Golimumab - Biologic Drug Details

Summary for golimumab

Tradenames:	2
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for golimumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for golimumab

Recent Clinical Trials for golimumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Washington	Phase 2
Janssen Scientific Affairs, LLC	Phase 2
University of Pennsylvania	Phase 3

See all golimumab clinical trials

Recent Litigation for golimumab

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
AMGEN INC. v. APOTEX INC.	2022-06-14

See all golimumab litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all golimumab litigation

Pharmacology for golimumab

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 golimumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	11,014,982	2037-02-07	Company disclosures
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	11,041,020	2039-07-20	Company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	SIMPONI	golimumab	Injection	125289	10,010,585	2034-06-16	Patent claims search
Janssen Biotech, Inc.	SIMPONI	golimumab	Injection	125289	10,012,654	2032-12-21	Patent claims search
Janssen Biotech, Inc.	SIMPONI	golimumab	Injection	125289	10,016,338	2033-03-11	Patent claims search

Market Dynamics and Financial Trajectory of Golimumab

Introduction to Golimumab

Golimumab, marketed under the brand name Simponi, is a monoclonal antibody used to treat various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The drug has been gaining significant traction in the pharmaceutical market due to its effectiveness and the rising demand for biologic medications.

Market Growth and CAGR

The global golimumab market is projected to register a Compound Annual Growth Rate (CAGR) of 5.73% from 2023 to 2031. This growth is driven by several key factors, including the increasing prevalence of autoimmune diseases and the rising demand for effective biologic treatments[1][3][5].

Key Drivers of Market Growth

Increasing Prevalence of Autoimmune Diseases

The global rise in autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is a significant driver of the golimumab market. As these conditions become more prevalent, the demand for effective treatments like golimumab increases, contributing to market growth[1][3].

Public Awareness and Diagnosis

Increased public awareness about the diagnosis and treatment of autoimmune diseases has also fueled the market's growth. Better diagnostic tools and higher awareness levels lead to more patients seeking treatment, thereby driving the demand for golimumab[1].

Geriatric Population and Healthcare Infrastructure

The rising geriatric population, which is more prone to autoimmune diseases, and the improvement in healthcare infrastructure, particularly in regions like North America and Europe, are additional factors driving the market. Advanced healthcare facilities and favorable reimbursement policies in these regions further support market growth[1][3].

Market Segmentation

Indications

The golimumab market is segmented based on indications, with rheumatoid arthritis being the dominant segment. This is due to the high global prevalence of rheumatoid arthritis and the growing acceptance of golimumab as a preferred therapy option because of its effectiveness and safety profile[1][3].

Distribution Channels

The market is also segmented by distribution channels, including acute hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies dominate this segment due to the presence of experienced healthcare experts who can provide personalized drug and dose recommendations[1].

Regional Growth Dynamics

• North America: This region is expected to dominate the global golimumab market with the largest revenue share. The dominance is attributed to the increasing prevalence of autoimmune disorders, the need for biologics, advanced healthcare infrastructure, favorable reimbursement policies, and the presence of leading market players[1][3].
• Europe: The European market is characterized by a high demand for biological drugs and a rising prevalence of autoimmune diseases. The growing geriatric population and increasing healthcare expenditure also contribute to market growth in this region[3].
• Asia Pacific: This region is expected to grow significantly due to the increasing prevalence of autoimmune diseases, the adoption of biological therapies, and improving healthcare infrastructure in emerging economies[3].

Competitive Landscape

The golimumab market is highly competitive, with several key players dominating the market share. These include:

• Janssen Biotech, Inc.
• Merck & Co., Inc.
• Pfizer, Inc.
• Teva Pharmaceuticals
• Sanofi Aventis Pharma India
• Zydus Cadila Healthcare Ltd.
• Viatris Inc.[1][3].

The competition is intensified by the development of biosimilars and the entry of new players, leading to price wars and a focus on innovation and differentiation strategies among companies.

Financial Trajectory

Revenue Growth

The global golimumab market is expected to see significant revenue growth, driven by the increasing demand for biologic treatments and the expanding patient base. The market's revenue is projected to grow at a CAGR of 5.73% from 2023 to 2031[1][3].

Investment and Partnerships

Companies in the golimumab market are increasingly involved in competitive strategies such as collaborations and partnerships to introduce new and innovative techniques. For example, agreements like the one between Lupin Limited and DKSH to commercialize biosimilars in the Philippines highlight the trend of expanding geographic reach and developing new products[3].

Challenges

Despite the positive growth trajectory, the high cost of golimumab and the availability of alternative treatments, including biosimilars, pose significant challenges to the market. These factors limit the accessibility of golimumab to patients and impact its overall growth[3].

Recent Developments

The market is witnessing several recent developments, including the expiration of patents for some key players and the introduction of new biosimilars. These developments are expected to further intensify competition and drive innovation in the market. Companies are focusing on developing innovative products and strategies to maintain their market position[3].

Key Takeaways

• The global golimumab market is expected to grow at a CAGR of 5.73% from 2023 to 2031.
• The increasing prevalence of autoimmune diseases and rising demand for biologics are key drivers of market growth.
• North America is expected to dominate the market with the largest revenue share.
• The market is highly competitive, with major players focusing on innovation and differentiation strategies.
• High costs and the availability of biosimilars are significant challenges to market growth.

FAQs

What is the projected CAGR of the global golimumab market from 2023 to 2031?

The global golimumab market is expected to register a CAGR of 5.73% from 2023 to 2031[1][3].

Which region is expected to dominate the global golimumab market?

North America is expected to dominate the global golimumab market with the largest revenue share due to the increasing prevalence of autoimmune disorders and favorable healthcare infrastructure[1][3].

What are the main indications for golimumab?

Golimumab is primarily used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis[1][3].

Who are the key players in the golimumab market?

Key players include Janssen Biotech, Inc., Merck & Co., Inc., Pfizer, Inc., Teva Pharmaceuticals, and others[1][3].

What are the major challenges facing the golimumab market?

The high cost of golimumab and the availability of alternative treatments, including biosimilars, are significant challenges to the market[3].

Sources

1. Golimumab Market Set to Register a CAGR of 5.73% During 2023 – 2031 – Growth Plus Reports. Globenewswire, April 28, 2023.
2. Johnson & Johnson Reports 2018 First-Quarter Results. Johnson & Johnson, April 17, 2018.
3. Golimumab Market Forecast 2031 - CAGR of 5.73% | GPR. Growth Plus Reports, April 27, 2023.
4. Innovative Medicine Presentation. Johnson & Johnson, December 19, 2023.
5. Global Golimumab(Simponi) Market Size, Scope And Forecast Report. Market Research Intellect.