Human Recombinant Insulin Market Size, Share and Industry Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2025 - 2034

Human Recombinant Insulin Market Size

The global human recombinant insulin market generated notable revenues in 2024 and is projected to grow at a substantial CAGR during 2025-2034, driven by the rising incidence of diabetes, the aging population worldwide, and the advancement of biotechnology. According to the International Diabetes Federation (IDF), in 2024, an estimated 589 million adults aged 20-79 years had diabetes globally, or approximately one in every 9 individuals in this age group.
 

It is further estimated that around 252 million people have undiagnosed diabetes. Human recombinant insulin produced from genetically engineered bacteria or yeast is much safer and more able to produce human insulin consistently, compared to animal-sourced insulin; therefore, it is no surprise that the increased use of human recombinant insulin is being adopted into both sophisticated and emerging healthcare systems.
 

Human recombinant insulin has become a standard of care for type 1 diabetes, is increasingly being used for type 2 diabetes for those patients who no longer attain glycemic targets with oral therapies. The market also has strong sustainable growth, with demand for affordable insulin products in low- and middle-income countries where the diabetes burden is rapidly rising. Innovation in the production, formulation, and delivery devices for insulin, including smart pens and continuous glucose monitors are cue for improving the outlook for the human recombinant insulin market. The market will also benefit from the new policies and global campaigns. However, high production cost associated with advanced biotechnological processes restrains the market growth.
 

Human Recombinant Insulin Market Trends

The human recombinant insulin industry is booming, due to several trends reshaping the global treatment options for diabetes. Medical developments in biotechnology, namely recombinant DNA technology, have increased production efficiencies of human insulin, leading to lower-cost and more accessible treatments, paving the way for the development of biosimilar insulins. This has allowed biosimilar insulins, such as insulin glargine, to be offered as cheaper alternatives to branded insulin products, further increasing market competition and accessibility.
 

The projected number of people diagnosed with diabetes, mainly older adults, has led to an increased need for insulin therapies; thus, the importance of scalable and affordable insulin is critical as the healthcare needs grow. Emerging market governments’ expansion of healthcare infrastructure and supportive government programs and reimbursement policies, with slower growth in patients who could benefit from insulin therapies, has helped.
 

This has had the greatest impact in countries with little to no healthcare infrastructure when affordable options are the only financial choices a patient may have. These factors create a more competitive and accessible human recombinant insulin market that has previously been considered a major obstacle in addressing global diabetes.
 

The regular (short-acting) insulin segment in the human recombinant insulin market held a sizeable growth in 2024, driven by the continued clinical use, established safety, and continued affordability compared to other rapid-acting insulin analogs. Regular insulin generally acts between 30 minutes of injection and maintains strong efficacy for up to 8 hours, which can be helpful for patients with scheduled meals. The segment is still prevalent in acute care circumstances in hospitals and among insulin-dependent patients from resource-limited economies.
 

Because of its regulatory acceptance, regular insulins continue to be the first-line treatment for many newly diagnosed diabetes patients and overtly financially constrained patients. However, biosimilar regular insulins produced by pharmaceutical companies have boosted affordability and access in low- and middle-income areas. In addition, several global public health entities and private organizations continue to endorse human regular insulin to address treatment inequities. The segment is now under moderate strain from analogs with more rapid uptake or prolonged duration, but it remains a viable therapy for existing diabetes cases in resource-limited scenarios.
 

The online pharmacies segment is expected to witness robust growth through 2034 driven by the convenience of using an online source for patients, the extensive utilization of digital sources initiated during the COVID pandemic as patients were still able to have access to the insulin needed, and the growing demand for home care and chronic disease management for diabetes and other diseases. Online pharmacies have automated processes that help patients stay on therapy with features like auto-refills, ordering in bulk, and product delivery to their homes. This is a considerable benefit for patients who are insulin dependent, so that their therapy is not interrupted.
 

Online pharmacies are also beneficial for patients with mobility issues or living in remote or rural areas with limited access to physical stores. Regulatory bodies have contributed to the increased confidence in online pharmacies with better approvals for the dispensing of medicines online, strengthened cold chain logistics, and digitalized e-prescriptions. Also, now there are some online pharmacy providers utilizing telemedicine abilities like virtual consultations, personalized dosage scheduling, or real-time support from AI applications for insulin management.
 

North America recombinant human insulin market held sizeable growth in 2024, backed by a large established healthcare system, high diabetes prevalence, and biotechnology capacity. The US particularly held a leading position in the region with the many insulin products adopted, excellent insurance coverage for diabetes treatment, and a lot of manufacturers that made insulin with global recognition. The market continued to show growth driven by the increase in people diagnosed with full-blown type 1 or type 2 diabetes and the clear support for early insulin use.
 

While the regulatory environment in North America is rigorous, it has been welcoming for biosimilar insulin products, which have fostered market competition that puts pressure on price. As players within the region, we have access to excellent research and deep investments in innovations that have led to the development of improved formulations like concentrated insulins, combination products, and delivery devices with patient convenience. In addition, the regional public health campaigns and existing government programs, such as Medicare and Medicaid, provide an avenue to continue access to our medicines for millions of patients. Nevertheless, the affordability of insulin products continues to be a challenge for some patients, and the price to pay for this important medicine is an ongoing public and policy discussion.
 

Human Recombinant Insulin Market Share

Major companies operating in the human recombinant insulin industry include:

• Zhuhai United Laboratories Co., Ltd.
• Eli Lilly and Company
• Novo Nordisk A/S
• Sanofi S.A.
• Biocon
• Gan & Lee Pharmaceuticals Ltd.
   

To build strong positioning in the human recombinant insulin market, pharmaceutical companies have implemented multiple strategies. Prominent companies are investing in developing biosimilar insulins to make the product more affordable and globally accessible. Companies are working to identify and develop strategic partnerships with governments, charitable organizations, and local manufacturers to expand their reach into underserved areas.
 

Companies are also integrating smart health technologies, such as connected insulin pens and mobile health apps, to improve patient compliance and personalization with the insulin delivery system. Lifecycle management strategies, which could include moving existing insulin types to reformulated variants that are more concentrated or longer acting, are used to maintain product and market relevance.
 

Human Recombinant Insulin Industry News

• In July 2023, PharmaSyntez, a leading technology enterprise in Russia, launched three innovative recombinant human insulin products: Gensulin M30, Gensulin P, and Gensulin H. These cutting-edge medical products were produced at the state-of-the-art Pharmasyntez-Nord plant, which could produce over 5 million insulin units annually. The products were available in various forms, including vials, disposable syringe pens, and cartridges for reusable syringe pens.
   
• In Api 2023, Eli Lilly and Company launched its insulin glargine biosimilar, Rezvoglar, in the US market, making it the second interchangeable insulin biosimilar available to American diabetes patients. Rezvoglar received FDA approval and was granted an interchangeability designation. Insulin glargine products, like Rezvoglar, manage blood sugar levels in both adult and pediatric patients with type 1 diabetes, as well as in adults with type 2 diabetes.