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The global biopharmaceuticals market size was valued at USD 437.12 billion in 2022. The market is projected to grow from USD 470.80 billion in 2023 to USD 799.76 billion by 2030, exhibiting a CAGR of 7.9% during the forecast period.
Biopharmaceuticals are complex medicines extracted or semisynthesized from biological sources using biotechnological methods. They can be sugars, proteins, nucleic acids, living cells, or tissues used for therapeutic or in vivo diagnostic purposes and are produced by means other than direct extraction from a native or non-engineered biological source. The growing population and the increase in age-related diseases, along with various medical conditions, are driving the demand for biopharmaceuticals across the globe.
This growing demand has led market players to actively invest in scaling up their research and development activities to introduce novel products for various indications. Moreover, the increased number of regulatory approvals for new products, as well as existing products for treating a range of diseases, is contributing to the global biopharmaceuticals market growth during the forecast period.
Increase in Regulatory Approvals Led to Positive Market Growth during COVID-19
During the COVID-19 pandemic, the global market witnessed positive growth. The pandemic served as the most significant and challenging threat to human health as it led to decreased routine screening procedures and medical check-ups, as several clinics and hospitals postponed non-essential tests and appointments for minimizing the risk of COVID-19 transmission. However, the development and deployment of effective COVID-19 vaccines and therapeutics and regulatory agility led to high demand for these products. Moreover, regulators shifted resources toward COVID-19-related activities and provided rapid scientific advice, compliance checks, and accelerated assessment and evaluation procedures to product developers.
In order to meet this growing demand, the market players accelerated their R&D activities to provide effective solutions against COVID-19. After the approval of the first COVID-19 vaccine, the government authorities strongly emphasized conducting a vaccination drive, which led to the strong sales performance of certain products in 2021.
From 2023, as the cases of COVID-19 would decline, the market is estimated to grow at a steady rate during the forecast period. The growth is anticipated to be driven by potential pipeline candidates who are likely to receive approval in the forthcoming years. Furthermore, the strong sales performance of certain drugs, such as Humira, Keytruda, and others, which are approved for multiple conditions, is expected to drive market growth during the forecast period.
Robust Pipeline Candidates in Emerging Regions to Propel Market Growth
An emerging region such as Asia Pacific has become a hotspot for clinical trials as it contributes almost 50% of the clinical trial global activity, as per the blog published by Cytel in 2023. The importance of Asia Pacific region trials has also evolved and is driven by its large patient population, lower cost of conducting trials, government support, and lower risk of competing trials, pragmatic regulatory processes, and strategic significance of Asian markets. This made the region’s patients/sites a key contributor to addressing global patient enrollment issues and being a key player in global trials.
Furthermore, there has also been a rising trend of licensing of assets developed in China to pharmaceutical industry players across the globe, especially with cancer therapies. These Asia Pacific-based biopharma are collaborating with global pharmaceutical companies for bringing their early-stage assets to clinical trials and more advanced stages.
In the innovative products arena, there has been a rising focus on cell gene therapies in Asia Pacific. In 2023, more CAR-T treatments are anticipated to be approved in 2023, with more IND applications submitted to the FDA. This makes it important to consider the adequacy of clinical evidence and the accelerating new Complicated Grief Treatment (CGT) trials to justify the cost of products.
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Rising Prevalence of Chronic Diseases to Drive the Demand for these Drugs
One of the most significant drivers positively influencing market growth is the wide surge in the global prevalence of chronic diseases. Additionally, governments across the globe are adopting measures to generate awareness about these diseases and are driving the adoption of these drugs. In terms of drug demand, the drug market in specialized fields focusing on the treatment of chronic diseases, rare diseases, and genetic diseases will gradually expand.
To reduce this health burden, various initiatives are undertaken by different healthcare agencies, government bodies, and industry participants to increase awareness among the general population regarding prevention and treatment measures. This is anticipated to increase the treatment and diagnosis rate among the population, surging the demand for more innovative and effective solutions, and eventually driving market growth.
Increasing Approvals for Monoclonal Antibodies to Drive Market Growth
Another factor contributing to market growth is the increase in the number of regulatory approvals for monoclonal antibodies across the globe. The players operating in this market have robust pipeline candidates seeking approval for multiple indications. Moreover, several monoclonal-based products, such as bamlanivimab and etesevimab, received conditional approval and emergency authorization to treat COVID-19.
As a result, market players increased their emphasis on the development and introduction of new therapies and drugs to treat multiple conditions. This is expected to escalate the demand for novel drugs and their adoption in the market over the study period.
High Cost Associated with Drug Development May Limit the Market Growth
Over the past decade, this industry has witnessed notable developments. However, the stringent regulatory policies of governments in various countries, coupled with the high investment required for product development, may influence biopharmaceutical companies' interest in entering this market. Moreover, the production costs of raw materials have significantly increased, while Western medicine preparations and biological medicines continue to grow slowly. Additionally, the availability of conventional biopharmaceuticals at relatively lower costs may impact market growth during the forecast period.
Another challenge is the high cost of drugs, attributed to the numerous expenses involved in their approvals and development, despite their many benefits. This factor may limit the adoption of these drugs.
These high-cost biopharmaceuticals increase the economic burden on the patient population, which may lead to treatment discontinuation or the search for alternative treatment options. This could result in a decline in the customer base for biopharmaceuticals, subsequently limiting market growth.
Immunomodulators Segment Dominated the Market Due to the Increasing Approvals for Monoclonal Antibody
On the basis of type, the market is segmented into immunomodulators, enzymes, vaccines, hormones, and others.
Among the types, the immunomodulators segment held a dominant position in the market in 2022. The segment’s dominance is mainly driven by the monoclonal antibodies segment, which are getting regulatory approvals for various applications. Moreoever, the market players are initiating strategic alliances to cater to the rising demand for the treatment of various key diseases. Along with monoclonal bodies, the segment’s growth is also driven by cytokines and interferons.
The vaccines segment held the second largest share in the global biopharmaceuticals market share in 2022. The segment includes recombinant/conjugate/subunit, live attenuated, inactivated, and toxoid. The vaccines segment growth is driven by the emergence of novel and seasonal diseases for which prevention is the only measure, such as COVID-19, influenza, and others. Moreover, the annual vaccination drives are responsible for the streamlined demand for vaccines, which is augmenting the segment growth during the forecast period.
The hormone segment includes human growth hormones, insulin, thyroid stimulating hormone, and others. The hormone segment growth is mainly driven by a rise in demand for insulin products. The increasing prevalence of endocrine diseases and awareness related to its treatment options is driving the segment growth.
The enzymes segment is expected to grow at a comparatively lower CAGR during the forecast period. The enzymes segment includes hydrolases, lyases, oxidoreductases, and others. Factors such as advancement in enzyme engineering, increased demand in the pharmaceutical sector, and the growing prevalence of gastrointestinal disorders, cancers, and tumors are contributing to the segment's growth.
The others segment includes anti-infectives such as antibacterial, antivirals, antifungals, and antiparasitic. The presence of several domestic and international players offering solutions at lower prices is expected to drive the segment’s growth during the forecast period.
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Increasing Prevalence of Cancers and Surging New Product Approvals by Regulatory Agencies Favored Oncology Segment Growth
In terms of application, the market is segmented into cardiology, oncology, respiratory, immunology, neurology, and others.
The oncology segment held a dominating share in the market in 2022, primarily due to the surging prevalence of cancer among the population. This is further driven by the growing number of initiatives for raising awareness about cancers and their treatment options, resulting in an escalated demand for therapeutic products and a surge in diagnosis rate.
Followed by oncology, the respiratory segment held the second largest market share in 2022. The growth of this segment is largely driven by the availability of products for several respiratory conditions. Moreover, the growing R&D expenditure by market players to accelerate the development of its pipeline candidate in order to expand the treatment regime is likely to augment the segment growth during the forecast period.
The immunology segment is estimated to grow with the second highest CAGR during the forecast period. The segment growth is driven by strong pipeline candidates expected to receive approval for various autoimmune diseases such as rheumatoid arthritis, ulcerative colitis, Crohn’s disease, psoriasis, and related conditions, as well as a new range of autoimmune dermatology conditions.
The neurology and cardiology segments are estimated to grow at comparatively lower CAGR during the forecast period. The growth of these segments is attributed to the availability of a large number of treatments approved for various neurological and cardiovascular diseases. Moreover, the growing healthcare expenditure of the patient population in availing these suitable treatment options is subsequently driving market growth.
Other segments include dermatology, ophthalmology, endocrinology, and others. The segment is expected to grow at the lowest CAGR over the study period due to limited clinical trials ongoing for diseases in these areas.
Rising Inpatient Admissions to Boost the Hospital Pharmacies Segment Growth
On the basis of distribution channel, the market is segmented into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies.
The hospital pharmacies segment held the dominating market share in 2022. The number of hospital pharmacies increases as the number of hospitals increases. Further, some of the drugs are expensive and available at hospital pharmacies at comparatively affordable rates due to reimbursement policies offered by various countries. This increases the patient's preference for this setting over others. In addition, certain instances may require patient hospitalization for a period of 7 to 10 days for enabling healthcare providers for the close monitoring of treatment response and effectively addressing the occurrence of any potential side effects.
The drug stores & retail pharmacies segment generated notable revenue in 2022. The increasing focus of retailers on the expansion of their business through strategic alliances in order to increase accessibility and ensure the timely availability of drugs is majorly contributing to the segment's growth.
Online pharmacies are estimated to grow at the highest CAGR during the forecast period. The segment’s growth is attributed to the increasing adoption of digital platforms that deliver medication at doorstep in a click at discounted rates. This option makes the medication cost more pocket-friendly for a patient population, subsequently contributing to the segment’s growth.
Geographically, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America Biopharmaceuticals Market Size, 2022 (USD Billion)
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North America accounts for the highest share and recorded a revenue of USD 197.31 billion in the year 2022. The region is estimated to dominate the market over the study period due to the rising prevalence of chronic diseases such as cancer and a higher rate of diagnosis and treatment. Moreover, the adequate reimbursement availability for inpatient hospital stays boosts the adoption of advanced and novel treatment in the major countries of the region.
Europe held a substantial market share. Rising partnerships between the industry players for the launch of novel drug therapy, increasing government funding, and surging research and development activities are expected to boost market growth in the European region over the study period.
Asia Pacific is anticipated to expand at the highest CAGR during the estimated period. This is due to the growing awareness among the patient population regarding recent and new treatments, increasing clinical trials, and emphasis of leading industry players on receiving regulatory approvals for the distribution and marketing of their products.
The Latin America and Middle East & Africa markets are expected to grow at comparatively lower CAGR during the analysis period. The increasing partnerships and collaborations among the major market participants and improving healthcare infrastructure for expanding its geographical reach, among others, are a few factors driving the industry expansion in these regions.
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Pfizer Inc. Dominated the Market with a Strong Sales Performance
In terms of the competitive landscape, the global market is highly competitive, with several players holding substantial shares. However, due to the outbreak of the COVID-19 pandemic, Pfizer Inc. dominated the market with its top-selling vaccine named Comirnaty. Pfizer and BioNTech jointly generated revenue of USD 59.1 billion from the sales of the COVID-19 vaccine.
On the other hand, the heavyweight tumor necrosis factor (TNF) blocker Humira by AbbVie, which had been the best-selling prescription medicine for the past decade, secured the second position, as the drug generated sales of USD 21.2 billion in 2022. Merck & Co., Inc. has also established its presence in the market with its star monoclonal antibody product named Keytruda, which primarily serves oncology therapy.
Other prominent players such as Bristol-Myers Squibb Company, Johnson & Johnson, F. Hoffmann-La Roche Ltd., Novartis AG, and others are enhancing their focus on gaining approval and introducing products globally through strategic acquisitions and mergers. Additionally, these companies are placing substantial emphasis on developing their distribution network to meet the rising demand from the population, which is set to strengthen their market position.
An Infographic Representation of Biopharmaceuticals Market
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The market research report covers a detailed analysis and overview. It focuses on key aspects such as competitive landscape, type, application, distribution channel, and region. Moreover, it offers insights into the market drivers, market trends, market dynamics, COVID-19 impact on the market, and other key insights. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market over recent years.
CAGR of 7.9% from 2023-2030
Value (USD Billion)
By Distribution Channel
Fortune Business Insights says that the global market stood at USD 437.12 billion in 2022 and is projected to reach USD 799.76 billion by 2030.
The market will exhibit rapid growth at a CAGR of 7.9% during the forecast period (2023-2030).
By type, the immunomodulators segment held a leading position in the market in 2022.
Increasing elderly-related disease, cancers in younger people, and the breakout of new infectious diseases is increasing medical expenditures, and preventive medical demand, are driving demand for biopharmaceuticals.
Pfizer Inc., AbbVie Inc., and Merck & Co., Inc. are the major players in the market.
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