The pharmaceutical / biotechnology modular facilities market is anticipated to grow at an annualized rate of 8.9% during the period 2017 - 2030
LONDON, Oct. 30, 2017 /PRNewswire/ -- INTRODUCTION
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.
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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.
SCOPE OF THE REPORT
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).
RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views
While the focus has been on forecasting the market till 2030, the report also provides our view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the current state of the market and its likely evolution in the mid-long term.
Chapter 3 provides a general overview of the modular design concept with information on its historical evolution, types of modules and the modular construction process. It also provides details related to the construction of modular facilities for use in the pharmaceutical / biotechnology industry along with the advantages of these facilities, and information on modular cleanrooms, including their classification and prevalent cleanroom standards.
Chapter 4 includes a comprehensive overview of the landscape of companies that offer pharmaceutical / biotechnology modular facilities. It features an analysis of these service providers on the basis of their geographical location, establishment year, company size and the type of industry served. Additionally, it contains information on regulatory certifications and examples of recent projects undertaken by these companies.
Chapter 5 features a comprehensive overview of the landscape of companies that specialize in offering modular cleanrooms. It features an analysis of the modular cleanroom providers on the basis of their geographical location, type of industry served and the type of modular cleanrooms offered. The chapter also provides information on the components of modular cleanrooms provided by different companies and regulatory certifications of these firms.
Chapter 6 contains detailed profiles of some of the key players that are actively providing modular facilities to pharmaceutical and biotechnology companies. Each company profile includes a brief overview of the company, financial information (if available), details on service offerings, recent developments and an informed future outlook.
Chapter 7 features an elaborate discussion and analysis of the collaborations and partnerships that have been inked amongst players in this market over the last five years (2012 - August 2017). We have also discussed the various partnership models that have been implemented, highlighting the most common forms of deals / agreements in this domain. It also lists other recent developments, such as facility / capability expansions and certifications, which have taken place in this domain.
Chapter 8 provides insights on the recent trends in the pharmaceutical / biotechnology industry that are expected to influence the adoption of modular facilities. Some of these trends include the integration of single use / continuous processing technologies with modular facilities, emergence of smaller, multi-purpose, multi-product modular facilities, and collaborations that have been established to provide integrated and flexible modular solutions.
Chapter 9 features a detailed discussion on potential areas, such as rise of personalized medicines, biosimilars and orphan drugs, and increasing adoption of modular solutions in emerging regions and CMOs, which are likely to act as growth drivers in the pharmaceutical / biotechnology modular facilities market, during the coming years.
Chapter 10 presents details on some modular facilities built by various pharmaceutical / biotechnology companies across different geographies. It also includes a discussion on why modular facilities may be preferred over traditional facilities in the long term. Additionally, the chapter includes a case study on JHL Biotech's recent installation of GE Healthcare Life Sciences' KUBio modular biomanufacturing facility, at the former company's site in Wuhan, China.
Chapter 11 presents a comprehensive market forecast analysis, highlighting the future potential of the pharmaceutical / biotechnology modular facilities market till the year 2030. We have segregated the opportunity on the basis of type of construction component, size of the facility, type of product, purpose of facility and type of facility. Our estimates are backed by robust analysis of data procured from both secondary and primary sources.
Chapter 12 summarizes the overall report. It presents a list of key takeaways and offers our independent opinion on the current scenario and evolutionary trends that are likely to determine the future of this market in the mid-long term.
Chapter 13 is a collection of transcripts of discussions that were held with key stakeholders in this market. We have presented the details of interviews 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).
Chapters 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 15 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.
EXAMPLE HIGHLIGHTS
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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