Somatrogon-ghla - Biologic Drug Details

Summary for somatrogon-ghla

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for somatrogon-ghla

Mechanism of Action	11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors
Established Pharmacologic Class	Recombinant Human Growth Hormone
Chemical Structure	Human Growth Hormone

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

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 somatrogon-ghla Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for somatrogon-ghla Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for somatrogon-ghla Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Somatrogon-ghla (NGENLA)

Introduction to Somatrogon-ghla (NGENLA)

Somatrogon-ghla, marketed as NGENLA, is a once-weekly human growth hormone analog developed by OPKO Health Inc. and Pfizer Inc. It is indicated for the treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

Market Approval and Regulatory Landscape

A significant driver for the somatrogon-ghla market is the recent approval by regulatory authorities. In June 2023, the U.S. Food and Drug Administration (FDA) approved NGENLA, marking a crucial milestone for its market entry[1].

Global Somatropin Market Overview

The global somatropin market, which includes somatrogon-ghla, is projected to grow substantially. It is estimated to be valued at US$ 3.85 billion in 2023 and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period from 2023 to 2030[1].

Key Drivers of Market Growth

Several factors are driving the growth of the somatrogon-ghla market:

Product Approval from Regulatory Authorities

Approvals from regulatory bodies such as the FDA are critical for market expansion. The recent FDA approval of NGENLA has opened up new opportunities for its adoption[1].

Increasing Long-Term Effects of Growth Hormone Therapy

The long-term benefits of growth hormone therapy, particularly in children with growth hormone deficiency, are well-documented. This has led to increased demand for effective and convenient treatments like somatrogon-ghla[1].

Rising Prevalence of Growth Hormone Deficiency

The growing prevalence of growth hormone deficiency and other related conditions, such as Turner syndrome, is driving the demand for somatropin products. For instance, Turner syndrome affects about 1 in every 2,000 to 2,500 live female births in the U.S.[1].

Regional Market Dynamics

The global somatropin market is segmented into various regions, with North America expected to dominate the market over the forecast period. This is due to the increased launch of products by key market players and the higher prevalence of conditions like Turner syndrome in this region[1].

Distribution Channels

The market is also segmented based on distribution channels, with hospital pharmacies expected to dominate due to the preference and ease of availability of somatropin products in these settings[1].

Clinical Studies and Efficacy

Clinical studies have demonstrated the efficacy of somatrogon-ghla. For example, treatment with once-weekly NGENLA for 52 weeks resulted in an annualized height velocity of 10.1 cm/year, which is comparable to daily somatropin therapy[2].

Competitive Landscape

The human growth hormone market is competitive, with several key players including Pfizer Inc., Eli Lilly & Co., Merck & Co. Inc., and Novo Nordisk A/S. Recent product launches, such as Novo Nordisk's once-weekly Sogroya, are also shaping the market landscape[4].

Financial Trajectory

The financial outlook for somatrogon-ghla is promising, given the growing demand for human growth hormone therapies. The global human growth hormone market was valued at USD 6.32 billion in 2023 and is expected to grow at a CAGR of 12.3% from 2024 to 2030[4].

Market Size and Growth Rate

The somatropin market, including somatrogon-ghla, is part of the broader biologics market, which is expected to reach USD 699.5 billion by 2032, growing at a CAGR of 7.8% during 2024-2032[3].

Revenue Potential

With its once-weekly administration and noninferior efficacy compared to daily somatropin, somatrogon-ghla is poised to capture a significant share of the market. The approval and subsequent market availability of NGENLA in August 2023 are expected to contribute substantially to the revenue growth of OPKO Health Inc. and Pfizer Inc.[1].

Challenges and Opportunities

While the market for somatrogon-ghla is promising, there are challenges to consider, such as competition from other long-acting growth hormone therapies and the need for continuous R&D to maintain market position. However, the robust investigational pipeline and recent product launches are fueling segment demand and providing opportunities for growth[4].

Expert Insights

Industry experts highlight the importance of innovative therapies in addressing growth hormone deficiency. For instance, the European Medicines Agency's favorable statement on Novo Nordisk's Sogroya underscores the potential of once-weekly therapies in this market[4].

"Somatrogon-ghla demonstrates noninferiority to somatropin in improving annual height velocity based on phase 3 trial data. With a similar safety profile to somatropin, this approval reinforces OPKO Health and Pfizer's commitment to addressing growth failure in children through innovative therapeutic solutions."[4]

Key Takeaways

• Regulatory Approvals: Recent FDA approval of NGENLA is a significant driver for market growth.
• Clinical Efficacy: Once-weekly administration with comparable efficacy to daily somatropin.
• Market Size and Growth: Part of a larger somatropin market valued at US$ 3.85 billion in 2023, with a CAGR of 7.3% from 2023 to 2030.
• Regional Dominance: North America expected to dominate the market due to product launches and prevalence of related conditions.
• Competitive Landscape: Competitive market with key players like Pfizer, Eli Lilly, Merck, and Novo Nordisk.

FAQs

What is somatrogon-ghla (NGENLA)?

Somatrogon-ghla, marketed as NGENLA, is a once-weekly human growth hormone analog used to treat pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.

What are the key drivers of the somatrogon-ghla market?

Key drivers include product approval from regulatory authorities, increasing long-term effects of growth hormone therapy, and rising prevalence of growth hormone deficiency.

How does somatrogon-ghla compare to daily somatropin therapy?

Somatrogon-ghla has demonstrated noninferiority to daily somatropin in improving annual height velocity, with a similar safety profile.

What is the expected market size and growth rate for the somatropin market?

The global somatropin market is estimated to be valued at US$ 3.85 billion in 2023 and is expected to exhibit a CAGR of 7.3% from 2023 to 2030.

Which regions are expected to dominate the somatropin market?

North America is expected to dominate the market due to increased product launches and the higher prevalence of related conditions.

Cited Sources:

1. Coherent Market Insights: Somatropin Market - Share, Size and Industry Analysis.
2. Pfizer Medical Information: NGENLA® (somatrogon-ghla) Clinical Studies Patient information - US.
3. BioSpace: Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems.
4. Grand View Research: Human Growth Hormone Market Size & Share Report, 2030.

Last updated: 2024-12-20