HPAPI and Cytotoxic Drugs Manufacturing Market (3rd Edition), 2020-2030

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May 12, 2020, 10:20 ET

NEW YORK, May 12, 2020 /PRNewswire/ --

INTRODUCTION
Highly potent active pharmaceutical ingredients (HPAPIs), which include cytotoxic APIs, are drug substances that can exhibit biological activity at approximately 150 ?g per kilogram of body weight, with a therapeutic dose of or below 10 mg. Owing to the widespread applications associated with these compounds, HPAPIs have emerged as one of the key areas of interest to researchers and manufacturers across the globe. As compared to conventional therapeutic products, highly potent compounds offer multiple advantages, such as high target specificity and low dosage requirements. 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 the pharmaceutical industry.

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The increasing focus on HPAPIs in development pipelines and the rising demand for cytotoxic drugs has led to a growing need for safe manufacturing and containment technologies. 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. In fact, since 2000, several contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), offering HPAPI and cytotoxic drug manufacturing services have been established. Amidst growing competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor. This has caused many service providers to actively expand their service portfolios, either through strategic acquisitions or facility / capability expansions. Over time, many CMOs / CDMOs claim to have developed end-to-end service capabilities, ranging from drug development (including preliminary R&D, preclinical studies and clinical trials), to regulatory filings, and commercial scale production.

SCOPE OF THE REPORT
The 'HPAPI and Cytotoxic Drugs Manufacturing Market, 2020-2030 (3rd Edition)' report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of HPAPIs and cytotoxic drugs. The study also features a detailed analysis of the key drivers and trends related to this evolving domain. Amongst other elements, the report includes:
• A detailed review of the overall landscape of companies offering contract services for the manufacturing of HPAPIs and cytotoxic drugs, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, facility size, type of service(s) offered (clinical manufacturing, commercial manufacturing, analytical testing, scale-up, process development / pre-formulation, formulation development, stability studies, regulatory support and fill / finish and packaging), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of pharmacological molecule (biologics and small molecules), type of highly potent finished dosage form manufactured (capsules, granules, injectables, liquids and tablets), and type of primary packaging used (ampoules, blisters, prefilled syringes, conventional syringes, vials and others).
• A competitiveness analysis of HPAPI and cytotoxic drugs contract manufacturers, taking into consideration supplier strength (based on company size and its experience in this field) and service strength (based on scale of operation, type of service(s) offered, type of product(s) manufactured, number and location of manufacturing facilities, type of highly potent finished dosage forms manufactured and type of primary packaging used).
• Elaborate profiles of the key players (shortlisted based on a proprietary criterion) that offer a diverse range of capabilities for the development, manufacturing and packaging of HPAPIs and cytotoxic drugs, across North America, Europe and Asia Pacific. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.
• An analysis of the various partnerships pertaining to the contract manufacturing of HPAPIs and cytotoxic drugs, which have been established since 2014, based on several parameters, such as the year of partnership, type of partnership, type of product, scale of operation, company size, amount invested in acquisitions, most active player and geographical analysis.
• An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective HPAPI and cytotoxic drug manufacturing capabilities, over the period 2014-2019, taking into consideration several relevant parameters, such as year of expansion, type of expansion (capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), and location of manufacturing facility.
• An estimate of the overall, installed capacity for manufacturing HPAPIs and cytotoxic drugs based on data reported by industry stakeholders in the public domain; it highlights the distribution of available HPAPIs and cytotoxic drugs production capacity on the basis of company size (small-sized, mid-sized, large and very large companies), scale of operation (preclinical, clinical and commercial), and across key geographical regions (North America, Europe, Asia Pacific and rest of the world).
• A qualitative analysis, highlighting the various factors that need to be taken into consideration by highly potent drug developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
• A discussion on affiliated trends, key drivers and challenges which are likely to impact the industry's evolution, under a comprehensive SWOT framework; it includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.
• A case study on the antibody drug conjugates (ADCs) manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. Additionally, it includes a detailed set of analyses of these companies based on several parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, and type of service(s) offered.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the HPAPI and cytotoxic drugs contract manufacturing market. Based on multiple parameters, such as projected growth of the overall highly potent drug products market, cost of goods sold and direct manufacturing costs, we have developed informed estimates on the financial evolution of the market, over the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] type of product (HPAPIs and highly potent finished dosage forms), [B] company size (small-sized, mid-sized and large / very large), [C] scale of operation (preclinical, clinical and commercial), [D] type of pharmacological molecule (small molecules and biologics), [E] type of highly potent finished dosage form (injectables, oral solids, creams and others), and [F] key geographical regions, covering North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Spain, Italy and rest of Europe), Asia Pacific (India, China, and rest of Asia-Pacific), and rest of the world. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
• Antonella Mancuso and Maria Elena Guadagno, Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals
• Stacy McDonald and Jennifer L Mitcham, Group Product Manager and 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
• Dr. Mark Wright, Site Head, Grangemouth, Piramal Healthcare
• Klaus Hellerbrand, Managing Director, ProJect Pharmaceutics
• Kevin Rosenthal, Business Head, Formulations and Finished Products, Alphora research

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry 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 evolve across different regions and 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
• Industry analysts' views

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the HPAPI and cytotoxic drugs contract manufacturing market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to HPAPIs and cytotoxic drugs, featuring information on the classification of APIs based on potency, types of HPAPIs, and challenges in associated with handling HPAPIs. Additionally, it includes a detailed description of specific containment requirements for handling HPAPIs and cytotoxic drugs, and provides details related to the growing need for outsourcing the manufacturing of such products.

Chapter 4 provides an overview of the HPAPI and cytotoxic drugs contract manufacturing landscape. It includes information on over 115 contract manufacturers that claim to offer HPAPI and cytotoxic drug manufacturing services. In addition, it features an in-depth analysis of the market, based on a number of parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, facility size, type of service(s) offered (clinical manufacturing, commercial manufacturing, analytical testing, scale-up, process development / pre-formulation, formulation development, stability studies, regulatory support, fill / finish and packaging), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of pharmacological molecule (biologics and small molecules), type of highly potent finished dosage form manufactured (capsules, granules, injectables, liquids and tablets), and type of primary packaging used (ampoules, blisters, prefilled syringes, conventional syringes, vials and others).

Chapter 5 features an insightful company competitiveness analysis of HPAPI and cytotoxic drugs contract manufacturers based in North America, Europe and Asia Pacific. The analysis presents a comparison of the companies within each geography on the basis of supplier strength (based on company size and its experience in this field) and service strength (based on scale of operation, type of service(s) offered, type of product(s) manufactured, number and location of manufacturing facilities, type of highly potent finished dosage forms manufactured and type of primary packaging used).

Chapter 6 provides detailed profiles of the key players that are active in the HPAPI and cytotoxic drugs contract manufacturing market in North America. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.

Chapter 7 includes detailed profiles of some of the key players that are active in the HPAPI and cytotoxic drugs contract manufacturing market in Europe. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.

Chapter 8 includes detailed profiles of some of the key players that are active in the HPAPI and cytotoxic drugs contract manufacturing market in Europe. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.

Chapter 9 features an analysis of the various partnerships and collaborations that have been inked amongst players in this domain, in the time period 2014-2019. It provides a brief description on the various types of partnership models (which include acquisitions, manufacturing agreements, technology licensing, R&D agreements, facility acquisitions, product development and commercialization, service alliances, product licensing and others) that have been adopted by stakeholders in this domain. Further, it includes analyses based on year of agreement, scale of operation, company size, amount invested in acquisitions, and most active players. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 10 presents a detailed analysis of the expansions that have taken place in the HPAPI and cytotoxic drugs contract manufacturing industry, since 2014. It includes information on the expansions carried out for increasing existing capabilities, as well as those intended for setting-up a new facility by manufacturers engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), and location of manufacturing facility.

Chapter 11 features a detailed analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of HPAPIs and cytotoxic drugs. The analysis takes into consideration the individual manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs) in the market, using data from both secondary and primary research. It also examines the likely distribution of the global HPAPIs and cytotoxic drugs manufacturing capacity available across different types of companies (small-sized, mid-sized, large and very large CMOs), scales of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific, and rest of the world).

Chapter 12 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by highly potent developers while deciding whether to manufacture their respective products in-house or engage the services of a CMOs.

Chapter 13 presents an insightful market forecast analysis, highlighting the likely growth of the HPAPI and cytotoxic drugs contract manufacturing market till the year 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] type of product (HPAPIs and highly potent finished dosage forms), [B] company size (small, mid-sized and large / very large), [C] scale of operation (preclinical, clinical and commercial), [D] type of pharmacological molecule (small molecules and biologics), [E] type of highly potent finished dosage form (injectables, oral solids, creams and others), and [F] key geographical regions, covering North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Spain, Italy and rest of Europe), Asia Pacific (India, China, and rest of Asia-Pacific), and rest of the world.

Chapter 14 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of HPAPI and cytotoxic drugs contract manufacturing market, under a comprehensive SWOT framework.

Chapter 15 presents a case study on the antibody drug conjugates (ADCs) manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. Additionally, it includes a detailed review of the overall landscape of companies offering contract services for the manufacturing of ADCs, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, and type of service(s) offered.

Chapter 16 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of this market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of HPAPI and cytotoxic drugs contract manufacturers.

Chapter 18 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals), Stacy McDonald and Jennifer L. Mitcham (Group Product Manager and 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), Dr. Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics), and Kevin Rosenthal (Business Head, Formulations and Finished Products, Alphora research).

Chapter 19 is an appendix that contains tabulated data for all the figures provided in the report.

Chapter 20 is an appendix that provides a list of companies and organizations mentioned in the report.

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