The global active pharmaceutical ingredients market size is expected to reach around US$ 328 billion by 2030. The global active pharmaceutical ingredients market size was valued at US$ 169 bn in 2020 and is anticipated to grow at a CAGR of 6.1% from 2021 to 2030.
The global active pharmaceutical ingredients market size is expected to reach around US$ 328 billion by 2030. The global active pharmaceutical ingredients market size was valued at US$ 169 bn in 2020 and is anticipated to grow at a CAGR of 6.1% from 2021 to 2030.
An active pharmaceutical ingredient (API) is any substance or mixture of substances used in the finished pharmaceutical product (FPP) that is intended to provide pharmacological action or to otherwise have a direct impact in the diagnosis, remedy, mitigation, therapy, or prevention of disease, or to have a direct effect in repairing, correcting, or altering physiological functions in humans.
The global active pharmaceutical ingredients (API) market has experienced significant growth in the last decade, due to increase in incidence of chronic diseases
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Increase in Abbreviated New Drug Applications (ANDA) drives demand for active pharmaceutical ingredients (API). In order to market a generic drug, a company needs to file Abbreviated New Drug Application (ANDA). An ANDA approval implies that the generic drug is comparable to the original drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and intended use.
However, companies cannot manufacture a drug unless the patent of a drug expires. Hence, as billion dollar drugs lose patents, other drug manufacturers grab the opportunity to manufacture low cost generics and file for ANDA to the U.S. FDA.
The pharmaceutical industry has suffered significantly due to patent expiry of blockbuster drugs in the past few years. Demand for low cost substitutes is high in low- and middle-income countries in Asia Pacific, Africa, and Latin America. This increases the number of API manufacturers, as pharmaceutical drug manufacturers did not have enough in-house capacity to meet the demand.
Currently, majority of API manufacturers is concentrated in Asia Pacific, primarily India, China, and Taiwan. Teva Active Pharmaceutical Ingredients (TAPI), Aurobindo, and Sun Pharma are the leading API manufacturers in the region.
Increase in incidence of chronic diseases drives the global active pharmaceutical ingredients (API) market. According to the International Diabetes Federation, in 2019, 463 million people across the world were diagnosed with diabetes. Moreover, the number of new cancer cases per year is expected to increase to 23.6 million by 2030. Apart from cancer, a number of other diseases have shown rise in prevalence rates. Rise in prevalence of cancer, cardiovascular diseases, and diabetes; surge in sedentary lifestyle; and increase in geriatric population are the key drivers of the active pharmaceutical ingredients (API) market.
Lung cancer is the leading cause of cancer deaths in Asia Pacific. China alone accounts for over 50% of all cancer cases in the region. Changes in lifestyle and socio-cultural factors are the leading causes of cervical cancer. Major countries affected by breast cancer in Asia Pacific are India, Thailand, and China.
Small molecule drugs account for major share of the current drug pipeline. Despite new biologic entities entering the market, small molecules are experiencing a surge in usage in the clinical pipeline. Maximum number of FDA approvals in the last decade have been for small molecule drugs, and the trend is likely to continue during the forecast period.
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In House Manufacturing to Dominate Global Market
In terms of manufacture type, the global active pharmaceutical ingredients (API) market has been segmented into in house manufacturing and contract manufacturing. The in house manufacturing segment dominated the global active pharmaceutical ingredients (API) market in 2020 and the trend is projected to continue during the forecast period. Global players, such as Merck KGaA, prefer in-house production of APIs. This is a major factor driving the segment. These players believe that in house manufacture provides control of the process from start to finish. It offers the flexibility to adapt as and when required. This is especially useful when a company wants to respond to the market quickly and make a consumer-led change to the product, as it does not have to go through another company or rely on anyone else. These factors are anticipated to boost the growth of the segment during the forecast period.
Labor costs constitute majority of the cost of any manufacturing process. Outsourcing manufacturing eliminates the responsibility and costs involved in hiring the staff required to do the job properly. This is a major factor likely to drive the demand for contract manufacturing in the near future.
Branded or Innovative Prescription Drugs to be Highly Lucrative
Based on drug type, the global active pharmaceutical ingredients (API) market has been categorized into branded or innovative prescription drugs, generic prescription drugs, and OTC drugs. The branded or innovative prescription drugs segment accounted for a prominent share of the global active pharmaceutical ingredients (API) market in 2020. According to TMR Research, medicine use has continued to rise, with people in the U.S. filling 5.8 billion prescriptions in 2018, an increase of 2.7% over the previous year. This was largely driven by more patients receiving existing branded drugs and using newly launched drugs.
Synthetic to be Highly Attractive API
In terms of API type, the global active pharmaceutical ingredients (API) market has been classified into synthetic, biological, and plant extracts. The synthetic segment accounted for a significant share of the global active pharmaceutical ingredients (API) market in 2020. This can be attributed to higher availability of raw materials and easier protocols for the synthesis of these molecules.
Cardiovascular to be Major Application of API
Based on application, the global active pharmaceutical ingredients (API) market has been divided into anti-infective, cardiovascular, neurological, metabolic disorder, respiratory, oncology, and others. The cardiovascular segment accounted for a major share of the global active pharmaceutical ingredients (API) market in 2020. Drug therapy is a major treatment modality in cardiovascular disease. Hypertension and cardiovascular diseases (CVD) are quite common conditions, and account for significant medical disability and death worldwide. New classes of cardiovascular drugs would be effective for the treatment of hypertension and CVD and decrease their socioeconomic consequences. New drug approval is one of the prominent factors that drives the demand for APIs. These factors are expected to propel the segment during the forecast period.
High Use of API in Pharmaceutical & Biotechnology Industry
In terms of end user, the global active pharmaceutical ingredients (API) market has been categorized into pharmaceutical & biotechnological industry, CROs, CMOs, and others. The pharmaceutical & biotechnological industry segment accounted for a major share of the global active pharmaceutical ingredients (API) market in 2020. A large number of pharmaceutical & biotechnology companies and their preference for in-house manufacturing of finished dose products drives the segment. Additionally, pharma companies are opening their own manufacturing plants in emerging markets instead of imports to sell products, which drives the segment.
North America to Dominate API Market
In terms of region, the global active pharmaceutical ingredients (API) market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global active pharmaceutical ingredients (API) market in 2020, followed by Asia Pacific. Rise in prevalence of lifestyle diseases and increase in healthcare expenditure are anticipated to boost the market in North America during the forecast period.
The active pharmaceutical ingredients (API) market in Asia Pacific is anticipated to expand at a significant CAGR from 2021 to 2031. Favorable government initiatives, changing lifestyles leading to the development of diseases, rise in investment in R&D, and technological developments in drug manufacturing processes boost the market in the region.
Competitive Landscape and Market Share Analysis
The active pharmaceutical ingredients market competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, active pharmaceutical ingredients sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2017-2020, this study provides the active pharmaceutical ingredients sales, revenue and market share for each player covered in this report.
- Crucial data regarding the major contenders, product portfolio, market remuneration, and production patterns are documented in the report.
- The report presents the pricing models followed by each company, alongside the gross margins and market share held by each company.
Key players operating in the global market include Merck & Co., Inc., Teva Pharmaceutical Industries Ltd., Sanofi, Pfizer, Inc., Novartis AG, Mylan N.V., Lonza, WuXiAppTec Co., Ltd., Piramal Pharma Solutions, Hisun USA, Inc., Ipca Laboratories Ltd., AbbVie, Inc., Alembic Pharmaceuticals Limited, BASF SE, Biocon Ltd., BoehringerIngelheim International GmbH, Bristol-Myers Squibb Company, Cambrex Corporation, Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, and GlaxoSmithKline plc.
Market Segmentation
By Manufacture Type
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- In House Manufacturing
- Contract Manufacturing
By Drug Type
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- Branded or Innovative Prescription Drugs
- Generic Prescription Drugs
- Over-the-counter (OTC) Drugs
By API Type
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- Synthetic
- Biological
- Plant Extracts
By Application
-
- Anti-infective
- Cardiovascular
- Neurological
- Metabolic Disorder
- Respiratory
- Oncology
- Others
By End User
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- Pharmaceutical & Biotechnological Industry
- CROs
- CMOs
- Others
By Region
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- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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