The global Breakthrough Therapy Designation Market is anticipated to reach USD 144.6 billion by
2025, according to a new report by Grand View Research, Inc. 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 EU 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 molecule.
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.
There has been a consistent
rise in the number of drugs receiving BT status in the U.S., and this trend is
also expected to drive the number of applications submitted for the same,
thereby contributing to the market growth.
Further Key Findings From the Study Suggest:
- The infectious diseases segment dominated the
market in 2016. However, it is expected to exhibit moderate growth in the
forecast period owing to decline in sales of blockbuster drugs such as
Harvoni and Sovaldi
- Oncology is expected to be the dominating segment
over the forecast period owing to rise in the demand for cancer medicines
and increase in the number of oncology molecules gaining BT status. As of
2017, the number of molecules gaining BT status is the highest in this
segment
- The rare diseases segment is estimated to
exhibit fastest growth owing to rise in demand and increase in the R&D
pipeline of orphan drugs
- North America is expected to dominate the
market over the forecast period owing to well-established intellectual
property laws and preference of patients and healthcare professionals for
innovative medicines
- Some of the key players are F. Hoffmann-La
Roche Ltd; Gilead; Novartis AG; Pfizer, Inc.; AbbVie, Inc.; Janssen Global
Services, LLC; Bristol-Myers Squibb Company; Eli Lilly and Company; Sanofi;
Regeneron; AcadiaPharmaceuticals, Inc.; Boehringer Ingelheim GmbH; Amgen,
Inc.; AstraZeneca; and GlaxoSmithKline plc.
Browse Details of Report @ https://www.grandviewresearch.com/industry-analysis/breakthrough-therapy-bt-designation-market
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