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Last Updated: December 23, 2024

TICE BCG Drug Profile


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Summary for Tradename: TICE BCG
High Confidence Patents:0
Applicants:1
BLAs:1
Drug Prices: Drug price information for TICE BCG
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 TICE BCG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

TICE BCG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: TICE BCG

Introduction

The TICE BCG vaccine, a biologic drug used primarily for the prevention of tuberculosis (TB) and the treatment of certain forms of bladder cancer, is a critical component in global health initiatives. Here, we will delve into the market dynamics and financial trajectory of this vaccine.

Market Overview

Global Demand and Supply

The demand for BCG vaccines, including TICE BCG, is significant, particularly in regions where TB is prevalent. UNICEF procures BCG vaccines for 72-77 countries annually, with two countries in Asia and Africa accounting for 36% of the total doses procured over the last decade[4].

Market Size and Growth

The global therapeutic BCG vaccine market was valued at USD 45.60 million in 2022 and is expected to grow at a CAGR of 3.30% through 2028. This growth is driven by increasing demand, especially in low- and middle-income countries where TB is a major public health concern[1].

Pricing Trends

Cost and Affordability

The BCG vaccine is relatively affordable compared to other traditional vaccines. The weighted average price (WAP) for BCG vaccine supply through UNICEF is expected to increase from $0.144 in 2023 to $0.180 in 2024, and remain stable over the next five years. This price increase is justified by manufacturers due to rising direct and indirect costs[4].

Manufacturing and Supply Chain

Production Challenges

Merck, the sole supplier of TICE BCG in many countries since 2012, has faced significant production challenges. Despite increasing production by over 100% and reducing lead times, the demand for TICE BCG has outpaced supply. To address this, Merck implemented a proportional allocation system to distribute the medicine across countries based on historical average ordered quantities[5].

Manufacturing Capacity

Merck operates at full manufacturing capacity, producing approximately 600,000 to 870,000 vials annually. However, occasional unanticipated issues in the complex manufacturing process have led to supply disruptions[5].

Financial Trajectory

Revenue and Growth

The financial trajectory of TICE BCG is closely tied to the overall market for BCG vaccines. With a projected market size of $153.6 million in 2024 and expected growth to $210 million by 2030, the revenue from TICE BCG is likely to increase, albeit with challenges in meeting demand[4].

Cost Optimization and Efficiency

Given the low-growth economic environment, companies like Merck must optimize costs and productivity to maintain profitability. This involves efficient use of free cash flow and leveraging technological advancements, such as AI, to streamline operations and improve supply chain management[2].

Competitive Landscape

Market Dominance

Merck's position as the sole supplier of TICE BCG in many countries gives it a significant market advantage. However, this also means that the company bears the full brunt of supply chain pressures and demand fluctuations[5].

Competitive Intensity

In a low-growth economy, competitive intensity increases as companies vie for market share. Merck must navigate these challenges while maintaining historical levels of revenue growth, which may only be achievable by winning market share and optimizing operations[2].

Regulatory and Health Policy Impact

Global Health Initiatives

The demand for BCG vaccines is heavily influenced by global health initiatives and policies. For instance, UNICEF's procurement strategies and WHO guidelines play a crucial role in shaping the market dynamics of BCG vaccines[4].

Pricing and Access

Regulatory bodies and health organizations often negotiate prices to ensure affordability and access to vaccines. The weighted average price increase for BCG vaccines, for example, is a result of negotiations that balance manufacturer costs with public health needs[4].

Technological Advancements

Role of AI and Technology

The integration of AI and other technological advancements can significantly impact the production and distribution of TICE BCG. Companies like Boston Consulting Group highlight the importance of leveraging AI to optimize operations and drive growth in a complex economic environment[3].

Sustainability and Social Impact

Long-Term Value Creation

Companies involved in the production and distribution of TICE BCG must focus on long-term value creation that benefits all stakeholders. This includes ensuring sustainable supply chains, optimizing costs, and contributing positively to societal health outcomes[3].

Key Takeaways

  • The global therapeutic BCG vaccine market is expected to grow at a CAGR of 3.30% through 2028.
  • TICE BCG faces significant production challenges despite increased manufacturing capacity.
  • Pricing trends are influenced by rising costs and global health initiatives.
  • Competitive intensity is high in a low-growth economy, necessitating efficient operations and market share gains.
  • Technological advancements, such as AI, are crucial for optimizing production and distribution.
  • Long-term value creation must balance financial growth with societal health benefits.

FAQs

What is the current market size of the therapeutic BCG vaccine market?

The global therapeutic BCG vaccine market was valued at USD 45.60 million in 2022[1].

Who is the primary supplier of TICE BCG?

Merck is the sole supplier of TICE BCG in many countries since 2012[5].

How is the demand for BCG vaccines expected to change in the coming years?

The demand for BCG vaccines is expected to reach 327 million doses in 2024 and remain relatively stable with a linear increase up to 340 million doses by 2030[4].

What are the main challenges in the production of TICE BCG?

The main challenges include meeting the high demand, managing complex manufacturing processes, and occasional unanticipated supply disruptions[5].

How does the integration of AI impact the production and distribution of TICE BCG?

The integration of AI can help optimize operations, streamline supply chains, and drive growth by improving efficiency and reducing costs[3].

Sources

  1. TechSci Research: Therapeutic BCG Vaccine Market By Size, Share and Forecast 2028
  2. BCG: Threading the Needle: Value Creation in a Low-Growth Economy
  3. BCG: BCG Delivers 20th Consecutive Year of Growth
  4. UNICEF: Bacillus Calmette-Guérin (BCG) Market and Supply Update - October 2024
  5. Merck: Merck Remains Committed to Producing TICE® BCG for the Treatment of Certain Forms of Bladder Cancer

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