Active Pharmaceutical Ingredients Market Research Report - Forecast till 2028

Active Pharmaceutical Ingredients Market Research Report: Information By Manufacturing Process (Captive Manufacturing and Contract Manufacturing), Type of Synthesis (Synthetic and Biotech), By API Formulation (Generic API and Branded/Innovative API), Application (Cardiovascular Disease, Oncology, Neurological Disorders, Orthopedic Disorders, Respiratory, Gastrointestinal Disorders, Urology and others), Molecules (Large Molecule and Small Molecule) and Region - Forecast till 2028

ID: MRFR/Pharma/0876-CR | February 2021 | Region: Global | 157 pages

Active Pharmaceutical Ingredient (API) Market Overview

Active Pharmaceutical Ingredient Market size is anticipated to disclose a 6.2% CAGR and touch USD 312 Billion by 2028. The active pharmaceutical ingredients share price has risen incrementally over the past few years due to medicinal properties. The drugs taken together with combined therapy have numerous active ingredients to treat a range of disorders. The various types of active pharmaceutical ingredients are prime elements in the production of drugs, and this global market is estimated to experience optimistic growth in the upcoming period.

COVID-19 Analysis of Active Pharmaceutical Ingredient Market 

The surge in COVID-19 cases globally has played an intrinsic role in active pharmaceutical ingredient manufacturers' development through the forecast period. In India's active pharmaceutical ingredient market, the administration has completed a molecule-by-molecule charting of active pharmaceutical ingredients (APIs) imported from China to elevate domestic construction and imports from third party suppliers in sight of the supply chain interruptions because of the COVID-19 pandemic. The administration is also organizing special provisions for APIs that still require to be sourced from China.

The COVID-19 pandemic has added a further hurdle as governments globally decided to boycott APIs manufactured in China. The COVID-19 contagion put a constraint on the manufacture and the supply chain of several strategic pharmaceutical companies. The global reliance on China for APIs for various biologics and generic drugs is estimated to exert a considerable pull on the global active pharmaceutical ingredient business model. Approximately 44 businesses were considered invalid during the pandemic lockdown restrictions put by the Chinese government. This trend has contributed mainly to nations rolling out native API production programs after reassessing their healthcare models to treat the virus and guarantee a steady inflow of API manufacture. Consequently, well-known pharmaceutical companies are altering their business standards based on key performance indicators.

Active Pharmaceutical Ingredient Market Dynamics


Raised Incidences Of Chronic Diseases

The increasing occurrences of chronic diseases have risen significantly in the past few years due to increased exposure to risk factors and better detection of the ailments at their initial stages.

Upsurge In Novel Drug Applications

The progress in reduced new drug applications (ANDA) is showing a sudden spike due to improved funding into the R & D aspect for treatment of the disease.

Promotion In The Biopharmaceutical Outlook

The intensifying approval of biopharmaceuticals is estimated to play out in favor of the active pharmaceutical ingredient industry in the coming period. The community's healthcare expenses and the present COVID-19 pandemic have led pharmaceutical producers to rearrange their capabilities to cater to a large patient pool.


Advancement In Generics

The developing status of generics in the global active pharmaceutical ingredient market is projected to augment the active pharmaceutical ingredients market growth. Also, the diminishing number of novel drugs in the pharmaceutical industry is estimated to add to the product development's active pharmaceutical ingredients in the upcoming period.


Regulatory Drawbacks

The rigorous supervisory strategies and hostile drug price control strategies throughout several countries are expected to limit the growth of the active pharmaceutical ingredients' companies. A shift to digital manufacturing and patents for blockbuster drugs is estimated to lower the market's development.

Active Pharmaceutical Ingredient Market Segment Overview

By Manufacturing Process

The contract manufacturing segment is estimated to enhance the active pharmaceutical ingredients market share.

Based On Type Of Synthesis

The biotech segment is foreseen to display promising growth in the duration of the forecast period.

Based On API Formulation

The generic API and branded/ innovative API segments are estimated to show notable progress in the forecast period.

Based on Application

The cardiovascular disease oncology and neurological disorders segment is estimated to perform extraordinarily in the upcoming period.

Based On Molecule

The small molecule is estimated to enhance the active pharmaceutical ingredients market share in the forecast period.

Active Pharmaceutical Ingredient Market Regional Analysis

The Americas active pharmaceutical ingredient market is anticipated to hold the principal portion of the global market. The North America active pharmaceutical ingredients market governs the global active pharmaceutical ingredients market due to the increasing technological progress in diagnostics linked with the growing occurrences of chronic diseases and other neurological conditions.

The European regional active pharmaceutical ingredient market is projected to account for a second principal market portion through the forecast period. Many CMOs present in manufacturing of APIs and the mounting need to advance generic drugs are likely to spur the market. 

The Asia Pacific active pharmaceutical ingredient market is evaluated to be the fastest encouraging region in the global active pharmaceutical ingredient market due to the commonness of quickly emerging markets such as India, China, and South Korea that are developing as main hubs for outsourcing drug manufacturing. Japan is estimated to advance the Asia Pacific active pharmaceutical ingredient market primarily.

The Middle Eastern & African active pharmaceutical ingredients market is anticipated to intensify due to the escalate emerging healthcare infrastructure and growing demand for healthcare products.

Active Pharmaceutical Ingredient Market Competitive Landscape

The noticeable companies in the active pharmaceutical ingredients market are

  • Sanofi SA (France),

  • Hoffmann-La Roche Ltd (Switzerland),

  • Pfizer Inc. (US), Abbott (US),

  • Bayer AG(UK), Merck & Co., Inc (US),

  • Boehringer Ingelheim GmbH (UK),

  • GlaxoSmithKline Plc (UK),

  • Novartis AG (UK),

  • Eli Lilly and Company (US),

  • Teva Pharmaceutical Industries Ltd (Israel).

The companies functioning in the global market are expanding their presence by strategic collaborations to increase production capacities and amass a bigger market share in the forecast period.

Recent Developments

  • Dec 2020 Piramal is planning to invest USD 32 million into its manufacturing plant in Michigan, US shoring up production and expansion for non-potent and potent active pharmaceutical ingredients (APIs) over the coming two years. The additional 25,000-square-foot expansion will enhance the 8,500 square feet of production area. It's also anticipated to lift volume for large-scale production because novel reactors can process projects up to 4,000 liters, boosting API production from 30% to 40%.

  • Dec 2020 EQT AB, a private equity firm, decided to purchase Swedish pharmaceuticals business Recipharm AB for USD 2.1 billion, evidencing the newest drug industry procurements trend. Recipharm AB has multi-purpose plants that can manufacture more than a few active pharmaceutical ingredients (APIs) at a time.

Report Overview

  • By Manufacturing Process

    • Captive Manufacturing

    • Contract Manufacturing

  • By Type of Synthesis

    • Synthetic

    • Biotech

  • By API Formulation

    • Generic API

    • Branded/ Innovative API

  • By Application

    • Cardiovascular Disease

    • Oncology

    • Neurological Disorders

    • Orthopedic Disorders

    • Respiratory

    • Gastrointestinal Disorders

    • Urology

    • Others

  • By Molecule

    • Large Molecule

    • Small Molecule

Report Scope:
Report Attribute/Metric Details
  Market Size   2028: USD 312 Billion
  CAGR   6.6% (2021-2028)
  Base Year   2019
  Forecast Period   2028
  Historical Data   2018
  Forecast Units   Value (USD Billion)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   By Manufacturing Process, Type of Synthesis, API Formulation, Application, Molecule, Region
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Sanofi SA (France), Hoffmann-La Roche Ltd (Switzerland), Pfizer Inc. (US), Abbott (US), Bayer AG(UK), Merck & Co., Inc (US), Boehringer Ingelheim GmbH (UK), GlaxoSmithKline Plc (UK), Novartis AG (UK), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd (Israel)
  Key Market Opportunities   Advancement In Generics
  Key Market Drivers

  • Raised Incidences Of Chronic Diseases
  • Upsurge In Novel Drug Applications
  • Biopharmaceutical Outlook

  • Frequently Asked Questions (FAQ) :

    The active pharmaceutical ingredients market is projected to grow at a 6.2% CAGR between 2021-2028.

    The Americas are predicted to command the highest share in the active pharmaceutical ingredients market.

    The active pharmaceutical ingredients market is predicted to touch USD 312 Billion by 2028.

    Rising prevalence of chronic diseases and rising importance of generics are boosting market growth.

    Strict regulatory policies may impede market growth.

    The Global Active Pharmaceutical Ingredients (API) Market is expected to reach an estimated valuation of USD 312 Bn by the end of 2028, recording steady CAGR of over 6.2% during the forecast period (2021-2028). This projection signals toward a steady upward growth of the market, which is primarily attributable to the global increase in chronic and acute diseases.

    Rapid urbanization has caused a change in lifestyles and led to the increase in incidences of chronic diseases such as cancer, diabetes and various pulmonary diseases among others; this is driving the sales of APIs as there is an increased demand for a variety of effective treatment options. Moreover, generic drugs have grown significantly in popularity over the years as patent expirations, particularly on well-known and effective drugs have allowed a superior degree of competition in the market. There are approximately 300 contract manufacturers that make generic API products across 40 different countries worldwide at present.

    Although the factors mentioned above are facilitating consistent growth for the market, several challenges are expected to hamper market growth including stringent drug price control policies across various countries. Several countries are implementing regulations which do not allow pharmaceutical companies to set prices freely. Price control is being done in an effort to protect the interest of the global patient population. Notably, increasing scope for high-potency API is projected to provide the market with room to expand during the assessment period. Pharmaceutical companies are quickly shifting their focus towards high potency APIs such as monoclonal antibodies and recombinant proteins. Moreover, ongoing research and development of effective APIs in the industry is expected to prompt further market growth.

    The global API market has been segmented on the basis of manufacturing process, type of synthesis, API formulation, application, molecule and region. By manufacturing, the market has been segmented into captive manufacturing and contract manufacturing. The contract manufacturing segment is expected to witness the highest CAGR during the forecast period, this is primarily due to the growing trend of pharmaceutical companies outsourcing API manufacturing, which allows a better focus on core competencies.

    By type of synthesis, the market has been segmented into synthetic and biotech, with the former commanding a significant share of the market. However, it is the biotech segment which has been growing considerably over the last few years and is expected to exhibit a relatively higher CAGR due to the reduced side effects associated with biotech synthesis. The biotech segment is further sub-segmented into monoclonal antibodies, recombinant proteins, vaccines and others. Presently, monoclonal antibodies segment holds pole position, while the recombinant proteins segment is projected to grow at the fastest pace during the assessment as recombinant proteins are finding wide range of applications in the pharmaceutical sector.

    By API formulation, the market has been segmented into generic API and innovative API. Patent expirations have propelled the generic API segment into leading position with a projected CAGR of 4.62% during the forecast period.

    By application, the market has been segmented into cardiovascular disease, oncology, neurological disorders, orthopedic disorders, respiratory, gastrointestinal, urology, and others. Of these, the oncology segment currently accounts for the largest market share. This is owing to the increased occurrences of cancer worldwide. This segment is set to grow at a CAGR of 5.48% during the review period.

    By molecule, the market has been segmented into small molecule and large molecule. Although the small molecule segment accounted for the largest market share in 2017, the large molecule segment is set to surpass in the near future and record a higher CAGR during the assessment period. This is primarily due to the growing focus on research and development of innovative APIs such as biologics to cater to the unmet patient needs.

    Regional Analysis

    Led by North America, the Americas command the largest market share due to a strong presence of competitors in the region. Countries such as U.S. and Canada have high occurrences of chronic and neurological diseases, which is a strong driver of market growth. Europe, is the second largest market for API. The growth of the market in the region can primarily be attributed to the initiatives taken in the region to support the growth of generic drugs. Improvement of pricing and reimbursement policies combined with a large number of manufacturing activities in Europe is creating growth opportunities for the market.

    The API market is reaching maturity in developed nations across the globe, which has shifted market focus to the Asia-Pacific region, making it the fastest growing segment during the assessment period. The presence of a truly massive patient population in countries such as India and China, coupled with increasing incidences of chronic diseases in this region is expected to drive market growth. Cheap labor and lower required investments in infrastructure have prompted many reputable pharmaceutical companies to outsource manufacturing to this region, thus facilitating further growth.

    Competitive Tracking

    Top market players included Merck & Co. Inc., Eli Lilly and Company, GlaxoSmithKline plc., Pfizer Inc., Novartis International AG, Boehringer Ingelheim, Teva Pharmaceuticals Industries Ltd, and Sanofi.

    Other reputable players who have been identified and analyzed in the report include Bristol-Myers Squibb, AbbVie, AstraZeneca plc, Abbott Laboratories and Johnson & Johnson Services Inc. among others. Research activities and innovation of products with improved efficiency is a key strategy employed by many of the leading pharmaceutical companies mentioned above.

    Active Pharmaceutical Ingredients or API, in short, are growing in an increscent manner due to the unmatched effects of active chemicals in the drugs and the portions that work on treating the condition. The bridging of foreign manufacturers and local distributors has led to extensive progress in the market over the past few years. The launch of innovative and improved APIs in the market will boost the market’s progress to a great extent in the forthcoming period. Moreover, the constantly growing demand for biotech API has stimulated the firms to present better and new products to address the unmet requirements of the market.

    The outlook for growth in the economy is likely to perceive a sweeping rise in the API industry owing to the growing occurrence of chronic disorders such as diabetes, cardiovascular diseases, obesity and other infectious diseases which will lead to the launch of numerous innovative drugs. The rising cases of chronic diseases are also one of the foremost reasons for hospitalization with a huge number of patients with these conditions who may need re-admission in hospitals owing to an infection that can cause other chronic diseases. The expiration of patents of branded drugs has created a serious impression on drug manufacturers, as the companies can incur tremendous losses after expiration. Hence, the producers favor generic drugs over the branded ones. The generics are also expected to be the most rapidly growing type due to patent expirations of many blockbuster drugs.

    However, the rapidly increasing scope for high-potency active pharmaceutical ingredients over the last decade has shifted the focus to the new biologics gold rush of recombinant proteins and monoclonal antibodies. As a result of this, the chemical API market for western contract manufacturers, on the whole, has undergone a sharp decline till 2015. Many custom manufacturing organizations (CMOs) have shifted their emphasis to rescheduling plants or manufacturing of higher-value biologics.

    Segmental Analysis

    The segmental analysis of the market is based on the segments of the manufacturing process, API formulation, application, type of synthesis, molecule, and region. The market segmentation by type of synthesis consists of biotech and synthetic segments. The synthetic segment in 2017 was worth USD 132,690.7 Mn. The manufacturing process based segmentation of the market comprises of contract manufacturing and captive manufacturing. The captive manufacturing segment presently has the significant market share and is expected to remain extremely lucrative throughout the assessment period. The API formulation segments the market into innovative API and generic API. The generic API segment presently held the leading market share in 2017. The segmentation based on molecule has been segmented into small molecule and large molecule. The small molecule segment is expected to maintain its top position till the end of 2028. The application based segmentation of the market has been segmented into oncology, cardiovascular disease, orthopedic disorders, neurological disorders, respiratory, urology, gastrointestinal disorders and others. The oncology segment is anticipated to develop with an incremental CAGR during the forecast period.

    Regional Analysis

    The market for APIs has been segmented into Europe, Americas, Asia Pacific (APAC), and the Middle East & Africa (MEA). The Americas region presently controls the significant market portion, and the trend will probably carry on in the foreseeable future. This factor is majorly related to the robust value sustained by the small molecule segment in both Canada and the U.S. Additionally the pharmaceutical industry is among one of the major and most exceptional ventures in the US nations. The pharmaceutical organizations in the USA have developed quickly in comparison with other countries. The European and Asia Pacific region are also anticipated to continue growth in the revenue pockets for the active pharmaceutical ingredients (API) market during the forecast period. Europe accounts for the second largest market for active pharmaceutical ingredients which is followed by the Asia Pacific region. While the APAC region, the market’s course is mostly directed by factors such as the amplified level of expense on equipment and infrastructure, expanding initiatives which are motivating investment in APIs from drug makers to increase the capacity to produce APIs.

    Competitive Analysis

    The players and key trends have created a positive tone for development. The competitors in the market are also leveraging their competitive benefits to secure their development in the market. The market progress by competitors also encompasses strong risk management strategies which are positively motivating the expansion of the market.

    Bayer AG, Eli Lilly and Company, Pfizer Inc., F. Hoffmann-La Roche AG, Sanofi, Boehringer Ingelheim GmbH, Abbott Laboratories, GlaxoSmithKline Plc (GSK), Novartis AG, Merck & Co., Inc., and Teva Pharmaceutical Industries Ltd.