Cell and Gene Therapy (CGT) CDMO Market – Global Outlook & Forecast 2021-2031

Cell and Gene Therapy (CGT) CDMO Market by Type [Cell Therapy and Gene Therapy], Development Stage [Preclinical, Clinical, and Commercial] – Global Analysis & Forecast 2021-2031

Clairvoyance Research conducted an in-depth market analysis study of the global cell and gene therapy CDMO market. According to the study, the market was valued at ~US$ 1.55 billion in 2020. The market is expected to witness a CAGR of ~27% from 2021 to 2031.

Growing prevalence of cancer, strong product pipeline, rising investments, adoption of decentralized manufacturing of cell and gene therapies, favorable funding environment, increasing application of AI & data analytics, favorable research landscape of cell & gene therapies, and rising collaborations among CDMOs & biotechnology companies are some of the pivotal factors propelling the growth of the cell and gene therapy CDMO market. However, capacity constraints and lack of skilled professionals are likely to hinder the growth of the market to a certain extent.

To fast-track the development of CGT and to meet the needs of the healthcare sector, several initiatives such as collaborations, providing necessary grants, permission, clearances & approvals have been instigated by various organizations and government agencies across the world. For instance, in Oct 2021, The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies, and five non-profit organizations partnered to accelerate the development of gene therapies for the 30 million Americans who suffer from a rare disease.

Cell and Gene Therapies (CGT) are not only transforming how humans treat genetic diseases but are also altering the entire healthcare ecosystem. The landmark approval of Novartis’ KYMRIAH to treat a rare form of childhood blindness in 2017 by the FDA, marked the beginning of a therapeutic revolution in the cell and gene therapy field. Since then, there has been tremendous demand for novel cell and gene therapies. An increase in investments in CGT has further risen the promise of curative treatments for high-unmet-need diseases. At present, around 1,200 experimental therapies are in pipeline and half of them are in Phase 2 clinical trials. The FDA predicts that by 2025 it will be approving 10 to 20 CGT every year. Owing to accelerated regulatory approvals, rising demands for effective therapy, the need for quick scale-up, and the necessity to stay competitive in the market; small & medium-sized companies are turning to CDMOs to outsource both development and manufacturing activities. Outsourcing of development and manufacturing activities to a CDMO allows a company to bring their products to market with greater efficiency, by eliminating all the hidden overhead costs as well as unnecessary spending, while meeting all the regulatory requirements set by the regulatory body. These factors are expected to boost the CGT CDMO market.

In the past few years, the industry has witnessed a rise in manufacturing agreements, production & distribution (PD) agreements, licensing agreements, joint ventures, and/or service alliances amongst developers, CDMOs, and technology vendors. There has been a constant demand for CDMOs with biotech expertise for long-term strategic collaborations, which will allow biotechnology companies to focus on innovation and marketing. The collaborations have increased almost 10-fold from 42 in 2013 to more than 444 in 2018. For instance, in Oct 2021, LEXEO Therapeutics, a clinical-stage gene therapy company partnered with Fujifilm Diosynth Biotechnologies (FDB) to support the development and manufacturing of its AAV-mediated gene therapies.

The number of cell and gene therapy clinical trials is growing at approximately 30% each year, mainly driven by small and mid-sized biotech companies that depend on CDMOs. This rapid expansion of the pipeline has created a shortage of manufacturing capacity. Biotech companies are facing an 18-24 month waiting period to access capacity at existing CDMOs. This factor is expected to restrain the market growth to a certain extent. Furthermore, the shortage of skilled professionals with expertise in process development and manufacturing of these complex next-generation medicines is another bottleneck for the market.
The European region is the 2nd largest cell and gene therapy CDMO market. The factors such as the presence of a large number of biotechnology companies, CGT CDMOs & life science universities, rising investments, and unmet clinical needs can be attributed for the growth of the market. Between 2005 and 2018, Europe accounted for around 16% of total CGT patent registrations. Furthermore, rising initiatives by prominent players to scale up the production facilities are also expected to boost the market. For instance, in Jun 2021, Yposkesi, a CDMO specialized in cell and gene therapies, announced the launch of project SKY, which includes the construction of its second commercial cell and gene therapy manufacturing facility on its campus in Corbeil-Essonnes, France.

The cell and gene therapy CDMO market is marked by the presence of prominent players such as Catalent, Inc, Lonza, Thermo Fisher Scientific/Patheon, WuXi Advanced Therapies (WuXi ATU), and Oxford Biomedica. Other prominent/emerging players operating in the market are Merck KGaA, AGC Biologics, Samsung Biologics, Boehringer Ingelheim International GmbH, BIOCENTRIQ, Minaris Regenerative Medicine, FUJIFILM Diosynth Biotechnologies, Exothera, Merck, VIVEbiotech, Vibalogics, among others.

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