CDMOs, or contract development and manufacturing organization, provide services ranging from drug development and manufacturing to pharmaceutical packaging, including serialization and aggregation. These organizations provide support services to multiple businesses based on their or their customers' designs, specifications, and formulas. Therapeutic nucleic acid (TNA), according to the National Center for Biotechnology Information, is a subset of nucleic acids that consists of closely related compounds used to treat disease (NCBI). Apart from gene therapy, the fundamental concept underlying the use of nucleic acids in therapeutics is to restrict DNA or RNA expression. This will prevent the production of abnormal proteins associated with a disease without affecting other proteins. TNA are high-molecular-weight, positively-charged compounds with distinct physicochemical properties from small-molecule drugs and biological instability.
The rapid development of novel cell and gene therapies has captivated the attention of major pharmaceutical companies and is further altering the conventional biopharmaceutical business model. Even though the initial drug approvals have been for relatively small patient populations and rare diseases, an extensive pipeline of cell and gene therapy studies is currently underway, which will significantly expand the impact of these treatments and unleash their true, unprecedented potential. In addition, according to a report by Pharmaceutical Research and Manufacturers of America (PhRMA), there will be 362 novel cell and gene therapies in the early to late stages of clinical trials by 2020. In addition, companies are investing heavily in establishing alliances and acquiring companies that offer cell and gene therapy products or finished therapeutics, thereby driving the market growth.
The growing outsourcing trend among pharmaceutical companies presents CDMOs with a lucrative opportunity. As pharmaceutical companies transfer their focus to scientific research and pharmaceutical marketing, contract development and manufacturing organizations (CDMOs) establish themselves as vital partners, promoting strategic and integrated partnerships with their clients. In addition, corporations frequently result in co-development, as some pharma companies contribute to financing specialized development and manufacturing facilities at strategic CDMOs.
Furthermore, the increasing number of small and medium-sized pharma companies responsible for the rise in drug approvals but frequently lacking their manufacturing capacities may increase the opportunities for CDMOs. CDMOs can focus more on smaller clients, comprehend their specific requirements, and implement a profitable differentiation strategy. The current competitive and fragmented market environment on the global market keeps prices low, whereas a more consolidated market is likely to offer higher profitability for the remaining CDMOs.
North America is the most significant global nucleic acid therapeutics CDMO market shareholder and is estimated to exhibit a CAGR of 10.68% during the forecast period. Some of the factors contributing to the growth of the North American nucleic acid therapeutics CDMO market include the presence of well-known and established pharmaceutical companies, the increasing demand for novel treatment options research, diagnostics, and synthetic biology, and the rising prevalence of infectious diseases, genetic disorders, and chronic diseases. Due to the large quantity of funding and the country's concentration of university-affiliated pharmaceutical research centers, the region remains the primary hub for pharmaceutical development and outsourcing. Moreover, the favorable regulatory environment and the improved availability of logistics and quality have resulted in a smooth market expansion, allowing businesses to develop gradually.
Europe is predicted to exhibit a CAGR of 10.87% over the forecast period. This region's development is primarily attributable to rising pharmaceutical R&D expenditures, a growing geriatric population coupled with rising disease prevalence, escalating healthcare expenditures, and an increasing emphasis on eradicating rare diseases throughout the region. In addition, the availability of qualified personnel for advanced technologies in oligonucleotide research implementation will increase the adoption rate of oligos in the region, thereby driving market expansion. The European Society of Gene and Cell Therapy (ESGCT) promotes basic and clinical research in cell and gene therapy by encouraging training, exchanging data and innovation, and serving as an expert guide to European partner networks and administrative entities. However, the region also confronts intense competition from Asian economies that offer inexpensive manufacturing materials and labor costs, inhibiting the future market growth.
The key global nucleic acid therapeutics CDMO market players are Bachem Holding AG, Biospring GmbH, Danaher Corporation, Guangzhou Ruibo Biotechnology Co., Ltd., LGC Limited, Merck KGaA, Nippon Shokubai Co., Ltd., QIAGEN N.V., ST Pharm Co Ltd, Nitto Denko Avecia Inc., Sumitomo Chemical Co., Ltd., Thermo Fisher Scientific Inc., Wuxi AppTec, Syngene International Limited, and others.