Global Cytotoxic Drugs and HPAPI Manufacturing Markets 2022-2035: Increasing Demand has Led to a Rise in the Number of HPAPIs in the Overall Pharmaceutical Development Pipeline

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Cytotoxic Drugs and HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies, Europe, Asia-Pacific and Rest of the World: Industry Trends and Global Forecasts, 2022-2035" report has been added to  ResearchAndMarkets.com's offering.

"Cytotoxic Drugs and HPAPI Manufacturing Market 2022-2035" 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.

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.

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.

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.

Frequently Asked Questions

What are the current opportunities within the HPAPI and cytotoxic drug 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.

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.

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.

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

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.

What are the key value drivers in the HPAPIs and cytotoxic drugs 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.

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

The cytotoxic drugs and HPAPI 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 cytotoxic drugs and HPAPI manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term.

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)

COMPANY COMPETITIVENESS ANALYSIS

• HPAPI Contract Manufacturers: Company Competitiveness Analysis
• Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis
• HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis

COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN NORTH AMERICA

• AbbVie
• Cambrex
• Catalent
• Pfizer CentreOne
• Piramal Pharma Solutions

COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE

• Abzena
• Aenova
• CARBOGEN AMCIS
• Hovione
• Lonza

COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN ASIA-PACIFIC AND REST OF THE WORLD

• Intas Pharmaceuticals
• Scinopharm
• STA Pharmaceutical (a WuXi AppTec company)
• Syngene
• Teva API

LIST OF COMPANIES AND ORGANIZATIONS

• AbbVie
• Abzena
• ACES Pharma
• Adare Pharma Solutions
• ADC Biotechnology
• ADC Therapeutics
• ADIENNE Pharma and Biotech
• Aenova
• AGC Pharma Chemicals (A subsidiary of AGC Group)
• Agno Pharma
• AIMEDBIO
• Ajinomoto Bio-Pharma Services
• ALB Technology
• Alcami
• Alkermes
• Almac
• Alphora Research
• Altasciences
• Alvogen
• Amneal Pharmaceuticals
• AMPAC Fine Chemicals (A SK pharmteco company)
• Angelini Fine Chemicals (A subsidiary of Angelini Pharma)
• ANI Pharmaceuticals
• Antengene
• ANVI Pharma
• Aptuit (An Evotec company)
• Ardena
• Arevipharma (Acquired by Yonsung Group)
• Aspen API
• Astellas Pharma
• Astorg
• AstraZeneca
• Asymchem Laboratories
• Aurigene Pharmaceutical Services
• Avra Laboratories (Acquired by Advent International)
• Baxter BioPharma Solutions
• Bio-Synthesis
• BioTechnique
• BioVectra
• BiVictriX Therapeutics
• BOC Sciences
• Boehringer Ingelheim
• Bolt Biotherapeutics
• Boryung Pharmaceutical
• Bright Peak Therapeutics
• Bristol Myers Squibb
• BrYet Health
• Bryllan
• BSP Pharmaceuticals
• Bushu Pharmaceuticals
• Byondis
• Cambrex
• Capsugel (A Lonza company)
• CARBOGEN AMCIS (A Dishman Carbogen Amcis Group company)
• Catalent
• CellMosaic
• Celon Laboratories
• Cerbios-Pharma
• ChemCon
• ChemPartner
• CordenPharma
• CoreRx
• Creative Biolabs
• CritiTech
• Curia
• Custom Pharmaceutical Services (A part of Dr. Reddy's Laboratories)
• Cytopharma
• Daiichi Sankyo
• Dalton Pharma Services
• Dipharma
• Divi's Laboratories
• DOTTIKON EXCLUSIVE SYNTHESIS
• EirGen Pharma (Acquired by OPKO Health)
• Eisai
• Eli Lilly
• Enteris BioPharma (A subsidiary of SWK Holdings)
• Esteve
• Eurofins Scientific
• EVER Pharma
• Excella (Acquired by Fareva)
• Exelixis
• Fabbrica Italiana Sintetici
• Fareva
• Farmabios (A PharmaZell Group company)
• Farmhispania
• Femtogenix
• Fermion (A subsidiary of Orion)
• Flamma
• Formex (A subsidiary of Biotech Investment Group (BIG))
• Formosa Laboratories
• Fresenius Kabi
• Frontida BioPharm (Acquired by Adare Pharma Solutions)
• Fujimoto Chemicals
• GeneQuantum Healthcare
• Genmab
• GENTEC PHARMACEUTICAL GROUP
• Gilead Sciences
• Glycotope
• Goodwin Biotechnology
• GP Pharm
• GTP Bioways
• Gustave Roussy
• Helsinn Advanced Synthesis
• Heraeus
• Hovione
• ICROM
• Idifarma (Acquired by Ardena)
• IDT Australia
• Iksuda Therapeutics
• ImmunoGen
• Indena
• Ind-Swift Laboratories
• Intas Pharmaceuticals
• Janssen Biotech
• Kodiak Sciences
• Kohlberg
• Kyongbo Pharmaceutical (A subsidiary of Chong Kun Dang Pharmaceutical)
• LakePharma
• Laurus Synthesis
• LegoChem Biosciences
• Levena Biopharma (A subsidiary of Sorrento Therapeutics)
• Lonza
• Lotus Pharmaceuticals
• Lubrizol Life Science
• MabPlex
• Mac-Chem (A NMS Group Company)
• Magle Chemoswed
• Malladi Drugs & Pharmaceuticals
• Mayne Pharma
• McSAF
• MEDICHEM
• Merck
• Mersana Therapeutics
• Metrics Contract Services
• MilliporeSigma
• Minafin
• Minakem (A subsidiary of Minafin)
• Mitsubishi Tanabe Pharma
• Mubadala
• MuseChem
• Natco Pharma
• Navrogen
• NBE-Therapeutics
• NerPharMa
• NJ Bio
• Normon
• Novartis
• Novasep
• Oasmia Pharmaceutical
• OEP Pharma
• Olon
• Oncotec Pharma Produktion
• Oxford BioTherapeutics
• Parabolic Drugs
• Patheon (Acquired by Thermo Fischer Scientific)
• PCI Pharma Services
• Pensatech Pharma
• Pfanstiehl
• Pfizer
• Pfizer CentreOne
• Pharmacare Premium
• Pharmaceutics International
• Pharmascience
• PharmaZell
• PILA PHARMA
• Piramal Pharma Solutions
• PrasFarma
• Procos (A subsidiary of CBC)
• ProJect Pharmaceutics
• Pyxis Oncology
• Quadira Biosciences
• Quotient Sciences
• Recipharm
• Recro Pharma
• Regis Technologies
• RemeGen
• Richman Chemical
• SafeBridge Consultants (Acquired by Trinity Consultants)
• Sai Life Sciences
• Sanofi
• Sartorius
• ScinoPharm Taiwan
• Seagen
• Seattle Genetics
• SEQENS (Acquired by SK Capital Partners)
• Shionogi Pharma
• Siegfried
• Sigma-Aldrich Fine Chemicals (SAFC) (a Sigma-Aldrich company)
• SK biotek
• SK Capital
• Societal CDMO
• Sofpromed
• Somatek
• SOTIO Biotech
• STA Pharmaceutical (A WuXi AppTec company)
• Stason Pharmaceuticals
• Sterling Pharma Solutions
• Sutro Biopharma
• Swedish Orphan Biovitrum (SOBI)
• SWK Holdings
• Symbiosis Pharmaceutical Services
• Synaffix
• Synbias Pharma
• Syngene
• Synthon
• TBD-Biodiscovery
• Tergus Pharma
• Teva API
• TRIO Pharmaceuticals
• Tubulis
• University of Goettingen
• UPM Pharmaceuticals
• Vectura
• Veranova
• VERAXA Biotech
• VUAB Pharma (A SAFICHEM company)
• VxP Pharma
• Wavelength Pharmaceuticals (A subsidiary of SEQENS)
• WuXi Biologics
• ZNZ Pharma

For more information about this report visit https://www.researchandmarkets.com/r/szmg8r

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