Market Dynamics and Financial Trajectory for the Biologic Drug: Tubersol
Introduction
Tubersol, a purified-protein derivative (PPD) tuberculin skin test (TST) antigen solution, is a crucial diagnostic tool in the fight against tuberculosis (TB). Produced by Sanofi Pasteur Limited, it is one of the two FDA-approved PPD TST antigen solutions, the other being Aplisol by JHP Pharmaceuticals, LLC. This article delves into the market dynamics and financial trajectory of Tubersol, highlighting its production challenges, market impact, and financial implications.
Production and Supply Chain Issues
Tubersol faced significant production challenges in recent years. From late 2012 through April 2013, Tubersol was out of production, leading to a shortage that affected TB control programs across the United States[1][4].
Impact of Production Halt
The halt in production resulted in increased demand for Aplisol, the alternative PPD TST antigen solution. This surge in demand led to shortages of Aplisol as well, exacerbating the overall shortage of PPD TST antigen solutions. By May 2013, Tubersol production resumed, but supplies were not fully restored until early June 2013[1][4].
Allocation and Distribution
To manage the shortage, Sanofi Pasteur implemented an allocation system for the 10-dose and 50-dose presentations of Tubersol. This system, based on historical purchasing practices, ensured that customers received a limited supply to meet critical needs. However, this allocation system also led to temporary instability in supplies, particularly after a compensatory surge in testing following the period of shortage[1][4].
Market Impact
The shortages of Tubersol and Aplisol had far-reaching consequences for TB control programs.
Health Department Shortages
In mid-August 2013, officials in 29 of 52 U.S. jurisdictions reported shortages of at least one PPD TST antigen solution in health departments, disrupting routine activities. These jurisdictions accounted for 93% of the TB cases reported in the United States in 2012[1].
Non-Public Health Sector
Healthcare providers in the non-public health sector also reported shortages, affecting a wide range of testing practices, including the screening of matriculating students. Some jurisdictions preemptively suspended routine testing practices to mitigate the impact of the shortages[1].
Alternative Testing Methods
In response to the shortages, some jurisdictions increased the use of Interferon-Gamma Release Assays (IGRAs) as an alternative to TSTs. However, switching between TSTs and IGRAs posed challenges due to inherent interproduct and intermethod variability, making it difficult to interpret serial changes in test results[1].
Financial Implications
While the financial reports of Sanofi Pasteur do not specifically detail the revenue impact of Tubersol shortages, several broader financial trends and market dynamics are relevant.
Sanofi Pasteur's Financial Performance
Sanofi Pasteur, as part of Sanofi, has seen significant growth in its vaccine segment. For instance, in 2020, Sanofi's vaccine sales crossed the €2 billion mark, with a 38% increase driven by strong influenza vaccine sales[2].
Market Growth for Biologic Therapeutic Drugs
The global market for biologic therapeutic drugs, which includes vaccines and diagnostic tools like Tubersol, is expected to grow significantly. From $452.9 billion in 2023, the market is projected to reach $823.4 billion by 2028, with a CAGR of 12.7% during the forecast period[3].
Competitive Environment
The market for biologic therapeutic drugs is highly competitive, with several key players and emerging technologies.
Market Segments
The biologics market is segmented into monoclonal antibodies, therapeutic proteins, and vaccines. Tubersol, as a diagnostic tool, falls under the broader category of vaccines and diagnostic agents[3].
Technological Advancements
Advancements in manufacturing technologies and the pursuit of biosimilars are driving growth in the biologics market. However, these advancements also pose competitive challenges for established products like Tubersol[3].
Regulatory and Public Health Recommendations
To address the shortages of PPD TST antigen solutions, the CDC recommended several strategies:
Substitute IGRA Blood Tests
One approach is to substitute IGRA blood tests for TSTs, especially for priority indications determined by public health authorities[1].
Allocate TST Supplies
Another strategy involves allocating TST supplies to priority indications, ensuring that critical testing needs are met during periods of shortage[1].
Substitute Aplisol for Tubersol
When possible, substituting Aplisol for Tubersol can help mitigate shortages, provided Aplisol is available[1].
Key Takeaways
- Production Challenges: Tubersol faced significant production halts, leading to shortages that impacted TB control programs.
- Market Impact: Shortages affected health departments and non-public health sectors, prompting the use of alternative testing methods like IGRAs.
- Financial Implications: While specific financial data for Tubersol is not detailed, the broader vaccine segment of Sanofi Pasteur has seen significant growth.
- Market Growth: The global biologic therapeutic drugs market, including vaccines and diagnostic tools, is expected to grow substantially.
- Competitive Environment: The market is competitive, driven by technological advancements and the pursuit of biosimilars.
FAQs
What are the primary causes of Tubersol shortages?
The primary causes include production halts and increased demand for alternative products like Aplisol during periods of shortage.
How did the CDC recommend addressing the shortages of PPD TST antigen solutions?
The CDC recommended substituting IGRA blood tests for TSTs, allocating TST supplies to priority indications, and substituting Aplisol for Tubersol when possible.
What is the expected growth rate of the global biologic therapeutic drugs market?
The global biologic therapeutic drugs market is expected to grow at a CAGR of 12.7% from 2023 to 2028.
How did the shortages of Tubersol affect TB control programs?
The shortages disrupted routine activities in health departments and prompted the suspension of some testing practices, affecting the overall TB control efforts.
What alternative testing methods were used during the Tubersol shortages?
IGRAs were increasingly used as an alternative to TSTs during the periods of shortage.
Sources
- CDC: Extent and Effects of Recurrent Shortages of Purified-Protein Derivative Tuberculin Skin Test Antigen Solutions — United States, 2013.
- Sanofi: Q4 and Full Year 2020 Results.
- BCC Research: Biologic Therapeutic Drugs: Technologies and Global Markets.
- PubMed: Extent and effects of recurrent shortages of purified-protein derivative tuberculin skin test antigen solutions.
