all report title image
  • Published On : May 2022
  • Code : CMI1312
  • Industry : Pharmaceutical
  • Pages : 309
  • Formats :

HPAPIs are characterized by the occupational exposure limit (OEL) of at or lower than 10 micrograms per cubic meter of air in micrograms / meter cube. The lower the value of OEL, the more potent is the compound that is being manufactured. Antibody drug conjugates (ADCs) are one of the example for HPAPIs.

The following table shows the operator exposure as per the OEL/OEB values along with the appropriate Equipment Supply Co. (ESCO) equipment for containment.

 
BAND OEB 1 OEB 2 OEB 3 OEB 4 OEB 5 OEB 6 OEB 7
OEL >1000 - 5000 µg/m3 >100 - ≤1000 µg/m3 >10 - ≤100 µg/m3 >1 - ≤10 µg/m3 <1.0 - 0.01 µg/m3 0.01 - 0.001 µg/m3

<0.001 µg/m3 - <1 ng/m3

Equipment to use Ventilation Contain-ment Ventilation Contain-ment or Flowhoods without downflow (single pass Fume cabinets) Downflow Booths or VBEs, Flowhoods VBEs or DFBs with higher containment, Flowhoods with downflow and inflow for small volume Isolators recommended however if handling less than 3kg and short task duration, low dust cloud potential reverse oRABs possible Isolators

Isolators

Global HPAPIs and Cytotoxic Drugs Manufacturing Market - Impact of the Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic is expected to increase the growth of the global HPAPIs and cytotoxic drugs manufacturing market, owing to the increase signing of the agreements by the market players. For instance, in 2021, Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, and Humanigen, Inc. a clinical-stage biopharmaceutical company, entered into agreement and is engaged in the development of its lead drug candidate lenzilumab. Under this agreement, Aji Bio-Pharma will help in the supply chain for Humanigen and Humanigen is continuing the active enroll of the patients in a Phase III clinical trial in the U.S. and Brazil and also preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.

Supply chain and manufacturing activities in North America, Asia Pacific, Europe, and other regions have been disrupted due to the lockdown. Furthermore, players operating in the global HPAPIs and cytotoxic drugs manufacturing market are facing major challenges on various fronts due to the COVID-19 pandemic. The major challenges include supply of raw materials required for manufacturing HPAPIs and cytotoxic drugs and due to irregularities in transportation facility. Moreover, pharmaceutical product distributors are experiencing irregular demand for products from the end users due to increasing number of patients suffering from COVID-19 and other life threatening disorders.

The global HPAPIs and cytotoxic drugs manufacturing market is estimated to be valued at US$ 27.78 Bn in 2022 and is expected to exhibit a CAGR of 8.0% over the forecast period (2022-2030)  

Figure 1: Global HPAPIs and Cytotoxic Drugs Manufacturing Market Share, (%), Analysis, By Drug Origin, 2022

HPAPIs And Cytotoxic Drugs Manufacturing  | Coherent Market Insights

Market players are indulged in inorganic activities such as collaboration, in order to enhance company’s product portfolio. This is expected to drive growth of the global HPAPIs and cytotoxic drugs manufacturing market over the forecast period.

Market players are engaged in the inorganic activities such as collaborations and this is expected to drive growth of the global HPAPIs and cytotoxic drugs manufacturing market over the forecast period. In April 2020, Trio Pharmaceuticals, Inc. and Ajinomoto Bio-Pharma Services announced a collaboration agreement to evaluate AJICAP, a proprietary site-specific conjugation technology offered by Aji Bio-Pharma for the development of TDCs (TRIObody Drug Conjugate). The AJICAP technology will be used to conjugate a cytotoxic payload to TRIO’s lead oncology candidate with TRIO evaluating functionality of the TDC.

Moreover, in March 2021, SEQENS, a company integrated in pharmaceutical synthesis and specialty ingredients announced a collaboration with RONDOL, a technology leader in the development and refinement of medication dosage extrusion technologies for formulation research and continuous manufacturing for more effective therapies and more efficient supply chains. The overall goal was to speed up the development and commercialization of extruded dosage forms with greater bioavailability, fewer adverse effects, and lower production costs.

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HPAPIs and Cytotoxic Drugs Manufacturing Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 27.78 Bn
Historical Data for: 2018 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 8.0% 2030 Value Projection: US$ 51.53 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Drug Origin: Chemical-based HPAPIs, Biologic-based HPAPIs
  • By Manufacturing Location: In-house Manufacturing, Outsourcing
  • By Drug Type: Novel HPAPIs, Generic HPAPIs
  • By Type of Pharmacological Molecule: Small Molecules, Biologics
  • By Application: Oncology, Respiratory, Ophthalmic Disorders, Others
Companies covered:

Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Lonza Group, CordenPharma International, Evonik Industries AG, Flamma Group, Merck KGaA, CARBOGEN AMCIS, Catalent, Inc., Piramal Enterprises Ltd., AbbVie Inc., Fareva Group, Cerbios-Pharma SA, Novasep, Ajinomoto Bio-Pharma, PCI Pharma Services, Sterling Pharma Solutions, Heraeus Holding,  Polpharma Biologics,  Helsinn Healthcare SA, Seqens, Cambrex Corporation

Growth Drivers:
  • Increasing inorganic activities such as collaborations by the market players
  • Increasing product approvals by the market players
  • Increasing manufacturing facility by the market players
Restraints & Challenges:
  • Stringent regulatory guidelines for the production of HPAPIs and Cytotoxic Drugs

Market players are indulged in expansion of new manufacturing facility and this is expected to drive the growth of the global HPAPIs and cytotoxic drugs manufacturing market over the forecast period

Expansion of manufacturing facilities by the market players is expected to drive growth of the global HPAPIs and cytotoxic drugs manufacturing market over the forecast period. For instance,  on March 21, 2022, SEQENS announced a multi-million dollar investment in  Devens, Massachusetts-based research and development lab. Seqens' capabilities in the development and production of active pharmaceutical ingredients (APIs) and active delivery systems (lipids and polymers) will be enhanced by the new facility. The project is expected to be completed in 2023

Moreover, in October 2021, Cambrex announced that its manufacturing center of excellence in High Point, North Carolina, will be expanded. The investment of more than US$ 30 million is intended to fulfil the growing demand for small molecule development and production services. New chemical laboratories, two new clinical manufacturing sites, and a small-scale commercial manufacturing operation with three work centers and 2,000 liter reactors will also be part of the expansion.

Global HPAPIs and Cytotoxic Drugs Manufacturing Market – Restraints

Stringent regulatory scenario against HPAPIs and manufacturing of the cytotoxic drugs is expected to hamper the growth of the global HPAPIs and cytotoxic drugs manufacturing market, over the forecast period. Strict regulatory guidelines such as quality assessments of high potent active pharmaceutical ingredients and cytotoxic drug manufacturing, facility certification, enhanced cGMP guidelines tightening surprise inspection regimes, and increased supply chain security issues across emerging countries have a large impact on the cost of final products.

Due to these strict guidelines, the new entrants willing to enter into active pharmaceutical ingredient manufacturing are facing financial challenges, owing to the aforementioned factors. This makes the HPAPIs and cytotoxic drugs manufacturing entry a financially unprofitable for small and medium-sized enterprises (SMEs). Such changing regulatory dynamics are hampering the growth of the HPAPIs and cytotoxic drugs manufacturing market in emerging economies.

Global HPAPIs and Cytotoxic Drugs Manufacturing Market – Regional Analysis

On the basis of region, global HPAPIs and cytotoxic drugs manufacturing market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa

Among regions, North America HPAPIs and cytotoxic drugs manufacturing market is expected to hold a dominant position during the forecast period, owing to the increasing number of product approvals in the region. For instance, in 2019, Pfizer Inc. received approval from the U.S. Food and Drug Administration (FDA) for RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan (rituximab) which is indicated for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Furthermore, Europe is also estimated to witness significant growth in the global HPAPIs and cytotoxic drugs manufacturing market, owing to expansion of the HPAPI manufacturing facility in the region. For instance, in May 2021, Novasep, a leading provider of services and solutions to the life sciences industry, announced that its manufacturing capabilities for Highly Potent Active Pharmaceutical Ingredients (HPAPIs) had been expanded at its Le Mans (72 – France) site. Novasep's position as a leading CDMO for the manufacturing of innovative and tailored medicines to treat cancer is strengthened by this new step.

Figure 2: Global HPAPIs and Cytotoxic Drugs Manufacturing Market (US$ Bn), by Region, 2022

HPAPIs And Cytotoxic Drugs Manufacturing  | Coherent Market Insights

Global HPAPIs and Cytotoxic Drugs Manufacturing Market – Competitive Landscape

Major players operating in the global HPAPIs and cytotoxic drugs manufacturing market include Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Lonza Group, CordenPharma International, Evonik Industries AG, Flamma Group, Merck KGaA, CARBOGEN AMCIS, Catalent, Inc., Piramal Enterprises Ltd., AbbVie Inc., Fareva Group, Cerbios-Pharma SA, Novasep, Ajinomoto Bio-Pharma, PCI Pharma Services, Sterling Pharma Solutions, Heraeus Holding,  Polpharma Biologics,  Helsinn Healthcare SA, Seqens, Cambrex Corporation.

Highly potent active pharmaceutical ingredients (HPAPI) has an increasingly significant share of the pharmaceutical drug pipeline including anti-cancer treatments. Manufacturing highly potent APIs in large volumes requires extensive project experience with HPAPIs and a strong track record for audits and supply security.

Cytotoxic drugs are agents used to destroy cancer cells and tumors by inhibiting cell division. These drugs are widely used as anti-cancer agents and are used to boost the outcomes of surgery or radiotherapy, reduce metastasis, and diminish cancer symptoms.

Market Dynamics

Market players are engaged in inorganic activities, such as acquisitions, in order to expand its product portfolio, this is expected to drive the growth of the global HPAPIs and cytotoxic drugs manufacturing market, over the forecast period. For instance, in January 2019, Flamma Group, a life science company, acquired Teva’s Chemical Synthesis Center, the 40,000 sq. ft. cGMP facility in Malvern (U.S.). This laboratory and manufacturing site possesses a cGMP Pilot Plant with hydrogenation capabilities as well as wet-milling, 5 standard cGMP kilo lab suites, and 1 cGMP HPAPI kilo lab suite.

Key players are focusing on receiving authorizations for their manufacturing facilities, from the regulatory authorities, and this is expected to drive the growth of the global HPAPIs and cytotoxic drugs manufacturing market, over the forecast period. For instance, in December 2019, Cerbios-Pharma SA announced the authorization by Swissmedic of its cGMP bioconjugation suite for up-to commercial scale manufacturing of Antibody Drug Conjugates (ADCs).

Moreover, in December 2019, Piramal Pharma Solutions, a division of Piramal Enterprises ltd., expanded its manufacturing facility in Riverview, Michigan, with an investment of approximately US$ 32 million to develop and manufacture potent and non-potent active pharmaceutical ingredients (API).

Key features of the study:

  • This report provides an in-depth analysis of the global HPAPIs and cytotoxic drugs manufacturing market, provides market size (US$ Billion), and compound annual growth rate (CAGR %) for the forecast period (2022-2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategies adopted by the leading players
  • It profiles leading players in the global HPAPIs and cytotoxic drugs manufacturing market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies, and future plans
  • Key companies covered as a part of this study include Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Lonza Group, CordenPharma International, Evonik Industries AG, Flamma Group, Merck KGaA, CARBOGEN AMCIS, Catalent, Inc., Piramal Enterprises Ltd., AbbVie Inc., Fareva Group, Cerbios-Pharma SA, Novasep, Ajinomoto Bio-Pharma, PCI Pharma Services, Sterling Pharma Solutions, Heraeus Holding, Polpharma Biologics,  Helsinn Healthcare SA, Seqens, Cambrex Corporation
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launch, technology up-gradation, market expansion, and marketing tactics
  • The global HPAPIs and cytotoxic drugs manufacturing market report caters to various stakeholders in this industry including investors, suppliers, manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global HPAPIs and cytotoxic drugs manufacturing market

Detailed Segmentation:

  • Global HPAPIs and Cytotoxic Drugs Manufacturing Market, By Drug Origin:
    • Chemical-based HPAPIs
    • Biologic-based HPAPIs
  • Global HPAPIs and Cytotoxic Drugs Manufacturing Market, By Manufacturing Location:
    • In-house Manufacturing
    • Outsourcing
  • Global HPAPIs and Cytotoxic Drugs Manufacturing Market, By Drug Type:
    • Novel HPAPIs
    • Generic HPAPIs
  • Global HPAPIs and Cytotoxic Drugs Manufacturing Market, By Type of Pharmacological Molecule:
    • Small Molecules
    • Biologics
  • Global HPAPIs and Cytotoxic Drugs Manufacturing Market, By Application:
    • Oncology
    • Respiratory
    • Ophthalmic Disorders
    • Others
  • Global HPAPIs and Cytotoxic Drugs Manufacturing Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Teva Pharmaceutical Industries Ltd.*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Pfizer, Inc.
    • Lonza Group
    • CordenPharma International
    • Evonik Industries AG
    • Flamma Group
    • Merck KGaA
    • CARBOGEN AMCIS
    • Catalent, Inc.
    • Piramal Enterprises Ltd.
    • AbbVie Inc.
    • Fareva Group
    • Cerbios-Pharma SA
    • Novasep
    • Ajinomoto Bio-Pharma
    • PCI Pharma Services
    • Sterling Pharma Solutions
    • Heraeus Holding
    • Polpharma Biologics
    • Helsinn Healthcare SA
    • Seqens
    • Cambrex Corporation

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global HPAPIs and cytotoxic drugs manufacturing market is expected to exhibit a CAGR of 8.0% during the forecast period (2022-2030).
The market is estimated to be valued at US$ 27.78 Bn in 2022.
Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Lonza Group, CordenPharma International, Evonik Industries AG, Flamma Group, Merck KGaA, CARBOGEN AMCIS, Catalent, Inc., Piramal Enterprises Ltd., AbbVie Inc., Fareva Group, Cerbios-Pharma SA, Novasep, Ajinomoto Bio-Pharma, PCI Pharma Services, Sterling Pharma Solutions, Heraeus Holding,  Polpharma Biologics,  Helsinn Healthcare SA, Seqens, Cambrex Corporation are some of the prominent players operating in the market.
The market is expected to be valued at US$ 51.53 Bn in 2030.
North America is the prominent region in the market.
Chemical-based HPAPIs is the prominent segment among the drug origin segment in the market.

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