Adalimumab - Biologic Drug Details

Summary for adalimumab

Tradenames:	1
High Confidence Patents:	63
Applicants:	11
BLAs:	11
Suppliers: see list	19
Recent Clinical Trials:	See clinical trials for adalimumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adalimumab

Recent Clinical Trials for adalimumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda France	Phase 4
Teva takeda	Phase 4
University Medical Center Groningen	Phase 1/Phase 2

See all adalimumab clinical trials

Recent Litigation for adalimumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all adalimumab litigation

PTAB Litigation

Petitioner	Date
Fresenius Kabi USA, LLC et al.	2019-09-17
	2017-12-20
Sandoz Inc.	2017-11-06

See all adalimumab litigation

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 Derived from Brand-Side Litigation

These patents were obtained from brand-side disclosures in response to biosimilar applications

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2027-04-04
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2027-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2022-05-06
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 28, 2017		2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2028-11-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		3031-03-31

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Adalimumab

Introduction

Adalimumab, a biologic drug used to treat various autoimmune diseases, has been a cornerstone in the pharmaceutical industry for decades. Here, we delve into the market dynamics and financial trajectory of adalimumab, highlighting key drivers, regional performances, and future projections.

Global Market Size and Growth

The global adalimumab market is substantial and growing. As of 2023, the global market size was estimated at USD 21,512.2 million, with a projected compound annual growth rate (CAGR) of 5.9% from 2023 to 2030[2].

Regional Market Performance

North America

North America 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. This region is expected to grow at a CAGR of 4.1% from 2023 to 2030. The sophisticated healthcare system and high incidence of autoimmune illnesses in North America drive this growth[2].

Europe

Europe also holds a significant share of the adalimumab market, with a market size of USD 6,453.66 million in 2023. The region's well-established healthcare infrastructure and high demand for biologic treatments contribute to its market position[2].

Asia Pacific

The Asia Pacific region is emerging as a promising market for adalimumab, with a market size of USD 4,947.81 million in 2023 and a projected CAGR of 7.9% from 2023 to 2030. Increasing investments in healthcare infrastructure and a rising incidence of autoimmune diseases are key drivers in this region[2].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa are also growing markets, driven by expanding healthcare sectors and increasing prevalence of autoimmune illnesses. Latin America's market size was USD 1,075.61 million in 2023, with a CAGR of 5.3%, while the Middle East & Africa had a market size of USD 430.24 million in 2023, with a CAGR of 5.6% from 2023 to 2030[2].

Drivers of Market Growth

Increasing Geriatric Population

The global population aged 65 and above is projected to rise significantly, from 727 million in 2020 to 1.5 billion by 2050. This demographic shift increases the incidence of chronic ailments, thereby boosting the demand for adalimumab[1].

Rising Incidence of Autoimmune Disorders

The growing prevalence of autoimmune diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel diseases (IBD) like Crohn's disease and ulcerative colitis drives the demand for adalimumab. For instance, the increasing prevalence of IBD in regions like Australia and Canada is expected to propel market growth[4].

Advanced Healthcare Infrastructure

Regions with sophisticated healthcare systems, such as North America and Europe, contribute significantly to the market growth due to their ability to provide specialized care and access to biologic treatments[2].

Financial Trajectory

Historical Performance

Adalimumab, marketed under the brand name Humira by AbbVie, has been the highest-selling pharmaceutical product in history, earning nearly $200 billion since its approval in 2002. This revenue has enabled AbbVie to invest in research and development, as well as strategic acquisitions[5].

Future Projections

The adalimumab market is expected to continue its growth trajectory. In North America, the market is projected to reach USD 25,709.4 million by 2030, growing at a CAGR of 5.40% from 2023 to 2030[1].

Biosimilars Market

The adalimumab biosimilars market is also poised for significant growth, with a projected CAGR of 23.4% from 2024 to 2033. This market is expected to expand from USD 738.3 million in 2023 to USD 6,044.9 million by 2033, driven by the expiration of patents and the entry of new biosimilar products[3].

Market Segmentation

By Indication

Adalimumab is used to treat a variety of autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and psoriasis. The growing prevalence of these conditions across different regions drives the market segmentation by indication[4].

By End-User

The market is segmented by end-users such as hospitals, specialty clinics, and others. Hospitals hold a dominant market share due to increased healthcare infrastructure spending and the need for specialized care for chronic inflammatory diseases[4].

Challenges and Opportunities

High Cost and Side Effects

Despite its efficacy, adalimumab is associated with high costs and potential side effects, which can pose challenges to market growth. However, the benefits of the drug often outweigh these concerns, especially in severe cases of autoimmune diseases[4].

Regulatory Framework

The regulatory environment plays a crucial role in the adalimumab market. Patent expirations and the approval of biosimilars are expected to increase competition and reduce prices, making the drug more accessible to a broader patient population[3].

Key Takeaways

• The global adalimumab market is projected to grow significantly, driven by increasing demand for biologic treatments and a rising incidence of autoimmune diseases.
• North America and Europe are dominant markets, while Asia Pacific is emerging as a key growth region.
• The adalimumab biosimilars market is expected to expand rapidly, driven by patent expirations and the entry of new biosimilar products.
• The growing geriatric population and advancements in healthcare infrastructure are critical drivers of market growth.

FAQs

What is the current global market size of adalimumab?

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

What is the projected CAGR for the adalimumab market from 2023 to 2030?

The global adalimumab market is expected to grow at a CAGR of 5.9% from 2023 to 2030[2].

Which region dominates the adalimumab market?

North America dominates the adalimumab market, accounting for more than 40% of the global revenue[2].

What are the key drivers of the adalimumab market growth?

Key drivers include the increasing geriatric population, rising incidence of autoimmune disorders, and advancements in healthcare infrastructure[1][2][4].

How is the adalimumab biosimilars market expected to grow?

The adalimumab biosimilars market is expected to grow at a CAGR of 23.4% from 2024 to 2033, reaching USD 6,044.9 million by 2033[3].

Sources

1. Data Bridge Market Research: North America Adalimumab Market Forecast |2023-2030
2. Cognitive Market Research: The Global Adalimumab market size...
3. PharmiWeb: Adalimumab Biosimilars Market to Hit USD 6044.9 Million by 2033...
4. IndustryARC: Adalimumab Market Size Report, 2022-2027
5. BioPharma Dive: Two decades and $200 billion: AbbVie's Humira monopoly nears its...

Last updated: 2024-12-17