Novo Nordisk A/S

Performance in the 2024 Index

12th place. Novo Nordisk is a middle-performing company. It has an above average performance in Governance of Access and Product Delivery, where it demonstrates Best Practice for its inclusive business model, but performs comparatively poorly in Research & Development. 

Opportunities for Novo Nordisk

Improve the quality and broaden the geographic reach of access plans. Novo Nordisk has access plans for half of its late-stage R&D candidates. However, these plans predominantly focus on registering in a limited number of upper-middle-income countries and emerging markets. It can enhance these plans by considering more access provisions such as affordability and expand them to include more low- and middle-income countries within scope. For example, it can improve its access plan for CagriSema, a once-weekly treatment for type 2 diabetes currently in Phase II of clinical trials, by expanding it beyond registration preparation in six countries in scope. 

Expand technology transfer agreements for insulin products. In 2022, Novo Nordisk signed a technology transfer agreement with Aspen in South Africa to manufacture and supply its human insulin. The company can expand partnerships with more manufacturers in LMICs to build manufacturing capacity and improve availability of insulin products, including essential analogue insulins.    

Expand access to analogue insulins listed in the WHO Model List of Essential Medicines. Novo Nordisk has comprehensive access strategies for its human insulins – Mixtard®, Actrapid®, Insulatard® – in countries in scope, whereas access strategies for its analogue insulin Tresiba® are more limited. Through increasing registrations and implementing equitable pricing strategies in more countries in scope of the Index, the company can bridge this gap and ensure that analogue insulins are as accessible as human insulins to diabetes patients in LMICs. 

Increase frequency of public reporting on progress and outcomes of its inclusive business model. iCARE was launched in 2021, aiming to improve access to diabetes products in 49 countries in Africa. Novo Nordisk reported on the list of countries where the model is active as well as the patient reach for 2023. Continuing to publicly report on country implementation and patient reach, and doing so frequently, can drive accountability and implementation. It can also help foster further partnerships and expand the model in further countries within iCARE's scope.

Changes since the 2022 Index

• In 2023, Novo Nordisk entered a manufacturing partnership with Aspen to improve availability and affordability of human insulin on the African continent. 

• In August 2023, Novo Nordisk acquired Inversago Pharma, extending the company's pipeline for obesity and metabolic disorders. 

• Received approval for its once-weekly basal insulin icodec (Awiqli®) from the European Medicines Agency, Canada, Australia, Japan and Switzerland for type 1 and type 2 diabetes, and for type 2 from China. 

• In June 2024, Novo Nordisk became a member company of Access Accelerated, a cross-industry collaboration that seeks to reduce barriers to prevention, treatment and care for non-communicable diseases in LMICs. Access Accelerated focuses specifically on NCD financing. 

• Since June 2022, the Changing Diabetes in Children programme expanded to an additional seven countries: Columbia, Malaysia, Morocco, Nigeria, the Philippines, Tunisia and Vietnam.

Sales and operations

Therapeutic areas: Biopharmaceuticals, diabetes, obesity, other serious chronic diseases 

Product categories: Innovative medicines 

M&A news: Novo Nordisk acquired Forma Therapeutics Holding Inc. for USD 1.1bn in 2022. In 2023, it acquired Biocorp for USD 165mn; Inversago Pharma for USD 1.1bn; Embark Biotech for USD 496mn; Paratek Pharmaceuticals for USD 462mn. 

Sample of pipeline and portfolio assessed by the Index

PIPELINE for diseases in scope

Novo Nordisk has 17 R&D projects in scope, none of which target priority diseases. All 17 projects target other diseases in scope, including diabetes mellitus (8), cardiovascular diseases (4) and sickle cell disease (2). Of the 17 R&D projects, 12 are in late-stage development, with evidence of access planning for 50% (6/12) of these.

PORTFOLIO as selected for analysis by the Index

Novo Nordisk has 15 medicines in scope, 5 of which are listed on the WHO EML, and 9 are on patent. The company’s medicines mainly target noncommunicable diseases and are indicated for the treatment of diabetes (14). It has 1 medicine indicated for maternal haemorrhage.

Performance breakdown

Governance of Access

RANK 8TH, SCORE 4.12

Novo Nordisk 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. Further, Novo Nordisk 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 with the CEO, under the supervision of the Board of Directors. Novo Nordisk has financial and non-financial access-related incentives at the executive level. It also incentivises its in-country leaders to act on its social sustainability objectives. The CEO has access-related incentives, linked to long-term social targets.  

Comprehensive access-to-medicine strategy integrated within the overall corporate strategy. Its strategy covers all therapeutic areas in which the company is involved. Novo Nordisk 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 Annual Report.  

Shows comparatively strong commitment to responsible business practices. Novo Nordisk sets individual-level targets for sales agents, but incentives are not solely based on sales volume.  The company’s incentive compensation plan includes guardrails, like limiting the proportion of the incentive plan that can be allocated to sales targets in specific therapeutic areas. The company commits to ensuring ethical interactions with healthcare professionals in its code of conduct. Further, it reports that transfers of value for healthcare professionals (e.g., payments for 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. Novo Nordisk 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 also has an ethical decision-making framework for employees. No breaches in countries in scope were found in the period of analysis.  

Novo Nordisk does not publicly share explicit support for the Doha Declaration on TRIPS and Public Health. However, the company publicly states that health emergencies requiring exceptions to intellectual property rights can and should be accommodated under the international legal framework and under extraordinary circumstances. Further, it does not support the routine use of compulsory licensing.  

Fulfils some criteria across 4 processes for measuring and reporting patient reach. For its diabetes care products process, which covers most of its products and most countries in scope of the Index, Novo Nordisk 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 18TH, SCORE 1.38

Novo Nordisk performs poorly in this Technical Area. It does not engage in R&D for priority diseases and has a small-sized R&D pipeline compared to its peers. The company has a new access planning framework in place, with evidence of access plans for half its late-stage projects – focusing predominantly on registration preparation in emerging markets. Novo Nordisk does not publicly disclose disaggregated R&D investment data, but it has improved its R&D capacity building activities. 

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.  

Novo Nordisk does not have any projects in its R&D pipeline targeting a priority disease in scope. 

Small-sized pipeline, compared to peers, addressing other diseases in scope, with 50% (6/12) of late-stage projects covered by access plans. The company has 12 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 diabetes mellitus, cardiovascular diseases and sickle cell disease. Novo Nordisk provides evidence of access plans for 6 of its 12 late-stage projects, including registration preparation and post-trial access. 

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

One R&D capacity building initiative was included for analysis, but it does not meet all Good Practice Standards (GPS). In this initiative, Novo Nordisk aims to build R&D capacity by training young scientists in India, focusing on innovative R&D. 

_{* Novo Nordisk currently has no pipeline candidates within the disease scope of Impact Global Health (formerly known as Policy Cures Research), an organisation that assesses disaggregated R&D data.} 

Product Delivery

RANK 7TH, SCORE 3.35

Novo Nordisk performs above average in this Technical Area. The company has access strategies for its self-administered products across countries with different income classifications, and it consistently reports their outcomes. It demonstrates Best Practice by operating an inclusive business model to improve access to its products in multiple low-income and least developed countries. Novo Nordisk does not engage in new or ongoing intellectual property sharing agreements or non-exclusive voluntary licensing agreements.   

Novo Nordisk registers products in 47 countries in scope on average. For the 1 newer product** analysed, it registers in 18 countries in scope and it registers 60% of products assessed in at least 1 of the 10 countries with the highest disease burden. There is evidence of registration in LICs for all products assessed. The company’s isophane human insulin (Insulatard®), indicated for diabetes, is most widely registered, totalling 87 countries, including 21 LICs. The company reports engaging in regulatory reliance to facilitate registration for multiple products.  

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

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

Novo Nordisk is not eligible for assessment of access strategies for healthcare practitioner (HCP)-administered products because it has no HCP-administered products in scope. 

Access strategies for most self-administered products, supported by information on outcomes. For 4 of the 5 products selected for analysis, Novo Nordisk provides access strategy examples in all 3 country income classifications (UMIC, LMIC, LIC). The 3 human insulins assessed – Insulatard®, Actrapid® and Mixtard® – are covered by the Access to Insulin Commitment in several LMICs and LICs. This is complemented by other initiatives, such as the company’s Changing Diabetes® in Children programme, which helps provide comprehensive care to children and youth with type 1 diabetes. For the other 2 diabetes products assessed – Liraglutide (Victoza®) and Insulin degludec (Tresiba®) – the company also demonstrates efforts in improving the product’s affordability for patients. In both UMIC and LMIC examples for both products, the company implements patient support programmes to provide financial support in mainly out-of-pocket markets. The company consistently shares patient reach data and the approaches applied to measure the outcomes of all strategies assessed. 

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

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

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

All 3 manufacturing capacity building initiatives included for analysis meet all GPS. For example, Novo Nordisk is transferring technology to South African manufacturer Aspen to fill and finish human insulin vials. The collaboration aims to supply over 4m patients on the African continent in 2026. 

Three of the four supply chain capacity building initiatives included for analysis meet all GPS. For example, Novo Nordisk provided funds to develop the non-communicable disease (NCD) Forecasting Methodology/Tool under the Coalition for Access to NCD Medicines and Products. The tool has been introduced in Ghana, Kenya and Uganda and supports demand forecasting for various essential NCD medicines.  

All 5 health system strengthening initiatives included for analysis meet all GPS. In 1 initiative, Novo Nordisk partners with the International Committee of Red Cross and Red Crescent (ICRC),  Danish Red Cross and London School of Hygiene and Tropical Medicine on chronic care in humanitarian settings, focusing on best practices for diabetes care in crises. Between 2022 and 2024, partners integrated NCD management and trained peer support groups in Lebanon and Iraq. 

Novo Nordisk has not entered into any new IP-sharing agreements, nor has it continued any existing agreements, with public research institutions or drug discovery initiatives to accelerate drug development.  

Fulfils all criteria for ad hoc donations. Novo Nordisk 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. For example, in September 2023, Novo Nordisk responded to aid requests from the International Committee of the Red Cross, by donating 413,200 vials of human insulin to earthquake-stricken Syria. 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, Novo Nordisk is transferring technology to Eskayef Bangladesh Limited to manufacture and supply insulin to the local market. In 2022, the partnership expanded to include cartridge manufacturing and export to additional countries.  

Novo Nordisk has a policy for reporting substandard and falsified medicines in countries in scope. It reports cases to the relevant regional, national, or local regulatory authorities within 7 days. The company does not provide evidence of shortened reporting timeframes for cases that only require visual inspection for confirmation.  

Novo Nordisk operates an inclusive business model that covers 9 products in 49*** countries in middle Africa, including 33 LICs and least developed countries. iCARE aims to improve access to diabetes products in 49 countries in middle Africa. The model, initially launched in 2021, includes supply chain and health system capacity building and patient education and affordability plans. 

_{*** 46 in scope.}