Biological Safety Testing Market by Application (Stem Cell, Blood, Gene Therapy), Product (Instruments, Services, Kits, Reagents), & Test (Bioburden, Endotoxin, Cell Line Authentication, Residual Contamination, Adventitious Agents) – Global Forecast to 2019

Date: 2015-07

“The biologics safety testing market is growing at a favorable rate. The major drivers for the market include growth of the pharmaceutical and biological industries and an increasing number of new drug launches. Over the years, the number of drug approvals in North American countries has increased. Between 2001 and 2010, the FDA approved 225 drug applications and Health Canada approved 99. In addition, according to WIPO, Europe accounted for 3,822 of the pharmaceutical and 1,998 of the biotechnology patents granted in 2012. Furthermore, according to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970. This will spur the growth of biologics safety testing market.

The global pharmaceutical industry is expected to grow at a CAGR between 5% and 8%. According to the IMS Institute of Healthcare Informatics, the global biologics market has increased from $46 billion in 2002 to $169 billion in 2012. Biologics accounted for 11% of the total sales of drugs in 2002, which increased to 18% in 2012. It is estimated that this figure will rise to 20% by 2017, with a total market value of $221 billion. According to Ernst & Young’s Global Biotechnology Report 2013, companies in biotech centers in the U.S., Europe, Canada, and Australia achieved revenues of about $90 billion in 2012. This was an 8% increase over their revenues in 2011. According to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970, followed by Spain (3,025 biotechnology companies), and France (1,481 biotechnology companies). Owing to the rise in the number of biotechnology companies, biopharmaceutical production has increased globally. Biologics safety testing is carried out at all levels of pharmaceutical and biopharmaceutical manufacturing process to minimize the risk of product contamination. Growth in pharmaceutical and biotechnology industries will drive the growth of the biologics safety testing market.

This report segments the global biologic safety testing market based on product, type of test, application, and geography. The product segments included in the report are instruments, kits & reagents, and services. Based on test, this market is categorized into adventitious agents detection test, bioburden tests, cell line authentication and characterization tests, endotoxin tests, residual host contaminant detection tests, sterility testing, and other tests (efficacy tests, toxicity tests, stability tests). The application segments included in the report are blood & blood products, cellular & gene therapy products, stem cell products, tissues & tissue products, and vaccines and therapeutics.

The geographic segments included in this report are Asia, Europe, North America and the Rest of the World (RoW). Asia is further divided into China, India, Japan, and the Rest of Asia. North America includes Canada and the U.S.

A combination of bottom-up and top-down approaches were used to calculate market sizes and growth rates of the global biologics safety testing market and its subsegments. Secondary information was used to identify overall revenue, geographic reach, and product portfolios of market players. Estimates of their biologics safety testing market segment revenues were validated through primary interviews. Primary interviews with key opinion leaders were also used to determine the percentage shares of each subsegment and the relative differences in growth rates.

The report provides qualitative insights on key market shares, growth rates, and market drivers for all important subsegments. It maps market sizes and the growth rates of each subsegment and identifies segments poised to see rapid growth. The report also includes company profiles of market leaders. These company profiles include the financial performances, product portfolios, and developments of each company. The report also provides a competitive landscape of the biologic safety testing market. The competitive landscape covers growth strategies adopted by industry players over the last three years, and includes analyses of industry developments like mergers and acquisitions, agreements and partnerships, and new product launches.

Reasons to Buy the Report:

The report will enable both established firms and new entrants to gauge the pulse of the market and help them make important strategic growth decisions.

The report provides insights on the following:
• Product Development/Innovation: Product portfolios of top players in the biologic safety testing market. Detailed insights on upcoming technologies, research and development activities, and new product launches in the biologic safety testing market
• Competitive Assessment: In-depth assessment of market shares, strategies, geographic and business segments, and product portfolios of leading players in the biologic safety testing market
• Market Development: Comprehensive information about lucrative emerging markets. The report analyzes the market for various biologics safety testing products across geographies
• Market Diversification: Exhaustive information about new products and services, recent developments, and investments in the biologics safety testing market

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