Cytotoxic Drugs and HPAPI Manufacturing Market

Cytotoxic Drugs and HPAPI Manufacturing Market

The cytotoxic drugs and HPAPI manufacturing market is estimated to be worth $9.6 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 11.6% during the forecast period. 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, high potency APIs are pharmacologically active compounds which are capable of eliciting a biological response even at extremely low concentrations. Specifically, high potency APIs 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.

Current Opportunities in the Cytotoxic Drugs and HPAPI Manufacturing Market

The cytotoxic drugs and HPAPI manufacturing 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.

Market Drivers for Contract Manufacturing in Cytotoxic Drugs and HPAPI Manufacturing Market

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. These factors will drive the market size for cytotoxic drugs and HPAPI contract manufacturing during the forecast period.

Current Cytotoxic Drugs and HPAPI Manufacturing Market Landscape

Answer: 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.

Key Challenges Faced by Cytotoxic Drugs and HPAPI Manufacturers

The primary challenge faced during the manufacturing of highly potent APIs 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.

Key Value Drivers in the Cytotoxic Drugs and HPAPI Contract Manufacturing Market

The increasing demand for high potency drug has led to a rise in the number of high potency APIs 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.

Cytotoxic Drugs and HPAPI Manufacturing Market Size 

The cytotoxic drugs and HPAPI manufacturing market is projected to grow at a CAGR of approximately 12% during the forecast period. 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 cytotoxic drugs and HPAPI manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term.

Key Companies in the Cytotoxic Drugs and HPAPI Manufacturing Market

Examples of key companies engaged in cytotoxic drugs and HPAPI manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie, Abzena, Aenova, Cambrex, Catalent, CARBOGEN AMCIS, Hovione, Intas Pharmaceuticals, Lonza, Pfizer CentreOne, Piramal Pharma Solutions, Scinopharm, STA Pharmaceutical (a WuXi AppTec company), Syngene and Teva API. This market report includes an easily searchable excel database of all the companies capable of cytotoxic drugs and HPAPI manufacturing, along with their manufacturing facilities worldwide.

Recent Developments in Cytotoxic Drugs and HPAPI Manufacturing Market

Several recent developments have taken place in the field of cytotoxic drugs and HPAPI manufacturing market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In July 2023, Evonik entered into a collaboration with Heraeus Precious Metals in order to expand range of services for highly potent active pharmaceutical ingredients (HPAPIs). Additionally, the alliance leverages specific HPAPI capabilities of both companies to provide an integrated offering from the preclinical stage to commercial manufacturing. 
• In May 2023, Millipore Sigma, announced the expansion by opening 70,000 sq. ft. facility in the US to increase the production capacity for highly potent active pharmaceutical ingredients (HPAPIs) and antibody-drug conjugate (ADC) linker-payload. 
• In January 2023, Sai Life Sciences expanded its portfolio by opening a new High-Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing campus in Bidar, India. 

Scope of the Report

The “Cytotoxic Drugs and HPAPI 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”  market report features an extensive study of the current market landscape, market size, market share, market growth, market forecast, market outlook and future opportunities for the cytotoxic drugs and HPAPI manufacturing market during the forecast period. The market research report also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in cytotoxic drugs and HPAPI manufacturing market. The table below highlights various market segmentations done in the market report.

Market Segmentations

Report Attribute	Details
Forecast Period	2022 – 2035
Type of Product	HPAPI and highly potent finished dosage form
Type of Highly Potent Finished Dosage Form	Injectables, oral solids, creams and 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, Europe, Asia-Pacific, MENA, Latin America, Rest of the World

 

Amongst other elements, the market research 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 cytotoxic drugs and HPAPI manufacturing market.
• 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 cytotoxic drugs and HPAPI manufacturing market, 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 cytotoxic drugs and HPAPI 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.

The key objective of cytotoxic drugs and HPAPI manufacturing market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for the cytotoxic drugs and HPAPI manufacturing market during the forecast period. 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 market 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 market research report are in USD, unless otherwise specified. 

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research 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)

Frequently Asked Questions

Question 1: What is a HPAPI in pharma?

Answer: HPAPIs are pharmacologically active compounds which are capable of eliciting a biological response even at extremely low concentrations.

Question 2: How big is the cytotoxic drugs and HPAPI manufacturing market?

Answer: The cytotoxic drugs and HPAPI manufacturing market size is estimated to be worth $9.6 billion in 2022.

Question 3: What is the projected market growth of the cytotoxic drugs and HPAPI manufacturing market?

Answer: The cytotoxic drugs and HPAPI manufacturing market is expected to grow at compounded annual growth rate (CAGR) of 11.6% during the forecast period 2022 - 2023.

Question 4: Who are the leading companies in the cytotoxic drugs and HPAPI manufacturing market?

Answer: Examples of key companies engaged in cytotoxic drugs and HPAPI manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie, Abzena, Aenova, Cambrex, Catalent, CARBOGEN AMCIS, Hovione, Intas Pharmaceuticals, Lonza, Pfizer CentreOne, Piramal Pharma Solutions, Scinopharm, STA Pharmaceutical (a WuXi AppTec company), Syngene and Teva API.

Question 5: What are the advantages of HPAPIs over conventional APIs?

Answer: HPAPIs offer a range of advantages over conventional APIs, including high target specificity, retention (in their active form) within the body for longer durations, and fewer side effects.

Question 6: How many expansions have been undertaken by the companies engaged in the cytotoxic drugs and HPAPI manufacturing market?

Answer: Since 2014, over 160 expansions have been undertaken by the companies engaged in the cytotoxic drugs and HPAPI manufacturing market.

Question 7: How many players offer contract manufacturing of HPAPIs worldwide?

Answer: Currently, over 140 CMO / CDMO claim to have the required expertise to offer contract manufacturing services for HPAPIs globally.