Cell and Gene Therapy Manufacturing QC Market

Market Overview

The global cell and gene therapy manufacturing QC market size was estimated to be worth $1.03 billion in 2021, and it is expected to reach $5.37 billion by 2030, expanding at a CAGR of 22.93% from 2021 to 2030.

Cell therapy refers to the process of administering live cells to patients with the purpose of treating various diseases. Both autologous and allogeneic cells, which can be produced from stem cells found in places like bone marrow, can serve as the source of the cell. The treatment of bone marrow transplant patients often involves stem cell therapy. In the context of medical practice, "gene therapy" refers to any procedure that modifies, deletes, or otherwise alters a patient's genetic code. In addition, it can change the way a person's genes are expressed or fix genes that aren't functioning properly. In this treatment, nucleic acid (DNA or RNA) is given to the patient together with carriers that are referred to as vectors.

The introduction of advanced therapeutics has played a significant part in the transformation of the treatment paradigm for a number of life-threatening and uncommon diseases, as well as in the restructuring of the biopharmaceutical sector as a whole. A primary element that is driving the expansion of the industry is the rapid development of new sophisticated therapies and associated infrastructure.

Quality control in manufacturing for cell and gene therapy is expected to be one of the markets with the highest rate of change. A persistent driving force behind the rise of overall acceptance of novel medicines is manufacturing, which is a hallmark of enabling advanced therapies to be spread across the patient community.  Quality Control is an essential component of the manufacturing process, particularly when it comes to developing cutting-edge treatments like cell and gene therapies.

Aside from the generating of profits, the primary means through which the cost of therapy may be managed is by optimizing the costs of manufacture.

In addition to this, the cost-effective improvement of the underlying components, such as quality control, will be required.

Market Dynamics

Cell and Gene Therapy Manufacturing QC Market Drivers

The Rise in The Incidence of Cancer and Heart Diseases

Cell therapy targets various diseases at the cellular level, such as by restoring a certain cell population or by using cells as carriers of the therapeutic carriers, whereas gene therapy aims to influence the course of various genetic and acquired disorders at the genetic level. Gene therapies also aim to treat inherited disorders as well as acquired ones. It is anticipated that the high incidence of cardiovascular illness would accelerate demand for cell and gene therapy, which will in turn fuel the growth of the market. As of May 2017, the World Health Organization (WHO) reported that cardiovascular disease was the cause of death for around 17.9 million persons throughout the world in 2016. This figure represents 31 percent of all deaths that occurred across the globe. According to the World Health Organization (WHO), in 2012, cancer was the second biggest cause of morbidity and mortality worldwide. In that same year, around 14 million new cases of cancer were diagnosed worldwide. In 2015, cancer was the cause of 8.8 million deaths throughout the globe. In addition, the WHO reported that they anticipate a rise in the number of new cases of around 70 percent by the year 2030.

Investing More in Pharmaceutical Research And Development

The majority of pharmaceutical companies continue to make significant investments in the development of new medications and equipment. The pharmaceutical business, in particular, is heavily invested in research and development. Pharmaceutical firms spend on research and development in order to bring high-quality, innovative goods to market. The trend implies that major pharma companies are enhancing their R&D efficiency by investing heavily in R&D in order to obtain long-term returns on their investment, as well as through collaborating on R&D. According to a survey published by EvaluatePharma, global pharmaceutical R&D investment was estimated at $136 billion in 2012, rising to USD 186 billion in 2019. The worldwide pharma R&D growth rate has slowed to 0.3 percent between 2019 and 2020 as a result of COVID-19. According to the conclusions of the analysis, R&D spending is predicted to expand at a CAGR of 3.2 percent between 2019 and 2026, reaching USD 232.5 billion, slower than the historical CAGR of 4.6 percent between 2012 and 2019.

Cell and Gene Therapy Manufacturing QC Market Restraints

High Operation Expense for Cell And Gene Therapy

There are around 1,200 cell and gene treatments being tested in clinical settings across the world. Only in the United States are there now more than 700 experimental cell and gene treatments being tested in human patients. However, the production facilities have not kept up with the demand. It is projected that hundreds of different types of facilities will be required in order to produce the medications that are now undergoing clinical testing. The capacity of the viruses is one of the areas that have to be improved upon. The vast majority of viral vectors are created by adherent manufacturing, which is a labor- and capital-intensive process. For example, the production of a vial containing 20 million cells can cost between 20,000 and 30,000 United States Dollars. The costs associated with manufacturing gene therapy can range anywhere from $500,000 to $1 million. This does not include the costs of research and development, the costs associated with running crucial clinical trials, or the costs associated with building the commercial infrastructure required to provide access to patients.

Cell and Gene Therapy Manufacturing QC Market Opportunity

Clinical Studies for Cell and Gene Therapy Are Becoming More Common

Clinical tests are an essential component of medical research, and they provide assistance to the pharmaceutical and biopharmaceutical industries in their efforts to develop and bring innovative cell and gene treatments to market. As a consequence of the increased need for innovative medications to satisfy unmet medical requirements, there has been a worldwide increase in the number of clinical trials that have been conducted during the past several years. In 2018, there were 289 cell and gene treatments that were in the clinical development stage at biopharmaceutical firms, as stated in a study that was published by PhRMA on the cell and gene therapy pipeline in 2020. In the year 2020, there were 362 cell and gene treatments that were in the clinical development stage. This represented a 25 % increase from the previous year. In addition to this, according to data that was made public by CGT Catapult, there were 154 ATMP clinical studies happening in the UK in the year 2020. This number represents an increase of more than 20 percent when compared to the 127 trials that were recorded in 2019. It is anticipated that the considerable increase in the number of cell and gene therapy clinical trials would boost the need for manufacturing services, which will, in turn, promote expansion in the market for cell and gene therapy manufacturing services.

Approvals for drugs and a robust pipeline of cell and gene therapies are also a great opportunity to drive growth in this market.

Regional Analysis

Based on Region the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East.

Because of a large number of ongoing cell and gene therapy clinical trials, massive amounts of government funding, expansion activities by major companies, and an overall high adoption rate for developing therapies, the North American region holds the largest share of the cell and gene therapy manufacturing quality control market. In addition to this, it is predicted that growth in the Asia-Pacific region would occur at the highest CAGR over the projection period of 2020-2030.

Segmental Analysis

The cell and gene therapy manufacturing QC market has been segmented into the following, Products, Processes, Analytical methods, technology and region.

Based on Products the global market is divided into Services and Products (Kits and Assays, Instruments, Reagents, and Software).

Based on process the global market is classified into the following: Starting Material Preparation, Upstream Processing, and Downstream Processing.

Based on analytical methods the global market is segmented into Safety Testing, Purity Testing, Potency Testing, Identity Testing, and Stability Testing.

Based on technology the global market is divided into Polymerase Chain Reaction (PCR), Flow Cytometry, Limulus Amebocyte Lysate (LAL), and Enzyme-Linked Immunosorbent Assay (ELISA), Chromatography, Mass Spectrometry, Western Blotting, Next-Generation Sequencing (NGS), and Electrophoresis, among others.

Recent Developments

In 2021, Charles River Laboratories expanded its cell and gene therapy manufacturing capabilities by purchasing Cognate BioServices, a contract manufacturing organization (CMO) specializing in cell and gene therapy.

Thermo Fisher Scientific paid roughly USD 859.7 million to buy Henogen S.A. in 2021. Halogen S.A. was the viral vector production company that Novasep operated in Belgium. Through this purchase, it will be able to strengthen its position in the manufacturing therapeutic market for cell and gene therapies.

In 2019, Thermo Fisher Scientific spent $1.7 billion to purchase Brammer Bio, a firm whose primary business was the production of viral vectors for use in gene and cell treatments.