Specialty Active Pharmaceutical Ingredients Market

2020 Analysis and Review: Specialty Active Pharmaceutical Ingredients by Product - Small Molecules API, Peptides API, Carbohydrate Drugs API, Steroidal Drugs API for 2020-2030

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,


  • Inalco Pharmaceuticals
  • Sussex Research Laboratories Inc.
  • PolyPeptide Laboratories
  • Nitto Denko Avecia Inc.
  • Dalton Pharma Services
  • Amneal Pharmaceuticals, Inc.
  • Mylan NV


  • 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.

Key Segments of Specialty Active Pharmaceutical Ingredients (API) Market

Product Type

  • Small Molecules API
    • Controlled Substances API
    • HPAPI
  • Peptides API
  • Carbohydrate Drugs API
  • Steroidal Drugs API


  • In-house
  • Outsourced


  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • Middle East and Africa

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Specialty Active Pharmaceutical Ingredients Market