Diabetes Disease

Redefining Diabetes Market: Where Solutions Meet Success

In the quiet battle beneath the surface, diabetes wages a relentless war on human lives. With stealth and cunning, it strikes at the heart of human health, leaving no organ untouched. From arteries to eyes, it weaves a web of complications, threatening the lives of millions. Unseen but potent, diabetes is caused by a host of issues, from heart disease to nerve damage, jeopardizing its existence. Ignoring this formidable foe is not an option, for the consequences are severe.

Despite these limitations, there are untapped prospects for development and innovation. The strength of DiseaseLandscape Insights services serves as a compass to fight this deadly disease. Chronic metabolic disease known as diabetes causes high blood glucose (or blood sugar) levels, which over time seriously harm the heart, blood vessels, eyes, kidneys, and nerves.

Around 537 million adults around the world now live with diabetes – an increase of 73.6 million between 2019 and 2022. China, with 140.9 million people, leads the pack, followed by India, Pakistan, the United States, Indonesia, Brazil, Mexico, Bangladesh, Japan, and Egypt, according to the International Diabetes Federation's (IDF) Diabetes Atlas 2022. Furthermore, in an article published on June 22, 2023, the statistics were broken down by Global Diabetes based on super-region, the highest rate for this age group was found to be in North Africa and the Middle East at 39.4%, while the lowest rate was found in Central Europe, Eastern Europe, and Central Asia at 19.8%.

Symptoms of Diabetes include:

• Blurred vision
• More frequent urge to urinate.

The data extracted from Health data (IHME) on June 22, 2023, indicates that- Diabetes was especially evident in people 65 and older in every country and recorded a prevalence rate of more than 20% for that demographic worldwide. The highest rate was ~24.4% for those between the ages of 75 and 79. A prevalence of diagnosed diabetes of approximately 11.3 percent of adults (37.3 million people; 28.7 million) with diagnosed diabetes, an estimated 8.5 million undiagnosed was reported in 2022.

Furthermore, WHO states that diabetes is responsible for 6.7 million deaths in 2021 - 1 every 5 seconds, and in 2019, diabetes was the direct cause of 1.5 million deaths. Approximately 48% of all deaths due to diabetes occurred before the age of 70 years.

Ranges of Blood-sugar level:

• 180 mg/dL: Too high- considered unhealthy
• 80 - 130 mg/dL: Normal sugar range for most people
• < 70 mg/dL: Too low- Unhealthy

One major cause of the spread of diabetes is an unhealthy lifestyle, which includes factors like poor dietary habits, lack of physical activity, and obesity resulting in increased rates of diabetes worldwide, as indicated in the graph.

Causes of Diabetes:

• Insulin resistance
• Autoimmune disease
• Hormonal imbalances
• Pancreatic damage
• Genetic mutations

In reference to The International Diabetes Federation (IDF), an annual report was released on global estimates of diabetes prevalence for the year 2021:

Diabetes & its Types:

• Prediabetes

The Centers for Disease Control and Prevention (CDC) defines prediabetes as a dangerous medical disease in which blood sugar levels are elevated but not high enough to be classified as type 2 diabetes, although prediabetes itself results in type 2 diabetes. Approximately 96 million adult Americans, or more than one in three, have prediabetes. Of those with prediabetes, more than 80% do not know they have it.

• Type 1 Diabetes

Deficient insulin production is a defining feature of type 1 diabetes, which calls for daily insulin injections. It has been found that diabetes is increasing in patients under the age of 20 years which is, 1.52 million of the 8.75 million people with type 1 diabetes worldwide in 2022, as reported by the Diabetes Atlas.

• Type 2 Diabetes

Hyperglycaemia, insulin resistance, and relative impairment in insulin production are the hallmarks of type 2 Diabetes Mellitus. Type 2 diabetes affects more than 95% of those who have the disease. The body's ability to use sugar (glucose) for energy is impacted by type 2 diabetes.

• Impaired Glucose Tolerance (IGT) and Insulin-Like Growth Factor (IFG)

IGT tends to be characterized by insulin resistance in muscle and decreased glucose uptake, while IFG is generally driven by insulin resistance in the liver and excess hepatic glucose production. The global prevalence of IGT in 2021 was ~9.1% (464 million). Globally, IFG cases in 2021 were 5.8% (298 million) according to the National Institute of Health.

• Brittle Diabetes

Blood sugar swings are significant and frequent, which is why it is also known as unstable diabetes or labile diabetes. This type is uncommon and mostly affects patients with Type 1 diabetes.

• Gestational Diabetes Mellitus (GDM)

GDM is a condition in which a hormone (Estrogen, cortisol, and human placental lactogen) has a blocking effect on insulin. It usually begins about 20 to 24 weeks into the pregnancy which prevents the body from using insulin effectively.

Diagnostic Techniques: Diabetes

Using Cutting-Edge DiseaseLandscape Insight Services Targeted at Diabetes Analysis, Helps to Greatly Improve the Diagnostic Services that are Offered. These Innovative Insights Enable Companies to Provide Clients with Products and Services that are Superior in Quality and Value.

In line with the CDC, the existing diagnostic techniques available in the market for detecting diabetes are as follows:

1. Blood Glucose Meter:

   A blood glucose meter is a small, portable machine that's used to measure how much glucose (a type of sugar) is in the blood (also known as the blood glucose level).

FDA states that: Readings of glucose meters are 95 percent accurate within 15 percent for all readings within the “usable” blood glucose range and 99 percent accurate within 20 percent for all readings within that usable range.

A brief examination of the best home glucose meters according to population usage:

• Overall, for new users: The Contour Next One
• Detailed glucose data: Guardian Connect System
• Best for blood-free readings: FreeStyle Libre
• Best for extra features under budget: Walgreens TrueMetrix Bluetooth Blood Glucose Meter
• Budget-friendly: Rite Aid TrueMetrix Meter

There are many advantages of using a glucometer but also some disadvantages, which are listed below: 

The Continuous Glucose Monitoring (CGM) System overcomes the limitations of the Glucometer.

2. Continuous Glucose Monitoring (CGM):

   Patients having type 1 or type 2 diabetes manage their blood sugar better by using the CGM system. It tracks blood glucose levels anytime during the day and night. For most people, the target is 70% and the target range is between 70 and 180 mg/dL. These target numbers are adjustable according to age and other conditions. On 31st May 2022, Abbott issued a press release announcing the FDA's approval of the FreeStyle Libre 3 CGM system for use by patients aged 4 and up.

The reason why CGM Systems are more accurate than Glucometers: MARD (Mean Absolute Relative Difference) is the primary metric used to measure CGM accuracy. As a point of comparison, the typical MARD for commercially accessible CGMs is 10%-12%, whereas commercially available finger stick meters produce MARD results of less than 5%.

3. Screening:

   All adults aged 35 and older, as well as those under 35, overweight or obese have one or more risk factors for diabetes, pregnant women, people with prediabetes, children having a family history of type 2 diabetes, and those with other risk factors, should undergo routine screening for type 2 diabetes with diagnostic tests.

4. Blood tests:

• Post Prandial Glucose Test (PPBS)
• Triglycerides
• Creatinine Blood Test
• Electrolytes
• Insulin Auto Antibodies (IAA)
• C-Peptide

Emerging Techniques with The Use of Needle-Free Diabetes Care and Devices for Easy Diagnosis of Diabetes:

1. GlucoTrack:

In 2023, Glucotrack’s two-year CGM implant passes the first feasibility study. It is developed by the U.S.–Israeli company Integrity Applications — now rebranded as GlucoTrack, Inc. — the GlucoTrack device monitors blood sugar levels through a combination of ultrasonic, electromagnetic, and thermal waves.

2. Eversense:

Eversense is a subcutaneous implant that continually monitors blood glucose levels. It was developed by the American company Senseonics and is distributed by Ascensia Diabetes Care. Although it initially needs to be installed under the skin by a doctor, the sensor lasts for up to three months before needing a replacement.  The FDA-approved (2022) Eversense 365 system is making progress. It is completely enrolled in the pivotal enhanced clinical study and has started enrolling the FDA-approved pediatric cohort.

3. glucoWISE:

glucoWISE has undergone two small-scale human studies and is still being developed by Meta Materials. The system received a U.S. patent for a non-invasive glucose measuring system earlier in 2023. It is a sensor under development that could measure blood sugar levels by simply placing it on the skin between the thumb and forefinger. The real-time measurements are then directly sent to a smartphone application.

4. SugarBEAT:

   A replaceable skin patch connected to a transmitter was created by U.K. biotech company Nemaura Medical and is suitable for people with type 1 and type 2 diabetes as well as pre-diabetes. Every five minutes, the rechargeable transmitter delivers data over Bluetooth to the user's phone, where the readings may be seen using a companion app. The U.S. FDA received a sugarBEAT® PMA (Premarket Approval Application) from Nemaura in 2021. ProBEATTM, a general wellness solution that is a component of its BEAT®diabetes program, combines non-invasive glucose data analyzed using artificial intelligence with a digital healthcare subscription service. It was introduced in the United States.

5. Occuity Indigo:

   According to the Association of Optometrists in 2021, medical technology start-up Occuity secured £2.85 million in funding to create the Occuity Indigo, a non-contact optical glucose meter. As with the Google Contact Lens, the U.K. developer Occuity examines the eyeball, which is clear and stable and whose glucose levels correlate with those of the blood, rather than measuring tear fluid.

6. D-Base:

   The D-Base blood sugar meter from DiaMonTech has shoebox-like dimensions.

D-Base was licensed for use by medical professionals in clinical trials and diabetes clinics in the EU in 2019. Additionally, DiaMonTech is developing scaled-down versions of the technology, such as the D-Pocket, a handheld device, and the tiny D-Sensor, a component for wearable electronics.

Unlock The Hidden Potential of The Diagnostic Market for Diabetes with DLI and Delve Deep into the Data-Rich Terrain to Extract Invaluable Insights. Arm the Business with the Knowledge it Needs to Thrive, Understanding the Scope of Growth in this Ever-Expanding Diabetes Diagnostic Market

The following is a list of market rivals whose ground-breaking diagnostic innovations are altering the healthcare sector:

Diabetes: Treatment Techniques

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Currently, there is a range of treatment options available for diabetic conditions:

1. Lifestyle Changes:

   A lifestyle intervention of a low-calorie and low-fat diet and moderate-intensity exercise for 150 minutes each week, patients in the lifestyle intervention group demonstrated a ~67% reduction in the risk of developing type 2 diabetes mellitus.

2. Diabetes Medications:

   There are various oral medications and injectables available to help manage diabetes. These medications work in different ways, such as increasing insulin sensitivity, stimulating insulin production, or slowing down glucose absorption in the intestines.

Oral Medications:

• Meglitinides (glinides).
• SGLT2

Injectable Drugs:

• Albiglutide (Tanzeum)
• Dulaglutide (Trulicity)
• Insulin aspart (NovoLog, NovoLog FlexPen)

There is a study by NCBI that states Metformin is a Biguanide that is used as the first-line treatment of type 2 diabetes mellitus and is effective as monotherapy and in combination with other glucose-lowering medications.

Furthermore, in a 2022 study comparing the monotherapy of Rosiglitazone, Metformin, and Glyburide in individuals with newly diagnosed diabetes, metformin was given to 36% of subjects, rosiglitazone to 40%, and Glyburide to only 26%. This indicates that Rosiglitazone is not as effective at lowering blood sugar as Metformin. Fawn Incorporation, Abbott, Lupin, Cipla, and Sun Pharmaceutical Industries Ltd. are a few of the top Metformin manufacturers in India.

3. Insulin Therapy:

   Insulin therapy replaces the insulin the body would normally make. It functions by assisting in the movement of blood sugar into other bodily tissues where it is utilized for energy. Additionally, it prevents the liver from generating additional sugar. Insulin must be taken daily by those with type 1 diabetes. When alternative therapies and medications fail to regulate blood sugar levels, people with type 2 diabetes must take insulin.

The following general insulin therapy options are available:

• Long-, ultralong-, or intermediate-acting insulin:

  Examples include Glargine (Lantus, Toujeo, and others), Detemir (Levemir), Degludec (Tresiba), and NPH (Humulin N, Novolin N, Novolin ReliOn Insulin N). Depending on the type, these insulins last anywhere from eight to forty hours.

• Rapid- or short-acting insulin:

  Examples: Aspart (NovoLog, Fiasp), Glulisine (Apidra), Lispro (Humalog, Admelog), and Regular (Humulin R, Novolin R, Myxredlin, ReliOn R). Insulin Delivery Options include Shots or pens and Insulin pumps.

4. Bariatric Surgery:

   In some cases of severe obesity and type 2 diabetes, bariatric surgery may be considered a treatment option. This surgery can lead to significant weight loss and help to improve blood sugar control.

Emerging Technique for the Treatment of Diabetes:

1. Closed-Loop Insulin Delivery Systems (Artificial Pancreas):

   An artificial pancreas is a system made of three parts that work together to mimic how a healthy pancreas controls blood glucose, also called blood sugar, in the body. A closed-loop insulin delivery system is mainly used to help people with type 1 diabetes.

Some approved Closed-Loop Insulin Delivery Systems: The MiniMed 670G (Medtronic), the first commercially available hybrid closed-loop system, was released in 2016. Other systems that have received FDA approval include the MiniMed 780G (Medtronic), CamAPS FX (CamDiab, Cambridge, UK) (29), and t: slim X2 insulin pump with Control-IQ (Tandem).

2. Recombinant DNA technology:

   When animal insulin sources became a limiting factor then rDNA technology & advanced protein chemistry made Human Insulin preparations available. In comparison to semisynthetic insulin, recombinant insulin is purer and consistently of high quality.

Market players of rDNA tech are:

• Sanofi: Insuman® (Bacteria- Escherichia coli)
• Novo Nordisk: Novolin® (US) (Yeast- Saccharomyces cerevisiae)
• Eli Lilly: Humulin® (US) (Bacteria - Escherichia coli)

Eli Lilly launched the first generic insulin, Insulin Lispro, in 2019. It is the inverse of Humalog, a well-known rapid-acting insulin. Since then, generic versions of Humalog 75/25 (insulin lispro 75/25), Novolog (insulin aspart), Novolog 70/30 (insulin aspart 70/30), and Lantus (insulin glargine) have been approved by the FDA. Tresiba (insulin degludec), is the FDA-approved generic in July 2022 for long-acting insulin.

Since 2020, the average retail price of insulin has fallen which is according to a report by NCBI. However, not all insulins received price decreases. Retail insulin prices for Afrezza, Xultophy, and Soliqua continue to grow. Even certain variants of long-established insulins Humalog and Novolog have seen price increases since the epidemic began.

3. Microbiome-Based Therapies:

   In reference to NCBI, Type 2 Diabetes Mellitus (T2DM) has become the fastest-growing metabolic disease in the world.

These emerging techniques will help the industry grow by attracting investment, regulatory support, patient education and awareness, improved efficacy, reduced side effects, technological advancements, and personalized medicine.

With Innovative Approaches, DLI is Revolutionizing Healthcare. The DiseaseLandscape Insight Services Utilize Comprehensive Market Research to Optimize Treatment Techniques and Enhance Patient Care.

The healthcare industry is witnessing a revolution with innovative treatment inventions from the following market competitors:

Regulatory Framework for Diabetes Disease:

Recent Updates in Regulatory Guidelines Provided by DiseaseLandscape Insights Services are Immensely Helpful for Growing Businesses. These Updates Ensure that Companies Stay Compliant with Evolving Industry Standards, Avoid Potential Legal Pitfalls, and Streamline their Product Development and Marketing Processes.

According to an FDA article (May 2023), Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry,

• Sponsors also suggest additional clinically significant goals for medications aimed toward Diabetic patients. Examples include the removal of dependency on exogenous insulin or a reduction in the number of daily insulin injections in subjects with T1D; a reduction in insulin dose alone is not sufficient. If a sponsor seeks to demonstrate a clinically meaningful improvement with respect to a diabetes-related safety issue such as a decrease in Diabetic Ketoacidosis events versus an active comparator (i.e., comparative safety claim), such a comparative claim should be based on a level of evidence like that of an efficacy endpoint. Sponsors seeking to pursue a novel approach should discuss their plans with the FDA early in the drug’s development program.
• Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes. When patients with type 2 diabetes reach HbA1c values below 6.5%, clinicians should think about reducing the intensity of their drug therapy.

In addition to diet and exercise, the FDA approved Mounjaro (tirzepatide) injection on May 13, 2022, to help adults with type 2 diabetes better control their blood sugar levels. Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies.  

According to the CDSCO, National List of Essential Medicine 2022 Report:

• Variations in Priority Health Care Concerns within a country: For India medicines for priority healthcare conditions for different regions of the country have been considered for inclusion in NLEM 2022. Indian healthcare needs are also peculiar as they involve not only problems of low-income countries but also those of high-income countries, such as hypertension, diabetes mellitus, and other lifestyle diseases.

Clinical Trial Assessment:

DiseaseLandscape Insight Clinical Trial Assessment Helps Growing Businesses by Providing Crucial Data on Ongoing and Upcoming Clinical Trials Related to Specific Diseases and Therapies.

The table below displays the latest clinical trials, including their study, title, condition, and respective stages:

Conclusion:

DiseaseLandscape Insight Services plays a pivotal role in understanding the market dynamics and identifying growth opportunities for businesses. These services provide comprehensive analysis of prevailing diseases, emerging trends, and their impact on various industries, enabling businesses to make informed decisions.

By tracking disease causes, prevalence, diagnostic options, treatment patterns, updates in regulatory guidelines, clinical trial assessments, and advancements in research and development, companies gain valuable insights into the demand for specific products and services within the healthcare sector. Armed with this knowledge, businesses strategically position themselves, develop targeted marketing strategies, and invest in the development of innovative solutions, thereby maximizing their growth potential and staying ahead in the competitive market.

DiseaseLandscape Insight Services equips businesses with vital information about the healthcare market, allowing them to capitalize on growing opportunities. By understanding disease patterns, treatment needs, and technological advancements, companies tailor their products and services to meet evolving demands and foster business expansion and success.