High potency active pharmaceutical ingredients (HPAPIs) and cytotoxic dugs are used for creating 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 used as novel approach to treat chronic disease such as cancer, cardiovascular drugs, and diabetes. Companies involved in research and development of such HPAPIs and cytotoxic drugs manufacture drugs in-house or outsource the production to other manufacturers.
Increasing prevalence of cancer is expected to drive growth of the HPAPIs and cytotoxic drug market
Most of high potency APIs are developed by pharmaceutical and biotech companies, in order to treat cancer. For instance, new immuno-oncology therapies such as antibody-drug conjugates are manufactured through HPAPIs manufacturing companies. Increasing mortality due to cancer is expected to be a factor for growth of the 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. For instance, according to study by Cancer Research UK, in 2016, 8.5% of patients suffering from lung cancer and 2.4% of patients suffering from breast cancer died within months after receiving chemotherapy due to side effects and toxicity. Therefore, companies are focusing on developing targeted therapies such as anti-body drug conjugates and other immune therapies to treat cancers, which is expected to propel growth of the HPAPIs and Cytotoxic drug market.
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.
However, stringent regulations in relation to chemical effluents and byproducts is 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. Also, guidelines for manufacturing on HPAIPs and cytotoxic drugs vary from country to country in terms of exposure limits and cross contamination limits. For instance, 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.
HPAPIs and cytotoxic drugs manufacturing market taxonomy:
On the basis of drug origin, the global HPAPIs and cytotoxic drugs manufacturing market is segmented into:
- Chemical based
- Biologic based
On the basis of manufacturing location, the global HPAPIs and cytotoxic drugs manufacturing market is segmented into:
- In-house manufacturing
On the basis of drug type, the global HPAPIs and cytotoxic drugs manufacturing market is segmented into:
- Novel HPAPIs
- Generic HPAPIs
On the basis of application, the global HPAPIs and cytotoxic drugs manufacturing market is segmented into:
Regional segmentation of the HPAPIs and cytotoxic drugs manufacturing market by Coherent Market Insights consists of North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America is expected to be dominant in the global HPAPIs and cytotoxic drug manufacturing market over the forecast period. This is owing to high incidence and prevalence of cancer in the U.S. According to American cancer Society, 2018, cancer is the second leading cause of death after cardio vascular disease in U.S. 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 WHO factsheet in 2012, there were more than 10 million cancer cases in Asia-pacific region
Key players in the market are focusing on expanding its manufacturing capacities, in order to enhance their 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 commercial scale Anti-body drug conjugate manufacturing.
Key players operating in the HPAPIs and cytotoxic drugs manufacturing 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.