AstraZeneca plc

Performance in the 2024 Index

5th place. AstraZeneca is a high-performing company. It performs well in Governance of Access and Product Delivery, and above average in Research & Development. It demonstrates Best Practice in reporting outcomes for its access strategies.  

Opportunities for AstraZeneca

Improve the quality and broaden the geographic reach of access plans. AstraZeneca has access plans for nearly all its late-stage projects. However, these plans predominantly focus on registration in emerging markets. For example, its late-stage oncology projects focus primarily on registration preparation and include four countries in scope, on average. The company can expand its plans, for example, by including supply and demand plans and/or licensing and broadening the geographic coverage of these plans to focus more on low- and middle-income countries. 

Expand access to innovative oncology products. AstraZeneca has comprehensive access strategies in place for most of its products targeting non-communicable diseases; however, it lacks access strategies in low-income countries for its oncology products. It can increase access to these products, such as osimertinib (Tagrisso®) – a key lung cancer medicine that is prioritised for voluntary licensing by public health organisations – through equitable access strategies or voluntary licensing. 

Publicly report on patient reach of the Healthy Heart Africa (HHA) programme. Through HHA, AstraZeneca aims to address the disease burden of cardiovascular disease and, since 2024, chronic kidney disease. The programme includes awareness raising, healthcare worker trainings, screenings and treatments, where applicable. As of the end of March 2024, the company reports that HHA has identified over 10.8 million people with elevated blood pressure, to be referred for appropriate treatment. While the company annually reports the number of people screened, it does not specify the number of patients reached by its antihypertensive product specifically. Publicly reporting these details can foster accountability and clarify the impact of the model. 

Changes since the 2022 Index

• Launched Cancer Care Africa in November 2022, an initiative which aims to improve patient outcomes by advocating for policy change and improved cancer screening. 

• Expanded the Healthy Heart Africa (HHA) programme to additional countries including Burkina Faso, Central African Republic, The Gambia, Madagascar, Malawi, Morocco, Mozambique, Sierra Leone, Zambia and Zimbabwe. HHA aims to improve access to end-to-end hypertension management and was recently expanded to encompass a broader spectrum of non-communicable diseases, such as chronic kidney disease. 

• Began the worldwide withdrawal of its COVID-19 vaccine (Vaxzevria®). 

• Announced plans to invest GBP 650mn (USD 826.8mn) in Britain to boost research, development and manufacturing of vaccines. 

• Signed agreement to invest USD 475mn to build a small-molecule drug factory in eastern China's Wuxi, the location of its first plant in China. 

• Opened the Africa Health Innovation Hub, which aims to use the latest technologies to increase access to healthcare. 

• Increased its investment in a manufacturing facility in Qingdao, China, that will produce its COPD treatment Breztri® aerosol inhalant.

Sales and Operations

Therapeutic areas: Biopharmaceuticals (including cardiovascular, immunology, metabolism, renal and respiratory), immune therapies, oncology, rare diseases, vaccines 

Product categories: Innovative medicines, vaccines 

M&A news: AstraZeneca acquired TeneoTwo Inc. for USD 1.2bn and Logic Bio for USD 68mn in 2022. In 2023, it acquired Neogene Therapeutics Inc. for USD 120mn; CinCor Pharma, Inc. for USD 1.1bn; and Pfizer’s pre-clinical rare disease gene therapy portfolio for USD 1bn. In 2024, it acquired Gracell Biotechnologies Inc. For USD 1.2bn; Icosavax for USD 1.1bn; and Amolyt Pharma for USD 1.08bn. 

Sample of pipeline and portfolio assessed by the Index

PIPELINE for diseases in scope

AstraZeneca has 79 R&D projects in scope, 10 of which target priority diseases, focusing on influenza (5) and COVID-19 (4). The remaining 69 projects target other diseases in scope, including cancer (44), cardiovascular diseases (6) and kidney diseases (5). Of the 79 R&D projects, 54 are in late-stage development, with evidence of access planning for 81% (44/54) of these.

PORTFOLIO as selected for analysis by the Index

AstraZeneca has 38 products in scope, including 36 medicines that primarily target non-communicable diseases, namely cancer (11), diabetes mellitus (7) and respiratory diseases, such as asthma and COPD (10). Most of its medicines are on patent (29). Of the 36 medicines in scope, 7 are listed on the WHO EML. In addition, it has 2 vaccines in scope that target influenza and COVID-19, 1 of which is listed on the WHO EML.

Governance of Access

RANK 4TH, SCORE 4.32

AstraZeneca performs well in this Technical Area. The company 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. Further, AstraZeneca provides evidence of a patient reach process that covers all products and countries in scope of the Index, as well as public reporting of the underlying methodology and resulting patient reach numbers.    

The highest responsibility for access lies directly with the Board, with a dedicated member of the Board of Directors responsible for sustainability, including access to healthcare. AstraZeneca incentivises select senior executives and in-country managers to act on access to medicine with financial and non-financial rewards. Additionally, the CEO has access-related incentives linked to their ESG performance. One of the performance indicators is the 'Contribution to society KPI', which measures progress on annual and long-term targets and includes 'Access to healthcare' as 1 of 3 pillars of sustainability.  

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

Shows comparatively strong commitment to responsible business practices. AstraZeneca does not disclose the level at which targets are set, but sales agents are not solely incentivised by sales volume.  It has a global policy on ensuring ethical interactions with healthcare professionals. AstraZeneca offers guidance on establishing and documenting a legitimate need for interaction and declares that transfers of value to healthcare professionals (e.g., payments for attending events or promotional activities) 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 non-compliant or corrupt activities. AstraZeneca 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. AstraZeneca lacks a framework, but its code of ethics guides employee decision-making. No breaches in countries in scope were found in the period of analysis.  

AstraZeneca publicly supports the Doha Declaration on TRIPS and Public Health. However, it favours the use of alternative avenues ahead of compulsory licensing. AstraZeneca states that compulsory licensing should be considered only when access to patented medicines is critical to maintaining public health and no appropriate alternative is available.  

Fulfils most criteria across 4 processes for measuring and reporting patient reach. For 1 process covering all its products and all countries (where the company operates) in scope of the Index, AstraZeneca 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. 

Research and Development

RANK 7TH, SCORE 2.83

AstraZeneca performs above average in this Technical Area. It has an access planning process in place from Phase II onwards and applies this to nearly all late-stage candidates – although plans primarily focus on registration in emerging markets. Its priority pipeline is small compared to its peers, but it has the largest pipeline for non-communicable diseases of companies in scope. AstraZeneca publicly discloses disaggregated R&D investment data by phase of development and has an average performance 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 does not make a public commitment addressing its systematic approach to access planning for LMICs.  

Average-sized priority R&D pipeline, compared to peers, with access plans in place for 100% (3/3) of the late-stage candidates. Priority R&D pipeline of 10 projects, including 3 late-stage projects targeting a priority gap. AstraZeneca focuses on various priority areas, including COVID-19 and influenza. All 3 of the late-stage projects targeting a priority gap have access plans in place, including registration preparation in countries in scope and equitable pricing plans.  

Largest pipeline addressing other diseases in scope, with 78% (41/51) of late-stage projects covered by access plans. The company has 51 late-stage R&D projects targeting diseases in scope, which have not been established as a priority by global health stakeholders. The projects mainly target cancer, cardiovascular diseases and kidney diseases. AstraZeneca provides evidence of access plans for 41 of its 51 late-stage projects, focusing mostly on registration preparation, post-trial access and equitable pricing plans.  

AstraZeneca publicly discloses disaggregated R&D investment data for phase of development.  It also discloses anonymised disaggregated R&D investment data to Impact Global Health (formerly Policy Cures Research).  

One of the four R&D capacity building initiatives included for analysis meets all Good Practice Standards (GPS). Through the initiative that meets all GPS, AstraZeneca aims to build clinical trial capacity for cancer research in Vietnam. 

Product Delivery

RANK 4TH, SCORE 3.51

AstraZeneca performs well in this Technical Area. The company has access strategies in place for its products across different countries' income classifications. AstraZeneca shows Best Practice in reporting outcomes for these strategies. It fulfills all criteria for ensuring continuous supply of its medicines and all its health system strengthening initiatives meet all Good Practice Standards (GPS). The company engages in some manufacturing capacity building initiatives, some of which meet all GPS.

AstraZeneca registers newer products* in 15 countries in scope on average. It registers 75% of products assessed in at least 1 of the 10 countries with the highest disease burden; however, only 1 is registered in an LIC. The company’s osimertinib (Tagrisso®), indicated for the treatment of lung cancer, is most widely registered, totalling 42 countries in scope. AstraZeneca reports engaging in mechanisms to facilitate registration, for example, through the WHO Collaborative Registration Procedure (SRA CRP). 

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

One product in scope supplied through a supranational agreement. AstraZeneca's COVID-19 vaccine (Vaxzevria®)** was supplied through COVAX during the period of analysis. In addition, the company demonstrates access strategies in countries that procured the vaccine outside of COVAX. The company discloses data on doses sold and provides evidence of an additional access strategy to increase patient reach. 

_{**In May 2024, AstraZeneca announced it was withdrawing the product worldwide.} 

Most healthcare practitioner (HCP)-administered products covered by an access strategy, with comprehensive methods to track outcomes. For 2 of the 5 products selected for analysis – fulvestrant (Faslodex®), indicated for breast cancer, and goserelin acetate (Zoladex®), indicated for breast and prostate cancer and endometriosis – AstraZeneca provides access strategy examples in all 3 country income classifications (UMIC, LMIC, LIC); 3 products lack access strategies in LICs. Access strategies in UMICs are more comprehensive in addressing product- and country-specific barriers to access; however, AstraZeneca shows some efforts to consider different payers’ ability to pay in most of its strategies. For all of the examples analysed, the company provides evidence of health system strengthening initiatives. In general, the company shares goals to maximise patient reach and reports patient reach data, as well as details on the approaches used to track the outcomes and the progress of its strategies. For example, for its cancer treatment durvalumab (Imfinzi®), AstraZeneca reported increased patient reach both in Mexico (UMIC) and Egypt (LMIC) from 2022 to 2023, with forecasts indicating continued growth in 2024. 

Majority of self-administered products are covered by an access strategy, with outcomes mostly tracked and reported. For 3 of the 5 products selected for analysis, AstraZeneca provides access strategy examples in all 3 country income classifications (UMIC, LMIC, LIC). Access strategies in UMICs are more comprehensive, with public reimbursement and additional support for patients paying out of pocket. For its 2 cancer products, the company provides testing support for early diagnosis in both UMIC and LMIC examples; for both its asthma products, it provides additional health system strengthening initiatives in the LMIC and LIC examples analysed. For almost all of the examples analysed, patient reach is reported, with details on the methodologies applied to measure and track the strategies’ outcomes. For example, for osimertinib (Tagrisso®), indicated for lung cancer, the company has reported an increased number of patients reached from 2022 and 2023 in Egypt (LMIC), calculated through sales and reports from the patient assistance programme. The company also reported an increase in EGFR testing rate and plans to further increase patient reach.  

AstraZeneca publicly commits not to file for or enforce patents for all products in over 80 countries in scope. This applies to all LICs and least developed countries, as well as many UMICs and LMICs. AstraZeneca publicly discloses the list of countries to which this commitment applies.  

Publicly discloses product patent status for countries in scope. AstraZeneca publicly discloses patent information for its products on its website. The information published includes brand name, nature of the patent, patent number, expiry date and jurisdiction.  

AstraZeneca has voluntary licensing agreements to enable generic supply for its COVID-19 vaccine. The agreements cover 70 countries in scope and are with multiple generic manufacturers. The terms of the licence are not publicly available. The agreement was active during the period of analysis; however, AstraZeneca subsequently withdrew the product from the market in May 2024.  

Two of the three manufacturing capacity building initiatives included for analysis meet all GPS. For example, AstraZeneca is providing a technology transfer to a local manufacturer in one country in scope. The transfer will allow the manufacturer to fully produce and package two medicines in scope that are indicated for hypertension. 

Two of the five supply chain capacity building initiatives included for analysis meet all GPS. For example, through United for Health II, AstraZeneca is collaborating with the Unified Procurement Authority in Egypt (LMIC) to educate pharmacists on topics such as health technology assessment, oncology burden and vaccines/immunology. So far, 200 pharmacists have been accredited.  

All 5 health system strengthening initiatives included for analysis meet all GPS. For example, AstraZeneca's Young Health Programme, in partnership with Johns Hopkins Bloomberg School of Public Health and Plan International, is a global initiative aimed at preventing non-communicable diseases in youth aged 10 to 24 through advocacy, awareness and prevention.  

AstraZeneca newly engaged in 2 IP-sharing agreements with public research institutions to accelerate drug development.  In 1 agreement, the company shares a diverse compound library with the Liverpool School of Tropical Medicine to identify novel snake venom toxin inhibitors. AstraZeneca also remains engaged in existing agreements.  

Fulfils all criteria for ad hoc donations. AstraZeneca has public policies and supply processes to carry out ad hoc donations rapidly in response to expressed need, with delivery monitored to ensure donations reach patients. Additionally, the company publicly commits to adhering to the most recent WHO Guidelines for Medicine Donations.  

Fulfils all criteria for mechanisms to ensure continuous supply in LMICs. For example, AstraZeneca is supporting an LMIC government’s aim to reduce reliance on imports by assisting a local manufacturer to manufacture and supply dapagliflozin (Forxiga®), indicated for diabetes mellitus.    

AstraZeneca has a policy for reporting substandard and falsified medicines in countries in scope. It reports cases to the national or local regulatory authorities within 5 days and to WHO Rapid Alert when cases are deemed significant. The company provides evidence of shortened timeframes for reporting cases that only require visual inspection for confirmation and aims to report within 3 working days when packaging is sufficient to assess the case.  

AstraZeneca operates an inclusive business model that covers 1 product in 9*** countries. Launched in 2014 with a focus on cardiovascular disease (CVD), Healthy Heart Africa (HHA) includes reduced-price CVD medication felodipine (Plendil®), treatment and screening capacity, awareness, and provision of equipment. Now in 9 countries, including Kenya and Senegal, HHA also addresses chronic kidney disease and continues to expand geographically.  

_{***The programme was closed in Tanzania in 2023.}