Gravitating towards process automation has become a common phenomenon for most industries in the world and the life sciences industry has emulated the same. Applying automation in cell line development is the newest trend that life sciences research institutions have been quick to adopt. witnessed by life science research institutions. For biopharmaceutical companies, maintaining a cell line is an important asset which contributes to research. However, the process also involves meticulous manual work which is prone to human error. Cell line development involves incredibly long workflows which can sometimes take several months for completion. Besides, with a consistent qualified lack of personnel in labs, automating processes has become necessary for cell culture process. Its maintenance is a vulnerable process which is now benefitting tremendously with the advent of automation in the field. Automation has highly sped up the process with performing tasks such as scheduling and recording date and time of cell growth, optimizing growth of cells on the weekends, and others. Introduction of robotics has therefore, brought consistency in cell culture and highly benefitted the global Cell Line Development Market. In a study conducted by key market player Lonza Biologics’ on glutamine synthetase expression system majorly used for monoclonal antibody production in CHO cells, automation made a fundamental difference by speeding up the process. Researchers recorded a three-fold increase in development projects based on the same premise with the use of automation. During the forecast period of 2018-2023, the cell line development market will grow with a CAGR of 12.2% and will earn a revenue of $6.4 billion by the end of 2023.

North America has emerged as the leading region of the global cell line development market. As per IndustryARC’s evaluation, the region earned a revenue of $1.4 billion in 2018, with approximately 38% of the global market share. High healthcare investment by the U.S. government trumps the number of factors responsible for this share. In FY 2018, the government of U.S. spent $225 billion on healthcare advancement in the country. This has provided adequate funding to research institutions working on cell line development. The U.S.-based key market players have followed suit and collaborated with biotechnology institutions to fund research. In 2017, GE Healthcare entered into a collaboration with Austrian Centre of Industrial Biotechnology for three years. This collaboration was primarily done with the objective of optimizing performance of Chinese Hamster Ovary cell-line. Moreover, the demand for vaccines is rising in countries such as Canada, Mexico, and the U.S., owing to increased public awareness pertaining to healthcare. These factors have collectively helped North America in gaining a majority share of the market.

Growth Drivers of the Market:

•    Technological Development of Pharmaceutical Industry

Pharmaceutical industry is the largest end-user of cell line development market, owing to several factors such as increasing demand for vaccines that is a direct result of governmental and non-profitable mass vaccination initiatives such as Expanded Immunization Program conducted by World Health Organization (WHO) and UNICEF in developing countries. According to recent statistics by UNICEF, owing to various mass vaccination initiatives, 100 million infants are provided with vaccines every year. Resultantly, the rising demand for vaccines has made pharmaceutical industry companies to invest in technological advancement for increasing medicinal reliability and production. Cell line development is a replacement for of animal testing that emulates in vivo cell formation and assists in assessing the genetic makeup of cells inside the body. An approaching complete reliance on cell line for pharmaceutical industry’s development will be highly propelling factor for the market growth.

•    Increasing Governmental Policies

For a long time, the research of cell culture had been plagued by contamination with harmful microorganisms and misidentification. These problems had negatively impacted cell line development but owing to governmental policies, the market for the same has seen robust advancement in the recent times. Governments of several countries have issues Codes of Practice for regulating these technical issues and making sure that they are properly and ethically encountered. A universal set of guidelines has been prepared by Cancer Research UK that lists out several points that cell culture specialists must follow at all times. Some of these points include obtaining consent of patients whose cells and tissues are involves in the study, preservation of images primary cell culture and changes that it undergoes, etc. These guidelines have helped in minimizing mishaps and led to growth of the cell development market.

Cell Line Development Market: Opportunity Analysis

Rising demand for regenerative medicine for restoring diseased tissues and organs will act as an opportunity for the market growth. Additionally, regenerative medicine will be the largest application for cell line development, owing to technological advancements. Increasing risks of pandemics and communicable diseases will impel healthcare experts to utilize regenerative medicine for accurate and faster treatment. One of the most common applications of cell lines has turned out to be use of stem cells in organ regeneration after several impactful studies. Adult stem cells are now being used in regenerative surgery, owing cell line development market.

Technologies and Trends Impacting Cell Development Market

•    Ensuring Monoclonality

Monoclonality of cell line production has always been an important factor that determines approval from regulatory organizations such as the Food and Drug Administration. Insufficient evidence can lead to delayed launch of drugs or extensive clinical trials. This is a major challenge faced by companies working in the field of cell line development. However, Sartorius Stedium Cellca has developed methods that utilize the process of FACS (fluorescence-activated cell sorting) and automatic imaging that ensure monoclonality. FACS is adept at segregating a single cell from a cell suspension and imaging, using automation records the process, thus storing evidence for clinical trials.

•    Synthetic Biology

Researchers around the world have addressed the growing benefits of adding synthetic biology to cell line development. In 2018, Cell Line Development and Engineering Conference conducted by Informa, an events publishing company, professors stressed on companies changing their focus towards accommodating synthetic biology into cell culture for achieving a better understanding of genetic progression that occurs in cell lines. For example, Novartis Healthcare have started using transcriptomics and engineering to increase recombinant antibody expressing. Through this, they were able to obtain better genetic analysis and cell line used in the research is now able to produce proteins with a 35 times increase.   
Major Players in the Market

Different biotechnology and life sciences research organizations and companies form the key players of the cell line development market. Their contribution has been pivotal in attracting governmental and private funding for further research. These companies include American Type Culture Collection (ATCC), Corning Incorporated, General Electric Company, Lonza, Sartorius AG, Sigma Aldrich Corporation, Thermo Fisher Scientific Inc., Selexis SA, Danaher, Samsung Biologics, Catalent Inc., and Wuxi Apptec.

In order to strengthen their position as a preferred choice for pharmaceutical and biotechnological services, Samsung BioLogics started offering their own Chinese Hamster Ovary (CHO) cell line that can assist other biopharma firms in conducting development projects. From 2019, the company will stop licensing an external cell expression system and instead develop their in-house cell line for their customer base.

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Related Reports:

A.    Cell Expansion Market

B.    Cell Culture Market

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