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Biopharmaceutical Contract Manufacturing Market, 2015 - 2025

  • May 2015
  • 316 pages
  • Roots Analysis Private Ltd.
Report ID: 2997634

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INTRODUCTION
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 WuXiAppTec (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.

RESEARCH METHODOLOGY
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
§ Annual reports
§ Investor presentations
§ SEC filings
§ Industry databases
§ 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.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on where the biopharmaceutical contract manufacturing market is headed in the mid-long term.

Chapter 3 provides a general overview on biopharmaceuticals along with manufacturing procedures and use of expression systems. We have also explained the need for biopharmaceutical outsourcing and identified the commonly outsourced bio-manufacturing activities.

Chapter 4 highlights the trends, regulatory landscape and key players of the two leading biopharmaceutical contract manufacturing destinations, the US and Europe. The chapter also provides the US and Europe sub-market forecast segmented on the basis of type of business operations and expression systems.

Chapter 5 details biopharmaceutical contract manufacturing activities in China and India, providing information on regulatory framework, growth drivers, challenges along with a high-level view on production capabilities of some the key players of each of these countries. The chapter provides the sub-market forecast in each of the countries by type of business operations and expression systems.

Chapter 6 provides a comprehensive view on the global landscape of biopharmaceutical CMOs. An in-depth review including regional distribution, analysis by scale of operation, type of biologics manufactured and expression systems has been covered in this chapter. The chapter provides additional information on the production capabilities of the CMOs on type of bioreactor, mode of bioreactor and fermentation capacity.

Chapter 7 focuses on some of the niche sectors of biopharmaceutical outsourcing; these include ADCs, bispecific antibodies and gene therapy. The chapter provides a detailed market review, including information on the pipeline, partnerships, investments and the presence of CMOs in each of these areas.

Chapter 8 focuses on outsourcing of biosimilars, a major growth opportunity for biopharmaceutical CMOs. The chapter provides an overview on biosimilars and CMOs that are actively involved in the biosimilars market.

Chapter 9 analyses the recent developments in the biopharmaceutical CMO market. It contains information about the investments and partnerships that have happened in the past few years, along with an analysis of the trends that have been observed over the years. It also contains a brief section on the technological advancements which have recently shaped the market.

Chapter 10 presents the detailed forecast for biopharmaceutical contract manufacturing segmented by type of business (API and FDF), type of expression systems and key geographies. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.

Chapter 11 highlights additional dimensions such as rising outsourcing budgets, capacity fluctuations and shift towards strategic partnering that will likely govern the growth and evolution of biopharmaceutical contract manufacturing market in the future.

Chapter 12 provides a SWOT analysis capturing the key elements likely to influence future growth.

Chapter 13 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapter 14 is a collection of transcripts of interviews conducted during the course of this study. Examples of companies interviewed are FUJIFILM Diosynth Technologies, Goodwin Biotechnology, Rentschler, Piramal Healthcare, Catalent and Novasep.

Chapter 15 is an appendix which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix which provides a list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS

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, Germanyand 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 highergrowth 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.

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