In 2023, worldwide sales of specialty active pharmaceutical ingredients are around USD 206.44 billion. The demand for specialty active pharmaceutical ingredients is expected to increase at a CAGR of 3.2% over the forecast period. The specialty active pharmaceutical ingredient (API) market value is expected to reach USD 282.88 billion by 2033.
Specialty Active Pharmaceutical Ingredient (API) Market Trends:
| Report Attribute | Details |
|---|---|
| Specialty Active Pharmaceutical Ingredient (API) Market Size (2023) | USD 206.44 billion |
| Anticipated Market Value (2033) | USD 282.88 billion |
| Market Projected Growth Rate (2023 to 2033) | 3.2% |
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The worldwide market experienced a significant drop in 2020 and 2021 as active medicinal components experienced a decline in demand. The overall market witnessed a CAGR of 4.9% from 2018 to 2022. The market valuation was USD 196.8 billion in 2022.
| Attributes | Details |
|---|---|
| Specialty Active Pharmaceutical Ingredient (API) Market Size (2018) | USD 153.08 billion |
| Historical Market Size (2022) | USD 196.8 billion |
| Historical CAGR (2018 to 2022) | 4.9% |
The pandemic years have had an unprecedented and overwhelming impact on the API development for orphan diseases as well. Though the specialty API industry revenue has returned to pre-pandemic levels after 2022, the CAGR is forecasted to remain low over the coming years.
Given the rising tendency toward developments and innovations in therapeutic medications by various pharmaceutical and biotechnology businesses, the industry could witness a rapid expansion. The key factor that could significantly contribute to this growth is the rising incidence of chronic diseases and the rising desire for customized medication.
Accurate quantification and characterization of the specialty APIs of interest are made possible by the development of analytical technologies, which help speed up manufacturing. For example, novel LC/MS techniques that employ triethylamine (TEA) and low hexafluoroisopropanol (HFIP) concentrations as mobile-phase buffers have recently been developed. Using such novel chemicals helps drive the purification processes while reducing the time and expense of production.
An important characteristic among regional participants is significant expenditures in the growth of authorized specialty active pharmaceutical ingredients (API). For instance, due to its FDA-inspected Colorado plant, CordenPharma extended operations in 2018 by adding new commercial oligonucleotide API production capabilities. WuXi STA constructed an oligonucleotide API production plant in Changzhou, China, to meet the rising demand in the early months of 2020.
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The active pharmaceutical component business is quite complicated, and strict restrictions on the manufacture of APIs pose a major challenge for the market players. In addition to this, legal concerns are delaying the construction of additional API facilities in many localities, impeding the overall market growth. For example, Dr. Reddy's Laboratories and Eli Lilly and Company encountered issues with the United States FDA for their API manufacturing facilities in 2020.
During the projection period, the massively successful medicine patent expiry is anticipated to keep competitive competition at a high level. Also, the rising trend of outsourcing research and development activities due to high manufacturing costs would limit the regional API industry revenue.
| Regional Markets | CAGR (2023 to 2033) |
|---|---|
| United Kingdom | 1.8% |
| China | 4.1% |
| India | 5.7% |
| Australia | 3.2% |
The United States specialty active pharmaceutical ingredients (APIs) industry is expected to generate a revenue of around USD 60 billion in 2023. Due to the high acceptance rate of novel or patented medications, the United States continues to be the most attractive market for specialty APIs.
The demand for unique pharmaceutical ingredients in European countries is worth USD 50 billion in 2023. Germany is the leading market, with a net contribution of 13.8 billion this year.
In addition to this, in Eastern Europe, chronic illnesses are more prevalent and are expected to provide sufficient market growth opportunities over the forecast years. However, developers of specialty APIs in Germany need to concentrate on cost control, product sales, and distribution to reach a larger geographic market.
China, with a vast pharmaceutical industry landscape, is predicted to remain the leading market in Asia for the production of novel APIs through the forecast years. China, with a large patient population and a rising need for accessible healthcare facilities, would provide manufacturers with several opportunities to build their businesses over the coming decade. The inclusion of new regional players is encouraged in China, and these players are anticipated to use specialized APIs as stand-ins for boosting the market further.
In the past few decades, many pharmaceutical and biotech firms have chosen to locate their production facilities in Asian countries in order to reduce costs.
For instance, in February 2021, Wavelength Pharmaceuticals' purchased a significant share of Vanamali Organics, a private company in India. The country is also leading the way in the use of generic drugs with a growing requirement for high-quality active pharmaceutical ingredients at affordable prices.
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| Top Product Type | Small molecules |
|---|---|
| Market Share in 2023 | 76.2% |
The demand for small molecule API in the pharmaceutical industry has increased significantly due to a higher patient pool with chronic illnesses and infectious diseases. The market value of small molecule ingredients in 2023 is estimated to be around USD 157.3 billion. This segment is also anticipated to acquire traction further as the market potential is rising in generic medicine demand, particularly in third-world countries.
| Top Consumption Type | In-house |
|---|---|
| Market Share in 2023 | 54.2% |
The in-house segment dominates the market by consumption, which accounts for almost 54.2% of total API produced in 2022. Rising concerns among governments to become self-sufficient in important medications are expected to propel this segment’s growth over the forecast period.
To maintain their dominant position, specialty pharmaceutical ingredient market players are concentrating on the creation of new technologies and exclusive product licensing. The top companies also resort to alliances and distribution contracts to dominate the specialty active pharmaceutical ingredients (API) industry. Pfizer Incorporated purchased Anacor Pharmaceuticals Company in 2016, a renowned pharmaceutical business engaged in developing small molecule therapies.
Several new firms are slowly entering the market for specialty active pharmaceutical ingredients (API) at regional and global levels in recent years. To maintain a unique market identity, roughly 20+ companies are actively engaged in research and development, technical innovation, and eCommerce activities. However, the chances of success for new entrants in the market are highly skeptical since it is challenging to match the substantial funding requirements.
Americas
Europe
Asia Pacific
Some of the Emerging Players in the Global API Market:
Cadila Healthcare Ltd.: The company is known for having offered 38 intermediates and APIs across therapeutic categories.
Jazz Pharmaceuticals Plc: The company’s unified business segment paves the way for a broad spectrum of APIs to produce finished products.
Lupin Ltd.: The company produces as well as commercializes finished pharmaceutical products and offers APIs for these products.
Mylan NV: The business segments in MylanCompany include Rx/Bx, Gx, and OTC. The products for which it offers APIs address therapeutic areas like proton pump inhibitors, antifungals, anti-diabetics, anti-virals, cardiovascular, anti-asthmatics/anti-histamines, CNS agents, anti-bacterial, and HIV/AIDs.
| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2033 |
| Historical Data Available | 2018 to 2022 |
| Market Analysis | USD million or billion for Value and Units for Volume |
| Key Regions Covered | North America; Latin America; Europe; Middle East & Africa (MEA); East Asia; South Asia and Oceania |
| Key Countries Covered | United States, Canada, Brazil, Mexico, Germany, Spain, Italy, France, United Kingdom, Russia, China, India, Australia & New Zealand, GCC Countries, and South Africa |
| Key Segments Covered | By Product Type, By Consumption, and By Region |
| Key Companies Profiled | Inalco Pharmaceuticals; Sussex Research Laboratories Inc.; PolyPeptide Laboratories; Nitto Denko Avecia Inc.; Dalton Pharma Services; Amneal Pharmaceuticals, Inc.; Mylan NV; CordenPharma International GmbH; Pepscan Holding NV; Provence Technologies Group; BCN Peptides S.A.; Senn Chemicals AG.; SantarisPharma A/S; Sanofi; Pfizer Inc.; Jazz Pharmaceuticals, Inc.; ST Pharm. Co. Ltd; SymbiotecPharma Lab Pvt. Ltd.; Cadila Healthcare Ltd.; Lupin Ltd.; Amneal Pharmaceuticals, Inc. |
| Report Coverage | Market Forecast, Company Share Analysis, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, and Strategic Growth Initiatives |
| Customization & Pricing | Available upon Request |
The global market is likely to grow at a 3.2% CAGR during the forecast period.
The overall market is predicted to be valued at USD 282.88 billion by 2033.
The global market grew at a CAGR of 4.1% from 2018 to 2022.
The United States accounts for nearly 29.2% of global revenue share in 2023.
Sales of specialty APIs in India are predicted to witness a CAGR of 5.7% through 2033.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product Type 5.1. Small Molecules API 5.1.1. Controlled Substances API 5.1.2. HPAPI 5.2. Peptides API 5.3. Carbohydrate Drugs API 5.4. Steroidal Drugs API 6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Consumption 6.1. In-house 6.2. Outsourced 7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region 7.1. North America 7.2. Latin America 7.3. Western Europe 7.4. Eastern Europe 7.5. South Asia and Pacific 7.6. East Asia 7.7. Middle East and Africa 8. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 9. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 10. Western Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 11. Eastern Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 12. South Asia and Pacific Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 13. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 14. Middle East and Africa Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 15. Key Countries Market Analysis 16. Market Structure Analysis 17. Competition Analysis 17.1. Inalco Pharmaceuticals 17.2. Sussex Research Laboratories Inc. 17.3. PolyPeptide Laboratories 17.4. Nitto Denko Avecia Inc. 17.5. Corden Pharma International GmbH 17.6. Pepscan Holding NV 17.7. Provence Technologies Group 17.8. BCN Peptides S.A. 17.9. Senn Chemicals AG. 17.10. Santaris Pharma A/S 17.11. ST Pharm. Co. Ltd 17.12. Symbiotec Pharma Lab Pvt. Ltd. 17.13. Cadila Healthcare Ltd. 17.14. Lupin Ltd 18. Assumptions & Acronyms Used 19. Research Methodology
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Specialty Active Pharmaceutical Ingredient Market
