Gene Therapy Cell Culture Media Market Size, Share & Trends Analysis Report By Type (Stem cell media, Serum-free media, Specialty media, Lysogeny broth, Chemically defined media, Custom media), By End-User (Pharmaceutical and biotechnology companies, Research laboratories, Academic institutions) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Market Overview

The global gene therapy cell culture media market size was valued at USD 143.42 billion in 2021. It is expected to reach USD 360.2 billion by 2030, growing at a CAGR of 10.8% during the forecast period (2022–2030).

Gene therapy and cell culture media refer to an experimental technique used for treating or preventing diseases. The technique includes replacing a default gene with a healthy gene and inactivating the function of the faulty gene. Cell culture media is composed of appropriate levels of amino acids, inorganic salts, vitamins, glucose, and serum, among others. The media requires additional supplementary reagents and sera such as hormones, growth factors, trace elements, lipids, and minerals for the cell cultures to grow and survive in the incubation environment.

The market's most prominent driver is the increased funding for R&D activities on gene therapy cell culture media. For instance, on April 11^th, 2019: Asklepios Biopharmaceutical Inc. invested about USD 235 million in R&D activities for performing extensive clinical trials of gene therapy.

Innovative medicines in pipeline

Market Dynamics

Fda's efforts to develop innovative technologies to drive the market

The utility of cell culture media stands as a platform to grow and modify genes and incorporate them by replacing damaged tissue or the default gene. In gene therapy, cell culture media technology is carried out by utilizing adult cells that are genetically reprogrammed and capable of becoming one of the main types of cells incorporated inside the patient's body. This technique helps to develop limitless specific human cells needed for therapeutic purposes. For instance, recently developed CAR-T cells are genetically modified before reintroducing it in the patient's body. Similarly, gene therapy using AAV vector delivers high activity Factor 9 gene to the liver for treating hemophilia B.

FDA is also channelizing efforts to develop innovative technologies that integrate genome editing technology, novel gene delivery method, and advanced manufacturing technology in the field of gene therapy and cell culture media. It is collaborating with leading players to foster the development of transformational technology that facilitates the manufacturing of safe and effective gene therapy products with therapeutic interventions. Similarly, the National Institute of Health (NIH) is one of the pioneers in gene therapy.

Growing biopharmaceutical drugs in pipeline  

Rising R&D activities in novel gene therapy cell culture media are bolstering the advent of a wide variety of treatments for a number of challenging diseases. For instance, on May 24^th, 2019: Novartis developed the novel technique of gene therapy that uses a recombinant AAV9 vector to deliver a specific gene, which is currently in development as a one-time treatment for spinal muscular atrophy (SMA). It will have the potential to prevent further muscular degeneration by addressing the primary defective SMN gene. Similarly, on September 10^th, 2018, Stargen developed the novel treatment of gene therapy for the treatment of Stargardt disease (juvenile-onset macular dystrophy) delivers a corrected version of the ABCR gene directly in the photoreceptor of the retina.

Rising fda approvals in the field of gene therapy

To date, the FDA has approved four gene therapy products. On August 30^th, 2017: the FDA approved Kymriah (tisagenlecleucel) for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients.

Gene editing

Gene editing is a technique used for modifying genome sequences through nucleases. The technique comprises insertion, replacement, removal, and modification at a particular location in the human genome to treat diseases. One such example is Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology. The CRISPR segment is expected to hold the largest market share of 45.97% in the market.  

Gene sequencing

The genome sequencing technique is a targeted sequencing approach that provides alternatives for in-depth investigation to the researchers. Currently, targeted sequencing is one of the novel techniques used for treating genetic disorders.

On March 26^th, 2019, Illunina collaborated with Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark. The collaboration of the companies is undertaking business strategies that drive down the next-generation sequencing cost to nearly USD 100.

Regional Analysis

Asia-pacific: home to the fastest-growing gene therapy cell culture media market

Asia-Pacific is the fastest-growing market globally. Several countries are investing heavily in gene therapy research in APAC countries. The partnerships between industries and Universities are bolstering the market growth in the region. Additionally, countries like India and China have introduced new regulations to attract investors and increase R&D activities in gene therapy. Similarly, the Singapore government is planning to invest USD 80 million in R&D activities, manufacturing, and clinical trials of gene therapy.

South Korea is pushing its bioethics law to assist local scientists and universities to focus on R&D of a variety of gene therapies and to boost the country's development in the biotechnology sector. Korea is considered a country that will strengthen and sustain the existence of novel techniques, such as gene therapy research. One such novel gene-editing tool is 'CRISPR-CAs9,' which is efficient in editing, removing, altering, and introducing new sections of the DNA sequence.

Segmental Analysis

The gene therapy cell culture media market is segmented by type and end-user.

By type

By type, the market is segmented into stem cell media, serum-free media, chemically defined media, lysogeny broth, specialty media, and custom media. The stem cell media segment is projected to hold significant market share during the forecast period. Increasing R&D funding, rising awareness regarding regenerative medicines, and development of advanced genetic methods for stem cell analysis are driving the segment growth. In addition, reduced regulatory barriers for conducting stem cell studies in developing countries are offering lucrative opportunities to the market leaders in the stem cell culture media segment.

Genetically modified stem cells express angiogenic factors and enable efficacy for therapeutic angiogenesis. The modification and overexpressing Mesenchymal stem cells (MSCs) enhances angiogenesis. The in-vivo technique of incorporation reduces heart attacks, improves therapeutic efficiency of cell transplantation, and helps in the treatment of myocardium.

The serum-free media segment is anticipated to grow at a CAGR of 7.28% during the forecast period. The segment's most prominent driver is its high utilization in biopharmaceutical companies. Serum-free media provides superior cell culture growth compared to serum-containing media. Serum contains several unidentified compounds, which might hamper the quality of the product. This is why, biopharmaceutical companies prefer serum-free media cell culture.

By end-user

By end-user, the market is segmented into pharmaceutical and biotechnology companies, research laboratories, and academic institutes. The pharmaceutical and biotechnology companies segment is expected to capture the largest market share and grow at a CAGR of 10.78%. Rising R&D activities, coupled with the development of novel drugs for the treatment of CVD, lysosomal storage diseases, and impaired metabolic pathways, is driving the segment growth.

Recent Developments

• On August 21^st, 2019, Pfizer invested USD 500 million for establishing new manufacturing and research facilities for gene therapy in Stanford, North Carolina.
• On January 28^th, 2020, FDA announced the Orphan Drug Regulation, which involves guidance on gene therapy manufacturing and clinical development of products, interpretation, and maintaining similarity of gene therapy products
• On November 12^th, 2019, Merck signed a license agreement with Evotec SE. The agreement provides Evotec access to Merck's foundational CRISPR intellectual property rights
• On May 6^th, 2013, Roche and BioLamina signed an R&D agreement to jointly develop new cell culture systems for various applications that highly integrates stem cell research. As per the agreement, Roche will offer R&D funding and scientific expertise to BioLamina
• On April 10^th, 2018, Lonza Group Ltd. established a new manufacturing facility in the U.S. to increase its production capacity in terms of viral gene and virally modified cell therapy products
• On June 17^th, 2015, WuXi AppTec's partnered with the University of Pennysylvania to develop viral vectors in gene therapy