23/06/2025
why biologic medication is expensive?
1. Complex Development Process
Long R&D timelines: Biologics can take 10–15 years to develop.
High failure rates: Most biologics fail during clinical trials. Only a small fraction reach the market, and the cost of failed drugs is factored into the price of successful ones.
Expensive clinical trials: Trials for biologics are typically large, lengthy, and expensive, costing hundreds of millions to over $1 billion.
2. Manufacturing Challenges
Living cells are involved: Biologics are made using living organisms (like bacteria, yeast, or mammalian cells), unlike conventional drugs made from chemicals.
Complex and sensitive processes: Production must happen in sterile, highly controlled environments, often using bioreactors and purification systems.
Batch variability: Even slight changes in conditions can affect the outcome, making consistent production harder and more expensive.
3. Strict Regulation and Quality Control
Regulatory agencies like the FDA or EMA require extensive testing and monitoring for safety, purity, and efficacy.
Quality control is continuous and rigorous, adding to operational costs.
4. Limited Competition
Biologics are protected by strong patent laws and market exclusivity periods (e.g., 12 years in the U.S.).
Even when patents expire, biosimilars (generic versions of biologics) are harder and more expensive to develop and get approved due to the complexity of replicating biologics.
5. Smaller Patient Populations
Some biologics treat rare or specialized conditions (e.g., autoimmune diseases, certain cancers), so the development costs are spread over fewer patients.
6. High Commercial Demand
For diseases like rheumatoid arthritis, Crohn's disease, or cancer, biologics can significantly improve outcomes—leading to strong demand and pricing power.
This is AI reply which is somewhat logic , but my more logic answer is the the SUPER GREEDY COMPANIES .
Sorry but this is the truth
