Global Insulin Glargine Market - 2021-2028
Insulin Glargine，是長時間作用型的胰島素注射液製劑。影響市場的要素，是糖尿病的盛行率增加，和第一型糖尿病增加。糖尿病患者對胰島素需求增加，是促進Insulin Glargine市場成長的主要原因。
The insulin glargine market. Size was valued at US$ XX billion in 2020 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Insulin glargine is a long-acting, manufactured version of human insulin. Insulin glargine works by replacing the insulin produced by the body and helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.
The rising prevalence of diabetes disease and the growth in Type 1 Diabetes of diabetes. The increase in demand for insulin for diabetes patients is the main factor driving the growth of the insulin glargine market.
The rising prevalence of diabetes disease will drive the market growth
In 2020, according to the International Diabetes Federation (IDF). 34.2 million Americans-just over 1 in 10-have diabetes. 88 million American adults, approximately 1 in 3, have prediabetes.
Over time, people who have diabetes and high blood sugar may develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication, making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking the blood sugar may help manage diabetes and improve health. The use of insulin glargine therapy may also decrease chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. It works by helping blood sugar (glucose) to get into cells so that body can use it for energy. Insulin glargine may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.
Insulin glargine was found to provide at least equivalent glycemic control as NPH insulin in children and adolescents with type 1 diabetes. The long duration of action and lack of peak activity has raised the possibility of insulin glargine being beneficial in several special clinical settings. Frail elderly patients with diabetes, in whom hypoglycemia is a particular risk, may benefit from a reduced number of injections and a reduced risk of hypoglycemia.
An increase in demand for insulin will drive the insulin glargine market in the forecast period
The estimated potential number of insulin users, the amount of insulin required, and the burden of diabetes complications under varying levels of insulin access and type 2 diabetes in adults aged 18 or older. Worldwide results showed that, the number of adults with type 2 diabetes is expected to rise by more than a fifth from 406 million in 2018 to 511 million in 2030, with over half living in just three countries: China, India and the United States.Researchers said the amount of insulin needed to treat type 2 diabetes effectively would rise by more than 20 percent over the next 12 years. Still, insulin would be beyond the reach of half of the 79 million type 2 diabetics predicted to need it in 2030.
The discovery of insulin heralded a new dawn for people with diabetes, with significant gains in both life expectancy and quality of life. The ultimate goal of insulin therapy is to mimic the physiological secretion of insulin to accommodate both fasting and prandial requirements, and advances in protein engineering have enabled the development of insulin analogs that mimic both basal and prandial requirements.
In people with T1DM, glargine offers improved convenience, with only once-daily administration and flexibility as to the timing of injection (morning, pre-dinner, or pre-bedtime). In people with T2DM, glargine offers increased safety (reduced risk of nocturnal hypoglycemia) and convenience (once-daily administration) when attempting to reach the target HbA1c level of 7.0 % and below, which is achieved in more than 50 % of subjects.
Side effects and the high cost of the product will hamper the market
As the price of insulin continues to rise, individuals with diabetes are often forced to choose between purchasing their medications or paying for other necessities, exposing them to serious short- and long-term health consequences The most commonly used forms of analog insulin cost ten times more in the United States than in any other developed country. There have been many other recent deaths in patients with type 1 diabetes because of a lack of affordable insulin.
The high prevalence of diabetes, the prefilled syringe lifelong nature of the disease, and the fact that patients with type 1 diabetes will die without access to insulin make this an major problem that should be solved expeditiously. The insulin's price is also a stark and troubling example of the rising cost of prescription drugs in the United States and highlights a systemic problem with how drugs are priced compared with every other commodity.
The more common side effects that can occur with insulin glargine are hypokalemia (low potassium levels); symptoms can include weakness, fatigue (lack of energy), muscle cramping, abnormal heart rhythm (a heartbeat that's too fast, too slow, or uneven), paralysis (loss of movement in a body part), respiratory failure (meaning your lungs can't release oxygen into your blood).Severe hypoglycemia (very low blood sugar levels) and allergic reaction.This will hamper the insulin glargine market.
COVID-19 Impact Analysis
As diabetes case numbers are expected to be further fuelled by COVID-19, and as the pathophysiology of COVID-19 induced diabetes is further explored, there will be more patients in need of targeted therapeutics. As stated, DM increases the complications of COVID-19 and the risk of COVID-19 related mortality. Current evidence demonstrates that patients with DM are more likely to experience severe symptoms and complications than patients without DM due to COVID-19. This will increase the demand for the insulin glargine market.
The single-dose vial will dominate the market in the forecast period
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) meant for use in a single patient for a single case, procedure, or injection. Every year, significant amounts of expensive drugs are discarded. This is due to the growing number of prescription drugs administered in variable doses (rather than fixed or flat doses) based on a patient's weight or body size. Because of safety considerations, the typical approach for manufacturers in the United States is to package these weight-based medications in single-dose vials intended for use by a single patient.
Single-dose formats offer several important programmatic benefits, such as increased vaccination opportunities and improved safety. One single-dose format, the prefilled auto-disable (AD) device, provides additional injection safety and convenience features because it physically combines the vaccine and AD syringe.
Type-1 diabetes has dominated the market
Type 1 diabetes (previously known as insulin-dependent, juvenile or childhood-onset) is characterized by low insulin production and requires daily insulin administration.
Approximately 1.6 million Americans have Type 1 diabetes.In coming years, almost 5 million people are expected to be diagnosed with type 1 diabetes. An estimated number of 64,000 people are diagnosed with type 1 diabetes each year. And 200,000 people under the age of 20 years old have type 1 diabetes. People with type 1 diabetes are not able to produce enough insulin. This type constitutes about 5%-10% of all cases of diabetes.
Lantus or insulin glargine can be prescribed for all types of diabetes. However, it is most commonly prescribed to people with type 1 diabetes. Insulin glargine is used to treat type 1 diabetes (a condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood).
The hospital Pharmacy segment will dominate the market
More than 29 million Americans have diabetes. It is one of the most common disease states encountered in the inpatient setting. In most clinical situations, insulin is the preferred method for hyperglycemia management in the inpatient setting, control of hyperglycemia in hospitalized patients is important for optimal clinical outcomes. For patients admitted in a general medical ward, the glycemic goal range maybe 110-140 mg/dl pre-prandially and 140-180 mg/dl postprandially. They select initial insulin doses in the hospital. Overall, it is highly recommended to use scheduled doses of insulin rather than "sliding-scale" insulin. Insulin therapy during hospitalization allows flexibility to change rapidly with the patients' condition and is best provided by what has been termed a basal/bolus insulin regimen. Glargine is generally preferred because of its longer duration of action with once-daily administration. Basal insulin, when dosed correctly, should not cause hypoglycemia when patients are restricted from oral nutritional intake (NPO).
North America dominated the insulin glargine market
Increased diabetes patients in this region and increasing medical expenditure will increase the growth of the insulin glargine market. Of the 34.2 million U.S. adults with diabetes, approximately 7.3 million of those are undiagnosed. (ADA, 2020) An estimated 88 million adults have prediabetes, 34.5% of the U.S. adult population.
Overall, among the US population, crude estimates for 2018 were 26.9 million people of all ages, or 8.2% of the US population had diagnosed diabetes. And 210,000 children, adolescents younger than age 20 years or 25 per 10,000 US youths had been diagnosed diabetes. This includes 187,000 with type 1 diabetes. 1.4 million adults aged 20 years or older, or 5.2% of all US adults with diagnosed diabetes, reported both having type 1 diabetes and using insulin. 2.9 million adults aged 20 years or older, or 10.9% of all US adults with diagnosed diabetes, started using insulin within a year of their Type 1 Diabetes.
Wealthy countries like U.S., tend to spend more per person on health care and related expenses than lower-income countries. The U.S. spends more on health of per person than comparable countries. In the U.S, health spending per person was $10,966 in 2019, which was 42% higher than Switzerland, the country with the next highest per capita health spending.
The US Food and Drug Administration has approved Biocon Biologics India Ltd's insulin glargine injection Semglee for controlling high blood sugar in adults with diabetes.
The insulin glargine market is moderately competitive with the presence of local as well as global companies. Some prominent key players in this market are Sanofi-Aventis, Novo Nordisk, Trumac Healthcare Ltd, ADOCIA, Trumac Healthcare Ltd, WOCKHARDT, Cipla Inc., Biocon Biologics, Biogenomics Limited., Loka BioSciences, Amigoz Lifesciences, Endocrine Technologies, Inc., Spectrum Chemical Mfg. Corp., Sekisui Diagnostics, LLC, Alfa Chemical Corp, Dongbro Pharmaceutical, Chongqing Fujin Biology Medical Company, Wanbang Medical Company.
Key Companies to Watch
Overview: Biocon Biologics is a subsidiary of Biocon Ltd, an innovation-led global biopharmaceuticals company. Biocon Biologics is engaged in developing high-quality, affordable biosimilars that can expand access to an advanced class of therapies to patients globally. It has unique position as a fully integrated 'pure play' biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions.
Product Portfolio: The Company has a large portfolio of biosimilars under global clinical development. Three of these commercialized in at least one of the developed markets of the EU, Japan and U.S . Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and many independently.
Key Development: On June 2020, Bicon and Mylan announced the U.S. launch of Semglee (insulin glargine injection) in a vial and prefilled pen presentations, approved to help control high blood sugar in adult and pediatric patients type 1 diabetes and adults with type 2 diabetes. It is not recommended for Type 2 Diabetes of diabetic ketoacidosis. Semglee, which received final approval from the U.S. Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi's Lantus and is approved for the same indications.
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Insulin Glargine Market. - By Type
Insulin Glargine Market. - By Application
Insulin Glargine Market. - By Distribution Channel
Insulin Glargine Market. - By Region
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