Global CGT CDMO Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

Global CGT CDMO Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

A contract development and manufacturing company (CDMO) is a company within the pharmaceutical industry that provides drug development and manufacturing services. Pharmaceutical companies partner with CDMOs as a way to outsource drug development and drug manufacturing. Cell and gene therapy (CGT) involves living cells, tissues, viral vectors and non-viral gene modification components. Its R&D technology and production process are more difficult than those of traditional biological drugs. CGT CDMO, as the upstream of CGT pharmaceutical companies, can help cell therapy companies overcome many difficulties in R&D and production while reducing costs, to improve R&D efficiency and enhance the commercialization success rate. Contract development and manufacturing organizations (CDMOs) offer services that include process development, assay development, cell therapy production, and testing services. The pressure for manufacturing innovation and optimization can incentivize cell and gene therapy companies to seek third-party partners with technical, manufacturing, and regulatory expertise. Benefits of partnering with a cell or gene therapy CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies. This report features CDMOs that specialize in manufacturing and clinical trial support specifically for cell and gene therapies (CGT).

Market Overview:

The latest research study on the global CGT CDMO market finds that the global CGT CDMO market reached a value of USD 4129.71 million in 2022. It’s expected that the market will achieve USD 20489.61 million by 2028, exhibiting a CAGR of 30.6% during the forecast period.

The COVID-19 pandemic has had a massive impact on the development and manufacturing of cell and gene therapy. The number of clinical trials for Advanced Therapy Medicinal Products (ATMPs) increases due to the efficacy of the product such as mesenchymal stem cells (MSCs) treatment to fight against the virus. The FDA has established a special program for the acceleration of possible therapies for COVID-19 treatment. The program extends support for continuous activity in the clinical trials space and testing of drug molecules for the virus, which will ensure the safety and effectiveness of the drug. Gene and cell therapy have been identified as a potential treatment for the COVID-19 virus, as a result, the regulatory authorities have accelerated the drug development process and supply chain management. In the first half of 2020, the number of companies working on regenerative medicine therapies globally passed the 1,000 mark for the first time, with 415 companies entering clinical development. Of these, 515 are developing gene therapies and 632 are developing cell therapies. But the pandemic has affected the progress of many clinical trials, causing delays to regulatory applications and approvals.

Development of cell and gene therapy industry

The global CGT CDMO market is driven by growing burden of cancer and other targeted diseases, rapidly expanding research on CGTs, substantial funding by VCs and technological innovations. Robust CGT pipeline with growing number of product approvals, strong support from large pharma and biotech, and consistent investor enthusiasm (~$20 bn raised in 2020) is set to boost the demand for CGT CDMO services. A growing pipeline of therapies are nearing regulatory decisions. Out of 1,220 ongoing clinical trials in 2020, 152 were in Phase 3 -FDA and EMA predict approval of 10-20 cell and gene therapies each year by 2025.

Powerful functions and benefits

The powerful functions and benefits of CGT CDMO drive demand, which is beneficial to the development of the industry. CDMO manufacturers are well-known for their ability to help pharmaceutical companies scale. Shifts in production volume or the addition of a new drug variation can be extremely high risk considerations for pharma companies. But when they're in a CDMO partnership, those decisions are a much lower risk, and they're accompanied with shorter lead times.

The difficulty of manufacturing of CGTs

The manufacture of CGTs is labor intensive and expensive with manufacturing accounting for approximately 25% of operating expenses, plus there is still significant variation in the amount of product produced. On the medical side, many patients may not be suitable candidates for CGTs or not produce durable responses due to pre-exposure to the viral vector, poor gene expression, and/or the development of immunogenicity due to pre-exposure to viral vectors. Those that can receive these therapies may suffer infusion site reactions and unique adverse events such as cytokine release syndrome and neurological problems both of which can be fatal if not treated promptly.

Manufacturing capacity continues to constrain production

Cell and gene therapy companies looking to outsource CGT production are hampered by the continued industry-wide lack of availability of manufacturing space. In fact, there can be up to a two-year wait to rent manufacturing space from a CDMO, which is a challenge for those unable to project their process requirements that far in advance while still working through process development.

Region Overview:

In global comparison, a significant portion of the revenue was generated in North America (46.14% in 2021).

Company Overview

Catalent
Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Catalent's comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.

Lonza

Lonza Group is a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, headquartered in Basel, with major facilities in Europe, North America and South Asia. Lonza was established under that name in the late 19th-century in Switzerland. The company provides product development services to the pharmaceutical and biologic industries, including custom manufacturing of biopharmaceuticals and detection systems and services for the bioscience sector.

Catalent is one of the major players operating in the CGT CDMO market, holding a share of 28.91% in 2022.

Segmentation Overview:

By type, Viral Vectors segment accounted for the largest share of market in 2021.

Application Overview:

By application, the Pharmaceutical and Biotechnology Companies segment occupied the biggest share from 2017 to 2022.

Cell and gene therapy pharmaceutical and biotechnology companies with a strong research focus benefit by hiring a CDMO that can provide it with the regulatory experience needed, including multiple site inspections, process validation, and product approvals. Almost three-quarters of those at startups plan to engage a CDMO for production while only 16% plan to rely exclusively on internal manufacturing. A CDMO is designed to meet GMP requirements and understands how to collect data and build quality into the process, smoothing the path to regulatory approval. Besides, in addition to a potential lack of existing capacity, smaller companies whose therapies are still moving through their R&D or clinical pipeline may lack experience with commercial manufacturing. They may run into challenges with capital demand, their ability to establish a robust quality program, and understanding GMP regulatory requirements.

The mission of CGT Research and Academic Institutions is to investigate and employ the use of gene and cell based therapeutics for prevention and treatment of human diseases such as neuromuscular and neurodegenerative diseases, lysosomal storage disorders, ischemia and re-perfusion injury, neonatal hypertension, cancer and infectious diseases. With the development of cell and gene therapy (CGT) industry, academic contract development and manufacturing organizations (CDMOs) are also playing a critical role in the ecosystem.

Key Companies in the global CGT CDMO market covered in Chapter 3:

Novartis
Oxford Biomedica (OXB)
Pharmaron
Thermo Fisher
Lonza
Porton
WuXi AppTec
GenScript
Charles River
Catalent

In Chapter 4 and Chapter 14.2, on the basis of types, the CGT CDMO market from 2018 to 2029 is primarily split into:

Immune Cells
Stem Cells
Viral Vectors
Plasmid DNA

In Chapter 5 and Chapter 14.3, on the basis of Downstream Industry, the CGT CDMO market from 2018 to 2029 covers:

Pharmaceutical and Biotechnology Companies
Research and Academic Institutions
Others

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2018-2029) of the following regions are covered in Chapter 8 to Chapter 14:

North America (United States, Canada)
Europe (Germany, UK, France, Italy, Spain, Russia, Netherlands, Turkey, Switzerland, Sweden)
Asia Pacific (China, Japan, South Korea, Australia, India, Indonesia, Philippines, Malaysia)
Latin America (Brazil, Mexico, Argentina)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa)