Breakthrough therapy drugs are intended to treat serious and life-threatening conditions. The breakthrough therapy is the designation given by FDA for the drugs when there is a preliminary clinical evidence indicates that the drug proves a substantial improvement over available drug treatment. Two factors determine the efficiency of breakthrough therapy drug, they are the magnitude of the treatment effect and observed clinical difference over the existed drug. The standard for breakthrough therapy drug is not same as standard drug approval because, in breakthrough therapy, morbidity and mortality considered for approval of the drug. They are meant to be administered by itself or in combinations. Breakthrough therapy drug development is cost effective due to faster approval of drugs on limited data from the FDA. Manufacturer of breakthrough therapy drugs has to develop additional post-marketing surveillance data for the other reimbursements and market access. Presently available breakthrough therapy medicinal products in the market belong to the treatment class of oncology, infectious diseases, cardiovascular conditions, etc. The designation is given when the drug is in 1st or 2nd stage of clinical trials.
Increasing prevalence of life-threatening conditions and for the speedy development of pipeline drugs is the primary driver for the breakthrough therapy drugs market. This is because of the high unmet need of presently available treatment for severe conditions. Breakthrough designation of the drug captures the more attention of the manufacturers due to the expedited market access and greater returns on their investments. Because of Breakthrough therapy drugs market are associated with less robust clinical developments. Increasing support of FDA for small scale industries in R&D by providing additional funding and faster approval of drugs fuelling the growth of the breakthrough therapy drugs market. All these factors are boosting the growth of the breakthrough therapy drug market.
Breakthrough therapy designation requires additional planning for the pricing, market access and reimbursements acts as restraints in the growth of the market. Uncertainty around the breakthrough therapy drugs acts as a primary challenge for the manufacturers.
Breakthrough therapy designation increases the opportunities to the company by decreasing the lengthy drug approvals and increasing the revenues by maximizing the patent time before their expiry. Globally Oncology, Hematology and antiviral drugs have acquired largest share globally in breakthrough therapy drug market because of the high severity of this diseases. The rapid advancement of the technology along with the increased spending of the R&D is driving the market. The number of breakthrough therapy designations is growing gradually from the past few decades due to increased demand for the life-threatening drugs. The future of breakthrough therapy drug market expected with double CAGR during the forecasted period.
The United States have dominated global breakthrough therapy drug market due to increasing research by companies. The United States is followed by European region in breakthrough therapy drug market due to increasing incidence rate of the life-threatening diseases. Asia-pacific is the fastest growing region due to increasing demand for life-saving drugs. The growth in underdeveloped countries is comparatively slow during the forecasting period.
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The key participants in the breakthrough therapy drugs market are Merck Sharp & Dohme Corp, Pfizer Inc, AbbVie Inc, Bristol-Myers Squibb Company, Genentech Inc, Gilead, Novartis AG, Vertex Pharmaceuticals Incorporated, etc. The companies are focusing on R&D, which is boosting the breakthrough therapy drugs market.
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