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17-Mar-2021

HPAPIs and Cytotoxic Drugs Manufacturing Market Size 2020 Industry Overview Growth Analysis, Regional Demand, Future Scope and Forecast To 2026

SEATTLE, March 17, 2021, (PHARMIWEB) — Global HPAPIs & Cytotoxic Drugs Market 

High potency active pharmaceutical ingredients (HPAPIs) and cytotoxic dugs are used for creating various therapeutic effect. Any active pharmaceutical ingredient (API) is considered to be potent in different scenarios. For instance, firstly when API produces biological activity at therapeutic dose of 1 milligram per day or below, secondly when API is having high selectivity(Mechanism of action and binding site is specific) and potential to cause cell toxicity, mutations, cancer at low doses and 3) when API which is a novel compound with unknown potency and toxicity. HPAPIs and cytotoxic drugs are increasingly being used as a novel approach to treating chronic diseases, such as cancer, cardiovascular drugs, and diabetes. Several companies involved in the research and development of such HPAPIs and cytotoxic drugs are known to manufacture drugs in-house or outsource their production to other manufacturers.

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Increasing prevalence of cancer is expected to drive the global market growth  

Most HPAPIs are developed by pharmaceutical and biotech companies around the globe, in order to treat cancer. For instance, new immuno-oncology therapies, such as antibody-drug conjugates, are manufactured through companies manufacturing HPAPIs. Increasing mortality rates due to cancer is expected to be a major factor for growth of the global market. According to World Health Organization, 2018, cancer is one of the leading causes of morbidity and mortality worldwide, with around 14 million new cases in 2012 and accounted for death of around 8.8 million people. Death from chemotherapy is a major concern worldwide as toxicity of the therapy can led to death. According to a study conducted by Cancer Research U.K. in 2016, about 8.5% of patients suffered from lung cancer, while, around 2.4% of patients suffered from breast cancer died within months after receiving chemotherapy due to side effects such as toxicity.

Furthermore, pharmaceutical companies are focusing on their core business of research and development and marketing instead of capital intensive manufacturing of these HPAPIs, which requires specialized containment( special equipment to handle manufacturing of HPAPIs) manufacturing. Therefore, these companies focus on contract manufacturing organizations, who can provide expertise and could achieve economy of scale, which would aid the HPAPIs and cytotoxic drugs manufacturing drug market.

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However, implementation of stringent regulations regarding the use of chemical effluents and byproducts is a pivotal factor increasing the manufacturing costs for HPAPIs and cytotoxic drugs, as the companies have to invest in effluent treatment plants. This is expected to hinder in growth of the HPAPIs and cytotoxic drugs manufacturing market. Moreover, guidelines for manufacturing on HPAIPs and cytotoxic drugs vary from country to country, in terms of exposure limits and cross-contamination limits. For instance, the FDA provides guidance for HPAPIs handling requirement on aseptic processing, which covers containment of ingredients during manufacturing, and same is covered by International Council for Harmonization (ICH) document on quality systems.

Global HPAPIs & Cytotoxic Drugs Market Taxonomy

Based on drug origin:

  • Chemical-based
  • Biologic-based

On the basis of manufacturing location:

  • In-house manufacturing
  • Outsourcing

With respect to drug type:

  • Novel HPAPIs
  • Generic HPAPIs

In terms of application:

  • Oncology
  • Others

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Global HPAPIs & Cytotoxic Drugs Market – Regional Segmentation

The global HPAPIs & cytotoxic drugs market covers various significant regions, including North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America is expected to hold the dominant position in the global HPAPIs and cytotoxic drugs market over the forecast period. The regional market growth can be attributed to the high prevalence of cancer in the U.S. According to the American cancer Society, cancer was recognized as the second leading cause of death after cardio vascular disease in U.S. in 2018. Furthermore, around 1.7 million new cancer cases were reported by 2017. Asia Pacific market is expected to witness high growth, owing to high prevalence of cancer in this region. According to the 2012 WHO factsheet, there were more than 10 million cancer cases found in the Asia Pacific region.

Global HPAPIs & Cytotoxic Drugs Market – Competitive Background

Key players operating in the global HPAPIs and cytotoxic drugs market are Lonza, Novartis International AG, Sigma-Aldrich Corporation, BASF AG, Carbogen Amcis AG, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Bristol-Myers Squibb, Pfizer Inc., Roche Diagnostics., Hospira Inc., Boehringer Ingelheim, Covidien Plc, Merck & Co, Bayer AG, and Sanofi Aventis. These players are currently focusing on expanding their manufacturing capacities, in order to enhance their global market share. For instance, in 2015, Sigma-Aldrich Corporation (acquired by Merck KGgA and rebranded as Millipore-Aldrich Corporation) expanded its manufacturing unit in the U.S. to support the commercial scale manufacturing of anti-body drug conjugate.

Table of Content

Global HPAPIs and Cytotoxic Drugs Manufacturing Market Research Report
Section 1: Global HPAPIs and Cytotoxic Drugs Manufacturing Industry Overview
Section 2: Global Economic Impact on HPAPIs and Cytotoxic Drugs Manufacturing Industry
Section 3: Global Market Competition by Industry Producers
Section 4: Global Productions, Revenue (Value), according to Regions
Section 5: Global Supplies (Production), Consumption, Export, Import, geographically
Section 6: Global Productions, Revenue (Value), Price Trend, Product Type
Section 7: Global Market Analysis, on the basis of Application
Section 8: HPAPIs and Cytotoxic Drugs Manufacturing Market Pricing Analysis
Section 9: Market Chain, Sourcing Strategy and Downstream Buyers
Section 10: Strategies and key policies by Distributors/Suppliers/Traders
Section 11: Key Marketing Strategy Analysis, by Market Vendors
Section 12: Market Effect Factors Analysis
Section 13: Global HPAPIs and Cytotoxic Drugs Manufacturing Market Forecast

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Last Updated: 17-Mar-2021