Table of Contents
Amongst the increasing financial pressures and the need to reduce cost and improve efficiencies, the pharmaceutical industry has witnessed a paradigm shift from vertically integrated business model to a network of suppliers. As such, contract manufacturing has evolved as one of the integral components of the pharmaceutical market. Started initially as a one-off activity, contract manufacturing has evolved into a dynamic business model; currently most prevalent in manufacturing, outsourcing is steadily spanning the entire pharmaceutical value chain. With CMOs now offering the entire multitude of services from design and discovery to final packaging, the concept of ‘one stop shop’ service provider is gradually gaining pace.
The market has witnessed several major trends that have governed the evolution of contract manufacturing over the past few years. One of the most significant changes in the outsourcing space is the emergence of strategic contract manufacturing. The conventional model of contract manufacturing involved a vendor-customer equation. However, phasing out that traditional concept, contract manufacturers nowadays believe in entering in strategic alliances with CMO partners with the objective of cutting down production cost and enhancing product pipelines.
The contract manufacturing market, broadly categorized into API manufacturing and FDF manufacturing, has witnessed significant growth in the past several years driven by factors such as cost efficiency, technical expertise, and increased time efficiency. The current marketplace is inundated with numerous established as well as emerging CMOs, with a diverse array of service offerings and scale of operation. Despite being faced with challenges such as heavy competition and lack of funding, contract manufacturing in itself characterizes a huge opportunity for the pharmaceutical sector. Inevitably, substantial growth prospects lie ahead for pharmaceutical contract manufacturers; CMOs who will be able to provide certain differentiating elements targeting diverse customer groups stand to benefit the most in this competitive landscape.
SCOPE OF THE REPORT
The ‘Contract Manufacturing in Pharmaceutical Industry, 2015 - 2025’ report provides an extensive study of the rapidly growing pharmaceutical contract manufacturing market. With pharmaceutical and biotechnology industry striving to minimize costs and maximize profits, outsourcing has emerged as an ever increasing trend. The study presents an in-depth analysis of a diverse set of CMOs on some of the key parameters such as type of business operation, scale of operation, packaging form, geographical location and range of services. In addition, it captures some of the key growth areas which will likely present tremendous opportunities for CMOs and ensure an accelerated pace of growth. Some of the potential growth areas include biopharmaceutical and high potency manufacturing. Specifically, in these markets, complex manufacturing requirements and capital intensive nature of the business make outsourcing an attractive option.
The report assesses some of the key drivers that have governed the evolution of 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 in the pharmaceutical contract manufacturing market over the next decade, segmented on the basis of business operations and key regions.
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, cultural differences and lack of transparency in the manufacturing process. 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 CMOs are located. Out of 509CMOs we studied, 189 have presence in multiple locations in the US. In Europe,the other major hub for CMOs, Germany, Italy and the UK have presence of 58, 37 and 32 CMOs respectively. Companies have also gradually moved their focus to developing countries in order to take advantage of the relatively lower costs.
2. The market is well distributed between API manufacturers and FDF manufacturers. Within FDF contract manufacturing, solid dose compounds currently dominate the market. However, future growth is likely to be driven by injectables dose manufacturing primarily due to increased focus on complex disease areas and the growing trend of self-administration.
3. In terms of analysis by scale of operation, majority of the CMOs have the capability to operate on clinical as well as commercial scale. Out of 394 CMOs evaluated for this exercise, 340 CMOs have the provision for both clinical and commercial stage manufacturing.
4. High potency and biopharmaceuticals manufacturing represent a major growth opportunity for CMOs. Owing to the capital intensive nature of the business and complex manufacturing requirements, CMOs have become the preferred manufacturing partners for majority of the pharmaceutical clients.
5. The intense competition in the marketplace is driving CMOs to explore innovation aspects such as eClinical systems, cloud based computing and risk monitoring tools to create differentiation. Specifically, for biopharmaceuticals manufacturing, CMOs have started utilizing novel bio-processing services and technologies such as single use bioreactors.
6. With respect to the market size, we have estimated the API and FDF contract manufacturing to be worth USD 35 Billion currently. Driven by the increasing trend of outsourcing, we expect the market to grow at an annualized rate of 8.3%.
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 nine 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 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on where the pharmaceutical contract manufacturing market is headed in the mid-long term.
Chapter 3 provides the definition of contract manufacturingand a general introduction on the role of a third party service provider in the pharmaceutical industry. We have also explained, in detail, the range of services offered by CMOs and challenges involved in contract manufacturing.
Chapter 4 highlights the key growth drivers and restraints of the contract manufacturing market. The chapter also talks about various models of contract manufacturing and some of the important trends that have shaped the market in the past several years.
Chapter 5 details contract manufacturing space specifically in China and India, providing information on regulatory framework, growth drivers, challenges and emerging opportunities in each of these countries. The chapter also provides a high-level view on production capabilities of some of the leading Chinese and Indian CMOs in the market.
Chapter 6 provides a detailed analysis of a diverse set of established and emerging pharmaceutical CMOs active in the market. An in-depth review including regional distribution, analysis by type of business operation, scale of operation, packaging and services has been covered in this chapter.
Chapter 7 focuses on biopharmaceutical contract manufacturing, a major growth opportunity for CMOs. The chapter provides an in-depth analysis specifically for biopharmaceutical CMOs on some of the key parameters including geographical location, scale of operation, types of expression systems, types of biologics manufactured, types of bioreactors and fermentation capacity.
Chapter 8 presents the detailed forecast for both API and FDF contract manufacturing. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.
Chapter 9 includes profiles of some of the key players in the pharmaceutical contract manufacturing market. Each company profile includes information such as geographical presence, financial performance, manufacturing capabilities, investments, partnerships and future outlook.
Chapter 10 highlights some of the important trends that will likely govern the growth and evolution of contract manufacturing market in the future.
Chapter 11 is a collection of transcripts of interviews conducted during the course of this study. Examples of companies interviewed include Corden Pharma, Helsinn, CiVentiChem and Novasep.
Chapter 12 summarizes 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 13 is an appendix which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix which provides a list of companies and organizations mentioned in the report.
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