Market Trends of Active Pharmaceutical Ingredients (API) Industry
Oncology Segment is Expected to Register Significant Growth Over the Forecast Period
The growing burden of cancer cases across the globe is one of the crucial health concerns witnessed by many countries. The incidence of cancer rises dramatically with age, which raises the demand for effective therapeutics.
The oncology segment is expected to witness significant growth in the active pharmaceutical ingredients market over the forecast period owing to factors such as the rising burden of cancer cases and raising awareness towards treating the early-onset cancer epidemic. For instance, in March 2023, another study published in the Indian Journal of Medical Research, the prevalence of cancer in India is expected to rise from 1.46 million in 2022 to 1.57 million by 2025. This data shows a rapid increase in the incidence of cancer cases in the country. Over the forecast period, the incidence of cancer will further increase, thus raising the demand for oncology drugs that need API for drug formulation. Hence, the market is expecting a significant impact over the forecast period.
Furthermore, the increasing focus of companies on adopting key strategic activities such as collaborations, agreements, and partnerships is expected to accelerate the development of novel cancer drugs. For instance, in October 2022, Mendus AB entered a deal to enable the technology transfer to manufacture the company's lead development program DCP-001 with Minaris Regenerative Medicine GmbH. DCP-001 is being evaluated in the ADVANCE II Phase 2 clinical trial to prevent cases of tumor recurrence in Acute Myeloid Leukemia (AML) and in the ALISON Phase 1 clinical trial in ovarian cancer.
Similarly, in October 2022, GenScript ProBio, a global CDMO, and GeneCraft entered a strategic partnership MOU concerning the development and production of new drugs needed for RX001. GenScript ProBio and GeneCraft are signing a contract for plasmid and AAV development and production of new drug candidate Pan-KRAS non-small cell lung cancer anti-cancer gene therapy (RX001).
Moreover, the increasing investments to accelerate the production of APIs are also expected to contribute to segment growth over the forecast period. For instance, in July 2022, NovasepPharmaZell Group invested EUR 7.3 (USD 7.6) million for its Mourenx site (southwestern France). This new industrial tool will support the growth of the Mourenx site and sustain the growing demand to produce active pharmaceutical ingredients (APIs), particularly the highly potent drugs (HPAPIs) used to treat cancer.
Hence, owing to the growing incidence of cancer and its risk factors, new company initiatives toward cancer drugs, and further research and development activities, the studied segment is expected to grow over the forecast period.
North America is Expected to Hold Significant Market Share Over the Forecast Period
North America is anticipated to hold a significant market share over the forecast period owing to factors such as the prevalence of chronic diseases such as cancer, diabetes, cardiovascular and neurological diseases coupled with the geriatric population. In addition, the high healthcare expenditures and the presence of key market players in the region are also anticipated to boost market growth over the forecast period.
The rising burden of chronic diseases is the key factor driving the demand for effective drugs for treatment, hence expected to fuel the market growth. For instance, according to 2024 statistics published by the American Cancer Society, about 2,001,140 new cancer cases are expected to be diagnosed in the United States in 2024, including 353,820 digestive system cancer, 313,510 breast cancer, and 252,950 respiratory-related cancer.
Similarly, as per the Canadian Institute for Health Information data published in July 2022, about 2.4 million Canadians have heart disease in 2022. This fuels the demand for APIs for manufacturing cancer and cardiovascular drugs, which is anticipated to propel the market growth in the North American region.
Furthermore, in February 2023, the Government of Canada issued Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104) for people who work with Active Pharmaceutical Ingredients (APIs) and their intermediates to understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations), which is about Good Manufacturing Practices (GMP). This guide applies to the fabricators, packagers/labelers (including re-packagers/re-labelers), testers, importers, distributors, and wholesalers. Such a government initiative is expected to increase the requirement for finished products and boost the API market over the forecast period.
Moreover, increasing company activities to increase API production by expanding manufacturing facilities is also expected to bolster market growth. For instance, in January 2023, Eurofins announced that it relocated and expanded its API development laboratories by moving to a new space in Ontario, Canada. Similarly, in May 2022, Piramal Pharma announced that a new active pharmaceutical ingredient (API) plant at the company's site in Aurora, Ontario, has come online and completed its initial production runs.
Therefore, the studied market is expected to grow over the forecast period due to the rising prevalence of cancer and cardiovascular diseases, increasing government initiatives, and growing company manufacturing facility expansion activities.
