Booming Global Market for Drugs with Breakthrough Status

February 07, 2017

Wellesley, Mass., Feb 07, 2017— The global market for drugs that fall under the new Breakthrough Therapy Designation (BTD) is predicted to grow from $48.8 billion in 2017 to $99.2 billion by 2022, according to a new comprehensive market analysis by BCC Research.

The U.S. Food and Drug Administration launched the BTD pathway in 2012 to expedite the approval process for drug candidates that treat serious or life-threatening diseases, and that outperform existing therapies. The European Medicines Agency introduced a similar fast-track program called PRIME (PRIority MEdicines) in March 2016.

“Our analysis of the breakthrough drug market shows companies have an opportunity to leapfrog the lengthy drug approval process by up to three years, generating hundreds of millions of dollars in revenue and maximizing the time their drug is on the market before their patent expires,” said Kevin Fitzgerald, BCC Research Editorial Director.

Opportunity and Challenges of a Breakthrough Status

Since the BTD pathway was introduced, 141 drugs gained BTD status and 49 have been approved in the U.S. Oncology therapies took the largest share (46.8 %) of the breakthrough designations and $11 billion of the global breakthrough drug market in 2016, according to the BCC report Breakthrough Therapies: Market Dynamics and Investment Opportunities (PHM176A).

“Lessons learned from the breakthrough therapy pioneers show the BTD process can pose a challenge,” said Mr. Fitzgerald. “To take full competitive advantage of the time saved during the approval process, pharmaceutical manufacturers must create new strategies in clinical research, manufacturing, and sales and market campaigns.”

Big pharmaceutical and biotech companies were largely the first to enter the BTD market. From their successes and failures, the BCC report found new strategies in clinical research programs, manufacturing, and sales and marketing campaigns will be key to a successful entry into the breakthrough therapy market.

As more companies adapt, BCC analysis predicts that pharmaceutical and bio tech companies of various sizes will gain a foothold in the breakthrough therapy market with drugs that target a wider variety of diseases.

By 2022, BCC Research forecasts drugs that treat rare diseases will generate $1.6 billion in the global breakthrough therapy market, while central nervous system and neurological therapies will generate $8.4 billion and cancer drugs will generate $58.6 billion designated breakthrough therapy sales.

Editors and reporters who wish to speak with the analyst should contact Steven Cumming at

Breakthrough Therapies: Market Dynamics and Investment Opportunities( PHM176A )
Publish Date: Jan 2017    

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