Pharmaceutical Continuous Manufacturing Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, China, Japan - Size and Forecast 2024-2028

Pharmaceutical Continuous Manufacturing Market Forecast 2024-2028

The global pharmaceutical continuous manufacturing market size is estimated to grow by USD 548.94 million at a CAGR of 12.74% between 2023 and 2028. The pharmaceutical industry, like many others, is increasingly focused on sustainability, recognizing its importance in reducing environmental impacts, conserving resources, and meeting corporate responsibility goals. Sustainability initiatives include minimizing waste, reducing energy consumption, and implementing environmentally friendly production methods. However, continuous manufacturing methods not only enhance efficiency and product quality but also significantly reduce the environmental impact of pharmaceutical production. As the industry continues to prioritize sustainability, the global market for continuous manufacturing is expected to grow substantially during the forecast period.

What will be the Size of the Market During the Forecast Period?

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The market is evolving with the adoption of Semi-Continuous System such as Continuous Granulators, Continuous Coaters, Continuous Blenders, Continuous Dryers, and Continuous Compressors. These systems are revolutionizing tablet production and granulation processes, enabling efficient production of Active Pharmaceutical Ingredients (APIs). The integration of Continuous Granulators, Continuous Coaters, Continuous Blenders, Continuous Dryers, and Continuous Compressors reflects a shift towards continuous manufacturing in the pharmaceutical sector, promoting streamlined and cost-effective production processes.

Market Segmentation

In the application segment of the market, the pharmaceutical industry is increasingly adopting continuous manufacturing to ensure a consistent supply of essential medicines and drugs. This approach is crucial for addressing drug shortages and meeting the demands of health systems and patients worldwide. Particularly in the production of sterile injectable and oncology/cancer treatments, it offers enhanced efficiency and quality control. The adoption of integrated continuous manufacturing systems is also expanding into untapped emerging markets, offering opportunities for improved production processes and addressing manual handling challenges associated with traditional batch manufacturing methods. Additionally, integrated continuous systems are facilitating the streamlined production of molecules and biologics, driving innovation and efficiency in pharmaceutical manufacturing.

Application Analysis 

Final drug product manufacturing

The market share growth by the final drug product manufacturing segment will be significant during the forecast period. The final drug product manufacturing segment encompasses the last stages of drug production, where APIs and other components are formulated into finished dosage forms, such as tablets, capsules, or injectables, in a continuous manufacturing process. This offers notable advantages in terms of efficiency and speed. The ability to continuously process raw materials into final dosage forms reduces production timelines and increases productivity. 

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The final drug product manufacturing segment was the largest and was valued at USD 222.19 million in 2018. The global prevalence of acute and chronic diseases, including cardiovascular, neurological, orthopedic, and respiratory diseases, is increasing significantly, which is driving the demand for drugs. For instance, chronic diseases such as cancer and cardiovascular diseases (CVDs), among others, are common among people in Europe. The incidences of chronic diseases such as cancer have increased in Europe. Similarly, CVDs are also prevalent among people of all ages in Europe. As a result of growing chronic conditions, the use of drugs has become more widespread as patients seek out effective and convenient treatment options for their chronic conditions. Thus, the growing chronic conditions worldwide will drive the demand for drugs and, in turn, will propel the growth of this segment during the forecast period.

Regional Analysis

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North America is estimated to contribute 35% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period.  The North American market is a dynamic and rapidly evolving sector. This region, which includes the US, Canada, and Mexico, has been at the forefront of adopting innovative manufacturing processes in the pharmaceutical industry. North America is a hub for technological innovations. The pharmaceutical industry in this region has been quick to adopt such techniques, leveraging automation, real-time monitoring, and process control. Moreover, the FDA has been supportive of technology. The FDA has issued guidance documents and conducted workshops to help pharmaceutical companies adopt this technology and also promotes with data models among manufacturers, as it enhances process control, lowers variability, and boosts the consistency and quality of the final product.

For instance, in March 2023, the FDA released the final guidelines on the use of continuous manufacturing in drug production, as mandated by the International Council for Harmonization (ICH). According to the announcement, this publication represents the proactive measures of the FDA to facilitate the pharmaceutical industry's transition to these sophisticated processes. Such initiatives from regulatory bodies will positively impact the growth of the regional market during the forecast period.

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Market Dynamics and Customer Landscape

The market is witnessing significant growth, driven by the Pharmaceuticals industry's need for essential medicines and drugs. This demand is exacerbated by health systems striving to meet the needs of patients amidst drug shortages, particularly in areas like sterile injectable and oncology/cancer treatments. Innovative solutions like semi-continuous systems and integrated continuous manufacturing are gaining traction, offering advantages such as reduced manual handling and enhanced production efficiency. These systems cater to various manufacturing processes, including tablet production, granulation, coating, and more. With untapped emerging markets and the rising demand for biologics, the market continues to expand, offering opportunities for growth and development. There are multiple factors influencing market growth. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. 

Key Market Drivers

The evolving API manufacturing scenario in developing countries is notably driving market growth. India and China are rapidly evolving as viable sources for key intermediates and bulk process intermediate (BPI). In the late 1980s and early 1990s, the majority of Chinese companies manufactured large volumes of low-cost drugs, with many focusing on fermentation products and simple synthetic compounds. Considering the presence of developed infrastructure and growing economic development, India and China have started producing high-quality APIs and drug intermediates for regulated markets. Also, innovators have started focusing on these countries for outsourcing late-stage intermediates, and a few global manufacturers have formed joint ventures with local API manufacturers. Furthermore, it was observed that the innovators are increasingly partnering with local API manufacturers for high-quality bulk manufacturing activities, particularly with those in developing countries, owing to low development and production costs.

However, developing countries are increasingly becoming significant players in API production, seeking to meet the global demand for pharmaceuticals. It offers cost-effective, efficient, and sustainable solutions that align with the objectives of these countries. This trend is expected to foster the adoption of these practices worldwide, contributing to the expansion of the market during the forecast period.

Significant Market Trends

Increasing demand for continuous manufacturing in the biopharmaceutical industry is an emerging trend shaping the market growth. It is extending beyond traditional small-molecule pharmaceuticals to biologics and vaccines. The biopharmaceutical industry is embracing continuous biomanufacturing, which offers benefits in terms of process flexibility and scalability. This offers several advantages over traditional batch manufacturing, including improved efficiency, reduced costs, and enhanced product quality. This eliminates the batch-to-batch variability inherent in traditional methods, leading to a more streamlined and efficient production process. This provides real-time data and monitors the production process, allowing for immediate adjustments to ensure product quality and consistency. This continuous monitoring and control can help prevent variability and reduce the risk of product recalls, leading to a higher overall level of product quality and safety.

Further, the growing demand for innovative biopharma therapies, such as monoclonal antibodies and gene therapies, is driving the adoption of continuous manufacturing. These complex therapies require a high level of consistency and quality which makes it an ideal approach to ensure their production. Overall, the growing demand for these processes in the biopharmaceutical industry is expected to be a major driving force behind the growth of the market during the forecast period.

Major Market Challenges

High initial investment  is a significant challenge hindering market growth. Transitioning from traditional batch manufacturing to continuous processes often requires substantial upfront investments in new equipment and technology. Companies may face financial constraints in making this transition. The product often demands specialized equipment and systems, which can be expensive to acquire and install. This includes continuous granulators, continuous mixers, and real-time monitoring and control systems. These capital-intensive investments can strain the budgets of pharmaceutical manufacturers, particularly smaller or emerging companies. Integrating technology into existing facilities may require facility upgrades, process modifications, and significant investments in infrastructure.

Moreover, the perceived risk of investing in a technology that may not yield immediate returns can be a barrier to entry. Companies may be uncertain about the return on investment (ROI) for continuous manufacturing. The lengthy payback period and uncertainty about the technology's long-term benefits can discourage investments. Thus, the high initial investment required can deter the growth of the market in focus during the forecast period by discouraging adoption, particularly among smaller pharmaceutical companies.

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Customer Landscape

The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Global Market Customer Landscape

Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

Coperion GmbH - The company offers products such as pharma extruders, and process equipment.

• Chemtrix BV
• Continuus Pharmaceuticals
• Corning Inc.
• Dr. Helmut Rothenberger Holding GmbH,
• Eli Lilly and Co.
• Freund Vector Corp.
• GE Healthcare Technologies Inc.
• GEA Group AG
• Gebruder Lodige Maschinenbau GmbH
• Gericke AG
• Honeywell International Inc.
• Hosokawa Micron Corp.
• Hovione
• KORSCH AG
• L.B. Bohle Maschinen und Verfahren GmbH
• LMT Group
• Novartis AG
• Pfizer Inc.
• Siemens A

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Analyst Overview

The market is witnessing robust growth as the pharmaceutical industry embraces innovative approaches to address challenges such as drug shortages and ensure the availability of essential medicines and drugs. It offers a solution to these issues by enabling the seamless production of sterile injectables and oncology/cancer treatments, among others. Industry initiatives like the Drug Shortage Task Force further underscore the importance of this approach. Moreover, the adoption of integrated continuous manufacturing systems facilitates efficient production processes for molecules and biologics, including tablet production, granulation, coating, and active pharmaceutical ingredient synthesis. This includes advanced equipment like continuous coaters, continuous blenders, continuous dryers, and other semi-continuous systems for both solid dosage and liquid dosage forms.

The market is experiencing significant growth as pharmaceutical companies strive to enhance efficiency and streamline drug production processes. Continuous manufacturing systems, such as an integrated continuous system and semi-continuous system, are being adopted to minimize manual handling and material waste while maximizing the benefits of health systems. These systems offer integrated process control for consistent drug quality monitoring and enable the production of various pharmaceutical forms, including solid dosage and liquid dosage forms. By utilizing continuous compressors and advanced technology, manufacturers can achieve high-quality finished products while reducing reliance on traditional batch manufacturing methods. This transformation also facilitates the utilization of base ingredients to produce pharmaceutical drug substances and small molecule drug molecules for the development of finished dosage forms in both established and untapped emerging markets.

The market is witnessing substantial growth, driven by advancements in technology and the need for enhanced efficiency in drug production processes. Continuous manufacturing techniques cater to various pharmaceutical forms, including solid dosage manufacturing and liquid dosage manufacturing forms, ensuring consistent quality in the finished dosage form. These systems streamline the production of pharmaceutical drug substances and active pharmaceutical ingredients, facilitating the development of small molecule drugs for both Preclinical / clinical applications. With upstream bioprocessing and downstream bioprocessing capabilities, manufacturers can optimize the production of drug molecules and pharmaceutical ingredients, meeting the demands of the evolving pharmaceutical industry landscape. It plays a crucial role in ensuring the scalability and efficiency of pharmaceutical production processes worldwide.

Segment Overview

The market research and growth report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

• Application Outlook
  • Final drug product manufacturing
  • API manufacturing

• Product Outlook
  • Integrated systems
  • Semi-continuous systems
  • Controls or software

• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest Of World
    • Brazil
    • Argentina
    • Australia 

Market Scope
Report Coverage	Details
Page number	171
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 12.74%
Market Growth 2024-2028	USD 548.94 million
Market structure	Fragmented
YoY growth 2023-2024(%)	12.26
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 35%
Key countries	US, Germany, UK, China, and Japan
Competitive landscape	Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks
Key companies profiled	Chemtrix BV, Continuus Pharmaceuticals, Coperion GmbH, Corning Inc., Dr. Helmut Rothenberger Holding GmbH, Eli Lilly and Co., Freund Vector Corp., GE Healthcare Technologies Inc., GEA Group AG, Gebruder Lodige Maschinenbau GmbH, Gericke AG, Honeywell International Inc., Hosokawa Micron Corp., Hovione, KORSCH AG, L.B. Bohle Maschinen und Verfahren GmbH, LMT Group, Novartis AG, Pfizer Inc., Siemens AG, SK Inc., Syntegon Technology GmbH, and Thermo Fisher Scientific Inc.
Market dynamics	Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period.
Customization purview	If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the market size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on company's position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Market growth analysis across North America, Europe, Asia, and Rest of World (ROW)
• A thorough analysis of the market’s competitive landscape and detailed information about companies
• Market forecasting of factors that will challenge the growth of market companies

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