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

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Dec 19, 2022, 14:45 ET

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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