TUBERSOL Drug Profile

Summary for Tradename: TUBERSOL

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for TUBERSOL

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 TUBERSOL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TUBERSOL Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi Pasteur Limited	TUBERSOL	tuberculin, purified protein derivative	Injection	103941		2013-09-22	Patent claims search
Sanofi Pasteur Limited	TUBERSOL	tuberculin, purified protein derivative	Injection	103941		2014-04-20	Patent claims search
Sanofi Pasteur Limited	TUBERSOL	tuberculin, purified protein derivative	Injection	103941		2017-02-24	Patent claims search
Sanofi Pasteur Limited	TUBERSOL	tuberculin, purified protein derivative	Injection	103941		2026-01-06	Patent claims search
Sanofi Pasteur Limited	TUBERSOL	tuberculin, purified protein derivative	Injection	103941		2028-04-17	Patent claims search

Market Dynamics and Financial Trajectory for TUBERSOL

Last updated: April 12, 2026

---

What is TUBERSOL and its market position?

TUBERSOL is the brand name for the purified protein derivative (PPD) used in tuberculosis (TB) testing, primarily in skin tests like the Mantoux test. It is manufactured by Eli Lilly and Company. Its primary use is in TB detection rather than treatment, positioning it within the diagnostic segment of biologics.

Market structure and demand drivers

Market size:
The global TB diagnostics market was valued at approximately $1.3 billion in 2022 and is projected to reach $2.4 billion by 2030, with a compound annual growth rate (CAGR) of roughly 8.4% [1].

Key demand factors:

• TB prevalence: Approximately 10 million new cases globally in 2021, according to WHO [2].
• Public health initiatives: Governments in high-burden countries continue large-scale screening programs.
• Diagnostic policy shifts: Moves toward more rapid tests impact demand for traditional PPD skin tests.
• Competition from Interferon-Gamma Release Assays (IGRAs): Tests like QuantiFERON-TB Gold reduce reliance on skin tests in developed countries.

Market share and competitors:

• Major players include the CDC-approved QuantiFERON-TB Gold (Qiagen), T-SPOT.TB (Oxford Immunotec), and local generic manufacturers. TUBERSOL holds a significant share in developing nations, owing to its long-standing regulatory approval and cost-effectiveness.

Regulatory and policy factors

Regulatory environment:

• TUBERSOL has received approval from agencies including the FDA and WHO prequalification.
• Updated guidelines favor IGRAs in certain scenarios but maintain skin testing in resource-limited settings [3].

Government procurement:

• Frequent procurement by agencies such as the CDC, WHO, and national ministries of health sustains steady revenues.
• International organizations' backing favors continued use in low-income markets.

Financial trajectory analysis

Revenue trends:

• TUBERSOL’s revenue is primarily driven by volume sales rather than price increases.
• Estimated annual sales in 2022 approximate $150 million, with forecasts indicating a modest decline of 2-3% annually in high-income markets due to competition from IGRAs [4].

Pricing landscape:

• Price per test kit varies between $1.50 and $3 in developing markets, higher in developed regions.
• Price competition persists due to the proliferation of generic options and economies of scale.

Profitability outlook:

• Margins are moderate, constrained by pricing pressures and procurement volume variability.
• Cost reductions in manufacturing and increased reliance on generic manufacturing in certain markets could improve profit margins over time.

Future growth potential and risks

Growth opportunities:

• Expansion into emerging markets with increasing TB burden.
• Integration with digital health platforms for test result management.

Risks:

• Increased adoption of IGRAs, especially in developed countries, threatens volume stability.
• Regulatory delays or reforms could impact procurement and sales cycles.
• Market consolidation among competitors, leading to pricing pressures.

Impact of technological innovations:

• Advances in molecular diagnostics could further displace PPD-based tests.
• Potential development of combined testing platforms may reduce demand for traditional skin tests like TUBERSOL.

Summary of market and financial outlook

Metric	2022	2025 (forecast)	2030 (forecast)
Market size	$1.3 billion	~$1.8 billion	$2.4 billion
TUBERSOL revenue (est.)	~$150 million	~$120 million	~$90 million
CAGR of market	8.4%	8.4%	8.4%
Decline in TUBERSOL revenue	-	2-3% annually	2-3% annually

---

Key Takeaways

• TUBERSOL maintains a stable yet declining position in the global TB diagnostics market, primarily driven by volume sales and demand in resource-limited settings.
• Market growth is influenced by TB prevalence, regulatory shifts, and competition from IGRAs.
• Revenue projections indicate gradual decline, with margins limited by competitive pricing and innovation threats.
• Opportunities exist in emerging markets, but technological shifts pose long-term risks.

---

FAQs

1. What factors are likely to impact TUBERSOL’s market share?
The adoption of IGRAs and technological advances in TB diagnostics reduce reliance on tuberculin skin testing, threatening market share in certain regions.

2. How does government procurement influence TUBERSOL's revenues?
Government procurement in high-burden countries provides steady demand, especially in the public health sector, supporting consistent revenues.

3. Will TUBERSOL’s revenue increase or decline in the coming years?
The revenue is expected to decline gradually due to competitive pressures, with potential stabilization in low-income markets where skin tests remain sole options.

4. How are regulatory changes affecting TUBERSOL?
While well-established, any shifts favoring new diagnostic methods or requiring additional approvals could impact sales volumes and market penetration.

5. Are there any recent innovations that threaten TUBERSOL’s dominance?
Yes, molecular and interferon-gamma release assays (IGRAs) are replacing skin tests in many settings, reducing the use of TUBERSOL.

---

References

[1] MarketsandMarkets. (2022). Tuberculosis diagnostics market size.

[2] World Health Organization. (2022). Global TB report.

[3] Centers for Disease Control and Prevention. (2021). Updated guidelines on TB testing.

[4] IBISWorld. (2022). Medical diagnostic testing services in the US.