An Incisive, In-depth Analysis on the Specialty Active Pharmaceutical Ingredients Market
This study offers a comprehensive, 360 degree analysis on the Specialty Active Pharmaceutical Ingredients market, bringing to fore insights that can help stakeholders identify the opportunities as well as challenges. It tracks the global Specialty Active Pharmaceutical Ingredients market across key regions, and offers in-depth commentary and accurate quantitative insights. The study also includes incisive competitive landscape analysis, and provides key recommendations to market players on winning imperatives and successful strategies.
Specialty Active Pharmaceutical Ingredients (API) Market Outlook & Key Findings
- Specialty active pharmaceutical ingredients (API) market likely to grow at over 7.0 % in 2020, as increasing patent expiry of various branded drugs boosts generics sales in the US and Europe
- Technological advancement in order to increase production capacity in API manufacturing providing high market potential for specialty active pharmaceutical ingredients (API) in developed markets
- Low-cost offerings from local players are putting pressures on profit margin of big companies
- Outbreak of COVID19 pandemic has also led to decrease in the production capability of various specialty API manufacturers including pharmaceutical companies and Contract Manufacturing Organization (CMOs)
Development of New Purification Technologies Reducing the Production Cost-Factor
Advancement of analytical methods provides better quantification and characterization of the specialty APIs of interest that also reduce the time and production.
- For example, the introduction of new LC/MS methods in the last few years which use both - low levels of hexafluoroisopropanol (HFIP) and triethylamine (TEA) as a mobile-phase buffer, drive the purification processes and also reduce time and cost.
Besides, there has been significant development in proprietary chemical processes to scale up manufacturing capabilities that have greatly reduced the cost of producing specialty active pharmaceutical ingredients.
Expansion of Manufacturing Facilities Creating Lucrative Opportunities for Market Growth
Majority of specialty API companies are expanding their manufacturing facilities for specialty active pharmaceutical ingredients (API) to maintain or gain market share. Substantial investments in the expansion of approved specialty active pharmaceutical ingredients (API) is one of the major factors among key players in the specialty active pharmaceutical ingredients (API) market.
For instance, in early 2020, WuXi STA opened oligonucleotide API manufacturing facility in Changzhou, China to cope up with the increasing demand.
In 2018, Corden Pharma expanded operations with new commercial oligonucleotide active pharmaceutical ingredients (API) manufacturing capabilities at its FDA inspected Colorado facility.
Specialty Active Pharmaceutical Ingredients (API) Market is Highly Consolidated Among Key Players
The key market players of specialty active pharmaceutical ingredients (API) market are developing highly innovative approaches and business strategies in order to keep the market significantly consolidated.
The major players of the market are focusing on the development of new technologies, acquisition of small and medium-sized companies and exclusive product licensing to hold their strong position in the market. Besides, new product development, partnerships, distribution agreements are the other strategies followed by the leading market players to dominate themselves in the specialty active pharmaceutical ingredients (API) market.
For instance, in June 2016, Anacor Pharmaceuticals, Inc. a leading pharmaceutical company involved in developing small molecule therapeutics API was acquired by Pfizer Inc.
Small Molecules Segment Remains Key in Specialty Active Pharmaceutical Ingredients (API) Market
Increasing adoption of small molecules (non-biologics) owing to patent expiry and large number of generic drugs in development has resulted in affordable healthcare expenditure which is expected to drive the specialty active pharmaceutical ingredients (API) market.
Growing prevalence of chronic diseases such as cancer, diabetes, cardiovascular, and the infectious diseases is also providing potential opportunities to the market player for developing small molecule APIs in specialty active pharmaceutical ingredients (API) market.
Complex Manufacturing Process and Stringent Regulations: Key Challenges for Specialty Active Pharmaceutical Ingredients (API) Market Players
Developing specialty active pharmaceutical ingredients can be complex due to the requirement of multiple production stages and the existence of limited patents of branded pharmaceuticals.
In addition, the stringent government regulations on quality assessment of specialty APIs and increase in supply chain security issues in the emerging countries imposing large impact on the cost of specialty APIs hence expected to hamper the growth of specialty active pharmaceutical ingredients (API) market. As such, the new entrants willing to enter the specialty active pharmaceutical ingredients market are facing financial challenges.
Type II DMFs to Keep the Cash Registers Ringing
Specialty API Market is shifting from Type I DMFs (Drug Master Files) to Type II DMFs Type II DMF drug documents drug substances, substance materials and intermediates used in drug product’s penetration. Extensive DMF filings could be credited to growing investments by Asia-Pacific-based players. Also, SAHPRA, Brazilian Health Regulatory Agency, MHRA, TGA, and U.S. FDA are into approvals of DMFs; thereby driving the market altogether.
Specialty Active Pharmaceutical Ingredients (API): Region-wise Analysis
Europe, followed by North America, continues to be the most lucrative market for specialty active pharmaceutical ingredients (APIs) due to high adoption rate of innovative/patented medicines. The U. S. remains most lucrative country in global specialty active pharmaceutical ingredients (API) market and it has consistently shown significant annual growth rates, and the market is set to grow at over 5.5% in 2020.
Outside of Europe and North America, Japan, China, India and GCC Countries represent significant opportunities for specialty active pharmaceutical ingredients (API) market players. The high patient population and growing demand for affordable healthcare facilities are expected to provide huge opportunities for the manufacturers to expand their business in this region. These economies like India and China are at the forefront on the count of adopting generics. Latin America is encouraging incorporation of novel regional players; which is expected to have specialty APIs as placeholders herein.
Contract manufacturing is also picking up across all the geographies. North America and Oceania are already in the saturation mode. There is more occurrence of chronic diseases in South Asia, East Asia, and MEA. This is another factor expected to create a major overhaul here.
Leading Players in Specialty Active Pharmaceutical Ingredients (API) Market
The specialty active pharmaceutical ingredients (API) market is witnessing a gradual entry of new players at a local or regional level. An estimated 20+ specialty active pharmaceutical ingredients (API) market players are actively involved in research and developments, technological advancement, and e-commerce to hold a distinct market identity. Some of the key players in the specialty active pharmaceutical ingredients (API) market are,
Americas
- Inalco Pharmaceuticals
- Sussex Research Laboratories Inc.
- PolyPeptide Laboratories
- Nitto Denko Avecia Inc.
- Dalton Pharma Services
- Amneal Pharmaceuticals, Inc.
- Mylan NV
Europe
- Corden Pharma International GmbH
- Pepscan Holding NV
- Provence Technologies Group
- BCN Peptides S.A.
- Senn Chemicals AG.
- Santaris Pharma A/S
- Sanofi
- Pfizer Inc.
- Jazz Pharmaceuticals, Inc.
Asia Pacific
- ST Pharm. Co. Ltd
- Symbiotec Pharma Lab Pvt. Ltd.
- Cadila Healthcare Ltd.
- Lupin Ltd.
- Amneal Pharmaceuticals, Inc.
They do operate all across “Specialty” and “Generics”. The company is known for APIs’ captive manufacturing for their own set of finished products.
- Cadila Healthcare Ltd.
The company is known for having offered 38 intermediates and APIs across therapeutic categories.
- Jazz Pharmaceuticals Plc
The company’s unified business segment does pave the way for a broad spectrum of APIs to produce finished products.
- Lupin Ltd.
The company produces as well as commercializes finished pharmaceutical products and offers APIs for these products.
- Mylan NV
The business segments Mylan caters to includes Rx/Bx, Gx, and OTC. The products for which it offers APIs address therapeutic areas like proton pump inhibitors, anti-fungals, anti-diebetics, anti-virals, cardiovascular, anti-asthamatics/anti-histamines, central nervous system agents, anti-bacterials, and HIV/AIDs.
*The list is not exhaustive, and only for representational purposes. Full competitive intelligence with SWOT analysis available in the report
Specialty Active Pharmaceutical Ingredients (API): The Way Forward
The long-term outlook on specialty active pharmaceutical ingredients (API) market remains bullish, with FMI’s analysis estimating revenues to grow at over 7.0% consistently. The global increase in the patient pool having chronic ailments and rising infectious diseases around the world has created huge long-term demand of the small molecule active pharmaceutical ingredients (API) in the specialty active pharmaceutical ingredients (API) global market. Plus, growing demand for generic drugs is also expected to gain traction in the long-term market opportunities.
Specialty active pharmaceutical ingredients (API) manufacturers will need to focus on cost management and product sale and distribution to target wider geography. Portfolio strengthening and development of specialty active pharmaceutical ingredients (API) for wider application such in the pediatric and geriatric patient base are the key strategies needed to be focused by the leading industry players. In addition, to increase sales in lucrative markets, collaborations with local manufacturers is much needed.
A recent market study published by Future Market Insights (FMI) on the Specialty Active Pharmaceutical Ingredients (API) market offers global industry analysis for 2015-2019 & opportunity assessment for 2020-2030. The report consists of a comprehensive assessment of the most important market dynamics. On conducting thorough research on the historical as well as current growth parameters of the market, growth prospects of the market are obtained with maximum precision. The report features unique and salient factors that may make a huge impact on the development of the market during the forecast period. It can help market players modify their manufacturing and marketing strategies to envisage maximum growth in the market in the coming years. The report provides detailed information about the current and future growth prospects of the market in the most comprehensive way for better understanding of readers.
Key Segments of Specialty Active Pharmaceutical Ingredients (API) Market
FMI’s study on the market offers information divided into four important segments— product type, technology, consumption, and region. This report offers comprehensive data and information about the important market dynamics and growth parameters associated with these categories.
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Chapter 1 – Executive Summary
The report commences with the executive summary of the specialty active pharmaceutical ingredients (API) market report, which includes the snapshot of key findings and statistics. It also includes the market value (US$ million) estimates of the leading segments as along with the key trends impacting the market.
Chapter 2 – Market Overview
Readers can find detailed taxonomy and product definition of the specialty active pharmaceutical ingredients (API) market in this chapter, which help readers understand basic information about specialty active pharmaceutical ingredients (API).
Chapter 3 – Key Market Trends
This section highlights the key trends impacting the API market, which will help readers understand the current trends and their impact on market growth.
Chapter 5 – Global Specialty Active Pharmaceutical Ingredients (API) Market Value (US$) Analysis 2015-2019 and Forecast 2020-2030
This section explains the global market value analysis and forecast for the API market during the forecast period. Along with the historical market and opportunity analysis of the future. Readers can also find the absolute $ opportunity for the current year (2020), and an incremental $ opportunity for the forecast period (2020–2030).
Chapter 7 – Market Background
This chapter explains the macroeconomic factors that are expected to influence the growth of the specialty active pharmaceutical ingredients (API) market during the forecast period. It also highlights the major forecast factors that will shape market growth. This section also apprises about value chain analysis of the market. Besides, it gives key dynamics of the market, which include the drivers, restraints, and opportunity analysis.
The chapter is also expected to enable readers to understand the factors that are propelling the growth of the specialty active pharmaceutical ingredients (API) market, as well as those likely to hamper the growth of the market. The opportunity analysis for the specialty active pharmaceutical ingredients (API) will help readers understand the market opportunities, based on which they can plan their strategies.
In addition this section does provide the current and expected impact of COVID-19 on the market.
Chapter 8 – Global Specialty Active Pharmaceutical Ingredients (API) Market Analysis (2015-2019) & Opportunity Assessment (2020-2030), By Product Type
Based on product type, the market is segmented into small molecules, peptides, carbohydrate drugs, and steroidal drugs. In this chapter, readers can find detailed analysis of the market by different product type of specialty active pharmaceutical ingredients (API) and their growth over the forecast period.
Chapter 09 – Global Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 & Opportunity Assessment, 2020-2030, By Consumption
Based on consumption, the market spans in-house and out sourced. In this chapter, readers can find information on market attractive analysis based on consumption.
Chapter 11 – Global Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 & Opportunity Assessment 2020-2030, By Region
This chapter explains how the market will grow across various geographic regions such as North America, Latin America, Europe, East Asia, South Asia, Oceania, and the Middle East & Africa (MEA).
Chapter 12 – North America Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 & Opportunity Assessment 2020-2030
This chapter includes a detailed analysis of the growth of North America’s specialty active pharmaceutical ingredients (API) market along with the country-wise assessment including the U.S. and Canada. Readers can also find key takeaways of this region, and market growth based on product type, consumption, and country of Specialty Active Pharmaceutical Ingredients (API) in the North American region.
Chapter 13 – Latin America Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 & Opportunity Assessment 2020-2030
This chapter includes the growth prospects of the specialty active pharmaceutical ingredients (API) market in leading countries such as Brazil, Mexico, and the rest of Latin America. Readers can find thorough information about the growth parameters of the Latin America’s market during 2020-2030.
Chapter 14 –Europe Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 & Opportunity Assessment 2020-2030
Important growth prospects of the market based on product type, consumption, and country in several European countries such as the U.K., Germany, France, Italy, Spain, Russia, BENELUX, and Rest of Europe are included in this chapter.
Chapter 15 – East Asia Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 and Forecast 2020-2030
Detailed information about factors such as incremental opportunity, Y-O-Y growth, and regional trends that are impacting the growth of East Asia’s market are included in this chapter. It also includes the growth prospects of the specialty active pharmaceutical ingredients (API) market in leading East Asian countries such as China, Japan, and South Korea.
Chapter 16– South Asia Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 and Forecast 2020-2030
India, Indonesia, Malaysia, Thailand, and the rest of South Asia are the leading countries/regions in South Asia that are the prime subjects of assessment to obtain the growth prospects of South Asia’s market. In this chapter, readers can find thorough information about the growth parameters of the South Asia’s specialty active pharmaceutical ingredients (API) market by 2030.
Chapter 17 – Oceania Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2014–2018 and Forecast 2020–2030
This chapter consists of important parameters that have a huge impact on the growth of the market in Oceania, based on market segmentation, during the forecast period. It also provides an overview of the drivers, restraints, and trends in the Oceania’s specialty active pharmaceutical ingredients (API) market.
Chapter 18 – MEA Specialty Active Pharmaceutical Ingredients (API) Market Analysis 2015-2019 & Opportunity Assessment 2020-2030
This chapter provides information on how the market will grow in the major countries in MEA region, such as GCC Countries, South Africa, Northern Africa, Turkey and Rest of MEA during 2020-2030.
Chapter 19 – Market Structure Analysis
This chapter covers the market analysis of competitors based on revenue tiers, single point view of portfolio across industry segments, and their relative market position.
Chapter 20 – Competition Analysis
In this chapter, readers can find a comprehensive list of all the leading stakeholders in the specialty active pharmaceutical ingredients (API) market, along with detailed information about each company, including company overview, revenue shares, strategic overview, and recent company developments. Players featured in the market report include Corden Pharma International GmbH, Pepscan Holding NV, Provence Technologies Group, BCN Peptides S.A., Senn Chemicals AG., Santaris Pharma A/S, Sanofi and Pfizer Inc. among others.
Chapter 21– Assumptions and Acronyms Used
This chapter includes a list of acronyms and assumptions that provide a base to the information and statistics included in the report.
Chapter 22 – Research Methodology
This chapter helps readers understand the research methodology followed to obtain various conclusions, important qualitative information, and quantitative information about the specialty active pharmaceutical ingredients (API) market.
Sources and Primary Research Splits (%)
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