Global Active Pharmaceutical Ingredients/API Market

The global active pharmaceutical ingredient market size in 2021 is estimated to be USD ~190 billion, and it is expected to expand at a compound annual growth rate (CAGR) of 7% from 2022 to 2030. This increase can be attributed to the advancement of active pharmaceutical ingredients (API) and the increasing prevalence of chronic diseases such as cardiovascular disease and cancer. The government’s favorable policies for API production, coupled with changes in the geopolitical situation, are driving market growth. Due to the disruption of the COVID-19 supply chain, the API market is undergoing tremendous changes. Due to the geopolitical situation and reduced demand for China's API products, countries such as India are more popular than China in API exports. In addition, governments in many countries have developed plans and provided incentives to promote the production of APIs.

The world’s elderly population is increasing. According to United Nations data, in 2017, the population aged 65 and over is expected to increase from 962 million in 2017 to 2.1 billion in 2050. Aging will weaken the immune system and increase the susceptibility of patients to infectious diseases. In addition, the deterioration of physical function increases the chance of suffering from other diseases, such as cardiovascular disease and diabetes.

The high capital requirement for API production is because the process requires a very systematic agreement, leading to the outsourcing of multiple APIs. In addition, pharmaceutical companies benefit from outsourcing API production because it eliminates the need for expensive setup of manufacturing units and labor. Therefore, the need to save costs has driven outsourcing. The company’s strategic outsourcing enables them to focus on their core competencies, which translates into higher productivity. In addition,

API is also used as an antibody-drug conjugate (ADC). ADC is an important and effective treatment modality, combined with bioactive drugs and monoclonal antibodies for the treatment of cancer. APIs effectively target cancer cells while minimizing drug exposure to healthy tissues. Therefore, the development of cancer-specific APIs is expected to drive the growth of the API market.

MANUFACTURE INSIGHT TYPE :

In 2020, the proprietary API part accounted for the largest share of revenue, at 60%. Due to the easy availability of raw materials and the main players in the development of high-end manufacturing facilities.

In addition, the recent developments and initiatives of major players indicate that they are mainly focused on in-house manufacturing rather than outsourcing. For example, in November 2019, Novartis announced the acquisition of France-based CDMO CellforCure to produce molecules in-house. It had previously signed a contract with CellforCure. These initiatives by major players are expected to drive growth in this field.

Large companies are seeking to use their production capacity in Asian countries to try to provide APIs to other pharmaceutical manufacturers. For example, in November 2017, Eisai Pharmaceutical invested more than 9.32 million US dollars to install API production equipment in India. It is expected that by 2020, the company will provide services to other drug manufacturers.

Major pharmaceutical companies are responsible for the substantial growth in the outsourcing sector. In addition, countries such as India and China have lower manufacturing costs, which makes them a popular choice for participants who wish to outsource API production. Outsourcing manufacturing to developing countries is a profitable measure that allows these companies to obtain higher profits, thereby accelerating the growth of this market segment.

TYPE INSIGHT:

In 2020, the share of innovative APIs is the largest, at 65%. This increase was attributed to increased research and development programs for new drug development and favorable government regulations. Due to extensive research in this field, many innovative products are under development and are expected to be released during the forecast period.

New entrants in this segment are expected to drive the market. Increasing demand for targeted therapies with high-efficiency API compounds (such as HPAPI) is expected to generate greater demand for personalized medicines. For example, ADC uses the specificity of antibodies to cancer cells.

These cells use linker technology to bind to antibodies. These advanced ADC functions are expected to drive market development, and most pharmaceutical companies will follow these development plans. The expiration of branded molecular patents is a key factor that can be attributed to the lucrative growth of generic API drugs. Due to a large number of unmet clinical needs and acceptance of over-the-counter drugs, the generic drug market is expected to show rapid growth in countries such as Brazil and India.

APPLICATION INSIGHT:

The cardiovascular disease market segment has the largest revenue share in 2020, at 21%. This is attributable to the increase in the prevalence of target diseases worldwide. Various organizations such as the World Heart Federation, the World Stroke Organization and the Stroke Association are working hard to raise awareness of cardiovascular disease. Government initiatives, such as the National Cholesterol Education Program, aim to raise awareness of lipid and cholesterol-related diseases. It is expected that during the forecast period, high prevalence and increased awareness of cardiovascular diseases will promote the development of this market segment, thereby driving the demand for heart disease drug APIs.

Oncology is expected to be the fastest growing application segment, with a compound annual growth rate of 8% during the forecast period. Factors such as lifestyle changes and increasing cancer prevalence are driving the market.

The increasing popularity of sedentary lifestyles is driving the prevalence of various metabolic disorders. Hormonal imbalance is a growing concern in most countries. These diseases include an imbalance of the thyroid and sex hormones. Levothyroxine is a popular API used to treat hypothyroidism. There are many types of hormone therapy: used in postmenopausal women, used in men undergoing cancer treatment, and used to promote normal growth in children. The increase in hormone-dependent aging is also expected to boost the market.

The prevalence of other diseases such as diabetic retinopathy and macular degeneration is also increasing, driving the demand for highly effective and cost-effective drugs. By 2030, diabetic retinopathy is expected to affect more than 190 million people. This is expected to drive demand for generic drugs and API drugs.

SYNTHETIC INFORMATION TYPE:

The synthetic API part has the highest revenue share in 2020, at 72%. This is due to the greater availability of raw materials and easier protocols for synthesizing these molecules. Many synthetic molecules are also expected to lose patents in the next few years, which is expected to drive growth. During the forecast period, the biotechnology sector is expected to grow at the fastest compound annual growth rate of 7%.

This market segment is driven by factors such as increased demand for biopharmaceuticals and increased efficiency of these molecules. In addition, the growth of the biotechnology sector can be attributed to high investment in biotechnology and biopharmaceuticals. This makes it possible to innovate new molecules that can help treat diseases such as cancer. The high revenue of biotechnology-related APIs makes the market lucrative and attracts major players. For example, Proleukin (aldesleukin) from Clinigen, Inc. is a biological therapy for metastatic renal cell carcinoma.

Recombinant proteins are widely used in gene sequencing, especially to create antibody probes in cells. Therefore, recombinant proteins are widely used in targeted therapy. These proteins play a vital role in the development of new therapies, such as cell therapy. Players are investing in protein manufacturing plants. For example, in November 2019, Bio-Techne announced an investment of more than 40 million U.S. dollars to upgrade its protein manufacturing plants to meet the needs of cell therapy. However, the number of players on the field is limited, which leads to an insufficient supply of current and future demand.

REGIONAL INFORMATION:

North America accounts for the largest revenue share in 2020, at 40%, and is expected to maintain its leading position during the forecast period. This is attributable to the increase in diseases caused by cancer epidemiology and other lifestyles, which encourage research and development activities, thereby driving market growth. The Asia-Pacific region is expected to show the fastest compound annual growth rate of 7% during the forecast period.

The existence of economies such as China and India, where the world relies on low-cost API production, is an advantage for the region. The increase in healthcare spending in the region is expected to drive market growth, and Europe is expected to achieve significant growth during the forecast period.

The increase in research funding and the local presence of major market participants in the region are expected to drive market development. Due to increased investment, the number of European biopharmaceutical companies is growing. For example, the biopharmaceutical industry raised US$20 billion in investment in 2017, which increased by 28% to US$27.5 billion in 2019. Several major global players conduct biopharmaceutical research and development in Europe.

MAJOR COMPANIES AND MARKET SHARE PROSPECTS:

Active pharmaceutical ingredients market operations are highly complex. Highly successful drug patent expiration, increased outsourcing activities due to high manufacturing costs, and strict regulations on API production are expected to maintain a high level of competition during the forecast period.

To the standard. For example, in August 2019, the US FDA issued 75 warning letters to API production facilities, half of which were directed at Indian and Chinese companies. These strict regulations are expected to become limiting factors for market growth. In addition, legal issues are slowing the establishment of new API facilities.

For example, in 2020, Dr. Reddys Laboratories and Eli Lilly and Company faced US FDA issues regarding their API factories. Due to the difficulty of meeting high capital requirements, the presence of well-known players in this market space greatly reduces the opportunity to enter new markets. Some of the major players in the global active pharmaceutical ingredient market include: Merck, AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim International Ltd., Cipla, Teva Pharmaceutical Industries Ltd., Albemarle, Viatris Inc Aurobindo PharmaSun Pharmaceutical Industry Co., Ltd., Ph.D. Reddy Laboratories Co., Ltd.

MARKET SEGMENT COVERED BY THE REPORT:

The report forecasts global, regional and national revenue growth, and analyzes the latest industry trends and opportunities in each market segment from 2017 to 2028. For the purpose of this research, Kenneth Research reports on the global active pharmaceutical ingredient market based on synthetic type, manufacturer type, type, application and region: synthetic type outlook (revenue, billions of dollars, 2017-2028) biotechnology monoclonal Antibody recombinant protein vaccine synthesis manufacturer outlook type (revenue, US$) 1 billion US dollars, 2017-2028) Captive API Merchant API outlook type (revenue, 1 billion US dollars, 2017-2028) Generic API innovative API application outlook (revenue, 1 billion US dollars) USD, 2017-2028) Cardiovascular Disease Oncology Central Nervous System and Neurology Orthopedics Endocrinology Oe Ophthalmology Gastronomy.

Geography Analysis:

The report further discusses the market opportunity, compound annual growth rate (CAGR) growth rate, competition, new technology innovations, market players analysis, government guidelines, export and import (EXIM) analysis, historical revenues, future forecasts etc. in the following regions and/or countries:

• North America (U.S. & Canada) Market Size, Y-O-Y Growth, Market Players Analysis & Opportunity Outlook
• Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market Size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook
• Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC(Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market Size, Y-O-Y Growth Market Players Analys  & Opportunity Outlook
• Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market Size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook
• Middle East and Africa  (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa) Market Size, Y-O-Y Growth Market Players Analysis & Opportunity Outlook

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