Industry stakeholders are regularly in pursuit of building strategic advantage(s) associated with product development and production processes; one of the ways to drive this is to establish flexible manufacturing capacity and deploy the associated infrastructure / facilities swiftly. Over the past few years, a large number of factors have converged to transform the facility construction paradigm within the pharmaceutical and biotechnology industries. The aforementioned factors include optimization of capital expenditure, reduction of construction timelines, integration of single-use technologies (e.g. single-use bioreactors), and the necessity to develop capabilities to support personalized medicine (driven by the need to address therapeutic requirements for rare / orphan clinical conditions).
Pre-engineered, modular facilities have emerged as a versatile solution to the abovementioned problem statement. In fact, this approach has been demonstrated to be capable of addressing several challenges, such as weather-related concerns, shortage of skilled labor, labor contract constraints and delays in supply of raw materials. Furthermore, traditional production platforms require extensive investments, in terms of both capital and time. Such facilities also consist of built-in operating equipment attached to the facility substructure, necessitating extensive renovations for equipment upgrade and reconfiguration. On the other hand, in a modular approach, individual units of a facility and the required equipment (which is integrated into the facility design) are fabricated in factories away from the actual location of the facility. Moreover, the aforementioned facility templates are built to be flexible, with provisions for future expansion of area and capacity. This has been shown to significantly improve infrastructure development and installation time.
For instance, in 2018, Janssen Pharmaceuticals, in collaboration with Legend Biotech, built a modular, commercial-scale facility, using a hybrid construction approach (which involved a combination of off-site and on-site construction); the edifice spanned 38,000 sq ft and was completed within a record time of nine months. It is also worth highlighting that the recent surge in demand for biopharmaceuticals due to COVID-19 pandemic has fueled the need for strategic changes in bioprocessing. In June 2020, Sanofi invested USD 554 million in the construction of a state-of-the-art modular vaccine production facility, in Neuville sur Saone, France, with the capacity to produce three to four vaccines simultaneously.
Productivity in the conventional construction has been shown to never exceed 80%; this is usually attributed to logistical delays (transport of building material to the construction site) and inconsistent availability of manpower. On the other hand, in the modular construction approach, productivities of over 100% (up to 140%) have been reported. This can primarily be attributed to the fact that the latter method is executed in a controlled, fabrication shop environment and much of the fabrication process is automated (which eliminates the excessive reliance on manual labor), thereby, alleviating external risks and minimizing schedule overruns. Next generation construction methods are projected to evolve under the effect of current market dynamics. Several important developments in the pharmaceutical industry are influencing the design and construction of manufacturing facilities.
Therefore, companies must retain the flexibility offered by contract manufacturers when they carry insourced projects in-house. Further, the advent of new modalities and next-generation drugs, such as cell and gene therapies and highly potent small molecule active pharmaceutical ingredients, which require specialized manufacturing facilities and equipment while avoiding cross-contamination and ensuring operator safety and protection, adds to need of platforms that are adaptable. Such trends, coupled to the increased pressure to improve efficiency, lower operating costs and acceleration of the drug development process, are considered to be the key drivers of the adoption of modular solutions. Moreover, biopharma industry continues to seek innovative ways of optimizing drug development costs and timelines. Off-site design and modularization demonstrate great potential to provide the industry with the agility to reduce the overall time to market for a particular product.
Amongst other elements, the report features:
A review of the market landscape of modular facilities along with information on their year of establishment, company size (small, mid-sized or large), location of headquarters (North America, Europe, Asia and rest of the world), geographical coverage, GMP compliance construction and type of industry served (pharmaceutical, biotechnology or others). It also includes details related to certifications obtained and COVID-19 related initiatives undertaken by modular service providers.
A review of the market landscape of modular cleanrooms along with information on their year of establishment, company size (small, mid-sized or large), location of headquarters (North America, Europe, Asia and rest of the world), type of industry served (pharmaceutical, biotechnology or others), type of modular cleanrooms (softwall and hardwall), type of modular cleanroom components (air handling units / HVAC system, fan filter units, laminar flow units, air showers, pass throughs, cleanroom furniture/furnishings, plumbing/piping, lighting/electricals). It also includes details related to regulatory approvals and certifications.
An analysis of the partnerships that have been inked by stakeholders in this domain, during the period between 2012 and 2021 (till January), covering facility construction agreements, cleanroom construction agreements, service alliances, service agreements and other relevant types of deals.
An analysis of modular projects undertaken across key geographical regions, featuring information on type of facility, facility area, most active manufacturers, most active clients, location of facility. We have provided a case study on JHL Biotech's KUBio biomanufacturing facility, which was constructed by GE Healthcare Life Sciences in China. It also includes information on modular projects received by key pharma/biotech players based on location, type and area of facility.
An insightful analysis on facility construction trends in the pharmaceutical industry for the last five years, highlighting facility construction projects established by top 20 pharma / biotech players, along with information on their number of facilities, type of facility, purpose, investments made in modular projects, area of facility and location of headquarters.
Elaborate profiles of key players that provide a wide range of modular manufacturing solutions to pharmaceutical and biotechnology industries. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key members of the executive team), details related to modular facility-focused services, modular projects, recent developments and an informed future outlook.
A review of emerging trends, including the combination of single-use technologies / continuous processing technologies with modular facilities, the shift to using smaller, multi-purpose modular facilities, and technological advancements in modular construction processes.
A detailed discussion on the various growth drivers, such as the development of personalized medicines, biosimilars, orphan drugs and the anticipated increase in the adoption of modular solutions in emerging markets by pharmaceutical/biopharmaceutical CMOs. It also highlights trends, such as expansion of existing facilities and adoption of modular facilities by emerging start-ups and small companies.
Key Questions Answered
Who are the key service providers engaged in domain of modular construction? What are the current trends fueling the adoption of modular construction solutions in the pharma/biotech industries?
Which key regions are targeted by pharma/biotech companies for expanding their existing facilities and capabilities?
What type of product lines are actively supported by integrated modular solutions in facility design and construction?
What are the recent initiatives undertaken by modular manufacturers in order to overcome the challenges related to the COVID-19 pandemic?
Which regions are the current hubs for modular construction service providers?
Which partnership models are most commonly adopted by stakeholders engaged in this industry?
How is the current and future opportunity likely to be distributed across key market segments?
6. COMPANY PROFILES 6.1. Chapter Overview 6.2. Cytiva 6.2.1. Company Overview 6.2.2. Modular Facility-related Services 6.2.3. Modular Projects 6.2.4. Recent Developments and Future Outlook 6.3. G-CON Manufacturing 6.3.1. Company Overview 6.3.2. Modular Facility-related Services 6.3.3. Modular Projects 6.3.4. Recent Developments and Future Outlook 6.4. Pharmadule Morimatsu 6.4.1. Company Overview 6.4.2. Modular Facility-related Services 6.3.3. Modular Projects 6.3.4. Recent Developments and Future Outlook 6.5. NNE 6.5.1. Company Overview 6.5.2. Modular Facility-related Services 6.5.3. Modular Projects 6.5.4. Recent Developments and Future Outlook 6.6. IPM Technologies 6.6.1. Company Overview 6.6.2. Modular Facility-related Services 6.6.3. Modular Projects 6.6.4. Recent Developments and Future Outlook 6.7. KeyPlants 6.7.1. Company Overview 6.7.2. Modular Facility-related Services 6.7.3. Modular Projects 6.7.4. Recent Developments and Future Outlook 6.8. Germfree Laboratories 6.8.1. Company Overview 6.8.2. Modular Facility-related Services 6.8.3. Modular Projects 6.8.4. Recent Developments and Future Outlook 6.9. ModuleCO Pharma 6.9.1. Company Overview 6.9.2. Modular Facility-related Services 6.9.3. Modular Projects 6.9.4. Recent Developments and Future Outlook
7. PARTNERSHIPS AND COLLABORATIONS 7.1. Chapter Overview 7.2. Types of Partnership Models 7.3. Modular Facility Providers: Partnerships and Collaborations 7.3.1. Analysis by Year of Partnership 7.3.2. Analysis by Type of Partnership 7.3.2.1. Analysis by Year and Type of Partnership 7.3.3. Analysis by Type of Product 7.3.3.1. Analysis by Type of Partnership and Type of Product 7.3.4. Analysis by Type of Modular Facility 7.3.4.1. Analysis by Type of Product and Type of Modular Facility 7.3.5. Most Active Players: Analysis by Number of Partnerships 7.3.6. Regional Analysis 7.3.6.1. Analysis by Location of Headquarters of Partner 7.3.6.2. Analysis by Location of Facility 7.3.6.3. Analysis by Type of Partnership and Location of Facility 7.3.6.4. Analysis by Type of Product and Location of Facility 7.3.7. Intercontinental and Intracontinental Partnerships 7.3.7.1. Country-wise Distribution 7.3.7.2. Regional Distribution 7.3.7.3 Analysis by Type of Partnership, Type of Product, Location of Facility and Type of Agreement
8. FEASIBILITY STUDY 8.1. Chapter Overview 8.2. Modular Facility Projects Undertaken in the Pharmaceutical / Biotechnology Industry 8.3. Analysis by Type of Facility 8.4. Analysis by Facility Area 8.5. Analysis by Type of Facility and Facility Area 8.6. Most Active Manufacturers: Analysis by Number of Projects Delivered 8.7. Most Active Clients: Analysis by Number of Projects Received 8.8. Analysis by Location of Facility 8.9. Analysis by Client and Location of Facility 8.10. Modular versus Conventional Construction Methods 8.11. Return on Investment 8.12. Case Study: Facility Based on KUBio Platform 8.12.1. GE Healthcare's KUBio Platform: Overview 8.12.2. JHL Biotech's KUBio Modular Project in China: Overview and Construction Details
9. FACILITY CONSTRUCTION TRENDS IN THE PHARMACEUTICAL INDUSTRY 9.1. Chapter Overview 9.2. Facility Construction Projects Undertaken in the Pharmaceutical / Biotechnology Industry (Top 20 Companies): Historical Data, 2016-2020 (Till December) 9.2.1. Analysis by Number of Facilities 9.2.2. Analysis by Type of Facility 9.2.3. Analysis by Purpose of Facility 9.2.4. Analysis by Investment 9.2.5. Analysis by Facility Area 9.2.6. Analysis by Location of Headquarters
