Human Insulin Market Size, Share & Industry Analysis, By Type (Analogue Insulin and Traditional Human Insulin), By Diabetes Type (Diabetes 1 and Diabetes 2), By Distribution Channel (Hospital Pharmacy and Retail & Online Pharmacy), and Regional Forecast, 2024-2032

The global human insulin market size was valued at USD 19.19 billion in 2023 and is projected to grow from USD 19.69 billion in 2024 to USD 25.08 billion by 2032, exhibiting a CAGR of 3.1% during the forecast period (2024-2032). North America dominated the human insulin market with a market share of 45.91% in 2023.

Insulin is a hormone that regulates the body's blood sugar level. Diabetes is a chronic medical condition in which the individual’s blood glucose or sugar level is high. There are currently two major types of diabetes. Type 1 diabetes is a condition where the beta cells of the pancreas stop producing insulin, and type 2 is where the cells of the body loses sensitivity to the insulin produced. 

• According to the ‘IDF Diabetes Atlas Tenth edition 2021’, globally, around 537.0 million are currently living with diabetes. It is further estimated that the number of patients will rise to 643.0 million by 2045.

The rapidly growing diabetic population across the globe is anticipated to propel the adoption of human insulin, which in turn is driving the market growth. The increasing prevalence of diabetes due to the higher adoption of a sedentary lifestyle is projected to propel the insulin market. Combined with this, favorable reimbursement policies in developed countries are estimated to boost the overall market.

The emergence of COVID-19 has impeded the demand for insulin due to fewer patients opted for the treatment of diabetes. In addition, key players operating in the market recorded a significant decline in their revenues due to the COVID-19 pandemic. The decline in the volume of diabetes testing and less focus on disease management other than COVID-19 and other major parameters affected insulin sales, especially during the first half of 2020. In terms of revenue, the market witnessed a decline of 5.5% in 2020.

However, revoking lockdown restrictions and stay-at-home orders in many countries, along with launches of novel drugs, and re-establishment of the supply chain network have been instrumental for the recovery during 2021. Novo Nordisk A/S insulin products revenue recovered by 4.3% compared to 2020. In addition, the revenues generated by Sanofi in 2021 increased 1.7% compared to the revenues in 2020. Therefore, the resumption of diabetes testing & new launches positively affected the demand for human insulin in 2021.

Human Insulin Market Trends

Growing Adoption of Insulin Analogues to Propel Market Progress

The launch of insulin analogues has provided replacement strategies proposed to mimic normal human physiology more closely. Various studies have demonstrated that their pharmacodynamics and pharmacokinetic profiles are closer, resulting in faster offset and onset of insulin effect compared to regular human insulin.

Also, basal insulin analogs (long-acting insulin detemir, insulin glargine) have been reported to offer less variability, longer duration of action, more predictability, favorable effect on weight, and less hypoglycemia (especially nocturnal). Hence, such factors support the usage of analog insulin products across the globe.

Despite the high prices of long-acting insulin analogues, the market is witnessing the increasing utilization of these products since the recent years, especially in Europe.

Human Insulin Market Growth Factors

Increasing Prevalence of Diabetes to Augment Market Growth

Obesity and a sedentary lifestyle are the prominent factors responsible for rising diabetes globally. The prevalence of diabetes has been increasing significantly in recent decades and is estimated to rise significantly in the upcoming decades. Diabetes is considered as one of the leading causes of death and disability across the globe. According to WHO, the number of deaths attributed to diabetes is around 1.5 million. The prevention of type 2 diabetes is possible. However, it remains as a leading challenge for healthcare professionals.

• According to the ‘IDF Diabetes Atlas Tenth edition 2021’, the diabetic population will grow during the upcoming years. It is projected to rise to 643.0 million in 2030 and is projected to rise to 783.0 million in 2045.


• Also, a large population suffers from type 1 diabetes. Insulin is very essential for type 1 diabetes patients and is required on a daily basis for glycemic control. According to a study published in Diabetologia, the Journal of the European Association for the Study of Diabetes (EASD), the prevalence of type-1 diabetes is estimated to be over 9.0 million people around the world. Moreover, according to International Diabetes Federation, around 10.0% of total diabetic people have type 1 diabetes.

This factor has led to a rise in demand for human insulin globally and is responsible for the market’s growth during the forecast duration.

Increased Launch of Novel Insulin Products to Stimulate Market Growth

The insulin industry is witnessing a significant number of new product launches across the globe. Manufacturers are focusing on the development of novel insulin products to gain a higher market share, thereby augmenting human insulin market growth. For instance, in March 2023, Sanofi introduced Soliqua (in pre-filled pen) in India after receiving marketing authorization from the Central Drugs Standard Control Organization (CDSCO). It is a long-acting insulin drug. Similarly, in May 2022, Eli Lilly and Company received approval for a Mounjaro injection, which aids in advancing glycemic control in patients with type 2 diabetes. Also, in June 2020, the U.S. FDA approved Lyumjev, Eli Lilly, and Company's new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Hence, such factors will strongly support market expansion.

Apart from this, researchers are also actively involved in the development of innovative products. For instance, a team of researchers has developed a new oral insulin which has the potential to replace insulin pens. This is based on the nano-carrier delivery. Such increasing efforts are anticipated to boost the market growth in the near future. 

RESTRAINING FACTORS

Lack of Health Reimbursement & Lower Diagnosis Rates to Restrict Growth in Emerging Countries

In the past decade, insulin has witnessed a significant rise in demand owing to new product adoption and further advancements. However, the lack of reimbursement in emerging and underdeveloped countries restricted the market growth to a certain extent.

• According to the article published in PharmaBoardroom, India lacks a reimbursement structure for drugs, medical devices, and biologics. In India, out-of-pocket expenditure is the prominent route of financing drugs, medical devices, and biologics.

Moreover, a higher rate of undiagnosed cases of diabetes in underdeveloped countries hampers the overall growth of the market.

• According to the International Diabetes Federation (IDF), the proportion of undiagnosed diabetes is 53.6% in the African region.

Generally, reimbursement encourages people to adopt the treatment, and diagnosis is the pre-requisite step to undergo treatment. The burden of undiagnosed diabetes is still high in several countries leading to a restricted market growth. According to a study published by Johns Hopkins Bloomberg School of Public Health in August 2022, out of the total diabetes burden in the U.S., an estimated 9.5% of the total patient population is undiagnosed. Hence, the lack of reimbursement and undiagnosed cases of diabetes limits the huge possible demand for human insulin globally and limits the market’s growth during the forecast duration.

Human Insulin Market Segmentation Analysis

By Type Analysis

Analogue Insulin Segment to Dominate Backed by Advantages of Analogue Insulin Products

Analogue insulin dominated the market in 2023, owing to the increasing advantages analogue insulin provides compared to traditional human insulin. According to various published articles and whitepapers, analog insulin has better adherence to therapy and glycemic control. In addition, it does not pose as much a risk of hypoglycemia compared to traditional products. In addition, according to Diabetes.co.uk, analogue insulins are rapidly and uniformly acting types of insulin.

Analogue insulin has hence witnessed a higher demand over the past five years. Combined with this, the recent launch of generic insulin is also expected to propel the analogue insulin market growth.

• In January 2020, Novo Nordisk A/S launched generic versions of NovoLog and NovoLog mix, both are available at around 50.0% discounted compared to their branded versions.

The traditional human insulin segment is estimated to grow at a slower CAGR compared to analogue insulin, owing to the lower adoption rate of the drug type. Though now there are different kinds of traditional products, such as intermediate-acting and a few others, the increased efficacy and response rate of analogue insulin has resulted in a shift of preference of healthcare providers from traditional to analogue insulin products.

By Diabetes Type Analysis

Type 1 Diabetes Segment to Grow Substantially Backed by Rising Prevalence of Diabetes

In terms of type, the type 1 diabetes segment is anticipated to exhibit a strong CAGR due to the increasing prevalence of diabetes & daily need for insulin injections to control blood glucose levels in type 1 diabetes patients.

• According to International Diabetes Federation (IDF), insulin is the most essential medicine for people living with type 1 diabetes. These factors are anticipated to drive this market segment.

The type 2 diabetes segment is estimated to grow at a slower CAGR than type 1 due to the various other treatment options available for type 2 diabetic patients. Type 2 diabetes patients have been prescribed human insulin only when they become refractory to previous other treatment options. However, there is an increased risk of developing type 2 diabetes globally. According to International Diabetes Federation (IDF), 541.0 million adults have Impaired Glucose Tolerance (IGT), which makes them more prone to type 2 diabetes. Hence, type 2 diabetes will experience steady growth during the forecast period.

By Distribution Channel Analysis

Entry of Giant Players Driving the Growth of the Retail & Online Pharmacies Segment 

The retail pharmacies & online pharmacies are projected to generate the highest revenue in the market during the forecast period. The entrance of big companies such as Amazon & Walmart into the retail & online pharmacy business and the introduction of affordable insulin products are projected to boost the retail & online pharmacies market segment.

• For instance, in June 2021, Walmart launched an analo insulin brand- ReilOn. It is available in vial and pen form. This product’s price is 58.0% to 75.0% lower compared to the price of branded insulin products. Also, in November 2020, Amazon pharmacy started sales & shipping of insulin, owing to which people have started to purchase insulin directly from Amazon’s online portal.

Hospital pharmacy is estimated to grow at an average CAGR during the forecast period owing to the development of hospital infrastructure globally.

REGIONAL ANALYSIS

North America generated a revenue of USD 8.81 billion in 2023. The robust presence of the major insulin manufacturers, strong competition among the companies, and the increasing prevalence of type 1 diabetes are some factors driving North America's insulin drug market. For instance, according to American Diabetes Association (ADA), 1.6 million Americans have type-1 diabetes, including 187,000 children and adolescents. Moreover, the increasing price of insulin in the U.S in the past decade has enabled the North American market to garner a huge portion of the overall market.

According to the Centers for Disease Control and Prevention (CDC), around USD 237.00 billion is spent on the direct medical cost of diabetes in U.S. Additionally, the constant ever greening of insulin products by the key players in the U.S has facilitated the companies to capture major market share in North America market. For instance, according to the article published in Industry Dive, in 2021, CGM and insulin pump penetration is about 30% in the U.S.

On the other hand, Europe is anticipated to be the second-most prominent region in terms of revenue by 2032 in the global market. The growth in this region is attributed to the rising penetration of key players in this region.

• For instance, in September 2021, Sanofi started supplies of its next-generation basal insulin Toujeo Solostar to the European Union countries.

Asia Pacific is projected to grow at the highest CAGR during the forecast period. This factor is attributed to the high risk for the development of diabetes in the population in this region, mostly the geriatric population.

• According to the Asian Diabetes Prevention Initiative, people in Asia are at a high risk of developing diabetes due to lifestyle & diet trends. These lifestyle & diet trends include smoking, unhealthy eating, lack of exercise, etc.

The market in Latin America and the Middle East, and Africa is estimated to grow at a slower rate compared to Asia Pacific. The unmet demand for insulin in countries of Latin America, such as Brazil, Mexico, and others, is estimated to be one of the major market drivers in the region.

List of Key Companies in Human Insulin Market

Novo Nordisk, Eli Lilly and Company, and Sanofi Accounts for a Dominant Share in Terms of Revenue

Novo Nordisk A/S captured the largest human insulin market share and is projected to retain its position, due to increasing partnerships strategies of the company and technological innovations in drug discovery. Furthermore, robust investments in research activities to develop a portfolio of superior treatment solutions has enabled the company to hold a leading position in the market.

• For instance, in November 2021, Novo Nordisk A/S completed the acquisition of Dicerna Pharmaceuticals, including its Dicerna’s RNAi (ribonucleic acid interference) platform, in addition to Novo Nordisk’s research technology platforms utilized across all Novo Nordisk’s therapeutic areas.

Novo Nordisk A/S, along with Sanofi, Eli Lilly, and Company, currently holds a major share of the market in terms of revenue. Other players operating in the market are Biocon, Julphar, Tonghua Dongbao Pharmaceutical, Wockhardt, and among others. Julphar Diabetes is the division of Julphar that manufactures recombinant human insulin and insulin analogues crystals. The company also it has several businesses in the Middle East. Tonghua Dongbao Pharmaceutical developed the first recombinant insulin in China. The company is involved in the research & development, production, and marketing of products.

LIST OF KEY COMPANIES PROFILED:

• Novo Nordisk A/S (Denmark)


• Eli Lilly and Company (U.S.)


• Sanofi (France)


• BIOTON S.A. (Poland)


• Gan & Lee Pharmaceuticals (China)


• Biocon (India)


• Tonghua Dongbao Pharmaceutical (China)


• Julphar (UAE)


• Wockhardt (India)

KEY INDUSTRY DEVELOPMENTS:

• September 2023: Novo Nordisk partnered with Aspen Pharmacare Holdings Limited (Aspen) and Aspen SA Operations (Pty) Ltd in South Africa for the establishment of human insulin production in the country.


• November 2022: The U.S. FDA approved Rezvoglar, the second interchangeable insulin glargine biosimilar for diabetes patients.


• April 2022: Biocon received the grant of a 3-year contract for the supply of recombinant human insulin, named Insugen, from the ministry of health Malaysia, valued at USD 90million, and strengthened its footprint in the emerging market like Malaysia.


• February 2022: Biocon entered into a collaboration with Viatris Inc. to acquire the biosimilar business of Viatris and strengthened the company’s R&D and manufacturing facility to commercialize its capabilities.


• November 2021: Biocon collaborated with the Research Society for the Study of Diabetes in India (RSSDI) and launched a comprehensive care program for type 1 diabetic patients that helped to maintain their brand image in the market.


• September 2021: Eli Lilly and Company reduced the price of the Lispro injection in the U.S., which helped patients to reduce their out-of-pocket expenses and make it available at a more affordable price.

REPORT COVERAGE

The market research report elaborates on the global market dynamics and competitive landscape. Various key insights presented in the report are the prevalence of diabetes in key countries, pricing analysis by key players, advancements in insulin products, key mergers, acquisitions, and partnerships, competitive landscape, and company profiles.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Historical Period	2019-2022
Growth Rate	CAGR of 3.1% from 2024-2032
Unit	Value (USD Billion)
Segmentation	By Type Analogue Insulin Long-acting Fast-acting Premix Traditional Human Insulin Long-acting Short-acting Fast-acting Premix
By Diabetes Type Diabetes Type 1 Diabetes Type 2
By Distribution Channel Hospital Pharmacies Retail & Online Pharmacies
By Geography North America (By Type, By Diabetes Type, By Distribution Channel, and By Country) U.S. (By Diabetes Type) Canada (By Diabetes Type) Europe (By Type, By Diabetes Type, By Distribution Channel, and By Country) U.K. (By Diabetes Type) Germany (By Diabetes Type) France (By Diabetes Type) Italy (By Diabetes Type) Spain (By Diabetes Type) Scandinavia (By Diabetes Type) Rest of Europe (By Diabetes Type) Asia Pacific (By Type, By Diabetes Type, By Distribution Channel, and By Country) China (By Diabetes Type) Japan (By Diabetes Type) India (By Diabetes Type) Australia (By Diabetes Type) Southeast Asia (By Diabetes Type) Rest of Asia Pacific (By Diabetes Type) Latin America (By Type, By Diabetes Type, By Distribution Channel, and By Country) Brazil (By Diabetes Type) Mexico (By Diabetes Type) Rest of Latin America (By Diabetes Type) Middle East & Africa (By Type, By Diabetes Type, By Distribution Channel, and By Country) GCC (By Diabetes Type) South Africa (By Diabetes Type) Rest of Middle East & Africa (By Diabetes Type)