BIOPHARMACEUTICAL AND BIOMEDICINE MARKET ANALYSIS

Biopharmaceutical and Biomedicine Market Size and Forecast – 2024 to 2031

The Global Biopharmaceutical and Biomedicine Market is estimated to be valued at USD 571.10 Bn in 2024 and is expected to reach USD 1,254.21 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 11.9% from 2024 to 2031.

Key Takeaways of the Biopharmaceutical and Biomedicine Market:

• Based on product type, the biopharmaceuticals segment is expected to contribute the highest share of the market with 40.1% in 2024
• Based on application, the therapeutics segment is expected to contribute the highest share of the market with 45.1% in 2024
• Based on type, the branded biopharmaceuticals segment is expected to contribute the highest share of the market with 52.3% in 2024
• North America is expected to top the market with 38.4% share, followed by Asia Pacific with 28.7% share in 2024

Market Overview:

Advancements in biomedical research have fueled the development of innovative therapeutic drugs and diagnostics. Significant investments by industry players and government organizations in R&D of novel biologics, cell, and gene therapies for the treatment of chronic diseases such as cancer and diabetes are also supporting market growth. The market is witnessing increasing adoption of personalized medicine aided by advancements in precision medicine and availability of patient specific data. Integration of AI and machine learning tools in drug discovery is also emerging as a key trend. Biopharmaceutical companies are exploring opportunities in developing biotherapeutics targeting disorders with high unmet needs.

Segmental Insights

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Product Type Insights - Focus on core therapeutic areas drives growth of biopharmaceuticals

In terms of product type, the biopharmaceuticals segment is expected to contribute the highest share of the market with 40.1% in 2024 owing to increased focus on developing novel biologics for core therapeutic areas. Biopharmaceuticals include recombinant proteins, monoclonal antibodies, vaccines, blood factors, cell and gene therapies which have revolutionized the treatment of various life-threatening diseases. Large pharmaceutical companies are actively pursuing both in-house development and strategic collaborations to strengthen their biologics pipeline. Successful product approvals and launches in areas of oncology, immunology and neurodegenerative diseases have boosted sales volumes.

Application Insights - Therapeutics dominates driven by aging population and rise of chronic diseases

In terms of application, the therapeutics segment is expected to contribute the highest share of the market with 45.1% in 2024 driven by the growing prevalence of chronic conditions worldwide coupled with an aging population. Diseases like cancer, diabetes, and cardiovascular disease pose a huge burden and therapeutic treatments are in higher demand. Biopharmaceutical innovations have massively expanded treatment options over the last two decades with advanced biologics, targeted therapies, and combination regimens.

Type Insights - Branded Biopharmaceuticals lead over affordability concerns of generics

In terms of type, the branded biopharmaceuticals segment is expected to contribute the highest share of the market with 52.3% in 2024 owing to perceived advantages over generics in safety, efficacy, and data exclusivity. Biologics are complex molecules manufactured through living systems and face formidable scientific hurdles for exact generic replication. Unlike conventional drugs, proven quality assurance of generic copies has not been well established. Pharmacovigilance also becomes critical for branded versions which have accumulated long-term clinical data on performance and adverse events.

Regional Insights

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North America Biopharmaceutical and Biomedicine Market Trends

In North America, the dominance in the biopharmaceutical and biomedicine market with a share of 38.4% in 2024 can be attributed to robust research and development funding, presence of leading global pharmaceutical companies, and favorable regulatory environment conducive for drug innovation. The region also attracts significant investment and business opportunities due to its highly skilled workforce and sophisticated healthcare infrastructure.

Asia Pacific Biopharmaceutical and Biomedicine Market Trends

Meanwhile, the Asia Pacific region exhibits the fastest growth and emerging as an important hub with share of 28.7% in 2024. Major factors driving the growth include rising healthcare expenditure, growing middle-class demographics seeking higher quality care, and government initiatives encouraging local manufacturing and international partnerships. Leading players such as GSK Plc are particularly leveraging opportunities in China, India, and Southeast Asian countries.

Biopharmaceutical and Biomedicine Market Outlook for Key Countries

United States Biopharmaceutical and Biomedicine Market Trends

The U.S. leads the biopharmaceutical sector, with substantial investments in research and development. In December 2022, members of the Pharmaceutical Research and Manufacturers of America (PhRMA) invested approximately US$ 101 billion in R&D, underscoring the country's commitment to innovation.

Germany Biopharmaceutical and Biomedicine Market Trends

Germany is a leader in Europe for biopharmaceuticals, supported by strong regulatory frameworks and funding for research. In October 2024, the German government announced a US$ 1.04 billion investment in biotechnology research, aimed at enhancing the development of innovative therapies. This initiative is likely to accelerate advancements in the sector.

China Biopharmaceutical and Biomedicine Market Trends

Th China biopharmaceutical market is expanding rapidly, attracting global pharmaceutical companies seeking acquisitions to enhance their drug pipelines. In February 2024, AstraZeneca acquired Gracell Biotechnologies for US$ 1.2 billion, reflecting the strategic interest in China's innovative biotech firms.

Japan Biopharmaceutical and Biomedicine Market Trends

Japan’s expanding capabilities in biopharmaceutical manufacturing and its focus on cutting-edge therapies position it as a global leader in the industry. AGC Inc., a world-leading manufacturer of glass, is investing approximately 50 billion to expand its biopharmaceutical contract development and manufacturing organization (CDMO) capabilities at its Yokohama Technical Center in Japan. The expansion will support the development of gene and cell therapies starting in 2025, and manufacturing services for mRNA pharmaceuticals, biopharmaceuticals using mammalian cell cultures by 2026.

Market Players, Key Devlopment, and Competitive Intelligence

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Key Developments:

• On December 7, 2024, Miltenyi Biomedicine, a pharmaceutical company, presented interim findings from the DALY II USA trial evaluating zamtocabtagene autoleucel (zamto-cel) in patients with third-line, relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). The analysis showed a favorable safety profile and promising overall response rate (ORR) and complete response rate (CRR).
• In September 2023, the U.S. Department of Health and Human Services (HHS) extended its partnership with Regeneron under Project NextGen to develop next-generation monoclonal antibodies for COVID-19 prevention. The US$ 326 million contract modification supports advanced development to enhance preparedness for future variants while aiming to lower drug costs for Americans.
• In April 2023, GSK, a biopharma company, announced its acquisition of BELLUS Health, a Canada-based biopharmaceutical company, for US$ 2 billion to gain camlipixant, a late-stage drug for refractory chronic cough (RCC). RCC affects millions globally, with no current treatments in the U.S. or EU. Camlipixant, in phase III trials, is expected to launch in 2026, strengthening GSK’s respiratory medicine pipeline.
• In March 2021, Ipsen Biopharmaceuticals Canada Inc. announced the availability of INCRELEX (mecasermin), the first recombinant human IGF-1 therapy approved in Canada for treating severe primary insulin-like growth factor-1 deficiency (SPIGFD) in children aged 2–18. Approved by Health Canada in December 2020, INCRELEX addresses an ultra-rare growth condition affecting fewer than 5 in 10,000 globally.

Top Strategies Followed by Global Biopharmaceutical and Biomedicine Market Players

• Established Players: Leading companies in the global biopharmaceutical and biomedicine market continue to focus extensively on research and development to drive innovation. They invest heavily in R&D to develop high-performing products including advanced therapeutics and medical technologies.
  • For instance, Johnson & Johnson allocates over US$ 11 billion annually towards R&D with the aim of discovering groundbreaking treatment options. Likewise, Roche invested US$ 11.7 billion in 2020 on R&D activities focused on areas like oncology, immunology, and neuroscience. These extensive investments enable major players to remain at the forefront of the industry with a strong pipeline of novel drugs and technologies.
• Mid-Level Players: Mid-sized companies in the market employ strategies centered around delivering quality and affordable product offerings. They target price-sensitive customer segments seeking cost-effective alternatives.
  • For example, Novartis China focuses on introducing generic and biosimilar drugs at lower price points compared to branded products. Similarly, India-based, Cipla, provides affordable anti-retroviral and respiratory drugs to developing global markets. Such cost-leadership enables mid-tier players to expand their customer base and volume sales.

Emerging Startups - Global Biopharmaceutical and Biomedicine Market Industry Ecosystem

• Innovative Technologies: Several startups are developing cutting-edge technologies with potential to significantly impact the industry. Companies like Anthropic are focused on using AI for drug discovery processes to reduce costs and timelines. Startups like Tempus are developing advanced technologies, including AI-driven analytics for personalized medicine. Their platform analyzes clinical and molecular data to provide insights that can significantly impact treatment decisions and patient outcomes
• Sustainable Solutions: Emerging startups are focusing on sustainability. For instance, a company named Genomatica is working on eco-friendly bioprocesses to produce biopharmaceuticals, utilizing renewable feedstocks to reduce environmental impact. Startups are addressing unique market needs by offering specialized services. For example, a startup called EQRx is focused on providing affordable versions of high-cost medications, collaborating with healthcare providers to improve access for underserved populations

Market Report Scope

Market Dynamics

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Market Driver - Increasing number of product approvals and R&D investments

The global biopharmaceutical and biomedicine market has witnessed substantial growth over the past decade owing to increasing investments in R&D by major pharmaceutical companies. There has been a consistent rise in the number of new drug approvals by regulatory authorities across the world as biopharma companies accelerate their clinical research pipelines. A key trend driving this is the large capital being pumped into the development of novel biologics and cell and gene therapies. With breakthrough discoveries in areas such as oncology, immunology, and neuroscience, many large pharmaceutical players have substantially ramped up their research budgets with the goal of bringing more innovative therapies to the market. For instance, in May 2024, Biocon Limited, a global biopharmaceutical leader, entered into an exclusive licensing and supply agreement with Handok, a specialty pharmaceutical company in South Korea, for the commercialization of Synthetic Liraglutide.

Biopharmaceutical and Biomedicine Market Challenge - Stringent regulatory requirements and lengthy approval processes

The stringent regulatory environment and lengthy approval processes for new biopharmaceutical drugs pose a major challenge for the growth of the global biopharmaceutical and biomedicine market. Most major regulatory bodies like the U.S. FDA and EMA in the EU have robust and meticulous approval systems to ensure safety and efficacy of new drugs. However, this often results in clinical trial periods lasting 7-10 years on an average before a new drug is approved. The extensive documentation and data requirements at each stage of development and regulatory review prolong the overall R&D cycle significantly. Additionally, failure in any stage leads to starting the process all over again, further draining resources and increasing costs for manufacturers. These regulatory hurdles make the drug development process highly risky, time-consuming and capital intensive, discouraging many companies especially startups. Harmonizing standards across markets and expediting approvals for breakthrough therapies can help address this challenge to some extent.

Biopharmaceutical and Biomedicine Market Opportunity - Growing demand for targeted therapies and biosimilars

The market presents robust opportunities stemming from the rising demand for biosimilars and targeted therapies. As the understanding of disease pathology improves at the molecular level, more targeted biologic drugs are being developed to precisely treat conditions. This shift from conventional drugs to precision medicines is being driven by their higher efficacy and fewer side effects. Additionally, patent expiration of major blockbuster biologics is paving the way for biosimilars which provide comparable quality at significantly lower costs. For instance, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, received the U.S. FDA approval for HERCESSI (trastuzumab-strf), a biosimilar to Herceptin. HERCESSI is approved for treating HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma, marking Accord BioPharma, Inc’s first USFDA-approved biosimilar.

Analyst Opinion (Expert Opinion)

• The global biopharmaceutical and biomedicine market is poised to grow significantly in the coming years. The industry is driven by rising investments in research and development of novel biologics and the increasing demand for personalized medicines. Furthermore, the growing global burden of chronic diseases such as cancer, diabetes, and cardiovascular diseases will continue boosting the demand for biopharmaceutical drugs and novel treatment options.
• The market is also presented with opportunities to develop biological therapies for unmet medical needs and neglected diseases. However, high R&D costs associated with drug development and commercialization pose a challenge to business profitability. Stringent regulations for clinical trials and product approval also add to development timelines and costs.
• Among regions, North America will continue dominating the market attributed to the presence of major biopharma companies and rising healthcare spending. However, Asia Pacific is expected to be the fastest growing market due to improving healthcare infrastructure, rising affluence, and increasing focus of global biopharma players on emerging Asian countries.
• The biopharmaceutical and biomedicine industry has a bright future driven by growing disease burden and increasing focus on precision medicine. While high costs remain a challenge, further investments in personalized therapeutic approaches can boost market potential. Collaborations between industry and academia can help expedite development and commercialization of novel biological therapies as well.

Market Segmentation

•  Product Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Biopharmaceuticals
  • Monoclonal Antibodies
  • Vaccines
  • Recombinant Human Insulin
  • Human Growth Hormone
  • Erythropoietin
  • Interferon
  • Colony Stimulating Factor
  • Blood Factors
  • Fusion Protein
  • Others
  • Nanomedicine
  • Cell & Gene Therapy
  • Bioinformatics
  • Molecular Enzymes & Kits
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
• • Therapeutics
  • Oncology
  • Cardiovascular Diseases
  • Neurological Disorders
  • Infectious Diseases
  • Immune Disorders
  • Diagnostics
  • In Vitro Diagnostics
  • In Vivo Diagnostics
  • Point-of-Care Testing
  • Research and Development
  • Preclinical Research
  • Clinical Trials
  • Biotechnology Research
  • Regulatory Research
•  Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Branded Biopharmaceuticals
  • Generic Biopharmaceuticals
•  Route of Administration Insights (Revenue, USD Bn, 2019 - 2031)
• • Oral
  • Intravenous
  • Subcutaneous
  • Intramuscular
•  Patient Demographics Insights (Revenue, USD Bn, 2019 - 2031)
• • Adult
  • Pediatric
  • Geriatric
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Novartis AG
  • Johnson & Johnson
  • Pfizer, Inc.
  • Sanofi S.A.
  • Eli Lilly and Company
  • Hoffmann-La Roche AG
  • AbbVie Inc.
  • Bristol-Myers Squibb
  • Qiagen N.V.
  • Affimed N.V.
  • Celgene Corporation
  • Amgen Inc.
  • Merck & Co., Inc.
  • GSK Plc
  • Regeneron Pharmaceuticals