世界の商用医薬品原薬(API)市場:2027年までの予測

出版:Daedal Research (デダルリサーチ) 出版年月:2023年1月

世界の商用医薬品原薬(API)市場:分子タイプ、セグメント、タイプ、合成のタイプ、エンドユーザー、地域規模別分析 – 2027年までの予測
Global Merchant API Market: Analysis By Molecular Type, By Segment, By Type, By Type of Synthesis, By End-User, By Region Size And Trends With Impact Of COVID-19 And Forecast up to 2027

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The global merchant API market was valued at US$79.50 billion in 2021. The market value is expected to reach US$119.11 billion by 2027. The merchant API (or contract manufacturing) sits within the wider Pharma value chain and encompasses all activities related to the development and manufacture of active pharmaceutical ingredients (API) both for products clinical trials and commercial products.

There has been an increase in the willingness of, especially smaller pharma and biotech companies to collaborate with specialized entities due to the expertise and equipment required to manufacture the compounds. Additionally, pharma companies are increasingly focusing on core capabilities like R&D and marketing, leaving the manufacturing side of the process to specialized entities. Thus, merchant API market growth has increased due to increased pharma outsourcing to improve margins and potentially shorten time-to-market. The market is expected to grow at a CAGR of approx. 7% during the forecasted period of 2022-2027.

Market Segmentation Analysis:

By Molecular Type: The report provides the bifurcation of the market into two segments based on molecular type: Small Molecules and Large Molecules. In 2021, Small molecules held the major share of the market owing to the market’s expanding need for small-molecule medications and the rising outsourcing trend. The large molecules segment is expected to be the fastest growing segment in the forecasted period owing to strong pipeline growth across all modalities, increasing complexity of therapies and vaccines, and maturing biotech projects entering the late stage of development & commercial launches.

By Segment: The report further provided the bifurcation based on the segment: CDMO and API Solutions. CDMO held the highest share in the market and is expected to be the fastest-growing segment in the forecasted period.

CDMO market has been further bifurcated based on molecular type: Small Molecule and Large Molecule. Small molecules held the highest share in the market, whereas the large molecule segment is expected to be the fastest-growing segment in the coming years. CDMO has also been analyzed based on end-user: Peptides, Oligos, and Others. As peptides have low stability in the stomach, the volume of API required for oral administration is 50-200x higher than the volume required for injectable forms. The conversion to oral should therefore further support the peptide market growth.

By Type: The report provides an analysis of the market based on type: Innovative API and Generic API. Generic API is expected to be the fastest growing segment in the coming years fueled by factors such as rising biopharmaceutical therapeutic demand and increasing patent expirations of drugs, and generic production capacities.

By Type of Synthesis: The report also provides a glimpse of merchant API market based on type of synthesis: Synthetic and Biotech. The synthetic molecules are cost-efficient, time-saving, and effective in the treatment of a wide range of diseases, and the specialized expertise offered by CDMOs are factors likely to propel the segment growth during the forecast period.

By Region: The report provides insight into the merchant API market based on the regions namely North America, Asia Pacific, Europe, and the Rest of the World. North America held the major share of the market. With increased competition, pricing pressures, and regulatory changes, drug manufacturers are resorting to outsourcing raw material procurement and manufacturing activities, thus the merchant API market has been growing in North America.

Due to the higher costs associated with the production of APIs in western countries, India and China have become the two most preferred regions for contract manufacturing outsourcing. The major factors responsible for the growth of this market in the region are the easy availability of required skilled labor at an effective cost, favorable government policies, tax benefits, and better trade relationships. APIs are an increasingly important sector in India, and a series of initiatives, including establishing/reviving clusters, offering production-linked schemes, as well as other measures, have been implemented to improve the country’s API production and to make it more competitive globally for pharmaceutical API manufacturers.

Market Dynamics:

Growth Drivers: The global merchant API market growth is predicted to be supported by numerous growth drivers such as increasing incidence of chronic and lifestyle diseases, aging population, increasing healthcare expenditure, increasing research and development spending, growing pharmaceutical industry, growing pharma outsourcing trend, and many other factors. Contract manufacturing offers many benefits to the associates as it provides them with a supply of drug products from clinical production to commercial manufacturing under Good manufacturing practices (GMP) manufacturing operations. Other than this, companies get the time and financial relief to work on selling and marketing products instead of only focusing on the drug manufacturing process. Thus, owing to these factors, the trend of outsourcing has increased which has positively influenced the merchant API market growth.

Challenges: However, the market growth would be negatively impacted by various challenges such as strict laws and regulations, lack of transparency and loss of control, etc.

Trends: The market is projected to grow at a fast pace during the forecast period, due to various latest trends such as growing use of artificial intelligence, new drug approvals, increasing patent expiry, etc. New and innovative drugs expand treatment options, for instance, for previously unmet needs or new population targets (e.g. children), increasing the number of drugs consumed. The need for APIs grows as more drugs are approved, thus companies outsource the manufacturing of the APIs to manufacture the drugs more economically. Thus, the demand for merchant APIs is anticipated to rise in the upcoming years as a result of the rise in novel medicine approvals.

Impact Analysis of COVID-19 and Way Forward:

In 2020, the global merchant API have experienced slower growth. Lower pharmaceutical volume demand has been seen in several areas, with lower rates of doctor visits and new diagnoses. However, many other contract manufacturing organizations saw some significantly increased demand related to new COVID vaccines and therapeutics projects. A significant spike in demand for novel drugs has led to the higher manufacturing, export, and import of APIs thus, leading to an average price hike in API products and intermediates. Moreover, favorable policies and initiatives taken by various governments are expected to smoothen the production of APIs in the long run, and this would support the merchant API market growth in the post-COVID era.

Competitive Landscape:

The global merchant API market is highly fragmented. The key players in the global merchant API market are:

Pfizer Inc. (Pfizer CenterOne)
Bachem Holding AG
Thermo Fisher Scientific Inc.
Teva Pharmaceutical Industries Ltd. (Teva API)
Sanofi (EuroAPI)
Siegfried Holding AG
Lonza Group AG
PolyPeptide Group AG
Divi’s Laboratories Limited
Centrient Pharmaceuticals
Cambrex
Fabbrica Italiana Sintetici

To keep ahead of the competition, companies in the market undergo regular R&D operations. In order to stay ahead of the competition, companies operating on the global market are also anticipated to turn to aggressive expansion methods including mergers, acquisitions, and strategic alliances. For instance, in 2022, Bachem Group announced the signing of a further work order for the delivery of large volumes of peptides over a five-year period from 2025-2029. On the other hand, Sanofi and Innovent Biologics announced a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Also, Siegfried announced that the company had decided to extend the collaboration with Novavax, a US-based biopharmaceutical company, for the aseptic fill & finish of Novavax’s protein-based coronavirus vaccine Nuvaxovid.

In 2021, Lonza held a share of 2.58% of the global merchant API market, whereas in CDMO market, Lonza had a market share of 4.6%.


目次

1. Executive Summary

2. Introduction

2.1 Active Pharmaceutical Ingredients (API): An Overview
2.1.1 Introduction to CDMOs and API
2.1.2 Pharma Value Chain

2.2 Merchant API: An Overview
2.2.1 Introduction to Merchant API
2.2.2 Advantages and Disadvantages of Merchant API

2.3 Merchant API Segmentation: An Analysis
2.3.1 Merchant API Segmentation

3. Global Market Analysis

3.1 Global Merchant API Market: An Analysis

3.1.1 Global Merchant API Market: An Overview
3.1.2 Global Merchant API Market by Value
3.1.3 Global Merchant API Market by Molecular Type (Small Molecules and Large Molecules)
3.1.4 Global Merchant API Market by Segment (CDMO and API Solutions)
3.1.5 Global Merchant API Market by Type (nnovative API and Generic API)
3.1.6 Global Merchant API Market by Type of Synthesis (Synthetic and Biotech)
3.1.7 Global Merchant API Market by Region (North America, Asia Pacific, Europe, and Rest of the World)

3.2 Global Merchant API Market: Molecular Type Analysis

3.2.1 Global Merchant API Market by Molecular Type: An Overview
3.2.2 Global Small Molecules Merchant API Market by Value
3.2.3 Global Large Molecules Merchant API Market by Value

3.3 Global Merchant API Market: Segment Analysis

3.3.1 Global Merchant API Market by Segment: An Overview
3.3.2 Global Merchant API CDMO Market by Value
3.3.3 Global Merchant API CDMO Market by Molecular Type (Small Molecules and Large Molecules)
3.3.4 Global Merchant API CDMO Molecular Type Market by Value
3.3.5 Global Merchant API CDMO Market by End-User (Peptides, Oligos, and Others)
3.3.6 Global Merchant API CDMO End-User Market by Value
3.3.7 Global Merchant API Solutions Market by Value

3.4 Global Merchant API Market: Type Analysis

3.4.1 Global Merchant API Market by Type: An Overview
3.4.2 Global Innovative Merchant API Market by Value
3.4.3 Global Generic Merchant API Market by Value

3.5 Global Merchant API Market: Type of Synthesis Analysis

3.5.1 Global Merchant API Market by Type of Synthesis: An Overview
3.5.2 Global Synthetic Merchant API Market by Value
3.5.3 Global Biotech Merchant API Market by Value

4. Regional Market Analysis

4.1 North America Merchant API Market: An Analysis

4.1.1 North America Merchant API Market: An Overview
4.1.2 North America Merchant API Market by Value
4.1.3 North America Merchant API Market by Region (The US, Canada, and Mexico)
4.1.4 The US Merchant API Market by Value
4.1.5 Canada Merchant API Market by Value
4.1.6 Mexico Merchant API Market by Value

4.2 Asia Pacific Merchant API Market: An Analysis

4.2.1 Asia Pacific Merchant API Market: An Overview
4.2.2 Asia Pacific Merchant API Market by Value
4.2.3 Asia Pacific Merchant API Market by Region (China, India, and Rest of the Asia Pacific)
4.2.4 China Merchant API Market by Value
4.2.5 India Merchant API Market by Value
4.2.6 Rest of Asia Pacific Merchant API Market by Value

4.3 Europe Merchant API Market: An Analysis

4.3.1 Europe Merchant API Market: An Overview
4.3.2 Europe Merchant API Market by Value
4.3.3 Europe Merchant API Market by Region (Germany, The UK, France, Italy, Spain, and Rest of the Europe)
4.3.4 Germany Merchant API Market by Value
4.3.5 The UK Merchant API Market by Value
4.3.6 France Merchant API Market by Value
4.3.7 Italy Merchant API Market by Value
4.3.8 Spain Merchant API Market by Value
4.3.9 Rest of Europe Merchant API Market by Value

4.4 Rest of World Merchant API Market: An Analysis

4.4.1 Rest of World Merchant API Market: An Overview
4.4.2 Rest of World Merchant API Market by Value

5. Impact of COVID-19

5.1 Impact of COVID-19 on Global Merchant API Market
5.2 Post COVID-19 Impact on Global Merchant API Market

6. Market Dynamics

6.1 Growth Drivers
6.1.1 Increasing Incidence of Diabetes
6.1.2 Aging Population
6.1.3 Increasing Healthcare Expenditure
6.1.4 Increasing Research and Development Spending
6.1.5 Growing Pharmaceutical Industry
6.1.6 Growing Pharma Outsourcing Trend

6.2 Challenges
6.2.1 Strict Laws and Regulations
6.2.2 Lack of Transparency and Loss of Control

6.3 Market Trends
6.3.1 Growing Use of Artificial Intelligence
6.3.2 New Drug Approvals
6.3.3 Increasing Patent Expiry
6.3.4 Growth of the High-potency Active Pharmaceutical Ingredients (HPAPI)

7. Competitive Landscape

7.1 Global Merchant API Players by Market Share
7.2 Global Merchant API CDMO Players by Market Share
7.3 Global Peptide Merchant API CDMO Players by Market Share
7.4 Global Oligos Merchant API CDMO Players by Market Share

8. Company Profiles

8.1 Pfizer Inc. (Pfizer CenterOne)
8.1.1 Business Overview
8.1.2 Operating Segments
8.1.3 Business Strategies

8.2 Bachem Holding AG
8.2.1 Business Overview
8.2.2 Net Sales by Product Categories
8.2.3 Business Strategies

8.3 Thermo Fisher Scientific Inc.
8.3.1 Business Overview
8.3.2 Operating Segments
8.3.3 Business Strategy

8.4 Teva Pharmaceutical Industries Ltd. (Teva API)
8.4.1 Business Overview
8.4.2 Operating Segments
8.4.3 Business Strategies

8.5 Sanofi (EuroAPI)
8.5.1 Business Overview
8.5.2 Operating Segments
8.5.3 Business Strategies

8.6 Siegfried Holding AG
8.6.1 Business Overview
8.6.2 Net Sales by Product Group
8.6.3 Business Strategies

8.7 Lonza Group AG
8.7.1 Business Overview
8.7.2 Operating Segments
8.7.3 Business Strategy

8.8 PolyPeptide Group AG
8.8.1 Business Overview
8.8.2 Operating Segments
8.8.3 Business Strategies

8.9 Divi’s Laboratories Limited
8.9.1 Business Overview
8.9.2 Revenue by Region

8.10 Centrient Pharmaceuticals
8.10.1 Business Overview
8.10.2 Business Strategies

8.11 Cambrex
8.11.1 Business Overview
8.11.2 Business Strategy

8.12 Fabbrica Italiana Sintetici
8.12.1 Business Overview

List of Figures

Figure 1: Pharma Value Chain
Figure 2: Advantages and Disadvantages of Merchant API
Figure 3: Merchant API Segmentation
Figure 4: Global Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 5: Global Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 6: Global Merchant API Market by Molecular Type; 2021 (Percentage, %)
Figure 7: Global Merchant API Market by Segment; 2021 (Percentage, %)
Figure 8: Global Merchant API Market by Type; 2021 (Percentage, %)
Figure 9: Global Merchant API Market by Type of Synthesis; 2021 (Percentage, %)
Figure 10: Global Merchant API Market by Region; 2021 (Percentage, %)
Figure 11: Global Small Molecules Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 12: Global Small Molecules Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 13: Global Large Molecules Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 14: Global Large Molecules Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 15: Global Merchant API CDMO Market by Value; 2017-2021 (US$ Billion)
Figure 16: Global Merchant API CDMO Market by Value; 2022-2027 (US$ Billion)
Figure 17: Global Merchant API CDMO Market by Molecular Type; 2021 (Percentage, %)
Figure 18: Global Merchant API CDMO Molecular Type Market by Value; 2017-2021 (US$ Billion)
Figure 19: Global Merchant API CDMO Molecular Type Market by Value; 2022-2027 (US$ Billion)
Figure 20: Global Merchant API CDMO Market by End-User; 2021 (Percentage, %)
Figure 21: Global Merchant API CDMO End-User Market by Value; 2017-2021 (US$ Billion)
Figure 22: Global Merchant API CDMO End-User Market by Value; 2022-2027 (US$ Billion)
Figure 23: Global Merchant API Solutions Market by Value; 2017-2021 (US$ Billion)
Figure 24: Global Merchant API Solutions Market by Value; 2022-2027 (US$ Billion)
Figure 25: Global Innovative Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 26: Global Innovative Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 27: Global Generic Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 28: Global Generic Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 29: Global Synthetic Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 30: Global Synthetic Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 31: Global Biotech Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 32: Global Biotech Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 33: North America Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 34: North America Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 35: North America Merchant API Market by Region; 2021 (Percentage, %)
Figure 36: The US Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 37: The US Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 38: Canada Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 39: Canada Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 40: Mexico Merchant API Market by Value; 2017-2021 (US$ Million)
Figure 41: Mexico Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 42: Asia Pacific Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 43: Asia Pacific Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 44: Asia Pacific Merchant API Market by Region; 2021 (Percentage, %)
Figure 45: China Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 46: China Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 47: India Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 48: India Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 49: Rest of Asia Pacific Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 50: Rest of Asia Pacific Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 51: Europe Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 52: Europe Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 53: Europe Merchant API Market by Region; 2021 (Percentage, %)
Figure 54: Germany Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 55: Germany Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 56: The UK Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 57: The UK Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 58: France Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 59: France Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 60: Italy Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 61: Italy Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 62: Spain Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 63: Spain Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 64: Rest of Europe Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 65: Rest of Europe Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 66: Rest of World Merchant API Market by Value; 2017-2021 (US$ Billion)
Figure 67: Rest of World Merchant API Market by Value; 2022-2027 (US$ Billion)
Figure 68: Global Number of Diabetic Population; 2000-2045 (Million)
Figure 69: Global Population Aged 65 Years Or Over; 2022-2050 (Percentage, %)
Figure 70: Global Health Spending Per Capita; 2017-2021 (US$ Thousand)
Figure 71: Global Spending on Pharmaceutical Research And Development; 2019-2028 (US$ Billion)
Figure 72: Global Pharmaceutical Market Revenue; 2013-2021 (US$ Trillion)
Figure 73: Global Artificial Intelligence Market Size; 2021–2025 (US$ Billion)
Figure 74: Global Merchant API Players by Market Share; 2021 (Percentage, %)
Figure 75: Global Merchant API CDMO Players by Market Share; 2021 (Percentage, %)
Figure 76: Global Peptide Merchant API CDMO Players by Market Share; 2021 (Percentage, %)
Figure 77: Global Oligos Merchant API CDMO Players by Market Share; 2021 (Percentage, %)
Figure 78: Pfizer Inc. Revenues by Operating Segments; 2021 (Percentage, %)
Figure 79: Bachem Holding AG Net Sales by Product Categories; 2021 (Percentage, %)
Figure 80: Thermo Fisher Scientific Inc. Revenues by Segments; 2021 (Percentage, %)
Figure 81: Teva Pharmaceutical Industries Ltd. Revenues by Segments; 2021 (Percentage, %)
Figure 82: Sanofi Net Sales by Segments; 2021 (Percentage, %)
Figure 83: Siegfried Holding AG Net Sales by Product Group; 2021 (Percentage, %)
Figure 84: Lonza Group AG Sales by Segments; 2021 (Percentage, %)
Figure 85: PolyPeptide Group AG Revenue by Segment; 2021 (Percentage, %)
Figure 86: Divi’s Laboratories Limited Revenue by Region; 2022 (Percentage, %)
Table 1: Novel Drug Approvals for 2021


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