Continuous manufacturing is distinguished from batch manufacturing, which entails production execution in discrete steps separated by intervals by the uninterrupted feeding of raw materials into a manufacturing system and the continuous extraction of the finished product. Continuous manufacturing is characterized by the operation of the production line continuously, which leads to increased efficiency and a more streamlined manufacturing process. Continuous manufacturing is an extensively implemented methodology in many sectors, such as the pharmaceutical, chemical, food processing, and electronics industries.
Continuous manufacturing process research and development expenditures have increased significantly due to the myriad advantages they offer. For instance, the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA) designated USD 82 million in July 2023 to fund a three-year research initiative spearheaded by faculty members from MIT to establish the inaugural fully integrated, continuous mRNA manufacturing platform.
The overarching objective of the pilot-scale system is to augment the capacity of society to confront impending pandemics while also accelerating the advancement and production of mRNA technologies. Pharmaceutical companies are allocating unprecedented resources to these industries in the hopes of developing innovative vaccines and remedies for metabolic disorders, genetic diseases, cancer, and other ailments. Such investments will boost market expansion.
Regulatory bodies are increasingly endorsing continuous manufacturing, specifically within the pharmaceutical sector. For instance, a spending measure authorized by Congress in December 2022 directed the U.S. FDA to establish centers of excellence for advanced manufacturing and designation programs for advanced manufacturing technologies. The omnibus spending measure, signed by President Biden on December 27, allocates USD 3.5 billion in budget authority to the U.S. Food and Drug Administration (FDA) for fiscal year 2023. This represents a 6.5% increase compared to the budget allocated for fiscal year 2022. The expenditure measure may serve as a motivating factor for manufacturers to implement more advanced and uninterrupted manufacturing procedures. This is predicted to create opportunities for market growth.
North America is the most significant global continuous manufacturing market shareholder and is expected to expand substantially during the forecast period. North America is anticipated to maintain a substantial market share over the forecast period due to the presence of major market participants and the availability of cutting-edge technologies. The projected market expansion in this region can be ascribed to the increasing support from governmental entities. For instance, the approval of H.R. 4369 by the United States House of Representatives in October 2021. This legislative initiative aimed to promote advanced manufacturing. This legislation aims to establish centers of excellence in continuous manufacturing at numerous institutions nationwide. This is anticipated to stimulate the North American market's expansion.
Furthermore, initiatives to advance the manufacturing sector in this region are increasing in number. For instance, the U.S. Pharmacopeia (USP) recently declared the opening of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, in December 2022. This advancement constitutes a substantial element of their endeavor to establish an extensive selection of analytical solutions derived from research and development (R&D). Pharmaceutical manufacturers will benefit from the assistance of analytical laboratory services when implementing advanced manufacturing technologies, including pharmaceutical continuous manufacturing (PCM). As a result, these variables are expected to contribute to the market's growth in the designated region over the anticipated period.
The key players in the global continuous manufacturing market are GEA Group Aktiengesellschaft, Thermo Fisher Scientific Inc., Glatt GmbH, Coperion GmbH, Munson Machinery Co., Inc., Robert Bosch GmbH, Novartis AG, Siemens Medical Solutions USA, Inc., Genzyme Corporation, Bayer AG, Janssen Global Services, LLC, Lilly, Syntegon Technology GmbH, 3P Biopharmaceuticals, Abbott, AbbVie Inc., and others.