바이오의약품 시장 : 제품 유형, 서비스, 원재료 유형, 용도, 지역별(2024-2031년)

Biopharmaceuticals Market Valuation - 2024-2031

The rising frequency of chronic diseases such as cancer, diabetes, and autoimmune disorders has created a greater demand for improved, tailored treatments. Biopharmaceuticals, which are well-known for their precision in treating these complicated disorders, are driving this need is fuelling the USD 413.83 Billion in 2024 and reaching USD 674.66 Billion by 2031.

Additionally, significant developments in science, such as gene therapy, monoclonal antibodies, and personalized medicine, have transformed the development of new medicines. Increased government and private sector investment in R&D, along with favorable regulatory frameworks that accelerate drug approvals, is hastening industry expansion is grow at a CAGR of about 6.30% from 2024 to 2031.

Biopharmaceuticals Market: Definition/ Overview

Biopharmaceuticals are therapeutic medicines made from living cells, proteins, or nucleic acids that are utilized to treat a wide range of complex ailments, including cancer, autoimmune disorders, and hereditary abnormalities. These treatments include monoclonal antibodies, vaccinations, gene therapies, and recombinant proteins. Their uses span the healthcare industry, providing focused, tailored treatments that are frequently more successful than standard medications. The future of biopharmaceuticals is huge, with further advances in biotechnology, gene editing, and personalised medicine expected to drive innovation. As research progresses, biopharmaceuticals are positioned to play a critical role in treating currently incurable diseases and improving global healthcare outcomes.

Will Rising Aging Populations Propel the Biopharmaceuticals Market?

The global trend of aging populations is becoming a major driver in the biopharmaceuticals market. According to the World Health Organization, the proportion of the global population over the age of 60 will nearly double between 2015 and 2050, from 12% to 22%. This demographic shift is driving up demand for improved therapies to treat age-related disorders. In March 2024, Roche, a renowned pharmaceutical company, announced a USD 2 Billion investment in biopharmaceuticals to treat neurodegenerative illnesses common in older persons. Furthermore, the United States Census Bureau predicts that by 2030, all baby boomers will be over the age of 65, bringing the total number of older people to 73 million. In response to this trend, the US National Institute on Aging boosted its budget for age-related research by 15% in 2024, compared to the previous year, USD 4.2 Billion was allocated to assist research on pharmacological therapies for age-related disorders.

In January 2024 to accelerate the development of biopharmaceuticals for age-related disorders, allocating 500 billion yen (about USD 4.5 Billion) over five years. In China, which is expected to have 330 million people over the age of 65 by 2050, Fosun Pharma reported a 30% year-over-year rise in sales of its biopharmaceutical treatments addressing chronic diseases common in older individuals. These improvements, combined with advances in personalized medicine and regenerative medicines, suggest that the aging global population will remain a major driver of growth in the biopharmaceuticals market.

Will High Cost of Biopharmaceutical Products Hinder the Growth of the Biopharmaceuticals Market?

The high cost of biopharmaceutical products can limit the growth of the biopharmaceuticals market to some extent. Biopharmaceuticals are frequently more expensive to develop and manufacture than standard small-molecule medications due to the complexity of their biological makeup, extensive R&D procedures, and severe regulatory requirements. These high development costs are passed on to patients and healthcare systems, making these therapies less affordable, particularly in poor countries with limited healthcare resources. As a result, affordability becomes a substantial hurdle, possibly stifling market growth, especially in price-sensitive areas. Governments and healthcare providers frequently have issues in financing these costs, which can delay the uptake of biopharmaceuticals.

Furthermore, the high cost may exacerbate competition from biosimilars, which are less expensive alternatives to branded biopharmaceuticals when patents expire. While biosimilars are a cost-effective choice, their arrival may put downward pressure on prices, causing a shift in market dynamics. However, pricing concerns are driving innovation in the biopharmaceutical industry, with companies investing in new technologies and manufacturing techniques to lower production costs and increase availability. Overall, while high costs provide hurdles, they are also motivating industry attempts to balance innovation and affordability, which may have a long-term impact on market growth.

Category-Wise Acumens

Will Rising Demand of Monoclonal Antibodies Propel the Biopharmaceuticals Market?

The increasing demand for monoclonal antibodies (mAbs) is predicted to significantly boost the biopharmaceuticals market. Monoclonal antibodies are highly successful treatments for a variety of complex diseases, including cancer, autoimmune disorders, and infections. Their capacity to precisely target certain cells or proteins has made them a top priority for healthcare practitioners and pharmaceutical businesses alike. As the prevalence of these illnesses rises, so will the demand for sophisticated treatments such as mAbs. For instance, in September 2024, Roche announced the successful approval of a new monoclonal antibody therapy for treating certain cancers, reflecting the growing investment and focus on this segment by key industry players. These developments are likely to drive the expansion of the biopharmaceutical market, as companies prioritize the development of more targeted, innovative therapies.

In August 2024, the United States Food and Drug Administration (FDA) expedited many monoclonal antibody medicines for cancer and autoimmune illnesses, displaying significant government support for these advanced therapies. This favorable regulatory environment promotes innovation and speeds up the introduction of new mAb therapeutics to the market. Furthermore, government support for biopharmaceutical research, particularly mAbs, is expanding globally, driving market expansion.

Recombinant growth factors are the fastest-growing market, driven by their expanding applications in regenerative medicine, wound healing, and the treatment of illnesses such as anemia and growth deficits. The rise in demand for biologics, advances in recombinant DNA technology, and increased R&D investments are all driving this segment's rapid expansion.

Will Rising Usage of API Raw Materials Fuel the Biopharmaceuticals Market?

The increasing use of active pharmaceutical ingredients (APIs) is expected to drive the expansion of the biopharmaceuticals industry. APIs, or physiologically active components in medicine formulations, are critical for developing biopharmaceutical products such as monoclonal antibodies, vaccines, and recombinant proteins. As the need for these innovative medicines grows, so will the necessity for high-quality, efficient API production. In August 2024, Lonza Group announced a large increase in API production capacity to fulfill escalating worldwide biologics demand. This move demonstrates how prominent firms are investing in API development and manufacturing to support the expanding biopharmaceutical market. The increased frequency of chronic diseases and complex health issues drives the demand for innovative biopharmaceutical treatments.

In June 2024, the European Medicines Agency (EMA) issued new recommendations to expedite the licensing process for APIs used in biopharmaceuticals, with the goal of accelerating access to important treatments across Europe. Furthermore, governments in North America and Asia are increasing funding for biopharmaceutical research and production, particularly API development, as they recognise the growing importance of self-sufficiency in pharmaceutical manufacture. These favorable regulatory frameworks and government initiatives are likely to boost API production and utilization, hence driving the overall expansion of the biopharmaceuticals market.

The fastest-growing segment is formulation excipients, which are non-active substances used in medication formulations to improve API stability, distribution, and absorption. Excipients are becoming increasingly important as complicated biologics and innovative drug delivery systems become more prevalent, fueling their rapid expansion as they improve the overall effectiveness and shelf life of biopharmaceuticals.

Country/Region-wise

Will Rising Investment in Research and Development in North America Drive the Biopharmaceuticals Market?

North America is expected to grow significantly in biopharmaceuticals market, owing in large part to the region's high R&D investments. According to Verified Market Research, the biopharmaceuticals market was valued at USD 413.83 Billion in 2023 and is predicted to increase at a 6.30% CAGR between 2024 and 2031. This expansion is most noticeable in the United States, which accounted for the highest proportion of the worldwide biopharmaceuticals market in 2021. For instance, in March 2024, Pfizer, announced a USD 5 Billion commitment to strengthen its R&D capabilities in the United States, with a focus on creating new biologics and gene therapies.

Furthermore, a report published by the Canadian Manufacturers & Exporters Association in 2023 revealed that the biopharmaceuticals sector in Canada saw a 12% rise in R&D spending compared to 2022, showing the industry's ambition to remain at the forefront of medical advancement. These expenditures, combined with the region's strong intellectual property protection and talented workforce, are projected to propel the biopharmaceuticals market in North America.

Will Growing Emphasis on Biotechnology and Personalized Medicine in Asia Pacific Propel the Biopharmaceuticals Market?

The Asia Pacific area is swiftly emerging as a hub for biotechnology and customized medicine, resulting in significant growth in the biopharmaceutical market. For instance, in February 2024, the Chinese government announced a strategic plan to invest $15 billion over the following five years to grow the country's biotechnology industry, with a special emphasis on personalized medicine and innovative biologic medicines. Similarly, India's Department of Biotechnology predicted a 20% rise in biopharmaceutical businesses' R&D investment in 2023 compared to the previous year, as firms develop their skills in areas such as gene therapy and precision medicine.

Meanwhile, in Japan, Takeda Pharmaceutical, a renowned biopharmaceutical company, plans to construct a new USD 500 Million R&D facility in 2023 to speed the development of revolutionary therapeutics, including personalized medications. These investments, combined with the region's large and diverse patient population, as well as the growing adoption of advanced genomic technologies, indicate that Asia Pacific's focus on biotechnology and personalized medicine will remain a significant driver of the global biopharmaceuticals market.

Competitive Landscape

The biopharmaceuticals market's competitive landscape is defined by a varied spectrum of competitors, including small and medium-sized businesses, biotechnology firms, and established pharmaceutical giants. This market is characterized by rapid innovation and an emphasis on research & development, resulting in the ongoing launch of innovative medicines and biologics. Companies, academic institutions, and research organizations frequently form partnerships and collaborate, allowing for the sharing of expertise and resources to improve drug development procedures. Furthermore, the rise of personalized medicine and advancements in technologies like as gene editing and biologics production have increased competitiveness, forcing corporations to take strategic tactics, such as mergers and acquisitions, to expand their product portfolios and market share.

Some of the prominent players operating in the biopharmaceuticals market include:

Abbott

Amgen, Inc.

Biogen, Inc.

Eli Lilly and Company

Hoffmann-La Roche AG

Johnson & Johnson Services, Inc.

Merck Sharp & Dohme Corp

Novo Nordisk A/S

Pfizer, Inc.

Sanofi

Latest Developments

In September 2024, Moderna announced good results from a clinical trial of a novel mRNA-based cancer vaccine. This research demonstrates the growing applicability of mRNA technology outside infectious disorders, which is driving market growth in oncology.

In August 2024, Lonza Group expanded its API manufacturing facilities in Switzerland to meet rising demand for biologics, including monoclonal antibodies. This increase demonstrates the increasing importance of APIs in biopharmaceutical development.

In May 2024, Roche gained FDA approval for their novel monoclonal antibody treatment for Alzheimer's disease, marking a significant advance in treating neurological illnesses and broadening the spectrum of biopharmaceutical uses.

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 MARKET DEFINITION
• 1.2 MARKET SEGMENTATION
• 1.3 RESEARCH TIMELINES
• 1.4 ASSUMPTIONS
• 1.5 LIMITATIONS

2 RESEARCH METHODOLOGY

• 2.1 DATA MINING
• 2.2 SECONDARY RESEARCH
• 2.3 PRIMARY RESEARCH
• 2.4 SUBJECT MATTER EXPERT ADVICE
• 2.5 QUALITY CHECK
• 2.6 FINAL REVIEW
• 2.7 DATA TRIANGULATION
• 2.8 BOTTOM-UP APPROACH
• 2.9 TOP-DOWN APPROACH
• 2.10 RESEARCH FLOW
• 2.11 DATA SOURCES

3 EXECUTIVE SUMMARY

• 3.1 GLOBAL BIOPHARMACEUTICALS MARKET OVERVIEW
• 3.2 GLOBAL BIOPHARMACEUTICALS ECOLOGY MAPPING (% SHARE IN 2023)
• 3.3 GLOBAL BIOPHARMACEUTICALS MARKET ABSOLUTE MARKET OPPORTUNITY
• 3.4 GLOBAL BIOPHARMACEUTICALS MARKET ATTRACTIVENESS ANALYSIS, BY REGION
• 3.5 GLOBAL BIOPHARMACEUTICALS MARKET ATTRACTIVENESS ANALYSIS, BY PRODUCT
• 3.6 GLOBAL BIOPHARMACEUTICALS MARKET ATTRACTIVENESS ANALYSIS, BY THERAPEUTIC AREA
• 3.7 GLOBAL BIOPHARMACEUTICALS MARKET ATTRACTIVENESS ANALYSIS, BY MODE OF DELIVERY
• 3.8 GLOBAL BIOPHARMACEUTICALS MARKET GEOGRAPHICAL ANALYSIS (CAGR %)
• 3.9 GLOBAL BIOPHARMACEUTICALS MARKET, BY PRODUCT (USD BILLION)
• 3.10 GLOBAL BIOPHARMACEUTICALS MARKET, BY THERAPEUTIC AREA (USD BILLION)
• 3.11 GLOBAL BIOPHARMACEUTICALS MARKET, BY MODE OF DELIVERY (USD BILLION)
• 3.12 FUTURE MARKET OPPORTUNITIES

4 MARKET OUTLOOK

• 4.1 GLOBAL BIOPHARMACEUTICALS MARKET EVOLUTION
• 4.2 GLOBAL BIOPHARMACEUTICALS MARKET OUTLOOK
• 4.3 MARKET DRIVERS
  • 4.3.1 RISING BURDEN OF CHRONIC DISEASES
  • 4.3.2 ADVANCEMENTS IN BIOTECHNOLOGY
  • 4.3.3 GROWING GERIATRIC POPULATION
• 4.4 MARKET RESTRAINTS
  • 4.4.1 HIGH DEVELOPMENT COSTS
  • 4.4.2 STRINGENT REGULATIONS
  • 4.4.3 INTELLECTUAL PROPERTY CHALLENGES
• 4.5 MARKET OPPORTUNITY
  • 4.5.1 ADVANCEMENTS IN DRUG DELIVERY SYSTEMS
  • 4.5.2 FOCUS ON EMERGING MARKETS
  • 4.5.3 RISING APPROVALS OF MONOCLONAL ANTIBODY
• 4.6 MARKET TRENDS
  • 4.6.1 RISE OF BIOSIMILARS
  • 4.6.2 PRECISION MEDICINE AND GENE EDITING
  • 4.6.3 RISE OF BIOCONVERGENCE
• 4.7 PORTER'S FIVE FORCES ANALYSIS
  • 4.7.1 THREAT OF NEW ENTRANTS
  • 4.7.2 THREAT OF SUBSTITUTES
  • 4.7.3 BARGAINING POWER OF SUPPLIERS
  • 4.7.4 BARGAINING POWER OF BUYERS
  • 4.7.5 INTENSITY OF COMPETITIVE RIVALRY
• 4.8 VALUE CHAIN ANALYSIS
  • 4.8.1 RESEARCH AND DEVELOPMENT (R&D)
  • 4.8.2 REGULATORY APPROVALS
  • 4.8.3 MANUFACTURING
  • 4.8.4 MARKETING AND SALES
  • 4.8.5 DISTRIBUTION
  • 4.8.6 END USERS
• 4.9 PRICING ANALYSIS
• 4.10 OVERVIEW OF THE MARKET BY THE DEVELOPMENT STAGE
  • 4.10.1 RESEARCH AND DEVELOPMENT (R&D)
  • 4.10.2 PRE-CLINICAL & CLINICAL TRIALS
  • 4.10.3 PRODUCTS THAT ARE MARKETED
• 4.11 MACROECONOMIC ANALYSIS

5 MARKET, BY PRODUCT

• 5.1 OVERVIEW
• 5.2 MONOCLONAL ANTIBODIES
• 5.3 RECOMBINANT GROWTH FACTORS
• 5.4 RECOMBINANT PROTEINS
• 5.5 RECOMBINANT HORMONES
• 5.6 VACCINES
• 5.7 CELL AND GENE THERAPIES
• 5.8 OTHERS

6 MARKET, BY THERAPEUTIC AREA

• 6.1 OVERVIEW
• 6.2 ONCOLOGY
• 6.3 IMMUNOLOGY
• 6.4 NEUROLOGY
• 6.5 CARDIOLOGY
• 6.6 INFECTIOUS DISEASES
• 6.7 ADDITIONAL THERAPEUTIC AREAS

7 MARKET, BY MODE OF DELIVERY

• 7.1 OVERVIEW
• 7.2 INJECTABLE
• 7.3 ORAL
• 7.4 INHALATION
• 7.5 TOPICAL

8 MARKET, BY GEOGRAPHY

• 8.1 OVERVIEW
• 8.2 NORTH AMERICA
  • 8.2.1 U.S.
  • 8.2.2 CANADA
  • 8.2.3 MEXICO
• 8.3 EUROPE
  • 8.3.1 GERMANY
  • 8.3.2 U.K.
  • 8.3.3 FRANCE
  • 8.3.4 ITALY
  • 8.3.5 SPAIN
  • 8.3.6 REST OF EUROPE
• 8.4 ASIA PACIFIC
  • 8.4.1 CHINA
  • 8.4.2 JAPAN
  • 8.4.3 INDIA
  • 8.4.4 REST OF ASIA PACIFIC
• 8.5 LATIN AMERICA
  • 8.5.1 BRAZIL
  • 8.5.2 ARGENTINA
  • 8.5.3 REST OF LATIN AMERICA
• 8.6 MIDDLE EAST AND AFRICA
  • 8.6.1 UAE
  • 8.6.2 SAUDI ARABIA
  • 8.6.3 SOUTH AFRICA
  • 8.6.4 REST OF MIDDLE EAST AND AFRICA

9 COMPETITIVE LANDSCAPE

• 9.1 OVERVIEW
• 9.2 COMPANY MARKET RANKING ANALYSIS
• 9.3 COMPANY REGIONAL FOOTPRINT
• 9.4 COMPANY INDUSTRY FOOTPRINT
• 9.5 ACE MATRIX
  • 9.5.1 ACTIVE
  • 9.5.2 CUTTING EDGE
  • 9.5.3 EMERGING
  • 9.5.4 INNOVATORS

10 COMPANY PROFILES

• 10.1 JOHNSON & JOHNSON
  • 10.1.1 COMPANY OVERVIEW
  • 10.1.2 COMPANY INSIGHTS
  • 10.1.3 PRODUCT BENCHMARKING
  • 10.1.4 SWOT ANALYSIS
  • 10.1.5 WINNING IMPERATIVES
  • 10.1.6 CURRENT FOCUS AND STRATEGIES
  • 10.1.7 THREAT FROM COMPETITION
• 10.2 F. HOFFMANN-LA ROCHE AG
  • 10.2.1 COMPANY OVERVIEW
  • 10.2.2 COMPANY INSIGHTS
  • 10.2.3 PRODUCT BENCHMARKING
  • 10.2.4 SWOT ANALYSIS
  • 10.2.5 WINNING IMPERATIVES
  • 10.2.6 CURRENT FOCUS & STRATEGIES
  • 10.2.7 THREAT FROM COMPETITION
• 10.3 MERCK & CO., INC.
  • 10.3.1 COMPANY OVERVIEW
  • 10.3.2 COMPANY INSIGHTS
  • 10.3.3 PRODUCT BENCHMARKING
  • 10.3.4 SWOT ANALYSIS
  • 10.3.5 WINNING IMPERATIVES
  • 10.3.6 CURRENT FOCUS AND STRATEGIES
  • 10.3.7 THREAT FROM COMPETITION
• 10.4 PFIZER INC.
  • 10.4.1 COMPANY OVERVIEW
  • 10.4.2 COMPANY INSIGHTS
  • 10.4.3 PRODUCT BENCHMARKING
  • 10.4.4 SWOT ANALYSIS
  • 10.4.5 WINNING IMPERATIVES
  • 10.4.6 CURRENT FOCUS AND STRATEGIES
  • 10.4.7 THREAT FROM COMPETITION
• 10.5 AMGEN INC.
  • 10.5.1 COMPANY OVERVIEW
  • 10.5.2 COMPANY INSIGHTS
  • 10.5.3 PRODUCT BENCHMARKING
  • 10.5.4 SWOT ANALYSIS
  • 10.5.5 WINNING IMPERATIVES
  • 10.5.6 CURRENT FOCUS AND STRATEGIES
  • 10.5.7 THREAT FROM COMPETITION
• 10.6 SANOFI S.A.
  • 10.6.1 COMPANY OVERVIEW
  • 10.6.2 COMPANY INSIGHTS
  • 10.6.3 PRODUCT BENCHMARKING
  • 10.6.4 SWOT ANALYSIS
  • 10.6.5 WINNING IMPERATIVES
  • 10.6.6 CURRENT FOCUS AND STRATEGIES
  • 10.6.7 THREAT FROM COMPETITION
• 10.7 BRISTOL-MYERS SQUIBB COMPANY
  • 10.7.1 COMPANY OVERVIEW
  • 10.7.2 COMPANY INSIGHTS
  • 10.7.3 PRODUCT BENCHMARKING
  • 10.7.4 SWOT ANALYSIS
  • 10.7.5 WINNING IMPERATIVES
  • 10.7.6 CURRENT FOCUS AND STRATEGIES
  • 10.7.7 THREAT FROM COMPETITION
• 10.8 NOVARTIS AG
  • 10.8.1 COMPANY OVERVIEW
  • 10.8.2 COMPANY INSIGHTS
  • 10.8.3 PRODUCT BENCHMARKING
  • 10.8.4 SWOT ANALYSIS
  • 10.8.5 WINNING IMPERATIVES
  • 10.8.6 CURRENT FOCUS AND STRATEGIES
  • 10.8.7 THREAT FROM COMPETITION
• 10.9 BIOGEN INC.
  • 10.9.1 COMPANY OVERVIEW
  • 10.9.2 COMPANY INSIGHTS
  • 10.9.3 PRODUCT BENCHMARKING
  • 10.9.4 SWOT ANALYSIS
  • 10.9.5 WINNING IMPERATIVES
  • 10.9.6 CURRENT FOCUS AND STRATEGIES
  • 10.9.7 THREAT FROM COMPETITION
• 10.10 GILEAD SCIENCES, INC.
  • 10.10.1 COMPANY OVERVIEW
  • 10.10.2 COMPANY INSIGHTS
  • 10.10.3 PRODUCT BENCHMARKING
  • 10.10.4 SWOT ANALYSIS
  • 10.10.5 WINNING IMPERATIVES
  • 10.10.6 CURRENT FOCUS AND STRATEGIES
  • 10.10.7 THREAT FROM COMPETITION