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Last Updated: January 20, 2025

Pegloticase - Biologic Drug Details


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Summary for pegloticase
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for pegloticase
Recent Clinical Trials for pegloticase

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University of California, Los AngelesPhase 1
Shanghai Institute Of Biological ProductsPhase 1
First Affiliated Hospital Bengbu Medical CollegePhase 1

See all pegloticase clinical trials

Pharmacology for pegloticase
Established Pharmacologic ClassUric Acid-specific Enzyme
Chemical StructureUrate Oxidase
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 pegloticase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Pegloticase

Introduction

Pegloticase, a biologic drug used for the treatment of chronic and refractory gout, is experiencing significant growth in the global market. This article delves into the market dynamics, financial trajectory, and key drivers influencing the intravenous pegloticase market.

Market Size and Growth Projections

The global intravenous pegloticase market is anticipated to witness substantial growth over the next decade. As of 2022, the market was valued at USD 2.8 billion and is expected to reach USD 3.19 billion by 2023 and USD 11.61 billion by 2033, growing at a CAGR of 13.8% from 2023 to 2033[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the intravenous pegloticase market:

Increasing Prevalence of Chronic and Refractory Gout

The rising number of chronic and refractory gout cases globally is a primary driver. This condition affects various age groups, including adults, pediatrics, and geriatrics, contributing to the increasing demand for effective treatments[1][4].

Lifestyle Factors and Aging Population

Altered lifestyle habits, such as higher alcohol consumption, and an aging population are contributing to the increased prevalence of gout. As people live longer, the number of elderly individuals with gout is rising, thereby increasing the demand for pegloticase[1][4].

Research and Development

Strong research and development pipelines, including clinical studies and FDA certifications for gout therapies, are expected to positively impact the market. Companies like Amgen are investing heavily in their pipelines, which includes treatments for rare diseases like gout[1][3].

Mergers and Collaborations

Increasing mergers and collaborations between major pharmaceutical companies are also driving the growth of the intravenous pegloticase market. For instance, Amgen's acquisition of Horizon Therapeutics has strengthened its position in the rare disease market, including gout treatments[1][3].

Regional Market Dynamics

North America

North America is expected to dominate the global intravenous pegloticase market due to a large patient population, the presence of key players, advanced healthcare infrastructure, and favorable payment practices. The region's strong healthcare system and high adoption rates of new treatments contribute to its leading position[1].

Asia-Pacific

The Asia-Pacific region is anticipated to show the highest CAGR of 12.5% during the forecast period. This growth is driven by increasing awareness of intravenous pegloticase, rising healthcare expenditure, and a growing population in countries like China and India[1].

Europe

Europe is also expected to be a significant market for intravenous pegloticase, driven by the higher adoption of the drug in the region. The presence of a well-developed healthcare system and a large patient base contribute to the market's growth in Europe[1].

Financial Performance of Key Players

Amgen

Amgen, a major player in the biologic drug market, has reported strong financial results. In Q3 2024, Amgen's total revenues increased by 23% to $8.5 billion, with product sales growing by 24% driven by 29% volume growth. Their rare disease products, including KRYSTEXXA (pegloticase), generated $1.2 billion in sales, highlighting the financial viability of pegloticase in the market[2].

Challenges and Limitations

Despite the positive growth trajectory, the intravenous pegloticase market faces some challenges:

Adverse Effects

The therapies' adverse effects could hinder market growth. Managing and mitigating these side effects are crucial for the long-term success of pegloticase treatments[1].

Supply Chain Disruptions

Global restrictions and disruptions in the production and supply of intravenous pegloticase have affected the market. Reduced patient flow in hospitals and clinics due to these disruptions has also impacted the market's performance[1].

Clinical Efficacy and Safety

Pegloticase has shown significant efficacy in treating chronic and refractory gout. Studies have highlighted its ability to lower uric acid levels effectively, making it a viable option when standard treatments fail. However, ongoing research is necessary to update its efficacy and safety profiles continuously[5].

Market Participants

Several key players are involved in the global intravenous pegloticase market, including Amgen, which is a significant player due to its product KRYSTEXXA (pegloticase). Other companies are also investing in research and development to expand their market share[1].

Future Outlook

The future outlook for the intravenous pegloticase market is promising, driven by increasing demand, strong R&D pipelines, and growing awareness in emerging markets. As the global population ages and lifestyle factors continue to contribute to the prevalence of gout, the market is expected to continue its upward trajectory.

Key Takeaways

  • The global intravenous pegloticase market is projected to reach USD 11.61 billion by 2033, growing at a CAGR of 13.8% from 2023 to 2033.
  • The increasing prevalence of chronic and refractory gout, along with an aging population and lifestyle factors, are key drivers of market growth.
  • North America is expected to dominate the market, while the Asia-Pacific region will show the highest CAGR.
  • Strong R&D pipelines and mergers/collaborations among pharmaceutical companies are driving the market forward.
  • Adverse effects and supply chain disruptions are potential challenges that need to be addressed.

FAQs

What is the current market size of the intravenous pegloticase market?

The global intravenous pegloticase market was valued at USD 2.8 billion in 2022 and is expected to reach USD 3.19 billion by 2023[1].

What is the projected CAGR for the intravenous pegloticase market from 2023 to 2033?

The market is expected to grow at a CAGR of 13.8% from 2023 to 2033[1].

Which region is expected to dominate the intravenous pegloticase market?

North America is anticipated to dominate the global intravenous pegloticase market due to its large patient population and advanced healthcare infrastructure[1].

What are the primary drivers of the intravenous pegloticase market growth?

The primary drivers include the increasing prevalence of chronic and refractory gout, an aging population, lifestyle factors such as higher alcohol consumption, and strong R&D pipelines[1][4].

Which company is a significant player in the intravenous pegloticase market?

Amgen is a significant player, with its product KRYSTEXXA (pegloticase) generating substantial revenue in the rare disease segment[2].

What challenges might affect the growth of the intravenous pegloticase market?

Adverse effects of the therapies and supply chain disruptions are potential challenges that could impact market growth[1].

More… ↓

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