i3 Consult is now releasing a new series of Clinical Trial Reports with market intelligence content, using SWOT analysis. This added-value format provides investors, pharma product managers, healthcare providers, pharmacists, and regulatory stakeholders with insight into the projected market potential and strategic positioning of drug candidates undergoing clinical trial development.
Our SWOT analysis framework enables stakeholders to assess a drug candidate’s strengths, weaknesses, opportunities, and threats within the market, assuming the candidate advances through all clinical trial phases and achieves regulatory approval. This approach highlights potential competitive advantages, market gaps, and risks, helping stakeholders anticipate a candidate’s market positioning and investment viability.
The analysis considers two primary dimensions: Strengths and Weaknesses, which include aspects like clinical efficacy, unique mechanisms, or production challenges, and Opportunities and Threats, which explore factors such as emerging market demands and regulatory landscape dynamics. Together, these dimensions provide insights into how effectively a candidate might capture market share and drive revenue, while also anticipating the investment required to nurture its market position.
For instance, a strong drug profile in a high-growth market can indicate substantial potential but may require significant R&D investment initially. This insight empowers life science companies to make informed decisions, balancing the initial investment against potential market dominance and long-term profitability. The SWOT analysis thus equips stakeholders with a well-rounded understanding of each drug candidate’s potential to contribute to sustainable growth and financial returns.
Market SWOT Analysis: Rybelsus® (Semaglutide) for Cardiovascular Risk Reduction in Type 2 Diabetes
The FDA has expanded approval for Rybelsus® (semaglutide) — the world’s first oral GLP-1 receptor agonist — to reduce major adverse cardiovascular events (MACE) in adults with type 2 diabetes at high cardiovascular risk.
Introduction
Rybelsus® (semaglutide) is the world’s first oral glucagon-like peptide-1 receptor agonist (GLP-1 RA), developed by Novo Nordisk. Initially approved in 2019 for glycaemic control in adults with type 2 diabetes mellitus (T2DM), Rybelsus recently received a significant FDA label expansion. On October 17, 2025, the U.S. FDA approved Rybelsus 7 mg and 14 mg tablets to reduce the risk of major adverse cardiovascular events (MACE) — cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke — in adults with T2DM at high cardiovascular risk.
This new indication was supported by data from the SOUL Phase III trial, which enrolled over 9,650 patients and demonstrated a 14% relative risk reduction in MACE compared with placebo. The approval reinforces semaglutide’s expanding role beyond glycaemic control, strengthening its position in cardiometabolic medicine.
This article by i3 Consult examines the market and strategic positioning of Rybelsus through a detailed SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis.
SWOT Analysis
Strengths
- First-in-class oral GLP-1 RA with MACE indication — Rybelsus is now the only oral GLP-1 therapy approved for cardiovascular risk reduction in high-risk T2DM patients, differentiating it from injectable competitors.
- Robust clinical evidence — The SOUL trial confirmed a statistically significant 14% relative risk reduction in MACE, including cardiovascular death, nonfatal MI, and nonfatal stroke.
- Convenient oral administration — Rybelsus eliminates the barrier of injections, improving patient comfort and potential adherence in daily practice.
- Strong brand lineage — As part of the broader semaglutide family (Ozempic® and Wegovy®), Rybelsus benefits from global recognition and trust among healthcare professionals.
- Expansive target market — The prevalence of T2DM and associated cardiovascular comorbidities ensures a large, high-value patient base.
Weaknesses
- Modest absolute benefit — Despite statistical significance, the absolute MACE risk reduction may appear modest to payers and clinicians, influencing cost-effectiveness debates.
- Gastrointestinal adverse events — GLP-1 RAs are associated with nausea, vomiting, and treatment discontinuation, which can affect patient adherence.
- Dosing complexity — The requirement to take Rybelsus on an empty stomach and delay other medications or food may reduce convenience for some users.
- Strong internal competition — Injectable semaglutide (Ozempic) already dominates the GLP-1 space, potentially limiting physician motivation to switch stable patients.
- Selective trial population — Data derived primarily from high-risk T2DM patients may not generalise fully to broader or lower-risk groups.
Opportunities
- Label expansion potential — Future clinical trials could support Rybelsus in other cardiometabolic indications such as obesity-related cardiovascular risk or chronic kidney disease.
- Global launch strategy — International regulatory submissions in Europe, Asia, and Latin America present substantial growth opportunities.
- Integrated cardiometabolic positioning — Marketing Rybelsus as part of holistic cardiovascular and metabolic care could enhance physician and payer engagement.
- Health-economic value proposition — Demonstrating reductions in hospitalisations, heart failure, and long-term complications can strengthen reimbursement outcomes.
- Patient preference shift — Growing aversion to injectables offers a strategic opening for oral GLP-1 uptake.
Threats
- Crowded GLP-1 market — Competing agents and dual-agonist therapies (e.g., tirzepatide) are capturing significant attention and market share.
- Payer resistance — Health insurers may challenge pricing and require long-term evidence of cost-effectiveness before granting broad coverage.
- Safety perception risks — Concerns about class-related adverse effects, including pancreatitis and thyroid C-cell tumours, could limit uptake.
- Clinical inertia — Physicians already familiar with injectable GLP-1 products may hesitate to transition to a new oral alternative without clear differentiation.
- Regulatory lag in guidelines — Global diabetes guidelines may take time to integrate the new MACE indication, slowing physician adoption.
Conclusion
The cardiovascular label expansion for Rybelsus® (semaglutide) represents a pivotal advancement in T2DM management, bridging metabolic control with proven cardiovascular protection. Its first-in-class oral formulation, strong brand credibility, and expanding evidence base offer a powerful growth platform.
However, commercial success will hinge on execution — ensuring physician education, payer acceptance, adherence management, and real-world validation of its cardiovascular benefits. As cardiometabolic treatment paradigms evolve, Rybelsus’s unique oral positioning could redefine how patients and clinicians view cardiovascular prevention within type 2 diabetes care.
Author: i3 Consult Life Science Market Insights Team
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