Active Pharmaceutical Ingredients Market

Global Active Pharmaceutical Ingredients Market Size (2023 to 2028)

As per our analysis report, the global active pharmaceutical ingredients market size is expected to be growing at a CAGR of 6.3% from 2023 to 2028. This market is estimated to value USD 361.59 million in 2023 and USD 490.7 million by 2028.

The active pharmaceutical ingredients are chemically and biologically active components of drugs directly affecting the mitigation, cure, prevention, and treatment of diseases. Chemical synthesis, fermentation, biotechnological approaches, and improved natural sources are all used to create APIs. The API represents the primary ingredient. Excipients are a term used to describe other substances. Medicine may include numerous APIs, and the impact on a patient is determined by the dose administered, which varies from person to person. Two or more active substances are used in combination treatments to treat different symptoms in various ways. Since the API is the key component examined when writing a prescription, strict quality control is required for medication manufacture. There are two main processes in the production of pharmaceuticals. Manufacturers turn raw ingredients into APIs in the first phase. The last step entails combining APIs and excipients into tablets, capsules, solutions, and other forms and packaging the medicine for usage by end-users. APIs are sold on the open market (also known as the merchant market) or used as inputs in final formulations by manufacturers.

MARKET DRIVERS:

Y-O-Y growth in the incidence of chronic diseases, the growing importance of generics, and the increased uptake of biopharmaceuticals are majorly accelerating the growth rate of the global active pharmaceutical ingredients market.

In the last few decades, there has been an increase in incidences of chronic diseases such as coronary artery disease, diabetes, chronic obstructive pulmonary disease (COPD), arthritis, hepatitis, cancer, and asthma across the globe, which is estimated to drive demand for the global active pharmaceutical ingredients market growth. In addition, the rise in the geriatric population around the globe and changes in lifestyle and diet due to rapid urbanization are significant factors contributing to the market's growth.

Favorable government policies with many preparations for drug activities and a price hike are significant positive signs for the global active pharmaceutical ingredients market growth. Companies cannot prepare a generic drug unless the drug's patent expires. Besides the emerging biosimilar market, the growing reach of HPAPI solutions, emerging markets, and emerging technologies have opened up many opportunities for the global active pharmaceutical ingredients market growth. The global active pharmaceutical ingredients market is providing opportunities for the emerging biosimilars market. Due to the rise in various disease incidences, numerous off-patent biologics demands for biosimilars in different therapeutic applications are incremented. Over the next decade, expect the expiration of patents and other intellectual property rights for biologics originators is growing, and many biosimilar opportunities help enter the API market.

MARKET RESTRAINTS:

Strict regulatory requirements and unfavorable drug price control policies can slow down several countries' global active pharmaceutical ingredients market.

The major restraint in the global active pharmaceutical ingredients market is the high costs of manufacturing APIs. However, to improve manufacturing facilities, increased investments are needed for key players to comply with standards like CGMP. Renovation of product facilities, inculcating familiarity with the requirement of qualification processes. In addition, there is a high expenditure to obtain regulatory approvals from authorities. Even chemical synthesis of APIs also requires high expenses, and uncommon building blocks and raw materials add to manufacturing costs. Factors such as lessening or shortening the developing time, cost of the development to be reduced, improving the process design, compromising the gain or profits, a meeting the standard quality are the challenges on the other side. The global active pharmaceutical ingredients market is marked by violent criminal competition, which is challenging.

Impact of COVID-19 on the global Active Pharmaceutical Ingredients Market:

After the WHO's declaration, a mixture of pharmaceutical and biopharmaceutical companies was established, and a few start-ups stepped forward to treat target diseases. In a few weeks, scientists found a list of molecules targeting COVID-19. Growth in funds and the development of research products are driving market growth. However, the active pharmaceutical ingredients market is affected by COVID-19 in many ways, especially economically. COVID-19 impacted the active pharmaceutical ingredients market in financial gain. Moreover, the supply chain of manufactured products is affected by the COVID-19 pandemic and expected that the active pharmaceutical ingredients market will regain the loss that occurred by the pandemic. Therefore, the active pharmaceutical ingredients market should be on track in the upcoming years.

REPORT COVERAGE:

This research report on the global active pharmaceutical ingredients market has been segmented and sub-segmented based on the manufacturing process type, synthesis, API formulation, application, molecules, and region.

Active Pharmaceutical Ingredients Market - By Type of Manufacturing Process:

• Captive Manufacturing
• Contract Manufacturing

Active Pharmaceutical Ingredients Market - By Type of Synthesis:

• Synthetic
• Biotech

Active Pharmaceutical Ingredients Market - By API Formulation:

• Generic API
• Innovative API

Based on API formulation, the innovative API segment is expected to account for the majority in 2022. The large share of this segment can be attributed to the increasing number of FDA approvals for new molecular entities, higher prices commanded by innovative APIs as compared to their generic equivalents, and the growing focus of innovator APIs companies on R&D for the development of novel, innovative API products to cater to the unmet medical needs of the Global active pharmaceutical ingredients market.

Active Pharmaceutical Ingredients Market - By Application:

• Cardiovascular Diseases
• Oncology
• Neurological Disorders
• Orthopedic Disorders
• Respiratory
• Gastrointestinal Disorders
• Urology
• Others

The cardiovascular disease segment is expected to dominate the market during the forecast period due to the rising cases of cardiovascular diseases and the incidences of rising cholesterol levels in cardiac patients resulting in a risk of heart attacks and diseases. For example, according to WHO stats, each year, 17.9 million people die from cardiovascular diseases (CVDs), the most significant cause of death in the world. Additionally, the government has taken several initiatives to raise awareness regarding the rising risks of high cholesterol and cardiovascular diseases ad has even promoted cardiac drugs leading to segment growth.

Active Pharmaceutical Ingredients Market - By Molecule:

• Large Molecule
• Small Molecule

The small molecules segment is expected to dominate the market during the forecast period, as 90% of the current pharmaceutical markets use small molecules. Drug development has always been based on small molecules. They are easily ingested in the gastrointestinal tract because of their small size, and their active ingredients are promptly absorbed into the bloodstream, where they can go to any part of the body. In addition, these molecules are tiny enough to easily pass through cell membranes as they move around the body. Therefore, their advantageous nature helps them dominate the market revenue.

Active Pharmaceutical Ingredients Market - By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa

Regionally, the North American Active pharmaceutical ingredients market is predicted to dominate the global API market during the forecast period due to technological advancements and the high development of the economy. Moreover, the increase in the prevalence of cancer diseases and other lifestyle-related diseases to encourage R& D activities propels the market's demand.

The Asia-Pacific API market is expected to register a high growth rate compared to other regions in the global active pharmaceutical ingredients market during the forecast period. Factors such as increasing healthcare expenditures and a growing aging population create a vast patient pool and rising economies in this region. Additionally, key players' initiatives in setting up API manufacturing plants in developing countries like India and China and laborers' availability contribute to growth in the Asia-Pacific region.

China is considered to be the leader in API manufacturing in the APAC region. Many domestic companies are involved in manufacturing and supplying API all over the world. Not just in the Asia-Pacific region, China exports a significant share of its domestically produced API worldwide.

KEY MARKET PLAYERS:

List of key market participants leading the global active pharmaceutical ingredients market profiled in this report is Sanofi, Bayer AG, Pfizer Inc., F. Hoffmann-La Roche AG, Abbott Laboratories, Merck & Co., Inc., Boehringer Ingelheim GmbH, GlaxoSmithKline Plc (GSK), Novartis AG, Eli Lilly and Company and Teva Pharmaceutical Industries Ltd.

RECENT MARKET DEVELOPMENTS:

• In 2020, to manufacture and supply Gilead's antiviral drug (Remdesivir), a multilayer agreement was signed by Pfizer (U.S.) with Gilead Sciences for the treatment of COVID-19. 
• In 2020, an acquisition was made by Novartis with Aspen's Japanese operations to strengthen its position globally by generics and the off-patent medicines market. Already Novartis agreed to manufacture and supply with Aspen. 
• In 2020, to focus on therapeutic antibodies by targeting the tumor microenvironment, an acquisition was made by Boehringer Ingelheim (Germany) with Northern Biologics. 
• On February 26, 2020, Sun Pharmacy launched the Riomet ER in the U.S. as an adjunct to diet and exercise to improve glycemic control.
• On February 18, 2020, Boehringer- Ingelheim launched patient Centric MyStudioWindow powered by Carebox.
• On February 07, 2020, Dr. Reddy's and its subsidiaries launched the Trientine Hydrochloride Capsules, USP 250, approved by the FDA. 
• On February 07, 2020, Dr. Reddy and their unit entered the Amendment of the Agreement with Aurigene Discovery Technologies.
• On February 27, 2020, Dr. Reddy's Laboratories announced the launch of naproxen and esomeprazole magnesium delayed-release tablets, which the FDA approved. 
• In June 2019, Primal Pharma solutions announced its lab space extension of its Michigan, a U.S.-based facility. This facility is dedicated to the high power of something to influence active pharmaceutical ingredients.