Biotherapeutics Cell Line Development Market Size, Share, Growth, Trends, Consumption, Revenue, Company Analysis, Regional Insights and Forecast 2021-2028

Published Date : Nov 2020 | No. of Pages : 200 Pages | Category : Healthcare

According to Vision Research Reports, the global biotherapeutics cell line development market size was valued at US$ 100 Mn in 2020 and to surpass around US$ 220 mn by 2028 with a CAGR of 7% during the forecast period 2021 to 2028.

Stable cell lines are widely used in various applications, including biologics production, drug screening, and gene functional studies. These cell lines developments have been gaining significance of late, as many blockbuster drugs include biologics. The process of developing stable cell lines often starts with transfecting selected host cells, typically CHO or HEK 293 cells, with desired plasmids. North America dominated the global biotherapeutics cell line development market in 2020. It is expected to continue its dominance by the end of 2028 in terms of revenue.

The market growth will be largely driven by research and development activities due to which, new solutions and technologies have gradually entered the market. Developments in the pharmaceutical sector will ideally focus on enhancing lab productivity and minimizing the overall time taken for biotherapeutics cell line development. While the COVID-19 pandemic will disrupt operations and workflow models across the biotherapeutics cell line development market, it presents an opportunity for market participants to focus on research activities that explore the possibilities of non-conventional antibody manufacturing techniques.

Overview

  • Biotherapeutics need cell lines for different activities such as new product development and research. The cell line development involves primary cells taken directly from an animal or living body, without any significant manipulation; the cells that have been transformed or partially transformed; or the cells continually derived from a culture with stem-like properties for biotherapeutics.
  • Transfection is the process of introducing foreign DNA into the cells by using either the physical (electroporation) or chemical (cationic lipid or calcium phosphate reagents) method
  • Single cell cloning is essentially a process of generation of single-cell clones from an original ‘multi-clonal’ population; however, this population is separated from the rest in order to create pure, clonal population that is genetically identical
  • Rise in the demand for biotherapeutics led by the recent launches of biopharmaceutical drugs is a major factor driving the global biotherapeutics cell line development market
  • For instance, the U.S. FDA approved total 12 biologics and 34 small-molecule drugs in 2017, while the number increased to 17 biologics and 42 small-molecule drugs in 2018
  • Increase in geriatric population, rise in the prevalence of diseases, and development of advanced technologies to meet the rising demand for monoclonal antibodies are some of the major factors augmenting the global biotherapeutics cell line development market
  • Moreover, government initiatives to boost the biotechnology & pharmaceutical sector are also fuelling the global biotherapeutics cell line development market

Rise in Demand for Biotherapeutics to Drive Biotherapeutics Cell Line Development Market

Blockbuster drugs that have been launched recently primarily contain biopharmaceutical ingredients. The biotherapeutics cell line development market has been expanding, owing to the rise in the demand for these biotherapeutics and biosimilar drugs. For instance, the U.S. FDA approved 12 biologics and 34 small molecules drugs in 2017, while the number increased to 17 biologics and 42 small-molecules new drug approvals in 2018. Increase in geriatric population and prevalence of diseases are key factors driving the global biotherapeutics cell line development market. Government initiatives to boost biotechnology & pharmaceutical sectors and development of advanced technologies to cater to the rising demand for monoclonal antibodies are some of the major factors boosting the global biotherapeutics cell line development market.

CHO Cells Likely to Remain Integral for Biological Therapeutics

As the protein pharmaceutical industry continues to take giant strides in the forward direction, it has a direct impact on the growth of the biotherapeutics cell line development market. For the longest time, Chinese Hamster Ovary (CHO) cells have remained the most popular expression system for biotherapeutics cell line development, as it is accepted by the FDA and thereby, makes the regulatory approval an easy process. In addition, these biotherapeutics cell lines have the ability to grow in suspension, resistant to viral infection, and are relatively easier to work with. These factors are expected to play a key role in the progress of the global biotherapeutics cell line development market during the assessment period.

Biotherapeutic cell line development plays a critical role in these research activities. However, at present, researchers and scientists are largely focusing on addressing the numerous challenges involved with cell lines such as quality, robustness, productivity, scaling-up, etc.

Mergers, Collaboration, and Entry of New Solutions Provide Impetus for Market Growth

Over the past decade, a number of organizations involved in the biotherapeutics cell line development market are highly inclined toward the development of new technologies that enable the production and manufacturing of various innovative biopharmaceuticals, including gene therapy vectors and complex therapeutic cell lines. In addition, several market participants are also roping in considerable efforts to fast-track screening and biotherapeutics cell line development to develop high-end biopharmaceutical solutions, including complex fusion proteins, viral particles, and largely glycosylated plasma proteins.

Several market players are launching new workflow models to optimize the identification process of top clones for complex antibody therapeutics. For instance, in March 2020, Berkeley Light launched the cell line development 2.0 workflow to identify the most ideal clones for complex antibody therapeutics. The newly launched Opto CLD 2.0 workflow allows the measurement of antibody production in over thousands of clones by utilizing the company’s assays. With a similar aim to increase lab productivity and minimize the timeline of biotherapeutics cell line development, in June 2019, Sartorius Stedim Biotech launched a new generation cell culture micro-bioreactor system.

Single Cell Cloning to Dominate Biotherapeutics Cell Line Development Market

Based on process, the global biotherapeutics cell line development market has been bifurcated into transfection & selection and single cell cloning. The single cell cloning segment is expected to dominate the global biotherapeutics cell line development market during the forecast period, owing to rise in demand for biotherapeutics, increase in adoption of instruments such as FACS & ClonePix, and higher throughput nature of this method. The single cell cloning segment has been further sub-segmented into manual LDC, FACs, ClonePix, and others.

Outsource CLD Option to Offer Lucrative Opportunities

In terms of CLD option, the global biotherapeutics cell line development market has been divided into in-house, outsource, Do-It-Yourself, and hybrid. The outsource segment accounted for a major share of the market in 2020 and is expected to be a highly promising segment during the forecast period. The increase in demand for outsourced products; cost saving; and rapid delivery of products are some of the major factors driving the outsource segment.

North America to Dominate Biotherapeutics Cell Line Development Market

Based on region, the global biotherapeutics cell line development market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America held a significant share of the global biotherapeutics cell line development market in 2020, owing to high funding in new biologic drugs, rise in geriatric population, increase in prevalence of various diseases in developed countries in the region, and growth in government funding for research and development activities. According to the Association of the British Pharmaceutical Industry, around US$ 52 Bn was invested in R&D in the pharmaceutical industry in the U.S. in 2016.

The biotherapeutics cell line development market in Asia Pacific is estimated to expand at a faster CAGR than that in other regions, owing to considerable expansion of the biopharmaceutical industry and significant investment by global players to build manufacturing plants in the region.

Competition Landscape

The global biotherapeutics cell line development market is fragmented, with a large number of players operating in the market. Key players operating in the global biotherapeutics cell line development market include Merck KGaA, Becton, Dickinson and Company (BD), Danaher Corporation, Boehringer Ingelheim Group, Thermo Fisher Scientific, Inc., Lonza Group Ltd., Probiogen AG, Solentim Ltd., Selexis SA, and Sysmex Corporation. Mergers, acquisitions, strategic collaborations, and new product & technology launches are some of the major strategies adopted by prominent companies operating in the global biotherapeutics cell line development market.

Market Segmentation

By Process

  • Transfection & Selection
  • Single Cell Cloning
      • Manual LDC
      • FACs
      • ClonePix
      • Others

By CLD Option

  • In-house
  • Outsource
  • Do-It-Yourself
  • Hybrid

By Region

    • North America
      • U.S.
      • Canada
    • Europe
      • Germany
      • U.K.
      • France
      • Italy
      • Spain
      • Rest of Europe
    • Asia Pacific          
      • China
      • India
      • Japan
      • Australia & New Zealand
      • Rest of Asia Pacific
    • Latin America
      • Brazil
      • Mexico
      • Rest of Latin America
    • Middle East & Africa
      • GCC Countries
      • South Africa
      • Rest of Middle East & Africa

Report Scope

The Biotherapeutics cell line development market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Biotherapeutics cell line development market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Biotherapeutics cell line development market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Biotherapeutics cell line development market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Biotherapeutics cell line development market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Biotherapeutics cell line development capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Biotherapeutics cell line development by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Biotherapeutics cell line development market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Biotherapeutics cell line development market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Biotherapeutics cell line development market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Biotherapeutics cell line development industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

Biotherapeutics cell line development market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Biotherapeutics cell line development market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Biotherapeutics cell line development market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Biotherapeutics cell line development market. These factors have benefited the growth of the global market for Biotherapeutics cell line development. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Biotherapeutics cell line development. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Biotherapeutics cell line development are as follows:

  • History Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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