NEW YORK, Dec. 2, 2014 /PRNewswire/ -- The 'HPAPIs and Cytotoxic Drugs Manufacturing Market, 2014-2024' report provides an extensive study of the rapidly growing manufacturing market of HPAPIs and cytotoxic drugs. Due to their numerous advantages and increased applications in treatment of cancer and other disorders, HPAPIs and cytotoxics have emerged as one of the key focus areas of researchers across the globe. When compared to conventional therapeutic products, these compounds offer multiple advantages. The focus of this report is primarily to understand the likely future evolution of contract manufacturing of HPAPIs and cytotoxics over the next decade.
The report covers various aspects such as analysis of CMOs involved in HPAPI/Cytotoxics manufacturing, pharmaceutical companies with in-house capabilities, regulatory guidelines, key drivers and upcoming opportunities for various stakeholders. Though a few pharmaceutical companies have in-house capabilities, a sizeable proportion of this market is covered by contract manufacturing. The future growth in the market will primarily be driven by the rapidly expanding market for oncology drugs; majority of the high potency and cytotoxic drugs are being developed for treatment of cancer. With evolving clinical research, use of HPAPIs and cytotoxics in other therapeutic areas such as glaucoma, hormonal imbalances and respiratory disorders have also been identified.
Despite some of these key benefits and a promising future, the study also highlights considerable challenges associated with production of these compounds. Due to their highly toxic nature, they can lead to occupational hazards, if not handled carefully. In addition, cross-contamination with other products can be highly detrimental for the patients. Thus, adequate containment strategies and proper classification of hazards is essential for the uptake of this market.
The base year for the report is 2013; actual sales data of respective companies has been presented for the latest year. The report provides short-mid term and long term market forecasts for the period 2014 - 2019 and 2019 - 2024, respectively. 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.
Oncology is the leading domain for HPAPIs and cytotoxic drugs. Around 60% of the HPAPIs are being developed for treatment of cancer. The trend is likely to continue and the anti-cancer market will drive the growth of HPAPIs and cytotoxics in the future.
A good proportion of HPAPI / cytotoxics manufacturing is currently outsourced. In fact, specifically for ADCs, the outsourcing proportion is as high as 75%-80%. During our research, we identified 76 CMOs (with over 100 production facilities worldwide) which are focused in this area. SAFC and Lonza are amongst some of the CMOs which are well-known.
Having said this, big pharma companies such as Merck, Roche, Pfizer and AbbVie have also established in-house capabilities.
Many CMOs offer commercial scale manufacturing of these compounds. A relatively less number of players, including Corden Pharma and Aptuit, provide one stop shop service ranging from manufacturing of APIs to formulation and fill/finish of the drug product.
North America and Europe are the predominant regions where HPAPI and cytotoxic drugs production facilities are located. The US accounts for 27% of the total HPAPI production facilities and 31% of the cytotoxic drugs production facilities. Companies have also recently moved their focus to developing countries in order to take advantage of relatively lower costs.
CMOs have regularly engaged in investment programs to expand their production set ups. Since 2006, there have been more than 60 investments to add new facilities and / or to expand existing capacities.
Stakeholders have also inked numerous partnerships to combine their manufacturing expertise. Of the 35 recent partnerships that we studied during our research, an overwhelming proportion was manufacturing collaborations and merger/acquisitions.
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 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 the likely evolution of manufacturing of HPAPIs and cytotoxic drugs.
Chapter 3 provides a general introduction on HPAPIs and cytotoxics. We have also explained, in detail, specific containment requirements for handling HPAPIs and cytotoxics.
Chapter 4 identifies the contract manufacturers actively involved in HPAPIs/cytotoxics market. The chapter provides details on production capabilities of these CMOs, specifically focussing on the scale of operation, OEL limits and geographic location of their facilities. It also highlights leading pharmaceutical companies which have in-house capabilities. In addition, we have also discussed the current regulatory landscape.
Chapter 5 provides a detailed analysis of CMOs focussed in the HPAPI market. An in-depth review including regional distribution, analysis by scale of operation and OEL limits has been covered in this chapter. The chapter also provides a high-level view on production specifications of leading manufacturers in the market.
Chapter 6 provides a detailed analysis of CMOs involved in cytotoxic drugs manufacturing. In addition to the regional distribution, it covers a comprehensive review of other parameters such as scale of operation, OEL limits, and fill/finish capabilities.
Chapter 7 introduces the 'one stop shop' model with respect to HPAPI and cytotoxics manufacturing. The chapter includes case studies of two leading companies, Aptuit and Corden Pharma who have adopted this model.
Chapter 8 presents the detailed forecasting analysis for both HPAPIs and cytotoxic drugs 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 the key contract manufacturers in the market. Each company profile includes information such as geographical presence, manufacturing capabilities, investments, partnerships and financial performance.
Chapter 10 analyses the recent developments which have shaped the market. The chapter contains information about the investments and partnerships which have taken place in the past few years. It also contains a brief section on technological advancements.
Chapter 11 provides a SWOT analysis capturing the key elements likely to influence future growth.
Chapter 12 provides specific details on the emerging field of Antibody Drug Conjugates (ADCs). This new class of therapeutic agents are likely to act as one of the key drivers of the cytotoxic drugs market. The chapter contains detailed information on in house manufacturing and contract manufacturing of ADCs.
Chapter 13 is a collection of transcripts of interviews conducted with stakeholders (e.g. Helsinn and Corden Pharma) during the course of this study. In addition to detailed interviews, we had also conducted a comprehensive survey to learn more about manufacturing capabilities / capacities of about 75 players in the industry.
Chapter 14 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 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.
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