Biotherapeutics Cell Line Development Market Perspective with Professional Survey & Competitive Dynamics till 2022-2030

Research and Development Activities to Redefine Next-generation Biotherapeutics Cell Line Development

The protein pharmaceutical space has gradually matured into a multibillion-dollar industry over the past couple of decades. However, identifying the ideal bio-therapeutic development cell lines has posed as a major barrier in the manufacturing process. Biotherapeutic cell line development has reached new frontiers, owing to considerable genomic research and development activities. In addition, existing as well as emerging technologies in the biotherapeutics cell line development have played an integral role in pushing cell engineering toward new frontiers. Over the past couple of decades, considerable work has been put in toward optimization of codons and construction of vectors due to which, biotherapeutics cell line development has garnered noteworthy attention.

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Regulatory changes, introduction of new technologies, and advent of an array of innovative concepts have played a key role in influencing the overall growth of the global biotherapeutics cell line development market over the past few years– a trend that is expected to continue during the forecast period. Over the past few decades, academic and commercial scientists have largely focused on addressing the shortcomings of initial formulations of biotherapeutics cell lines. Several companies operating in the current biotherapeutics cell line development market landscape are introducing new variants of cell line development solutions to cater to industrial requirements.

At the back of these factors, along with consistent rise in the number of investments, the global biotherapeutics cell line development market is expected to reach ~US$ 224 Mn by 2030. Apart from these factors, the growing support offered by government bodies around the world to promote biotechnology and the pharmaceutical industry is another factor that is expected to set the tone for the development of the global biotherapeutics cell line development market during the assessment period.

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.

However, at present, market players are increasingly focusing on streamlining the process of segregating high-producing protein secretors from low-producing protein secretors, which are highly tedious and time-consuming as over thousands of clones are screened in a period of few weeks. However, the onset of the multi-open reading frame (ORF) constructs in cells could possibly lead to a compromise, fragmented DNA being integrated into the genome in place of the requisite sequence. Market players operating in the current market for biotherapeutics cell line development are increasingly focusing on streamlining segregation processes to fast-track cell line development. At present, the pursuit of novel biopharmaceutical agents continues to remain one of the most critical challenges in the pharmaceutical research and drug development sphere.

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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.

Market Players Scramble to Find New Solutions to Stop COVID-19 Transmission

The COVID-19 pandemic is currently playing a huge role in derailing the world economy, as industries and businesses around the world continue to remain shut due to social distancing norms and lockdowns enforced by governments. While several industrial sectors are witnessing minimal activity during the COVID-19 event, the pharmaceutical sector is currently burdened with the demand for effective solutions and products to combat the COVID-19 infection. Several players operating in the current biotherapeutics cell line development market are investing in research and development activities to combat the COVID-19 virus. Market players are expected to look beyond the conventional means of antibody-drug manufacturing and discover novel ways to enhance productivity. Several market players are currently collaborating with scientists to discover potential solutions to prevent the spread of the COVID-19 infection. While the market is likely to witness steady growth in 2020 due to the COVID-19 event, all eyes will be on research and development activities.

Analysts’ Viewpoint

The global biotherapeutics cell line development market is expected to grow at a CAGR of ~7% during the forecast period. 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.

Biotherapeutics Cell Line Development Market: 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

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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

Market Segmentation: Global 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 has been sub-divided into manual LDC, FACs, ClonePix, and others

In terms of CLD option, the global biotherapeutics cell line development market has been divided into in-house, outsourced, Do-It-Yourself, and hybrid

Each of the segments of the global biotherapeutics cell line development market has been analyzed in detail for recent trends and developments, drivers, restraints, opportunities, and useful insights. The report on the global biotherapeutics cell line development market provides current and future revenues (US$ Mn) for each of these segments for the period from 2018 to 2030, considering 2019 as the base year. The compounded annual growth rate (% CAGR) has been provided for each segment of the market from 2020 to 2030, along with market size estimations.

Regional Overview: Biotherapeutics Cell Line Development Market

In terms of region, the global biotherapeutics cell line development market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The markets in these regions have been further divided into major countries and sub-regions.

North America dominated the global biotherapeutics cell line development market in 2019 and the trend is expected to continue during the forecast period

Asia Pacific is likely to be a highly lucrative market for biotherapeutics cell line development during the forecast period

The biotherapeutics cell line development market size in terms of revenue (US$ Mn) for different regions and their major countries have been provided in the report for the period from 2018 to 2030, along with their CAGRs for the period from 2020 to 2030

The study also offers a list of recommendations, highlights, and useful insights of the global market, which would help new companies willing to enter the market and the existing companies gain higher market share. It would also help them in the decision-making process.

Major Players

The report on the global biotherapeutics cell line development market concludes with the company profiles section, which includes key information about major players operating in the market

Key players analyzed in the report on the global biotherapeutics cell line development market are 

  • 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
  • Sysmex Corporation.

Each of these players has been profiled in the report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments.

Key Questions Answered in Biotherapeutics Cell Line Development Market Report

  • What is the sales/revenue generated by each process and CLD option segment of the biotherapeutics cell line development market across all regions during the forecast period?
  • What are the opportunities in the global biotherapeutics cell line development market?
  • What are the major drivers, restraints, opportunities, and threats in the market?
  • Which region is likely to expand at the fastest CAGR during the forecast period?
  • Which biotherapeutics cell line development segments are expected to generate the highest revenue globally in 2030? Which segment is projected to expand at the highest CAGR during the forecast period?
  • What is the market share or position of different companies operating in the global market in 2019?

Biotherapeutics Cell Line Development Market – Segmentation

Process

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

CLD Option

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

Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

TABLE OF CONTENT

1. Preface

1.1. Market Definition and Scope

1.2. Market Segmentation

1.3. Key Research Objectives

1.4. Research Highlights

2. Assumptions and Research Methodology

3. Executive Summary: Global Biotherapeutics Cell Line Development Market

4. Market Overview

4.1. Introduction

4.1.1. Process Definition

4.1.2. Industry Evolution / Developments

4.2. Overview

4.3. Market Dynamics

4.3.1. Drivers

4.3.2. Restraints

4.3.3. Opportunities

4.4. Global Biotherapeutics Cell Line Development Market Analysis and Forecast, 2018–2030

4.4.1. Market Revenue Projections (US$ Mn)

5. Key Insights

5.1. Key Mergers & Acquisitions

5.2. Overview of Cell Line Development Process for Biotherapeutics

5.3. COVID-19 Pandemics Impact on Industry (Value Chain and Short / Mid / Long Term Impact)

6. Global Biotherapeutics Cell Line Development Market Analysis and Forecast, by Process

6.1. Introduction & Definition

6.2. Key Findings / Developments

6.3. Market Value Forecast, by Process, 2018–2030

6.3.1. Transfection & Selection

6.3.2. Single Cell Cloning

6.3.2.1. Manual LDC

6.3.2.2. FACs

6.3.2.3. ClonePix

6.3.2.4. Others

6.4. Market Attractiveness, by Process, 2020-2030

7. Global Biotherapeutics Cell Line Development Market Analysis and Forecast, by  CLD Option

7.1. Introduction & Definition

7.2. Key Findings / Developments

7.3. Market Value Forecast, by  CLD Option, 2018–2030

7.3.1. In-house

7.3.2. Outsource

7.3.3. Do-It-Yourself

7.3.4. Hybrid

7.4. Market Attractiveness, by CLD Option, 2020-2030

8. Global Biotherapeutics Cell Line Development Market Analysis and Forecast, by  Region

8.1. Key Findings

8.2. Market Value Forecast, by  Region

8.2.1. North America

8.2.2. Europe

8.2.3. Asia Pacific

8.2.4. Latin America

8.2.5. Middle East & Africa

8.3. Market Attractiveness, by Country/Region, 2020-2030

9. North America Biotherapeutics Cell Line Development Market Analysis and Forecast

……

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