Cell and Gene Therapy CDMOs Catalyzing the Cell and Gene Therapy Revolution

The Global Cell and Gene Therapy (CGT) CDMO Market pegged at US$ 1.55 billion (2020) is expected to witness a precipitous growth rate of ~27% from 2021 to 2031.

Growing prevalence of cancer, favorable research landscape of cell & gene therapies, strong product pipeline, adoption of decentralized manufacturing of cell and gene therapies, rising collaborations among CDMOs & biotechnology companies, favorable funding climate, increasing government initiatives, rising investments, and increasing application of AI & data analytics 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.

Clairvoyance Research conducted an in-depth market analysis study of the global cell and gene therapy CDMO market. The study comprehensively analyzes the market from different perspectives and provides granular insights on hot revenue pockets, headwinds & tailwinds impacting the market, quantitative (market size & forecasts) and qualitative analysis on different segments, product pipeline assessment, value chain analysis, key criteria’s assessment for selecting a CGT CDMO, key strategies and competitive landscape.

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Growing Preference for Outsourcing of Manufacturing and Development Activities Set to Drive the Global Cell and Gene Therapy CDMO Market

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 & manufacturing activities to a CDMO allows a company to leverage:

• Scientific expertise
• Process expertise & efficiency
• Manufacturing capacity
• Process security
• Technical support
• Regulatory expertise
• Cost-effectiveness

Adoption of AI, Machine Learning and Data analytics – A Growing Trend

Small & medium-sized biotech companies have limited resources. Therefore, there is increasing demand to outsource and a constant push among CDMOs for digitization & exploration of technologies as it solves various issues. Embracing digitization and technologies such as AI, Machine Learning, and Data analytics allows CDMOs to gain a competitive advantage, as it allows them to improve manufacturing, enhance process efficiency and reduce overall project timeline & cost.

Growing Strategic Collaborations to Further Augment the Growth of Global Cell and Gene Therapy 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.

“Across the cell and gene therapy sector, collaborations are key to accelerating process improvements and commercialization of life-saving therapies.”

- General Manager, Leading Cell and Gene Therapy Company, United States

Capacity Constraint Due to High Demand – A Bottleneck for The Market

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.

Snapshot - Competitive Landscape

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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