Product News | Eli Lilly: 20th Century Insulin Specialist, 21st Century Glp-1 Supplier

Apr.07.2023

Eli Lilly and Company, which seems to be losing the battle for the insulin market - facing the squeeze from Sanofi and Novo Nordisk - has seen its insulin market share slip from 38% in 2000 to 13.14% currently.

In the mid-20th century, Eli Lilly and Company led three generations of insulin innovation and became a veritable diabetes giant. However, with the advent of long-acting insulins, Eli Lilly and Company's dominance quickly flipped. To break the ice, Eli Lilly and Company has made a number of moves over the years.

In 2019, Eli Lilly and Company launched a generic version of its long-acting insulin, priced at 50% less than the branded drug, and will reduce its price by a further 40% in 2022; in 2020, Eli Lilly and Company created an insulin program that makes Eli Lilly and Company insulin available to the uninsured and those with commercial insurance for $35; and in 2021, all of Eli Lilly and Company's insulins will be included in US Medicare Part D, expanding $35 access.

Still, this has not halted the decline in insulin share.

Heading into 2023, Eli Lilly and Company decided to take another dose. on 1 March, Eli Lilly and Company announced that it would pay out of pocket to keep patient co-payments below $35. The company also announced a 70% price reduction on its best-selling insulin products, Humalog and Humulin, which is expected to be implemented in the 4th quarter of this year.

However, the insulin market has become mired in competition for stock. The insulin defence has retreated again and again in the face of the onslaught of new glucose-lowering drugs.

The giants of the diabetes market are beginning to embrace change. GLP-1, which has both glucose-lowering and weight-lowering effects, is growing rapidly and has become the second most important glucose-lowering drug after insulin.

Eli Lilly and Company has caught the new wind. But will it be able to regain the glory of insulin in this new century? For the moment, hopes still seem high.

1. History of insulin

The year 2021 marks the first hundred years of insulin's discovery. This treatment, one of the great inventions of the 20th century, transformed type 1 diabetes, once considered a fatal disease, into a chronic, medically manageable condition.

In 1922, at the age of 14, Leonard Thompson became the first person to be treated with insulin for type 1 diabetes. At the time, Leonard was on the verge of death and was given dog insulin on an experimental basis. An unexpected 'miracle' occurred. As Leonard's case became widespread, the clinical demand for insulin grew.

Eli Lilly was the first to see this opportunity. By optimising methods such as isoelectric precipitation, Lilly scientists were able to extract large quantities of insulin from the pig pancreas and purify it for commercial sale - in 1923, Lilly's extracted insulin Iletin became commercially available.

But at the same time, German Aventis (later acquired by Sanofi) and Danish Novo (later merged to form Novo Nordisk) also began producing extracted insulin. The insulin triumvirate was beginning to take shape.

However, the production capacity of insulin extracted from animals is limited, and the extraction process is outdated, making it difficult to ensure consistent quality over long distances. In 1965, Chinese scientists synthesized crystalline bovine insulin with full biological activity for the first time in the laboratory; and then in 1978, Genentech biosynthesized human insulin for the first time through genetic recombination technology.

Having tasted the sweet spot in the diabetes chronic disease market, Lilly followed the insulin R&D trend. In 1982, shortly after it received the license to produce recombinant human insulin, Lilly launched the first recombinant human insulin Humulin, and later Novo also launched its own second-generation insulin products NovoLin. However, on the whole, due to technical limitations, the second-generation insulin products did not fully penetrate the diabetes market, the early 1990s, Humulin sales can only exceeded US$500 million.

Competition, began to shift to the 3 generation insulin. In 1996, Lilly launched Humalog, the first insulin analogue, which significantly reduced the onset of action and improved blood glucose control compared to the 2nd generation products.

Lilly's swift action saw it quickly become the dominant insulin player in the last century, increasing its insulin revenues to $1.5 billion in 2000, capturing 38% of the market. That year, Sanofi also launched Lantus (glargine insulin), and Novo Nordisk launched Novo Rapid (menthol insulin) and Levemir (diste insulin) respectively.

Novo Rapid is an ultra-short-acting insulin, splitting the short-acting market of Humalog; Lilly's Humulin is an intermediate-acting insulin, which is overwhelmed by long-acting insulins such as Lantus and Levemir.

Long-acting insulins have become one of the pressing shortcomings facing Lilly. In an attempt to redeem itself, in 2014, Lilly launched a generic version of its glargine insulin, Basaglar, priced at half the price of the original, and has since cut its price by another 40%.

But despite this largesse, Lilly has not been able to hold on to its insulin supremacy. In terms of volume, Novo Nordisk is the clear leader in terms of volume, with significant sales of Novo Rapid, and Sanofi's Lantus, the best-selling long-acting insulin, compared to Lilly's generic version of Basaglar, which is a magnitude less than Lantus.

Insulin Market (Pill Ferry)

2. GLP-1 is becoming increasingly important

As of August 2022, insulin still holds approximately 34% of the global market share of diabetes drugs.

According to Novo Nordisk, GLP-1 is expanding rapidly at a compound annual growth rate of 9% between 2017 and 2021. By August 2022, the market share of the class has reached 28%, making it the second largest diabetes treatment drug in the world today. An additional condition to be mentioned here is that GLP-1 has a penetration rate of only 8% in the patient population. In the field of diabetes, GLP-1j will therefore play an even greater role.

As a hormone secreted by intestinal cells, GLP-1 stimulates and enhances insulin secretion and inhibits glucagon secretion, synergistically lowering blood glucose. It also has applications in weight reduction as it slows gastric emptying and reduces appetite.

GLP-1 market share (Novo Nordisk)

To date, the FDA has approved seven GLP-1 agonist drugs. In order of marketing, these are exenatide (Eli Lilly), liraglutide (Novo Nordisk), albiglutide (GSK), dulcolactone (Eli Lilly), lisnatide (Zealand), semaglutide (Novo Nordisk) and tirzepatide (Eli Lilly). They are mainly used for the treatment of type 2 diabetes and, in addition, liraglutide and semaglutide have approved labels for weight loss indications.

Lilly and Novo Nordisk are the rightful leaders in terms of GLP-1, both in terms of volume and in terms of global sales.

Learning from the lessons of long-acting insulins, Eli Lilly and Company has focused on the development of weekly formulations in its GLP-1 portfolio. While the first exenatide was a daily formulation requiring two injections a day, the later launches of dulaglutide and tirzepatide are both weekly formulations that require only one injection a week, significantly improving patient compliance.

Global sales of major GLP-1 drugs (US$ billion, Societe Generale Securities)

Phase III clinical studies have shown that after 26 weeks of treatment, dulaglutide reduced glycosylated haemoglobin (HbA1c) by up to 1.73% and increased blood glucose compliance to 64.8%, and in Chinese patients with HbA1c ≥8.5%, dulaglutide reduced HbA1c by up to 2.3%. The drug was officially approved for entry into China in 2019 and is reimbursed under Medicare Category B.

Semaglutide, is the strongest rival to dulaglutide. In addition to lowering blood glucose, it has shown significant metabolic benefits in terms of weight, blood pressure and lipids. More specifically, Novo Nordisk has also developed an oral dosage form of semaglutide, making it the first and only oral GLP-1. In addition, semaglutide is also approved for weight reduction indications.

In 2022, semaglutide took away the GLP-1 sales title. According to Novo Nordisk's financial report, the drug has reached $10.9 billion in full-year sales, surpassing dulaglutide's $7.44 billion and becoming the first GLP-1 drug to exceed $10 billion in annual sales.

In 2022, Eli Lilly and Company launched Tirzepatide, which is listed as one of the top 10 heavyweight drugs for 2022. Priced at $974, down from $1349 for semaglutide, the drug outperforms semaglutide in terms of weight loss and glucose reduction, and some analysts see Eli Lilly and Company as "opening the door to off-label use".

Learning from the lessons of long-acting insulins, Eli Lilly and Company has focused on the development of weekly formulations in its GLP-1 portfolio. While the first exenatide was a daily formulation requiring two injections a day, the later launches of dulaglutide and tirzepatide are both weekly formulations that require only one injection a week, significantly improving patient compliance.

Phase III clinical studies have shown that after 26 weeks of treatment, dulaglutide reduced glycosylated haemoglobin (HbA1c) by up to 1.73% and increased blood glucose compliance to 64.8%, and in Chinese patients with HbA1c ≥8.5%, dulaglutide reduced HbA1c by up to 2.3%. The drug was officially approved for entry into China in 2019 and is reimbursed under Medicare Category B.

Semaglutide, is the strongest rival to dulaglutide. In addition to lowering blood glucose, it has shown significant metabolic benefits in terms of weight, blood pressure and lipids. More specifically, Novo Nordisk has also developed an oral dosage form of semaglutide, making it the first and only oral GLP-1. In addition, semaglutide is also approved for weight reduction indications.

In 2022, semaglutide took away the GLP-1 sales title. According to Novo Nordisk's financial report, the drug has reached $10.9 billion in full-year sales, surpassing dulaglutide's $7.44 billion and becoming the first GLP-1 drug to exceed $10 billion in annual sales.

In 2022, Eli Lilly and Company launched Tirzepatide, which is listed as one of the top 10 heavyweight drugs for 2022. Priced at $974, down from $1349 for semaglutide, the drug outperforms semaglutide in terms of weight loss and glucose reduction, and some analysts see Eli Lilly and Company as "opening the door to off-label use".

Analysts predict that Tirzepatide sales are expected to exceed $1 billion in the commercialisation year ending in 2023 and reach $17.5 billion by the end of 2030.

If things go as expected, then with Tirzepatide and dulaglutide on board, Eli Lilly and Company could still take the crown in the diabetes track. But will rival Novo Nordisk stop there? It will be interesting to see if the competition will also launch a better GLP-1.

- Summary -

Novo Nordisk has analysed the regional distribution of liraglutide sales and found that the drug has about half of the world market and the highest penetration in North America. In the future, the biggest growth market for these drugs will most likely be in China.

Firstly, due to its large population base, China already has the highest number of people with diabetes in the world. And with increasing ageing and people's ability to pay, China's diabetes market is expected to grow from 63.2 billion yuan in 2020 to 116.1 billion yuan in 2025, with plenty of market potential.

However, in such a huge market, the mainstream of anti-diabetic drugs used in China are still traditional drugs: such as biguanides, sulfonylureas and alpha-glucosidase inhibitors. There is a certain time lag for new hypoglycemic drugs to enter China, and thus they have not yet achieved full volume release and have great growth potential.

In addition, GLP-1 drugs also have good therapeutic effects in weight loss, and this type of indication will also become an important revenue growth point for GLP-1 in the future.

For the pharmaceutical giants, the diabetes market's an important growth driver for their operations. While competing for the market, they are also constantly pushing for new products. And both price reductions and the launch of new products are great benefits for patients with chronic diseases.

References:

1. Insulin drops wildly by 70%, why did Lilly do it? ; Drugwise.com

2. Lilly Insulin for $35 or Less a Month; Eli Lilly

3. The history of Lilly's fortunes

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