Thyrotropin alfa - Biologic Drug Details

Summary for thyrotropin alfa

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for thyrotropin alfa

Recent Clinical Trials for thyrotropin alfa

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sun Yat-sen University	Phase 2
Eli Lilly and Company	Phase 2
Massachusetts General Hospital	Phase 2

See all thyrotropin alfa clinical trials

Pharmacology for thyrotropin alfa

Established Pharmacologic Class	Thyroid Stimulating Hormone
Chemical Structure	Thyrotropin

Note on Biologic Patents

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

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1. Brand-side disclosures in response to biosimilar applications

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 thyrotropin alfa Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Thyrotropin Alfa

Introduction

Thyrotropin alfa, marketed under the brand name Thyrogen, is a recombinant human thyroid-stimulating hormone (rhTSH) used primarily in the management of thyroid cancer and for diagnostic purposes. This article delves into the market dynamics and financial trajectory of thyrotropin alfa, providing insights into its current market status, future projections, and the factors influencing its financial performance.

Market Size and Growth

The global Thyrogen market has been experiencing steady growth. As of 2023, the market was valued at US$ 689 million. It is anticipated to reach US$ 852.7 million by 2030, with a Compound Annual Growth Rate (CAGR) of 3.1% during the forecast period of 2024-2030[1].

Key Players

Sanofi Genzyme is the primary company associated with the Thyrogen market. The dominance of Sanofi Genzyme in this market is due to its exclusive rights and extensive distribution network[1].

Applications and Consumption

Thyrotropin alfa is used in various settings, including hospitals and drug stores. Its primary applications include the management of thyroid cancer, particularly for patients undergoing radioactive iodine therapy, and for diagnostic purposes to assess the recurrence of thyroid cancer without the need for thyroid hormone withdrawal[4].

Production and Manufacturing

Thyrogen is produced using a Chinese Hamster Ovary (CHO) cell line co-transfected with recombinant plasmids containing DNA sequences encoding the alpha and beta subunits of TSH. The manufacturing process involves rigorous testing for bacterial, mycoplasmal, fungal, and viral agents to ensure the product's safety and efficacy[4].

Regulatory Approval and Compliance

Thyrogen has undergone comprehensive structural analysis to ensure its authenticity with human pituitary TSH. The European Medicines Agency (EMA) has approved thyrotropin alfa, and the product has been subject to Good Manufacturing Practice (GMP) inspections to address quality assurance issues[4].

Financial Assistance Programs

To make Thyrogen more accessible, financial assistance programs are available for eligible patients. These programs can be accessed through dedicated customer service lines, helping to mitigate the financial burden associated with the treatment[5].

Cost-Effectiveness and Pricing Dynamics

The cost-effectiveness of thyrotropin alfa can be influenced by drug price dynamics. Studies have shown that price increases during the exclusivity period and subsequent price decreases after the loss of exclusivity can significantly impact the cost per quality-adjusted life-year (QALY) gained. For instance, a 2% yearly price increase followed by a post-exclusivity price reduction can either increase or decrease the cost-effectiveness ratio, depending on the magnitude of the price changes[3].

Market Trends and Growth Factors

Several factors contribute to the growth of the Thyrogen market:

• Increasing Incidence of Thyroid Cancer: The rising incidence of thyroid cancer is a significant driver, as thyrotropin alfa is a critical component in the management and diagnosis of this condition.
• Advancements in Diagnostic Techniques: Improvements in diagnostic methods that rely on thyrotropin alfa are also driving market growth.
• Regulatory Approvals and Compliance: Strict regulatory standards ensure the quality and safety of the product, which can enhance market trust and adoption.

Competitive Landscape

The competitive landscape of the Thyrogen market is relatively concentrated, with Sanofi Genzyme being the major player. However, the market may see increased competition as other biotechnology companies develop similar recombinant TSH products.

Regional Consumption

The consumption of thyrotropin alfa varies by region, with developed countries generally having higher demand due to better healthcare infrastructure and higher awareness of thyroid cancer management. Emerging markets are also expected to grow as healthcare access and awareness improve[1].

Future Projections

Given the steady CAGR of 3.1%, the Thyrogen market is expected to continue growing over the next several years. This growth will be driven by increasing demand for effective diagnostic and therapeutic tools in the management of thyroid cancer.

Challenges and Opportunities

Challenges

• High Production Costs: The production of recombinant proteins like thyrotropin alfa is complex and costly, which can affect pricing and accessibility.
• Regulatory Hurdles: Strict regulatory requirements can pose challenges for new entrants in the market.

Opportunities

• Expanding into Emerging Markets: There is significant potential for growth in emerging markets where access to advanced healthcare is increasing.
• Research and Development: Continuous R&D can lead to improved versions of thyrotropin alfa or new applications, further expanding the market.

Key Takeaways

• The global Thyrogen market is valued at US$ 689 million in 2023 and is projected to reach US$ 852.7 million by 2030.
• Sanofi Genzyme is the primary company in the Thyrogen market.
• The market is driven by the increasing incidence of thyroid cancer and advancements in diagnostic techniques.
• Financial assistance programs are available to make the treatment more accessible.
• Pricing dynamics, including pre- and post-exclusivity price changes, can significantly impact the cost-effectiveness of thyrotropin alfa.

FAQs

What is thyrotropin alfa used for?

Thyrotropin alfa, marketed as Thyrogen, is used primarily for the management of thyroid cancer and for diagnostic purposes to assess the recurrence of thyroid cancer.

Who is the main player in the Thyrogen market?

Sanofi Genzyme is the primary company associated with the Thyrogen market.

What is the projected CAGR for the Thyrogen market from 2024 to 2030?

The Thyrogen market is expected to grow at a CAGR of 3.1% from 2024 to 2030.

How is thyrotropin alfa produced?

Thyrogen is produced using a Chinese Hamster Ovary (CHO) cell line co-transfected with recombinant plasmids containing DNA sequences encoding the alpha and beta subunits of TSH.

Are there financial assistance programs available for Thyrogen?

Yes, financial assistance programs are available for eligible patients to help make the treatment more accessible.

Sources

1. Global Thyrogen Market Research Report 2024 - Valuates Reports
2. 39th Annual Meeting of the European Thyroid Association - European Thyroid Journal
3. The Influence of US Drug Price Dynamics on Cost-Effectiveness Analyses - PubMed
4. Thyrogen, INN-Thyrotropin alfa - European Medicines Agency
5. Patient Financial Assistance Programs - Thyrogen.com

Last updated: 2024-12-17