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Published Date: 2016-03-23Number of Pages: 115

Active Pharmaceutical Ingredient Market: (Manufacturing Process- Captive Manufacturing, Contract Manufacturing; API Type - Synthetic Chemical API, and Biological API; Drug Type - Branded Prescription Drugs, Generic Prescription Drugs and OTC Prescription Drugs; Therapeutic Area- Cardiovascular Disorders, Metabolic Disorder, Neurological Disorders, Oncology, Musculoskeletal Disorders, NSAIDs, and Other Therapeutics Uses) Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023

Active pharmaceutical ingredients (APIs) are bulk drug products that are used as raw materials for formulations. APIs of good quality are essential for the manufacture of effective and safe medicines. However, not all pharmaceutical companies possess in-house API manufacturing capabilities. Furthermore, a single company cannot produce all the APIs required for their formulation offerings.

The global active pharmaceutical ingredients market has been broadly segmented on the basis of manufacturing process, type of active pharmaceutical ingredient, types of drugs, therapeutic areas and geography. This report analyzes the current scenario as well as future market potential for active pharmaceutical ingredients market globally. This report comprises an elaborate executive summary, demonstrating a snapshot on market dynamics of various segments and sub-segments in a precise manner. Moreover, executive summary also comprises a waterfall chart, which reflects the market size of various segments in descending order.

The report provides detailed qualitative analysis of the market dynamics that affect the growth of the global active pharmaceutical ingredients market. Factors responsible for driving and restraining the growth of the global active pharmaceutical ingredients market and future opportunities has been provided in the market overview section. This section of the report also provides comprehensive market comparative analysis and market attractiveness analysis for the global active pharmaceutical ingredients market by geography for the base year, Porter’s Five Forces analysis, and market share analysis by key players (%) for the base year, operating in the active pharmaceutical ingredients market. The report also encompasses detailed event impact analysis and value chain analysis for the global active pharmaceutical ingredients market.

The global active pharmaceutical ingredient market is categorized in to captive manufacturing and contract manufacturing. Types of active pharmaceutical ingredients described in the global active pharmaceutical ingredient market include synthetic chemical API and biological API. Branded prescription drugs, generic prescription drugs, and over-the-counter drugs are various types of drugs covered in the global active pharmaceutical ingredients market. The global active pharmaceutical ingredients market encompasses various therapeutic areas such as cardiovascular disorders, oncology, metabolic disorders, neurological disorders, musculoskeletal disorders, NSAIDs and other therapeutic uses (such as infectious diseases). The market for these types has been extensively analyzed based on consistency, effectiveness, and sales revenue of the various products developed by the manufacturers.

Geographies discussed and analyzed in the global active pharmaceutical ingredients market include North America, Europe, Asia Pacific, and Rest of the World. In addition the report also comprises the precise and detailed country wise analysis for the global active pharmaceutical ingredients market such as North America (U.S. and Canada), Asia Pacific (China, Japan, India and Rest of Asia Pacific), and Europe (Germany, U.K. and Rest of Europe). The market size and forecast in terms of US$ Mn for each segment has been provided for the period from 2013 to 2023. The report on the active pharmaceutical ingredients market also provides compound annual growth rate (CAGR %) for each of the market segments mentioned above for the forecast period from 2015 to 2023, considering 2014 as the base year.

A list of recommendations have been provided for new entrants to help establish a strong presence and for existing market players to take strategic decisions and to increase their market shares in the global active pharmaceutical ingredient market. The report concludes with the profiles of major players in the active pharmaceutical ingredients market based on various attributes such as company overview, financial overview, business strategies, product portfolio, and recent developments. Major players profiled in this report include Allergan plc, BASF SE, Boehringer Ingelheim Group, Cambrex Corporation, Dr. Reddy’s Laboratories Ltd., Lonza Group, Mylan, Inc., Sandoz (Novartis AG), Pfizer, Inc., Teva Pharmaceutical Industries Ltd., and WuXi Apptec.

The global active pharmaceutical ingredients market is segmented as follows:

Global Active Pharmaceutical Ingredients Market, by Manufacturing Process, 2013-2023 (US$ Mn)

  • Captive Manufacturing
  • Contract Manufacturing

Global Active Pharmaceutical Ingredients Market, by API Type, 2013 – 2023 (US$ Mn)

  • Synthetic Chemical API
  • Biological API

Global Active Pharmaceutical Ingredients Market, by Drug Type, 2013 – 2023 (US$ Mn)

  • Branded Prescription Drugs
  • Generic Prescription Drugs
  • OTC Prescription Drugs

Global Active Pharmaceutical Ingredients Market, by Therapeutic Area, 2013 – 2023 (US$ Mn)

  • Cardiovascular Disorders
  • Metabolic Disorders
  • Neurological Disorders
  • Oncology
  • Musculoskeletal Disorders
  • NSAIDs
  • Other Therapeutics Uses

Global Active Pharmaceutical Ingredients Market, by Geography, 2013 – 2023 (US$ Mn)

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Rest of Asia Pacific
  • Rest of the World (RoW)


Chapter 1 Preface 

Chapter 2 Executive Summary 
2.1 Introduction 
2.2 Global Active Pharmaceutical Ingredients Market: Market Snapshot 
2.3 Comparative Analysis: Global Active Pharmaceutical Ingredients Market, by Geography (2015 & 2023) 
2.4 Waterfall Diagram: Global API Market Revenue, by Therapeutic Area, 2015 (US$ Mn) 

Chapter 3 Market Overview 
3.1 Introduction 
3.2 Market Dynamics 
      3.2.1 Drivers 
              3.2.1.1 Increase in healthcare expenditure to drive market growth
              3.2.1.2 Rapidly aging of global population expected to aid growth of the API market 
              3.2.1.3 Increase in Abbreviated New Drug Applications (ANDA) in the recent past to boost the demand for APIs 
      3.2.2 Restraint 
              3.2.2.1 Adverse regulatory policies to be an important restraining factor 
      3.2.3 Opportunity 
              3.2.3.1 Patent Expiry of Major Biological Drugs in the U.S. and EU 
              3.2.3.2 Growth of the healthcare market in Asia-Pacific and rest of the world (RoW) segments 
3.3 Event Impact Analysis 
3.4 Value Chain Analysis
3.5 Porter’s Five Forces Analysis 
3.6 Market Attractiveness Analysis: Global Active Pharmaceutical Ingredients Market, by Geography, 2015 
3.7 Competitive Landscape: Global Active Pharmaceutical Ingredients Market, by Key Players, 2015 (USD Million) 

Chapter 4 By Manufacturing Process 
4.1 Introduction 
4.2 Captive Manufacturing Market Revenue, 2013-2023 (US$ Mn)
4.3 Contract Manufacturing Market Revenue, 2013-2023 (US$ Mn)

Chapter 5 By API Type
5.1 Introduction 
5.2 Synthetic Chemical Market Revenue, 2013-2023 (US$ Mn)
5.3 API Biological API Market Revenue, 2013-2023 (US$ Mn)

Chapter 6 By Drug Type 
6.1 Introduction 
6.2 API Market Revenue for Branded Prescription Drugs, 2013-2023 (US$ Mn)
6.3 API Market Revenue for Generic Prescription Drugs, 2013-2023 (US$ Mn)
6.4 API Market Revenue for OTC Prescription Drugs, 2013-2023 (US$ Mn)

Chapter 7 By Therapeutic Area
7.1 Introduction 
7.2 API Market Revenue for Cardiovascular Disorders Drug, 2013-2023 (US$ Mn)
7.3 API Market for Drugs for Metabolic Disorders, 2013-2023 (US$ Mn)
7.4 API Market for Drugs for Neurological Disorders, 2013-2023 (US$ Mn)
7.5 API Market for Drugs for Oncology, 2013-2023 (US$ Mn)
7.6 API Market for Drugs for Musculoskeletal Disorders, 2013-2023 (US$ Mn) 
7.7 API Market for NSAIDs, 2013-2023 (US$ Mn) 
7.8 API Market for Drugs for Other Therapeutics Uses, 2013-2023 (US$ Mn) 

Chapter 8 By Region  
8.1 Introduction 
8.2 North America API Market Revenue, by Country, 2013-2023 (US$ Mn)
      8.2.1 U.S. API Market Revenue,, 2013–2023, (US$ Mn)
      8.2.2 Canada API Market Revenue, 2013–2023, (US$ Mn)
8.3 Asia-Pacific Market Revenue, by Country, 2013-2023 (US$ Mn)
      8.3.1 China API Market Revenue,, 2013–2023, (US$ Mn)
      8.3.2 Japan API Market Revenue,, 2013–2023, (US$ Mn)
      8.3.3 India API Market Revenue,, 2013–2023, (US$ Mn)
      8.3.4 Rest of Asia-Pacific API Market Revenue,, 2013–2023, (US$ Mn)
8.4 Europe 
      8.4.1 Germany API Market Revenue,, 2013–2023, (US$ Mn)
      8.4.2 U.K. API Market Revenue,, 2013–2023, (US$ Mn)
      8.4.3 Rest of Europe API Market Revenue,, 2013–2023, (US$ Mn)
8.5 Rest of the World 

Chapter 9 Recommendations 
9.1 Enhance manufacturing capacity through acquisitions in targeted geographies 
9.2 Achieve cost leadership in specific API molecules 

Chapter 10 Company Profiles 
10.1 Allergan plc 
10.2 BASF SE
10.3 Boehringer Ingelheim GmbH 
10.4 Cambrex Corporation 
10.5 Dr. Reddy's Laboratories 
10.6 Lonza Group 
10.7 Mylan N.V. 
10.8 Pfizer, Inc. 
10.9 Sandoz (Novartis AG) 
10.10 Teva Pharmaceutical Industries Ltd.
10.11 WuXi AppTec

Active Pharmaceutical Ingredient (API) refers to a substance or substance combination used in manufacturing a drug product. The active pharmaceutical ingredient market has been categorized by manufacturing process, API type, drug type, therapeutic area and geography. Manufacturing processes in the global API market include captive and contract manufacturing. The captive API manufacturing segment comprises the active pharmaceutical ingredients produced for internal consumption of a pharmaceutical company. Captive manufacturing accounted for the highest market share in 2014, however the share of this market segment is expected to witness a decline due high degree of competition from contract manufacturing and reduced profitability and thus increased preference for outsourcing API production over captive production. Outsourcing production helps pharmaceutical companies focus on their core business of developing new drug products. Contract manufacturing is being preferred because of its advantage in terms of capital and labor costs, access to advanced manufacturing technologies, and benefits from the global distribution network. 

The global active pharmaceutical market is segmented into API types: synthetic chemical API and biological API. The synthetic chemical API segment held the largest share of more than 70% of active pharmaceutical market in 2014. This market segment has evolved in the past few years due to innovations in the methods of synthesizing chemical APIs, which improves their stability and potency. The large volume of the demand is an important reason for the larger share of synthetic chemical API segment. On the other hand, the biological API market segment is expected to have the highest growth rate of 8.1% during the forecast period of 2015-2023. Large pharmaceutical companies are scaling down their small molecule manufacturing facilities to focus on biologic drugs, thereby presenting greater opportunities for contract manufacturing companies. The overall cost of drug development program for biologics is less as compared to chemical APIs, primarily because of high success rates in the pipeline phase. This factor has attracted higher investments in the biologics and biosimilars market.

Drug types in the global API market include branded prescription drug, generic prescription drug and OTC drugs. The branded API segment accounted for the largest share of 76% in the global API market in 2014. The factors driving the branded prescription drugs include government initiatives that has lowered the copayment on generics while raising it on the branded drugs. The increasing demand for biological drugs and supportive policies of the European Union toward biosimilars is also one of the major driving factors to boost branded API market. Moreover, the generic prescription drugs segment is expected to grow at the highest rate of 7.3% during the forecast period. With the rising cost of healthcare, governments and payers are pushing for the increasing generics consumption over branded drugs, thus driving growth of the generic APIs market. Over-the-counter (drugs) are considered sufficiently safe and effective for use without prescriptions from health care professionals and hence would continue to grow at a steady rate during the forecast period. 

Based on the therapeutic area, the global API market is segmented into various disorders such as cardiovascular, metabolic, disorders, oncology, musculoskeletal, non-steroidal anti-inflammatory drugs (NSAIDs), and others. The cardiovascular disorder segment held the largest share of global active pharmaceutical ingredient market during the forecast period. Cardiovascular, metabolic, and neurological disorders held a combined market share of over 50% in 2014 due to the rising geriatric population, increasing prevalence of cardiovascular diseases, diabetes and neurological disease globally. Whereas, the oncology segment is expected to grow at the highest rate of 8.2% during the forecast period owing to the rising prevalence of cancer. The significant growth observed in oncology API has helped companies to prefer specialized manufacturing plants for oncology drugs. The musculoskeletal disorders, NSAIDs and other therapeutics area is anticipated to grow at a steady rate during the forecast period of 2015 to 2023.

Geographically, North America dominated the active pharmaceutical ingredient market in 2014 with a share of 35.1% owing to factors such as higher consumption of API due to the presence of major pharmaceutical companies in this region. Biologics have become one of the top-selling drugs in North America. Thus, the expected market entry of biosimilars with flexible regulatory process would further boost the API market in North America. Japan, China, India and South Korea, the leading pharmaceutical hubs in Asia are majorly responsible for almost 30% of the total market share placing the region at the second position in the world. Major factors driving the API markets in China and India are the availability of low cost production facilities and labor cost. Other factors driving the market in the region include the tax incentives, rising government expenditure on health care and government plans to restructure the fragmented industry. Europe accounted for a market share of 21.6% in 2014. The governments of various countries in Europe have started supporting the manufacture of generic drugs post the financial crisis. Patent expirations of major blockbuster drugs in Europe would fuel the growth of the API market in the near future. Demand for generic drugs is increasing not only in developed countries, but also in developing and underdeveloped countries in South America and Africa. Brazil and South Africa are the important centers of pharmaceutical manufacturing in this regional segment. Factors boosting the growth of the market in developing regions are cost-efficient manufacturing, large number of patients, rising demand for generic drugs, and improvement in the healthcare infrastructure.

Teva Pharmaceutical Industries Ltd dominated active pharmaceutical ingredients market in 2014. Major factors attributed to its dominance are broad product portfolio and high market penetration. Zhejiang Medicine Co., Ltd. and Zhejiang NHU Co., Ltd secured the second market position in 2015. North China Pharmaceutical Group Corp. (NCPC) and Northeast Pharmaceutical Group Co., Ltd. held the third position in 2015. Other players in the active pharmaceutical ingredients market include Dr.Reddy's Laboratories Limited, Sandoz (Novartis AG), Aurobindo Pharma Limited, Zhejiang Hisun Pharmaceutical Co., Ltd. and Zhejiang Huahai Pharmaceuticals Co., Ltd. and others.

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