The global breakthrough therapy designation market is anticipated to reach $144.6 billion by 2025, according to a new report by Grand View Research.
Breakthrough Therapy (BT) designation is granted to drugs that display substantial results in the treatment of life-threatening diseases in initial stages of the drug development process. Expedited regulatory process in North America and European Union regions is driving growth. Increase in the number of innovative molecules receiving the BT status, coupled with rise in the demand for orphan drugs as well as those for the treatment of cancer, is anticipated to boost the market over the forecast period.
The development time of BT therapy is 30.0% to 50.0% lesser than those without the designation. This significantly increases the net present value of investigational molecules, the report notes. Reduction in the development time of these drugs is expected to accelerate their approval process as compared to standard drugs as well as boost growth opportunities. The BT tag also increases the value of the drug due to its high scientific value.
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