Global Biosimilars Market Could Exceed $55 Billion by 2020

There are currently more than 600 trials of biosimilars ongoing.

The global market for biosimilars could hit $20 billion by the end of the year and may reach $55 billion by the end of the decade, according to recent analysis from business intelligence provider GBI Research.

The latest CBR Pharma report from GBI noted that biologics currently comprise between 17—20% of the pharmaceutical arena, with a value of nearly $200 billion. The company finds that biologic drugs may replace 70% of chemical drugs within the next two decades.

Meanwhile, the 30% to 50% reduction in biosimilar prices when compared with branded biologics may eventually generate considerable health care savings, the report suggests.

“There are currently 642 biosimilar trials being conducted, with 146 unique molecules,” GBI analyst Sumith Ladda said in a press release. “Biosimilars are most focused on oncology therapy, with a 36% share, while immunology treatment comprises 21% of the pipeline, meaning these two segments account for more than half of the total trials. Historically, simple proteins, such as filgastrim and epotien, were the prime targets of biosimilar development, but the focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent.”

After years of debate and regulatory hurdles, the FDA approved the first biosimilar in the United States in March 2015. Filgrastim-sndz (Zarxio) manufactured by Sandoz, Inc, is biosimilar to Amgen Inc’s Neupogen (filgrastim), which was originally approved in 1991.

“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret A. Hamburg, MD, said in a press release. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy, and quality standards.”

A paper published in February 2014 on the Social Science Research Network projected that over the next 10 years, American consumers could save more than $250 billion from biosimilar competition from just 11 biologic drugs if they were approved by the FDA. The optimism for the savings ultimately realized from biosimilars may be overstated, however.

A recent report sponsored by Prime Therapeutics projects that biosimilars will achieve savings, but adverse regulatory decisions and market risks may cause manufacturers to carefully consider pouring resources into the research and development of the drugs.

Ultimately, the report from Prime found there may be a less than robust market awaiting biosimilars that could potentially reduce the savings for payers and consumers as a result of regulatory hurdles at the state and federal level. The report, authored by economist Alex Brill, projects that even under favorable assumptions, only biosimilars for biologics with sales greater than $898 million would be worth the investment for manufacturers.

As a result, biosimilars for biologics with a smaller sales market may never reach the market.

The GBI report indicated that despite an established biosimilar regulatory framework across all major markets, issues such as interchangeability, naming conventions, and extrapolation across indications still need clarification.

“The European Medicines Agency has the most robust and longest-standing guidelines for biosimilars. Countries such as Japan, China, and South Korea have developed guidelines similar to these,” Ladda said. “The US Food and Drug Administration finalized guidelines for biosimilars in 2014 and approved its first biosimilar, Zarxio, on March 6, 2015. This marks the entry of biosimilars in the US, and has increased industry confidence in the country’s biosimilars market.”

Ladda added that the US biologics space is twice the size in value of its European counterpart, however the European uptake of biosimilars is nearly 4 times higher, which is an indication of the significant future potential of biosimilars in the US.