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[ 英語タイトル ] High Potency API /HPAPI Market by Type (Innovative, Generic), Synthesis (Synthetic, Biotech (Biologic, Biosimilar)), Manufacturer (Captive, Merchant), Therapy (Oncology, Glaucoma, Hormonal Imbalance) - Global Forecast to 2021


Product Code : MNMHC00108641
Survey : MarketsandMarkets
Publish On : February, 2021
Category : Healthcare and Pharmaceuticals
Study Area : Global
Report format : PDF
Sales price option (consumption tax not included)
Single User USD5650 / Question Form
5 User USD6650 / Question Form
Enterprise User USD10000 / Question Form

[Report Description]

The global high potency active pharmaceutical ingredients (HPAPI) market is expected to reach USD 24.09 billion by 2021 from USD 16.02 billion in 2016, growing at a CAGR of 8.5% from 2016 to 2021. This market is categorized on the basis of type, type of manufacturer, type of synthesis, therapeutic application, and region.
Major factors contributing to the growth of the high potency rapid growth in the oncology drugs market, increasing focus of pharmaceutical companies on HPAPIs, and advancements in HPAPI technologies. Growing demand for antibody drug conjugates also provide an impetus for the growth of this market. Their high specificity of action, has caused ACDs to gain significant attention, resulting in a noteworthy increase in the number of ADCs under development. Considering the growing opportunities in this market, many companies are making significant investments for the development of novel ACDs. In October 2015, ADC Biotechnology (U.K.) invested USD 10 million to build a manufacturing facility for advanced anticancer drugs. Many companies are also cross collaborating for research in the development of next-generation ADCs. For example, in June 2014, Merck Serono entered into a collaboration with Mersana Therapeutics Inc. for the development of next-generation ADCs.
Emerging markets have opened an array of opportunities for the high potency active pharmaceutical ingredients market. Moreover, the market also offers lucrative opportunities for CMOs and CDMOs. However, factors such as a stringent regulatory requirements and requirement of large investments may restrain the growth of this market.
Based on type, the market is segmented into innovative and generic HPAPIs. On the basis of type of manufacture, the HPAPIs market is categorized into two segments, captive manufacturer and merchant manufacturer. On the basis of type of synthesis, the HPAPIs market is segmented into synthetic HPAPIs and biotech HPAPIs. On the basis of therapeutic application, the HPAPIs market is further segmented into oncology, hormonal disorders, glaucoma, and other therapeutic applications.
Research Coverage:
Apart from the comprehensive geographical and product analysis and market sizing, the report also provides a competitive landscape that covers the growth strategies adopted by industry players over the last three years. In addition, the company profiles comprise basic views on key players in the active pharmaceutical ingredients market and their product portfolios, developments, and strategies. The above-mentioned market research data, current market size, and forecast of the future trends will help key players and new entrants to make the necessary decisions regarding product offerings, geographical focus, changes in strategic approach, R&D investments for innovations in products and technologies, and levels of output in order to remain successful.
Reasons to Buy the Report:
The report will enrich both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help firms garner a greater market share. Firms purchasing the report can use any one or a combination of the below-mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for strengthening their market shares.
The report provides insights on the following pointers:
• Market Penetration: Comprehensive information on the product portfolios of top players in the active pharmaceutical ingredients market. The report analyzes the active pharmaceutical ingredients market by application, sales channel, and region
• Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and new product launches in the active pharmaceutical ingredients market
• Competitive Assessment: In-depth assessment of market strategies, geographical and business segments, and product portfolios of leading players in the active pharmaceutical ingredients market
• Market Development: Comprehensive information about lucrative emerging markets. The report analyzes the market for various active pharmaceutical ingredients products across geographies
• Market Diversification: Exhaustive information about new products and services, untapped geographies, recent developments, and investments in the active pharmaceutical ingredients market

TABLE OF CONTENTS

1 INTRODUCTION 21
1.1 OBJECTIVES OF THE STUDY 21
1.2 MARKET DEFINITION 21
1.3 STUDY SCOPE 22
1.3.1 MARKETS COVERED 22
1.3.2 YEARS CONSIDERED FOR THE STUDY 23
1.4 CURRENCY 24
1.5 LIMITATIONS 24
1.6 MARKET STAKEHOLDERS 24
2 RESEARCH METHODOLOGY 25
2.1 MARKET SIZE ESTIMATION 26
2.2 MARKET BREAKDOWN AND DATA TRIANGULATION 29
2.3 KEY DATA FROM SECONDARY SOURCES 30
2.4 INSIGHTS FROM PRIMARY SOURCES 30
2.5 ASSUMPTIONS FOR THE STUDY 31
3 EXECUTIVE SUMMARY 32
4 PREMIUM INSIGHTS 37
4.1 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET OVERVIEW 37
4.2 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE 38
4.3 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE OF SYNTHESIS 38
4.4 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY THERAPEUTIC AREA 39
4.5 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET: GEOGRAPHIC SNAPSHOT 40
5 MARKET OVERVIEW 41
5.1 INTRODUCTION 42
5.2 MARKET DYNAMICS 42
5.2.1 DRIVERS 43
5.2.1.1 Rapid growth in the oncology drugs market 43
5.2.1.2 Growing demand for antibody drug conjugates 43
5.2.1.3 Increasing focus of leading pharmaceutical companies on HPAPIs 44
5.2.1.4 Advancements in HPAPI manufacturing technologies 44
5.2.2 RESTRAINTS 45
5.2.2.1 Stringent regulatory requirements 45
5.2.2.2 Requirement of large investments 45
5.2.3 OPPORTUNITIES 46
5.2.3.1 Growing opportunities for CMOs and CDMOs 46
5.2.3.2 Emerging markets 46
5.2.4 CHALLENGES 47
5.2.4.1 Stringent safety and handling specifications 47
5.2.4.2 Uncertainty associated with products 47
5.2.4.3 Need for appropriate process design 47
5.2.4.4 Constant evolution of industry standards and technologies 48
6 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS CLASSIFICATION AND OVERVIEW 49
6.1 INTRODUCTION 49
6.2 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS CLASSIFICATION AS PER SAFEBRIDGE CONSULTANTS 49
7 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE 52
7.1 INTRODUCTION 53
7.2 INNOVATIVE HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS 55
7.3 GENERIC HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS 57
8 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE OF SYNTHESIS 60
8.1 INTRODUCTION 61
8.2 SYNTHETIC HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS 62
8.2.1 SYNTHETIC HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE 65
8.2.1.1 Innovative synthetic HPAPIs 65
8.2.1.2 Generic synthetic HPAPIs 68
8.3 BIOTECH HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS 70
8.3.1 BIOTECH HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE 72
8.3.1.1 Innovative biotech HPAPIs 73
8.3.1.2 Biosimilars 75
9 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET, BY TYPE OF MANUFACTURER 77
9.1 INTRODUCTION 78
9.2 CAPTIVE MANUFACTURERS 80
9.3 MERCHANT MANUFACTURERS 82
9.3.1 MERCHANT HPAPI MANUFACTURERS MARKET, BY TYPE 84
9.3.1.1 Innovative merchant HPAPI manufacturers 84
9.3.1.2 Generic merchant HPAPI manufacturers 86
9.3.2 MERCHANT HPAPI MANUFACTURERS MARKET, BY TYPE OF SYNTHESIS 88
9.3.2.1 Synthetic HPAPIs 89
9.3.2.2 Biotech HPAPIs 91
10 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET,
BY THERAPEUTIC APPLICATION 93
10.1 INTRODUCTION 94
10.2 ONCOLOGY 95
10.3 HORMONAL IMBALANCE 97
10.4 GLAUCOMA 100
10.5 OTHER THERAPEUTIC APPLICATIONS 102
11 HIGH-POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET,
BY REGION 104
11.1 INTRODUCTION 105
11.2 NORTH AMERICA 106
11.2.1 U.S. 110
11.2.2 CANADA 114
11.3 EUROPE 118
11.3.1 GERMANY 123
11.3.2 FRANCE 126
11.3.3 U.K. 130
11.3.4 ITALY 133
11.3.5 SPAIN 136
11.3.6 REST OF EUROPE (ROE) 140
11.4 ASIA 144
11.4.1 JAPAN 148
11.4.2 CHINA 152
11.4.3 INDIA 155
11.4.4 REST OF ASIA (ROA) 158
11.5 REST OF THE WORLD (ROW) 162
12 COMPETITIVE LANDSCAPE 166
12.1 OVERVIEW 166
12.2 MARKET SHARE ANALYSIS 167
12.3 COMPETITIVE SITUATION AND TRENDS 168
12.3.1 AGREEMENTS, COLLABORATIONS, PARTNERSHIPS, AND ALLIANCES 168
12.3.2 MERGERS AND ACQUISITIONS 169
12.3.3 REGULATORY APPROVALS 170
12.3.4 EXPANSIONS 171
13 COMPANY PROFILES 172
(Introduction, Products & Services, Strategy, & Analyst Insights, Developments, MnM View)*
13.1 INTRODUCTION 172
13.2 PFIZER, INC. 173
13.3 NOVARTIS INTERNATIONAL AG 176
13.4 SANOFI 179
13.5 F. HOFFMANN-LA ROCHE LTD. 182
13.6 BRISTOL-MYERS SQUIBB 185
13.7 BOEHRINGER INGELHEIM 188
13.8 TEVA PHARMACEUTICAL INDUSTRIES LTD. 190
13.9 ELI LILLY AND COMPANY 192
13.10 MERCK & CO., INC. 194
13.11 ABBVIE INC. 196
13.12 MYLAN N.V. 198

*Details on MarketsandMarkets view, Introduction, Product & Services, Strategy, & Analyst Insights, New Developments might not be captured in case of unlisted companies.
14 APPENDIX 200
14.1 INSIGHTS FROM INDUSTRY EXPERTS 200
14.2 DISCUSSION GUIDE 201
14.3 OTHER DEVELOPMENTS 204
14.4 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 210
14.5 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 212
14.6 AVAILABLE CUSTOMIZATIONS 212
14.7 RELATED REPORTS 213
14.8 AUTHOR DETAILS 214

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