Active Pharmaceutical Ingredients Market

Active Pharmaceutical Ingredients (API) Market:

The global active pharmaceutical ingredients (API) market size reached US$ 234.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 357.0 Billion by 2032, exhibiting a growth rate (CAGR) of 4.6% during 2024-2032. The market is primarily driven by the increasing prevalence of chronic diseases, including diabetes, cancer, and neurological and cardiovascular disorders, the escalating demand for biosimilars and generic drugs, and the inflating investments in pharmaceutical research and development (R&D) activities.

Active pharmaceutical ingredients (API) Market Analysis:

• Major Market Drivers: The extensive utilization of APIs by generic drug manufacturers to produce affordable alternatives to brand-name medications is catalyzing the active pharmaceutical ingredient (API) market growth rate. Moreover, the emerging trend of commercialization of biopharmaceuticals and biologics, such as monoclonal antibodies, recombinant proteins, and vaccines, is also stimulating the market growth.
• Key Market Trends: The escalating demand for high-potency APIs to manufacture potent drugs, including oncology medications and hormone therapies is catalyzing the market growth. Besides this, the shifting consumer preferences towards personalized medicine and precision therapies are anticipated to drive the active pharmaceutical ingredient (API) market future outlook.
• Competitive Landscape: Some of the major market players in the active pharmaceutical industry include Pfizer, Inc., Novartis International AG, Sanofi, Boehringer Ingelheim, Bristol-Myers Squibb, Teva Pharmaceutical Industries Ltd., ELI Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., Abbvie Inc., among many others.
• Geographical Trends: North America accounted for the largest market share, owing to the expanding medical industry and the inflating investments in research and development (R&D) activities. Besides this, the rising adoption of green chemistry principles and eco-friendly processes by the leading players is also stimulating the market growth. Moreover, the high presence of major pharmaceutical companies and API manufacturers is bolstering the growth of the market in the region.
• Challenges and Opportunities: The implementation of stringent regulations by government bodies, including good manufacturing practices (GMP) and quality standards affects the market growth. However, the ongoing technological advancements, such as process automation and data analytics to enhance efficiency, reduce costs, and improve the quality of API production present significant growth opportunities for the active pharmaceutical ingredient (API) market statistics.
   

Active Pharmaceutical Ingredients (API) Market Trends:

Rising Prevalence of Chronic Diseases

The rising cases of chronic diseases, such as cancer, heart conditions, and diabetes are positively influencing the market growth. For instance, according to the 2022 statistics published by the International Diabetes Federation (IDF), diabetic cases are projected to reach US$ 643 Million and US$ 784 Million by 2030 and 2045, respectively. Additionally, in December 2023, the Australian Bureau of Statistics reported that around 1.3 million people in Australia had diabetes in 2022, which accounted for 5.3% of the population. Moreover, the extensive utilization of APIs for new and improved medications is also catalyzing the global market. 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.

Advancements in Biotechnology and Biopharmaceuticals

The integration of digital technologies and data analytics into API manufacturing processes to monitor product methods, optimize efficiency, and improve the product quality is primarily driving the active pharmaceutical ingredient market share. Moreover, the development of biopharmaceuticals, including vaccines, monoclonal antibodies, and recombinant proteins, is also catalyzing the market growth. For instance, in September 2022, the Center for Biologics Evaluation and Research (CBER) approved Bluebird Bio, Inc.'s SKYSONA (elivaldogene autotemcel), which is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). Similarly, in June 2022, CBER approved GlaxoSmithKline's PRIORIX, a live vaccine for measles, mumps, and rubella. Thus, such product approvals increase the availability of novel drugs in the market, which is expected to boost the market studied over the forecast period.

Focus on Personalized Medicine and Targeted Drug Delivery Systems

The shifting preferences of the leading players towards more patient-specific therapies are propelling the active pharmaceutical ingredient industry growth. Besides this, the continuous advancements in targeted drug delivery systems to improve medicine efficacy, minimize side effects, and enhance patient compliance are also positively influencing the market growth. For instance, in April 2022, an article published in the journal Nature Medicine reported that the elevating utilization of genomic profiling for diagnosis and therapy guidance in many tumor types has increased the use of precision medicine in cancer patients. Moreover, Zuberitamab from BioRay Biopharmaceutical Co., Ltd. Additionally, the world’s first allosteric inhibitor targeting TYK2, Sotyktu (deucravacitinib), has been approved for the treatment of psoriasis and Selumetinib, a MEK inhibitor co-developed by AstraZeneca and Merck Sharp & Dohme (MSD), became the first approved drug in China for the treatment of neurofibromatosis type I (NF1).

Active Pharmaceutical Ingredients (API) Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional and country levels for 2024-2032. Our report has categorized the market based on drug type, type of manufacturer, type of synthesis, and therapeutic application.

Breakup by Drug Type:

• Innovative Active Pharmaceutical Ingredients (API)
• Generic Active Pharmaceutical Ingredients (API)
   

The report has provided a detailed breakup and analysis of the market based on the drug type. This includes innovative active pharmaceutical ingredients (API) and generic active pharmaceutical ingredients (API). According to the report, innovative active pharmaceutical ingredients (API) represented the largest segment. The extensive utilization of innovative APIs for the development of cutting-edge and advanced drugs to target specific diseases and offer enhanced therapeutic benefits is primarily driving the market growth. New entrants in this segment are expected to drive the market. For instance, in November 2021, Novo Nordisk launched a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the form of oral pills, an innovative technology and treatment in the Kingdom of Saudi Arabia, to treat patients with type-2 diabetes.

Breakup by Type of Manufacturer:

• Captive Manufacturers 
• Merchant API Manufacturers 
  • Innovative Merchant API Manufacturers
  • Generic Merchant API Manufacturers
     

The report has provided a detailed breakup and analysis of the market based on the type of manufacturer. This includes captive manufacturers and merchant API manufacturers ( innovative merchant API manufacturers and generic merchant API manufacturers). According to the report, captive manufacturers represented the largest market share. They utilize APIs extensively for the production of branded medications. Additionally, captive manufacturers ensure a reliable and secure supply chain vital for the consistent manufacturing of pharmaceutical products. Moreover, according to the Japan Pharmaceutical Manufacturers Association, Japanese pharmaceutical companies have continuously increased their investments in R&D for discovery and development of novel drugs every year. These investments represent more than 17% of total net sales. These companies have also launched their own research funds to collaborate with outside researchers to develop new drugs. For example, a3 (a-cube) and TaNeDS launched by Astellas Pharma and Daiichi Sankyo, respectively.

Breakup by Type of Synthesis:

• Synthetic Active Pharmaceutical Ingredients (API)
  • Market Breakup by Type
    • Innovative Synthetic APIs
    • Generic Synthetic APIs
• Biotech Active Pharmaceutical Ingredients (API)
  • Market Breakup by Type
    • Innovative Biotech APIs
    • Biosimilars
  • Market Breakup By Product 
    • Monoclonal Antibodies 
    • Vaccines 
    • Cytokines 
    • Fusion Proteins 
    • Therapeutic Enzymes 
    • Blood Factors
  • Market Breakup By Expression System 
    • Mammalian Expression Systems 
    • Microbial Expression Systems
    • Yeast Expression Systems 
    • Transgenic Animal Systems
    • Others
       

The report has provided a detailed breakup and analysis of the market based on the type of synthesis. This includes Synthetic Active Pharmaceutical Ingredients (API) [Market Breakup By Type {Innovative Synthetic APIs and Generic Synthetic APIs}]; and Biotech Active Pharmaceutical Ingredients (API) [Market Breakup By Type {Innovative Biotech APIs and Biosimilars}, Market Breakup By Product {Monoclonal Antibodies, Vaccines, Cytokines, Fusion Proteins, Therapeutic Enzymes, and Blood Factors}, and Market Breakup By Expression System {Mammalian Expression Systems, Microbial Expression Systems, Yeast Expression Systems, Transgenic Animal Systems and Others}]. According to the report, synthetic active pharmaceutical ingredients (API) accounted for the largest market share. The extensive utilization of synthetic APIs for the development of safe and effective medications is propelling the market growth. Moreover, synthetic APIs offer various options in chemical modifications and derivatizations to optimize the therapeutic properties of drugs, which is also catalyzing the active pharmaceutical ingredients market statistics. For instance, in December 2021, Novasep, a supplier of services and technologies for the life sciences industry, invested EUR 6 million (US$ 6.8 Million) to increase and modernize its manufacturing capabilities to support the production of APIs, in areas such as oncology, central nervous system (CNS) and infectious diseases. Also, in October 2021, Trodelvy plus chemotherapy, a new antibody treatment for an aggressive form of breast cancer, was approved by the Minister of Health Olivier Véran in France.

Breakup by Therapeutic Application:

• Oncology
• Cardiovascular and Respiratory
• Diabetes 
• Central Nervous System Disorders
• Neurological Disorders
• Others
   

The report has provided a detailed breakup and analysis of the market based on the therapeutic application. This includes oncology, cardiovascular and respiratory, diabetes, central nervous system disorders, neurological disorders, and others. According to the report, oncology represented the largest segment. The rising prevalence of cancer globally is primarily driving the market growth. Besides this, the development of advanced cancer therapies is also stimulating the global market. Moreover, the inflating investments by the leading pharmaceutical companies in oncology research and development (R&D) are also catalyzing the market growth. For instance, Abdul Latif Jameel Health partnered with EQRx to bring two novel and affordable cancer treatments to 1.5 billion people suffering from non-small cell lung cancer (NSCLC) in the Middle East, including Saudi Arabia. Additionally, 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.

Breakup by Region:

• North America 
  • United States
  • Canada
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share, on account of the increasing geriatric population and the high incidence of cancer, diabetes, and cardiovascular and neurological disorders. Moreover, the inflating healthcare expenditures and the development of high-quality APIs are contributing to the growth of the market in the region. 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. Additionally, 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).

Competitive Landscape:

• The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided. Some of the major market players in Active Pharmaceutical Ingredients (API) industry include Pfizer, Inc., Novartis International AG, Sanofi, Boehringer Ingelheim, Bristol-Myers Squibb, Teva Pharmaceutical Industries Ltd. , ELI Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., Abbvie Inc., among many others.
  
  (Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Active Pharmaceutical Ingredients (API) Market News:

• January 2023: Novartis sold its active pharmaceutical ingredient (API) manufacturing facility in Ringaskiddy, Ireland, to Sterling Pharma Solutions. Under the terms of the agreement, Novartis continues to manufacture several APIs for cardiovascular, immunology, and oncology medicines at Ringaskiddy.
• April 2023: Aurobindo Pharma approved the transfer of two API units (Unit V and XVII) to its wholly-owned subsidiary Apitoria Pharma Private Limited.
• May 2023: Novartis International AG purchased cystinosis gene therapy from AVROBIO Novartis and has acquired an investigational gene therapy program for the treatment of cystinosis, a rare genetic disease, from AVROBIO for US$87.5 Million. The purchase is aimed at extending Novartis' cash runway and aligns with their platform strategy in Gene & Cell Therapy.
• June 2023: Pfizer Inc. invested US$25 Million in a biopharma company Caribou Biosciences to support the development of an immune-cloaked allogeneic CAR-T cell therapy.

Active Pharmaceutical Ingredients (API) Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the global active pharmaceutical ingredients (API) market from 2018-2032.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global active pharmaceutical ingredients (API) market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the active pharmaceutical ingredients (API) industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.