Issue: March 2017, Posted Date: 3/13/2017
$100 Billion of Revenues up for Grabs for Drug Manufacturers by 2020 as Patents for Key Biologics Expire
complexities inherent in biological drug manufacturing are creating barriers for
further expansion of the biosimilars market, imminent patent expiries of key
biologics are set to create new opportunities for biosimilar manufacturers,
according to business intelligence provider GBI Research.
Bradbury and Rishikesh Mandilwar, Analysts at GBI Research and co-authors of
the company’s latest report, Global Biosimilar Pipeline and Market Prospects:
Addressing Production Complexities Through Risk Management and Quality by Design, state that one of the key challenges biosimilar
manufacturers face is the knowledge gap under which these products are
developed. Indeed, the innovator product information remains proprietary, and
manufacturers must adopt a reverse engineering process.
Mandilwar explains “In order to be successful in the biosimilars sector,
companies must adopt the latest technology and quality initiatives, such as
quality by design, design of experiments, and process analytical technology.
They must also take a proactive approach in risk mitigation by compiling
risk-management plans and adopting production best practices outlined by
industry associations and regulatory agencies.”
number of biologics are set to go off patent before 2020, which presents a huge
opportunity for biosimilar manufacturers. Biologics have managed to leverage
relatively high prices, with the average annual price currently $16,425 – more
than 20 times the cost of small molecule drugs. However, it is increasingly
difficult to maintain high prices. For example, in the UK, NICE has issued
recommendations against a series of key drugs based on cost-effectiveness.
for biosimilars is usually 30%-50% lower than the innovator product. These cost
advantages will lead to greater access to these drugs, and significantly reduce
the cost of healthcare in many countries. By 2020, $100 billion of biologics
will be exposed to competition due to patent expiration.
Bradbury concludes “The biosimilar pipeline is robust, and most products are
being developed for the oncology and immunology therapy areas. Over 126
companies are currently involved in biosimilar development, which reflects the
significant commercial potential that these products represent.”
This report was built using data and information sourced from
proprietary databases, primary and secondary research, and in-house analysis
conducted by GBI Research’s team of industry experts. GBI Research is a
market-leading provider of business intelligence reports, offering actionable
data and forecasts based on the insights of key industry leaders to ensure you
stay up-to-date with the latest emerging trends in your markets. GBI Research
is a trading name of GlobalData plc. For more information, please contact our
Press Office on +44 (0)161 359 5822 or at email@example.com. Follow us online for the
latest industry updates: Facebook | LinkedIn | Twitter.
This record has been viewed 233 times.