Dublin, Dec. 07, 2018 (GLOBE NEWSWIRE) -- The "Active Pharmaceuticals Ingredients Market - Segmented by Business mode, Synthesis Type, Customer Base, Therapeutic Area, And Geography - Growth, Trends, and Forecast (2018 - 2023)" report has been added to ResearchAndMarkets.com's offering.

The active pharmaceutical ingredients market was valued at USD 160.3 million in 2017, is expected to register a CAGR of about 6.1% during the forecast period, 2018-2023.


A huge impact from pharmaceutical industry, increasing adoption of biological and biosimilars, and rising prevalence of cancer are the major factors fueling the growth of the active pharmaceutical ingredients market.


Increasing Adoption of Biologicals and Biosimilars Propels the Active Pharmaceutical Ingredients Market

Biosimilars, sometimes referred to as biogenerics, are highly similar versions of biologics - medicines that are made from living microorganisms found in plant or animal cells. Most biologics are very large and complex molecules, or mixtures of molecules, used to treat cancer, Alzheimer's disease, multiple sclerosis, HIV/AIDS, and other serious diseases.


Biosimilars may serve as lower-cost options, and may hold the potential to create a more sustainable healthcare system by making room for innovation, so that more patients continue to receive the best possible care. As per a report by Amgen on biosimilars, in 2015, the first biosimilar approved by the US FDA was Zarxio. Since then, there has been a dramatic increase in applications submitted to the FDA for review, and many more are expected in the near future.


The US healthcare community has firmly taken the first step into a new reality, which includes assessing the addition of biosimilars to the specialty drug portfolio.Other factors driving this market are huge impact from pharmaceutical industry, increasing adoption of biological and biosimilars, and rising prevalence of cancer.


Stringent Regulations Acts as a Major Barrier for the Active Pharmaceutical Ingredients Market

One of the major factors acting as an obstacle is the stringent regulatory framework across several regions. The quality of APIs has a significant effect on the efficacy and safety of medications. Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses and even death. Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the country they are shipped to.


For example, API manufacturing plants overseas still go through an inspection by the US Food & Drug Administration. Moreover, the differences in the regulatory requirements in each country have made this an extremely complex market in the recent times. With European Union, several other countries are adopting fierce regulatory requirements and enforcing API inspection system similar to the level of FDA. This is a step towards standardized regulatory framework globally.


These factors restrict the growth of companies in many regions and hinder the growth of this market.Other factors affecting this market are the drug price control policies across various countries, large capital investment, production cost, and the fierce competition between the API manufacturers.


Market Segmentation Insights

The global API market is segmented by the business mode, type of synthesis, by customer base, and by geography.


By business mode, it is further segmented into captive API and merchant API. The captive API segment of the market studied is defined as APIs used by pharmaceutical companies for in-house production of finished dosage forms. In 2017, this segment held 60% revenue share in the market.


By type of synthesis, it is further segmented into synthetic and biotech. Active pharmaceutical ingredients based on their sources can be divided into two major categories, including chemical synthetic drugs and natural chemical drugs.

By customer base, the market is further segmented into generic and branded. The generic API segment of the market studied holds the largest share and is expected to outpace the growth rates of branded APIs.

By application, it is further segmented into cardiology, pulmonology, oncology, ophthalmology, neurology, and orthopedics. The incidence and prevalence of cancer is increasing year on year, which implies the requirement for the research and development of new APIs in the oncology segment to meet the demands of growing incidence which drives the market in the forecast period.

Asia-Pacific is expected to have High Growth Opportunities in Active Pharmaceutical Ingredients Market

The Asia-Pacific is expected to register a high growth rate compared to other regions during the forecast period, owing to the factors such as increasing healthcare expenditures, growing aging population creating a huge patient pool, and rising economies in this region.


For example, China is considered as the leader in API manufacturing in the APAC region. There are many domestic companies involved in the manufacturing and supplying of API all over the world. Not just in the Asia-Pacific region, China exports the major share of its domestically produced API around the world.


The low price of the API has boosted the China API export market. Moreover, the Japanese Ministry of Health, Labor, and Welfare (MHLW) have taken measure to reduce the healthcare expenditure and decided to promote the use of generic drugs.


Market Developments

  • ACETO Corporation with Rising Pharmaceuticals launched Atenolol tablets, 25mg, 50mg, and 100mg for hypertension.
  • Novo Nordisk invested an additional USD 65 million into the plant established in Clayton, North Carolina for building a USD 2 billion API facility there.
  • Sterling Pharma Solutions expanded its presence in the Asia region with growth experienced in the Japanese API market.

Key Topics Covered

1. Introduction

2. Research Methodology

3. Executive Summary

4. Key Inferences

5. Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Product and Services
5.2.5 Degree of Competition

6. Drivers, Restraints, Opportunities and Challenges Analysis (DROC)
6.1 Market Drivers
6.1.1 Huge Impact from Pharmaceutical Industry
6.1.2 Increasing Adoption of Biologicals and Biosimilars
6.1.3 Rising Prevalence of Cancer
6.2 Market Restraints
6.2.1 Drug Price Control Policies Across Various Countries
6.2.2 Fierce Competition Between the API Manufacturers
6.2.3 Stringent Regulations
6.3 Opportunities
6.4 Key Challenges

7. Market Segmentation
7.1 By Business Mode
7.1.1 Captive Active Pharmaceutical Ingredients (API)
7.1.2 Merchant Active Pharmaceutical Ingredients (API)
7.2 By Type of Synthesis
7.2.1 Synthetic
7.2.2 Biotech
7.3 By Customer Base
7.3.1 Generic
7.3.2 Branded
7.4 By Application
7.4.1 Cardiology
7.4.2 Pulmonology
7.4.3 Oncology
7.4.4 Ophthalmology
7.4.5 Neurology
7.4.6 Orthopedics
7.5 By Geography
7.5.1 North America
7.5.1.1 United states
7.5.1.2 Canada
7.5.1.3 Mexico
7.5.2 Europe
7.5.2.1 France
7.5.2.2 United kingdom
7.5.2.3 Germany
7.5.2.4 Spain
7.5.2.5 Italy
7.5.2.6 Rest of Europe
7.5.3 Asia-Pacific
7.5.3.1 India
7.5.3.2 China
7.5.3.3 Japan
7.5.3.4 Australia
7.5.3.5 South Korea
7.5.3.6 Rest of Asia-Pacific
7.5.4 Middle East Africa
7.5.4.1 GCC
7.5.4.2 South Africa
7.5.4.3 Rest of Middle East & Africa
7.5.5 South America
7.5.5.1 Brazil
7.5.5.2 Argentina
7.5.5.3 Rest of South America

8. Competitive Landscape
8.1 Mergers & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches

9. Major Players
9.1 Albemarle Corporation
9.2 Aurobindo pharma
9.3 Boehringer Ingelheim GmbH
9.4 Dr. Reddy's Lab
9.5 Lupin
9.6 Mylan N.V
9.7 Novartis
9.8 Pfizer, Inc
9.9 Ranbaxy Laboratories
9.10 Teva Active Pharmaceutical Industries Limited

10. Future Market Outlook

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Related Topics: Drug Discovery