Breakthrough Therapy (BT) Designation Market To Hit Value $144.6 Billion By 2025 |Grand View Research, Inc.


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.
Multiple therapeutic regimens are being followed across the globe in attempts to come up with a reliable treatment for Covid-19. One line of treatment includes the use of hydroxychloroquine, while a second treatment line focuses to use antiviral drugs used in the disease management of HIV. Both these approaches have surged demand from advanced antivirals and antimalarial drugs. This impacts the drug manufacturers as an off label indication for these drug classes has to be worked upon. At the moment, the WHO has not prescribed any of these approaches, neither they have commented if one is better than the other. The report will account for Covid19 as a key market contributor.
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.
Some of the key players in the BT designation market 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; Acadia Pharmaceuticals, Inc.; Boehringer Ingelheim GmbH; Amgen, Inc.; AstraZeneca; and GlaxoSmithKline plc.
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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.
The global Breakthrough Therapy (BT) designation market size was valued at USD 44.1 billion in 2016 and is expected to grow at a CAGR of 14.1% during the forecast period. The BT designation is granted to drugs that bring about substantial improvement in disease conditions compared to existing therapies during preliminary stages of clinical trials for the treatment of life-threatening diseases.
Increasing number of molecules gaining BT status, coupled with rise in the demand for cancer therapies and drugs for rare diseases, is expected to propel the market over the forecast period. Increasing prevalence of cancer and rise in healthcare spending is also expected to contribute to market growth.
There has been a consistent rise in the number of drugs gaining BT status in the U.S. This is also expected to drive the number of applications submitted for the same, thereby contributing to market growth. Increase in the number of patients preferring innovative medicines in developed countries is also a major factor boosting the market. The U.S, EU5 countries, and Japan are three major markets for BT drugs. The recently expedited approval process in Europe, which is comparable to that of the U.S., is also expected to boost the number of approvals for BT drugs in the region.
FDA-approved drugs in the oncology and rare diseases segment are expected to dominate the market over the forecast period. However, several drugs that have been granted the BT status by FDA have failed to show fruitful results in late-stage clinical trials. For instance, SER 109, a Tylenol-sized capsule for the treatment of Clostridium difficile Infection (CDI), was granted BT designation in 2015. However, in 2016, it failed the placebo-controlled SER-109 Phase 2 ECOSPORTM clinical study for the prevention of recurring CDI. Increase in the number of similar cases is likely to restrain the market.
Rising healthcare expenditure in developing countries and the development of Intellectual Property (IP) laws are also among factors expected to drive the demand for innovative medicines for the treatment of life-threatening diseases. At present, developing countries such as India and China hold a larger share of the generic medicines market owing to unfavorable IP laws and relatively low healthcare spending. Countries such as Saudi Arabia and South Africa have relatively high spending power, owing to which they are lucrative markets for BT drugs.
Browse Press Release of this report:
https://www.grandviewresearch.com/press-release/global-breakthrough-therapy-bt-designation-market
Grand View Research has segmented the breakthrough therapy market report on the basis of application.
Breakthrough Therapy Designation Application Outlook (Revenue, USD Million, 2015 - 2025)
·         Oncology
·         Infectious Diseases
·         Rare Diseases
·         Auto Immune Diseases
·         Pulmonary Diseases
·         Neurological Disorder
·         Others
About Grand View Research
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.



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