Continuous Manufacturing Market In Pharmaceuticals & Biopharmaceuticals: Solid Formulations Dominated With A Revenue Share
Continuous Manufacturing Industry Overview In Pharmaceuticals & Biopharmaceuticals
The global continuous manufacturing market in pharmaceuticals and biopharmaceuticals size is expected to reach USD 2.3 billion by 2027, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 13.85% from 2021 to 2027. Although batch manufacturing is the dominant mode of product development within the pharma and biopharma industry, the companies have begun shifting their focus toward continuous manufacturing (CM). The key drivers for the transition from batch to continuous manufacturing include drug shortage, more stringent requirements for consistent quality, the need for reduced processing costs, and the demand for higher and improved productivity.
Regulatory authorities are increasingly supportive of this therapeutic development model. They are encouraging the adoption of CM through releasing drafts and guidelines. Moreover, the presence of communities and organizations that are devoted to the commercialization of this market within the pharma and biopharma sector is driving the revenue. CCP Summit 2020 is one of such summits that is engaged in exploring scientific and technological advancements to address the technology challenges and accelerate upfront investment in the market.
In addition, the growing demand for biosimilars and an ever-increasing pressure for reducing drug development costs have driven the interest of biopharma players in this space. With a plethora of research activities available on making individual unit operations continuous, studies are also conducted to explore the possibility of a continuous end-to-end development process. Ongoing research efforts in this area are anticipated to greatly favor the revenue growth in the coming years.
Based on mode, in-house pharmaceutical companies are anticipated to witness lucrative growth in the coming years owing to the shift of well-established pharma players toward the continuous manufacturing market. On the basis of scale, the clinical and preclinical scale manufacturing segments collectively captured a significant revenue share in 2020 owing to the easy integration of systems and a high number of ongoing R&D activities.
North America led the global market in 2020. This is attributed to the presence of key technology developers as well as high R&D expenditure in drug development by the end-users in the U.S. Key players are implementing various strategies to strengthen their product offerings and offer diverse technologically advanced products to accelerate therapeutics development.
Continuous Manufacturing Market In Pharmaceuticals & Biopharmaceuticals Segmentation
Grand View Research has segmented the global continuous manufacturing market in pharmaceuticals and biopharmaceuticals on the basis of therapeutics type, application, formulation, mode, scale, product, and region:
Based on the Therapeutics Type Insights, the market is segmented into Large Molecules, and Small Molecules.
- Small molecules dominated the market with a revenue share of 75.7% in 2020 with the increasing shift in focus from batch processing to continuous manufacturing for drug development. This transition is majorly due to its several commercial advantages such as reduced equipment size, cost-effectiveness, less time consumption, and rapid final product launch.
- The large molecule/biopharmaceutical production is witnessing a similar transition. Technological advancements in single-use technologies and fully integrated control systems and optimization in upstream and downstream processing are anticipated to positively impact the growth of the biopharmaceutical continuous manufacturing segment.
Based on the Application Insights, the market is segmented into Finished Product Manufacturing, and API Manufacturing.
- Finished-product manufacturing captured the largest share of 53.9% in 2020 owing to the high penetration of drug developers adopting this technique for the production of drugs. With the emergence of new products and services by different companies, the use of continuous manufacturing processes for drug products is anticipated to increase in the coming years, thus contributing to overall segment growth.
- Continuous manufacturing of active pharmaceutical ingredients(API) is an emerging trend within the pharmaceutical industry owing to the fact that it is cost-effective and less time-consuming. A substantial number of companies around the world use this technique for API production. Pfizer is one of such companies, which is implementing a hybrid approach for continuous API manufacturing.
Based on the Formulation Insights, the market is segmented into Solid Formulation, and Liquid & Semi-solid Formulation.
- Solid formulations dominated the market in 2020 with a revenue share of 63.3%. As of November 2018, five solid dosage drugs have received FDA approvals, which are manufactured by continuous manufacturing. This has resulted in the dominance of this segment.
- With the increasing use of continuous manufacturing processes in solid dosage formations, the manufacturers and companies offering products in this segment are being receptive toward the development of these manufacturing processes for liquid dosage formulations.
Based on the Mode Insights, the market is segmented into In-house, and Contract.
- The contract manufacturers dominated the market with a revenue share of 66.1% in 2020 with the increasing availability of this technology in the market. CMOs are continuously investing in the expansion of their production facility to advance the segment growth.
- In-house pharmaceutical companies are anticipated to witness lucrative growth in the forecast period. The presence of the U.S. FDA approved drugs that deployed CM technology has resulted in a significant share of this segment. The FDA approval of the drugs has propelled several major pharma players to mark their entry into this market.
Based on the Scale Insights, the market is segmented into Preclinical, Clinical, and Commercial.
- The clinical segment held the largest share of 46.5% in 2020. Continuous Manufacturing (CM) technology has higher penetration in clinical production. The companies using small-scale CM systems have reported potential API savings of more than 60.0% and a significant reduction in time-to-market for the final product, thereby driving revenue flow in the clinical scale segment.
- One of the key reasons for low penetration in the commercial manufacturing space is the presence of well-established batch process-based workflow and facilities. However, the drug developers are seeking flexibility in the production process, which is anticipated to accelerate the adoption of CM systems for commercial scale.
Based on the Product Insights, the market is segmented into Integrated Systems, Semi-continuous Systems, and Others.
- Semi-continuous systems accounted for the largest revenue share of 45.9% in 2020 owing to the increasing adoption of a hybrid model of manufacturing within small to medium-sized drug developers as well as major pharma companies.
- Companies such as Pall Corporation and Merck (MilliporeSigma) provide integrated systems for the production of monoclonal antibodies, gene therapy, cell therapy, recombinant proteins, and vaccines. Moreover, companies like Syntegon provide integrated solutions for pharmaceutical manufacturing.
Continuous Manufacturing Market In Pharmaceuticals & Biopharmaceuticals Regional Outlook
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
Key Companies Profile & Market Share Insights
Companies are undertaking various business measures to enhance their revenue share and gain a competitive advantage in the market. Furthermore, the companies are engaged in mutually beneficial alliances with research entities to accelerate the implementation of CM at the industrial scale. For instance, in September 2020, Continuus Pharmaceuticals signed a contract with Roche to establish an end-to-end integrated CM process for the development of the latter’s new antiviral drug. It will include API manufacturing and drug product formulation.
In addition, the companies are acquiring other key players in the space to expand their client base and product and service portfolio. For instance, in April 2020, Danaher completed the acquisition of the bioprocessing unit of GE Healthcare. With this acquisition, it became a complete end-end supplier of bioprocessing solutions and was able to boost competitive rivalry with other key bioprocessing leaders, such as Sartorius. Some prominent players in the global continuous manufacturing market in pharmaceuticals and biopharmaceuticals include:
- Thermo Fisher Scientific, Inc.
- Pall Corporation
- Applikon Biotechnology
- Sartorius Stedim Biotech
- GEA Group Aktiengesellschaft
- Corning Incorporated
- Merck KGaA
- Glatt GmbH
- Repligen Corporation
- Eppendorf AG
- Electrolab Biotech Ltd.
- Solesis Medical
- Scott Equipment Company
- B. Bohle
- LONZA
- 3M
- CellGenix GmbH
- Boehringer Ingelheim International GmbH
- Bio-Rad Laboratories
- Avantor, Inc.
- Ajinomoto Bio-Pharma
- GlaxoSmithKline
- Continuus Pharmaceuticals
- Arcinova
- Amgen
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About Grand View Research
Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.
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