Use this report to: - Analyze the challenges and opportunities of developing breakthrough therapies, compare difference fast track drug development approaches and the potential risk and rewards of gaining BTD. - Discuss the potential challenges and opportunities of utilizing PRIME and BTD pathways’ fast track routes to get new products. - Evaluate BTD in different therapy areas, leading companies, approved and pipeline products, pricing market access and product revenues. - Review BTD successes and failures and discusses the different business strategies to maximize the competitive advantage of BTD.
Highlights - The global market for breakthrough therapy designation (BTD) drugs should reach $99.2 billion by 2022 from $48.8 billion in 2017 at a compound annual growth rate (CAGR) of 15.2%, from 2017 to 2022. - The cancer therapy segment of the breakthrough therapy designation drugs industry is the largest market. The market is expected to grow from $19.6 billion in 2017 to $58.6 billion in 2022 at a CAGR of 24.5% for the period 2017-2022. - The CNS and neurology therapy segment of the breakthrough therapy designation drugs industry is expected to grow from $956 million in 2017 to $8.4 billion in 2022 at a CAGR of 54.3% for the period 2017-2022.
STUDY GOALS AND OBJECTIVES In July 2012, the FDA introduced a new breakthrough therapy designation (BTD) Food and pathway by the Drug Administration Safety and Innovation Act (FDASIA) whereby a development drug can treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
By filing for approval based on compelling Phase 2 data, a BTD product can reach the market up to three years sooner than a drug without the BTD. A similar pathway has been introduced by the EMA (European Medicines Agency) on March 7, 2016, known as the PRIME (PRIority MEdicines).
To date, the main beneficiaries have been big pharma and big biotech’s; the majority of approved breakthrough therapies have been in oncology. However, companies are increasingly active in pursuing the use of this new pathway in other areas of therapy including rare diseases, infectious diseases, CNS and neurology, and cardiovascular disease. In 2015, approved breakthrough therapies generated more than $33.6 billion per annum and by 2022 approved, and new BTDs are forecasted to generate over $99.2 billion as companies become more familiar with the BTD process.
REASONS FOR DOING THE REPORT The regulators and pharmaceutical industry continue to explore new ways to improve market access to innovative medicines, particularly in areas of high unmet clinical need. The advent of the BTD pathway in the U.S. and the PRIME pathway in Europe is one route by which this can be achieved. Since the BTD pathway was introduced, 141 drugs have been granted BTD and 49 have been approved. Similarly, 18 applications have been submitted and 14 have been granted PRIME status since the EMA’s introduction in March 2016. The report discusses the potential challenges and opportunities of utilizing these fast track routes to get new products to market quicker, and the criteria that need to be met in or to do so.
SCOPE OF REPORT This report highlights the challenges and opportunities of developing breakthrough therapies, it compares and contrasts difference fast track drug development approaches (logistics, criteria, and implications) and the potential risk and rewards of gaining BTD. It analyzes BTD in different therapy areas (cardiovascular, central nervous systems and neurology, rare diseases, oncology and other diseases), leading companies, approved and pipeline products, pricing market access and product revenues. It reviews BTD successes and failures and discusses the different business strategies that companies have adopted in order to maximize the competitive advantage of BTD.
It summarizes the current regulatory framework and the potential application of BTD in other regions of the world, and the potential to combine BTD with early access to medicine schemes to improve patient access to medicine to treat rare diseases and address areas of high unmet clinical need.
INTENDED AUDIENCE This report provides a detailed analysis of the recent advances in breakthrough therapy designation products and success, and the impact that this fast track route may have on future drug development in the U.S. It provides summaries of products that have received breakthrough therapy designation approval and identifies the market potential through 2022.
METHODOLOGY AND INFORMATION SOURCES Both primary and secondary sources were used in preparing this study. This analysis of breakthrough therapy designation drugs breaks down the market by therapeutic field and also analyzes current and potential opportunities for development. It includes market forecasts from 2015 and forecasts market revenues through 2022.
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