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Last Updated: January 6, 2025

SIMPONI Drug Profile


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Recent Clinical Trials for SIMPONI

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Janssen Scientific Affairs, LLCPhase 3
University of PennsylvaniaPhase 3
The First Hospital of Jilin UniversityPhase 1

See all SIMPONI clinical trials

Recent Litigation for SIMPONI

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
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 SIMPONI litigation

PTAB Litigation
PetitionerDate
2017-12-20

See all SIMPONI litigation

Pharmacology for SIMPONI
Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic ClassTumor 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
  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 SIMPONI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SIMPONI 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 ⤷  Subscribe Company disclosures
Janssen Biotech, Inc. SIMPONI ARIA golimumab Injection 125433 ⤷  Subscribe 2039-07-20 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

SIMPONI Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: SIMPONI (Golimumab)

Introduction to SIMPONI (Golimumab)

Golimumab, marketed under the brand name SIMPONI, is a monoclonal antibody used in the treatment of various autoimmune diseases, including rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis. This biologic medication has been a significant player in the pharmaceutical market, driven by several key factors.

Market Size and Forecast

The Golimumab (SIMPONI) market was valued at USD 20.1 billion in 2023 and is projected to reach USD 39.3 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% during the forecast period of 2024-2031[1][4].

Key Market Drivers

Several factors are driving the growth of the Golimumab market:

Increasing Prevalence of Autoimmune Diseases

The rising incidence of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is a major driver. As the global population ages, the demand for effective treatments for these conditions increases[1][4].

High Unmet Medical Need

Despite the availability of various treatments, a segment of patients does not respond well to conventional therapies, creating a strong demand for biologics like Golimumab[1].

Healthcare Infrastructure Improvements

Enhanced healthcare access in developing regions leads to increased diagnosis and treatment of autoimmune disorders, expanding the market reach for Golimumab[1].

Strategic Partnerships and Collaborations

Pharmaceutical companies engage in partnerships, collaborations, and acquisitions to enhance drug development and marketing capabilities, positively impacting the Golimumab market[1].

Insurance Coverage and Reimbursement

Favorable reimbursement policies and insurance coverage for biologic therapies improve access for patients, driving market growth[1].

Market Challenges

While the market for Golimumab is growing, it also faces several challenges:

High Cost of Treatment

The cost associated with Golimumab therapy can be prohibitively high for some patients and healthcare systems, leading to lower accessibility and adoption rates[1].

Stringent Regulatory Requirements

The rigorous approval process for biologic drugs can lead to delays in market entry for new competitors or indications, hindering market growth[1].

Competition from Biosimilars

As patents expire, the entry of biosimilars can significantly impact the market share of Golimumab, leading to price reductions and affecting profitability[1][3].

Safety and Side Effects

Concerns regarding the safety profile and potential side effects, including risks of infections and malignancies, can limit its use among certain patient populations[1].

Market Saturation

In certain therapeutic areas, the market might become saturated with alternative treatments and biologics, limiting growth opportunities for Golimumab[1].

Market Segmentation by Geography

The Golimumab market is segmented by geography, reflecting unique regional dynamics:

North America

Characterized by high market penetration due to advanced healthcare infrastructure, strong reimbursement policies, and increased awareness among healthcare professionals. This region is anticipated to drive significant revenue growth[1][4].

Europe

Features diverse healthcare systems and varying levels of access to medications across countries. Countries like Germany, France, and the UK show substantial adoption rates of Golimumab[1].

Asia-Pacific

Witnessing rapid economic development and improving healthcare facilities, this region represents a burgeoning market for Golimumab, particularly in densely populated countries like China and India[1].

Middle East and Africa

Characterized by growing awareness of biologics and an increase in healthcare expenditure, although market penetration remains comparatively low due to sporadic access to healthcare resources and medications[1].

Key Players in the Market

The major players in the Golimumab (SIMPONI) market include:

  • Johnson & Johnson
  • Merck & Co., Inc.
  • AbbVie Inc.
  • Pfizer Inc.
  • Amgen Inc.
  • Bristol-Myers Squibb Company
  • Eli Lilly and Company
  • Roche Holding AG
  • Novartis AG
  • Sanofi S.A.[1]

Financial Performance and Trends

Revenue Growth

The market's revenue growth is driven by the increasing prevalence of autoimmune diseases and the demand for biologic medications. The North American segment is expected to register the fastest revenue growth[1][4].

Impact of Biosimilars

The entry of biosimilars has been a significant factor in the financial trajectory of Golimumab. For instance, the market share of biologics like infliximab and adalimumab has decreased with the introduction of biosimilars, while Golimumab has seen an increase in its market share[3].

Public Awareness and Diagnosis

Increased public awareness about the diagnosis and treatment of autoimmune diseases has fueled the market's growth. Improved diagnosis and treatment options contribute to the revenue growth rate[4].

Clinical and Regulatory Landscape

Regulatory Requirements

The approval process for biologic drugs is rigorous and can lead to delays in market entry. This stringent regulatory environment is a challenge for new competitors and indications[1].

Clinical Guidelines

Changes in clinical guidelines can impact the market. For example, updates in treatment protocols can influence the adoption rates of biologics like Golimumab[1].

Public Health Impact

Patient Access

Favorable reimbursement policies and insurance coverage are crucial for improving patient access to biologic therapies like Golimumab. This access is vital for managing chronic autoimmune diseases effectively[1].

Safety Profile

Concerns about the safety profile of Golimumab, including potential side effects, are closely monitored. These concerns can affect its use, particularly among vulnerable patient populations[1].

Future Outlook

The future of the Golimumab market looks promising, driven by the increasing prevalence of autoimmune diseases and the need for effective biologic treatments. Here are some key points to consider:

Growing Demand

The demand for Golimumab is expected to grow as the global population ages and the incidence of autoimmune diseases increases[1][4].

Technological Advancements

Advancements in biotechnology and pharmaceutical research are likely to enhance the efficacy and safety of biologic medications like Golimumab[1].

Market Expansion

The market is expected to expand in regions with improving healthcare infrastructure and increasing awareness about autoimmune diseases[1].

Key Takeaways

  • Market Growth: The Golimumab market is projected to grow at a CAGR of 5% from 2024 to 2031.
  • Key Drivers: Increasing prevalence of autoimmune diseases, high unmet medical need, and improvements in healthcare infrastructure.
  • Challenges: High cost of treatment, stringent regulatory requirements, competition from biosimilars, and safety concerns.
  • Geographical Segmentation: North America, Europe, Asia-Pacific, Middle East, and Africa, with North America expected to register the fastest revenue growth.
  • Public Health Impact: Favorable reimbursement policies and insurance coverage are crucial for patient access.

FAQs

Q: What is the projected market size of Golimumab by 2031?

A: The Golimumab market is projected to reach USD 39.3 billion by 2031[1].

Q: What are the main drivers of the Golimumab market?

A: The main drivers include the increasing prevalence of autoimmune diseases, high unmet medical need, and improvements in healthcare infrastructure[1][4].

Q: Which region is expected to register the fastest revenue growth in the Golimumab market?

A: North America is expected to register the fastest revenue growth[1][4].

Q: How do biosimilars impact the Golimumab market?

A: The entry of biosimilars can lead to price reductions and affect the profitability of Golimumab, but Golimumab has seen an increase in its market share despite this competition[3].

Q: What are the major challenges facing the Golimumab market?

A: The major challenges include the high cost of treatment, stringent regulatory requirements, competition from biosimilars, and safety concerns[1].

Sources

  1. Verified Market Research: Golimumab (Simponi) Market Size, Share, Scope and Trends.
  2. Merck: Merck Announces Fourth-Quarter and Full-Year 2022 Financial Results.
  3. Keele Repository: Results of a budget impact analysis.
  4. GlobeNewswire: Golimumab Market Set to Register a CAGR of 5.73% During 2023 – 2031 – Growth Plus Reports.
  5. Merck: Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results.

More… ↓

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