Cleanroom Pods are Reshaping Flexibility in Pharma and Biotech Manufacturing
The pharmaceutical and biotechnology industries have undergone a radical transformation over the past couple of decades – new classes of therapies, massive changes in vaccine technology, and advancements in laboratory and manufacturing facilities.
Novel health products of different kinds have entered the market and many more are expected. Certainly, these innovations have the potential to revolutionise population health outcomes but before that can happen, the pharma and biotech ecosystems must keep up to ensure the feasible production and distribution of these innovations. One of the critical foci of these ecosystems is biopharma manufacturing capability development, with modular cleanroom pods being central to this focus.
The need for flexibility in pharma and biotech manufacturing.
Fueled by new products, the rapid growth of the pharma and biotech industries has increased the demand for flexible manufacturing capabilities. A centralised manufacturing unit with fixed infrastructure to produce one specific product for the global market will no longer do. Speed, scalability, and repurposability are key to making cleanrooms—vital in biopharma manufacturing—flexible and adaptable to the changing demands of the market.
Traditionally, GMP-compliant cleanrooms were built brick by brick for a specific purpose. With the proliferation of novel therapies, constructing such traditional facilities with low flexibility for each new drug is not feasible anymore. In this scenario, prefabricated cleanrooms or modular cleanroom pods are the best option to prevent bottlenecks in biopharma R&D and commercial manufacturing.
Adding to these concerns is the evolution of manufacturing technologies, particularly in the case of cell and gene therapies. Conventional stick-built cleanrooms just don’t have the flexibility to accommodate new manufacturing technologies as they develop.
Finally, with a changing epidemiological landscape and more disease outbreaks, there is a certain urgency in bringing even existing health products to new markets as soon as possible. Cutting facility construction time is one of the best ways to reduce your time to market.
Whether you’re expanding your existing capacity or setting up biopharma operations from scratch, cleanroom pods are a relatively simple, quick, cost-effective, and GMP-compliant solution.
Currently, conventional stick-built facilities dominate the cleanroom market, but as the demand for cleanrooms for biopharma grows exponentially, cleanroom pods are the way to go. The shift to modular cleanroom pods is inevitable.
What are prefabricated cleanrooms or cleanroom pods?
Cleanroom pods are modular, prefabricated cleanrooms that meet all regulatory and industry standards of traditional cleanrooms. Generally used in biopharmaceutical and biotechnology production, they provide a controlled environment within which sterile processes that call for strict GMP compliance can be carried out.
Cleanroom pods are suitable for any activity that requires stringent contamination control. Think advanced therapy medicinal production (ATMP), R&D, laboratories, aseptic filling, process development, or the manufacture of biologics, drug conjugates, and cell and gene therapies for clinical trials or mass distribution.
The modular nature of prefabricated facilities allows cleanroom pod manufacturers to streamline the design and build process. Facility manufacturers can use them in greenfield projects as well as existing facilities. With their portable and modular design, cleanroom pods provide a flexibility that is unmatched by traditional construction, making them the best choice for businesses both old and new alike.
The market for cleanrooms.
Estimates suggest that the global cleanroom market across industries—biopharma and beyond—stands at about USD 12 billion/year. The electronics and semiconductors industry claims the lion’s share of the market, with the pharmaceutical industry in second place with ~40% of the market.
At 8 to 10% CAGR, revenue growth in the cleanroom industry is lower than the roughly 12% witnessed in the biopharmaceutical supplies market. This isn’t a matter of low demand; rather, this relatively low growth rate is, in part, due to greater efficiency in recent years. This high rate of efficiency results in cleanrooms which maximise productivity in smaller spaces. In future, the growth of the cleanroom industry will likely be driven by greater demand for prefabricated modular cleanroom pods, the demand for which will be driven by the development and production of new and maturing therapeutic entities.
Research predicts that there about 11,000 pharmaceutical cleanrooms in 2025, with the number forecast to go up to 15,000 by 2030. Cellular and viral vector gene therapies manufacturing are poised to drive this expansion. This number does not even account for cleanrooms required in other healthcare and industrial applications. Cleanroom pod manufacturers’ revenues are also expected to grow significantly in response to the demand for more prefabricated cleanrooms.
A growing opportunity for cleanroom pod manufacturers.
In the past few years, the biopharma world has been witness to several breakthrough therapies—in precision medicine, oncology, and rare and orphan diseases. Consequently, this has increased the pressure on pharma manufacturers to speed up product development and commercialisation, all while keeping costs low.
Cleanroom pods have emerged as the solution of choice for many biopharma manufacturers grappling with these challenges. They have been increasingly relying on these flexible manufacturing solutions to meet the upward demand curve shaped by the following trends.
- Growing biopharmaceutical markets, driven by new products.
- Shortages and high costs related to skilled labour.
- Stringent regulatory standards, with traditional cleanrooms posing concerns about contaminating building materials.
- Increasing use of cleanroom pods by contract manufacturers who also struggle with bottlenecks through clinical and commercial production.
- Growing demand for personalised medicine (also called precision medicine), particularly for cell and gene therapies. The implications of this are that pharmaceutical manufacturers now have to produce a wide variety of products on an accelerated timeline and at significantly lower volumes.
- Increases in orphan pharmaceutical development i.e. the development of therapies for rare diseases which affect a fairly small proportion of the population. Large-scale production of these drugs is not necessary while producing only small quantities is not usually commercially viable. Prefabricated modular cleanroom pods make the development and production of such drugs a lot more feasible.
- New biopharma growth opportunities in developing markets in Africa, Asia and Latin America make the deployment of modular cleanroom pods very appealing. They offer a quick and cost-effective way of localising biopharmaceutical manufacturing.
- Growth in the advanced parenterals market. Drugs administered in any way other than orally are called parenterals or sterile injectables (SI). Data from Fortune Business Insights forecasts that the global injectable drug delivery market will reach USD 1.2 trillion by 2027. Biopharmaceuticals for chronic conditions like diabetes and arthritis will be key market drivers, with this category alone predicted to reach a value of USD 856 billion by 2030. All parenterals must be sterile and produced in highly controlled cleanroom environments. So whether they are manufactured internally or by contract manufacturers, sterile injectable drugs will also drive the growth of the cleanroom pods market.
- Quicker evolutions in product life cycles, with technological advancements over the past decade or so leading to increasing rates of breakthrough therapies being approved. Since they are designed to rapidly keep up with cycles of pharmaceutical development and production, cleanroom pods are increasingly deployed across different stages in product life cycles. They significantly enhance the speed to market and quality of production during clinical and commercial stages.
- ESG demands and the need for smaller carbon footprints in biopharmaceutical manufacturing, with modular cleanroom pods requiring less construction material, being reusable and recyclable, and generally more energy efficient than their stick-built counterparts.
All of these trends in the biopharmaceutical industry have been drivers for the increasing demand for prefabricated cleanrooms. How are prefabricated cleanrooms, in turn, reshaping flexibility in pharma and biotech manufacturing? That’s a function of the off-site manufacturing and modular nature.