Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

IQ4I Research & Consultancy Published a New Report on 'Active Pharmaceutical Ingredients (API) Global Market - Forecast To 2025'


News provided by

IQ4I Research and Consultancy

02 May, 2019, 13:42 GMT

Share this article

Share toX

Share this article

Share toX

BOSTON, May 2, 2019 /PRNewswire/ -- Active pharmaceutical ingredient (API) is any substance or combination of substances used in a finished pharmaceutical product (FPP), with pharmacological activity and has direct effect in the cure, mitigation, treatment of the disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings. API manufacturing involves conversion of raw materials like fine chemicals and intermediates into active ingredient, which will be used for formulating drug product.

According to IQ4I analysis, Active pharmaceutical ingredients global market is expected to grow at a CAGR of 7.7% to reach $307.2 billion by 2025. Adoption of biologics in disease management and increasing regulatory approvals in the last few years, increasing scope of HPAPI market, patent expiration of major drugs, increasing trend of outsourcing and increase in geriatric population are some of the factors driving the market growth. Whereas contamination of API, fierce competition between API players, high cost for the manufacturing of APIs, requirement of highly skilled technicians, stringent regulatory policies and rising environmental concerns are the factors that are hindering API market growth.

The global API market is segmented based on synthesis, business type, therapeutic applications and geography. Depending on synthesis, the market is classified into synthetic API, biotech API and HPAPI (High Potent Active Pharmaceutical Ingredient). Synthetic API holds the maximum share in 2018 and expected to grow at a high single digit CAGR from 2018 to 2025. The major factors driving the synthetic chemical API market are patent expiration of synthetic drugs (small molecule drugs), increasing number of small molecules in clinical trials, increasing outsourcing by the pharmaceutical companies, CMOs investment to expand manufacturing facilities, rise in incidence of chronic and age-related diseases, rapid growth in oncology market, technological advancement like cryogenic and continuous flow manufacturing. Biotech API holds the second largest share in 2018 and expected to grow at a high single digit CAGR from 2018 to 2025. Biotech API is further segmented into monoclonal antibodies, recombinant proteins, vaccines and others. Monoclonal antibodies accounted for the largest share in 2018, growing at double digit CAGR from 2018 to 2025. Increased investment in R&D by pharmaceutical companies for developing biologic drugs, adoption of biological therapies in disease management, increasing outsourcing are few factors driving the biotech API market. HPAPI segment is expected to grow at a high single digit CAGR from 2018 to 2025. Rapid growth in oncology market, low toxicity and lower side effects, technological advancements in HPAPI, increasing outsourcing, increasing incidence of chronic and age related diseases are few factors driving the HPAPI market growth.

API market based on business type is segmented into captive and merchant. Captive market accounted for the largest revenue in 2018 and is expected to grow at a mid-single digit CAGR from 2018 to 2025. Merchant market is expected to grow at a high single digit CAGR from 2018 to 2025, due to increasing outsourcing, advanced manufacturing facilities, lack of in-house manufacturing capability, high capital investment and cost of API manufacturing.

Among applications, oncology market accounted for the largest share in 2018 and is expected to grow at a high single digit CAGR from 2018 to 2025. Infectious diseases segment is the second largest segment and expected to grow at a high single digit CAGR from 2018 to 2025. Patent expiration of major drugs, increased generic drug sales, high uptake of biologics, increase in chronic and infectious diseases are the factors driving API application market whereas stringent regulations are hindering the market growth.

According to IQ4I analysis, during 2017-2018 majority of the ANDA approvals received by generic API manufacturers were focused on therapeutic areas like infectious diseases, musculoskeletal disorder, cardiovascular disorders, endocrinology and oncology. Some of the high demand API based on ANDA approvals are Efavirenz (Atripla), Epinephrine (Epipen) for infectious diseases, Dexmedetomidine (Brecedex), Azelaic acid (Finacea) for musculoskeletal disorder, Dorzolamide (Cosopt), Buprenorphine (Suboxone) for cardiovascular disorders, Abiraterone (Zytiga), Arsenic trioxide (Trisenox ) for oncology. Similarly, our analysis of patent expiration data indicates that during 2019-2021 some of the key drugs going off patent are Pramlintide, Erlotinib, Rivastigmine, Ipratropium, Dexlansoprazole, Axitinib, Asenapine, Dasatinib, Nebivolol, Indinavir, Hydrocodone, Fluticasone furoate, Rivaroxaban and others, which creates opportunity for generic API manufacturers.

Geographically, API market is segmented into North America, Europe, Asia-Pacific and Rest of the world regions. North American region dominated the global API market and is expected to grow at a high single digit CAGR from 2018 to 2025. Patent expiration of the major drugs, rising demand for biotech APIs from government and private companies, market entry of biosimilars, increasing scope of high potent drugs and increase in the prevalence of chronic diseases such as cancer, musculoskeletal disorder, cardiac disease are some of the major factors that are driving the market growth. Asia pacific market is expected to grow at a double digit CAGR from 2018 to 2025. Low labor cost, abundance availability of raw materials, infrastructure facility, rise in generic drugs demand, increased production capabilities, the presence of large number of domestic and international players, and concentration of CMO companies are some of the factors that are driving the market growth.

In 2018, FDA approved 59 drugs, of that 42 were small molecules and 17 were biologics which accounts to about 28.8% of total approvals which has risen from 26.1% from the year 2017. Few biologic drugs approved in 2018 are Trogarzo, Ilumya, Crysvita, Aimovig, Poteligeo, Emgality, Libtayo and Takyzyro. Due to increased demand for biotech API manufacturers are expanding their manufacturing capacity in order to maintain their leadership. For instance, in April 2018, Lonza opened the world's largest dedicated cell and gene therapy manufacturing facility in Pearland, Greater Houston, TX (USA), with 300,000 square feet area. In the last few years, though there is an increase in the growth of biologics market, small molecules continue to dominate the global therapeutics market. Many small molecules are going off-patent, paving way for generics into the market through ANDA approval. In 2018, 23 new drugs received ANDA approval, creating a favorable opportunity for API manufacturers.

API manufacturers with advanced manufacturing technologies like continuous flow manufacturing, cryogenic process, high containment facility and capability to produce controlled substances, HPAPI and opioids will attract the pharmaceutical companies to outsource API manufacturing. For instance, in August 2018, Nemus Bioscience, Inc. signed an agreement with AMRI for the development and manufacturing of Nemus' proprietary cannabinoid-based active pharmaceutical ingredients (API) which is a controlled substance.

The global small molecules manufacturing installed capacity is estimated to be xx million Litres in 2018. Total small molecule utilization volume is xx million litres at x.x% capacity utilization rate and is expected to grow at a CAGR of x.x% from 2018 to 2025 to reach xx million litres volume by 2025, at x.x% capacity utilization rate. The global biologics manufacturing installed capacity is estimated to be xx million Litres in the year 2018 at x.x% capacity utilization and is expected to grow at a CAGR of x.x% from 2018 to 2025 to reach xx million litres volume by 2025, at x.x% capacity utilization rate. The global API production in 2018 was estimated to be xx Metric tons of which small molecules API production is xx Metric tons and biologics API production is xx Metric tons.

Even though, the Active pharmaceutical ingredients global market witnessed some of the strategic acquisition and mergers by API manufactures to expand their respective service portfolios, the market remained fragmented with the major players in the sector occupying mid-single digit market share and the remaining player's occupied major share in this market. Some of the contract API manufacturing organizations (CMOs) are transforming into Contract development and manufacturing organization (CDMO) by offering end to end services, ranging from development activities including clinical trials to commercial scale production and regulatory filings.

Major players in the API market include AMRI (U.S.), Aurobindo pharma (India), Boehringer Ingelheim GmbH (Germany), Cambrex Corporation (U.S.), Divis Laboratories (India), Olon S.p.A (Italy), Lonza group (Switzerland), Pfizer Inc. (U.S.), Sanofi SA (France), Seigfried Holdings AG (Switzerland), Thermo Fisher Scientific (Patheon N.V.) (U.S.) and Teva Pharmaceutical Industries Limited (Israel).

Reasons for buying this report:

  • Global Active Pharmaceutical Ingredient market is expected to grow at a CAGR of 7.7% from 2018 to 2025 to reach $307.2 billion by 2025.
  • Identification and analysis of the Global active pharmaceutical ingredient market by identifying various segments by synthesis (by customer base), by business type, application, and geography.
  • Revenue forecast of the Global active pharmaceutical ingredient market and strategic analysis of each sub-segment with respect to segmental growth trends.
  • Identification of major market trends, Porter's model, supply chain and factors driving, restraining, threatening and providing opportunities for the active pharmaceutical ingredient market growth.
  • API average selling price (ASP) by therapeutic application, overall market share, company capabilities, acquisitions, collaborations, expansions, ANDA approvals, patent expiry, API manufacturing units, and company matrix.
  • Global pharmaceutical API production and utilization volume of small molecule and biologics (In-house, contract manufacturing).
  • Global active pharmaceutical ingredients market share analysis of major players.
  • Revenue forecast of the active pharmaceutical ingredient market with respect to North America (U.S., Rest of North America), Europe (Italy, Germany, France, and Rest of Europe), Asia-pacific (China, Japan, India and Rest of Asia-Pacific) and Rest of the World (Brazil, Rest of Latin America, Middle East and Others).
  • Analysis of the opportunities for stakeholders by identifying the high-growth segments of the market.
  • Profiles of major players in active pharmaceutical ingredient manufacturing market and analysis of their financial revenue, business strategies, SWOTs and market shares.

Media contact:
Mr. Satish Birudukota
Email: bd@iq4i.com
satish.birudukota@iq4i.com
Phone: +91-8147030229

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.