BURLINGAME, Calif. , Dec. 8, 2023 /PRNewswire/ — According to Coherent Market Insights, The global Active Pharmaceutical Ingredients market was valued at US$ 235 Billion in 2023 and is forecast to reach a value of US$ 372.4 Billion by 2030 at a CAGR of 6.8% between 2023 and 2030.
As global populations continue to increase and age, there is a growing demand for pharmaceuticals to treat various medical conditions, including chronic diseases, infectious diseases, and lifestyle-related disorders. Events like pandemics (e.g., COVID-19) can result in a surge in demand for specific pharmaceuticals and APIs to treat and prevent diseases.
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Market Drivers:
The rise in the prevalence of various infectious diseases and chronic disorders
Among product type, the high potent APIs segment is expected to witness the fastest growth in the global active pharmaceutical ingredients (API) market over the forecast period. Chronic diseases like diabetes, cardiovascular diseases, cancer, and autoimmune disorders are on the rise, especially in aging populations. The management and treatment of these conditions often rely on pharmaceuticals that contain APIs. Additionally, the development and production of vaccines, which are crucial for preventing infectious diseases, rely heavily on APIs. The demand for vaccines has surged in response to various disease outbreaks and the need for routine immunization.
Market key Developments:
On June 6, 2023, RK Pharma Inc., a vertically integrated pharmaceutical company based in the U.S. with subsidiaries in India, announced an investment of up to US$ 200 million from PAG, a leading global investment firm. The terms of the deal were not disclosed.
On May 26, 2023, Ferring Pharmaceuticals (Ferring), a Swiss multinational biopharmaceutical company, announced that its clinical development partner, Seikagaku Corporation (Seikagaku), achieved positive topline results for its registrational Phase 3 clinical trial of SI-6603, an investigational treatment for lumbar disc herniation (generic name: Condoliase). The study was a randomized, double-blind, controlled, parallel-group, comparative study of SI-6603 in 352 patients with lumbar disc herniation.
In May 2022, Propanc Biopharma, Inc., a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, announced that pharma-grade raw materials were purchased for the manufacture of PRP in preparation for the Phase I First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors.
In December 2021, Altasciences’ pharmaceutical contract manufacturing site in Philadelphia, PA, was chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the world’s first inhaled smoking cessation therapy. This treatment uses RespiRx, a vibrating mesh nebulizer (VMN) with a maintenance-free disposable cartridge that reduces and potentially eliminates the risk of patient misuse and non-compliance.
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Market Opportunity:
The development in biopharmaceuticals and innovative drug therapies
The development of biopharmaceuticals, including monoclonal antibodies, gene therapies, and other biologics, presents a significant opportunity in the API market. These products often require specialized APIs produced through biotechnological processes. Rising approvals for innovative drug therapies are also causing the market to grow. For instance, in September 2022, AstraZeneca, a British-Swedish multinational pharmaceutical and biotechnology company’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, was approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID–19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID–19.
Market Cross Sectional Analysis:
The demand for high-potency active pharmaceutical ingredientss (HPAPIs) has been increasing due to the rising prevalence of cancer in North America. HPAPIs are commonly used in the manufacturing of oncology drugs, including chemotherapy and targeted therapies. Market players are expanding its businesses for the development and manufacturing of HPAPIs by opening new facilties or expanding the existing ones. For instance, in June 2022, Merck, a leading science and technology company, announced that its Life Science business sector has doubled its high-potent active pharmaceutical ingredientss (HPAPI) production capacity with the expansion of its facility in Verona, near Madison, Wisconsin, USA. This new US$61 million, 70,000-square-foot facility, officially opened today, brings 50 new jobs to the area.
Market Restraint:
Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose strict quality standards for APIs. Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure the quality, safety, and efficacy of APIs. Compliance with these standards often requires significant investments in facilities, equipment, and quality control systems.
Key Market Takeaways:
Highly potent API (HPAPI) medicines are a significant portion of the small molecule therapeutic research pipeline, and this group of products is expanding at a faster rate, owing to its use in cancer therapies. For instance, in August 2020, Pfizer CentreOne, a global contract development and manufacturing organization (CDMO) introduced high potent drugs to cure cancer, inhibit immune responses to avoid organ rejection, and offer contraception.
Among molecular type, the small molecules segment is expected to witness the fastest growth over the forecast period in the global active pharmaceutical ingredients (API) market, owing to increasing demand for biologics and increasing approval of small molecule pharmaceuticals. For instance, as per Drug, Chemical & Associated Technologies Association (DCAT) articles, small molecules dominated new drug approvals in 2019, accounting for 79% of all new molecular entity (NME) approvals and representing 38 of the 48 NMEs approved by the U.S. Food and Drug Administration (U.S. FDA) in 2020.
On the basis of formulation, the injectable segment is estimated to witness the fastest growth in the global active pharmaceutical ingredients (API) market in 2021, owing to regulatory approvals of new injectable molecules. For instance, in January 2020, Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., received the U.S. FDA approval for an autoinjector device for AJOVY (fremanezumab-vfrm) injection. AJOVY is the only U.S. FDA-approved anti-calcitonin gene-related peptide (CGRP) that allows either quarterly (675 mg) or monthly (225 mg) dosage.
In terms of application, the cardiovascular segment is expected to witness the fastest growth during the forecast period in the global active pharmaceutical ingredients (API) market, owing to the increasing prevalence of cardiovascular diseases. For instance, in December 2020, according to the American College of Cardiology, cardiovascular diseases (CVD) were the underlying cause of 9.6 million deaths among men and 8.9 million deaths among women. Over 6 million of these deaths occurred in people between the ages of 30 and 70. The highest number of CVD deaths occurred in China, followed by India, Russia, the U.S., and Indonesia.
Among regions, Asia Pacific is expected to exhibit the highest CAGR in the active pharmaceutical ingredients (API) market growth over the forecast period due to lower costs of production, lower labor costs, and high quality production centers. For instance, as per the China Chamber of Commerce for Import and Export of Medicine and Health Products (CCCMHPIE) data, the total active pharmaceutical ingredientss produced and exported by China reached 10.1 million tons by volume in 2020.
Major players operating in the global active pharmaceutical ingredients (API) market include Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Dr. Reddy’s Laboratories Ltd., Novartis AG, Mylan N.V., Amneal Pharmaceuticals LLC, Lonza Group, Lupin Limited, Fresenius Kabi, Hikma Pharmaceuticals, Cipla Limited, Glenmark Pharmaceuticals Limited, Sun Pharmaceutical Industries Ltd., Endo International plc, Aurobindo Pharma Limited, Apotex Inc, Taro Pharmaceutical Industries Ltd, Stada Arzneimittel AG, Krka Pharmaceuticals, CordenPharma International, Evonik Industries AG, and Biological E. Limited.
Read complete market research report,” Active Pharmaceutical Ingredients (API) Market, By Product Type, By Molecular Type, By Formulation, By Application, By Region, and Segment Forecast 2023-2030“, Published by Coherent Market Insights.
Detailed Segmentation:
- By Product Type:
- Low Potent APIs
- High Potent APIs
- By Molecular Type:
- Small Molecules
- Large Molecules
- By Formulation:
- Oral
- Topical
- Injectables
- Drops
- By Application:
- Diabetes
- Oncology
- Cardiovascular
- CNS
- Analgesics
- Ophthalmic
- Respiratory
- Dermatology
- Others
- By Region:
o North America
– U.S.
– Canada
o Latin America
– Brazil
– Mexico
– Rest of Latin America
o Europe
– Germany
– U.K.
– Spain
– France
– Italy
– Russia
– Rest of Europe
o Asia Pacific
– China
– India
– Japan
– Australia
– South Korea
– Rest of Asia Pacific
o Middle East & Africa
– South Africa
– GCC Countries
– Rest of Middle East & Africa
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