Biosimilars is set to be one of the fastest growing segments of the global pharma industry, with major opportunities across therapeutic areas like rheumatoid arthritis with AbbVie‘s Humira (adalimumab), cancer with Roche‘s Herceptin (trastuzumab), and diabetes with Sanofi‘s Lantus (insulin glargine). The combination of technology related disruptions, emerging clinical requirements, ongoing investments, and new entrants across the industry value chain will fuel a remarkable 62.1 percent compound annual growth rate (CAGR) during 2014-2020 to take revenues to USD 30 billion.
“As patents expire, better defined regulatory pathways, and escalating healthcare costs boost demand for biosimilars, early entry into new opportunities can offer participants the competitive advantage through experience, brand recognition and new patents,” noted Transformational Health Research Analyst Saravanan Thangaraj.
Biosimilars Market, Europe, Forecast to 2025, new research from Frost & Sullivan‘s Life Sciences Growth Partnership Service program, finds that Europe will remain the largest contributor to global biosimilar revenues for the next 5-7 years, supported by pricing, physician awareness, and regulatory agencies. Across the region, payers are adopting a variety of approaches to encourage physicians to prescribe biosimilar medicines, motivate manufacturers to participate in the market, and provide adequate clinical evidence to support the prescribing of these treatments. Novartis, Lonza, Boehringer Ingelheim, Amgen, Sandoz, Pfizer, Mylan, Samsung Bioepis, Hospira, Eli Lilly are among key market players.
The presence of over 400 commercial providers worldwide makes it challenging to differentiate and compete against market leaders. Reluctance of physicians to prescribe biosimilars, given its lack of long-term safety and efficacy data, high capital requirements, complex regulatory approval processes, and upcoming biobetters, can rein in the potentially explosive growth of biosimilars.
With healthcare rapidly becoming more patient-centric, providing access to medications and a better quality of life for patients becomes a crucial factor for payers. As the majority of patients are not receiving treatment due to its high cost and lack of insurance coverage, there is a willingness to use low-cost biosimilars.
“Establishing interchangeability is an important step to ensure complete acceptance of biosimilars and high market penetration,” said Thangaraj. “Currently, lack of clarity in guidelines and regulations owing to technical barriers and complexity associated with the manufacturing process prevents regulators from designating a biosimilar as interchangeable. While biosimilars promise the same effect at a reduced price, a biobetter will possess some molecular or chemical modification that constitutes an improvement over the originator drug and its biosimilar competitors.”
Approval of new biosimilars can help European healthcare systems realise savings of more than EUR 10 billion in the EU5 (France, Germany, Italy, Spain, United Kingdom) between 2016 and 2020. This is based on direct competition for the originator molecule, excluding any indirect competition for other in-class or therapy-area specific product sales. A 30 percent reduction in price per treatment day across eight key originator biologics, scheduled to lose exclusivity by 2020, could also yield cumulative savings for of about EUR 15 billion over the next five years.
(Source: PR Newswire)
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