Biopharmaceutical Contract Manufacturing Market, 2015 - 2025
Characterized by a rapidly expanding product pipeline and a capital intensive manufacturing business, the biopharmaceutical market is witnessing a growing trend towards contract manufacturing. In addition to serving as a cost-cutting tool, contract manufacturing provides several other advantages to biopharmaceutical companies including technical expertise, operational efficiency, regulatory support and the ability to focus on core competencies. Spanning multiple operations within the wider manufacturing processes, outsourcing is increasingly being viewed as a strategic imperative.
The current marketplace has the presence of over 160 biopharmaceutical CMOs, offering a multitude of services ranging from cell line development and API manufacturing to fill/ finish of the product. Lonza, Boehringer Ingelheim and FUJIFILM Diosynth Biotechnologies are amongst the leading companies in this market. In addition, there are several key players operating in emerging regions that contribute significantly to this market; examples include Kemwell Biopharma (India), Shasun Pharma (India) and WuXi AppTec (China).
Despite being surrounded with several challenges associated with cost and complexity in bio-manufacturing, the contract manufacturing market has witnessed considerable growth in the past few years. Driven by the strong growth in the biologics market and advancement in technologies, biopharmaceutical contract manufacturing is well positioned to achieve an accelerated growth in the coming years. An intensive framework of collaborations and investment activity further supports the optimistic growth outlook.
SCOPE OF THE REPORT
The ‘Biopharmaceutical Contract Manufacturing Market, 2015 - 2025’ report provides an extensive study of the contract manufacturing market for biopharmaceuticals. With biotechnology industry striving to maximize profits, outsourcing has emerged as an ever increasing trend. The study presents an in-depth analysis of a diverse set of biopharmaceutical CMOs on some of the key parameters such as geographical location, scale of operation, type of biologics manufactured, expression systems, type of bioreactors used and fermentation capacity. In addition, it captures some of the potential growth areas which will likely present tremendous opportunities for biopharmaceutical CMOs and ensure an accelerated pace of growth. Some of the niche service areas include manufacturing of ADCs and bispecific antibodies. Specifically, these markets typify huge unmet manufacturing requirements and represent untapped areas of targeted therapy revenue making outsourcing an attractive option.
The report assesses the key drivers that have governed the evolution of biopharmaceutical contract manufacturing market over the past several years along with an elaborate discussion on the future trends that will shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity for biopharmaceutical CMOs market over the next decade, segmented on the basis of business operations, type of expression systems and key regions.
In addition, the study provides information on some of the most important aspects of biopharmaceutical outsourcing; these include growing collaborations, investment activity, technological advancements and development of biosimilars. In addition to some of the well-known benefits and a promising outlook, the study also highlights considerable challenges currently prevalent in the market. Examples include quality concerns, stringent regulations and lack of funding. Nevertheless, these challenges are paving the way for new strategies and technological improvements, which will indeed be advantageous in the long run.
The base year for the report is 2014; the report provides market forecasts for the period 2015 - 2025. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.
1. North America and Europe are the predominant regions where majority of the production facilities of biopharmaceutical CMOs are located. Of the 160 CMOs we studied, 80 have presence in multiple locations in the US. In Europe, the other major hub for CMOs, Germany and the UK have presence of over 20 CMOs. Companies have also gradually moved their focus to developing countries in order to take advantage of the relatively lower costs.
2. With respect to the bio-manufacturing capabilities of contract manufacturers, majority of the CMOs currently are capable of manufacturing proteins and antibodies; mammalian based manufacturing represents the predominantly used production method and will continue to achieve a relatively higher growth rate.
3. In terms of analysis by scale of operation, majority of the biopharmaceutical CMOs have the capability to operate on clinical as well as commercial scale. Out of 153 CMOs evaluated for this exercise, over 70% have the provision for both clinical and commercial stage manufacturing.
4. Although the ‘one stop shop’ model is steadily gaining pace in the biopharmaceutical CMO industry, certain operations are witnessing an increased extent of outsourcing. Fill/ finish operations represents one of the most heavily outsourced operations; owing to the requirement of specialized technologies and technical expertise, this segment is projected to be outsourced significantly in the near future.
5. Certain niche segments within bio-manufacturing which have garnered the interest of biopharmaceutical CMOs include manufacturing of ADCs, bispecific antibodies and gene therapy; these markets, characterized by an untapped potential and optimistic growth prospects will continue to benefit from an increasing presence of CMOs. In addition, the emerging biosimilars industry represents another key demand sector for biopharmaceutical CMOs.
6. The highly competitive market landscape is abuzz with an intensive framework of growing investment activities and collaborations. In addition, technological advancements including the use of disposable technologies is another key bio-manufacturing trend that is emblematic of the current market intensity.
7. Driven by the rapidly expanding biopharmaceutical market and technological advancements, we expect the overall market to grow at an annualized rate of 8.3%. The rate of growth is likely to vary significantly across different segments / activities and across geographical regions.
Most of the data presented in this report has been gathered by secondary research. We have also conducted 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 shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
News releases from company websites
Government policy documents
Other analysts’ opinion reports
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent 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.
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