Continuous Manufacturing Market In Pharmaceuticals & Biopharmaceuticals Size, Share & Trends Analysis Report By Therapeutics Type, By Application, By Formulation, By Mode, By Scale, By Product, And Segment Forecasts, 2021 - 2027

Report Overview

The global continuous manufacturing market in pharmaceuticals and biopharmaceuticals size was valued at USD 919.7 million in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 13.85% from 2021 to 2027. In recent years, continuous manufacturing has gained traction as a viable solution within the pharmaceutical industry. This is primarily to minimize the pressure pertaining to reduce drug development time and costs while maintaining the supply and quality of the final product. As a result, the continuous manufacturing market is anticipated to witness healthy growth in the coming years. Continuous manufacturing enables the therapeutics developers to keep pace with the changing market demands. It allows a seamless drug production process from raw materials to the final product. Moreover, the risk of human error is reduced because it entails a smaller number of human resources in the entire production process. Thus, it can be effectively adopted for the production of precision medicines and drugs with breakthrough therapy designations.

The pharma and biopharma industry is engaged in strategic alliances with academic institutes to develop commercial continuous processing technologies as a strategy toward a completely continuous system. Several publications have reported the development of a fully integrated end-to-end commercial continuous process for biologics production. This is anticipated to boost the implementation of this technology in commercial product development.

Novartis and other pharma/biopharma companies are engaged in transforming the drug product process by supplanting conventional batch-based systems with continuous manufacturing. For instance, in October 2019, Sanofi opened its first digitally-enabled, continuous manufacturing facility in Massachusetts. The facility was established to accelerate biologics production. In addition, regulatory authorities are making focused efforts to encourage continuous processing.

Both the U.S. FDA and the European Medicines Agency (EMA) are making amendments in guidelines or releasing new statements with the increasing investment in this market. The FDA has released a statement titled “modern approach to advanced pharmaceutical manufacturing” in February 2019 that elaborates the ongoing innovations in the market. Active participation of regulatory bodies is anticipated to significantly spur the market revenue in the coming years.

Therapeutics Type Insights

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.

Some companies such as Eli Lilly, GlaxoSmithKline, AstraZeneca, Merck, Bayer, and Novartis have already implemented the process in their production units. This indicates the increasing interest of major pharma players in this drug development mode for both brands and generics. Furthermore, this technology has garnered much attention in the production of small-molecule active pharmaceutical ingredients.

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.

Application Insights

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.

Formulation Insights

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. Furthermore, companies such as Merck, GEA group, and Pfizer are innovating new products, such as the Portable Continuous Miniature and Modular (PCMM) system by Pfizer, which is anticipated to increase the use of this manufacturing process for solid dosage manufacturing.

Furthermore, as many oral solid dosage products are now off-patent and new oral solid dosage products are manufactured for smaller volumes, the demand for continuous manufacturing processes for solid dosage manufacturing is increasing in the pharmaceutical industry. The adoption of continuous manufacturing processes for liquid dosage forms is slow as compared to solid dosage forms.

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. Liquid dosage forms have several advantages such as easy handling, faster absorption than solids, and more flexibility. Such advantages can lead to the increased need for the manufacturing of liquid dosage forms.

Mode Insights

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. For instance, in June 2019, FUJIFILM Corporation announced a funding of USD 10 million investment to establish a full scale, fully integrated contract manufacturing facility in Billingham, U.K. for non-GMP manufacturing of biopharmaceuticals.

In addition, the number of Contract Manufacturing Organizations (CMOs) embracing CM technology as a flexible manufacturing alternative continues to increase. In recent times, several new therapies are gaining fast track or Breakthrough Drug status. This shortens the clinical development path to regulatory approval. This has posed a challenge to the CMOs to significantly speed up the development processes, thereby creating avenues for this market.

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. The drug developers are engaged with the regulatory bodies to develop and integrate this technology in their drug development processes.

Scale Insights

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. The companies are collaborating to advance the commercial-scale manufacturing processes, including blending, wet or dry granulation, fluid bed drying, and tableting and coating operations.

Product Insights

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.

Integrated systems provide complete end-to-end solutions for different bioprocesses. These systems are centrally automated processes that operate as a single operating unit. The benefits of integrated systems include reduced overall cost, simplified process, low risk of an operating error, better quality outcomes, and compliance with CGMP. Such advantages are anticipated to be the contributing factors for the increased use of integrated systems in continuous bioprocessing.

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.

In addition, GE Healthcare offers an integrated semi-continuous process for the production of monoclonal antibodies. Furthermore, Pall Corporation offers a fully automated virus inactivation process solution, which can be used in semi-continuous mode. Such companies are anticipated to witness lucrative growth in the coming years with the increasing adoption of this process.

Regional Insights

North America accounted for the largest revenue share of 33.8% in 2020. The increasing number of end-users that have adopted CM technology or who are planning to implement it in their facility in the North American countries have contributed to the largest share of the regional market. Furthermore, the regulatory bodies are playing a vital role in driving revenue growth in this region.

The U.S. FDA and U.S. Pharmacopoeia are developing guidelines for continuous manufacturing in the pharmaceutical industry. For instance, in February 2019, the FDA launched draft guidance for industry, “Quality Considerations for Continuous Manufacturing”, which is expected to increase the number of companies embracing this technology.

Asia Pacific, with China and Japan at the forefront, is anticipated to expand at the fastest CAGR during the forecast period. The constantly expanding CMO and biopharmaceutical sector in the region is anticipated to positively impact the revenue growth. Furthermore, global players are expanding their business footprints in this region considering it as a lucrative source of revenue in the pharma and biopharma industry.

Key Companies & 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

• L.B. Bohle

• LONZA

• 3M

• CellGenix GmbH

• Boehringer Ingelheim International GmbH

• Bio-Rad Laboratories

• Avantor, Inc.

• Ajinomoto Bio-Pharma

• GlaxoSmithKline

• Continuus Pharmaceuticals

• Arcinova

• Amgen

Continuous Manufacturing Market In Pharmaceuticals & Biopharmaceuticals Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global continuous manufacturing market in pharmaceuticals and biopharmaceuticals report on the basis of therapeutics type, application, formulation, mode, scale, product, and region:

• Therapeutics Type Outlook (Revenue, USD Million, 2016 - 2027)

  • Large Molecules

  • Small Molecules

• Application Outlook (Revenue, USD Million, 2016 - 2027)

  • Finished Product Manufacturing

  • API Manufacturing

• Formulation Outlook (Revenue, USD Million, 2016 - 2027)

  • Solid Formulation

  • Liquid & Semi-solid Formulation

• Mode Outlook (Revenue, USD Million, 2016 - 2027)

  • In-house

  • Contract

• Scale Outlook (Revenue, USD Million, 2016 - 2027)

  • Preclinical

  • Clinical

  • Commercial

• Product Outlook (Revenue, USD Million, 2016 - 2027)

  • Integrated Systems

  • Semi-continuous Systems

    • Continuous Granulators

    • Continuous Blenders

    • Continuous Compressors

    • Continuous Coaters

    • Continuous Dryers

    • Other Semi-continuous Systems

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • Spain

    • France

    • Italy

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia