The opportunity within the HPAPI and cytotoxic drug manufacturing market is projected to grow at an annualized rate of ~12%, till 2035, claims Roots Analysis

Highly potent compounds have emerged as one of the key modalities in the healthcare community owing to their numerous advantages, including stable nature, enhanced efficacy at lower doses, selective mechanism of action and significantly lower side effects

Roots Analysis has announced the addition of “HPAPI and Cytotoxic Drug Manufacturing Market (4th Edition), 2022 – 2035” report to its list of offerings.

Manufacturing of highly potent compounds is a laborious procedure, plagued with various difficulties, including high capital investment, extensive operational expertise, as well as access to advanced infrastructure and technologies. As a result, outsourcing has become a preferred business model in this domain, providing increased flexibility, reduced costs and timely launch of drugs. Further, to keep up with the evolving client requirements, several contract manufacturing organizations have upgraded their existing capabilities / facilities.


Key Market Insights

More than 140 companies claim to offer highly potent active pharmaceutical ingredients (HPAPI) and cytotoxic drug contract manufacturing services, globally
Majority (44%) of the industry stakeholders are based in Europe, followed by those having headquarters in North America (35%). Further, more than 30% of the service providers claim to have the required capabilities to manufacture both HPAPIs and highly potent finished dosage forms. It is also worth mentioning that over 50% of the players offer contract manufacturing services for HPAPI and cytotoxic drugs across all the three scales of operation.

Around 35% of partnership agreements were inked post 2020
Majority of the agreements related to HPAPI manufacturing were observed to be instances of acquisitions, representing 21% of the total partnerships. Further, most of the intercontinental, as well as intracontinental, deals have been inked by players based in Europe.

Over 95 expansion initiatives have been observed since 2018
Around 50% of the initiatives were focused on expanding the existing highly potent compound manufacturing facilities, followed by instances of capacity expansions (27%) and new facility additions (24%). More than 65% of the expansions reported in this domain were local initiatives, followed by international initiatives (33%).

Global installed HPAPI contract manufacturing capacity is currently estimated to be more than 2.5 million liters
The maximum share (83%) of the current installed capacity is expected to be captured by very large players. Moreover, close to 40% of the global, installed manufacturing capacity is available with facilities located in the Europe region.

North America and Europe are anticipated to capture more than 70% of the market share, by 2035
The market in Asia Pacific is likely to grow at a relatively faster pace (12.8%), in the long term. Currently, majority share (62%) of the overall HPAPI and cytotoxic drug contract manufacturing market is captured by HPAPIs; this trend is unlikely to change in the foreseen future as well. Further, in 2035, over 80% of the market share is likely to be captured by highly potent small molecules.

To request a sample copy / brochure of this report, please visit
https://www.rootsanalysis.com/....reports/299/request-

Key Questions Answered
 Who are the key players engaged in offering contract manufacturing services for HPAPIs and cytotoxic drugs?
 What are the current opportunities within the HPAPI and cytotoxic drug market?
 What is the relative competitiveness of HPAPI and cytotoxic drug contract manufacturers?
 What types of partnership models are commonly adopted by stakeholders in this industry?
 What are the different types of expansion initiatives being undertaken by HPAPI and cytotoxic drug contract manufacturers?
 What are the key challenges faced by HPAPI and cytotoxic drug contract manufacturers?
 What are the key market trends and driving factors that are likely to impact this market?
 How is the revenue generation potential associated with HPAPI and cytotoxic drug manufacturing market likely to evolve in the coming years?

The financial opportunity within the HPAPI and cytotoxic drug manufacturing market has been analyzed across the following segments:
 Type of Product
 Highly Potent Active Pharmaceutical Ingredient
 Highly Potent Finished Dosage Form

 Company Size
 Small
 Mid-sized
 Large
 Very Large

 Scale of Operation
 Preclinical
 Clinical
 Commercial

 Type of Molecule
 Small Molecules
 Biologics

 Type of Highly Potent Finished Dosage Form
 Injectables
 Oral Solids
 Creams
 Others

 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

The report also features inputs from eminent industry stakeholders, according to whom, continuous growth of the oncological therapeutics pipeline and the increasing preference for outsourcing is likely to drive the growth of the overall HPAPI and cytotoxic drug manufacturing market, in the foreseen future. The report includes detailed transcripts of discussions held with the following experts:
 Justin Mason-Home (Owner and Director, HPAPI Project Service)
 Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals)
 Scott Patterson (Vice President Pharma/Bio Technical Support, ILC Dover)
 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 (Acquired by Eurofins))
 Mark Wright (Ex-Site Head, Grangemouth, Piramal)
 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)

The research includes profiles of key players (listed below); each profile features a brief overview of the company, details related to its financial performance (if available), recent developments and an informed future outlook.
 AbbVie
 Abzena
 Aenova
 Cambrex
 CARBOGEN AMCIS
 Catalent
 Hovione
 Intas Pharmaceuticals
 Lonza
 Pfizer CentreOne
 Piramal Pharma Solutions
 Scinopharm
 STA Pharmaceutical (a WuXi AppTec company)
 Syngene
 Teva API

For additional details, please visit
https://www.rootsanalysis.com/....reports/view_documen or email sales@rootsanalysis.com

You may also be interested in the following titles:
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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com

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Pre-engineered, modular facilities have emerged as a versatile solution for industry stakeholders in pursuit of flexible manufacturing solutions

Modular facilities are prefabricated buildings that are built using multiple sections, often known as modules.

Primarily, the key difference between these and conventional buildings is the fact that modular constructs are designed, engineered and manufactured off-site, and later delivered to the intended site of use for final installation. It is worth noting that, in order to ensure that all critical systems are precisely configured, compliant to existing guidelines and fully operational, the modules are tested before shipping. Even though the concept of using modular manufacturing facilities in the pharmaceutical industry is not new, in recent years, it has witnessed renewed interest from several industry players. The increasing demand for improved processes and production facilities that are capable of handling multiple product types, as well as the shift towards manufacturing of smaller batches of drugs, in case of personalized therapies or candidates targeting rare diseases, are some of the key driving forces for the growing popularity of modular manufacturing plants in the pharmaceutical industry. Modular biomanufacturing includes division of individual production processes, such as fermentation, purification and formulation, into separate modules that can be easily assembled and disassembled, allowing for flexibility and scalability. In addition, modular manufacturing allows the use of smaller-scale production units, which can be more flexible and responsive to dynamic market demands.

To request a sample copy / brochure of this report, please visit
https://www.rootsanalysis.com/....reports/178/request-

As indicated earlier, modular construction is a process wherein factory-produced, pre-engineered building units, which are constructed offsite under controlled plant conditions, are assembled on site to construct the final structure. It is worth mentioning that such buildings use the same material and designed according to the same codes and standards established for conventionally built structures. These fundamental building units are called modules. Integrated assemblies are joined together to create facilities of a significant size, housing multiple functions and equipment. The assembled modular building units may form complete rooms, parts of rooms or separate highly serviced units, such as elevators and toilets. There are different types of modules used for construction of buildings. Examples of various modular constructs include 4-sided modules, partially open-sided (corner-supported) modules, mixed modules and planar floor cassettes, modules supported by a primary structural frame, non-load bearing modules, stair modules, skid-mounted process equipment modules, plug and play pods, and balconies and atria.

The modular construction process is believed to reduce the overall time by 50%, as many of the processes are conducted simultaneously. Although the initial planning required to ensure that all modular units fit together properly is complex, the overall modular construction strategy is simple.

In recent years, the focus of the pharmaceutical industry has shifted from mass production of blockbuster drugs for large patient populations to small batch production of personalized drugs targeting specific subpopulations of patients. Modular facilities were first introduced to the pharmaceutical market at a time when the mass production of tablets and capsules for large patient population was the norm; one of first products to be manufactured in such facilities was statins (prescribed to lower cholesterol).

With the advent of generic copies of billion-dollar blockbuster drugs, targeting major disease indications, drug manufacturers are focusing on developing lower doses of highly potent biopharmaceutical drugs for targeted treatments. This shift has resulted in the segregation of large populations of patients into smaller, more specific sub-groups. Moreover, there is immense pressure on drug manufacturers to market novel drugs as soon as possible, before patent expiry. Increased pressure to expedite time to market, coupled with the need to decrease operating costs and increase manufacturing efficiencies, have amplified the value of smaller production facilities, which are more efficient and flexible. These market developments have made modular facilities more attractive to drug manufacturers today, as these facilities can quickly switch between multiple drugs, enabling formulation and packaging in multiple formats, such as solid, liquid, semi-solid and parenteral dosage forms. With this new set of requirements, drug manufacturers have started showing evident interest in modular facilities and using modularity in design approaches. The increased demand for multi-product, multi-purpose, smaller batch size facilities has also prompted equipment manufacturers to revisit their product offerings.

For additional details, please visit
https://www.rootsanalysis.com/....reports/view_documen or email sales@rootsanalysis.com

You may also be interested in the following titles:
1. Smart Labels Market: Industry Trends and Global Forecasts, 2022-2035
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About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com

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The pharmaceutical industry is presently experiencing a prominent need for bioavailability enhancement technologies and services

Over the last couple of decades, the concept of bioavailability has garnered significant attention in the pharmaceutical industry. It is considered to be one of the most important pharmacokinetic properties of a drug.For additional details, please visit
https://www.rootsanalysis.com/....reports/view_documen or email sales@rootsanalysis.com

Over 175 Players Worldwide Claim Offer Fill / Finish Services For A Variety Of Biological Interventions

During our research, we were able to capture more than 178 companies that provide fill / finish services for biologics. Further, more than 50% of the players engaged in this domain, were established after 2000.
The industry has witnessed the entry of 7% players, since 2015. Of these, over four are based in Asia-Pacific and five in North America. Examples of the recently established players include (established post 2016, in reverse chronological order) Resilience (202, Liof Pharma (202, JOINN Biologics (2018), Exelead (2017), Esco Aster (2017) and CMAB Biopharma (2017). Of these, three companies, namely JOINN Biologics, Exelead and Esco Aster have spun-out from their parent companies, which have been operating in the biopharmaceutical domain for several decades.

To request a sample copy / brochure of this report, please visit this https://www.rootsanalysis.com/....reports/256/request-


Moreover, companies offering biologics fill / finish have been segregated under three categories, namely small (less than 50 employees), mid-sized (51-500 employees) and large companies (more than 500 employees). It is important to mention that, for the purpose of this analysis, information has been sourced primarily from company websites and other reliable sources, such as LinkedIn.

It is evident from the figure that more than 70% of the service providers have capabilities to operate at all scales; majority (over 35%) of such players are based in North America, followed by Europe (around 35%). Examples of such players include (established post 2010, in alphabetical order), AbbVie Contract Manufacturing, Argonaut Manufacturing Services, Alcami, Berkshire Sterile Manufacturing, Exelead, JOINN Biologics, Novex Innovations, PCI Pharma Services, Pfizer CentreOne, Tanvex BioPharma and Resilience.

Further, 95% of the services providers employ vials for packaging of biologic drug products. This is followed by players that use syringes (over 65%) for filling biologics. It is worth highlighting that player, such as (in alphabetical order) Argonaut Manufacturing Services, Lonza, Pfizer CentreOne, Recipharm, Siegfried Holding and Sharp employ all type of packaging containers to offer the biologics fill / finish services.

Moreover, around 70% service providers claim to have the required capabilities to process proteins / peptides. This is followed by players that offer fill / finish services for antibodies (67%) and vaccines (63%). Further, vials emerged as the most popular type of container, being employed by 164 service providers for the packaging various type of biologics.

For additional details, please visit
https://www.rootsanalysis.com/....reports/view_documen or email sales@rootsanalysis.com

You may also be interested in the following titles:
1. Smart Labels Market: Industry Trends and Global Forecasts, 2022-2035
2. AI-based Digital Pathology / AI Pathology Market: Industry Trends and Global Forecasts, 2022-2035
About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.

Contact:
Ben Johnson
+1 (415) 800 3415
Ben.johnson@rootsanalysis.com

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