According to a report published by Grand View Research, Inc.; the breakthrough therapy (BT) designation market is likely to reach a valuation of around USD 144.6 billion by 2025.
High prevalence of cancer worldwide, growing healthcare expenditure, and intellectual property (IP) laws can propel the market over the forecast period (2014 to 2025).
Rising number of molecules gaining BT status along with for cancer therapies and drugs for rare and life-threatening diseases is likely to boost the market growth over the forecast period. The time required to develop BT therapy is 30.0% to 50.0% less than those without the designation. This augments the net present value of investigational molecule. Reduction in drug development time of these medicines is likely to fast-track their approval procedure as compared to standard medicines. This is anticipated to create more opportunities in the market.
Worldwide breakthrough therapy designation market can be divided into application and region. Based on application, the market can be bifurcated into oncology, rare diseases, infectious diseases, auto immune diseases, neurological disorder, pulmonary diseases, and others.
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In 2016, infectious diseases segment acquired the largest market share. In addition, anti-infective drugs are also gaining BT status, which may bode well for the segment. But, the segment is expected to show restrained growth during the forecast period due to decline in sale of bestseller medicines such as Sovaldi and Harvoni along with rise in competition in the hepatitis market. Oncology segment is anticipated to exhibit highest growth over the forecast period due to growing incidence of cancers and intensifying demand for cancer medicines. In 2027, the number of molecules gaining BT status was highest in this segment. The rare diseases segment is likely to show rapid growth over the forecast period due to its rising demand and growing research and development (R&D) and pipeline of orphan drugs. This segment does not involve rare cancer diseases. Since, they are treat under the oncology segment.
The drugs intended for rare diseases gets designation called “Orphan Drug”, if they can treat or prevent diseases that may happen in less than 2,00,000 patients in the U.S. In addition, the benefit of 50% tax benefits are also arranged to conduct clinical research for these drugs.
Geographically, the market can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa (MEA).
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North America has been dominating the market and expected to continue its dominance over the forecast period. Factors such as availability of well-established intellectual property laws and regulatory environment, which allows innovation through patent and data protection are expected to support the market growth in the region. In addition, availability of established healthcare facility, growing occurrence of chronic diseases, high per capita income, and growing preference for innovative drugs across the consumers are expected to boost the market. Rising number of drugs getting BT status in the U.S., and high number of applications submitted to get BT status is anticipated to support the market growth. In addition, FDA-approved drugs in the rare diseases and oncology segment are likely to support the market over the forecast period.
Europe stands on the second position due to availability of established healthcare infrastructure, better reimbursement policies, and rising consumers preference for innovative drugs. Complaints regarding nervous system, digestive system, respiratory system, cardiovascular system, and caners are the major reasons of deaths in Europe, As per European Federation of Pharmaceutical Industries and Associations.
Asia Pacific and Latin America are likely to show profitable gains over the forecast period. This can be attributed due to implementation of of favorable intellectual property laws and growing budget for healthcare. However, increasing popularity for generic medications in countries like India and China is considered as the major challenge for the development of innovative medicine.
In Middle East and Africa, countries like Saudi Arabia and South Africa holds comparatively high spending power, therefore expected to show lucrative growth in the coming years.
Major players operating in the market include Pfizer, Inc.; F. Hoffmann-La Roche Ltd; AbbVie, Inc.; Eli Lilly and Company; and AcadiaPharmaceuticals, Inc.
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