Tuberculin, purified protein derivative - Biologic Drug Details

Summary for tuberculin, purified protein derivative

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	3

Pharmacology for tuberculin, purified protein derivative

Physiological Effect	Cell-mediated Immunity
Established Pharmacologic Class	Skin Test Antigen Tuberculosis Skin Test
Chemical Structure	Antigens, Bacterial

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 tuberculin, purified protein derivative Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tuberculin, purified protein derivative Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tuberculin, purified protein derivative Derived from Patent Text Search

No patents found based on company disclosures

Tuberculin, purified protein derivative Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Tuberculin Purified Protein Derivative

Introduction

Tuberculin purified protein derivative (PPD) is a crucial biologic drug used in the diagnosis of tuberculosis (TB) through the Mantoux test. This article delves into the market dynamics and financial trajectory of this essential diagnostic tool.

Global Market Size and Growth

The global Tuberculin Market is projected to experience significant growth over the coming years. As of 2023, the market was valued at USD 285 million and is expected to reach USD 467.2 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period from 2024 to 2033[1].

Market Segmentation

Type of Tuberculin

The market is dominated by Standard PPD Tuberculin, which accounts for 65% of the market share due to its proven efficacy and widespread use in TB screening[1].

Strength Analysis

The 5 TU (Tuberculin Units) formulation is the most prevalent, capturing 70% of the market. This formulation is preferred for its optimal balance of sensitivity and specificity[1].

Application Analysis

The Tuberculin Skin Test (TST) is the primary application, holding 80% of the market. This test is essential for global TB screening programs[1].

End User Analysis

Hospitals are the primary end-users, accounting for 60% of the market due to their central role in TB diagnosis and treatment[1].

Regional Market Dynamics

Dominant Region

The Asia Pacific region dominates the market with a 45% share, driven by a large patient base and growing healthcare infrastructure. India, in particular, accounts for a significant portion of this market due to its high incidence of TB, with 2.8 million cases reported in 2022[1].

High Growth Region

North America holds approximately 25% of the market share, driven by advanced healthcare systems and standardized TB screening protocols. Europe accounts for about 20% of the market, supported by strong public health policies and government funding for TB control[1].

Innovation and Growth Opportunities

New Formulations and Delivery Methods

Innovation in tuberculin formulations and delivery methods is a key growth driver. Researchers are developing more stable formulations, such as freeze-dried tuberculin, which can improve transportation, storage, and handling. New delivery methods, including intradermal and dry powder formulations, aim to simplify administration and enhance user experience[1].

Public Health Impact

Tuberculin PPD is critical in global TB control strategies. According to the World Health Organization (WHO), TB remains a significant public health issue, with 1.5 million deaths and 10 million new cases reported in 2020. The diagnostic accuracy provided by tuberculin PPD is essential for early diagnosis and therapeutic intervention, thereby reducing the transmission and mortality rates associated with TB[3].

Financial Trajectory

Market Value

The financial trajectory of the Tuberculin Market is robust, with a projected growth from USD 285 million in 2023 to USD 467.2 million by 2033. This growth is driven by increasing demand for effective diagnostic solutions, particularly in high-burden regions such as Asia and Africa[1].

Investment and Expansion

Key players in the industry are expected to focus on innovation, scaling up production, and strategic expansions in high-burden regions. These efforts are likely to be supported by governmental initiatives and investments in healthcare infrastructure, further propelling market growth[1].

Competitive Landscape

The market is characterized by a few key players, including manufacturers of branded tuberculin products like Aplisol and Tubersol. These companies are involved in continuous innovation to enhance diagnostic accuracy and adapt to evolving health standards[2].

Regulatory and Standardization

Tuberculin PPD is included in the WHO's List of Essential Medicines, underscoring its importance in public health. Each batch of tuberculin PPD is tested for potency in comparison with the US Standard Tuberculin PPD-S to ensure consistency and efficacy[2][5].

Challenges and Opportunities

Challenges

Despite the growth prospects, the market faces challenges such as the need for consistent supply chains, especially in regions with high TB prevalence. Additionally, the development of new diagnostic technologies could potentially disrupt the market if they offer superior accuracy or convenience.

Opportunities

The increasing awareness about TB prevention and the growing healthcare infrastructure in developing countries present significant opportunities for market growth. Innovations in tuberculin formulations and delivery methods can attract a broader range of healthcare settings, contributing to market expansion[1].

Key Takeaways

• The global Tuberculin Market is expected to grow from USD 285 million in 2023 to USD 467.2 million by 2033 at a CAGR of 5.2%.
• Standard PPD Tuberculin and 5 TU formulations dominate the market.
• Hospitals are the primary end-users, and the Asia Pacific region leads in market share.
• Innovation in formulations and delivery methods is a key growth driver.
• Public health initiatives and growing healthcare infrastructure support market growth.

FAQs

What is the primary use of tuberculin purified protein derivative?

Tuberculin purified protein derivative is primarily used in the Mantoux test for the diagnosis of tuberculosis (TB)[2].

Which region dominates the global Tuberculin Market?

The Asia Pacific region dominates the global Tuberculin Market with a 45% market share[1].

What are the key growth drivers for the Tuberculin Market?

Key growth drivers include innovation in tuberculin formulations and delivery methods, increasing demand in high-burden regions, and advancements in healthcare infrastructure[1].

What is the expected market value of the global Tuberculin Market by 2033?

The global Tuberculin Market is expected to reach USD 467.2 million by 2033[1].

How does the Tuberculin Market contribute to public health?

The Tuberculin Market contributes significantly to public health by providing essential diagnostic tools for TB screening and monitoring, thereby aiding in early diagnosis and reducing transmission and mortality rates associated with TB[1][3].

Sources

1. MarketResearch.biz: Tuberculin Market Size, Share, Growth | CAGR of 5.2%
2. DrugBank: Tuberculin purified protein derivative - DrugBank
3. Mordor Intelligence: BCG Vaccine Market - Size, Share & Growth Trends
4. FDA: Tuberculin Purified Protein Derivative (Mantoux) - TUBERSOL - FDA