High potency active pharmaceutical ingredients (HPAPI) are highly effective in small doses, and require sophisticated manufacturing facilities and specialized technical capabilities. These APIs have drastically improved the standards of medical treatment. Advantages of targeted therapy and high revenue returns has boosted research and development in this field. High potency API manufacturing is a challenging task and mainly confined to captive manufacturing. Pharmaceutical companies have only recently started outsourcing HPAPI production to contract manufacturing organization to effectively utilize outside expertise, while managing escalating drug development and commercialization costs.
Advances in pharmacology and oncology research has resulted in rapid growth in the demand for high potency APIs. To meet this ever increasing demand, contract manufacturers are trying to strengthen HPAPI manufacturing capacities and also acquire necessary technological expertise. Although the HPAPI market currently accounts for a small percentage of total active pharmaceutical ingredient market, advances in oncology therapeutics research and strong drug pipeline comprising HPAPI is expected to fuel the global market growth. The global HPAPI market was valued at US$ 12,644.6 Mn in 2014 and is projected to reach US$ 25,118.7 Mn by 2023, expanding at a CAGR of 7.8% from 2015 to 2023.
Various blockbuster drugs in oncology segment comprising HPAPIs are scheduled to loose patent protection in the near future. This would create profitable opportunities for generic drug manufacturers, and in turn for HPAPI contract manufacturing organizations. In spite of patent expiry of key blockbuster drugs, the market for branded HPAPIs would continue to lead, on the grounds of their high cost. Oncology segment accounts for more than 50% of the global HPAPI market (in 2015) owing to large number of branded drugs. This segment would continue to lead the market throughout the forecast period and is also expected to be the fastest growing HPAPI market segment by therapeutic area. Anticipated launch of antibody drug conjugates and monoclonal antibodies in the segment would propel market growth.
North America and Europe currently house majority of the HPAPI manufacturing organization and pharmaceutical drug manufacturing organization. Leading pharmaceutical companies with portfolio comprising HPAPIs were skeptical in outsourcing HPAPI production outside the country, especially in the Asian countries to avoid patent infringement. However with improving legal and regulatory policies, coupled with low production opportunities, HPAPI manufacturing in Asia Pacific would grow at a faster rate as compared to North America and Europe.
Key players in the market include Alkermes plc, Cambrex Corporation, Dr. Reddy's Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC., WuXi AppTec
Chapter 1 Introduction
1.1 Report Description
1.2 Market Segmentation
1.3 Research Methodology
Chapter 2 Executive Summary
2.1 Market Snapshot: Global HPAPI Market
2.2 Comparative Analysis: HPAPI Market, by Geography, 2014 & 2023
2.3 Waterfall Chart: Global HPAPI Market, by Product, 2014 (US$ Mn)
Chapter 3 Global HPAPI Market Overview
3.1 Market Definition and Overview
3.2 Regulatory Landscape
3.3 HPAPI Manufacturing Capabilities of Major HPAPI CMOs
3.2 Market Dynamics
3.3 Porter’s Five Forces Analysis: Global HPAPI Market
3.5 Event Impact analysis
3.6 Value Chain Analysis
3.7 Market Attractiveness Analysis
3.8 Market Share Analysis
Chapter 4 Global HPAPI Market, by Type of HPAPI, 2013 – 2023 (US$ Mn)
4.1 Synthetic HPAPI Market Revenue, 2013 – 2023 (US$ Mn)
4.2 Biological HPAPI Market Revenue, 2013 – 2023 (US$ Mn)
Chapter 5 Global HPAPI Market, by Type of Manufacturer, 2013 – 2023 (US$ Mn)
5.1 Captive or In-house HPAPI Market Revenue, 2013 – 2023 (US$ Mn)
5.2 Contract or Third Party HPAPI Market Revenue, 2013 – 2023 (US$ Mn)
Chapter 6 Global HPAPI Market, by Type of Drug, 2013 – 2023 (US$ Mn)
6.1 Branded HPAPI Market Revenue, 2013 – 2023 (US$ Mn)
6.2 Generic HPAPI Market Revenue, 2013 – 2023 (US$ Mn)
Chapter 7 Global HPAPI Market, by Therapeutic Area, 2013 – 2023 (US$ Mn)
7.1 Oncology Drugs Market Revenue, 2013 – 2023 (US$ Mn)
7.2 Anti-diabetic Drugs Market Revenue, 2013 – 2023 (US$ Mn)
7.3 Cardiovascular Drugs Market Revenue, 2013 – 2023 (US$ Mn)
7.4 Central Nervous System Drugs Market Revenue, 2013 – 2023 (US$ Mn)
7.5 Musculoskeletal Drugs Market Revenue, 2013 – 2023 (US$ Mn)
7.6 Other Drugs Market Revenue, 2013 – 2023 (US$ Mn)
Chapter 8 Global HPAPI Market, by Geography, 2013 – 2023 (US$ Mn)
8.2 North America
8.2.1 U.S. Market Revenue, 2013 – 2023 (US$ Mn)
8.2.2 Canada Market Revenue, 2013 – 2023 (US$ Mn)
8.3.1 U.K. Market Revenue, 2013 – 2023 (US$ Mn)
8.3.2 Germany Market Revenue, 2013 – 2023 (US$ Mn)
8.3.3 Rest of Europe Market Revenue, 2013 – 2023 (US$ Mn)
8.4 Asia Pacific
8.4.1 Japan Market Revenue, 2013 – 2023 (US$ Mn)
8.4.2 China Market Revenue, 2013 – 2023 (US$ Mn)
8.4.3 Rest of Asia Pacific Market Revenue, 2013 – 2023 (US$ Mn)
8.5 Latin America
8.5.1 Brazil Market Revenue, 2013 – 2023 (US$ Mn)
8.5.2 Rest of Latin America Market Revenue, 2013 – 2023 (US$ Mn)
8.6 Middle East & Africa
8.6.1 GCC Countries Market Revenue, 2013 – 2023 (US$ Mn)
8.6.2 Rest of Middle East and Africa Market Revenue, 2013 – 2023 (US$ Mn)
Chapter 9 Recommendations
Chapter 10 Company Profiles
10.1 Alkermes plc
10.2 Cambrex Corporation
10.3 Dr. Reddy's Laboratories
10.4 Lonza Group
10.6 Sandoz International GmbH
10.7 Pfizer, Inc.
10.8 Sigma-Aldrich Co. LLC.
10.9 WuXi AppTec
Global high potency active pharmaceutical ingredient (HPAPI) market report provides comprehensive analysis considering various macro as well as micro economic factors. The report studies the HPAPI market from five perspectives: type of HPAPI, type of manufacturer, type of drug, therapeutic area, and geography.
The global high potency active pharmaceutical ingredient market report provides insights on contract versus captive HPAPI, synthetic versus biological HPAPI, and branded versus generic HPAPI. The global high potency active pharmaceutical ingredient market is also segmented into major therapeutic areas which include oncology, anti-diabetic, cardiovascular, central nervous system, musculoskeletal and others. From geography perspective, the market is studied for five main geographies: North America, Europe, Asia Pacific, Latin America and Middle East and Africa. North America HPAPI market is sub-segmented for the U.S., Canada, while Europe HPAPI market is further segmented for Germany, U.K., and Rest of Europe. Asia Pacific HPAPI market is segmented for Japan, China and Rest of Asia Pacific. Latin America market is segmented for Brazil and Rest of Latin America. Middle East and Africa HPAPI market segmented for GCC Countries and Rest of Middle East and Africa.
Market size for each of the aforementioned segments and sub-segments is provided in US$ Mn considering 2013 and 2014 as base years and forecast from 2015 to 2023. The forecast model considers various factors such as drug patent expiry, therapeutic indication, prevalence, generic competition, anticipated drug approvals, impact of regulatory policies, industry pricing strategies and others. The research methodology is a blend of primary as well as secondary market research, where market estimates based on desk research are further refined considering inputs from expert interviews.
The global high potency active pharmaceutical ingredient market report also provides qualitative information on HPAPI manufacturing capabilities of major players in the market. The report also includes details on current regulatory policies. Major factors driving and restraining the global HPAPI market are also discussed in the report, while lucrative opportunities from future perspective are also mentioned. Furthermore, the global high potency active pharmaceutical ingredient market report also provides event impact analysis, which maps key events impacting market growth including facility expansion, mergers and acquisitions, changes in regulatory policies, drug approval, drug patent expiry and generic or biosimilars drug approval. Value chain analysis is also provided for comprehensive analysis. Porter’s five forces analysis and market share analysis of high potency active pharmaceutical ingredient market provides detailed information on current competitive landscape of the global HPAPI market. Furthermore, market attractiveness analysis provides information on most attractive geographies for HPAPI manufacturing.
Finally, the report profiles major players in the global HPAPI market which include Alkermes plc, Cambrex Corporation, Dr. Reddy's Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC., WuXi AppTec. Each of the companies are profiled for parameters including: company overview, financial overview, product portfolio, business strategies and recent developments The report represents HPAPI market estimation and forecast in the form of 26 charts and figures, and 4 tables and comprises 85 slides.