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Last Updated: April 25, 2025

ADAGEN Drug Profile


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Summary for Tradename: ADAGEN
Recent Clinical Trials for ADAGEN

Identify potential brand extensions & biosimilar entrants

SponsorPhase
National Human Genome Research Institute (NHGRI)Phase 1

See all ADAGEN 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 ADAGEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for Biologic Drugs: A Focus on ADAGEN and the Broader Biologics Market

Introduction

The biologics market is experiencing significant growth, driven by several key factors including the increasing prevalence of chronic diseases, technological advancements, and the growing adoption of biosimilars. This article will delve into the market dynamics and financial trajectory of biologic drugs, with a specific focus on ADAGEN and the broader biologics market.

Biologics Market Outlook

The biologics market has been expanding rapidly, with the global market size reaching USD 349.6 billion in 2023. It is projected to grow to USD 699.5 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 7.8% during the period 2024-2032[1].

Key Drivers of the Biologics Market

  • Increasing Burden of Chronic Diseases: The high prevalence of chronic diseases is a significant driver, leading to increased demand for biologic therapies.
  • Technological Advancements: Continuous advancements in drug delivery systems and the development of targeted therapies are crucial.
  • Growing Adoption of Biosimilars: Biosimilars are becoming more accepted, offering cost-effective alternatives to original biologic drugs.
  • Improved Healthcare Infrastructure: Enhancements in healthcare infrastructure, particularly in emerging economies, are boosting market growth.
  • Regulatory Approvals: The escalating approvals of biologics by regulatory agencies further drive market expansion[1].

ADAGEN Market Dynamics

Overview of ADAGEN

ADAGEN is a drug used for the treatment of Severe Combined Immunodeficiency (SCID) due to Adenosine Deaminase Deficiency (ADA-SCID). It is developed by Leadiant Biosciences and is one of the few treatments available for this rare disease.

Market Size and Growth

The ADAGEN market, although smaller compared to the broader biologics market, is expected to register considerable growth. The market size for ADA-SCID treatments was USD 7 million in 2015, and it is anticipated to grow due to the essential nature of the drug for patients and the lack of alternative treatments[4].

Regional Growth

The market for ADAGEN is expected to be more expansive in developed regions such as North America and Europe, where advanced healthcare infrastructure and higher investment in the healthcare sector are prevalent. Early diagnosis and timely treatment are crucial for ADA-SCID, and these regions are better equipped to handle such requirements[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry. While it has diverted resources towards vaccine development, the demand for essential drugs like ADAGEN has remained relatively unaffected. Once the pandemic subsides, the market is expected to register positive growth[4].

Financial Trajectory of Biologic Drug Developers

Adagene Inc. Financials

Adagene Inc., a company involved in the development of biologic drugs, including the promising candidate ADG126, has reported mixed financial results. For the first half of 2024, Adagene reported a net loss of $17.0 million with no revenue, but a cash balance of $95.7 million that is expected to fund operations until 2026. Research and Development (R&D) expenses decreased by 31% to $14.7 million, indicating a focus on cost management[2].

Revenue and Loss

The lack of revenue in the first half of 2024 compared to the previous year highlights the challenges faced by the company. However, the promising results of ADG126, particularly in combination with pembrolizumab, suggest potential future revenue streams[2].

Collaborations and Pipeline

Adagene's collaborations with major pharmaceutical companies like Exelixis, Sanofi, and Roche are crucial for advancing their pipeline. These partnerships are expected to generate future value and revenue, making the next 12-18 months critical for the company's long-term viability[2].

Broader Financial Implications for Biologic Drug Developers

Funding and Investments

Biologic drug developers often rely heavily on non-dilutive funding from business development collaborations. For instance, Adagene received total non-dilutive funding of $21.9 million in 2022, which is essential for sustaining R&D activities[5].

R&D Expenses

Research and Development expenses are a significant component of the financials for biologic drug developers. These expenses can be substantial, but they are crucial for advancing the clinical pipeline and generating future revenue streams[5].

Regulatory and Market Approval

The approval of biologic drugs by regulatory agencies is a critical financial milestone. The approval process can be lengthy and costly, but successful approvals can significantly boost a company's financial trajectory[1].

Regional Market Dynamics

Asia-Pacific Region

The Asia-Pacific region is a significant contributor to the biologics market, driven by a large patient population and growing healthcare infrastructure. Countries like China and India are expanding their healthcare systems, increasing demand for biologics. Favorable government policies and a focus on personalized medicine also contribute to the region's prominence[1].

Developed Markets

In developed regions such as North America and Europe, the biologics market is driven by favorable reimbursement policies, large R&D investments, and the presence of top biopharmaceutical companies. These factors contribute to a higher market share and growth potential[1].

Economic Perspective

Cost and Pricing

Biologic drugs are often high-priced, which contributes to their significant market value. The economic perspective highlights that the growth of biologics is driven by both the increasing number of biologics on the market and their high price. This is in contrast to chemically-synthesized drugs, which have seen relatively stagnant growth[3].

Biosimilars Market

The market potential for biosimilars is closely tied to the biologics market. As patents for blockbuster biologic drugs expire, the market for biosimilars is expected to grow, offering cost-effective alternatives and driving further expansion in the biologics market[3].

Key Takeaways

  • The biologics market is projected to reach USD 699.5 billion by 2032, driven by chronic diseases, technological advancements, and the adoption of biosimilars.
  • ADAGEN, a treatment for ADA-SCID, has a niche but growing market due to its essential nature and lack of alternatives.
  • Adagene Inc.'s financial trajectory is challenging but promising, with a focus on advancing their clinical pipeline and collaborations with major pharmaceutical companies.
  • Regional dynamics, particularly in the Asia-Pacific region and developed markets, play a crucial role in the growth of the biologics market.
  • The economic perspective highlights the high cost and pricing of biologic drugs and the growing importance of biosimilars.

FAQs

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].

What are the key drivers of the biologics market?

Key drivers include the increasing burden of chronic diseases, technological advancements, growing adoption of biosimilars, improved healthcare infrastructure, and regulatory approvals[1].

What is ADAGEN used for?

ADAGEN is used for the treatment of Severe Combined Immunodeficiency (SCID) due to Adenosine Deaminase Deficiency (ADA-SCID)[4].

How has the COVID-19 pandemic impacted the ADAGEN market?

The demand for ADAGEN has remained relatively unaffected by the COVID-19 pandemic, but the overall healthcare infrastructure has been impacted, diverting resources towards vaccine development[4].

What is the significance of Adagene Inc.'s ADG126?

ADG126, a masked anti-CTLA-4 SAFEbody, shows a promising therapeutic profile in combination with pembrolizumab, particularly in microsatellite-stable colorectal cancer (MSS CRC)[2].

Sources

  1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems. Biospace.
  2. Adagene Reports Six Month Financial Results for 2024 and Provides Corporate Update. Stock Titan.
  3. Understanding the market dynamics of biosimilars. Business Chemistry.
  4. Adagen Market | Size, Share, Growth. Reports and Data.
  5. Adagene Reports Full Year 2022 Financial Results and Provides Corporate Update. Adagene Investor Relations.

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