Calfactant - Biologic Drug Details

Summary for calfactant

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for calfactant

Recent Clinical Trials for calfactant

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
NorthShore University HealthSystem	Phase 4
VENTO GIOVANNI	Phase 2
AHRM	Phase 3

See all calfactant clinical trials

Pharmacology for calfactant

Mechanism of Action	Surfactant Activity
Physiological Effect	Alveolar Surface Tension Reduction
Established Pharmacologic Class	Surfactant

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 calfactant Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Calfactant

Overview of Calfactant

Calfactant, also known as bovactant or calf lung surfactant extract (CLSE), is a biologic drug used primarily to treat respiratory distress syndrome (RDS) in premature infants. It is derived from calf lungs and works by enhancing cell membrane permeability, thereby improving lung function.

Market Size and Growth

The global pulmonary surfactant market, which includes calfactant, was valued at approximately USD 598.7 million in 2022[1][4].

Compound Annual Growth Rate (CAGR)

The pulmonary surfactant market, including calfactant, is expected to grow at a CAGR of 4.98% from 2023 to 2030[1]. This growth is driven by increasing demand for effective treatments for respiratory distress syndrome and other respiratory infections.

Market Segmentation

By Drug Type

Calfactant is part of the animal-derived surfactants segment, which dominates the market due to its higher benefits and lower complications compared to synthetic surfactants. The Poractant alfa segment, however, currently holds the largest market share within the pulmonary surfactant market[1].

By Application

The primary application of calfactant is in hospitals, where it is used to treat respiratory distress syndrome in newborns. Hospital pharmacies hold the largest revenue share in the distribution of pulmonary surfactants due to reimbursement advantages and cost-effectiveness[1].

By Indications

Calfactant is primarily indicated for the treatment of respiratory infections, which is the dominant segment driving the market growth. Other indications include obstructive lung diseases and chronic lung disease of prematurity[1].

Distribution Channels

Calfactant is predominantly distributed through hospital pharmacies, which account for the largest revenue share. This is due to the critical nature of the treatment and the need for immediate access in hospital settings[1].

Key Players and Competition

The pulmonary surfactant market, including calfactant, is competitive with several key players such as Boehringer Ingelheim, AbbVie, Lyomark Pharma, and ONY Biotech. ONY Biotech, in particular, has been involved in the development and distribution of calfactant[1].

Regulatory and Approval Status

Calfactant was first approved in the US on July 1, 1998, and it holds an orphan drug designation. This status provides certain regulatory benefits and market exclusivity, which can influence its market dynamics[2].

Market Drivers

Increasing Prevalence of Respiratory Infections

The rising prevalence of respiratory infections, such as Respiratory Syncytial Virus (RSV), is a significant driver for the pulmonary surfactant market. For instance, RSV leads to substantial hospitalizations and deaths among vulnerable populations, increasing the demand for effective treatments like calfactant[4].

Research and Development

The COVID-19 pandemic has accelerated research and development in the pulmonary surfactant market. Studies like the Phase 2 trial by Windtree Therapeutics on lucinactant for COVID-19 associated acute respiratory distress syndrome (ARDS) highlight the ongoing efforts to expand the use of surfactants in critical respiratory conditions[4].

Market Restraints

Cost and Accessibility

Despite its benefits, calfactant is a costly treatment, which can limit its accessibility in some regions. The high cost of biologic drugs and the need for specialized care can act as restraints to market growth[4].

Competition from Biosimilars

As the biologics market evolves, the potential for biosimilars to enter the market could impact the sales of branded biologic drugs like calfactant. However, given the complex nature of biologics, the transition to biosimilars is slower compared to small molecule generics[3].

Financial Trajectory

Revenue Growth

The global pulmonary surfactant market, including calfactant, is expected to grow steadily over the forecast period from 2023 to 2030. With a CAGR of 4.98%, the market is projected to increase significantly, driven by the increasing demand for effective treatments for respiratory conditions[1].

Regional Analysis

North America holds a significant share of the global pulmonary surfactant market, driven by the high prevalence of respiratory infections in the region. The market in this region is expected to continue growing due to advanced healthcare infrastructure and higher adoption rates of biologic treatments[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pulmonary surfactant market. On one hand, it has accelerated research and development, particularly in treating COVID-19 associated respiratory distress. On the other hand, it has posed challenges in terms of supply chain disruptions and changes in healthcare priorities[4].

Key Takeaways

• Market Growth: The pulmonary surfactant market, including calfactant, is expected to grow at a CAGR of 4.98% from 2023 to 2030.
• Dominant Segment: Animal-derived surfactants, including calfactant, dominate the market due to higher benefits and lower complications.
• Distribution: Hospital pharmacies are the primary distribution channel due to reimbursement advantages and cost-effectiveness.
• Regulatory Status: Calfactant is approved and holds an orphan drug designation, providing market exclusivity benefits.
• Market Drivers: Increasing prevalence of respiratory infections and ongoing research and development are key drivers.
• Market Restraints: High cost and potential competition from biosimilars are significant restraints.

FAQs

What is the current market size of the global pulmonary surfactant market?

The global pulmonary surfactant market size was approximately USD 598.7 million in 2022[1].

What is the expected CAGR for the pulmonary surfactant market from 2023 to 2030?

The pulmonary surfactant market is expected to grow at a CAGR of 4.98% from 2023 to 2030[1].

Which segment dominates the pulmonary surfactant market by drug type?

The animal-derived surfactants segment, which includes calfactant, dominates the market due to higher benefits and lower complications[1].

What are the primary indications for calfactant?

Calfactant is primarily indicated for the treatment of respiratory infections, including respiratory distress syndrome in newborns[1].

How has the COVID-19 pandemic impacted the pulmonary surfactant market?

The COVID-19 pandemic has accelerated research and development in the pulmonary surfactant market, particularly in treating COVID-19 associated respiratory distress, but also posed challenges in supply chain and healthcare priorities[4].

Which distribution channel holds the largest revenue share for pulmonary surfactants?

Hospital pharmacies hold the largest revenue share due to reimbursement advantages and cost-effectiveness[1].

Sources

1. Cognitive Market Research: Global Pulmonary Surfactant Market Report 2024.
2. Patsnap Synapse: Calfactant - Drug Targets, Indications, Patents.
3. FTC: Biologics Market Dynamics: Setting the Stage for Biosimilars.
4. Coherent Market Insights: Pulmonary Surfactant Market Size, Trends and Forecast to 2030.

Last updated: 2024-12-16