Over the past few years, the demand for biotherapeutics has witnessed a significant rise, thanks to the increasing prevalence of chronic diseases such as diabetes, rheumatoid arthritis, cancer, and multiple sclerosis. This growth in the demand for biotherapeutics, together with the imminent launch of several biopharmaceutical drugs, has created a substantial demand for cell line development.

On the other hand, the strict rules and policies, regulating cell culture procedures in the production of biotherapeutics are creating difficulties for participants in their business expansion. However, unmet medical needs in emerging economies of Asia Pacific, Latin America, and Africa, is expected to provide lucrative opportunities for market players over the next few years.

The global market for is estimated to with the opportunity in biotherapeutics cell line development will rise from US$56 mn in 2014 to nearly US$100 mn by 2022, rising at a CAGR of 7.50% between 2015 and 2022.

Asia Pacific to Provide Potential Opportunities for Cell Line Development in Biotherapeutics

North America has acquired the leading position in the worldwide market for biotherapeutics cell line development. In 2014, the opportunity in this region stood at US$23.5 mn, which is likely to increase to US$41 mn by the end of 2022. The presence of a large pool of leading biopharmaceutical companies has stimulated the biotherapeutics cell line development activities in this region, leading to remarkable growth in the market. The increasing base of geriatric population in this region is also presenting huge opportunities for the development of cell lines in biotherapeutics.

Europe, which emerged second in this market in 2014, is expected to report steady growth in the near future, thanks to the rising demand for biotherapeutics. The future of cell line development in biotherapeutics, however, lies in Asia Pacific, which stood at third position in 2014. The potential that this region holds can be understood by the fact that Asia Pacific is expected to register the fastest CAGR of 9.40% during the forecast period. The unmet medical needs and the increasing investments by major pharma companies is projected to amplify the development of biotherapeutics cell line in this region.

Transfection and Selection to Report Higher Growth Rate in Near Future

Single cell cloning and transfection and selection are the two main processes for biotherapeutics cell line development. Single cell cloning led the market with a share of 96% in 2014. The growing adoption of instruments such as FACS and ClonePix has added significantly to the growth of single cell cloning in the recent times.

Although the single cell cloning segment is likely to remain leading throughout the forecast period; the transfection and selection segment with register a higher growth rate in the coming years, owing to the increase in the demand for monoclonal antibodies.

The top two players in the global biotherapeutics cell line development market are Becton Dickinson and Co. and Beckman Coulter. Boehringer Ingelheim Pharma GmbH & Co KG., CMC Biologics, Catalent Inc., Lonza Group Ltd., ProBioGen AG, Partec, SAFC, Sony Biotechnology Inc., Selexis SA, and Thermo Fisher Scientific Inc. are some of the other prominent market participants.

With the increasing number of recombinant protein therapeutics gaining approval by the U.S. Food and Drug Administration (FDA) annually, there is an increase in the demand of cell lines for production of these biotherapeutics. From 2006 to 2011 an average of 15 novel recombinant protein therapeutics and in 2014, 11 novel recombinant protein therapeutics have been approved by US FDA. About forty-seven monoclonal antibody products have been approved in the U.S., Europe and other global markets, of which over 60% were produced in mammalian cell culture. Moreover, the rise in the geriatric population coupled with prevalence of diseases is one of the major factors driving the demand for cell line development for biotherapeutics. The increasing demand for monoclonal antibodies across the globe boosts the market growth. In addition, the increasing number of initiatives taken by the government of various countries by funding the life science research and development is expected to propel this market in coming years. 

The global biotherapeutics cell line development market is segmented by process, by cell line development option and by geography. The market by process segment has been sub-segmented as transfection and single cell cloning. The single cell cloning market is further sub-segmented by method into manual limited dilution cloning, FACS, ClonePix and Others. The market by CLD option is segmented as In-house, outsource, hybrid and do-it-yourself. The ClonePix accounted for the largest market share of 37.4% in 2014. Geographically, the market has been studied and estimated for five regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. 

The market overview section of the report demonstrates major market dynamics such as drivers, restraints, and opportunities that influence the current and future status of the industry. The market overview section includes market attractiveness analysis, by geography, to provide a thorough analysis of the overall competitive scenario in the global biotherapeutics cell line development market. The market overview section of the report also includes the qualitative and quantitative analysis of the competitive landscape. 

Market share analysis for FACS market is also provided in the market overview section of the report for 2014 in terms of value (%). The report also provides important recommendations for market players and new entrants. These recommendations would enable existing market players to expand their market shares and help new companies to establish their presence in the biotherapeutics cell line development market across the world. The report concludes with the company profiles section, which includes key information about major players in the market such as financial overview, business strategies, and recent developments. Major players in this market are Becton Dickinson & Company (U.S.), Beckman Coulter (U.S.), Boehringer Ingelheim Group (Germany), Catalent Inc. (U.S.), CMC Biologics A/S (Denmark), Lonza Group Ltd. (Switzerland), EMD Millipore (U.S.), Partec (Sysmex Corporation) (Japan), ProBioGen AG (Germany), Selexis SA (Germany), Sigma-Aldrich Co. LLC. (U.S.), Sony Biotechnology Inc. (U.S.), and Thermo Fisher Scientific Inc. (U.S.). 

The global biotherapeutics cell line development market has been segmented as follows: 

  • Global Biotherapeutics Cell Line Development Market, by Process
    • Transfection & Selection
    • Single Cell Cloning
      • Manual limited dilution cloning
      • FACS
      • ClonePix
      • Others
  • Global Biotherapeutics Cell Line Development Market, by CLD Option
    • In-house
    • Outsource
    • Hybrid
    • Do-It-Yourself (DIY) 
  • Global Medical Cameras and Microscopes Market, by Geography
    • North America
    • Europe
    • Asia Pacific (APAC)
    • Latin America (LATAM)
    • Middle East & Africa

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Biotherapeutics Cell Line Development Market

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