Cell Line Development Market Size, Share & Trends Analysis Report by Product, By Source (Mammalian, Non-Mammalian), By Type of Cells, By Application, By Technology, And Segment Forecasts, 2012 - 2022

Industry Insights

The global cell line development market size was estimated at USD 2.67 billion in 2015 and is anticipated to grow at a CAGR of 12.9% over the forecast period. The growing biopharmaceutical industry is anticipated to drive the demand for cell line development procedures.

Most of the biopharma companies used cells as an expression host for recombinant monoclonal antibody production. Increase in demand for monoclonal antibodies, cancer therapeutics, and the availability of advanced technologies to produce novel cell lines are expected to propel the market growth in the coming years.

In addition, the rise in the production of biosimilars due to patent expiry of branded therapeutics and recombinant proteins is anticipated to boost the demand. Increasing chronic disease incidence demands effective treatment solutions thereby fueling the demand to produce biosimilars, vaccines, therapeutic proteins, and novel drugs during the forecast period.

For instance, the human cell lines used for vaccine production are WI-38 cell line developed in the U.S., and MRC-5 cell line developed in the U.K. The vaccines developed by using animal cells are used for the treatment of polio, rotavirus, smallpox, and Japanese encephalitis. The vaccines produced include hepatitis A, rubella, varicella, zoster, adenovirus type 4 & 7 oral, and rabies.

Furthermore, the growing adoption of regenerative medicine, healthcare expenditure levels, and an increase in investments in the biotechnology industry are some of the factors attributing to the industry growth. Gene therapy, cell culture, and drug discovery are few of the biotechnology-based applications of this industry.

Product Insights

Reagents and media accounted for the largest revenue share as of 2014 due to increasing bio-production that requires these products from incubation to preservation. These products are cost-intensive nature and have repetitive use in the production of biologics hence accounted for the largest revenue share.

Reagents used are attachments and matrix factors, antibiotics, biological buffers, cell freezing, separation and dissociation reagents, and other miscellaneous reagents. Media and salt are essential in bio-production as they provide nutrients to cells and fuel the growth. Some of the most commonly used products are Hans F-10 media, RPMI media, medium 199, MEM media, and DMEM media.

Equipment used are incubators, bioreactors, storage equipment, centrifuge, and microscopes. Bioreactors held the dominant share as of 2014 in the equipment segment due to its usage in large-scale manufacturing of biologics. The introduction of single-use bioreactors is a major driver contributing to the growth of the bioreactor segment over the forecast period. Single-use bioreactors are accompanied by advantages such as cost-effectiveness, time management, and protection against cross-contamination.

On the other hand, the accessories and consumables segment is anticipated to show lucrative growth due to the rising adoption of disposables in these procedures. Increasing laboratory setups for biologics production and R&D activities is attributing to this.

Source Insights

Cell lines development is initiated via organs or tissues collected from mammalians or non-mammalian sources. The source selection is a prerequisite for the development of stable cell lines for commercial purposes. Rising adoption of a mammalian source for the monoclonal antibodies production and the need for expressing complex proteins similar to human beings are expected to boost the adoption of this segment in the coming years.

In addition, enhanced cell engineering and expression systems for this source development are expected to propel the demand.  There are over 4,000 mammalian cell lines available for the use in biologics production and research is going on for the introduction of a few more. This is expected to serve the mammalian source segment with lucrative opportunities.

In general, this technology is based on Glutamine Synthetase (GS) system or methotrexate (MTX) amplification technology. However, the clones produced by these technologies are heterogeneous in nature and hence need to be screened for the selection of stable high productive cell clones and require six to twelve months.

Advancements in clone screening and protein expression in the mammalian source to improve efficiency and speed of producing highly productive cell lines on large-scale production of therapeutic proteins are the factors responsible for segment spearheading.

Type Insights

The recombinant segment accounted for the largest revenue share as of 2014 due to its wide applications in protein interactions, gene activation, and biologics production methods. Furthermore, rising demand for toxicity testing and drug screening are anticipated to fuel the demand in the coming years.

Increase in demand for biologic therapeutics to treat autoimmune disorders, and cancer is the key contributing factor for the high adoption of recombinant proteins during the forecast period. These products are enzymes, blood factors, monoclonal antibodies, hormones, and antibody-related molecules. There are around 650 protein therapeutics approved globally, out of which more than 400 products are recombinant.

Cell line development is an important step in recombinant protein production. The lucrative growth of these proteins due to advancements in expression vector design, clone screening, and cell engineering technologies. Increasing focus on the development of monoclonal cell lines that are stable & consistently expressing the protein with high quality is also expected to fuel the segment growth in the coming years.

Primary cell culture is the fastest-growing segment due to its wide application in genetics, cell morphology, cell metabolism, and physiology. Cell culture is initiated from embryonic, normal, and malignant tissues. From single blood cells, a variety of cells are produced, hence, primary cell cultures are often mixed and grow in in-vitro conditions. The increasing demand for in vitro production of biologics is expected to fuel the demand for this segment during the forecast period.

Application Insights

Cell line development found the largest significance and application in the bio-production of biosimilars, biologics, vaccines, a therapeutic protein, and Mabs. Increasing prevalence of chronic diseases such as cancer and autoimmune diseases is pushing demand for faster and effective therapeutics.

The bioproduction segment accounted for the largest revenue share in 2014 owing to increasing antibiotic and vaccine production. Production of biologics based therapeutic drugs including vaccines, therapeutic proteins, cell therapies, and gene therapies together constitutes the bioproduction application segment. Antibiotics and vaccine production are the most prominent applications of bioproduction and the demand is expected to grow exponentially in the future due to the rise of pandemic and communicable diseases especially in the developing economies.

Currently available vaccines produced by this technology are polio vaccines produced by monkey kidney and neoplastic cell lines. Therapeutic protein is one of the rapidly growing industries due to molecular engineered proteins with optimal target recognition, bio-distribution, pharmacokinetics, and therapeutic functioning.

The bioproduction segment is driven by factors such as increasing in-vitro research activities, safety and efficacy concerns about the product, introduction of biosimilars, and high demand for cellular medicines. Commonly used cell lines for the production of biologics are CHO, GS-knockout CHO-K1, CHO-K1, 293T, HEK293, 293EC18/CRE-Luc, 1321N1, 293EC18, U-2OS, and RH7777 

Regional Insights

North America regional market is accounted for the largest revenue share as of 2014 due to the presence of constant technological developments followed by new discoveries triggering the adoption of novel procedures for bioproduction. The presence of rigorous initiatives conducted by research organizations functioning in this region such as Thermo Fisher Scientific Inc., American Type Culture Collection (ATCC), and Sigma-Aldrich Corporation which provide high-quality biologics services is attributing toward the growth.

In addition, supportive government initiatives and growing awareness pertaining to monoclonal antibodies application in cancer treatment are some of the factors expected to drive the regional industry growth.

Asia Pacific regional market is anticipated to witness lucrative growth owing to increasing expenditure on healthcare by government and private sector companies. The biotechnology industry in developing economies is expected to show significant growth during the forecast period. In the developing economies, government initiatives such as public healthcare programs and improved healthcare infrastructure are contributing to the growth of the biotechnology sector.

For instance, in India, organizations such as the Department of Science and Technology (DST), Department of Scientific & Industrial Research (DSIR) and Department of Biotechnology (DBT) are regulating the production and guidelines for biotechnology products. These organizations provide guidelines related to manufacture or transfer technology, raising funds, and generating manpower for production.  Initiatives like these are expected to fuel the growth over the forecast period.

Cell Line Development Market Share Insights

Some of the key players operating in this market are GE Healthcare, Lonza Group AG, Sartorious AG, WuXi AppTec Inc., Sigma-Aldrich Corporation, Selexis SA, Thermo Fisher Scientific Inc., and Corning Inc. Government organizations such as the European Collection of Cell Cultures (ECACC) and American Type Culture Collection (ATCC) are also operating in this industry.

ATCC and ECACC had a considerable market share as they are exclusive suppliers of authentic cell lines. Key factors attributing to the aforementioned conclusion include the presence of an extensive product portfolio especially catering to cell lines, media, and reagent, equipment, and consumables globally.

The market is competitive in nature with high industry rivalry. Market players are struggling to gain competitive advantage via capitalizing untapped opportunities in the market space. Similarly, strategic initiatives such as partnership agreements, patent registration, licensing and merger, and acquisition are expected to fuel the growth of the market.

The entry of multinational healthcare establishments promoting safe and effective medical practices will enhance the healthcare quality in countries especially India and China are also anticipated to fuel the market growth.

Report Scope 

Segments Covered in the Report

This report forecasts revenue growth at global, regional, & country levels, and provides an analysis of the industry trends in each of the sub-segments from 2012 to 2022. For the purpose of this study, Grand View Research has segmented the global cell line development market on the basis of product, source, types, application, and region:

• Product Outlook (Revenue, USD Million, 2012 - 2022)

  • Reagents and media

  • Equipment

    • Incubators

    • Centrifuges

    • Bioreactors

    • Storage equipment

    • Microscopes

  • Accessories and consumables

• Source Outlook (Revenue, USD Million, 2012 - 2022)

  • Mammalian cell line

  • Non-mammalian cell line

    • Insects

    • Amphibians

• Type of Cell Line Outlook (Revenue, USD Million, 2012 - 2022)

  • Recombinant cell lines

  • Hybridomas

  • Continuous cell lines

  • Primary cell lines

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Bioproduction

  • Drug discovery

  • Toxicity testing

  • Tissue engineering

  • Research

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • Germany

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • The Middle East & Africa

    • South Africa