Takeda Pharmaceutical Co, Ltd

Performance in the 2024 Index

 9th place. Takeda ranks in the top ten, performing above average across the three technical areas: Governance of Access, Research & Development and Product Delivery. The company demonstrates Best Practice in Product Delivery for transferring technology for end-to-end vaccine manufacturing. 

Opportunities for Takeda

Broaden the geographic reach of access plans to include more low- and lower-middle-income countries. Takeda has comprehensive access plans in place for all its late-stage R&D candidates. These plans focus primarily on upper-middle-income countries. It can expand these plans to include more low- and middle-income countries within scope, in particular those with a high burden of disease. 

Expand access to its oncology products. Takeda has access strategies for its oncology medicines, including on-patent products brentuximab vedotin (Adcetris®), indicated for non-Hodgkin lymphoma, and brigatinib (Alunbrig®), indicated for lung cancer, in upper-middle-income countries and lower-middle-income countries. The company can increase access in low-income countries and improve the affordability of these medicines through increasing registration and/or implementing equitable access strategies. 

Expand access to its dengue vaccine QDENGA® (TAK-003). Takeda's dengue vaccine was approved in 2022 and is currently registered in six countries in scope. In 2024, the World Health Organization recommended the use of QDENGA® (TAK-003) in children aged 6–16 years in settings with high dengue transmission intensity. In line with this recommendation, Takeda can expand access to the vaccine in countries where dengue is endemic, through increased registration, equitable access strategies and/or supranational procurement mechanisms. 

Changes since the 2022 Index

• Launched dengue fever vaccine QDENGA® in multiple LMICs and achieved WHO prequalification to facilitate its potential procurement by UN agencies, including UNICEF and the Pan American Health Organization (PAHO). 

• Announced five new partnerships in its global corporate social responsibility programme to strengthen health systems in LMICs, aiming to reach 25.2 million people in 92 countries by 2028. 

• Engaged in a technology transfer agreement with Biological E. Limited to manufacture and supply up to 50mn doses annually of its dengue vaccine, QDENGA®. 

• Evolved its integrated business approach for access to medicines (ATM) in LMICs with the establishment of ATM Units and implemented these units in six countries in scope of the Index, with a focus on oncology, rare diseases and gastroenterology products. 

• Integrated access metrics within the Corporate Philosophy metrics in its Annual Integrated Report and increased the publication frequency of its Access to Medicines Progress Report from bi-annual to annual.

Sales and operations

Therapeutic areas: Gastroenterology, neuroscience, oncology, plasma-derived therapies, rare diseases 

Product categories: Innovative medicines, vaccines 

M&A news: Takeda acquired Nimbus Lakshimi Inc. for USD 6bn in 2023. 

Sample of pipeline and portfolio assessed by the Index

PIPELINE for diseases in scope

Takeda has 11 R&D projects in scope, 3 of which target priority diseases, focusing on Chagas disease and leishmaniasis (1), dengue (1) and malaria (1). The remaining 8 projects target other diseases in scope, including cancer (5). Of the 11 R&D projects, 3 are in late-stage development, with evidence of access planning for 100% (3/3) of these. 

PORTFOLIO as selected for analysis by the Index

Takeda has 15 products in scope, including 14 medicines and 1 vaccine for the prevention of the neglected tropical disease, dengue fever. Four of its products are listed on the WHO EML and 11 medicines are on patent. Takeda’s medicines are all indicated for non-communicable diseases, namely cancer (6), diabetes (4) and cardiovascular diseases (3). 

Performance breakdown

Governance of Access

RANK 7TH, SCORE 4.16

Takeda performs above average in this Technical Area. The company has a comprehensive access-to-medicine strategy integrated within its overall corporate strategy, as well as direct board-level responsibility for access. Takeda does not set individual-level targets for its sales agents; rather, targets are assessed collectively at a team level. It also 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. 

The highest responsibility for access lies directly with the Board, namely the CEO of the Takeda Executive Team. Takeda incentivises its senior executives and in-country managers in its Growth and Emerging Markets units to act on access to medicine with financial and non-financial targets. The CEO has long-term access-related incentives. 

Comprehensive access-to-medicine strategy integrated within the overall corporate strategy. Its strategy covers all therapeutic areas in which the company is involved. Takeda publicly discloses its commitments to access to medicine, along with company-specific targets, goals and objectives. Reporting is mostly clear, linked to these goals, centrally available, and updated regularly in its Annual Integrated Report. 

Shows comparatively strong commitment to responsible business practices.  Takeda does not set individual-level targets for sales agents; rather, targets are assessed collectively at team level,  and incentives are not solely based on sales volume. Takeda commits to ensuring ethical interactions with healthcare professionals in its code of conduct. It also declares that transfers of value to healthcare professionals (e.g., payments for ad-hoc consulting) are made at fair market value. However, it only publicly discloses information on such payments in countries in scope if required by law or local regulation. 

Has robust set of controls to promote ethical conduct and mitigate risk to ensure that governance efforts are not undermined by noncompliant or corrupt activities. Takeda 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. Takeda also has an ethical decision-making framework for employees. No breaches in countries in scope were found in the period of analysis. 

Takeda publicly supports the Doha Declaration on TRIPS and Public Health. However, it expresses reservations on some provisions of TRIPS flexibilities, namely compulsory licensing. Takeda states that compulsory licensing is not a sustainable solution for addressing challenges in accessing medicines. 

Fulfils some criteria with its process for measuring and reporting the patient reach of its affordability-based patient assistance programmes (PAPs). For this process, which covers some of its products and some countries in scope of the Index, Takeda publicly provides the underlying equation, metrics, assumptions and limitations. The resulting patient reach numbers are published regularly and demonstrate improvements. No associated patient reach and health outcomes goals were identified for this process. 

Research and Development

RANK 10TH, SCORE 2.63

Takeda performs above average in this Technical Area. It has an access planning framework and publicly commits to access planning from Phase II onwards, applying this to all late-stage pipeline candidates. It has a mixed pipeline, with projects targeting both priority and non-communicable diseases, although the number of priority projects has fallen. Some access plans are comprehensive, although often focused on a small number of countries, mainly UMICs. Takeda does not disclose disaggregated R&D investment data, but it performs strongly in R&D capacity building. 

Structured process in place to develop access plans during R&D. The process is intended to be applied to all R&D projects in scope, no later than Phase II. The company makes a public commitment addressing its systematic approach to access planning for LMICs. 

Small-sized priority R&D pipeline, compared to peers, with access plans in place for 100% (1/1) of the late-stage candidates. Priority R&D pipeline of 3 projects, including 1 late-stage project that targets a priority gap. The company focuses on various priority areas, including Chagas disease, leishmaniasis and dengue. Takeda's 1 late-stage project targeting a priority product gap has evidence of an access plan in place and includes multiple components, among others, a tech transfer manufacturing agreement, equitable pricing plans and WHO prequalification. 

Small-sized pipeline, compared to peers, addressing other diseases in scope, with 100% (2/2) of late-stage projects covered by access plans. The company has 2 late-stage R&D projects targeting diseases in scope that have not been established as a priority by global health stakeholders. The projects mainly target cancer. Takeda provides evidence of access plans for both of its late-stage projects, including registration preparation, post-trial access and the inclusion of special populations in clinical trials. 

Takeda does not publicly disclose R&D investment data disaggregated by disease category, product type or phase of development. However, it does disclose anonymised disaggregated R&D investment data to Impact Global Health (formerly Policy Cures Research). 

All 5 R&D capacity building initiatives included for analysis meet all Good Practice Standards (GPS). For example, Takeda builds R&D capacity in Asia and Africa by educating, supporting and funding local researchers in their knowledge and securing follow-up funding for research gaps.

Product Delivery

RANK 11TH, SCORE 3.17

Takeda performs above average in this Technical Area. The company has access strategies in place for its products; however, these are limited to upper-middle and lower-middle-income countries. It reports data on the outcomes of these strategies. The company did not engage in new intellectual property sharing agreements during the period of analysis. All its supply chain and health system strengthening initiatives meet all Good Practice Standards. 

Takeda registers newer products* in 6 countries in scope on average. It registers 44% of products assessed in at least 1 of the 10 countries with the highest disease burden; only 1 product is registered in LICs. The company’s brentuximab vedotin (Adcetris®), indicated for non-Hodgkin lymphoma, is most widely registered, totalling 19 countries in scope. The company reports engaging in mechanisms to facilitate registration, for example, the European Medicines Agency EU-M4all (former Article 58). 

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

Takeda is not eligible for assessment of supranational access strategies because it has no products in scope that are supranationally procured. 

Access strategies for its healthcare practitioner (HCP)-administered products in some countries, with outcomes tracked and reported. For the 3 products analysed, Takeda provides access strategy examples in UMICs and one example in an LMIC but not in any LICs. The strategies are comprehensive, and the company shows some efforts to consider different payers’ ability to pay. For example, for 2 of its products Takeda has achieved or works towards public reimbursement in Thailand (UMIC) and the Philippines (LMIC). Health system strengthening initiatives are also reported as part of the strategies for these products. The company supplies its dengue vaccine (QDENGA®) through the public health system in Brazil (UMIC). The company also reported on several metrics that are monitored to track the strategy and has measurable goals for providing access in additional countries subject to approval. In addition, for the other strategies, Takeda provides patient reach data and some details on the approaches applied to measure the strategies’ outcomes. 

Provides evidence of access strategies for self-administered products in some countries, supported by information on outcomes. For 3 of the 4 products selected for analysis, Takeda provides access strategy examples in UMICs and for only one of them also an LMIC example. The company supplies the fourth product included in the analysis – ponatinib (Iclusig®) – as a donation via the Max Foundation in all 3 country income classification examples. In the strategies analysed, Takeda demonstrates efforts in improving the availability and affordability of its products. For example, for one of its oncology products the company is working towards national reimbursement in Thailand (UMIC); in the interim Takeda has offered an affordability-based patient assistance programme (PAP) to support patients’ costs. For the same product, different PAPs are also implemented in the Philippines (LMIC), where the company offers a fixed-scheme co-payment support, or an affordability-based PAP based on the individual patient's ability to pay. Takeda shares plans to advance its strategies and reports on the patients reached, as well as the approaches used to track the strategies' outcomes. 

Takeda publicly commits not to file for or enforce patents for all products in least developed countries and LICs. 

Publicly discloses product patent status for countries in scope. Like most peers, Takeda 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. 

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

Both manufacturing capacity building initiatives included for analysis meet all GPS. For example, Takeda is supporting Brazilian manufacturer Hemobras to build its infrastructure and biologics manufacturing capacity through a technology transfer initiative. Takeda is investing USD 250mn in the construction of a new manufacturing facility for the partner. 

All 5 supply chain capacity building initiatives included for analysis meet all GPS. For example, through the Blueprint for Innovative Healthcare Access, Takeda and BIO Ventures for Global Health aim to improve cancer drug access in Nigeria by enhancing procurement processes, forecasting to stabilise supply and tracking shipments to the patient. 

All 5 health system strengthening initiatives included for analysis meet all GPS. In 1 initiative, Takeda is supporting IntraHealth International to improve maternal and child healthcare for rural populations in Mali, Niger and Senegal through improving quality education for nurses and midwives. To date 3,073 students, faculty, and staff across the 3 countries developed new or enhanced healthcare skills and knowledge. 

Takeda remains engaged in an existing IP-sharing agreement with a drug discovery initiative. The company shares IP assets through the Corona Accelerated R&D in Europe, which aims to deliver new coronaviral products. However, Takeda has not entered into any new agreements during the period of analysis. 

Fulfils most criteria for ad hoc donations. Takeda has policies and supply processes to carry out ad hoc donations rapidly in response to expressed need, with delivery monitored to ensure donations reach patients. For example, in May 2023, Takeda responded to aid requests from Direct Relief, by donating medicines to Ukraine. The donation comprised 77,000 bottles of 11 products, including 1 product in scope, lanthanum carbonate (Fosrenol®). Takeda reports that it adheres to the most recent WHO Guidelines for Medicine Donations. However, it has not made a public commitment to doing so. 

Fulfils all criteria for mechanisms to ensure continuous supply in LMICs. For example, Takeda is transferring technology for full manufacturing of its dengue tetravalent vaccine (live, attenuated) (QDENGA®) to Biological E. Limited.  Biological E. Limited will make the vaccine available in endemic countries, potentially through organisations such as Gavi, the Vaccine Alliance (Gavi) and the Pan American Health Organization (PAHO). 

Takeda has a policy for reporting substandard and falsified medicines in countries in scope. It reports cases to national or local regulatory authorities within 7 days. The company provides evidence of shortened reporting timeframes for cases that only require visual inspection for confirmation. 

Takeda operates an inclusive business model that covers 6 countries in scope and offers 2 products. Launched in 2023, and evolving from a previous model, Takeda's Access to Medicine Units (ATMUs) operate in countries, such as Thailand and Vietnam alongside regular business units. ATMUs focus on expanding access for patients and receive temporary relief on profitability targets, allowing for reinvestment of revenues. The model includes oncology products, brentuximab vedotin (Adcetris®) and brigatinib (Alunbrig®), and plans to expand the disease scope to include rare and neurological diseases.