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HPAPIs and Cytotoxic Drugs Manufacturing Market (2nd Edition), 2016 - 2026

  • March 2016
  • -
  • Roots Analysis Private Ltd.
  • -
  • 345 pages

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INTRODUCTION
With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide attention in recent years.

Some of the key benefits of these compounds include low dosage requirement and lower side effects. With over 25% of the total drugs worldwide being classified as highly potent, the HPAPI market is currently cited as one of the most important segments of pharmaceutical industry. The market is currently dominated by contract manufacturers. Though some pharmaceutical companies have invested in building in-house capabilities, the capital intensive nature and specialized containment requirements make the role of contract manufacturers crucial. SAFC, Lonza and Evonik are amongst the pioneers in the field of manufacturing highly potent compounds. In addition, new entrants such as Labochim, Medichem, OPKO Health, Project Pharmaceutics, Regis Technologies, ScinoPharm and Wuxi Pharma have also recently sprung up.

The growing number of investments and partnerships in this field are evident of the current market intensity. Majority of the investments in recent years have been expansion programs highlighting that manufacturers are keen to expand their existing production facilities to meet the growing demand. Looking at the ongoing focus, we certainly believe that stakeholders will continue to invest in this area. The current market landscape will gradually evolve as manufacturers look to gain competitive advantage in the near future.

SCOPE OF THE REPORT
The ‘HPAPIs and Cytotoxic Drugs Manufacturing Market, 2016-2026 (2nd edition)’ report provides an extensive study of the rapidly growing manufacturing market of HPAPIs and cytotoxic drugs. Due to their numerous advantages and widespread application 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 including low dosage requirements, low cost and high target specificity. The focus of this report is primarily to understand the current competitive landscape and the likely future evolution of both the HPAPIs and cytotoxic drugs market over the next decade. Amongst other elements, the report covers the following aspects:
- Review of the manufacturing sites of various CMOs involved in HPAPIs / cytotoxic drugs manufacturing.
- Overview of the pharmaceutical companies with in-house manufacturing capabilities.
- Investments in the expansion or for setting up of new facilities as well as collaborations that have taken place in the recent past.
- A detailed case study on the manufacturing of antibody drug conjugates (ADCs), one of the well-known emerging classes of cytotoxic drugs.

Though some pharmaceutical companies have in-house capabilities, the development of HPAPIs / cytotoxic drugs is primarily outsourced to contract manufacturers. The future growth of this market is likely to be driven by the increasing demand for oncology drugs, as majority of high potency and cytotoxic drugs are being developed for the treatment of cancer. As this segment continues to evolve, the use of HPAPIs and cytotoxic drugs in other therapeutic areas such as glaucoma, hormonal imbalances and respiratory disorders are also being investigated.

Despite their benefits and the scope of a promising future, the study also highlights that there are considerable challenges associated with the production of these compounds. Due to their highly toxic nature, they pose significant occupational hazards, if not handled carefully. In addition, cross-contamination with other products can be highly detrimental for the patients. Therefore, adequate containment strategies and a proper classification of hazards is essential for the uptake of this market.

The base year for this report is 2015; actual sales data of respective companies has been presented for up to last five years. The report provides market forecasts for the period 2016 – 2026. 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 via secondary and primary research. For all our projects, we conduct 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 is likely to evolve across different geographical regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The various secondary sources of information that we use include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts’ views

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.

1.1. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the key insights captured in our research. The summary offers a high-level view on the likely evolution of the contract manufacturing market for HPAPIs and cytotoxic drugs.

Chapter 3 provides a general introduction to HPAPIs and cytotoxic drugs. In this chapter, we have also explained, in detail, specific containment requirements for handling HPAPIs and cytotoxic drugs.

Chapter 4 identifies the contract manufacturers actively involved in the HPAPIs / cytotoxic drugs market. The chapter also provides details on various aspects related to these CMOs including their production capabilities, scale of operation, occupational exposure limits (OELs) and the geographic location of their facilities. It also highlights the leading pharmaceutical companies that have in-house capabilities for developing HPAPIs / cytotoxic drugs. In addition, the chapter provides a comprehensive overview of the current regulatory landscape governing this segment of the industry.

Chapter 5 provides a detailed analysis of the various CMOs involved in the manufacturing of HPAPIs. The chapter presents an in-depth comparative analysis of the major players in this segment based on regional distribution, scale of operation and OELs. The chapter also highlights the production specifications of the leading manufacturers in the market.

Chapter 6 provides a detailed analysis of the CMOs involved in the manufacturing of cytotoxic drugs. In addition to regional distribution of these organizations, the chapter presents a comprehensive review of various other parameters related to their capabilities such as scale of operation, OELs and fill / finish.

Chapter 7 introduces the one-stop-shop model with respect to HPAPIs / cytotoxic drugs manufacturing. The chapter includes case studies of five leading companies: AMRI, Baxter BioPharma Solutions, CordenPharma, Fareva and Pierre Fabre Laboratories that are operating as one-stop-shops.
Chapter 8 presents our forecast for both HPAPIs and cytotoxic drugs contract manufacturing market. All our predictions related to this market’s future have been backed up by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios. The chapter also presents a region-wise market forecast for both HPAPIs and cytotoxic drugs contract manufacturing.

Chapter 9 contains detailed profiles of key CMOs, located in the US, that are involved in the manufacturing of HPAPIs and cytotoxic drugs. Each profile includes information such as the company’s geographical presence, its financial performance, manufacturing capabilities, investments and partnerships.

Chapter 10 provides detailed profiles of key CMOs, located in Europe, that are involved in the manufacturing of HPAPIs and cytotoxic drugs. Similar to chapter 9, each profile includes information on the company’s geographical presence, its financial performance, manufacturing capabilities, investments and partnerships.

Chapter 11 provides detailed profiles of key CMOs that provide manufacturing services for HPAPIs and cytotoxic drugs in the Asia Pacific region. Similar to the earlier two chapters, each company profile includes information on the company’s geographical presence, its financial performance, manufacturing capabilities, investments and partnerships.

Chapter 12 provides profiles of several emerging CMOs in the HPAPIs and cytotoxic drugs manufacturing market. As in the earlier chapters, each profile contains information on the company’s geographical presence, financial performance (where available), manufacturing capabilities, investments and partnerships.

Chapter 13 analyzes the recent developments in the HPAPIs / cytotoxic drugs manufacturing market. This chapter contains information on the investments that have been made and the various partnerships that have been established in the past few years. It also presents an analysis of how the market has evolved over the years. In addition, the chapter contains a brief section on how recent technological advancements have led to the market’s evolution.

Chapter 14 provides a SWOT analysis capturing the key elements that are likely to influence future growth in this market.
Chapter 15 presents a case study on antibody drug conjugates (ADCs) manufacturing market; ADCs represent one of the rapidly expanding segments of biopharmaceutical industry and are expected to emerge as a significant opportunity for the CMOs in near future. The case study contains detailed information on both in-house and contract manufacturing in the ADC market.

Chapter 16 is a collection of transcripts of interviews conducted during the course of this study. The senior people interviewed for this study were Antonella Mancuso, Vice President & Chief Operating Officer and Maria Elena Guadagno, Business Director (BSP Pharmaceuticals), Stacy McDonald, Group Product Manager & Jennifer L. Mitcham, Director - Business Development (Catalent Pharma Solutions), Roberto Margarita, Business Development Director (CordenPharma), Allison Vavala, Senior Manager, Business Development (Helsinn), Javier E. Aznárez Araiz, Business Development (Idifarma), Mark Wright, Site Head, Grangemouth (Piramal Healthcare) and Klaus Hellerbrand, Managing Director (ProJect Pharmaceutics). In addition to detailed interviews, we had also conducted a comprehensive survey to learn more about the manufacturing capabilities / capacities of various stakeholders in the industry.

Chapter 17 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 the previous chapters.

Chapter 18 is an appendix that provides tabulated data for all the figures provided in the report.

Chapter 19 is an appendix that provides a list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Oncology is the key driver behind the growth of HPAPIs and cytotoxic drugs. Around 60% of the HPAPIs are being developed for the treatment of cancer. The trend is likely to continue and the anti-cancer market will sustain the growth of HPAPIs and cytotoxics in the future.
2. CMOs are the key stakeholders in the market as a good proportion of HPAPIs / cytotoxics manufacturing is currently outsourced due to stringent manufacturing protocols and safety requirements. During our research, we identified 96 CMOs (with over 130 production facilities worldwide) that are focused in this area; approximately 40% of these facilities are dedicated to manufacturing of both HPAPIs and cytotoxic drugs.
3. The market is highly fragmented; companies such as Capsugel, Idifarma, Labochim, Medichem, OPKO Health, ScinoPharm, WuXi PharmaTech are some of the new entrants in this market that have recently expanded their service portfolio. Having said this, established pharma companies such as Roche, Merck, GSK, BMS and Boehringer Ingelheim have also established in-house capabilities.
4. Over 15% CMOs have established one-stop-shop model to provide manufacturing services for both HPAPIs and finished cytotoxic drugs. Examples include AbbVie, AMRI, Baxter BioPharma Solutions, CordenPharma and Fareva.
5. North America and Europe are the predominant regions where HPAPIs and cytotoxic drugs production facilities are located. The US accounts for around 23% of the total HPAPI production facilities followed by Italy (13%) and Switzerland (11%). In the case of cytotoxic drugs, 30% of production facilities are located in the US; this is followed by Germany (14%) and the UK (10%). Companies have also moved their focus to developing countries such as China and India in order to take advantage of relatively lower costs.
6. Several collaborations have been recently inked between stakeholders with an aim to combine their manufacturing expertise. Of the 50 partnerships we studied during our research, an overwhelming proportion were acquisitions (55%) and manufacturing collaborations (38%).
7. Catering to the wider demand, several CMOs have regularly engaged in investment programs to expand their production set ups. Since 2006, there have been more than 100 investments to add new facilities and / or to expand existing capacities; SAFC has led this activity followed by Novasep, Aesica Pharmaceuticals, CARBOGEN AMCIS, Lonza, Piramal, Helsinn and Baxter BioPharma Solutions.
8. Overall, the HPAPIs and cytotoxic drugs market holds enormous potential for the contract manufacturers. We anticipate this opportunity for the CMOs to grow at an annualized rate of ~10% over the next ten years. North American and Western European CMOs will continue to dominate with a share of over 70% in the overall market. Developing countries, such as India and China, are likely to emerge with a share of around 13% by 2026.

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