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Last Updated: December 26, 2024

ZOMACTON Drug Profile


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Summary for Tradename: ZOMACTON
Recent Clinical Trials for ZOMACTON

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Belgian Study Group for Pediatric EndocrinologyPhase 4
Ferring Pharmaceuticals
Ferring PharmaceuticalsPhase 3

See all ZOMACTON 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 ZOMACTON Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

ZOMACTON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ZOMACTON

Overview of ZOMACTON

ZOMACTON, also known as somatropin, is a recombinant human growth hormone (GH) used to treat growth hormone deficiency (GHD) in children and adults, as well as other conditions such as Turner syndrome, Prader-Willi syndrome, and idiopathic short stature.

Market Size and Growth

The global somatropin market, which includes ZOMACTON, is projected to exhibit significant growth. As of 2023, the global somatropin market is valued at US$ 3.85 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.3% from 2023 to 2030, reaching a projected value of US$ 6.30 billion by 2030[1].

Key Drivers of Growth

Several factors are driving the growth of the somatropin market, including:

Regulatory Approvals

Recent approvals by regulatory bodies are a significant driver. For instance, in January 2020, the U.S. Food and Drug Administration (FDA) approved ZOMACTON for injection in 5 mg and 10 mg doses for the replacement of GH in adults with GH deficiency[1].

Product Launches

The market is also driven by the launch of new products and formulations by major market players. Companies like Ferring B.V., Pfizer, Inc., and Merck KGaA are continuously innovating and expanding their product portfolios[1].

Increasing Prevalence of Indications

The rising prevalence of conditions such as Turner syndrome and Prader-Willi syndrome, for which somatropin is a treatment, is another key driver. Turner syndrome, for example, is estimated to occur in about 1 in every 2,000 to 2,500 live female births in the U.S.[1].

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to dominate the market due to the preference and ease of availability of somatropin in these settings[1].

Regional Analysis

Geographically, the North American market is expected to dominate the somatropin market due to the increased launch of products by key players and the higher prevalence of conditions like Turner syndrome in this region[1].

Competitive Landscape

The somatropin market is highly competitive, with several major players including Novo Nordisk A/S, Pfizer, Inc., Eli Lilly and Company, and Ferring B.V. These companies are engaged in continuous innovation, collaborations, and strategic partnerships to enhance their market share.

Example: Ferring B.V.

Ferring B.V.'s approval of ZOMACTON by the FDA is a significant example of competitive activity in this market. This approval has expanded the treatment options for adults with GH deficiency, contributing to the overall growth of the somatropin market[1].

Financial Trajectory

The financial trajectory of ZOMACTON and similar somatropin products is influenced by several factors:

Revenue Growth

The revenue from somatropin products is expected to grow substantially over the forecast period. This growth is driven by increasing product approvals, launches, and the expanding patient base due to rising awareness and diagnosis of GH-related conditions[1].

Collaboration and Partnerships

Companies involved in the somatropin market are engaging in strategic collaborations to enhance their product offerings and patient monitoring systems. For example, Merck KGaA has partnered with PRA Health Sciences to integrate its HGH treatment system with remote patient monitoring platforms, which is expected to improve patient adherence and outcomes[1].

Research and Development

Significant investments are being made in research and development to improve existing products and develop new formulations. Ascendis Pharma A/S, for instance, is developing TransCon hGH, a long-acting growth hormone therapy, which is in Phase 3 clinical trials for pediatric GHD patients[3].

Challenges and Opportunities

Despite the positive growth trajectory, there are challenges and opportunities to consider:

Regulatory Challenges

The approval process for biologic drugs like ZOMACTON is stringent and time-consuming. Companies must navigate complex regulatory environments to secure approvals, which can be a significant challenge[3].

Competitive Pressure

The somatropin market is highly competitive, with multiple players vying for market share. This competition drives innovation but also increases the pressure to maintain market position[1].

Biosimilar Impact

The emergence of biosimilars could impact the market dynamics of innovator biologics like ZOMACTON. However, as of now, innovator products still dominate the market, with biosimilars growing but not yet significantly eroding the market share of branded products[4].

Key Takeaways

  • The global somatropin market, including ZOMACTON, is expected to grow at a CAGR of 7.3% from 2023 to 2030.
  • Regulatory approvals, product launches, and increasing prevalence of GH-related conditions are key drivers of growth.
  • Hospital pharmacies are expected to dominate the distribution channels.
  • North America is anticipated to lead the market geographically.
  • Strategic collaborations and investments in R&D are crucial for maintaining competitive edge.

FAQs

What is ZOMACTON used for?

ZOMACTON is used to treat growth hormone deficiency (GHD) in children and adults, as well as other conditions such as Turner syndrome, Prader-Willi syndrome, and idiopathic short stature.

Who are the major players in the somatropin market?

Major players include Novo Nordisk A/S, Pfizer, Inc., Eli Lilly and Company, Ferring B.V., and Merck KGaA.

What is the expected market size of the somatropin market by 2030?

The global somatropin market is projected to reach US$ 6.30 billion by 2030.

What are the key distribution channels for somatropin products?

The key distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies expected to dominate.

How does the emergence of biosimilars impact the somatropin market?

While biosimilars are growing, they have not yet significantly eroded the market share of branded somatropin products like ZOMACTON.

Sources

  1. Coherent Market Insights: Somatropin Market - Share, Size and Industry Analysis
  2. Small-Cap Research: Antares Pharma, Inc. Coverage Initiation
  3. Ascendis Pharma A/S: Annual Reports
  4. IQVIA: Realizing Biosimilar Potential in the Middle East & Africa
  5. SNS Insider: Growth Hormone Deficiency Market Size, Share & Analysis 2032

More… ↓

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