Adalimumab-bwwd - Biologic Drug Details

Summary for adalimumab-bwwd

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for adalimumab-bwwd

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker
Chemical Structure	Antibodies, Monoclonal

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 adalimumab-bwwd Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Adalimumab

Market Definition and Overview

Adalimumab, marketed under the brand name Humira, is a biologic drug used to treat various autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis, and Crohn's disease. The global adalimumab market has been experiencing significant growth driven by several key factors.

Drivers of Market Growth

Rise in Incidence of Autoimmune Diseases

The increasing incidence of autoimmune diseases is a major driver of the adalimumab market. Conditions such as psoriatic arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, and Crohn's disease are becoming more prevalent, leading to a higher demand for adalimumab[1].

Increasing Healthcare Expenditure

The rise in healthcare expenditure is improving healthcare infrastructure, which in turn supports the growth of the adalimumab market. This increased investment in healthcare enhances the availability and accessibility of adalimumab for patients[1].

Rising Geriatric Population

The surging number of geriatric individuals is another significant factor. The global population aged 65 and above is projected to increase from 727 million in 2020 to 1.5 billion by 2050. This demographic shift is anticipated to enhance the market’s growth rate as older populations are more prone to chronic ailments[1].

Financial Performance and Revenue

Historical Revenue and Price Increases

AbbVie, the manufacturer of Humira, has seen substantial revenue growth from the drug. Since its introduction, Humira has generated over $170 billion in worldwide net revenue, with $107 billion coming from the U.S. health care system alone. The net price of Humira increased by 110% between 2009 and 2018, from $16,663 per year to $35,041 per year[2].

Current Market Size and Forecast

As of 2021, the adalimumab market was valued at USD 20,912.1 million and is expected to reach USD 31,610.01 million by 2029, growing at a CAGR of 5.30% during the forecast period of 2022 to 2029[1].

Regional Market Performance

• North America: This region holds a significant share of the global adalimumab market, 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[5].
• Asia Pacific: This region is emerging as a promising market with a market size of USD 4,947.81 million in 2023 and a CAGR of 7.9% from 2023 to 2030. The growth is attributed to investments in healthcare infrastructure and an increasing incidence of autoimmune diseases[5].
• Latin America and Middle East & Africa: These regions are also growing, with Latin America expected to grow at a CAGR of 5.3% and the Middle East & Africa at a CAGR of 5.6% from 2023 to 2030, driven by expanding healthcare sectors and increasing prevalence of autoimmune illnesses[5].

Impact of Biosimilars

Market Share and Uptake

The introduction of adalimumab biosimilars has significantly impacted the market. By September 2024, adalimumab biosimilars have increased their market share from 2% to 22%, driven by payers and pharmacy benefit managers prioritizing these biosimilars over the reference product, Humira[4].

Cost Savings and Market Dynamics

Biosimilars are expected to generate significant cost savings, with projected savings exceeding $180 billion by 2027. The biologics market, including biosimilars, has grown at an average annual rate of 12.5% over the past five years, and this trend is expected to continue[3].

Opportunities and Challenges

Research and Development Activities

An increase in research and development activities is expected to further enhance the market growth. New clinical trials and pipeline analyses are crucial for the development of new indications and formulations of adalimumab[1].

Regulatory Framework and Pricing

The regulatory environment and pricing strategies play critical roles in the market dynamics. The approval of biosimilars and the subsequent price competition are likely to affect the market trajectory. For instance, the average sales prices (ASPs) of biosimilars have decreased by 53% over the first five years post-launch[4].

Executive Compensation and Corporate Revenue

AbbVie's financial success with Humira has also reflected in the compensation of its executives. Since separating from Abbott in 2013, AbbVie has paid its highest-ranking executives over $480 million in compensation, with the CEO alone receiving nearly $170 million over that period. Executive bonuses have been tied directly to Humira's net revenue, aligning their incentives with the drug's financial performance[2].

Key Takeaways

• The global adalimumab market is driven by the increasing incidence of autoimmune diseases, rising healthcare expenditure, and a growing geriatric population.
• The market is expected to grow at a CAGR of 5.30% from 2022 to 2029, reaching USD 31,610.01 million.
• North America, Asia Pacific, Latin America, and the Middle East & Africa are significant regions contributing to the market growth.
• Biosimilars are gaining market share, leading to cost savings and changing market dynamics.
• Research and development activities and regulatory frameworks are crucial for future market growth.

FAQs

Q: What is the current market size of the global adalimumab market? A: As of 2021, the adalimumab market was valued at USD 20,912.1 million[1].

Q: How is the market expected to grow in the forecast period? A: The market is expected to reach USD 31,610.01 million by 2029, growing at a CAGR of 5.30% from 2022 to 2029[1].

Q: What role do biosimilars play in the adalimumab market? A: Biosimilars are gaining market share, with adalimumab biosimilars increasing their market share from 2% to 22% by September 2024, and are expected to generate significant cost savings[4].

Q: Which regions are significant contributors to the adalimumab market? A: North America, Asia Pacific, Latin America, and the Middle East & Africa are significant regions contributing to the market growth[5].

Q: How have price increases impacted AbbVie's revenue from Humira? A: The net price of Humira increased by 110% between 2009 and 2018, leading to substantial revenue growth for AbbVie, with U.S. net revenue from Humira reaching $16.1 billion in 2020[2].

Cited Sources

1. Data Bridge Market Research - Global Adalimumab Market – Industry Trends and Forecast to 2029
2. House Committee on Oversight and Reform - Drug Pricing Investigation - Document Repository
3. Drug Topics - A Biosimilar Wave Looms Large Over US Biologics Market
4. Center for Biosimilars - Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
5. 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.

Last updated: 2024-12-18