:Market Dynamics:
Drivers:
# Increasing Incidence of Chronic Diseases
# Rising Prevalence of Cancer
# Technological Advancements in API Manufacturing
# Growing Importance of Generics
# Rapidly Increasing Geriatric Population
# Increase in Abbreviated New Drug Applications (ANDA)
# Increasing Uptake of Biopharmaceuticals
Restraints:
# Stringent Regulatory Requirements
# Unfavorable Drug Price Control Policies Across Various Countries
Opportunities:
Emerging Biosimilars Market
# Increasing Scope for High-Potency Active Pharmaceutical Ingredients
# Emerging Markets
# Emerging Technologies
Challenges:
# Product Differentiation
# High Manufacturing Costs
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The global active pharmaceutical ingredients market is expected to reach USD 213.97 Billion by 2021 from USD 157.95 Billion in 2016, growing at a CAGR of 6.3% from 2016 to 2021.
On the basis of type, the active pharmaceutical ingredients market is segmented into innovative and generic APIs. The innovative APIs segment is estimated to command the largest share in 2016. Some of the major factors contributing to its large share include growing demand for innovative therapeutics for treatment of dreadful diseases, especially cancer, the increase in the number of FDA approvals for new molecular entities and the higher prices of innovative APIs (as compared to generics). On the basis of type of manufacturer, the active pharmaceutical ingredients market is segmented into captive and merchant API manufacturers.
The APIs market, on the basis of type of synthesis, is segmented into synthetic and biotech APIs. Synthetic APIs is estimated to dominate this market in 2016.The large share of this segment can be attributed to the emergence of new synthetic molecules in the market, increasing number of new product approvals, less complex manufacturing and approval processes as compared to biologics and technological advancements in the method of synthesis. However, the biotech APIs market is expected to grow at a substantially higher rate during the forecast period owing to advances in biotechnology, growing demand for biopharmaceuticals due to their specificity in action, their similarity with the natural biological compounds, and significant growth in the demand for monoclonal antibodies.
Based on product, the biotech active pharmaceutical ingredients market is segmented into monoclonal antibodies, hormones, vaccines, cytokines, fusion proteins, therapeutic enzymes, and blood factors.
In 2015, the monoclonal antibodies segment account accounted for the largest share of the global biotech active pharmaceutical ingredients market. Growing incidence of cancer, increasing investments in R&D, technological advances in genetic sequencing and target gene selection, and increasing application of mAbs in oncology reduced side effects as compared to chemotherapy are some of the major factors responsible for the large share of monoclonal antibodies in this market.
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Based on geography, the global active pharmaceutical ingredients market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). North America is expected to account for the largest share of the market by the end of 2016. This large share can be attributed to various factors including increasing incidence of chronic diseases, increasing focus of the government on the growing adoption of generic drugs, rising demand for biologics and specialty drugs, and technological advances in API manufacturing.
Prominent players in the active pharmaceutical ingredients market include Pfizer, Inc. (U.S.), Novartis International AG (Switzerland), Sanofi (France), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (U.S.), Teva Pharmaceutical Industries Ltd. (Israel), Eli Lilly and Company (U.S.), GlaxoSmithKline plc (U.K.), Merck & Co., Inc. (U.S.) and AbbVie Inc. (U.S.).
