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Semaglutide: Partnering with Lannett CDMO for Superior Manufacturing of Weight Loss Treatments

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Understanding Semaglutide

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that has gained recognition as an effective treatment for semaglutide weight loss. Commonly known as the active ingredient in brand names such Ozempic, Rybelsus, and Novo Nordisk’s popular weight loss drug Wegovy, semaglutide was originally approved for managing type 2 diabetes.

It has shown remarkable potential in aiding weight management, making it a vital option for individuals struggling with obesity. In 2024, the Food and Drug Administration (FDA) approved the use of Wegovy for the prevention of heart attacks and stroke, after a study demonstrated that it significantly lowered the risk of major adverse cardiovascular events by up to 20% in overweight or obese adults with heart disease.

How Semaglutide Works

Semaglutide functions by mimicking the natural hormone GLP-1, which plays a crucial role in appetite regulation and blood sugar control. By activating GLP-1 receptors, semaglutide reduces hunger, enhances feelings of fullness, and slows gastric emptying. This mechanism results in decreased calorie intake, contributing to effective weight loss.

https://www.news-medical.net/health/How-Does-Semaglutide-Work-to-Lose-Weight.aspx

Benefits of Semaglutide for Weight Loss

Significant Weight Loss: Clinical studies indicate that semaglutide can lead to substantial weight loss, even among those who have previously struggled with weight management. Patients can lose an average of 20% or more of their body weight and maintain weight reduction long term.
Improved Blood Sugar Control: For individuals with type 2 diabetes, semaglutide aids in regulating blood sugar levels, thereby lowering the risk of complications.
Reduced Cardiovascular Risk: Semaglutide has been shown to lower the risk of cardiovascular death, heart attack and stroke when combined with a reduced calorie diet and increased physical activity.

The Semaglutide Market

The surge of obesity and diabetes is a major health concern worldwide. In conjunction, the market for semaglutide is experiencing significant growth driven by its effectiveness in treating obesity and type 2 diabetes.

While research agrees that the obesity driven GLP-1 market is sizeable, it’s difficult to quantify. According to a report by Cognitive Market Research, the global semaglutide market is projected to reach USD 112.5 million in 2024, with an expected compound annual growth rate (CAGR) of 5.00% from 2024 to 2031. The report highlights that semaglutide’s role as a glucagon-like peptide-1 (GLP-1) receptor agonist has made it a promising therapeutic option, further propelled by advancements in drug delivery systems and favorable reimbursement policies.

Bloomberg reports that semaglutide has the potential to become one of the world’s top-selling drug franchises, with estimates suggesting that the obesity treatment market could reach USD 130 billion by 2030. Research companies Morningstar and PitchBook are much more optimistic about the semaglutide market, with their forecast estimating a potential $200 billion total GLP-1 market by 2031.

These sources collectively provide a verifiable overview of the rising market for semaglutide, reflecting the increasing demand for effective weight management solutions, the ongoing research into new indications for semaglutide and the need for pharmaceutical manufacturers to have the ability to produce and the capability and capacity to produce at scale.

Dual-Action GIP and GLP-1 Mechanisms: A Growing Market Opportunity

GIP compounds, associated with Gastric Inhibitory Polypeptide (GIP), also known as glucose-dependent insulinotropic polypeptide, are gaining considerable attention in the pharmaceutical industry. GIP, a key player in regulating insulin secretion in response to food intake, is part of the incretin hormone family alongside GLP-1 (glucagon-like peptide-1).

How Tirzepatide Works

One ground-breaking innovation is tirzepatide, an FDA-approved dual GIP and GLP-1 receptor agonist. This peptide, engineered from the native GIP sequence, exhibits agonist activity at both receptors. Tirzepatide decreases calorie intake by suppressing appetite, stimulates insulin secretion, and enhances insulin sensitivity, thereby inducing “clinically relevant weight reduction, warranting further investigation for the treatment of obesity”.

Tirzepatide and other formulations which leverage the dual action of GIP and GLP-1 receptor agonism offer a competitive edge by providing better glycemic control, effectively reducing HbA1c levels and excess body weight. It addresses multiple aspects of metabolic syndrome, an advantage in treating patients with complex needs. Tirzepatide is the active ingredient in Mounjaro (for blood sugar control in adults with type 2 diabetes) and Zepbound (for weight loss), made by Eli Lilly and Company.

The market opportunities for GIP compounds, particularly dual agonists like tirzepatide, are vast. These emerging antiobesity medications, developed as standalone products or in combination with GLP-1 therapies like semaglutide, are reshaping the treatment landscape for metabolic disorders, including type 2 diabetes and obesity.

As demand grows for effective solutions to manage these widespread health challenges, dual-action GIP and GLP-1 mechanisms represent a promising frontier in the pharmaceutical industry.

Lannett CDMO: Your Partner in Accelerating Weight Loss Drug Production

Lannett CDMO offers a strategic advantage for businesses aiming to bring anti-obesity medications like semaglutide to market more efficiently, primarily due to our expertise, experience and production capacity.

Our unwavering commitment to quality assurance ensures that every product we manufacture meets the highest standards of safety and efficacy, providing peace of mind to our partners and their end-users.

Streamlined Development

Rapid prototyping is a key feature of our approach. With our expertise as a pharmaceutical CDMO, we collaborate with trusted partners to support their product development process and substantially reduce time-to-market. Our scalable manufacturing capabilities also allow us to adjust production levels swiftly to meet demand and provide continuity of supply.

Regulatory Approval

Lannett CDMO’s regulatory expertise plays a crucial role in guiding our partners through the often-complex regulatory approval process, providing essential support at every step. Beyond this, we maintain strong partnerships with regulatory authorities to facilitate smooth and timely regulatory approvals.

Our Value Proposition

By partnering with Lannett CDMO, pharmaceutical companies can leverage our expertise to accelerate their timelines for bringing innovative semaglutide weight loss OSDs to market.

Lannett’s CDMO services demonstrate a strong capability in manufacturing high quality Oral Solid Dose (OSD) products through several key factors:

Specialized contract manufacturing of OSDs, including high potency substances and small molecules.
Extensive experience as a trusted provider of high-quality pharmaceuticals in the industry, dating back to 1942.
World-class manufacturing facilities equipped to handle the complete manufacturing process and commercial supply to efficiently meet diverse client needs.
High production capacity, manufacturing approximately 3.5 billion oral solid doses annually.
224,000 square feet dedicated to production facilities and an additional 204,000 square feet for warehousing and distribution.
Scalable operations to meet effectively increasing demand while maintaining stringent quality standards.
Strict adherence to regulatory standards, including ICH Q8, Q10, and FDA cGMP compliance to meet high safety and efficacy requirements.
Robust quality assurance processes, operational efficiency and reliability contribute to a consistent average product yield rate of 96%.

Lannett CDMO also offers tech transfer services that streamline the transition from product development to manufacturing, further enhancing efficiency and responsiveness to client needs.

Overall, this combination of extensive experience, advanced facilities, regulatory compliance, and commitment to quality positions us as a leading CDMO of oral solid dosage forms (OSDs) for obesity treatment in the pharmaceutical sector.

Partner With Lannett for OSD Semaglutide

For pharmaceutical companies currently in the semaglutide market or wholesale distributors looking to enter the semaglutide weight loss market, Lannett CDMO stands out as an ideal partner in this burgeoning space.

Demand for semaglutide continues to rise, due to its proven effectiveness. Known for its potent effects on regulating blood sugar levels and appetite control, even at relatively low doses, semaglutide is classified as a high-potency drug. This potency is an important consideration in both its formulation and dosing for patients.

With the capacity to manufacture approximately 3.5 billion Oral Solid Dosage (OSD) forms annually and advanced facilities capable of handling high-potency substances, Lannett CDMO is equipped to meet the increasing demand for semaglutide formulations.

Lannett’s scalable pharmaceutical contract manufacturing capabilities allows you to capitalize on market growth, given our ability to swiftly adjust production levels in response to market fluctuations to meet both current and future demand.

By partnering with Lannett CDMO, you not only enhance production efficiency but also strengthen your market position. As more patients seek out these treatments and competitors develop new weight-loss drugs and biosimilars to meet the market need for semaglutide formulations, Lannett’s established reputation, and operational efficiencies will be crucial in maintaining a competitive edge.

Conclusion

With approximately 70% of American adults affected by obesity or overweight, the increasing incidence has fuelled demand for effective weight management solutions.

Semaglutide has emerged as a groundbreaking treatment for weight loss, particularly for individuals struggling with obesity and type 2 diabetes. Its FDA approval and recognition as a leading therapeutic option underscore its effectiveness in promoting significant weight loss and improving overall health outcomes.

As competition intensifies within the obesity treatment landscape, Lannett’s deep understanding of the pharmaceutical landscape and regulatory environment will allow us to navigate complex challenges with efficiency and precision. Our commitment to quality assurance and regulatory compliance ensures that products are developed to the highest standards, addressing critical safety and efficacy concerns.

By leveraging Lannett’s extensive experience and advanced facilities as a CDMO company, pharmaceutical companies can accelerate their timelines for bringing innovative semaglutide weight loss solutions to market.

Contact Us for More Information

With your partnership, Lannett is poised to play a pivotal role in the development and production of oral solid dosage semaglutide formulations that can notably improve patient outcomes in an ever-growing market.

Our team looks forward to empowering your businesses to bring life-changing medications to market more quickly and effectively than ever before.

If you’re interested in learning more about our initiatives or partnering with us in the GLP-1 space, please reach out today!

Learn more about partnership with Lannett.