Safeguarding supply and improving access across expanding markets

Demand for Novo Nordisk’s GLP-1-based medicines, particularly Ozempic^®, continued to soar throughout 2024, reflecting the growing global prevalence of diabetes.

Administered as a once-weekly injection for the treatment of type 2 diabetes, Ozempic^® maintains its position as the world’s biggest-selling diabetes medicine, backed by its proven efficacy in controlling blood sugar and reducing body weight, as well as a growing body of evidence demonstrating broader cardiometabolic benefits. Over the past year alone, the clinical profile of Ozempic^® has been further boosted by data demonstrating a reduction in the risk of kidney disease progression in people with type 2 diabetes and chronic kidney disease, as well as functional improvements in people with type 2 diabetes and symptomatic peripheral artery disease vs placebo.

Now available in more than 70 markets, Ozempic^® sales have been central to the continued growth in sales of our diabetes products. Our strategic aspiration to secure a value market share of at least one-third by 2025 has already been achieved, and the continued uptake of Ozempic^® across launch markets has enabled us to maintain a value market share of 33.7% in 2024. This demand has been fuelled by a broader acceptance and understanding of the importance of GLP-1-based therapies among healthcare professionals, patients and payers as a cornerstone of effective diabetes care and management.

Novo Nordisk is not the only healthcare company investing in the growth and development of the GLP-1 segment, and competition has increased significantly over the past year. Nevertheless, we remain the market leader in the diabetes GLP-1 space with a value share of 55.1%, a slight increase compared to 2023 when our value share stood at 54.8%.

Despite the sales penetration of Ozempic^®, high demand has also posed challenges, necessitating strategic decisions to prioritise distribution to regions and patient groups with the most pressing needs. We have also continued to invest heavily in expanding production capacity, seeking to stabilise supply and ensure that Ozempic^® remains accessible to the growing number of patients who have already initiated treatment.

Through our industry-leading portfolio, relentless focus on innovation and robust pipeline of next-generation treatments, we remain well-positioned to maintain and enhance our leadership position in diabetes care.

Our company is built upon a century-long legacy of innovation in diabetes care, and we are still pushing boundaries as we search for new breakthroughs in this ever-evolving space.

These efforts are exemplified by the launch of Awiqli^® – the world’s first once-weekly basal insulin – in China, Germany and Canada.

Awiqli^® represents a critical and innovative addition to our diabetes portfolio and a key milestone for patients seeking to reduce some of the challenges of diabetes management – particularly the burden of multiple injections. Its approval in the EU was based on phase 3a clinical trial results demonstrating superior blood sugar reduction and superior time in range (time spent within the recommended blood sugar range), compared with daily basal insulin in people living with type 2 diabetes not previously treated with insulin. Trial data also showed low rates of clinically significant or severe hypoglycaemia – less than one event per patient-year of exposure – with no statistically significant difference compared to daily basal insulin in insulin naïve people living with type 2 diabetes.

However, the therapy’s journey to market in the US has been more challenging, with the US Food and Drug Administration (FDA) issuing a Complete Response Letter (CRL) in July 2024.

This followed a meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee in May 2024, where a panel of independent scientific experts discussed the benefit-risk of once-weekly insulin icodec in type 1 diabetes. The panel determined that the data available were not sufficient to conclude on a positive benefit-risk in type 1 diabetes.

In the CRL, the FDA requests more information relating to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed. The CRL did not mention the use of once-weekly insulin icodec in type 2 diabetes. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests.

Despite this setback in the US, the rollout of Awiqli^® in other major markets underscores our continuing commitment to insulin innovation more than 100 years after our founders first commercialised production of this life-saving medicine.

The past year has been transformative for the burgeoning obesity market, marked by increasing competition and soaring demand for GLP-1 receptor agonists and other incretin-based therapies. Wegovy^®, our flagship obesity therapy, has been at the forefront of this competitive landscape, maintaining its market-leading position despite new entrants to the segment.

Following its initial launch in the US, Wegovy^® is now available in more than 15 markets worldwide. As the obesity market continues to grow worldwide, so does the demand for Wegovy^®. This is driven by the rising global prevalence of obesity – which has more than tripled over the past 50 years – and a broader shift in the perception of treatment. Once considered a lifestyle issue, obesity is now widely recognised as a serious chronic disease that requires medical intervention.

We have responded by investing heavily in scaling up our production capacity and carefully prioritising launches and distribution. Our expanding global production network is operating around the clock to ensure a stable and consistent supply of Wegovy^® and a proportion of Wegovy^® volumes is being allocated in every launch market for people with a high medical need and low socioeconomic status.

The continued success of Wegovy^® is underpinned by its clinical profile as the world’s first weight management therapy also approved to reduce the risk of major adverse cardiovascular events – a key differentiator in an increasingly competitive segment. This has enabled us to capture much of the growth to date in a rapidly-expanding and dynamic market, helping us to build on our position of strength and reputation as first-movers in the space following the success of our first-generation GLP-1-based therapy, Saxenda^®.

Despite advancements in treatment and growing acceptance of obesity as a serious chronic disease, significant unmet needs remain. Many people living with obesity still lack access to effective therapies, and there is a clear need for continued innovation to develop treatments that can deliver greater efficacy and additional benefits. Moreover, there is a need for more holistic, preventive approaches that can address the multifaceted nature of obesity – including behavioural, psychological and environmental factors.

Novo Nordisk is dedicated to addressing these unmet needs through a steadfast commitment to innovation. Our obesity pipeline includes numerous promising candidates aiming to further reduce the burden of obesity and related conditions on patients and healthcare systems alike. By leveraging our expertise in GLP-1-based therapies and exploring new therapeutic avenues, we are well-placed to continue leading the way in obesity treatment.

The robust clinical profile of our market-leading weight loss therapy, Wegovy^®, has been further validated after regulatory bodies approved label expansions acknowledging its efficacy in mitigating cardiovascular risks. These updates highlight the extensive cardiometabolic benefits of our market-leading GLP-1-based therapy, extending beyond weight reduction.

The new indications are based on robust clinical evidence from key trial programmes SELECT and STEP HFpEF. Data from SELECT demonstrated that Wegovy^® reduced the risk of major adverse cardiovascular events in people with overweight or obesity and established cardiovascular disease, on top of cardiovascular standard of care treatments vs placebo. Findings from the STEP HFpEF trials, meanwhile, showed that Wegovy^® reduced symptoms of heart failure and physical limitations in people with obesity and heart failure with preserved ejection fraction (HFpEF) vs placebo.

These data add to a growing body of evidence showcasing semaglutide’s potential to address critical unmet needs in cardiovascular health.

By broadening the approved uses of Wegovy^® and helping to differentiate the treatment in an increasingly competitive market, we are aspiring to both strengthen our leadership position in obesity and enhance our impact on broader public health.

2024 has been a year of significant progress in our rare disease portfolio, building on our strong legacy of innovation in rare blood and endocrine disorders. With the pending submission of Mim8, first launches of Alhemo^® and continued rollout of Sogroya^®, we are building on a return to growth for our Rare Disease franchise following a positive year in which overall sales increased 9% at constant exchange rates (CER).

Sales of our rare endocrine disorder products increased by 31% at CER over the course of the year, mainly driven by the rollout of Sogroya^® – the world’s first once-weekly treatment for both children and adults with growth hormone deficiency. Sogroya^® is now available in seven countries, including the US.

In rare blood disorders, phase 3 clinical trials have demonstrated the transformative potential of Mim8 in reducing bleeds. The investigational therapy is designed to mimic the activity of Factor VIIIa, the clotting protein missing or defective in people with haemophilia A.

Alhemo^® addresses significant unmet needs in haemophilia A and B with inhibitors – the latter being an area with very limited treatment options. Administered once-daily by subcutaneous injection, the therapy offers routine treatment to prevent bleeding in a prefilled pen device. Alhemo^® is now approved in several markets worldwide, including the US and EU.

Over the past four years, we have more than quadrupled the global reach of our GLP-1-based medicines, increasing our volume market share in the GLP-1 segment to 63% over the same period. With demand still growing, we continued to expand our production network throughout 2024, making significant investments in capital expenditure (CapEx) and acquisitions totalling more than DKK 129 billion.

Through the targeted acquisitions of brownfield sites, the strategic expansion of existing facilities, the establishment of new sites and the upscaling of our global production workforce, we are equipping ourselves to support the launch of multiple next-generation therapies and meet the needs of millions more people worldwide.

The scope of these investments is measured not only in financial terms, but also by the increased volume of active pharmaceutical ingredients (API) and the number of devices we can produce. By investing in state-of-the-art, multi-product facilities designed to accommodate current and future products, we are laying a foundation for sustainable long-term growth.

The ongoing expansions of our production sites across the globe exemplify our approach to scaling up. We are investing more than DKK 80 billion into expanding our API production capacity, including the construction of a new 170,000 square metre, multi-product API facility in Kalundborg, Denmark. Alongside additional expansions of sites in Denmark, France, Brazil, China and the US, these efforts will significantly enhance our ability to meet future demand across our portfolio.

Our acquisition of three new fill-finish sites at the turn of the year complements the ongoing expansion of our internal supply chain, enabling us to expand our manufacturing capacity and provide future optionality and flexibility for our existing supply network. The three former Catalent sites were acquired as part of a transaction that saw Novo Holdings – the holding and investment company responsible for managing the wealth and assets of the Novo Nordisk Foundation – acquire the US-based contract manufacturing and development organisation. Approximately 3,200 highly skilled Catalent employees became part of Novo Nordisk under the terms of the agreement, which will ensure that existing obligations towards other customers currently being served by the three sites will be honoured.

Removing bottlenecks in our existing supply chain also remains a top priority as we seek to keep pace with demand. The consolidation of our insulin portfolio will free up vital capacity and resources for production of our next-generation innovations, while our transition towards reusable devices and once-weekly rather than once-daily formulations continues.