Overview

Global Active Pharmaceutical Ingredient Market is estimated to value over USD 240.1 billion by 2026 end and register a CAGR of over 5.9% during the forecast period 2019 to 2026.

An abundance of capital is needed for the production of API, as the procedures require very systematic and precise protocols. As a result, there is no focus on physical manpower and setting up of costly manufacturing units. By adopting tactful and strategic outsourcing, the companies can emphasize more on their competencies, thereby, culminating in heightened productivity.

Active pharmaceutical ingredients (APIs) which have good quality, are crucial for the production of safe and effective medicines. However, it should be noted that not all pharmaceutical companies have adopted their own individual API manufacturing units. According to the market analysis, the rise of ailments such as cardiovascular and periodontal diseases, back pain, cancer and dental caries are factors which are expected to propel the active pharmaceutical ingredients market growth. The need for affordable medication and the rise in the volume of ANDA filings is projected to augment the market.

The acceptance of biologics and biosimilars and the rise in ailments such as cancer and chronic diseases, are factors which have been predicted to drive the market. However, aspects such as strict regulatory bodies and intense competition among other players, coupled with issues relating to price control regulations are all likely to pose potential threats to the market growth

Going by the product type, the market is divided into innovative and generic APIs. Innovative drugs segment is expected to rise owing to relaxed government rules and regulations. The segment for generic drugs is anticipated to grow in the future because of the affordability and patent expiry of branded drugs. This segment is predicted to expand in the developing nations owing to the untreated medical needs and rapid adoption of over-the-counter drugs.

With the type of manufacturer, the market is classified into merchant and captive APIs.

Captive API segment holds much strength in the market because of capitalist oriented focus with companies active in the production of availability of raw materials and top-of-the- line manufacturing facilities. With merchant API segment, it is forecasted to be a thriving segment precisely because of a growing need for biopharmaceuticals and exorbitant cost of in-house production of molecules. Moreover, because the captive production of APIs is costly, companies have begun to look to outsourcing to cut back on costs.

The biotech type is then categorized recombinant proteins, vaccines and antibodies. Synthetic segment has captured significant market share due to easy accessibility of raw materials, an abundance of revenue shares and relatively easy process of synthesis. Application-wise, the market is broken down into oncology, cardiology, endocrinology and neurology. The cardiology sub-segment has seen a spur in the market because of illnesses such as stroke and heart attack.

 

Some major global players in the APIs market include Sanofi (France), Teva Pharmaceutical Industries Ltd. (Israel), AbbVie Inc. (US), Pfizer, Inc. (US), Boehringer Ingelheim (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), GlaxoSmithKline plc (UK), Novartis AG (Switzerland), Merck & Co., Inc. (US), Bristol-Myers Squibb (US), AstraZeneca plc (UK), Eli Lilly and Company (US).

Active Pharmaceutical Ingredient Market Segmentation:

By Type   

• Innovative Active Pharmaceutical Ingredients
•  Generic Active Pharmaceutical Ingredients 

By Type of Manufacturer

• Captive API Manufacturers
• Merchant API Manufacturers

 By Type

~ Merchant Innovative API Manufacturers

~ Merchant Generic API Manufacturers                

           By Type of Synthesis

 ~ Merchant Synthetic API Manufacturers

~ Merchant Biotech API Manufacturers

By Type of Synthesis

• Synthetic Active Pharmaceutical Ingredients

- Innovative Synthetic APIS

- Generic Synthetic APIS        

• Biotech Active Pharmaceutical Ingredients

           By Type

~  Innovative Biotech APIS

~  Generic Biotech APIS  

           By Product

~  Monoclonal Antibodies

~  Hormones & Growth Factors

~  Cytokines

~  Fusion Proteins

~  Recombinant Vaccines

  Therapeutic Enzymes

  Blood Factors

By Expression System

~ Mammalian Expression Systems

~ Microbial Expression Systems

~ Yeast Expression Systems

~ Insect Expression Systems

~ Other Expression Systems

By Type of Drug

•   Prescription Drugs
•   Over-The-Counter Drugs

By Potency

•     Low-To-Moderate Potency Active Pharmaceutical Ingredients
•     Potent-To-Highly Potent Active Pharmaceutical Ingredients

By Therapeutic Application

•    Communicable Diseases
•    Oncology  
•    Pain Management
•    Cardiovascular Diseases
•    Diabetes
•    Respiratory Diseases
•    Other Therapeutic Applications

By Region                                                                            

• North America
• Europe
• Asia- Pacific
• World                                                                         

 

FutureWise Key Takeaways:

•     Growth prospects
•     SWOT analysis
•     Key trends
•     Key data-points affecting market growth

 

Objectives of the Study:

• To provide with an exhaustive analysis on the active pharmaceuticals market by type, by manufacturer, by type of synthesis, by product, by type of drug, by potency, by therapeutic application and by region
• To cater comprehensive information on factors impacting market growth (drivers, restraints, industry-specific restraints and opportunities)
• To forecast and evaluate micro-markets and the overall market 
• To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific, Latin America and the rest of the world 
• To record, evaluate and analyse competitive landscape mapping- technological advancements, product launches, expansions and mergers 

Table of Contents

1 Introduction 

1.1 Objectives of the Study 

1.2 Market Definition 

1.3 Market Scope 

        1.3.1 Markets Covered

        1.3.2 Years Considered for the Study

1.4 Currency 

1.5 Limitations 

1.6 Stakeholders 

 

2 Research Methodology 

2.1 Research Data 

        2.1.1 Secondary Sources

                 2.1.1.1 Key Data From Secondary Sources

        2.1.2 Primary Sources

                 2.1.2.1 Key Data From Primary Sources

                 2.1.2.2 Key Industry Insights

2.2 Market Size Estimation 

2.3 Market Breakdown and Data Triangulation 

2.4 Market Share Estimation 

2.5 Assumptions for the Study 

 

3 Executive Summary 

 

4 Premium Insights 

4.1 Active Pharmaceutical Ingredient Market: Overview 

4.2 Global Market, By Type 

4.3 Global Market, By Type of Manufacturer 

4.4 Global Market, By Type of Synthesis 

4.5 Active Pharmaceutical Ingredients Market, By Type of Drug 

4.6 Geographic Snapshot: Active Pharmaceutical Ingredient Market 

 

5 Market Overview 

5.1 Introduction 

5.2 Market Dynamics 

        5.2.1 Drivers

                 5.2.1.1 Increasing Incidence of Chronic Diseases

                 5.2.1.2 Technological Advancements in API Manufacturing

                 5.2.1.3 Growing Importance of Generics

                 5.2.1.4 Increasing Uptake of Biopharmaceuticals

                 5.2.1.5 Growing Adoption of Artificial Intelligence-Based Tools for Drug Discovery

                 5.2.1.6 Adoption of Organ-On-Chip Models in Drug Development

                 5.2.1.7 Growing Focus on Precision Medicine

                 5.2.1.8 Growing Investments in Real-World Evidence By Pharmaceutical Companies

        5.2.2 Restraints

                 5.2.2.1 Unfavorable Drug Price Control Policies Across Various Countries

                 5.2.2.2 Increasing Penetration of Counterfeit Drugs

        5.2.3 Opportunities

                 5.2.3.1 Emerging Biosimilars Market

                 5.2.3.2 Highly Potent Active Pharmaceutical Ingredients

                 5.2.3.3 Emerging Markets

                 5.2.3.4 Emerging Technologies

        5.2.4 Challenges

                 5.2.4.1 Product Differentiation - A Major Concern for API Manufacturers

                 5.2.4.2 High Manufacturing Costs

 

6 Active Pharmaceutical Ingredient Market, By Type 

6.1 Introduction 

6.2 Innovative Active Pharmaceutical Ingredients 

        6.2.1 Growing Number of New Molecular Entities Gaining Regulatory Approval to Drive Market Growth

6.3 Generic Active Pharmaceutical Ingredients 

        6.3.1 Government Initiatives Supporting the Adoption of Generic Drugs to Boost Market Growth

 

7 Active Pharmaceutical Ingredient Market, By Type of Manufacturer

7.1 Introduction 

7.2 Captive API Manufacturers 

        7.2.1 High Manufacturing Flexibility and Assurance of Product Quality have Driven Focus on Captive Manufacturing

7.3 Merchant API Manufacturers 

        7.3.1 Merchant API Manufacturers Market, By Type

                 7.3.1.1 Merchant Innovative API Manufacturers

                            7.3.1.1.1 Impending Patent Expiries and Increasing Costs of Innovative Drugs May Restrain Market Growth

                 7.3.1.2 Merchant Generic API Manufacturers

                            7.3.1.2.1 Low Manufacturing Cost of Generics Likely to Drive the Growth of This Segment

        7.3.2 Merchant API Manufacturers Market, By Type of Synthesis

                 7.3.2.1 Merchant Synthetic API Manufacturers

                            7.3.2.1.1 Need for Specialized Manufacturing Capabilities has Resulted in Expansion Among Market Players in This Segment

                 7.3.2.2 Merchant Biotech API Manufacturers

                            7.3.2.2.1 Complexity of Manufacturing Biotech APIS has Driven Focus on Partnerships Between Companies and Cmos

 

8 Active Pharmaceutical Ingredient Market, By Type of Synthesis 

8.1 Introduction 

8.2 Synthetic Active Pharmaceutical Ingredients 

        8.2.1 Synthetic Active Pharmaceutical Ingredients Market, By Type

                 8.2.1.1 Innovative Synthetic APIS

                            8.2.1.1.1 The High Value of Innovative APIS to Drive the Growth of This Segment

                 8.2.1.2 Generic Synthetic APIS

                            8.2.1.2.1 Initiatives to Promote the Penetration of Generics to Bring Down Healthcare Costs—A Major Growth Driver

8.3 Biotech Active Pharmaceutical Ingredients 

        8.3.1 Biotech Active Pharmaceutical Ingredients Market, By Type

                 8.3.1.1 Innovative Biotech APIS

                            8.3.1.1.1 Growing Demand for Innovative Biopharmaceuticals to Drive the Market for This Segment

                 8.3.1.2 Generic Biotech APIS

                            8.3.1.2.1 Increasing Demand for Biosimilar Drugs Due to Their Cost-Effectiveness to Drive the Growth of This Segment

        8.3.2 Biotech Active Pharmaceutical Ingredients Market, By Product

                 8.3.2.1 Monoclonal Antibodies

                            8.3.2.1.1 Growing Applications of Antibody-Drug Conjugates in the Treatment of Cancer to Drive the Growth of This Segment

                 8.3.2.2 Hormones & Growth Factors

                            8.3.2.2.1 The Growing Incidence of Hormonal Disorders to Drive the Market for This Segment

                 8.3.2.3 Cytokines

                            8.3.2.3.1 Interferons and Interleukins Boost the Immune System and have Important Applications in Cancer Treatment

                 8.3.2.4 Fusion Proteins

                            8.3.2.4.1 Growing Applications of Fc Fusion Proteins in Biopharmaceuticals to Drive the Growth of This Segment

                 8.3.2.5 Recombinant Vaccines

                            8.3.2.5.1 Growing Prevalence of Infectious Diseases has Boosted Vaccine Development—A Positive Indicator of Growth

                 8.3.2.6 Therapeutic Enzymes

                            8.3.2.6.1 Growing Significance of Enzymes in Therapies for Cancer and Pain Management to Drive the Growth of This Segment

                 8.3.2.7 Blood Factors

                            8.3.2.7.1 Growing Incidence of Hemophilia to Drive the Growth of This Segment

        8.3.3 Biotech Active Pharmaceutical Ingredients Market, By Expression System

                 8.3.3.1 Mammalian Expression Systems

                            8.3.3.1.1 Ability of These Systems to Carry Post-Translational Modification to Drive the Market for This Segment

                 8.3.3.2 Microbial Expression Systems

                            8.3.3.2.1 Ability of These Expression Systems to Provide High Expression Levels of Proteins to Drive the Market for This Segment

                 8.3.3.3 Yeast Expression Systems

                            8.3.3.3.1 Advantages Such as Efficient Protein Secretion, Simple Purification, and Endotoxin-Free Products to Boost Demand

                 8.3.3.4 Insect Expression Systems

                            8.3.3.4.1 Efficient Post-Translational Modifications Provided By These Systems to Boost Their Demand

                 8.3.3.5 Other Expression Systems

 

9 Active Pharmaceutical Ingredient Market, By Type of Drug 

9.1 Introduction 

9.2 Prescription Drugs 

        9.2.1 Growing Disease Prevalence is Expected to Drive the Prescription Drugs Market

9.3 Over-The-Counter Drugs 

        9.3.1 Sales of Otc Drugs have Risen Due to Innovations, Promotion of Self-Medication, and Increased Access

9.4 Active Pharmaceutical Ingredient Market, By Potency 

        9.4.1 Low-To-Moderate Potency Active Pharmaceutical Ingredients

        9.4.2 Potent-To-Highly Potent Active Pharmaceutical Ingredients

 

10 Active Pharmaceutical Ingredient Market, By Therapeutic Application 

  10.1 Introduction 

  10.2 Communicable Diseases 

          10.2.1 Global Health Impact of Communicable Diseases and Increasing Antimicrobial Resistance—Key Market Drivers

  10.3 Oncology 

          10.3.1 Increase in Global Spending on Cancer Medication to Boost the Market for This Segment

  10.4 Pain Management 

          10.4.1 Increasing Demand for Innovative and Advanced Pain Medications is A Major Growth Driver for This Market

  10.5 Cardiovascular Diseases 

          10.5.1 Growing Incidence of Cardiovascular Diseases Owing to Sedentary Lifestyles is A Major Growth Driver

  10.6 Diabetes 

          10.6.1 High Global Prevalence of Diabetes to Drive the Growth of This Segment

  10.7 Respiratory Diseases 

          10.7.1 High Global Prevalence of Respiratory Diseases to Drive the Growth of This Segment

  10.8 Other Therapeutic Applications 

 

11 Active Pharmaceutical Ingredient Market, By Region 

  11.1 Introduction 

  11.2 North America 

          11.2.1 US

                     11.2.1.1 Increasing Expenditure on Medicine is Expected to Drive the APIS Market in the US

          11.2.2 Canada

                     11.2.2.1 Support From Government Organizations is Driving the Growth of the APIS Market in Canada

  11.3 Europe 

          11.3.1 Germany

                     11.3.1.1 Germany to Dominate the Market in Europe

          11.3.2 France

                     11.3.2.1 Emergence of Pharmerging Markets in Asia May Hinder Market Growth in France

          11.3.3 UK

                     11.3.3.1 Growing Adoption of Generics Will Drive the Growth of the UK Market

          11.3.4 Italy

                     11.3.4.1 Italy’s Share in the Global Merchant APIS Market is Expected to Remain Stable Over the Forecast Period

          11.3.5 Spain

                     11.3.5.1 Spanish Market has Been Typically Dominated By Branded Drugs

          11.3.6 Rest of Europe

  11.4 Asia 

          11.4.1 Japan

                     11.4.1.1 Japanese Government Aims to Boost the Use of Generics By 2020

          11.4.2 China

                     11.4.2.1 Government Policies to Increase Medicine Access and Affordability Will Support Market Growth

          11.4.3 India

                     11.4.3.1 India is A Leading Producer of Generics

          11.4.4 South Korea

                     11.4.4.1 Government Initiatives to Introduce Full Medical Coverage for Major Chronic Diseases Likely to Drive This Market

          11.4.5 Rest of Asia

  11.5 Rest of the World 

 

12 Competitive Landscape

  12.1 Overview 

  12.2 Market Player Ranking 

  12.3 Competitive Leadership Mapping – Overall Market 

          12.3.1 Visionary Leaders

          12.3.2 Dynamic Differentiators

          12.3.3 Innovators

          12.3.4 Emerging Players

  12.4 Competitive Leadership Mapping – Start-Up/Sme 

          12.4.1 Progressive Companies

          12.4.2 Starting Blocks

          12.4.3 Responsive Companies

          12.4.4 Dynamic Companies

  12.5 Competitive Situation and Trends 

          12.5.1 Product Launches

          12.5.2 Expansions

          12.5.3 Acquisitions

          12.5.4 Other Strategies

 

13 Company Profiles 

  13.1 Pfizer, Inc. 

  13.2 Novartis AG 

  13.3 Sanofi 

  13.4 Boehringer Ingelheim 

  13.5 Bristol-Myers Squibb 

  13.6 Teva Pharmaceutical Industries Ltd. 

  13.7 ELI Lilly and Company 

  13.8 Glaxosmithkline PLC 

  13.9 Merck & Co., Inc. 

  13.10 Abbvie Inc. 

  13.11 F. Hoffmann-La Roche 

  13.12 Astrazeneca

 

Chapter 14 Research Finding and Conclusion 

 

Chapter 15  Research Methodology 

 

Chapter 16  Research Data Source 

Tables

Figures