The North America active pharmaceutical ingredients market size was USD 91.60 billion in 2023, calculated at USD 96.00 billion in 2024 and is expected to reach around USD 146.39 billion by 2033, expanding at a CAGR of 4.8% from 2024 to 2033. North America accrued the largest revenue share of 38.13% in 2023.
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The North American active pharmaceutical ingredients (API) market is poised for significant growth, driven by the critical need to enhance the security of the US healthcare system.
The North America active pharmaceutical ingredients market is undergoing rapid growth, driven by the essential role of APIs in modern medicine. Defined as substances that become active ingredients in drug products, APIs are designed to have maximum biological effect with minimal dosage, necessitating stringent monitoring and control of employee exposure during manufacturing. Primarily combined with other ingredients to diagnose, cure, mitigate, and treat diseases, APIs are critical to the efficacy of medications. Historically, many pharmaceutical companies have relied on importing APIs from global producers, highlighting a dependency that is prompting a shift towards domestic manufacturing.
Modern medications, composed of chemically active APIs and inert excipients, are formulated into various dosage forms like tablets, solutions, and creams. The production of APIs involves complex multi-step chemical processes aimed at directly treating diseases through their pharmacological activity. With the global consumption of pharmaceutical products exceeding 100,000 tons, the environmental impact of API production, including chemical emissions, is a growing concern. The North America active pharmaceutical ingredients market is not only expanding due to increasing therapeutic demand but also adapting to address environmental and supply chain challenges, positioning itself for substantial future growth.
With over 80% of APIs for essential medicines and key therapeutic areas currently sourced from outside the United States, there is a pressing demand for domestic manufacturing capabilities. The adoption of advanced manufacturing technologies represents a pivotal growth factor, promising to bolster US-based production of APIs. This shift not only ensures a more reliable and secure supply chain but also positions the North American market for robust expansion in the API sector, addressing both current dependencies and future healthcare needs.
- In June 2022, Aldic B.V. announced the acquisition of Active Pharmaceutica Ltda., a value-add pharma distribution company specialized in providing innovative products and solutions to the Brazilian pharmaceutical market. The acquisition of Active Pharmaceutica helped Caldic increase its focus on life science and accelerate growth in America.
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Key Takeaways:
- North America accrued the largest revenue share of 38.13% in 2023.
- U.S. led the market with a share of 91.89% in 2023.
- Canada is projected to depict the fastest growth rate over the forecast period.
- The synthetic segment held the largest revenue share of 72.9% in 2023.
- Biotech API is expected to witness fastest growth during the forecast period.
- Captive APIs segment held the largest market share of 51.21% in 2023.
- Merchant APIs segment is expected to experience the fastest growth over the forecast period.
- Innovative APIs segment dominated the overall API market with a revenue share of 67.15% in 2023.
- Cardiology segment dominated the API market with a revenue share of 21.14% in 2023.
- Oncology segment is anticipated to grow at the fastest rate over the forecast period.
- Prescription dominated the market with a revenue share of 81.19% in 2023.
- OTC segment is expected to depict the fastest growth over the forecast period.
Global Active Pharmaceutical Ingredients (API) Market Size and share 2024 to 2033
The global active pharmaceutical ingredients market size was estimated at USD 237.50 billion in 2023 and is projected to hit around USD 417.76 billion by 2033, growing at a CAGR of 5.81% during the forecast period from 2024 to 2033.
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Market Dynamics
Driver
Rising Personalized Medicine
Personalized medicine, also known as precision medicine, is driving significant growth in North America active pharmaceutical ingredients market. This revolutionary approach to healthcare tailors treatments to individual patients based on their genetic makeup, lifestyle, and other pertinent factors. API manufacturing is adapting to this trend by embracing modular manufacturing approaches, enabling the production of smaller batches and customized therapies. Modular manufacturing involves utilizing smaller, self-contained units that can be easily configured and reconfigured to produce different APIs. This flexibility empowers manufacturers to efficiently produce personalized medicines, quickly adapting to changing treatment requirements and producing smaller quantities without sacrificing cost-effectiveness. As a result, the North America API market is experiencing robust growth, propelled by the demand for APIs essential in the production of personalized therapies.
Restraint
Environmental Concerns
The increasing threat of pollution to the environment has prompted API-producing companies to adopt greener practices aimed at reducing waste generation, particularly in terms of chemicals and solvents. This shift towards sustainability presents challenges for manufacturers seeking faster and more economical production methods. Reducing waste necessitates a decrease in the number of steps involved in API production, as each step typically generates solvents or chemicals as by-products. This requirement for fewer and less complex steps poses a significant constraint on API manufacturers. Manufacturers are urged to select nonhazardous solvents to minimize environmental impact while maintaining production efficiency. These limitations on production processes and solvent selection are constraining the growth of the North America active pharmaceutical ingredients market, as companies navigate the balance between sustainability and operational efficiency.
Opportunity
Automation Revolutionizing
The integration of automation and robotics in API manufacturing presents a significant opportunity for growth in the North America active pharmaceutical ingredients market. These advanced technologies bring a multitude of benefits, including enhanced efficiency, improved quality control, and increased productivity. Robotic systems excel at performing repetitive tasks with precision, minimizing errors and contamination risks. Automated systems handle complex processes such as formulation and dispensing with superior accuracy and consistency, leading to enhanced product quality and reduced batch variations.
Automation enables real-time monitoring and data collection, facilitating process optimization and rapid decision-making. As a result, the adoption of automation technologies creates vast opportunities for innovation and advancement in the North America active pharmaceutical ingredients market, driving increased efficiency, productivity, and competitiveness in the industry.
U.S. Active Pharmaceutical Ingredient (API) Market Size to Surpass USD 72.21 Bn by 2033
The U.S. active pharmaceutical ingredients market size was valued at USD 37.19 billion in 2023 and is projected to surpass around USD 72.21 billion by 2033, registering a CAGR of 6.86% over the forecast period of 2024 to 2033.
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Report Highlights
By Type of Synthesis Insights
The synthetic segment held the largest revenue share of 72.9% in 2023 the North America active pharmaceutical ingredients market, primarily due to the ease of obtaining raw materials and the simplified processes involved in the synthesis of APIs. Synthetic APIs, which are chemically synthesized in laboratories, offer robust performance and availability monitoring for HTTP(s) based APIs, whether they are internal, external, or third-party, and from various global geo-locations. These APIs are prevalent in numerous medications, with common examples including ibuprofen, paracetamol, and aspirin. Their widespread use and the streamlined synthesis processes make synthetic APIs a crucial component in the pharmaceutical industry, driving their market dominance and ensuring their continued relevance in the production of a wide range of therapeutic drugs.
The growth of the biotech segment is expected to significantly augment the North America active pharmaceutical ingredients market, driven by the increasing demand for biopharmaceuticals and their ability to treat previously incurable diseases. Biotech APIs, derived from living organisms or their components, are becoming pivotal due to their applications, technological advancements, and the benefits of biologics and biosimilars. Biologics include recombinant proteins, tissues, genes, allergens, cells, blood components, and vaccines, while biosimilars are biotherapeutic products similar in quality, safety, and efficacy to biologic drugs, developed when original biologics expire. Notably, biotech API manufacturing has advanced with innovations such as single-use bioreactors, which are composed of sealed, sterilized plastic materials and have become crucial tools in producing biotech APIs and high-potency APIs (HPAPIs). These advancements and the diverse applications of biotech APIs are propelling their segment’s growth, underscoring their critical role in the evolving pharmaceutical landscape.
By Type Insights
The innovative APIs is the leading segment in the North America active pharmaceutical ingredients market, driven by advancements in usability, reusability, and consistency through open standards. This evolution in API development has positioned innovative APIs at the forefront, enabling the creation of more sustainable healthcare systems by fostering the introduction of cutting-edge products. The emphasis on innovation within APIs enhances their functionality and application, ensuring they meet the growing demands of modern medicine and healthcare. Innovative APIs are not only contributing to the efficiency and effectiveness of treatments but also driving the overall growth and transformation of the pharmaceutical industry.
The generic APIs segment is projected to be the fastest-growing segment during the forecast period. Generic Active Pharmaceutical Ingredients (APIs) serve as the foundational raw materials for generic medicines, distinct from final drug products consumed by patients. While the active ingredient is the core component of a drug, other components, known as excipients, aid in its delivery. Generic APIs may differ slightly from original APIs, particularly when original drugs possess unique crystal forms or patents that must be circumvented. Generic drugs, are designed to mirror brand-name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use, ensuring bioequivalence. This guarantees that generic medicines deliver the same clinical benefits as their brand-name counterparts, driving the rapid growth of the North America active pharmaceutical ingredients market.
By Type Of Manufacturer Insights
Captive APIs segment held the largest market share of 51.21% in 2023. Numerous companies are investing in solving challenges and developing new chemical ways for in-house production of APIs. This aids in reducing costs and the risk of contamination. Protein synthesis and artificial intelligence are expected to accelerate development with greater control over the process. Furthermore, recent initiatives and developments by key players indicate a strong preference for in-house manufacturing over outsourcing. For instance, in September 2021, AstraZeneca announced an investment of USD 360 million in its API manufacturing facility in Ireland to commercialize novel products. Such initiatives undertaken by key players are anticipated to boost segment growth.
Merchant APIs segment is expected to experience the fastest growth over the forecast period. Contract manufacturing and outsourcing of API molecule development are growing trends in the pharmaceutical sector. As captive production of APIs is expensive, companies have started opting for outsourcing to minimize expenses. Merchant APIs eliminate the need for investing in expensive equipment and sophisticated infrastructure. Post-pandemic, key companies are expanding their capacities to enhance their market presence. For instance, in May 2023, MilliporeSigma announced the expansion of its U.S.-based facility, with an investment of USD 69 million, doubling its manufacturing capacity for Highly Potent Active Pharmaceutical Ingredient (HPAPI). The facility is dedicated to the development and commercial manufacturing of Antibody Drug Conjugates (ADCs).
By Application Insights
Cardiology segment dominated the API market with a revenue share of 21.14% in 2023 the rising prevalence of cardiovascular diseases (CVDs) worldwide. Effective prevention, control, and early detection of cardiovascular risks are critical for patient outcomes, making cardiovascular medications essential for CVD prevention and treatment. The WHO Anatomical Therapeutic Chemical (ATC) classification includes approximately 400 APIs or API combinations for managing CVDs. High-quality cardiovascular medicines and devices are indispensable for combating the growing global threat of CVDs, underscoring the crucial role of APIs in this domain.
Type Of Drug Insights
Prescription dominated the market with a revenue share of 81.19% in 2023. The uptake of prescription drugs is largely dependent on physicians’ prescriptions. Use of prescription drugs, such as Proton Pump Inhibitors (PPI), in the management of general conditions, heartburn, has plateaued owing to several adverse effects. However, Histamine-2 Receptor Antagonist (H2RA) prescription rate has been impacted. Prescription drugs dominated in oncology segment as cancer is primarily treated using chemotherapy, targeted therapy, immunotherapy, and hormonal therapy. The use of biology is also increasing.Due to the increased efficacy of novel targeted therapies, the number of prescriptions for targeted therapies is rapidly increasing. Furthermore, major players are launching novel targeted therapies.
OTC segment is expected to depict the fastest growth over the forecast period. OTC products are easily accessible to the population and is frequently impacted by changes in consumer behavior. Consumer preference is shifting from use of antacids for heartburn to ensuring gut health by taking probiotics. This paradigm shift is creating greater opportunities for preventive products, such as health supplements, nutraceuticals, and probiotics, while slashing the growth of existing products.
By Country Insights
North America accrued the largest revenue share of 38.13% in 2023 owing to rising prevalence of cardiovascular, genetic, and other chronic diseases aided with growing research in field of drug development. The region shows high value manufacturing areas, including complex & high potent APIs, gene therapies & biologicals, which is expected to provide relative growth. Moreover, there is significant expansion of innovators and CDMOs seen in the region, which is creating an added advantage for manufacturing and commercializing APIs.
U.S. Active Pharmaceutical Ingredients Market Trends
U.S. led the market with a share of 91.89% in 2023. Presence of key players such as AbbVie Inc.; Curia; Pfizer Inc. (Pfizer Center One); Viatris Inc.; and Fresenius Kabi AG is positively influencing the market growth. For instance, in February 2022, Viatris received FDA approval for Generic Restasis—a cyclosporine ophthalmic emulsion for the treatment of dry eye disease.
Canada Active Pharmaceutical Ingredients Market Trends
Canada is projected to depict the fastest growth rate over the forecast period. The growing interest of key players in entering the Canadian market is opportunistic for the market growth. For instance, in March 2022, Viatris Inc., in collaboration with Biocon, launched oncology biosimilar Abevmy in Canada. Moreover, in July 2021, MediPharm Labs received a license from Health Canada for manufacturing and sale of cannabis API in Canada. In January 2021, 5N Plus, Inc. announced its expansion into the API segment to include new class of antibiofilm and antibiotic drugs.
Related Blogs
Pharmaceutical CDMO Market: https://www.biospace.com/article/releases/pharmaceutical-cdmo-industry-is-rising-rapidly-up-to-usd-295-95-bn-by-2033/
U.S. Active Pharmaceutical Ingredient (API) Market: https://www.biospace.com/article/u-s-active-pharmaceutical-ingredient-api-market-size-to-reach-usd-72-21-bn-by-2033/
U.S. High Potency Active Pharmaceutical Ingredients Market: https://www.biospace.com/article/releases/u-s-high-potency-active-pharmaceutical-ingredients-market-size-to-hit-usd-16-74-bn-by-2033/
Generic Drugs Market : https://www.biospace.com/article/releases/generic-drugs-market-size-to-worth-around-usd-779-68-bn-by-2033/
U.S. Compounding Pharmacies Market: https://www.biospace.com/article/u-s-compounding-pharmacies-market-size-to-hit-usd-10-76-bn-by-2033/
U.S. Nuclear Medicine Market : https://www.biospace.com/article/releases/u-s-nuclear-medicine-market-size-to-hit-usd-19-34-bn-by-2033/
Recent Developments
- In July 2023, Croda successfully completed the acquisition of Solus Biotech.
- In July 2023, Minafin strengthened the industrial and commercial base of its Healthcare Chemicals division with the acquisition of Delmar in Montreal, Canada.
- In May 2024, Novo Nordisk boosted production as Wegovy sales doubled.
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Key North America Active Pharmaceutical Ingredients Company Insights
AbbVie Inc., Pfizer Inc., and Viatris Inc. are some of the key companies in the market. Presence of pipeline products in the API market is expected to launch in the coming years and is anticipated to drive market growth. Further, increasing outsourcing activities due to high manufacturing costs and stringent regulations on the production of APIs are expected to maintain the competitive rivalry at a high level during the forecast period.
- In October 2023, Cambrex announced the completion of its USD 38 million small molecule API manufacturing facility. This investment doubled the size of the company’s manufacturing facility and enhanced its ability to acquire more customers to meet their evolving needs.
- In August 2023, BARDA and Regeneron entered into an agreement wherein the former will support the latter in developing an antibody therapy to prevent SARS-CoV-2. This contract is worth USD 326 million and is anticipated to drive the market with production of novel vaccines in the coming years.
- In April 2023, Eli Lilly announced an investment of USD 1.6 billion in U.S.-based LEAP Innovation Park. This brings the total investment to USD 3.7 billion to manufacture complex APIs for products such as genetic medicine.
- In April 2022, Geocann entered into a strategic partnership with Averix Bio for supplying API phytocannabinoid ingredients.
North America Active Pharmaceutical Ingredients Market Top Key Companies:
- Dr. Reddy’s Laboratories Ltd.
- Sun Pharmaceutical Industries Ltd.
- Teva Pharmaceutical Industries Ltd.
- Cipla Inc.
- AbbVie Inc.
- Aurobindo Pharma
- Sandoz International GmbH (Novartis AG)
- Viatris Inc.
- Fresenius Kabi AG
- STADA Arzneimittel AG
- Lonza
- Curia
- Pfizer Inc.
- Bristol-Myers Squibb Company
- Merck KGaA
- Catalent, Inc.
North America Active Pharmaceutical Ingredients Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the North America Active Pharmaceutical Ingredients market.
By Type of Synthesis
- Biotech
- By Biotech APIs Market, by Type
- Generic APIs
- Innovative APIs
- By Biotech APIs Market, by Product
- Monoclonal Antibodies
- Hormones
- Cytokines
- Recombinant Proteins
- Therapeutic Enzymes
- Vaccines
- Blood Factors
- By Biotech APIs Market, by Type
- Synthetic
- By Synthetic APIs Market, by Type
- Generic APIs
- Innovative APIs
- By Synthetic APIs Market, by Type
By Type of Manufacturer
- Captive APIs
- Merchant APIs
By Type
- Generic APIs
- Innovative APIs
By Application
- Cardiovascular Diseases
- Oncology
- CNS and Neurology
- Orthopedic
- Endocrinology
- Pulmonology
- Gastroenterology
- Nephrology
- Ophthalmology
- Others
By Type of Drug
- Prescription
- OTC
By Country
- U.S.
- Canada
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