Insulin Degludec (Tresiba) Market: Biosimilar Disruption And Pricing Pressures Post-Patent Cliff

Report Overview

Insulin Degludec (Tresiba), developed by Novo Nordisk, is a leading ultra-long-acting basal insulin used for managing type 1 and type 2 diabetes. Approved in over 80 countries, Tresiba offers a flexible dosing schedule, extended 42-hour action, and reduced risk of hypoglycemia, making it a preferred option for patients requiring stable glycemic control. With U.S. patents expiring in 2031 and European patents by 2029, the market is expected to face growing competition from biosimilar insulins, potentially driving price reductions and improving accessibility. Despite this, Tresiba continues to maintain strong brand loyalty, supported by ongoing clinical trials exploring new delivery devices, combination therapies, and broader diabetes indications. The market trajectory will be influenced by regulatory developments, the entry of biosimilars, and Novo Nordisk’s strategic initiatives to maintain market share through patient support programs, innovative delivery solutions, and expansion in emerging regions such as Asia Pacific and Latin America.

Key Report Deliverables

• A comprehensive analysis of the Insulin Degludec (Tresiba) market landscape, covering global revenue size, key growth drivers in the diabetes care sector, adoption trends across type 1 and type 2 diabetes populations, and the evolving competitive dynamics within the long-acting basal insulin segment.

• Forecasts evaluating post-patent market trajectories, including projected biosimilar entry timelines in major regions, anticipated impact on revenue streams, pricing dynamics, and patient access trends following patent expirations in the U.S. (2031) and Europe (2029).

• Identification of regulatory and market barriers affecting biosimilar penetration, including approval complexities, interchangeability requirements, pricing and reimbursement policies, and payer-driven access limitations in key geographies, particularly North America and Europe.

• A comprehensive competitive landscape overview, highlighting direct rivals in the long-acting insulin class (e.g., Insulin Glargine, Insulin Detemir), emerging biosimilar candidates, combination therapy opportunities, and innovation strategies shaping the future of diabetes management.

• Strategic implications for Novo Nordisk, including lifecycle management initiatives, biosimilar strategies, next-generation delivery systems, expanded indications, digital health solutions, clinical development pipelines, pricing strategies, and regional positioning to sustain leadership in the basal insulin market amid growing biosimilar competition and evolving patient needs.

Current Market Scenarios

Insulin Degludec (Tresiba) benefits from strong patent protection and market exclusivity in major regions, with U.S. patents extending until 2031 and European patents until 2029, allowing Novo Nordisk to maintain a period of market leadership before the entry of biosimilar insulins. However, as biosimilars gain regulatory approvals, particularly in Europe and the U.S., the global insulin landscape is expected to shift, introducing heightened competition and pricing pressures. Regional differences in patent expirations, biosimilar adoption, and healthcare reimbursement policies will shape market dynamics and influence Novo Nordisk’s competitive positioning.

In Europe, where healthcare systems are increasingly cost-conscious, biosimilar insulin uptake is expected to accelerate, exerting downward pressure on Tresiba pricing and market share. Conversely, in Asia Pacific, including China and India, early biosimilar launches are anticipated, driven by government initiatives to improve affordability and expand access to diabetes care. Markets such as Japan, while offering high treatment value, may experience slower biosimilar penetration due to stringent regulatory requirements and conservative clinical adoption practices. These regional variations will necessitate tailored strategies for Novo Nordisk to maintain brand preference and market share.

Despite the growing presence of biosimilars, demand for Tresiba remains strong, supported by its clinical benefits, including ultra-long-acting basal coverage, reduced hypoglycemia risk, and flexible dosing. Ongoing innovation in next-generation delivery devices, combination therapies, and expanded indications ensures Tresiba continues to be a central player in the diabetes market. As biosimilar competition intensifies, pricing pressures, reimbursement challenges, and evolving regulatory landscapes will shape the future trajectory of the basal insulin market, with Novo Nordisk focusing on lifecycle management, digital health integration, and strategic regional expansion to sustain its leadership position.

Market Dynamics

Growing Demand for Basal Insulins:

The global rise in diabetes prevalence, particularly type 2 diabetes, combined with increasing awareness of glycemic control, is driving strong demand for long-acting basal insulins like Insulin Degludec (Tresiba). Tresiba is widely prescribed for its ultra-long-acting profile, flexible dosing, and lower risk of hypoglycemia, making it a preferred choice in both type 1 and type 2 diabetes populations. Ongoing clinical trials and real-world evidence supporting its use in combination therapies and novel insulin regimens further reinforce its position as a cornerstone in diabetes management. Demand is especially robust in developed markets, where patient access, reimbursement coverage, and clinical familiarity support sustained adoption.

Pricing and Market Erosion Post-Patent:

The upcoming expiration of Tresiba’s patents in major markets, with the U.S. in 2031 and Europe in 2029, is expected to open the market to biosimilar competition, introducing downward pricing pressures. Payers, particularly in Europe, Asia Pacific, and Latin America, are likely to prioritize cost-effective alternatives, driving faster adoption of biosimilars in these regions. While initial clinical adoption of biosimilars may be moderated by regulatory requirements and physician preference for the established brand, the overall trend toward affordability and improved access will challenge Novo Nordisk’s market dominance. Cost-sensitive regions are expected to see significant shifts in pricing and access dynamics, reshaping competitive strategies.

Opportunities in Lifecycle Management and Regional Divergence:

Novo Nordisk is focusing on lifecycle management strategies to defend market share, including development of next-generation delivery devices, combination therapies, digital health solutions, and expanded indications. The impact of biosimilars will vary by region: in mature markets like the U.S., Europe, and Japan, regulatory scrutiny and conservative clinical adoption may slow uptake, whereas emerging markets such as China, India, and Latin America are likely to experience quicker transitions due to affordability initiatives, government support, and cost-conscious healthcare policies. By navigating these regional differences strategically, Novo Nordisk can sustain Tresiba’s leadership in the global basal insulin market and capitalize on growth opportunities in both established and emerging diabetes care markets.

The Pressure of Pricing and Market Erosion Post-Patent

As Insulin Degludec (Tresiba) patents approach expiration U.S. in 2031 and Europe in 2029 the market is poised to face growing competition from biosimilar insulins, leading to downward pricing pressures and potential market share erosion for Novo Nordisk. Cost-sensitive regions, including Asia Pacific and Latin America, are likely to adopt biosimilars rapidly due to government initiatives and affordability programs, while mature markets such as the U.S., Europe, and Japan may experience slower uptake due to regulatory scrutiny, physician preference for established brands, and concerns over clinical comparability and patient outcomes. The speed of biosimilar penetration will be influenced by regional regulations, payer policies, reimbursement strategies, and tender systems, creating diverse competitive dynamics. Despite these challenges, Tresiba’s strong clinical differentiation, flexible dosing, and patient support programs are expected to sustain demand, while Novo Nordisk will need to focus on innovation, lifecycle management, next-generation delivery systems, and patient-centric strategies to maintain leadership amid increasing biosimilar competition and evolving pricing pressures.

Innovating Beyond the Patent - Unlocking Future Growth Paths

As Insulin Degludec (Tresiba) faces increasing competition from biosimilar insulins following patent expirations in the U.S. (2031) and Europe (2029), significant opportunities remain to drive future growth in the basal insulin market. Innovation through next-generation delivery systems, including smart insulin pens, connected digital devices, and combination therapies with GLP-1 receptor agonists, can enhance patient convenience, adherence, and clinical outcomes, supporting broader adoption. Ongoing research into novel formulations and expanded indications provides differentiation and strengthens Tresiba’s role in multi-modal diabetes management. Novo Nordisk’s strategy of focusing on lifecycle management, patient-centric solutions, and digital health integration will be crucial to maintaining clinical relevance amid rising biosimilar competition. Additionally, the increasing availability of biosimilars in emerging markets creates opportunities to expand market access, enabling more patients in regions such as Asia Pacific, Latin America, and parts of Africa to benefit from cost-effective treatment options, while simultaneously supporting Novo Nordisk’s strategic positioning in the global diabetes care landscape.

Shaping the Future - Generics, Patient-Centric Models, And Regional Shifts

The shift towards patient-centric diabetes care is gaining momentum, emphasizing convenience, adherence, and overall quality of life. Innovations such as next-generation insulin delivery systems, smart pens, optimized dosing schedules, and combination therapies with GLP-1 receptor agonists will enable more personalized treatment options, reinforcing the clinical relevance of Insulin Degludec (Tresiba) despite the rise of biosimilar insulins. The growing adoption of value-based healthcare models will accelerate the uptake of biosimilars in price-sensitive markets, where cost-effectiveness is a primary driver, reshaping competitive dynamics for Tresiba and its alternatives. Regional variations will be pivotal: mature markets like the U.S., Europe, and Japan are likely to experience slower biosimilar adoption due to regulatory scrutiny, physician preference, and established brand loyalty, whereas emerging markets such as China, India, and Latin America are expected to see faster uptake, fueled by government initiatives, affordability pressures, and streamlined regulatory processes. These trends will create distinct competitive landscapes across regions, necessitating strategic patient-centric and market-specific approaches by Novo Nordisk to sustain Tresiba’s leadership in global diabetes care.

Overview of Alternative Therapeutics

Insulin Degludec (Tresiba) faces growing competition from other long-acting basal insulins and emerging therapies in diabetes management, including Insulin Glargine (Lantus, Toujeo), Insulin Detemir, and next-generation basal insulin analogues. These competitors are expanding indications, dosing regimens, and geographic reach to capture larger shares of the global diabetes care market. Innovations such as combination therapies with GLP-1 receptor agonists, fixed-ratio regimens, smart delivery devices, and digital health solutions are shaping the future treatment landscape, intensifying competitive pressures in both type 1 and type 2 diabetes management.

A wave of biosimilar insulins is advancing through global regulatory and clinical pathways, with market entry expected as Tresiba’s patents expire in the U.S. (2031) and Europe (2029). The market success of these biosimilars will depend on demonstrating clinical equivalence, securing regulatory approvals, offering cost advantages, and implementing competitive pricing strategies to gain traction in price-sensitive regions, where healthcare payers and government policies heavily influence treatment decisions.

Overall, the evolving competitive landscape highlights the need for Novo Nordisk to leverage innovation, lifecycle management, and strategic partnerships to maintain leadership in the basal insulin market. As biosimilars and alternative therapies reshape the diabetes treatment environment, Novo Nordisk must focus on differentiating Tresiba through clinical advantages, patient-centric solutions, and broader market access strategies to sustain its position amid rising competition.

Competitive Landscape

The competitive landscape for Insulin Degludec (Tresiba) is rapidly evolving as emerging biosimilar insulins and next-generation basal insulin analogues intensify competition in the diabetes care market. Novo Nordisk, the primary developer of Tresiba, continues to leverage its strong market position through clinical differentiation, flexible dosing advantages, patient support programs, and proactive lifecycle management strategies, including next-generation delivery devices and combination therapies. Competitors such as Insulin Glargine (Lantus, Toujeo), Insulin Detemir, and newer basal insulin analogues are broadening their indications, treatment regimens, and geographic reach, creating a more competitive environment in both type 1 and type 2 diabetes management.

On the biosimilar front, biosimilar insulins are advancing through regulatory and clinical pathways, with market entry expected as Tresiba’s patents expire in the U.S. (2031) and Europe (2029). In emerging markets such as China, India, and Latin America, local manufacturers and supportive government policies are facilitating faster market access, increasing competitive pressures and accelerating biosimilar adoption. Additionally, next-generation therapies, including ultra-long-acting insulins with digital integration and fixed-ratio combination therapies, represent longer-term competition due to their potential for enhanced efficacy, convenience, and patient adherence.

To maintain market leadership, Novo Nordisk is focusing on lifecycle management, strategic partnerships, digital health integration, and patient-centric initiatives, while competitors emphasize pipeline diversification and innovative delivery solutions. The rise of biosimilars and next-generation basal insulins is expected to drive pricing pressures, enhance treatment accessibility, and reshape the diabetes care landscape. Ultimately, the ability to innovate, differentiate clinically, and deliver patient-centered solutions will be key for Novo Nordisk and other market players to maintain resilience and leadership in the evolving basal insulin market.

North America Insulin Degludec Market

North America remains the largest market for Insulin Degludec (Tresiba), with the U.S. driving the majority of sales due to its advanced healthcare infrastructure, high diabetes prevalence, and strong adoption of biologic insulin therapies. Tresiba’s U.S. patents are set to expire in 2031, creating a window for biosimilar competition and potential pricing pressure. Following patent expiration, payers are expected to prioritize cost-effective alternatives, prompting significant market adjustments. Canada, with patent exclusivity ending around 2029-2030, is likely to experience similar dynamics, with biosimilars entering the market and intensifying competition. Regulatory and clinical adoption hurdles may initially slow biosimilar penetration, but pricing erosion will become inevitable once biosimilars gain physician and payer confidence.

Europe Insulin Degludec Market

Europe represents a key growth region for Tresiba, with Germany, France, and the U.K. being major contributors. Patent protection in most European countries is expected to last until 2029, after which biosimilar insulins are likely to enter the market. Europe’s cost-sensitive healthcare systems will encourage a swift transition to lower-cost alternatives, with tender-based procurement and competitive pricing reshaping market dynamics. Regulatory delays may slow initial adoption, but once approved, biosimilars are expected to rapidly gain market share, significantly affecting branded insulin pricing and access.

Asia Pacific Insulin Degludec Market

The Asia Pacific region offers substantial growth opportunities for Tresiba, particularly in China, India, and Japan, where diabetes prevalence is rising rapidly. China is expected to see early biosimilar launches due to local patent challenges and government support for domestic therapies, increasing competitive pressure. In India, affordability will be a major driver, with biosimilars likely to gain rapid adoption once patent exclusivity ends. Japan, with a stringent regulatory environment, may experience slower biosimilar penetration despite high demand for advanced insulin therapies. Overall, Asia Pacific presents significant growth potential but requires strategic navigation of regulatory timelines and local competition.

Latin America Insulin Degludec Market

In Latin America, the rising burden of diabetes is driving demand for Tresiba, with Brazil, Mexico, and Argentina serving as key markets. Cost and affordability are central concerns, and biosimilar entry post-patent expiration is expected to reduce prices and broaden access to long-acting insulins. Regulatory agencies in Brazil and Mexico are anticipated to facilitate faster biosimilar approvals, accelerating competition. However, logistical challenges and limitations in healthcare infrastructure in certain areas will require innovative pricing, distribution, and patient support strategies to ensure widespread access.

Middle East and Africa Insulin Degludec Market

The Middle East and Africa (MEA) market is in an emerging phase, with relatively lower penetration compared to more established regions. Key markets include Saudi Arabia, UAE, and South Africa, where diabetes prevalence and awareness of modern insulin therapies are growing. High treatment costs remain a barrier, making biosimilars essential for expanding patient access. Regulatory pathways vary across countries, with more efficient approval processes in the UAE and Saudi Arabia, while others may experience delays. As healthcare infrastructure improves and patient access grows, MEA is expected to see steady long-term growth, with biosimilar insulins playing a pivotal role in increasing treatment availability.

Analyst Perspective

The Insulin Degludec (Tresiba) market is approaching a pivotal phase as key patents near expiration, with U.S. patents expected to expire in 2031 and European patents by 2029. Dominated by Novo Nordisk, the market is likely to face growing competition from biosimilar insulins and next-generation basal insulin analogues, which are expected to drive significant price reductions and shifts in market share. Additionally, competitors such as Insulin Glargine (Lantus, Toujeo), Insulin Detemir, and emerging combination therapies are poised to intensify competitive pressures, particularly in price-sensitive regions including Europe, Asia Pacific, and Latin America.

Despite these challenges, demand for Tresiba remains robust, supported by its ultra-long-acting profile, flexible dosing, and lower risk of hypoglycemia, making it a preferred choice in both type 1 and type 2 diabetes management. Expanding indications through combination therapies and digital health-enabled delivery devices further reinforce its clinical relevance and adoption across global markets.

To maintain competitiveness, Novo Nordisk must focus on lifecycle innovation, real-world evidence generation, and next-generation delivery systems to stay ahead in the evolving insulin market. Patient-centric strategies-including adherence support programs, expanded indications, and combination therapies-will be critical to sustaining market leadership. Strategic initiatives such as partnerships, biosimilar management, and region-specific positioning will help navigate the post-patent landscape, ensuring Tresiba retains its position as a leading basal insulin in the global diabetes care market.

Case Study (Recent Engagement): Keytruda Patent-Cliff & Price- Erosion Impact Model

PROJECT OBJECTIVE

To evaluate the potential revenue, price, and patient access implications of Keytruda’s 2028 patent cliff, incorporating biosimilar entry dynamics, country-specific adoption curves, and Merck’s lifecycle defense strategies (remarkably the subcutaneous formulation). The goal was to provide the client with a transparent, scenario-based model to anticipate outcomes and inform strategy

GVR SOLUTION

• Built a bottom-up commodity-flow and analogue-based model, anchored on Merck’s $29.5B Keytruda sales in 2024.

• Integrated jurisdictional LOE timelines (EU mid-2028, U.S. 2028-2029 pending litigation outcomes).

• Modeled biosimilar adoption S-curves calibrated to oncology antibody analogues (EU faster via tenders, U.S. slower via contracting).

• Applied price-erosion benchmarks (EU −15-30% Yr-1, deepening to −45-60% by Yr-3; U.S. −10-25% net decline over same horizon).

• Layered lifecycle defenses (SC uptake assumptions of 25-40% of innovator units, combo refresh, contracting) to quantify buffers.

• Delivered outputs as a dynamic Excel scenario tool and a management-ready PPT deck with revenue bridges, sensitivity tornadoes, and SC migration visuals.

IMPACT FOR CLIENT

• Enabled the client to quantify downside vs. defense-optimized revenue trajectories:

  • Base case: 30-40% global revenue decline by Year-3 post-LOE.

  • Downside: 45-55% decline in tender-heavy markets.

  • Defense-optimized: Contained erosion to ~−20-25% with strong SC adoption.

• Gave the client a clear view of which markets drive early erosion (EU) and where strategic contracting or SC migration can preserve share (U.S.).

• Equipped decision-makers with a playbook of watch-points (tender concentration, litigation outcomes, SC IP coverage, combo pipeline) to guide commercial strategy.

• Provided a transparent methodology that could be presented to boards/investors with evidence-backed assumptions

WHY THIS MATTERS

• Keytruda is the world’s best-selling cancer drug, representing nearly one-third of Merck’s revenue.

• Patent expiry will reshape both Merck’s earnings profile and global oncology access dynamics.

• Payers and governments stand to benefit from biosimilar entry through lower costs, but manufacturers need to manage cliff risk while capturing upside from lifecycle innovations.

• Understanding how quickly revenues erode and how patient access expands post-biosimilar is critical for:

  • Biopharma companies (strategic planning, pipeline prioritization).

  • Investors (valuing Merck’s cash flows beyond 2028).

  • Payers and policymakers (budgeting for oncology drug spend).

A robust patent cliff model helps clients navigate the dual challenge of price erosion and patient expansion, ensuring strategies are grounded in real-world benchmarks.