API Manufacturing: Global Opportunities & Forthcoming Trends

Global Growth Driving Factors:

Some of the key factors propelling this market's growth are the expansion of production capacity by biopharmaceutical and pharmaceutical companies, the increasing significance of generics, and technological developments in API manufacturing. However, it is anticipated that in the upcoming years, the market for active pharmaceutical ingredients will be restrained by the unfavorable drug price control policies in many different countries as well as the growing prevalence of counterfeit drugs.

Market Size Estimation:

The global API market size was estimated using the revenue-based approach separately for the consumable and instrument segments.

Revenue Growth Dynamics:

The market for active pharmaceutical ingredients is expected to grow at a compound annual growth rate (CAGR) of 8.2% from 2022 to 2027, from an estimated $145.9 billion in revenue in 2022 to $216.4 billion.

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Objectives of this Study:

# To define, describe, and forecast the global APIs market on the basis of type, potency, type of synthesis, type of drug, therapeutic application, and region.

# To provide detailed information regarding the major factors influencing the growth of the market (drivers, restraints, opportunities, and challenges).

# To strategically analyze micromarkets with respect to individual growth trends, future prospects, and contributions to the overall market.

# To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders.

# To forecast the size of the market segments with respect to four main regions, namely, North America, Europe, the Asia Pacific, and the Rest of the World.

# To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies.

# To track and analyze competitive developments such as partnerships, agreements, collaborations, joint ventures, alliances, mergers & acquisitions, approvals, expansions, and R&D activities in the global APIs market.

Opportunity: Emerging biosimilars market

The main factors propelling the growth of the biosimilars market are the rising incidence of various diseases, the rise in off-patent biologic drugs, the positive results of ongoing biosimilar clinical trials, and the growing demand for biosimilars in various therapeutic applications (like blood disorders and rheumatoid arthritis). Because biosimilars are generic versions of biologics that are patented, they are less expensive than patented biologics because they are exempt from the strict regulations of many regulatory bodies. It is anticipated that over the course of the next ten years, the patents and other intellectual property rights pertaining to originator biologics will expire, providing biosimilars with an opportunity to enter the market.

Challenge: Increasing penetration of counterfeit drugs

Falsified or fake medications may contain toxic or subpar ingredients administered in the incorrect dosage amounts. The WHO estimates that less than 10% of medications are fake. It is estimated that in nations with stronger regulatory frameworks and stricter control over the pharmaceutical supply, the rate of pharmaceutical fraud is approximately 1% of all pharmaceuticals. But in low- and middle-income nations, the percentage of phony medications increases to about 50%.

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The increasing prevalence of fake medications is costing legitimate API producers money. According to estimates from the EU Intellectual Property Office (EUIPO), counterfeit drugs cost the EU pharmaceutical industry USD 30.70 billion (or EUR 26.9 billion) a year, or almost 7% of its total sales. Also, the region loses about 7,100 jobs a year as a result of fake or counterfeit medications.

The European Union's (EU) legal supply chain is intended to be kept free of counterfeit medications through the implementation of the European Falsified Medicines Directive (FMD). The European Union (EU) is concentrating on enforcing stricter safety regulations throughout Europe in areas like APIs and excipients, pharmaceutical safety features, supply chains, GDPs, and online sales.

Geographical Growth Dynamics:

North America is expected to account for the largest size of active pharmaceutical ingredient industry during the forecast period.

The market for active pharmaceutical ingredients are divided geographically into the Rest of the World (RoW), Europe, Asia Pacific, and North America. The market was dominated by North America and then by Europe. Major pharmaceutical and biopharmaceutical manufacturing facilities, a growing government emphasis on generic drugs, the growing demand for biologics and specialty drugs, and technological advancements in API manufacturing processes are the main factors propelling the overall growth of the APIs market in this region. The introduction of affordable generic versions of branded drugs, coupled with healthcare severity measures and economic factors, is expected to contribute to the modest growth of this market segment.

Global Leading Players:

The key players in the market are Pfizer, Inc. (US), Novartis AG (Switzerland), Sanofi (France), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (US), Teva Pharmaceutical Industries Ltd. (Israel), Eli Lilly and Company (US), GlaxoSmithKline plc (UK), Merck & Co., Inc. (US), AbbVie Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), and AstraZeneca plc (UK).

Growth Strategies Opted by Them:

To stay competitive and grow their market share, these businesses are primarily concentrating on tactics like agreements, product launches, acquisitions, partnerships, collaborations, and expansions.

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