Continuous Manufacturing Market

Market Overview

The global continuous manufacturing market size was valued at USD 504.25 million in 2022. It is estimated to reach USD 1,420.95 million by 2031, growing at a CAGR of 12.2% during the forecast period (2023–2031). Continuous manufacturing has numerous benefits over batch manufacturing, which has led to increasing adoption of continuous manufacturing in the end-user industries. Thus, due to its manifold advantages, there has been a notable increase in investment in the R&D of continuous manufacturing processes. These factors are driving the global continuous manufacturing market growth.

Continuous manufacturing is a manufacturing process characterized by the uninterrupted feeding of raw materials into a manufacturing system and the continuous extraction of the finished product, in contrast to batch manufacturing, which involves the execution of production in distinct steps with intervals between each step. Continuous manufacturing involves the production line operation on a round-the-clock basis, resulting in heightened efficiency and a more streamlined manufacturing process.

Continuous manufacturing is a prevalent practice observed in various industries, including medicines, chemicals, food processing, and certain segments of electronics manufacturing. It is important to acknowledge that implementing continuous production may necessitate a substantial initial investment in specialist equipment and technology. In general, continuous manufacturing is regarded as a contemporary and inventive methodology that has the potential to augment efficiency and quality throughout diverse industrial operations.

Market Dynamics

Global Continuous Manufacturing Market Drivers

Rising Investment in R&D

Owing to its numerous benefits, there has been a surge in the investment for research development of continuous manufacturing processes. For instance, in July 2023, the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research allocated USD 82 million to support a three-year research program led by MIT faculty to develop the first completely integrated, continuous mRNA manufacturing platform.

The pilot-scale system's ultimate goal is to enhance society's capacity to address forthcoming pandemics and expedite the progress and manufacturing of mRNA technologies. Companies are making unprecedented investments in these sectors, expecting to create novel vaccines and treatments for metabolic disorders, genetic diseases, cancer, and other conditions. Such investments are estimated to contribute to continuous manufacturing market growth.

Potential Advantages of Continuous Manufacturing over Batch Manufacturing

There are numerous benefits to continuous manufacturing as opposed to batch manufacturing. Consistent and uniform product quality frequently results from continuous manufacturing's stable and uninterrupted process. This may reduce the likelihood of variations observed in batch procedures by enabling greater control over numerous parameters. Moreover, compared to batch processes, continuous processes frequently produce less waste. Reduced material losses and waste may result from the system's continuous operation, eliminating intermediate storage and management necessity.

Furthermore, it is generally more efficient than batch production due to reduced delay between batches. The continuous functioning of the apparatus decreases the duration required for cleaning, setup, and changeovers. Overall productivity may increase as a result of this enhanced efficacy. Long-term operational costs may be reduced in continuous manufacturing due to increased efficiency, decreased labor requirements, and decreased waste generation despite higher initial setup costs. Such advantages of continuous manufacturing are expected to drive market growth.

Global Continuous Manufacturing Market Restraint

Challenges associated with Continuous Manufacturing

Continuous manufacturing encounters numerous obstacles that could impede its broad adoption and expansion across industries. The establishment of continuous manufacturing systems frequently necessitates substantial financial investments in training, technology, and apparatus. It may be difficult for numerous businesses, especially those of a lesser scale, to allocate sufficient funds to cover such a significant initial investment.

Frequently, continuous production is more appropriate for mass-scale manufacturing. It may be difficult for small and medium-sized businesses to justify the investment, and they might not produce enough to benefit from continuous manufacturing completely. Continuous manufacturing frequently employs automation and cutting-edge technologies. Organizations might encounter difficulties recruiting and educating personnel with the necessary expertise to operate and maintain such systems. Such factors hinder the market's growth.

Global Continuous Manufacturing Market Opportunities

Regulatory Support

Continuous manufacturing is gaining increasing support from regulatory bodies, particularly in the pharmaceutical industry. For instance, in December 2022, Congress approved a spending measure instructing the U.S. FDA to establish advanced manufacturing technologies designation programs and centers of excellence for advanced manufacturing. On December 27, President Biden signed the omnibus spending measure, which grants the US Food and Drug Administration (FDA) budget authority of USD 3.5 billion for FY 2023, representing a 6.5% augmentation compared to the budget allocated for FY 2022.

Additionally, the spending measure could incentivize manufacturers to adopt more sophisticated and continuous manufacturing processes. Since more than a decade ago, the FDA has promoted the use of these manufacturing techniques, asserting that they can assist businesses in reducing costs and quality defects and enhance the global competitiveness of U.S. manufacturing. Thus, regulatory support is expected to create opportunities for vendors operating in the global market.

Regional Analysis

Based on region, the global continuous manufacturing market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global continuous manufacturing market shareholder and is expected to expand substantially during the forecast period. The continuous manufacturing market share of North America is anticipated to be substantial throughout the forecast period because of the presence of major market participants and the accessibility of cutting-edge technologies. The anticipated market rise in this region can be attributed to the escalating backing from government organizations. For instance, in October 2021, the U.S. House of Representatives approved H.R. 4369, a legislative measure to foster advanced manufacturing. This bill seeks to establish national centers for excellence in continuous manufacturing at many colleges nationwide. This is expected to boost the market growth in the North American region.

Furthermore, there is a surge in the initiatives taken to advance the manufacturing sector in this region. For instance, in December 2022, the establishment of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, was recently announced by the U.S. Pharmacopeia (USP). This development is a significant component of their initiative to introduce a comprehensive range of research and development (R&D) analytical solutions. The provision of analytical laboratory services will assist drug manufacturers in implementing advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM). This adoption of PCM serves as a means to enhance geographic diversity in pharmaceutical manufacturing and bolster the resilience of the medicines supply chain. Therefore, it is anticipated that the variables above will augment the expansion of the market in the specified region throughout the projected timeframe.

The Asia-Pacific region is growing at a substantial rate. The key players are strategically growing their market presence in this region, recognizing it as a highly profitable income stream within the pharmaceutical and biopharmaceutical sectors. For instance, in March 2022, the United States Pharmacopeia (USP) India expanded its presence in Hyderabad, India, by establishing a new continuous manufacturing facility. This expansion involves a significant capital investment of USD 20 million. Similarly, the pharmaceutical companies in the region are increasingly adopting the process of continuous manufacturing for the production of drugs. For instance, in May 2023, Enzene Biosciences, a company headquartered in Pune, India, introduced Cetuximab as the pioneering biosimilar in the field of oncology.

Cetuximab, marketed as Erbitux, is a therapeutic chimeric monoclonal antibody employed as a targeted therapy for metastatic colorectal cancer (mCRC) and head and neck cancer. Dr. Himanshu Gadgil, CEO of Enzene Biosciences, provided his perspective on introducing Cetuximab. It was stated that Cetuximab is the most recent addition to their biosimilar portfolio, which is being produced utilizing their patented continuous manufacturing platform. This development is expected to significantly reduce the expenses associated with treating metastatic colorectal cancer (mCRC) and head and neck cancer for patients in India. This is expected to expedite the market expansion in the region.

Segmental Analysis

The global continuous manufacturing market is segmented by product, application, and end-user.

Based on product, the global market is divided into integrated continuous manufacturing and semi-continuous manufacturing. 

A production method that lies between batch manufacturing and continuous manufacturing is known as semi-continuous manufacturing. Semi-continuous manufacturing involves the integration of certain characteristics from both batch and continuous processes. Consequently, specific segments of the manufacturing procedure may operate continuously, whereas others are executed in portions. Frequently, consolidating the adaptability of batch processing with the productivity of continuous manufacturing is the objective. Industries that require an optimal balance of flexibility and efficiency frequently implement semi-continuous manufacturing. It permits a degree of adjustment and customization in the manufacturing process while preserving a degree of continuous operation. This strategy can be especially advantageous in fluctuating demand or requiring product customization.

Based on application, the global continuous manufacturing market is bifurcated into API systems, end product manufacturing, solid dosage, and liquid dosage. 

An Active Pharmaceutical Ingredient (API) is the biologically active component in a pharmaceutical drug. It is the substance responsible for the therapeutic effects of the drug. APIs can be synthetic or naturally derived and are formulated with other inactive ingredients to create a final medication. In drug development and manufacturing, an API is the key ingredient that produces the desired pharmacological effect. In addition, the formulation of a drug involves combining the API with excipients, which are inactive substances such as binders, fillers, preservatives, and flavorings. In continuous manufacturing, an API system typically refers to the continuous manufacturing process employed in the Active Pharmaceutical Ingredient (API) manufacturing system.

Based on end-user, the global market is divided into Research and development departments, contract research organizations (CRO), pharmaceutical companies, full-scale manufacturing companies, pharmaceutical companies, and contract manufacturing organizations (CMO).

Contract Manufacturing Organizations (CMOs) refer to corporate entities that offer manufacturing services to other enterprises through contractual agreements. In the pharmaceutical and biotechnology sectors, it is customary to designate CMOs as Contract Development and Manufacturing Organizations (CDMOs). The principal role of a CMO or CDMO is to assume the duty of producing goods for a third-party company, enabling the client company to concentrate on its fundamental strengths, such as research, development, and marketing.

In addition, numerous factors drive companies to outsource their product manufacturing to contract manufacturing organizations (CMOs). Potential benefits of outsourcing include financial advantages, the acquisition of specialized knowledge and skills, enhanced adaptability in manufacturing capabilities, and the potential to expedite time-to-market.

Recent Developments

• June 2023- Enzene Biosciences, a subsidiary of Alkem Laboratories based in India, announced its intention to establish a manufacturing plant with continuous manufacturing technology near Princeton, New Jersey, with an estimated investment of USD 50 million.
• May 2023- WuXi STA, a subsidiary of WuXi AppTec, announced that its drug product site in Wuxi, China, is equipped with its first drug product continuous manufacturing (CM) line for oral solids. According to the organization's statement, this novel CM line offers an improved solution for developing oral drugs for clients worldwide, facilitating increased yields and reduced time to market.