Allogeneic cultured keratinocytes and fibroblasts in bovine collagen - Biologic Drug Details

Summary for allogeneic cultured keratinocytes and fibroblasts in bovine collagen

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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1) High Certainty: US Patents for allogeneic cultured keratinocytes and fibroblasts in bovine collagen Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for allogeneic cultured keratinocytes and fibroblasts in bovine collagen Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for allogeneic cultured keratinocytes and fibroblasts in bovine collagen Derived from Patent Text Search

No patents found based on company disclosures

Allogeneic cultured keratinocytes and fibroblasts in bovine collagen Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen

Introduction

Allogeneic cultured keratinocytes and fibroblasts in bovine collagen, marketed under the brand name Gintuit, is a cellular therapy used for the treatment of mucogingival conditions. This product has been approved by the US FDA and is utilized in the field of oral and dental health. Here, we will delve into the market dynamics and financial trajectory of this biologic drug.

Market Overview

Product Description

Gintuit is a cellular sheet consisting of two layers: an upper layer of living human keratinocytes and a lower layer of bovine-derived collagen, human extracellular matrix proteins, and living human dermal fibroblasts. It is applied topically to a surgically created vascular wound bed to treat mucogingival conditions in adults[2][4][5].

Clinical Indications

Gintuit is specifically indicated for the treatment of mucogingival conditions, such as insufficient gingival tissue. Clinical trials have shown that it can increase gingival tissue by at least 2 mm in a significant percentage of patients[2][4].

Market Segmentation

Target Market

The primary target market for Gintuit includes adults with mucogingival conditions, particularly those requiring surgical intervention to address insufficient gingival tissue. This market segment is niche but significant within the broader dental and oral health care industry[2][5].

Competitive Landscape

The market for tissue replacement and cellular therapies is growing, with various products available for different indications. Gintuit competes with other cellular and acellular dermal substitutes, but its unique composition and FDA approval set it apart in the treatment of mucogingival conditions[3].

Financial Performance

Approval and Launch

Gintuit was approved by the FDA in March 2012, marking a significant milestone in its commercialization. The approval was a result of successful clinical trials that demonstrated its efficacy and safety[2][4].

Revenue Stream

The revenue generated by Gintuit comes from its application in dental and oral surgical procedures. Given its niche market, the revenue is substantial but not as broad as more widely used medical products. The financial performance is influenced by the number of procedures performed, the cost of the product, and reimbursement policies from healthcare providers and insurance companies.

Clinical Trials and R&D Expenses

The development and clinical trials of Gintuit involved significant investment from its originator, Organogenesis, Inc. While the product has been approved, ongoing clinical trials and research to expand its indications or improve its efficacy continue to incur costs. These expenses are balanced against the revenue generated from product sales[4].

Market Trends

Growing Demand for Cellular Therapies

There is an increasing demand for cellular therapies and tissue replacements due to their potential to offer more effective and less invasive treatments compared to traditional methods. This trend is expected to drive the growth of Gintuit and similar products in the market[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs like Gintuit. FDA approval and compliance with regulatory standards are essential for maintaining market presence and expanding indications. Any changes in regulatory policies can significantly impact the financial trajectory of the product[2][4].

Challenges and Opportunities

Challenges

• Competition: The presence of other tissue replacement products and the potential for new entrants in the market pose a challenge to Gintuit's market share.
• Cost and Reimbursement: The high cost of cellular therapies and the variability in reimbursement policies can limit accessibility and impact revenue.
• Side Effects and Safety: Common side effects such as sinusitis, nasopharyngitis, and local surgery site reactions need to be managed to maintain patient trust and compliance[5].

Opportunities

• Expanding Indications: There is potential to expand the indications of Gintuit beyond mucogingival conditions, which could significantly increase its market share.
• Technological Advancements: Improvements in cellular therapy technology could enhance the efficacy and safety of Gintuit, making it more competitive in the market.
• Global Market: Expanding into international markets could provide additional revenue streams and growth opportunities[2][4].

Financial Projections

Historical Performance

Since its approval in 2012, Gintuit has generated steady revenue, although specific financial figures are not publicly disclosed. The product's performance has been influenced by its clinical efficacy, market acceptance, and competition.

Future Outlook

The future financial trajectory of Gintuit is expected to be positive, driven by the growing demand for cellular therapies and the potential for expanded indications. However, this growth will be influenced by factors such as competition, regulatory changes, and advancements in technology.

Key Takeaways

• Niche Market: Gintuit operates in a niche market focused on mucogingival conditions, which provides a dedicated but limited customer base.
• Regulatory Approval: FDA approval is a critical factor in the market success of Gintuit.
• Clinical Efficacy: The product's ability to increase gingival tissue and its safety profile are key drivers of its market performance.
• Expanding Indications: Potential expansion into other indications could significantly boost revenue.
• Competitive Landscape: The market is competitive, with other cellular and acellular products available.

FAQs

What is Gintuit used for?

Gintuit is used for the topical treatment of mucogingival conditions in adults, particularly for insufficient gingival tissue.

When was Gintuit approved by the FDA?

Gintuit was approved by the FDA in March 2012.

What are the common side effects of Gintuit?

Common side effects include sinusitis, nasopharyngitis, respiratory tract infections, and local surgery site reactions.

How is Gintuit applied?

Gintuit is applied topically to a surgically created vascular wound bed.

Who developed Gintuit?

Gintuit was developed by Organogenesis, Inc.

References

1. DrugBank: Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen.
2. Wikipedia: Allogeneic cultured keratinocytes and fibroblasts in bovine collagen.
3. CMS: Skin Substitutes for Treating Chronic Wounds: Technical Brief.
4. Patsnap: Allogeneic cultured keratinocytes and fibroblasts in bovine collagen.
5. RxList: Allogeneic Cultured Keratinocytes/Fibroblasts in Bovine Collagen.