The Modular Facilities in Pharmaceutical/Biotechnology Industry, 2017-2030 Report has been published. It provides updated in 2018 year analysis of industries from Biotechnology, Healthcare Markets.
The business strategies and operational processes in the pharmaceutical industry have regularly evolved over time. Over the past few years, there has been an increased pressure on drug manufacturers to optimize drug development costs and speed up the drug development process. Specifically, with the rise of personalized therapies and orphan drugs, manufacturers are now expected to produce significantly low volumes of a wide range of drugs owing to the patient specific nature of such therapies. In addition, with the increasing number of biosimilars in the pipeline, companies are aiming to reduce the time to market in order to ensure faster patient access. In general, the current market scenario demands the existing operational modes to be altered in such a way that the focus shifts to faster processes, lower manufacturing costs and smaller batch sizes.
Modular facilities have demonstrated tremendous potential in several fields; specifically, the shorter time taken to establish such facilities has a significant impact on expediting various operational processes. Over the years, the interest in such facilities has also gradually risen amongst drug manufacturers within the pharmaceutical and biopharmaceutical industries. In fact, various companies have already transitioned from establishing conventional manufacturing facilities (focused on the large-scale production of a single product) to using small, flexible and modular facilities that can handle multiple products, simultaneously.
It has been reported that the time required for the construction of modular facilities, starting from design to approval, could be reduced to half the time required for the construction of conventional facilities. This is primarily due to the fact that modular buildings (modules) are typically constructed offsite, transported to the site and then assembled into fully functional entities. As a consequence of the approach used, facility construction, site preparation and regulatory documentation can proceed in parallel. This is very different from the traditional approach where the aforementioned activities have to be performed sequentially.
The ‘Modular Facilities in the Pharmaceutical/Biotechnology Industry, 2017-2030’ report provides an extensive study on the current market landscape and future outlook of modular facility manufacturers that cater to the demands of pharmaceutical and biopharmaceutical companies. The study presents an in-depth analysis of a diverse set of companies that provide complete modular facilities and/or modular cleanrooms to drug researchers/developers.
In addition to other elements, the report features:
- A review of the competitive market landscape of modular facility/modular cleanroom manufacturers with information on their geographical location (North America, Europe, Asia Pacific and rest of the world), establishment year, size (small-sized, mid-sized or large-sized) and type of industries served (pharmaceutical, biotechnology or others). It also includes information on regulatory certifications and recent projects undertaken by these companies.
- Elaborate profiles of established players that offer a wide range of modular manufacturing solutions to pharmaceutical and biotechnology industries; each profile includes a brief overview of the company, information on its financial status, comprehensive modular services portfolio, recent collaborations, information on capability/facility expansions and an informed future outlook.
- An analysis of the most active regions based on the locations of modular manufacturing solution providers; the report contains schematic representations of world maps that clearly indicate the modular facility/cleanroom manufacturing hubs.
- 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 and multi-product modular facilities.
- A discussion on key points that should be considered to facilitate the shift from using conventional facilities to modular facilities. We have provided a case study on JHL Biotech’s KUBio biomanufacturing facility, which was constructed by GE Healthcare Life Sciences in China.
- A detailed discussion on the various growth drivers, such as the development of personalized medicines, biosimilars, orphan drugs, and the anticipated increase in adoption of modular solutions in emerging markets and by pharmaceutical/biopharmaceutical CMOs.
- A detailed analysis of the collaborations and agreements, covering facility construction agreements, service alliances and acquisitions, which have been established amongst various stakeholders in the past few years.
The study features a detailed analysis on the likely evolution of the pharmaceutical/biotechnology modular manufacturing market over the time period 2017 to 2030. We have provided insights on the expected growth of the market in different regions, including North America, Europe, Asia Pacific and rest of the world. In addition, we have segmented the likely evolution of the market on the basis of type of construction component (process equipment, base building, mechanical, electrical, process utilities, process piping and others), size of the facility (small-sized, mid-sized and large-sized), type of product (small molecules, biologics and others), purpose of facility (manufacturing facility, R&D facility and others) and type of facility (new facility and expansions). In order to account for the uncertainties associated with some of the parameters used and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market’s evolution.
The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. The opinions and insights presented in the report were also influenced by discussions with senior stakeholders in the industry. The report presents detailed transcripts of discussions held with Maik Jornitz (CEO, G-CON Manufacturing), Pär Almhem (President, ModWave), Sulogna Roy (Sales Manager/Project Manager, Zeton) and Vernon Solomon (President, Environmental Systems Corporation).
1. During the course of our study, we identified close to 20 companies that offer modular facilities to pharmaceutical/biotechnology industry. Majority of these companies are located in North America and Europe. Examples of players based in these regions include (in alphabetical order) Biologics Modular, G-CON Manufacturing, GE Healthcare Life Sciences, Germfree Laboratories, IPM Technologies, Jacobs Engineering Group, KeyPlants, ModWave, NNE, Pharmadule Morimatsu and WH Partnership.
2. In addition, there are a number of players that specialize in providing modular cleanrooms; during our research, we identified more than 160 such companies. Of these, there are several companies that solely focus on serving the pharmaceutical and biotechnology industries; examples include (in alphabetical order, no specific shortlisting criteria) American Cleanroom Systems, Asgard Cleanroom Solutions, AWS BIO PHARMA Technologies, CID Associates, Clean Air Flow, Clean Room Depot, Environmental Systems Corporation, Modulus Cleanrooms and Shanghai HJ Modular Cleanroom.
3. Several pharmaceutical and biotechnology companies have adopted the modular concept for constructing new facilities or expanding existing infrastructure. Examples of some established companies include (in alphabetical order) AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Pfizer, Merck, Roche, Novartis and Sanofi. Additionally, small to mid-sized companies that have installed modular facilities include (in alphabetical order) 3P Biotherapeutics, JHL Biotech, Just Biotherapeutics, Stragen Pharma and Strike Bio. In fact, in May 2016, JHL Biotech inaugurated a 2,400 square meters new manufacturing facility, based on the modular KUBio™ platform of GE Healthcare Sciences, at its site in Wuhan, China. More recently, in March 2017, Just Biotherapeutics contracted G-CON Manufacturing for the construction of a cGMP biologics facility in the Hangzhou Economic and Technology Development Area (HEDA) in China. The facility is currently under construction and is anticipated to be completed and operational in early 2018.
4. A number of strategic collaborations have been inked in this domain. We came across over 35 collaborations established during the period 2014-H12017. Majority (~80%) of these collaborations are facility construction agreements. Prominent pharmaceutical/biotechnology modular facility or cleanroom providers that have entered into multiple partnerships include G-CON Manufacturing, GE Healthcare Life Sciences, AES Technology, M+W Group, and Pharmadule Morimatsu.
5. Companies manufacturing niche and emerging therapeutic classes, such as personalized therapies, along with the rising number of biosimilars, hold significant promise for modular facility manufacturers. The adoption of such facilities is also likely to increase in emerging regions, some of which have struggled to meet GMP standards. In addition, CMOs, adopting modular facilities to reduce initial capital investment and handle multiple products, are expected to create incremental business opportunities for modular facility manufacturers.
6. The pharmaceutical/biotechnology modular facilities market is anticipated to grow at an annualized rate of 8.9% during the period 2017-2030. Modular facilities for biologics manufacturing are expected to dominate (with more than 80% share) the market. Further, 85% of the overall market share is accounted for by facilities being used for manufacturing purposes. This is followed by facilities for R&D applications (12% of the overall market). In terms of type of facility, the opportunity is likely to be driven by construction of new facilities (65%) followed by modular expansions projects that will likely account for the remaining 35% of the market’s share.
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