projects, 3 are in late-stage development, with evidence of access planning for 0% (0/3) of these.

PORTFOLIO as selected for analysis by the Index

Astellas has 5 medicines in scope, 1 of which is listed on the WHO EML. All its medicines are on patent and exclusively target NCDs, such as cancer (4) and kidney diseases (1).

Performance breakdown

Governance of Access

RANK 15th, SCORE 3.28

15th place. Astellas is among the lower-performing companies in Governance of Access. It has board-level oversight of access to medicine and robust controls to mitigate non-compliance and corruption risks.  However, access-related goals are not linked to incentives for senior executives or in-country managers. It has a systematic, company-wide patient reach approach, but does not publicly disclose the components. Its measurable, time-bound target spans product reach and capacity-building activities, limiting assessment of product-level reach. 

Has board-level oversight of access to medicine via its Sustainability Committee. Progress on access-to-medicine activities is reported to the Board of Directors at least annually. Astellas' access-related goals are not tied to incentive plans for senior executives or in-country managers. Astellas provides training, awareness-raising or guidance to employees on the access-to-medicine strategy and activities at least annually.  

Shows strong commitment to responsible sales and promotional practices. Astellas sets team-level sales targets when individual-level targets are not possible, and incentives are not solely based on sales volume. It has a policy on ensuring ethical interactions with healthcare professionals and declares that transfers of value to healthcare professionals (e.g., payments for attending events) are made at fair market value. It also offers guidance on establishing and documenting a legitimate need for interactions with healthcare professionals. It publicly discloses information on such payments in countries in scope if required by law or local regulation. 

Has a robust set of controls to promote ethical conduct and mitigate risk to ensure that governance efforts are not undermined by non-compliant or corrupt activities. Astellas performs strongly in this respect. It has policies to mitigate non-compliance risks, including processes to ensure third-party compliance with company standards, fraud-specific risk assessments and region or country risk-based assessments. It has an ethical decision-making framework for employees, but it does not publicly disclose the frequency of related training. No breaches in countries in scope were found during the analysis period.  

Publicly supports the Doha Declaration on TRIPS and Public Health. However, Astellas expresses reservations on some provisions of TRIPS flexibilities, namely compulsory licensing. It states that compulsory licensing is justified only in national emergencies or other urgent situations, in line with international regulations, and only after exhausting all other options.  

Performs moderately in its approach to measuring and reporting on patient reach. Astellas applies a systematic, company-wide approach across its full portfolio and all countries where it supplies products. Only the metrics are disclosed but provided under NDA; other components are not disclosed publicly or to the Index. It has set a measurable, time-bound goal. However, this combines product reach with capacity-building activities, so progress on product-level patient reach cannot be demonstrated. Patient reach is reported at least annually and is disaggregated for a limited number of products.  

Research and Development

RANK 20th, SCORE 0.22

20th place. Astellas is among the lowest-performing companies in R&D. It has no pipeline projects addressing priority diseases in scope and no evidence of access plans for any of its late-stage projects addressing other diseases. It also does not disclose disaggregated R&D investment data publicly, and no qualifying R&D capacity-building initiatives were identified. 

Does not have any pipeline projects addressing priority diseases in scope.  

Small-sized pipeline addressing other diseases in scope, compared to peers, consisting of 8 projects, with access plans identified for 0% (0/3) of its late-stage R&D projects. These projects target diseases not currently identified as priorities by global health stakeholders. Astellas does not provide evidence of access plans for any of the 3 late-stage projects. 

Does not publicly disclose R&D investment data disaggregated by disease category, product type or phase of development. Furthermore, Astellas does not disclose disaggregated R&D investment data to global health organisations. *  

^{*Astellas currently has no pipeline candidates within the disease scope of Impact Global Health, an organisation that assesses disaggregated R&D data.} 

No evidence of R&D capacity-building initiatives that meet inclusion criteria. 

Product Delivery

RANK 16th, SCORE 2.02

16th place. Astellas is among the lower-performing companies in Product Delivery. It registers newer products in fewer countries than its peers on average, none in low-income countries. It reports access strategies for its products, though geographic coverage and data on outcomes of the strategies are limited. Some of its supply chain capacity-building initiatives and health system strengthening initiatives meet all Good Practice Standards (GPS), and it has mechanisms in place to ensure continuous supply in LMICs. 

Registers newer products* in fewer countries (8) than its peers on average. Astellas’ products are, on average, registered in 2 of the countries with the highest disease burden, in line with the industry average. None of the products assessed are registered in LICs. Enzalutamide (Xtandi®), indicated for prostate cancer, is its most widely registered product, totalling 29 countries in scope. It did not report on participating in any mechanisms to facilitate registration. 

*Products that received their first marketing authorisation within the last 5 years.  

Not eligible for assessment of supranational access strategies because none of its products in scope are supranationally procured.  

Access strategies for its HCP-administered product, but with limited geographic coverage and limited data on outcomes. For the 1 product analysed, Astellas provides evidence of access strategies in upper-middle-income country (UMIC) and LMIC examples, with no evidence in LICs. It provides evidence of efforts to ensure affordability. It shows some evidence of tracking outcomes of its strategies and reports the number of patients reached in the UMIC example only. 

Access strategies for self-administered products vary in comprehensiveness, with limited data on outcomes. For the 2 products analysed, Astellas provides examples of access strategies in UMICs and LMICs, but not in LICs. It provides evidence that it considers the ability to pay for different segments of the population for both products. These strategies are supported by additional initiatives, including financial support and patient support programmes, as well as capacity-building initiatives, for example through collaboration with the national government in 1 LMIC. For both UMIC examples and 1 LMIC example, Astellas reports its methodology for tracking outcomes, but not any corresponding numbers of patients reached. 

Publicly commits not to file for or enforce patents on all products in LDCs and LICs. 

Publicly discloses product patent status for countries in scope. Astellas publicly discloses patent information for small molecules in scope via the Pat-INFORMED database, including information such as filing date, grant number, grant date and jurisdiction.  

Does not engage in non-exclusive voluntary licensing for products in scope.  

No evidence of manufacturing capacity-building initiatives that meet inclusion criteria.  

The 1 supply chain capacity-building initiative included for analysis meets all GPS. Since 2024, Astellas has been partnering with PATH in Kenya to support integrated HIV and TB care. This includes conducting a supply chain assessment for contraceptives and HIV prevention supplies and improving their availability in health centres.  

3 of the 5 health system strengthening initiatives included for analysis meet all GPS. For example, Astellas is supporting MAP International in improving awareness, early detection and treatment of prostate cancer in Vietnam to reach underserved populations. The initiative involves training programmes for healthcare professionals and data sharing.  

Remains engaged in existing IP-sharing agreements with public research institutions and drug discovery initiatives to accelerate drug development. One such agreement is Astellas’ exclusive agreement with Tutela Pharmaceuticals, maintained since 2022, to develop treatments for filovirus indications. However, the company has not made new agreements during the period of analysis.  

Fulfils 2 of 3 mechanisms to ensure continuous supply in LMICs and is involved in local manufacturing at its own site in a country in scope. For example, Astellas holds buffer stocks lasting 4-6 months for enzalutamide (Xtandi®), indicated for prostate cancer, at its own warehouses in Brazil, Colombia and Mexico to support supply to Latin American countries. Where it does not have a warehouse, it requires third party distributors to hold buffer stocks.  

Has a policy for reporting substandard and falsified medicines in countries in scope. Astellas reports cases to WHO Rapid Alert and/or national or local regulatory authorities within 10 business days. It provides evidence of shortened timeframes for reporting cases that only require visual inspection for confirmation.  

 No evidence of inclusive business models that meet all inclusion criteria.