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Analysis of the Global Biosimilars Market

  • January 2014
  • -
  • Frost & Sullivan
  • -
  • 380 pages

Summary

Table of Contents

Impending Patent Expiries and Next-generation Biosimilars Pipeline Provide Impetus for Growth

Patent expirations of blockbuster biologics and a promising pipeline of biosimilars present positive opportunities for the global market. The research service provides analysis on regional market penetration and market dynamics. This study also provides a market overview, market engineering measurements, revenue forecasts, competitive analysis, and key trends for the biosimilars market and its segments. Regional analysis includes The United States, European countries such as the United Kingdom, Germany, France, Italy, Spain, Benelux, and Scandinavia as well as Asia-Pacific and Latin America. The study period is 2009–2019, with 2012 as the base year.

Methodology

•The information contained in this research service was derived from a variety of relevant primary and secondary information sources.
•Primary interviews were conducted with industry participants in positions such as chairman and chief executive officer (CEO), director of investor relations, director of business development, chief business officer, media relations, and international key opinion leaders (KOL).
•Secondary data sources include government and public health organisation websites, the World Health Organization (WHO), European Medicines Agency (EMA), the US Food and Drug Administration (FDA) publications (annual reports, US Securities and Exchange Commission (SEC) filings, investor presentations, earnings transcripts, and press releases), government public sources, pharmaceutical industry databases, and published articles in scientific and medical journals.
•For the United States, Europe, and Latin America (LATAM), revenue forecasting is performed using a robust, data-driven, bottom-up approach. Marketed drugs, patent expiries, and potential new entrants in phase 3 of development and beyond are individually forecasted, and aggregate figures are provided. For the Asia-Pacific (APAC) region, forecasting is performed using a top-down model.

Key Findings

•The global biosimilars market will continue to grow from $X million in 2012 to approximately $X million in 2019, at a compound annual growth rate (CAGR) of X%.
•The biosimilars market is a growth market. The period from 2013 to 2015 is considered a time of significance for higher growth, with new products and segments adding up during this time period. Regulatory guidelines have been drafted by the EMA for erythropoietins (EPO), granulocyte colony stimulating factors (G-CSF), human growth hormone (HGH), and monoclonal antibodies (mAbs). The United States, India, and other regions have also drafted guidelines as the pathways are gradually becoming clear.
•The European market seems favourable due to increasing pressure to control the spiralling costs of healthcare. Biosimilar mAbs are thus expected to experience a positive trend in the region.
•The US market is underpenetrated, and a huge opportunity awaits biosimilar manufacturers.
•The Russian government plans to promote the country’s domestic biosimilars industry through subsidies and contracts for companies actively developing biosimilars.
•Several regional governments are actively promoting the growth of biosimilars. For example, the South Korean government is striving to make its country a global market leader, with the goal of attaining a global market share of X% by 2020 and with provisions of both financial and institutional support for those involved.
•Partnerships and alliances are the major focus of firms entering the biosimilars market, and there have been some notable deals between generic participants and biotech firms. Examples include generics giant Teva and a biologicals firm Cephalon, Indian generics manufacturer Lupin Pharmaceuticals and Australian biotech Neuclone, and German STADA Arzneimittel’s mAbs deal with Hungary-based Gedeon Richter.
•Non-pharma participants have made their entry into biosimilars through partnerships. For example, Japanese digital camera maker Fujifilm is developing biosimilars with the biotech firm Kyowa Hakko Kirin, and Korean electronics giant Samsung struck biosimilar deals with contract research organisation (CRO) Quintiles and, more recently, with the US biotech Biogen Idec.

Scope and Segmentation

Geographic Coverage: Global
Study Period: 2009–2019
Base Year: 2012
Forecast Period: 2013–2019
Monetary Unit: US Dollars

This report covers the following geographic markets:
•The United States
•European countries such as the United Kingdom, Germany, France, Italy, and Spain
oThe Benelux region: Belgium, Netherlands, and Luxembourg
oThe Scandinavian region: Denmark, Norway, and Sweden
•APAC: India, China, South Korea, Japan, and Australia
•LATAM: Brazil, Mexico, and Argentina

Key Questions This Study Will Answer

What is the current scenario of the global biosimilars market, and how far will it go?
What are the key factors driving the market, and what are the barriers that need to be resolved?
Which are the key market segments to look out for, and what are the key trends and regulatory aspects?
Who are the key market participants involved, and where do they stand?
What are the factors affecting the biosimilars market in different regions of Europe, and how will these factors affect the market in the future?
What is the future biosimilars market scenario, and what should market participants do to succeed?

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