Riding the Oral GLP-1 Wave
As more innovators look to develop orally administered GLP-1s further demand will be placed onto CDMOs to provide the expertise and capabilities needed to support the next generation of these drugs.
Glucagon-like peptide-1 (GLP-1) receptor agonists first penetrated the market 20 years ago when exenatide (Byetta, originally developed by Amylin Pharmaceuticals and Eli Lilly) gained regulatory approval as a novel treatment option for type 2 diabetes (1). Since that time, there have been approvals for multiple GLP-1s indicated for the treatment of diabetes and a few, over the course of the past decade, indicated for weight loss.
The latter indication, for weight loss, of GLP-1s has been a significant driver of market growth and has led to an evolution in the patient population for these therapies to include more people who are not diabetic (2). Growth in the GLP-1 market is expected to continue, both for the treatment of type 2 diabetes and obesity, with some analysts forecasting it to reach USD 156.72 billion by 2030 (3).
For CDMOs, rising demand from patients for GLP-1s has inevitably equated to rapidly increasing demand for their services. The main focus of CDMO demand has been around sterile capabilities and capacity, as the GLP-1s have primarily been administered parenterally; however, as more innovators set about researching orally administered GLP-1s (4), demand will also impact solid-dose partners.
A Real Revolution for CDMOs
“Injectable GLP-1 products have already caused a real revolution in the fill/finish CDMO space, driving volumes only eclipsed by COVID vaccines, upending the seemingly unstoppable march to smaller and smaller rare and orphan indications, spurring construction of massive new facilities in-house at many CDMOs, and creating awesome new fortunes of many,” remarks Elliott Berger, Board of Directors and Strategic Advisor, Orientation Marketing, and former Chief Marketing Officer at Catalent. “Now that revolution is about to hit the oral dose CDMO segment and, with recent positive interim Phase III news from Lilly (5), this day is coming soon. This [new demand] will require a similar revolution in terms of volumes, new facilities, supply chains, and delivery technologies!”
As a result of the large-scale production demands for GLP-1 analogs, CRO and CDMOs have been required to rapidly invest in peptide synthesis capabilities and capacity to meet demand, adds Kevin Li, MBA, Chief Marketing Officer, BioDuro — a global contract research, development, and manufacturing organization (CRDMO). “Rising demand for GLP-1 therapies is driving innovation in novel formulation technologies, particularly for oral peptide delivery systems,” he specifies.
The massive demands being seen within the GLP-1 space and the need for affordability — injectables and peptides are costly to develop and manufacture — mean that oral delivery is a necessity, asserts Dan Smithey, PhD, CEP and Co-founder of Serán Bioscience — a science and data-driven CDMO. “Molecules that are orally bioavailable are difficult to develop and will likely require manufacturing techniques that are not widely available internally in many pharmaceutical companies, thus requiring outsourcing to CDMOs who have this technology, at least initially,” he says.
“Given the scientific complexity of GLP-1 development,” Li concurs, “CDMOs are increasingly offering integrated solutions — combining expertise in peptide chemistry, biology, and DMPK — to deliver faster, more specialized, and efficient services from synthesis through to testing.”
Hurdles to Success
With oral GLP-1s, however, CDMOs are faced with a new set of challenges. Delivering peptides orally is not easy due to the fundamental bioavailability issues, confirms Smithey. “Thus, orally bioavailable small molecules are the preferred option,” he says.
“Low oral bioavailability of peptides remains a key challenge,” agrees Li. “Peptides like semaglutide are inherently unstable in the gastrointestinal (GI) tract—they degrade in stomach acid and are poorly absorbed through the intestine. Developing robust oral peptide formulations requires advanced delivery technologies (e.g., permeation enhancers, enteric coatings, nanocarriers), which many CDMOs do not yet possess in-house.”
However, these more advanced technologies add further complexities for service providers, such as the need for more intricate scale-up processes and specialized manufacturing expertise, Li explains. “Leading CDMOs are now actively investing in these novel capabilities to support the oral delivery of next-generation GLP-1 products,” Li specifies.
Steps to Achieve End-to-End Services
To be able to provide end-to-end services, there are several steps that CDMOs should consider, Li notes. Firstly, CDMOs should “establish comprehensive early discovery platforms,” he says. “Build integrated target-to-lead processes supported by novel technologies such as AI-assisted drug design to accelerate discovery process with lower cost and higher quality.”
It is important for CDMOs to consider combining their capabilities to improve efficiencies, Li continues. “Co-locate medicinal chemistry, assay development, DMPK, and in vivo pharmacology teams to enhance collaboration, speed, and data consistency,” he says.
Additionally, CDMOs should have a fully integrated workflow that includes each step through the product development lifecycle, which will help with the transition to investigational new drug-enabling chemistry, manufacturing, and controls activities, Li remarks. Supply chains must also be robust, reliable, scalable, and global for both APIs and drug products to meet worldwide regulatory standards, he adds.
Finally, CDMOs should be seeking to form strategic partnerships, Li specifies. “CDMOs must go beyond transactional relationships and form strategic partnerships with pharma and biotech companies, demonstrating a willingness to invest in emerging areas and ensuring strong intellectual property protection,” he confirms.
The Tip of the Iceberg
To ensure continued growth and success for CDMOs in the GLP-1 space in the future there are a few areas that need to be addressed. “Solid-phase peptide synthesis (SPPS) must evolve to become more efficient and environmentally sustainable. Current processes rely heavily on large volumes of solvents and energy-intensive steps such as lengthy separation, purification and lyophilization process,” Li states. “In the future, greener, more cost-effective technologies are expected to emerge, improving both sustainability and operational efficiency.”
Manufacturing capacity for GLP-1s is another significant consideration for CDMOs in the near future. “As demand for GLP-1 therapies and other peptide-based drugs continues to grow, more large-scale peptide manufacturing facilities will be established in the CDMO industry to meet commercial-scale needs,” Li notes.
“The scale of manufacturing that will be required [for success in the GLP-1 arena] is massive, and will require investment from CDMOs, pharma, and likely government,” concurs Smithey.
“Oral small-molecule GLP-1s are redefining the future of drug manufacturing, forcing the market leading CDMOs to rapidly adapt to specialized oral peptide formulation capabilities and the need for near term large-scale tablet production. The firms that succeed will be those that have already invested in scalable equipment trains, GMP [good manufacturing practice] compliant systems, resilient supply chains, and regulatory excellence to support the emerging yet massive, chronic-use markets for GLP-1s and their various cousins,” emphasizes Kurt Nielsen, Ph.D., Managing Director of Expert Insights Consulting. “This is a rare opportunity where scientific innovation, operational execution, and industrial scale are converging for the CDMOs that have prepared to meet the next great wave in metabolic disease and obesity treatment.”
However, what has been seen so far in the GLP-1 space is just the tip of the iceberg, particularly when the low current penetration to potential patient populations, expanding indications, and rich pipeline are considered, Berger remarks. He questions: “What will it take and who would be the winner of the next CDMO GLP-1 fortune?”
References
Eli Lilly. Amylin and Lilly Announce FDA Approval of Byetta(TM) (Exenatide) Injection. Press Release, April 29, 2005.
Glass, R.; Foster, E. New Demand in an Old Market. IQVIA, Blog, Sept. 5, 2023.
Grand View Research. GLP-1 Receptor Agonist Market Size, Share, and Trends Analysis Report by Product (Ozempic, Zepbound), by Application (Diabetes, Obesity), by Route of Administration (Parenteral, Oral), by Region, and Segment Forecasts, 2025–2030. Market Research Report, November 2024.
Sarkar, S. The State of the GLP-1 Market and What to Expect Throughout the Next Decade. The Smart Cube, Aug. 14, 2024.
Eli Lilly.Lilly’s Oral GLP-1, Orforglipron, Demonstrated Statistically Significant Efficacy Results and a Safety Profile Consistent with Injectable GLP-1 Medicines in Successful Phase III Trial. Press Release, April 17, 2025.