Ultra Market Research | Active Pharmaceutical Ingredient Market
Global Active Pharmaceutical Ingredient Market Analysis and Trends

Active Pharmaceutical Ingredient Market

  • Report ID : 600

  • Category : Pharmaceuticals

  • No Of Pages : 150

  • Published on: July 2024

  • Status: Published

  • Format : Power Point PDF Excel Word

Key Question Answer

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Global Market Outlook

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In-depth analysis of global and regional trends

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Analyze and identify the major players in the market, their market share, key developments, etc.

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To understand the capability of the major players based on products offered, financials, and strategies.

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Identify disrupting products, companies, and trends.

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To identify opportunities in the market.

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Analyze the regional penetration of players, products, and services in the market.

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Comparison of major players financial performance.

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Evaluate strategies adopted by major players.

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Recommendations

Active Pharmaceutical Ingredient Market
Market for active pharmaceutical ingredients was estimated to be worth US$ XX billion globally in 2023 and is projected to increase at a compound annual growth rate (CAGR) of XX% from 2024 to 2033, reaching around US$ XX billion. In several medical specialities, such as cardiology, cancer, neurology, pulmonology, gastroenterology, nephrology, ophthalmology, and endocrinology, the integration of Active Pharmaceutical Ingredients (APIs) is essential to growth. The foundation of premium medications are active pharmaceutical ingredients (APIs), which impact physiological processes and provide the pharmacological activity necessary for illness diagnosis, treatment, and prevention. Through the use of APIs, the healthcare industry may promote innovation and increase the sustainability of healthcare systems by creating more sophisticated and potent therapeutic treatments.


Market Overview
Market for active pharmaceutical ingredients (APIs) is expanding quickly because of its essential function as the main component of drugs that is in charge of producing the intended therapeutic effects. Biologically active ingredients (APIs) are found in a variety of pharmaceutical forms, including tablets, capsules, creams, and injectables. They are sometimes referred to as drug substances or pharmacologic substances. They influence physiological processes and treat illnesses through their pharmacological actions. Active ingredient prescribing appears as an approach to reduce medication errors because certain drugs contain multiple APIs that work in different ways within the body. The fact that many medications with different brand names have the same active components highlights the importance of APIs in pharmaceutical formulations and their potential for industry standardisation.
 


Key Insights

•    North America region hit a largest market share.
•    Asia Pacific region is growing at the highest CAGR. 
•    By type of manufacturer, the captive API segment has garnered the highest market share. 
•    By type, the innovative APIs segment accounted largest market share. 
•    By application, the cardiovascular diseases segment exhibited a largest market share. However, the oncology segment is growing at  CAGR over the forecast period.
•    By type of synthesis, the synthetic API segment accounted largest market share. However, the biotech segment is growing at largest CAGR over the forecast period.

 

Regional Stance
North America is the leading region in the world market for active pharmaceutical ingredients (APIs), but it has difficulties because more than 80% of critical medications and important therapeutic APIs are not manufactured in the US. Only 5 percent of significant API sites are located in the United States; most are hosted in China and India. This discrepancy is a result of international pricing forces that favour non-US producers who receive government subsidies, lower input costs, and laxer regulations. In order to protect the security of US healthcare, the country's manufacturing infrastructure must be strengthened, fair international competition must be promoted, and sustainable home markets must be developed. Policymakers and the media are urged to closely examine the medical supply chain because there is still a significant reliance on foreign factories for APIs, even though US sources primarily involve prohibited chemicals or speciality APIs appropriate for smaller-scale production. Despite these obstacles, biopharmaceutical businesses have strengthened worldwide supply chains; in the last five years, the US has seen a remarkable 50% growth in the number of pharmaceutical production facilities, including those that produce APIs.  

With a CAGR expected to surpass other areas, the active pharmaceutical ingredient (API) market in the Asia Pacific area is expected to rise at a quick rate during the forecast period. But there are issues with outsourcing API production to Asia, which could exacerbate supply chain disruptions in the pharmaceutical industry. The pricing pressure that Chinese and Indian manufacturers are applying to their Western counterparts because to their competitiveness in the global market has caused a major shift in the production of pharmaceuticals towards Asia. Asian manufacturers either dominate the market for newer APIs or experience a faster migration rate. The balance of production for most APIs is skewed towards Asia, despite Europe and Asia emerging as the two main centres, highlighting the region's critical significance in the pharmaceutical industry.

Report Highlights     
By Technology
Ease of availability to raw materials and the streamlined synthesis procedures have led to the synthetic segment's rise to prominence in the worldwide active pharmaceutical ingredient (API) market. Chemically synthesised chemicals are created via a variety of chemical reactions; aspirin, paracetamol, and many antibiotics are examples of these molecules. Focused on chemically synthesised APIs and intermediates and pharmaceutical fine chemicals, synthetic APIs dominate the market, demonstrating improvements in technology and manufacturing techniques in the pharmaceutical sector.
 

By Type
There are two main categories of APIs on the market: general and innovative. Globally, new APIs lead the way because of strong legal frameworks, well-established R&D facilities, and increased government funding that support the creation of novel pharmaceuticals. This category is led by innovator medications with particular active components that have received initial approval for usage. These medications are put through rigorous testing to guarantee their quality, safety, and efficacy. The original manufacturer also obtains drug patents for these medications, protecting their market exclusivity for a maximum of 20 years. The original business is granted exclusive rights to manufacture and distribute the drug until the patent expires, providing protection against competition and paving the way for long-term market domination and profitability.
Generic APIs are the chemical components that were previously patent-protected in different types of API markets. The active chemicals in these generic medications are the same as those in their innovative equivalents, resulting in the same pharmacological effects. The active component of a generic medication is what gives it its primary therapeutic efficacy. When patents expire, several businesses are able to manufacture these generic drugs, which increases competition and expands the pool of accessible, reasonably priced drugs. This ever-changing landscape of generic APIs highlights their equivalent to innovator medications, facilitating post-patent accessibility and affordability of pharmaceuticals.
 

By Type of Manufacturers
Bulk of revenue in the API industry is earned by captive API producers, whose products are used internally by pharmaceutical firms to create completed dosage forms. In contrast, APIs are sold by third-party sellers in the Merchant API market. Investments in cutting-edge chemical processes for internal API manufacturing are rising as more businesses place a higher priority on cost containment and risk reduction from contamination. The future of API manufacturing will be shaped by developments in artificial intelligence and protein synthesis, which have the potential to further optimise development processes and provide increased control and efficiency.
It is anticipated that in the upcoming years, the Merchant APIs market will develop at the fastest rate. This market offers a number of benefits, including the elimination of the need for large capital expenditures for elaborate infrastructure and expensive machinery. Pharmaceutical businesses can therefore improve efficiency and agility in meeting market demands by streamlining their processes and concentrating resources on core skills.


By Application 
Among the many medical specialities that depend on Active Pharmaceutical Ingredients (APIs) are CNS and neurology, oncology, orthopaedics, cardiology, pulmonology, ophthalmology, gastroenterology, endocrinology, and nephrology. Due to the widespread use of cardiovascular medications in the treatment of ailments including heart failure and vascular problems, the cardiovascular diseases segment leads the API industry. This family of drugs includes angiotensin II receptor antagonists, calcium channel blockers, beta-blockers, lipid modifiers, cardiac glycosides, vasodilators, and vasoconstrictors, among other a variety of cardiovascular chemicals. This highlights the pivotal function of APIs in managing an extensive range of cardiovascular conditions, mirroring the noteworthy portion of the API market occupied by cardiovascular medications.
Oncology market is expected to develop at the quickest Compound Annual Growth Rate (CAGR) over the forecast period, making it a significant growth driver in the pharmaceutical industry. In this section, anticancer medications are highlighted as essential parts of Active Pharmaceutical Ingredients (APIs), which are carefully crafted to fight cancer cells. These powerful drugs are essential to the treatment of cancer because they selectively target and destroy cancerous cells, preventing them from proliferating and spreading. Anticancer medications fall into several categories, such as hormone treatment, immunotherapy, targeted therapy, and chemotherapy. Each type of medication is designed to stop the proliferation of malignant cells by a different mode of action. 

Market Dynamics
Driver
Crucial Role of APIs in the Pharmaceutical Industry
Essential components of pharmaceutical goods, active pharmaceutical ingredients (APIs) have a significant impact on the therapeutic and clinical efficaciousness of these medicines. Ensuring the safety and efficacy of drugs requires careful consideration of API selection and exact dosing. APIs are the active ingredients that are manufactured or encapsulated in pharmaceutical formulations. Drug formulations use a wide range of ingredients, including excipients, binders, fillers, and coatings, in addition to APIs, to maximise patient adherence, stability, and delivery. The interaction between active pharmaceutical ingredients (APIs) and drug products works in concert to improve patient outcomes and meet medical needs, which in turn drives the growth of the API market.
 

Restraints
Challenges in the Manufacturing of APIs
European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) maintain strict regulatory criteria that pose substantial obstacles to the production of Active Pharmaceutical Ingredients (APIs). Adherence to these laws is crucial in guaranteeing the uniformity, security, and effectiveness of active ingredients. Strong quality management systems require significant investments in order to comply with Good Manufacturing Practices (GMP). To successfully maintain regulatory compliance, manufacturers need to carefully record the controls, methods, and validation procedures specified in GMP requirements. Validating manufacturing techniques, keeping thorough records, and conducting regular audits are all crucial components. These strict regulations function as barriers, preventing the market for active medicinal ingredients from expanding.
 

Opportunities
Continuous Processing Innovations for Small-Molecule APIs

Promising potential exist in the pharmaceutical business for small-molecule APIs due to ongoing processing advances. These developments enable photochemical, electrochemical, and serial biochemical catalysis by fusing flow chemistry with unique reaction mechanisms and reactor configurations. Heterogeneous reactions in upstream processes are facilitated by the development of hybrid batch-continuous reactors or intermittent-flow stirred tank reactors, while membrane separations take the role of conventional distillation or crystallisation procedures in downstream processes. It is expected that periodic continuous-chromatography formats would be converted to fully continuous formats, including countercurrent tangential chromatography, in the biologics manufacturing process. Through the management of physical material feedback, these developments present prospects for improved API yield, more economical use of raw materials, decreased waste formation, and improved process control. Opportunities within the active pharmaceutical ingredient are further fuelled by unit operations' acceptance of recirculation.


Recent Developments

•    In November 2022, Roquette, a global leader in plant-based ingredients and a prominent provider of pharmaceutical and nutraceutical excipients, launched two next-generation mannitol products for direct compression – PEARLITOL CR-H and PEARLITOL 200 GT 
•    In November 2022, Advent International introduced Cohance Lifesciences, a new brand identity for its API and CDMO platform, consisting of three portfolio companies: RA Chem Pharma, ZCL Chemicals, and Avra Laboratories 
•    In November 2023, EUROAPI completed the acquisition of BianoGMP, enhancing its CDMO expertise in the high-growth oligonucleotide market.
•    In January 2023, Sterling finalized the acquisition of an API manufacturing facility in Ringaskiddy, Ireland Source: 
•    In April 2024, Evonik bolstered its biosolutions offering with the introduction of a new Botanicals & Natural Actives business segment 
•    In February 2024, Novo Nordisk’s parent company acquired Catalent to enhance the supply of Wegovy Source: https://www.pharmexec.com/view/novo-nordisk-parent-company-catalent-acquisition-wegovy.


Key Players in the Active Pharmaceutical Ingredient Market
Albemarle Corporation
AurobindoPharma
Reddy’s Laboratories Ltd.
AbbVieInc
Teva Pharmaceutical Industries Ltd
Mylan N.V.
CiplaInc
BoehringerIngelheim International GmbH
Merck & Co., Inc
Sun Pharmaceutical Industries Ltd
Bristol-Myers Squibb Company


Market Segmentation
By Type of Synthesis
Biotech
Monoclonal Antibodies
Recombinant Proteins
Vaccines
Synthetic

By Type of Manufacturer
Captive APIs
Merchant APIs
Generic APIs
 Innovative APIs

By Type
Generic APIs
Innovative APIs

By Application
Cardiovascular Diseases
 Oncology
 CNS & Neurological Disorders
 Orthopedic Disorders
Endocrinology
Pulmonology
Gastrointestinal Disorders
Nephrology
Ophthalmology
Others

By Geography
North America
U.S.
Canada
Europe
Germany
France
United Kingdom
Rest of Europe
Asia Pacific
China
Japan
India
Southeast Asia
Rest of Asia Pacific
Latin America
Brazil
Rest of Latin America
Middle East & Africa (MEA)
 GCC
North Africa
South Africa
Rest of Middle East & Africa

 

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