The global short-acting insulin market size is to grow to USD 10288 million by 2030 at a CAGR of 2% from the early figures of USD 9257 million in 2021. The short-acting insulin market is largely consolidated, with Sanofi, Novo Nordisk, and Eli Lilly dominating the industry. Each of these businesses has successfully established its brand in the marketplace. In order to penetrate the local markets, however, these manufacturers must exert considerable effort due to the fierce competition there. Therefore, they employ powerful competitive strategies to strengthen their market position.
Numerous generic insulin (biosimilars) producers and major corporations attempting to introduce innovative products are motivated by the market's high profitability. This is why the short-acting insulin market is in the eye of major business persons who are looking to enter the said market segment to earn whopping profits.
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Government policies play a crucial role in enhancing the quality and safety of healthcare at the federal, state, and local levels of authority. Changes in policy, systems, and the environment (PSE) are crucial components of a long-term plan to prevent chronic diseases. The purpose of government policies and environmental modifications is to make healthy behaviors more accessible or desirable and unhealthy exposures more challenging or prohibited. Interventions at the system level aim to enhance the operation of an agency or organization and the delivery of its services to the community. Diabetes is a chronic disease that affects more than 30 million people. The 2010 Affordable Care Act (ACA) established a paradigm of shared responsibility between the government, employers, and individuals to ensure that all have unrestricted access to affordable, high-quality health insurance in their respective regions.
All patients with Type 1 diabetes and a minority of patients with Type 2 diabetes require daily insulin injections as part of their treatment. According to the American Diabetes Association, approximately 67.3% of the cost of diabetes care in the United States is covered by government insurance (including Medicare, Medicaid, and the military). The remainder is covered by private insurance (30.7%) and uninsured individuals, which are merely 2%. Efforts to make insulin accessible to a greater number of diabetes patients at reasonable prices are anticipated to boost the market outlook during the forecast period.
According to the World Health Organization, there are over 400 million diabetics worldwide, and its treatment accounts for approximately 12 percent of global healthcare expenditures. In 2018, the American Diabetes Association (ADA) reported an increase in newly diagnosed cases of Type 1 and Type 2 diabetes in the United States, with nearly 40,000 new cases of Type 1 diabetes being registered annually. As the patents for major branded insulin products are expected to expire within the next decade, diabetes monitoring and prevention agencies such as the ADA are investing significant resources in the R&D of biosimilars or generic insulins to improve the quality of medical services and the efficacy of administered treatments. In 2018, the American Diabetes Association (ADA) funded 318 new and ongoing projects addressing all types of diabetes and its numerous complications using a wide range of scientific approaches.
Biosimilar Insulin is a biological copy of the original insulin. There is a growing global interest in developing and utilizing this insulin. Biosimilar insulins can drastically reduce the costs associated with diabetes treatment while increasing insulin treatment accessibility and market competition by increasing the number of insulin brands on the market. Currently, two biosimilar insulins have been approved in the United States using the old pathway. They are Basaglar (Lilly), a 2015-approved successor to Glargine (Lantus, Sanofi), and Admelog (Sanofi), a 2017-approved successor to Lispro (Humalog, Lilly).
The US Food and Drug Administration (FDA) released new draft guidance in December 2019 that permits the development of insulin biosimilars, potentially allowing cheaper, nearly identical versions of these biological drugs to be substituted for the originator. It outlined the circumstances in which insulin biosimilar developers may not be required to conduct comparative clinical immunogenicity studies. With these two major driving factors of the short-acting insulin market, the said market segment is progressing on the inclined path of growth, thus creating huge opportunities in the global healthcare sector.
Globally, there are currently five major insulin types on the market: regular insulin, NPH, rapid-acting analogs, basal analogs, and pre-mixed insulin. Insulin analogs are typically significantly more expensive than regular insulin or NPH as they are bioengineered with altered amino acid sequences to achieve the desired chemical properties. Since the beginning of the twenty-first century, the price of insulin has multiplied due to the combined effect of several factors.
Lack of competition from generics is one of the primary reasons manufacturers continue to increase insulin prices. Insulin cannot be manufactured in a generic fashion as it is a therapeutic biological product and not a chemically synthesized molecule. Moreover, the associated technological and cost obstacles associated with the R&D of biosimilars, such as the numerous development stages and rigorous clinical trials, limit the viability of a potential insulin substitute.
With patents and other legal restrictions preventing the entry of new players with comparable product offerings, insulin prices have skyrocketed and show no sign of stabilizing. Sanofi has filed 74 patent applications on Lantus alone, indicating that the company has created the potential for a 37-year monopoly without competition. Drug companies may implement a price increase at any time; therefore, they must be regulated through the implementation of reforms to prevent a price increase.
In response to insulin price increases, some private insurance companies are independently working to cap out-of-pocket insulin costs for consumers, and a 2019 change to the Insulin Receptor Substrate (IRS) rule allows preventive medication and services to be covered for individuals with certain high-deductible health plans. The government has taken several steps to increase insulin's accessibility and affordability.
In April 2019, the FDA announced new policies to increase competition in the insulin market, and in July 2019, the US Senate introduced bipartisan legislation that could reduce insulin prices by as much as 75 percent compared to the projected levels for 2020. As a daily treatment for Type 1 diabetes, insulin is inaccessible to low-income populations due to its escalating price, thereby limiting the market's growth potential and exposing a large portion of the diabetic population to serious health issues.
Even though the demand is driven by the increasing number of insulin users worldwide, only a small number of companies are able to meet this demand in most regions. Thus, the sole authority to set prices lies with the insulin manufacturers. Even government end-users have limited or no price control. Since the production of insulin is highly regulated through patents and other legal violations, new companies are prohibited from manufacturing similar drugs before the patent expires.
This demonstrates the dominance of a small number of market participants, who seek to capitalize on their technological prowess for maximum profit. Historically, there were no suitable alternatives to rapid-acting insulins. Recent emphasis on the development of less expensive biosimilars has altered the established market dynamic, which is why there is a generating opportunity to develop a new type of insulins.
However, the development of biosimilars is still in its infancy, and only a small number of these drugs are currently available in the market. It is widely anticipated that the recently drafted FDA resolution will encourage the research and development (R&D) of biosimilars and promote their adoption as less expensive alternatives for the treatment of diabetes.
Through their established supply chain and branding, prominent players such as Sanofi, Novo Nordisk, and Lilly have created a monopoly in the market, resulting in significant global market penetration. These companies collaborate with a number of administrative and health agencies to develop and implement competitive strategies, which is opening a wide window for newcomers and professionals in the industry to gain some business through the said market segment.
The global supply chain disruption that caused the shortage of raw materials for manufacturing and production in every industrial segment was the only adverse effect on the short-acting insulin market. But still, as the insulins are related to the public health issues, and owing to the pandemic, the healthcare sector was operating at its prime, which made the availability of the insulins easier at some locations.
Due to the supply chain difference and the shortage of raw materials, there was limited stock of such insulins in many regions of the world, making it difficult for health professionals and patients. These limited stocks caused insulin prices to rise at the highest level, which made it inaccessible for poor people and even resulted in the deaths of patients due to the unavailability of the insulins.
The global short-acting insulin market is segmented on the basis of drug used, which is classified further into Novolog, Humalog, and Humulin drugs. Out of these drugs, the Novolog drug segment dominates the global insulin market with a market share of USD 2651 million in 2021 and is expected to be at USD 2695 million by 2030 at a CAGR of 0.18%. Novolog is rapid-acting insulin used in conjunction with mealtime insulin. It was created primarily to obtain pharmacokinetic and pharmacodynamic properties that more closely resemble the physiological mealtime response of insulin in a person without diabetes.
The Humalog is the second dominant segment that accounts for a market value of USD 2463 million in 2021 and is to be at USD 1966 million by 2030 at a CAGR of -2.47%. The third and the one with a positive growth rate segment is the Humulin, which has a market value of USD 1284 million in 2021 and is expected to reach USD 1564 million by 2030 at a CAGR of 2%.
The global short-acting insulin market is primarily segmented into North America, Europe, and Asia-Pacific.
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Which, North America is dominating the market with a market value of USD 482 million in 2021 and is expected to reach USD 589 million by 2030 at a CAGR of 2%. North America is the most developed and the major economy in the world and has the best-in-class health facilities, which is the main reason behind its dominance in the said market.
The Asia-Pacific region is listed second in the said segmentation with a market value of USD 48 million in 2021 and is expected to reach USD 69 million in 2030 at a CAGR of 4%. The exceptional growth of the healthcare sector in the Asia-Pacific region with an impeccable growth rate has led to the growth and development of the short-acting insulin market in the region. Europe is the third on the list having a market value of USD 9 million in 2021 and growing to USD 13 million by 2030 at a CAGR of 4%.
Europe has some major manufacturers as well as research institutes that are contributing to the overall revenue generation for the region.