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Last Updated: May 22, 2025

Lixisenatide - Biologic Drug Details


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Summary for lixisenatide
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for lixisenatide
Recent Clinical Trials for lixisenatide

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University of TartuPhase 4
Tartu University HospitalPhase 4
Hospital Universitario San IgnacioPhase 3

See all lixisenatide clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for lixisenatide Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for lixisenatide Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for lixisenatide Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Lixisenatide

Introduction

Lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a biologic drug used primarily for the treatment of type 2 diabetes. This article delves into the market dynamics and financial trajectory of lixisenatide, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Growth Prospects

The global lixisenatide market is anticipated to experience significant growth over the forecast period. It is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from its estimated valuation by 2031[1][4].

Drivers of Market Growth

Several factors are driving the growth of the lixisenatide market:

Rising Prevalence of Diabetes

The increasing prevalence of type 2 diabetes globally is a major driver. According to the International Diabetes Federation (IDF), there were 463 million diabetics worldwide in 2020, with type 2 diabetes accounting for around 90% of these cases[4].

Regulatory Approvals and Expansions

Recent regulatory approvals, such as the FDA's approval of Sanofi’s Soliqua 100/33 (insulin glargine and lixisenatide injection) in 2019, have expanded the treatment options for patients with type 2 diabetes. This has contributed to the market's growth[4].

Awareness and Healthcare Infrastructure

Increased awareness campaigns, particularly in the Asia-Pacific region, and improvements in healthcare infrastructure are also driving the market forward[4].

Market Segmentation

The lixisenatide market is segmented based on several criteria:

By Type

The market is segmented into tablet and liquid injection forms. The liquid injection form is more common due to the drug's administration requirements[1].

By Application

Lixisenatide is used in various healthcare settings, including hospitals, clinics, and medical centers. The hospital segment is expected to drive significant growth due to the rise in hospital visits for diabetes treatment[4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, and the Rest of the World. North America, particularly the United States, holds a prominent share due to the high prevalence of diabetes in the region[1][4].

Financial Trajectory

Cost-Effectiveness

Studies have shown that while lixisenatide may have lower direct costs compared to other GLP-1 receptor agonists like liraglutide, the latter can offer better cost-effectiveness in terms of quality-adjusted life years (QALYs) and reduced complications[2].

Total Healthcare Costs

Treatment with lixisenatide has been associated with lower total healthcare costs compared to prandial insulin, making it a financially attractive option for patients and healthcare systems[5].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the lixisenatide market due to social distancing measures, reduced clinic hours, and disruptions in the supply chain. However, the market is expected to recover as these restrictions ease[4].

Competitive Landscape

The lixisenatide market is competitive, with several major players:

Key Companies

Companies such as Zealand Pharma, Sanofi-Aventis, and Eli Lilly & Co. are significant players in the market. These companies are adopting various strategies, including mergers and acquisitions, collaborations, and new product launches, to maintain their competitive edge[1][4].

Biosimilar Competition

The biologics market, including lixisenatide, is facing increasing competition from biosimilars. Pharmaceutical companies are investing in biosimilar development to mitigate the impact of patent expirations and maintain market share[3].

Regional Outlook

North America

North America, particularly the United States, is expected to hold a prominent share in the lixisenatide market due to the high prevalence of diabetes and well-developed healthcare infrastructure[4].

Asia-Pacific

The Asia-Pacific region is anticipated to grow significantly, driven by increasing awareness campaigns and improvements in healthcare infrastructure[4].

Challenges and Opportunities

Challenges

  • Biosimilar Competition: The increasing presence of biosimilars poses a significant challenge to the market.
  • Regulatory Hurdles: Stringent regulatory requirements can slow down market growth.
  • Economic Factors: Economic downturns and healthcare budget constraints can impact market performance[3].

Opportunities

  • Emerging Markets: Growing awareness and improving healthcare infrastructure in emerging markets offer significant opportunities.
  • Research and Development: Continuous R&D in biologics can lead to new and improved treatment options.
  • Cost-Effectiveness: Demonstrating cost-effectiveness can help in gaining market share and regulatory approvals[3][4].

Cost-Effectiveness Analysis

A cost-effectiveness analysis comparing lixisenatide with liraglutide showed that while lixisenatide had lower direct costs, liraglutide offered better value in terms of QALYs and reduced complications. For instance, liraglutide added to basal insulin was found to be dominant over lixisenatide in certain scenarios, especially when considering the avoidance of complications such as retinopathy, neuropathy, and nephropathy[2].

Conclusion

The lixisenatide market is poised for significant growth driven by the rising prevalence of type 2 diabetes, regulatory approvals, and increasing awareness. However, it faces challenges from biosimilar competition and regulatory hurdles. The financial trajectory of lixisenatide is influenced by its cost-effectiveness, total healthcare costs, and the competitive landscape.

"Sales of biologics are predicted to significantly overtake innovative small molecules by $120 billion by 2027, accounting for 55% of all innovative drug sales."[3]

Key Takeaways

  • The global lixisenatide market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
  • The rising prevalence of type 2 diabetes and regulatory approvals are key drivers of market growth.
  • The market is segmented by type, application, and geography, with North America holding a prominent share.
  • Lixisenatide faces competition from biosimilars and other GLP-1 receptor agonists.
  • Cost-effectiveness and total healthcare costs are crucial factors in the financial trajectory of lixisenatide.

FAQs

What is lixisenatide used for?

Lixisenatide is used for the treatment of type 2 diabetes. It works by increasing insulin levels in the blood, thereby reducing the body's absorption of sugar.

How is the lixisenatide market segmented?

The lixisenatide market is segmented by type (tablet and liquid injection), application (hospitals, clinics, medical centers), and geography (North America, Europe, Asia-Pacific, and the Rest of the World).

What are the key drivers of the lixisenatide market?

The key drivers include the rising prevalence of type 2 diabetes, regulatory approvals, and increasing awareness campaigns, particularly in the Asia-Pacific region.

How does lixisenatide compare to other GLP-1 receptor agonists in terms of cost-effectiveness?

Lixisenatide may have lower direct costs compared to liraglutide, but liraglutide offers better cost-effectiveness in terms of QALYs and reduced complications.

What impact did the COVID-19 pandemic have on the lixisenatide market?

The COVID-19 pandemic had a negative impact on the lixisenatide market due to social distancing measures, reduced clinic hours, and disruptions in the supply chain.

Sources

  1. Market Research Intellect: Global Lixisenatide Market Size and Forecast.
  2. PLOS ONE: Cost-effectiveness of liraglutide versus lixisenatide as add-on to basal insulin in patients with type 2 diabetes.
  3. CAS.org: The Rise of Biologics: Emerging Trends and Opportunities.
  4. OMR Global: Lixisenatide Market Size, Share | Industry Growth Analysis and Forecast.
  5. NCBI: Information on the Pharmacoeconomic Submission.
Last updated: 2024-12-16

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