HPAPI and Cytotoxic Drug Manufacturing Market (4th Edition), 2022-2035

HPAPI and Cytotoxic Drug Manufacturing Market (4th Edition), 2022-2035

Aided by the ongoing advancements in clinical pharmacology and oncology research, as well as the rising demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have emerged as one of the key areas of interest for researchers and drug developers worldwide. As is well known, HPAPIs are pharmacologically active compounds which are capable of eliciting a biological response even at extremely low concentrations. Specifically, HPAPIs are categorized on the basis of their toxicity, occupational exposure limit (OEL) and pharmacological potency. OEL is defined as the maximum admissible exposure to a physical or chemical hazard, for a specific period of time (usually 8 hours), without endangering the health and safety of workers; typically, highly potent compounds have an OEL less than or equal to 10 µg / m3. It is worth highlighting that HPAPIs offer a range of benefits over conventional APIs, including high target specificity, retention (in their active form) within the body for longer durations, and fewer side effects. As a result, at present, such products are being developed / evaluated for the treatment of a myriad of indications, including asthma, autoimmune disorders, cancer, diabetes and hormone imbalances.

Q1. What are the current opportunities within the HPAPI and cytotoxic drug market?

The HPAPI and cytotoxic drug market is presently considered as one of the most powerful and dynamic sectors of the pharmaceutical industry. At present, more than 40% of the total number of drugs are highly potent in nature. Further, around 60% of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including antibody-drug conjugates (ADCs), high potency compounds have generated significant interest among several researchers and industry stakeholders.

Q2. What is the need for contract manufacturing organizations (CMOs) in the HPAPI and cytotoxic drug domain?

The manufacturing of highly potent APIs and cytotoxic drugs requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing highly potent and cytotoxic compounds and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits.

Q3. What is the current market landscape and recent trends in the HPAPI and cytotoxic drug contract manufacturing domain?

Presently, close to 145 companies have the required capabilities to offer HPAPI and cytotoxic drug manufacturing services across different scales of operation. In addition, several contract service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for high potency molecules. It is worth mentioning that close to 50% of the expansion activities carried out in this market have been focused on improving the existing manufacturing facilities for highly potent molecules, through the addition of new structures and equipment.

Q4. What are the key challenges faced by HPAPI and cytotoxic drug CMOs?

The primary challenge faced during the manufacturing of HPAPI and cytotoxic drugs is related to limiting / altogether preventing cross-contamination of the highly potent molecule with other molecules being produced at the same site. Further, the lack of information related to safe exposure levels and toxicity of new chemical entities can risk the lives of workers and harm the environment. As a result, comprehensive management systems are required for safe handling and containment of highly potent molecules. In addition, proper cleaning techniques and waste treatment systems are extremely essential while producing such compounds.

Q5. What are the key value drivers in the HPAPI and cytotoxic drug contract manufacturing market?

The increasing demand for cytotoxic drugs has led to a rise in the number of HPAPIs in the overall pharmaceutical development pipeline. In order to cater to the growing demand for the production of such drug candidates, there is a requirement for safe manufacturing and containment technologies. Even though some pharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized players.

Q6. How is the revenue generation potential associated with HPAPI and cytotoxic drug manufacturing market likely to evolve in the coming years?

The HPAPI and cytotoxic drug manufacturing market is projected to grow at a CAGR of approximately 12% in the coming years. Currently, in terms of type of molecule, the market is likely to be driven by highly potent small molecules. However, this trend is expected to change in the foreseen future, as the demand for highly potent biologics, such as cell and gene therapies, increases further. In addition, in terms of scale of operation, majority share of the contract service revenues is expected to be generated by commercial scale manufacturing operations. Specifically, in terms of geography, the HPAPI and cytotoxic drug manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term.

1.1. SCOPE OF THE REPORT

The “HPAPI and Cytotoxic Drugs Manufacturing Market (4th Edition), 2022-2035: Distribution by Type of Product (HPAPIs and Highly Potent Finished Dosage Forms), Company Size (Small, Mid-sized, Large and Very Large), Scale of Operation (Preclinical, Clinical and Commercial), Type of Molecule (Small Molecules and Biologics), Type of Highly Potent Finished Dosage Form (Injectables, Oral Solids, Creams and Others), and Key Geographies (North America (US, Canada and Mexico), Europe (UK, Italy, Germany, France, Spain, and Rest of Europe), Asia-Pacific (China, India, and Rest of Asia-Pacific) and Rest of the World” report features an extensive study of the current market landscape and future potential of the HPAPI and cytotoxic drug manufacturing market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the report includes:

A general overview of HPAPIs and cytotoxic drugs, along with information on the different types of HPAPIs and challenges associated with the handling of HPAPIs. The chapter also lays emphasis on the growing need for outsourcing the manufacturing of highly potent compounds, and provides details related to the regulatory considerations in this domain.

A detailed assessment of the overall landscape of companies offering contract manufacturing services for HPAPI and cytotoxic drugs, along with information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of manufacturing facility, area of manufacturing facility (less than 10,000 sq. ft., 10,000 to 40,000 sq. ft., 40,001 to 80,000 sq. ft. and more than 80,000 sq. ft.), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of highly potent finished dosage form (capsules, tablets, liquids / injectables, granules and others), Occupational Exposure Limit (less than 0.1 µg/m3, 0.1 µg/m3 to 1 µg/m3 and more than 1 µg/m3), type of molecule manufactured (small molecules and biologics), type of primary packaging system (blisters, vials, prefilled syringes, ampoules, syringes and others), regulatory certifications / accreditations received and type of service(s) offered (analytical testing, process development / pre-formulation, scale-up, packaging, stability studies, formulation development, regulatory support and fill / finish).

A detailed competitiveness analysis of HPAPI and cytotoxic drug contract manufacturers, taking into consideration supplier strength (based on company size and their experience in this field) and service strength (based on scale of operation, number of highly potent finished dosage form, number of primary packaging system and number of service(s) offered).

Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) offering contract manufacturing services for HPAPI and cytotoxic drugs, across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, along with details related to its HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

An insightful analysis of the recent collaborations within the HPAPI and cytotoxic drug manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership (acquisitions, manufacturing agreements, research and development agreements, product development and commercialization agreements, technology licensing agreements and others), scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2014-2022.

A detailed analysis of the recent expansions undertaken by several HPAPI and cytotoxic drug contract manufacturers, based on various relevant parameters, such as year of expansion, type of expansion (capacity expansions, facility expansions and new facility addition), company size (small, mid-sized, large and very large companies), location of headquarters, scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), location of expanded facility, area of expanded facility, amount invested in expansions, most active players (in terms of number of recent expansions) and geographical distribution.

An estimate of the overall installed capacity for the manufacturing of HPAPIs, based on information reported by various industry stakeholders in the public domain. The analysis highlights the distribution of global installed capacity, based on company size (small, mid-sized and large), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

A regional capability assessment framework, which compares the HPAPI and cytotoxic drug manufacturing capabilities across key geographies, based on several parameters, such as the number of HPAPI and cytotoxic drug contract manufacturers, number of HPAPI and cytotoxic drug manufacturing facilities, number of facility expansions and installed HPAPI capacity in that particular geographical region.

A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution highlighting the relative effect of each SWOT parameter on the overall HPAPI and cytotoxic drug manufacturing market.

A case study on companies offering manufacturing services for antibody drug conjugates (ADCs). The chapter also highlights the key components of ADCs and the key challenges associated with the manufacturing of these products. Further, the chapter presents a list of players that provide contract manufacturing services for ADCs.

One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the HPAPI and cytotoxic drug manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters, such as [A] type of product (HPAPI and highly potent finished dosage form), [B] type of highly potent finished dosage form (injectables, oral solids, creams and others), [C] type of molecule (small molecules and biologics), [D] scale of operation (preclinical, clinical and commercial), [E] company size (small, mid-sized, large and very large) and [F] key geographies (North America, Europe, 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 market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

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.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. 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 (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent)

Roberto Margarita (Business Development Director, CordenPharma)

Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics)

Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research)

Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare)

Allison Vavala (Ex-Senior Manager, Business Development, Helsinn)

Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma)

Javier E. Aznarez Araiz (Ex-Business Development, Idifarma)

1.2. MARKET SEGMENTATIONS

HPAPI and Cytotoxic Drug Manufacturing: Market Segmentations

Market Segments Details

Forecast Period 2022 - 2035

Type of Product HPAPI

Highly Potent Finished Dosage Form

Type of Highly Potent Finished Dosage Form Injectables

Oral Solids

Creams

Others

Type of Molecule Small Molecules

Biologics

Scale of Operation Preclinical

Clinical

Commercial

Company Size Small

Mid-sized

Large

Very Large

Key Geographical Regions North America (US, Canada and Mexico)

Europe (UK, Italy, Germany, France, Spain and Rest of Europe)

Asia-Pacific (China, India and Rest of Asia-Pacific)

Rest of the World

Source: Roots Analysis

1.3. 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, 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 evolve across different regions and technology segments. Wherever 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

While the focus has been on forecasting the market till 2035, 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.

1.4. CHAPTER OUTLINES

Chapter 2 is an executive summary of the insights captured in our report. It offers a high-level view of the current state of HPAPI and cytotoxic drug manufacturing market and its likely evolution in the short term, mid-term and long term.

Chapter 3 provides a general overview of HPAPIs and cytotoxic drugs, featuring information on the different types of HPAPIs and challenges associated with the handling of HPAPIs. The chapter also lays emphasis on the growing need for outsourcing the manufacturing of highly potent compounds, and provides details related to the regulatory considerations in this domain.

Chapter 4 features a detailed review of the overall landscape of HPAPI and cytotoxic drug manufacturing market, along with information on their year of establishment, company size (in terms of employee count), location of headquarters, location of manufacturing facilities, area of manufacturing facility (less than 10,000 sq. ft., 10,000 to 40,000 sq. ft., 40,001 to 80,000 sq. ft. and more than 80,000 sq. ft.), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of highly potent finished dosage form (capsules, tablets, liquids / injectables, granules and others), Occupational Exposure Limit (less than 0.1 µg/m3, 0.1 µg/m3 to 1 µg/m3 and more than 1 µg/m3), type of molecule manufactured (small molecules and biologics), type of primary packaging system (blisters, vials, prefilled syringes, ampoules, syringes and others), regulatory certifications / accreditations received and type of service(s) offered (analytical testing, process development / pre-formulation, scale-up, packaging, stability studies, formulation development, regulatory support and fill / finish).

Chapter 5 presents an insightful company competitiveness analysis of HPAPI and highly potent finished dosage form manufacturers. The companies are further segmented based on their geography, into three categories, namely North America, Europe and, Asia Pacific and Rest of the World. The analysis compares the contract manufacturers on the basis of various parameters, such as number of manufacturing facilities, scale of operation, number of highly potent finished dosage form, number of primary packaging system and number of service(s) offered.

Chapter 6 features detailed profiles of the prominent companies that offer contract manufacturing services for HPAPI and cytotoxic drugs in North America. Each company profile features a brief overview of the company, details related to HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

Chapter 7 features detailed profiles of the prominent companies that offer contract manufacturing services for HPAPI and cytotoxic drugs in Europe. Each company profile features a brief overview of the company, details related to HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

Chapter 8 features detailed profiles of the prominent companies that offer contract manufacturing services for HPAPI and cytotoxic drugs in Asia-Pacific. Each company profile features a brief overview of the company, details related to HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

Chapter 9 features an elaborate analysis of the several recent collaborations within various HPAPI and cytotoxic drug manufacturers, in the period 2014 - 2022. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership model (acquisitions, manufacturing agreements, research and development agreements, product development and commercialization agreements, technology licensing agreements and others), scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), most active player(s) (in terms of number of deals inked) and regional distribution of partnership activity.

Chapter 10 provides a detailed analysis of the various expansion initiatives undertaken by HPAPI and cytotoxic drug manufacturers, during the period 2014-2022, along with information on several relevant parameters, such as year of expansion, type of expansion (capacity expansions, facility expansions and new facility additions), company size (small, mid-sized, large and very large companies), location of headquarters, scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), location of expanded facility, area of expanded facility, amount invested in expansions, most active players (in terms of number of recent expansions) and geographical distribution.

Chapter 11 features an estimate of the overall installed capacity for manufacturing HPAPIs, based on information reported by various industry stakeholders in the public domain. It also features the distribution of global installed HPAPIs and cytotoxic drugs manufacturing capacity across different type of companies (small, mid-sized, large and very large), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World).

Chapter 12 presents a detailed regional capability assessment framework, which compares the HPAPI and cytotoxic drug manufacturing capabilities across key geographies, based on a number of parameters, such as the number of HPAPI and cytotoxic drugs contract manufacturers, number of HPAPI and cytotoxic drugs manufacturing facilities, number of facility expansions and installed HPAPI capacity in that particular geographical region.

Chapter 13 presents a qualitative analysis highlighting the affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution highlighting the relative effect of each SWOT parameter on the overall HPAPI and cytotoxic drug manufacturing market.

Chapter 14 features a comprehensive market forecast analysis, highlighting the likely growth of the HPAPI and cytotoxic drug manufacturing market, till 2035. In order to provide details on the future outlook, our projections have been segmented on the basis of [A] type of product (HPAPI and highly potent finished dosage form), [B] type of highly potent finished dosage form (injectables, oral solids, creams and others), [C] type of molecule (small molecules and biologics), [D] scale of operation (preclinical, clinical and commercial), [E] company size (small, mid-sized, large and very large) and [F] key geographies (North America, Europe, Asia-Pacific, and Rest of the World). It is worth mentioning that we have adopted a top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 15 presents a discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall HPAPI and cytotoxic drugs manufacturing market.

Chapter 16 features a case study on companies offering contract manufacturing services for ADCs, highlighting the key components of ADCs, its manufacturing process and, the challenges associated with supply chain and method transfer. Further, the chapter presents a list of players that provide contract manufacturing for ADCs.

Chapter 17 presents the summary of the overall report. The chapter provides the key takeaways from the report and expresses our independent opinion of the HPAPI and cytotoxic drug manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 18 is a collection of interview transcripts of the discussions held with several key stakeholders in this domain. In this chapter, we have presented the details of interview 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 (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent), Roberto Margarita (Business Development Director, CordenPharma), Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics), Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research), Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare), Allison Vavala (Ex-Senior Manager, Business Development, Helsinn), Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma) and Javier E. Aznárez Araiz (Ex-Business Development, Idifarma).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which contains the list of companies and organizations mentioned in the report.