It is rare to see a new business segment emerge in any market, but this is what is happening within the biopharmaceutical development industry, according to a new report from Thomson Reuters BioWorld, the premier biopharmaceutical news service.
There are currently 700 follow-on biologics therapies moving through pipelines with many already approved and 245 biopharma companies and institutes developing or already marketing follow-on biologics in markets throughout the world. Biosimilars are expected to account for approximately one quarter of the $100 billion worth of sales stemming from off-patent biologics by the end of the decade, the report said.
South Korea is a notable standout in the race for global leadership in this space, and India anticipates biosimilars becoming the most important economic and therapeutic component of its already robust biopharma industry. The study-the culmination of BioWorld's research combined with key data and insights gathered from CortellisTM Competitive Intelligence and input from Thomson Reuters Life Sciences Professional Services, provides a comprehensive view of this emerging market with a listing of approved biosimilars, company and deal terms for more than 100 alliances, and an examination of global markets.
Key highlights from the report include:
* Big pharma and generics makers face a steep learning curve: While generic makers currently lead the pack, the expertise in this market is held by the biologics makers. New pure-play biosimilar makers funded by governments and private investors also have a strong presence in this arena.
* Biosimilars promise to deliver big savings: Typically offering 20 to 30 percent discounts from innovator biologics, biosimilars are expected to deliver $11 billion to $33 billion in savings across the European Union (EU) by 2020.
* Opportunities for smaller players: Start-ups working to make and sell biosimilars in emerging territories could be the "David" ticket to beat pharma "Goliaths" that dominate those realms.
* Lower-prices: Slow market uptake of biosimilars in the EU may not also hold true for the U.S. Unlike most of the EU, the U.S. will allow interchangeability, which is expected to speed adoption and lead to lower prices.
* A level playing field: The World Health Organization recently proposed a voluntary, global naming scheme that could level the playing field for biosimilars and their reference biologics.
* Accessible treatment: In many parts of the world, follow-ons offer new hope to patients who previously did not have access to pricey biologics, bringing the power of biologics for the first time to markets in Africa, Asia, Eastern Europe and Latin America.
"Rather than forgo the benefits of biologics, governments and payers are counting on biosimilars to dramatically change drug development and patient costs by reducing the price tag of important biologics and increasing access to life-saving drugs," said Jon Brett-Harris, managing director of Thomson Reuters Life Sciences. "For this to happen, biosimilars must deliver the power of the reference drugs at a price developing countries can afford and gain the confidence of the marketplace. They have to create their own market."