US biosimilars market to be worth US$11bn by 2020, finds new research

Published: 17-Aug-2015

By 2019, 50% of the biologics market will belong to off-patent drugs, creating a high market potential for biosimilars


The US, Europe and Japan are spending the most on biologics and will become the largest biosimilar market hubs by 2020, says a new report by online market researcher Reportsandreports.com.

The Global & USA Biosimilar Market Analysis to 2021 finds that biosimilars generated revenue of US$1.1m in 2007, gradually rising to $86.9m in 2014. During this period, the market penetration of biosimilars in Europe and emerging markets was only about 8%.

By 2019, 50% of the biologics market will belong to off-patent drugs, creating a high market potential for biosimilars, the report says.

The top five biologics targeted most by biosimilar developers are Avastin, Enbrel, Herceptin, Humira and Rituxan, which together generate revenue of about $50bn annually.

In the EU, where biosimilars are already competing with biologics, biosimilars are sold at a 30% discount compared with branded biologic drugs. In spite of the approval of 21 biosimilars in Europe, only 18% of doctors are aware of these similar versions of biologics, the report says.

By 2019, 50% of the biologics market will belong to off-patent drugs

With the approval of the first biosimilar in the US early this year and the expected patent expiration of 12 biologics by 2020, biosimilars are expected to competitively penetrate the biologics market. Biosimilars have thus become a threat and opportunity for biotechnology and pharmaceutical sectors.

Zarxio (Filgrastim, Sandoz) will be launched into the US market next month (September) and will compete with Neupogen (Amgen) within the US G-CSF market.

Biosimilars will account for 4–10% of the biologics market total by 2020, depending on the number of biosimilars launched in the US. The US is the largest market for biologics and biosimilars can achieve 10% of global sales in 2020, only if the volume growth for biologics is achieved in the US market, the report finds.

The main players looking to penetrate the US biosimilar market are currently Amgen, Mylan, Pfizer, Sandoz and Hospira.

Another research report from Reportsand reports.com, Biosimilars Market by Product (Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Interferons, rHGH), Glycosylated (Monoclonal Antibodies, EPO), Peptides (Glucagon, Calcitonin)) & Application (Oncology, Blood Disorders) - Global Forecast to 2020, estimates that the global biosimilars market will be worth $2.29bn this year, and is poised to grow at a CAGR of 22.1% during the forecast period.

The recombinant glycosylated proteins segment is expected to witness the highest growth rate owing to increased demand for monoclonal antibodies in the treatment of cancer, autoimmune disorders, blood disorders, and infectious diseases.

On the other hand, the recombinant non-glycosylated proteins segment currently accounts for the largest share of the market, with the insulin segment poised to be the fastest-growing part of this market, growing at a CAGR of 28.1% from 2015 to 2020. Growth in the insulin market is attributed to rising incidences of diabetes; ongoing patent expirations of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost-effectiveness of insulin.

Geographically, Europe is expected to account for the largest share of the global biosimilars market in 2015 followed by Asia-Pacific.

A third report, Biosimilars – Regulatory Framework and Pipeline Analysis, provides information on regulatory overview, biosimilar guidelines, the regulatory framework for biosimilars, and market outlook for: Europe, US, India, South Korea, Japan and China.

It covers market dynamics (trends, drivers and barriers), WHO guidance for biosimilars, key players and pipeline analysis as well as an overview by stage of development/molecule therapy area/indication and late stage/Phase II/Phase I pipeline biosimilars.

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