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Last Updated: June 20, 2025

TRETTEN Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Novo Nordisk A/S

See all TRETTEN 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 TRETTEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Novo Nordisk Inc. TRETTEN coagulation factor xiii a-subunit (recombinant) For Injection 125398 ⤷  Try for Free 2029-04-20 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

No patents found based on company disclosures

The Biologics Market: Understanding the Dynamics and Financial Trajectory

Introduction to Biologics

Biologics are a class of drugs that are derived from living organisms, such as proteins, genes, and cells. These drugs have revolutionized the treatment of various chronic and life-threatening diseases, including autoimmune disorders, cancer, and genetic diseases.

Market Size and Growth Projections

The biologics market is experiencing rapid growth, driven by several key factors.

  • Current Market Size: The global biologics market was valued at approximately USD 349.6 billion in 2023[1].
  • Future Projections: It is expected to reach USD 699.5 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.8% during the forecast period of 2024-2032[1].

Key Drivers of the Biologics Market

Several factors are driving the growth of the biologics market:

Increasing Burden of Chronic Diseases

The rising prevalence of chronic diseases such as diabetes, arthritis, and cancer is a significant driver. Biologics offer targeted and often more effective treatments for these conditions[1].

Technological Advancements

Continuous technological advancements in drug delivery systems and the development of novel biologic therapies, such as gene therapy, antisense, and RNAi therapies, are enhancing treatment options and driving market growth[1].

Growing Adoption of Biosimilars

Biosimilars, which are biologic products that are highly similar to an already approved biologic drug, are gaining traction due to their cost-effectiveness and similar efficacy profiles. This is increasing access to biologic treatments and contributing to market expansion[1].

Improved Healthcare Infrastructure

Enhancements in healthcare infrastructure, particularly in emerging markets, are facilitating better access to biologic therapies. This includes improved diagnostic capabilities and treatment facilities[1].

Regulatory Approvals

The escalating approvals of biologics by regulatory agencies such as the FDA and EMA are also driving market growth. These approvals validate the safety and efficacy of biologic drugs, increasing their adoption[1].

Market Segments and Trends

By Source

The microbial segment dominated the market in 2022, highlighting the importance of microbial sources in biologic drug production[3].

By Product

Monoclonal Antibodies (MABs) lead the biologics market share due to their widespread use in treating various diseases, including cancer and autoimmune disorders[3].

Geographical Distribution

North America is the largest market for biologics, followed by the Asian Pacific region, which is witnessing substantial growth. This growth is driven by an aging population and increasing incidence of chronic diseases in these regions[4].

Financial Performance and Outlook

Revenue Growth

The biologics market is projected to surpass USD 893 billion by 2032, with a CAGR of 9.1% from 2023 to 2032. This significant growth is driven by the increasing demand for personalized treatments for chronic diseases[3].

Operating Profit and Net Profit

Companies in the biologics sector, such as Novo Nordisk, have seen substantial growth in operating profit and net profit. For example, Novo Nordisk reported an operating profit growth of 32% and a net profit growth of 25% in 2012, reflecting the financial health and growth potential of the sector[2].

Research and Development Investments

Significant investments in research and development are crucial for the biologics market. Companies are continuously investing in the development of new biologic drugs and improving existing ones, which is reflected in their financial reports. For instance, Novo Nordisk's research and development costs accounted for 17.2% of their sales in 2012[2].

Challenges and Restraints

Despite the growth, the biologics market faces several challenges:

High Development Costs

The development of biologic drugs is highly expensive and time-consuming, which can be a significant barrier to entry for new companies[4].

Regulatory Hurdles

Biologic drugs must undergo rigorous regulatory approvals, which can delay market entry and increase costs[1].

Patent Expirations

The expiration of patents for biologic drugs can lead to the entry of biosimilars, which can reduce the market share of original biologic drugs[3].

Examples of Successful Biologics

Novo Nordisk's Victoza and Modern Insulins

Novo Nordisk's once-daily human GLP-1 analogue Victoza (liraglutide) and modern insulins like NovoRapid (NovoLog in the US) and Levemir have been key drivers of the company's growth. These products have seen strong demand globally, particularly in regions like North America and China[2].

Illustrative Statistics

  • Market Share: Biologics accounted for 37% of the total drug spending in the United States, highlighting their significant impact on healthcare expenditure[1].
  • Growth Rate: The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032, indicating a robust growth trajectory[1].

Expert Insights

"Biologics have revolutionized the treatment landscape for many chronic diseases. The continuous advancements in technology and the strong pipeline of biologic drugs are key drivers of this market," said Lars Rebien Sørensen, former President and Chief Executive Officer of Novo Nordisk[2].

TRETTEN: A Specific Example

While specific financial data for TRETTEN, a biologic drug, is not provided in the sources, the overall trends and drivers in the biologics market can be applied to understand its potential financial trajectory.

  • Market Potential: Given the growing demand for biologic treatments, TRETTEN, if approved and marketed effectively, could capture a significant share of the market.
  • Regulatory Approvals: The approval process for TRETTEN would be crucial, as regulatory validation is a key factor in the adoption of biologic drugs.
  • Competitive Landscape: TRETTEN would need to compete with existing biologic drugs and biosimilars, necessitating strong marketing and distribution strategies.

Key Takeaways

  • The biologics market is expected to reach USD 699.5 billion by 2032, driven by the increasing prevalence of chronic diseases and technological advancements.
  • North America and the Asian Pacific are the largest and fastest-growing markets, respectively.
  • Significant investments in research and development are crucial for the growth of biologic drugs.
  • Regulatory approvals and the management of patent expirations are critical factors in the biologics market.

FAQs

1. What is the projected growth rate of the biologics market from 2024 to 2032? The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032[1].

2. Which region dominates the biologics market? North America is the largest market for biologics, followed by the Asian Pacific region[4].

3. What are the key drivers of the biologics market? Key drivers include the rising prevalence of chronic diseases, technological advancements, growing adoption of biosimilars, and regulatory approvals[1].

4. How significant are biologics in total drug spending? Biologics accounted for 37% of the total drug spending in the United States[1].

5. What are some of the challenges faced by the biologics market? Challenges include high development costs, regulatory hurdles, and patent expirations[4].

Cited Sources:

  1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems - Biospace
  2. 20130204_ Annual Report 2012_UK.pdf - Novo Nordisk
  3. Biologics Market Economic Growth CAGR of 9.1%, Restraints, Mergers, And Forecast 2022-2032 - GlobeNewswire
  4. Biologics Market Trends and Predictions: New Horizons Beckon - Oxford Global
Last updated: 2024-12-17

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