Table of Contents
Lyophilization, used in life sciences, and freeze-drying, used in other industries, are synonymous and both processes are the same. In principle, the process uses a vacuum to rapidly evaporate moisture from the core material while at the same time keeping the materials frozen to preserve its essential properties. For pharmaceutical or biotechnology products, this is critical to maintain the function and integrity of the drug or biomolecule. For the food or other industries, it is essential to preserve the freshness of the product and prevent spoilage. In this report the two terms, lyophilization and freeze-drying, are used interchangeably.While the U.S. and Europe (especially Germany) have the majority of the market, China is gaining market share rapidly. One Chinese company alone, IMA Life Pharmaceutical Systems Co. Ltd., is the largest manufacturer of this equipment in China and is selling products into 70 countries worldwide.
STUDY GOALS AND OBJECTIVES
Assess the various technologies and equipment used for lyophilization of various product types.
Understand the process, the technical requirements and problems in scale up of lyophilization for large-scale production.
Examine the regulatory landscape and government’s role.
Examine the current market for lyophilization equipment and contract services.
Examine geographic distribution of current and future market potential.
REASONS FOR DOING THE STUDY
For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.There are more than 130 pharmaceutical products on the 2012 market, worth over $50 billion, that require lyophilization processing. Biologicals and biopharmaceuticals remain the fastest growing segment among novel pharmaceutical entities. It is estimated that the market for lyophilizing compounds such as biologicals and biopharmaceuticals is currently approaching 200 million units and it is set to continue year-on-year double-digit growth. The lyophilization market is expected to achieve significant growth from 2012 to 2017. This is primarily due to a greater demand for injectable biotech drugs and vaccine market expansion caused by the entry of new products and technologies.Without the use of lyophilization, 60% of biotherapeutics, including recombinant proteins, plasma, vaccines, and antibodies, could not be made commercially viable. The freeze-drying process has become increasingly more efficient in recent years. It is easier to use, more cost-effective, and extremely good at maintaining product integrity.The market for freeze-drying equipment for all industries including pharmaceutical/biotechnology, food industry, and chemicals, is projected to increase at a CAGR of 4.5% over the next five-year period. Freeze-dried food products will have a market advantage in countries where proper refrigeration or electricity is limited or inadequate to meet consumer needs. The ability to store freeze-dried foods in developing countries will increase the demand for equipment and freeze-drying contract services companies. Continued growth is expected in emerging geographies, driven by the health awareness of the growing middle class in emerging countries such as Brazil, Russia, India, and China (the BRIC countries.).The report addresses the critically important topics of analyzing a changing market dynamic, emerging players and products, strategies for accessing emerging markets, specific disease prevalence, and geographies, in order to allocate resources and make effective decisions.
SCOPE OF REPORT
Current and projected equipment and services markets are forecast during the five-year period, 2013 to 2018. New equipment and process improvements are discussed. Revenue figures for 2011 are an actual figure. Revenue figures for 2012 are an actual figure except where actual results have not been reported, due to the release timing of the report.The report includes analysis of leading and emerging products. Profiles of producers of leading products and their specific products are provided. The report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. Market figures are based on revenues at the manufacturers’ level and are projected at 2012-dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, for new product introductions, expanded markets for existing products, and other factors affecting the market.Included in this report are forecasts by product, product category, and by company from 2011 through 2018. The study is arranged to offer an overview of existing equipment, companies, products, and geography with forecasts broken down and covered by geographic region or country. Patent and Merger and Acquisition (M&A) activities are discussed.Figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.All market share data presented is on a global basis, unless specifically noted.
The report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants, and anyone interested in the lyophilization equipment and services markets, its products, its industry participants and its future.The importance of identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities and insights that provide guidance for sales growth or defensive moves cannot be overstated for a variety of constituents, including:
Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development, and R&D.
Emerging players in the segment must understand specific opportunities for out-licensing, originating from the elements of differentiation of their product or technology as compared to leading, competitive, and emerging products. As well, market forecasts can support investment, as long as a thorough and detailed substantiation is provided for the market forecast, as is found in this study.
Investment firms evaluating candidates for venture capital or hedged investments will gain insights into the opportunity and risks that are being encountered in the industry, in a product- and company-specific analysis.
Equity analysts are provided detailed forecasts for the next five years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.
METHODOLOGY AND INFORMATION SOURCES
In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts, and leading individuals in the field.Information to prepare this report was obtained from participating and emerging companies in the lyophilization equipment and contract services areas. From the National Institute of Health (NIH), the National Human Genomic Research Institute (NHGRI, NIH), the Center of Information Technology (CIT), National Library of Medicine (NLM, NIH), the Pharmaceutical Manufacturers Association (PMA), the Biotechnology Industry Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA), National Pasta Association (NPA), International Society of Lyophilization and Freeze-drying (ISLFD), Lyophilization Association (LA), Freeze-drying Technologies Group of the American Association of Pharmaceutical Scientists (AAPS), the Singapore Association of Pharmaceutical Industries and the International Nut and Dried Fruit Council (INC).Additional information was obtained from a variety of medical and technical journals in the various specialties of the lyophilization and freeze-drying industries including: Pharmaceutical Processing Magazine, Pharmaceutical Manufacturing Magazine, Food Engineering magazine, Processed Foods Industry magazine, and Modern Food Processing magazine. Other sources included the New York Times, the Wall Street Journal, the Washington Post, other newspapers and company documents and other Internet websites. Population estimates are based on those reported by the International database of the U.S. Census Bureau. Statistical data was obtained from the World Health Organization (WHO), National Institute of Health (NIH), and the WHO Collaborating Centre for Drug Statistics Methodology (Norway).Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.
Get Industry Insights. Simply.
Talk to Ahmad
+1 718 618 4302