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Last Updated: February 7, 2025

Adalimumab-afzb - Biologic Drug Details


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Summary for adalimumab-afzb
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
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 adalimumab-afzb Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for adalimumab-afzb Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for adalimumab-afzb Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Adalimumab (Humira and Biosimilars)

Introduction

Adalimumab, marketed under the brand name Humira among others, is a pivotal biologic drug used to treat various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. The market for adalimumab is undergoing significant changes with the emergence of biosimilars, which are impacting its market dynamics and financial trajectory.

Global Market Size and Growth

The global adalimumab market was estimated to be USD 21,512.2 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 5.9% from 2023 to 2030[2][3].

Regional Market Breakdown

  • North America: This region dominates the adalimumab market, accounting for more than 40% of the global revenue with a market size of USD 8,604.88 million in 2023. It is expected to grow at a CAGR of 4.1% from 2023 to 2030, driven by a sophisticated healthcare system and a high incidence of autoimmune illnesses[2][3].
  • Europe: Europe is another significant market, with key players and increasing investments in research and development activities. The market size here was USD 6,453.66 million in 2023[2].
  • Asia Pacific: This region is emerging as a promising market, with a market size of USD 4,947.81 million in 2023 and a projected CAGR of 7.9% from 2023 to 2030. The growth is driven by increasing awareness of autoimmune diseases and investments in healthcare infrastructure[2][3].
  • Latin America and Middle East & Africa: These regions also show potential growth, with market sizes of USD 1,075.61 million and USD 430.24 million in 2023, respectively. They are expected to grow at CAGRs of 5.3% and 5.6% from 2023 to 2030[2].

Impact of Biosimilars

Biosimilars have significantly altered the market dynamics for adalimumab.

Market Share of Biosimilars

As of 2024, adalimumab biosimilars have seen a substantial increase in market share, rising from 2% in early 2024 to 22%. This growth is driven by payers and pharmacy benefit managers prioritizing biosimilars over the reference product, Humira[4].

Price Erosion

The introduction of biosimilars has led to significant price erosion. For example, the average sales price (ASP) of all adalimumab products has decreased by 53% over the first five years post-biosimilar launch. As of Q3 2024, the ASP for biosimilars alone was significantly lower than that of the reference product[1][4].

Key Biosimilars

Several biosimilars have entered the market, including those from companies like Samsung Bioepis, Amgen, and Celltrion. These biosimilars, such as Hyrimoz and Hadlima, are gaining market share due to their lower prices and equivalent efficacy to Humira[1][4].

Financial Trajectory

Revenue Impact

The increasing market share of biosimilars is expected to impact the revenue of the original Humira product. As biosimilars continue to gain traction, the revenue from Humira is likely to decline. For instance, Humira's market share has dropped to 82% as of May 2024, down from 95% in previous quarters[1].

Cost and Pricing Strategies

Biosimilars are priced lower than the reference product, which has forced manufacturers to adjust their pricing strategies. The ASP of biosimilars has been declining, making them more attractive to payers and patients. For example, the ASP of trastuzumab biosimilars has decreased by 70% compared to the reference product[1].

Research and Development

Despite the challenges posed by biosimilars, the adalimumab market continues to see significant investments in research and development. New biosimilars and emerging drugs, such as IBI303 and CT-P17, are in the pipeline, which will further shape the market[3].

Challenges and Opportunities

High R&D Costs

One of the major challenges in the adalimumab market is the high cost of clinical trials and research and development. This limits the growth opportunities for manufacturers, as they need to balance R&D spending with the need to keep product prices low[3].

Increasing Demand

The growing prevalence of autoimmune diseases and the increasing awareness about biologic treatments present significant opportunities for the adalimumab market. The demand for effective treatments is driving the market growth, particularly in regions with expanding healthcare infrastructure[2][3].

Regulatory Environment

The regulatory environment plays a crucial role in the adalimumab market. The FDA has approved 61 biosimilars across 17 molecules as of September 2024, with 41 biosimilars launched in the US market. This regulatory support is facilitating the entry of new biosimilars, which is changing the market landscape[4].

Market Players

Key players in the global adalimumab market include AbbVie Inc., Amgen Inc., Fresenius Kabi AG, Celltrion Healthcare Co Ltd, and Samsung Bioepis. These companies are actively involved in developing and marketing biosimilars, which is driving the market competition and innovation[3].

Conclusion

The adalimumab market is experiencing a significant transformation due to the emergence of biosimilars. The market is expected to continue growing, driven by increasing demand for biologic treatments and expanding healthcare infrastructure. However, the entry of biosimilars is leading to price erosion and changes in market share, which manufacturers must navigate through strategic pricing and R&D investments.

Key Takeaways

  • The global adalimumab market is projected to grow at a CAGR of 5.9% from 2023 to 2030.
  • Biosimilars have significantly increased their market share, leading to price erosion and reduced revenue for the original Humira product.
  • North America, Europe, and the Asia Pacific are key regions driving the market growth.
  • High R&D costs and regulatory environments are critical factors influencing the market.
  • Key players are investing heavily in biosimilar development and marketing.

FAQs

What is the current market size of the global adalimumab market?

The global adalimumab market was estimated to be USD 21,512.2 million in 2023[2].

How are biosimilars impacting the adalimumab market?

Biosimilars have increased their market share significantly, from 2% in early 2024 to 22%, and have led to substantial price erosion, reducing the ASP by 53% over the first five years post-biosimilar launch[1][4].

Which regions are driving the growth of the adalimumab market?

North America, Europe, and the Asia Pacific are the key regions driving the growth of the adalimumab market, with the Asia Pacific region expected to grow at the highest CAGR[2][3].

What are the challenges faced by manufacturers in the adalimumab market?

Manufacturers face high R&D costs and the need to balance these costs with keeping product prices low, especially in the face of increasing competition from biosimilars[3].

How is the regulatory environment affecting the adalimumab market?

The FDA has approved numerous biosimilars, facilitating their entry into the market. This regulatory support is driving competition and innovation in the adalimumab market[4].

Who are the key players in the global adalimumab market?

Key players include AbbVie Inc., Amgen Inc., Fresenius Kabi AG, Celltrion Healthcare Co Ltd, and Samsung Bioepis[3].

Sources

  1. Samsung Bioepis. Biosimilar Market Dynamics - SAMSUNG BIOEPIS. May 2024.
  2. Cognitive Market Research. The Global Adalimumab market size was USD 21512.2 Million in 2023 and will expand at a compound annual growth rate (CAGR) of 5.90% from 2023 to 2030. May 23, 2024.
  3. Expert Market Research. HUMIRA (Adalimumab) drug Market Research, Size, Share, 2032.
  4. Center for Biosimilars. Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share. October 11, 2024.

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