About Active Pharmaceutical Ingredients
Active pharmaceutical ingredient (API) refers to drug with wide ranges of biologically active substances such as synthetic, biotechnological and natural products that are used to manufacture pharmaceutical drugs. These drugs are intended to provide direct effect in the diagnosis process. Active pharmaceutical ingredient market has high growth prospects owing to increasing number of chronic diseases. For instance, according to World Health Organization (WHO) in 2018, cancer led to 9.6 million deaths globally, and cardiovascular disease accounted for nearly 836,546 deaths in the United States and 3.9 million deaths in Europe which are driving the need to develop novel drugs. Further, increasing demand from emerging economies and technological advancement in the API industry expected to drive the demand for API over the forecasted period.
Attributes | Details |
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Study Period | 2018-2030 |
Base Year | 2023 |
Unit | Value (USD Million) |
The competitive landscape of active pharmaceutical ingredients (APIs) is highly dynamic and competitive due to the growing demand for pharmaceutical products worldwide. Major global players like Pfizer, Novartis, Teva Pharmaceutical Industries, Sanofi, and Merck & Co. dominate the API market. It's important to note that the competitive landscape can vary depending on the specific therapeutic area, geographical region, and the type of API involved. Market dynamics, mergers and acquisitions, and regulatory changes can also influence the competitive landscape over time. Analyst at AMA Research estimates that United States Players will contribute the maximum growth to Global Active Pharmaceutical Ingredients market throughout the forecasted period. Established and emerging Players should take a closer view at their existing organizations and reinvent traditional business and operating models to adapt to the future.
Pfizer, Inc. (United States), Novartis AG (Switzerland), Sanofi (France), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (United States), Teva Pharmaceutical Industries Ltd. (Israel), Eli Lilly and Company (United States), GlaxoSmithKline plc (United Kingdom), Merck & Co., Inc. (United States), Sun Pharmaceutical Industries Ltd. (India), F. Hoffmann-La Roche Ltd. (Switzerland) and AstraZeneca plc (United Kingdom) are some of the key players that are part of study coverage. Additionally, the Players which are also part of the research coverage are Olon S.p.A. (Italy), ZETA (Austria), AbbVie Inc. (United States), Corden Pharma (Germany) and Inalco Pharma (United States).
Segmentation Overview
AMA Research has segmented the market of Global Active Pharmaceutical Ingredients market by Type (Innovative Active Pharmaceutical Ingredients and Generic Active Pharmaceutical Ingredients) and Region.
On the basis of geography, the market of Active Pharmaceutical Ingredients has been segmented into South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico). If we see Market by Synthesis, the sub-segment i.e. Biotech will boost the Active Pharmaceutical Ingredients market. Additionally, the rising demand from SMEs and various industry verticals gives enough cushion to market growth. If we see Market by Manufacturer, the sub-segment i.e. Captive API Manufacturers will boost the Active Pharmaceutical Ingredients market. Additionally, the rising demand from SMEs and various industry verticals gives enough cushion to market growth. If we see Market by Therapy Area, the sub-segment i.e. Oncology will boost the Active Pharmaceutical Ingredients market. Additionally, the rising demand from SMEs and various industry verticals gives enough cushion to market growth.
Influencing Trend:
Growing Focus of Biopharmaceutical Industry on Gene Editing Technology and Emphasizing On Polymorphism of Active Pharmaceutical Ingredients
Market Growth Drivers:
Increasing Number of Patients with Chronic Diseases and Emergence of Artificial Intelligence-Based Tools for Drug Discovery
Challenges:
Lack of Advance Healthcare Infrastructure in Emerging Countries
Restraints:
High Manufacturing Cost of Active Pharmaceutical Ingredient and Stringent Regulatory Framework Regarding Drugs Approval
Opportunities:
Increasing Demand from Developing Countries Owing to Growing Healthcare Infrastructure and Rise in Demand of Precision and Generic Medicines
Market Leaders and their expansionary development strategies
21st march 2019, Pfizer a research-based biopharmaceutical company collaborated with Vivet Therapeutics. As Pfizer announced, it has acquired 15% of equity interest in Vivet Therapeutics with the option to acquire all outstanding shares in near future. and 2nd April 2019, Novartis acquired IFM Tre a biopharmaceutical company. This acquisition will help Novartis to expand its portfolio in immunomodulatory medicines.
1st April 2019, Olon S.p.A., engaged in development and production of APIs, generic drug and contract development and manufacturing (CDMO) services announced acquisition of the manufacturing facility in Mahad, India. This will help company to expand their footprints in the Indian market.
“According to Food and Drug Administration (FDA) the ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.”
Key Target Audience
API Manufacturer, Healthcare Institutions (Hospitals, Medical Schools, and Outpatient Clinics), Biopharmaceutical Companies, Potential Investors, Contract Development and Manufacturing Organization (CDMO), Clinical Research Organizations/ Contract Research Organizations, Market Research and Consulting Firms and Others
About Approach
To evaluate and validate the market size various sources including primary and secondary analysis is utilized. AMA Research follows regulatory standards such as NAICS/SIC/ICB/TRCB, to have a better understanding of the market. The market study is conducted on basis of more than 200 companies dealing in the market regional as well as global areas with the purpose to understand the companies positioning regarding the market value, volume, and their market share for regional as well as global.
Further to bring relevance specific to any niche market we set and apply a number of criteria like Geographic Footprints, Regional Segments of Revenue, Operational Centres, etc. The next step is to finalize a team (In-House + Data Agencies) who then starts collecting C & D level executives and profiles, Industry experts, Opinion leaders, etc., and work towards appointment generation.
The primary research is performed by taking the interviews of executives of various companies dealing in the market as well as using the survey reports, research institute, and latest research reports. Meanwhile, the analyst team keeps preparing a set of questionnaires, and after getting the appointee list; the target audience is then tapped and segregated with various mediums and channels that are feasible for making connections that including email communication, telephonic, skype, LinkedIn Group & InMail, Community Forums, Community Forums, open Survey, SurveyMonkey, etc.