Market Trends of United States Active Pharmaceutical Ingredients (API) Industry
Oncology Segment Expects to Register a High CAGR
The oncology segment is expected to witness significant growth in the API market over the forecast period. This is because of various factors, such as the rising prevalence of multiple types of cancer, increasing company activities in developing drugs like biologics and biosimilars, and growing awareness programs in the country.
The statistics published by the American Cancer Society expected the diagnosis of over 1.9 million new cancer cases in the United States in 2022. Also, as per 2022 statistics published by Breastcancer.org, an estimated 287,850 new cases of invasive breast cancer and 51,400 new cases of non-invasive (in situ) breast cancer were expected to be diagnosed in the United States in 2022. With the growing burden of cancer cases, the demand for oncology drugs increases which needs API for drug formulation. Hence, the market is expecting a significant impact over the forecast period.
In addition, the presence of well-established healthcare infrastructure and high healthcare expenditure in the country is also contributing to market growth. The data published by the CMS in March 2022 observed that the annual increase in national health spending is expected to be an average of 5.1% over 2021-2030. According to the same source, the National Health Spending in 2020 was USD 4.1 trillion and is projected to reach USD 6.8 trillion by 2030. Thus, the increasing healthcare spending is expected to increase the company's activities in developing pharmaceutical products, raising the need for drug development APIs. This is anticipated to fuel market growth over the forecast period.
Furthermore, the rising company activities and increasing drug approvals in the country are expected to boost the market growth. For instance, in November 2022, the FDA approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation. Also, in August 2022, the USFDA approved Enhertu, an IV infusion, for treating unresectable or metastatic HER2-low breast cancer. Such developments are expected to increase the demand for APIs for manufacturing drugs and other formulations, hence bolstering market growth.
Therefore, owing to the factors such as the high burden of cancer, the presence of established healthcare expenditure along with high spending and increasing drug approvals in the country, the studied segment is anticipated to witness growth over the forecast period.
Branded Segment Expected to Have the Significant Market Share
The branded segment is expected to grow over the forecast period owing to factors such as the high burden of chronic diseases, growing awareness regarding branded drugs among the population, as well as increasing company activities in developing drugs in the country. For instance, as per a research study published by Giuseppe Lippi et al. in July 2021, it was observed that about 6-12 million people in the United States are expected to suffer from atrial fibrillation by 2050 and 17.9 million people by 2060. Additionally, as per 2022 statistics published by Parkinson's Foundation, about 1 million people were living with Parkinson's in the United States in 2021, and this number is projected to reach 1.2 million by 2030. Thus, the high burden of cardiovascular and Parkinson's disease among the population is anticipated to increase the demand for effective drugs which require APIs for drug development. This is expected to increase segment growth over the forecast period.
The rising company activities in developing branded drugs also contribute to market growth. For instance, in February 2021, Adamas Pharmaceuticals, Inc. received marketing authorization from the United States Food and Drug Administration (FDA) for a supplemental New Drug Application for GOCOVRI (amantadine) extended-release capsules. GOCOVRI is approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes, in addition to its indication for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
Furthermore, initiatives such as facility expansion by key market players are expected to increase company focus on developing high-quality APIs, which is anticipated to fuel the market growth over the forecast period. In July 2021, AbbVie expanded its global operations, enabling end-to-end drug substance and product supply for AbbVie CMO manufacturing partners. New AbbVie Contract Manufacturing service offerings include biologics fill-finish, topical creams and ointments, sterile ophthalmic ointments, and custom API. Also, the acquisition of Allergan and capital expenditure enable AbbVie CMO to provide expanded capabilities to clients on several manufacturing fronts in the United States.
Moreover, in October 2021, Merck's Life Science business sector launched new technology and expanded its capacity to advance antibody-drug-conjugates (ADC) therapies. This new initiative by the company will focus on investment in ADC and high-potent active pharmaceutical ingredient capacity.
Therefore, owing to the factors such as the rising burden of cardiovascular and Parkinson's diseases, increasing branded product launches as well as a growing company focus on facility expansion to grow their API business, the studied segment is anticipated to witness growth over the forecast period.
