Biopharmaceuticals Market Size, Share, Growth, COVID-19 Impact & Industry Analysis, By Type (Immunomodulators {Monoclonal Antibodies, Cytokines, Interferons, and Others}, Enzymes {Hyrolyases, Lyases, Oxidoreductases, and Others}, Vaccines {Recombinant/Conjugate/Subunit, Inactivated, Live Attenuated, and Toxoid}, Hormones {Human Growth Hormones, Insulin and Others}, and Others), By Application (Cardiology, Oncology, Respiratory and Others), By Distribution Channel (Hospital Pharmacies and Online Pharmacies), and Regional Forecast, 2023-2030

The global biopharmaceuticals market size was valued at USD 437.12 billion in 2022 and 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 2023-2030. North America dominated the global market with a share of 45.13% in 2022.

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.

• According to World Health Organization (WHO) statistics, in 2020, people aged 65 years and older outnumbered children under age five across the globe. By 2050, these groups will be about the same size. An aging or geriatric population means a higher use of healthcare services and a greater need for family and professional caregivers.

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 biopharmaceuticals market growth during the forecast period.

COVID-19 IMPACT

Increase in Regulatory Approvals Led to Positive Market Growth during COVID-19

During the COVID-19 pandemic, the biopharmaceuticals industry 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.

• According to WHO, 639 million confirmed cases and 6.6 million deaths were reported due to COVID-19 globally in November 2019. However, the U.S. FDA approved 40 of the 50 novel drugs in 2020. This indicates that 75% were approved in the U.S. before receiving approval in any other country.


• Parallelly, Bharat Biotech received Drug Controller General of India (DCGI) approval for Phase I & II Human Clinical Trials for COVID-19 in July 2020.

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.

• In 2021, the Comirnaty COVID-19 vaccine of Pfizer Inc. generated a revenue of USD 36,781.0 million and topped the list of blockbuster drugs list. The vaccines maintained its top position in 2022 as well by generating a revenue of USD 37,806.0 million.

• In response to the pandemic, by September 2022, the FDA and EMA approved or authorized 22 different COVID-19 medicines (6 vaccines and 16 therapeutics), of which 16 are biopharmaceuticals, mainly vaccines and monoclonal antibodies.

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 biopharmaceuticals industry growth during the forecast period.

LATEST TRENDS

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.

• Trialtrove 2022 reports indicate that Phase I clinical trials in 2022 held a third of clinical trial activities. The top five locations for Phase I clinical trials in Asia comprise China, Australia, Japan, India, and South Korea, with China alone responsible for almost 40%.

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 February 2021, AbbVie and Caribou Biosciences, Inc. partnered and entered into a license agreement for the research and development of chimeric antigen receptor T cell therapeutics.

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.

• In March 2023, there were 443 pipeline candidates for chimeric antigen receptor T-cell therapy listed on ClinicalTrials.gov, while in 2012, only 12 clinical trials were investigating this type of treatment.

BIOPHARMACEUTICALS MARKET GROWTH FACTORS

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.

• According to WHO 2023 data, every year, 41 million people die due to non-communicable diseases or chronic diseases, which is equivalent to 74% of all global deaths. Furthermore, it states that these conditions are often associated with older age groups. However, evidence shows that 17 million chronic deaths occur before the age of 70 years. Of these premature deaths, 86% are estimated to occur in low and middle-income countries.

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.

• According to a study published by the Nature Biotechnology Journal in 2022, annual approval rates exceeded those in the U.S. and Europe regions in 2020 and 2021, reflecting a strong regulatory response despite the unexpected burden on the agencies caused by the pandemic. Products approved over the period include 97 monoclonal antibodies, 19 hormones, 16 nucleic acid/gene-therapy-based products, and 16 vaccines.

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.

RESTRAINING FACTORS

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.

• According to a 2022 study by the World Health Organization (WHO), the estimated average cost to develop a new drug ranges from USD 43.4 million to USD 4.2 billion.

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.

• For instance, Novartis, the manufacturer of Kymriah, stated that one treatment cycle for this chimeric antigen receptor T cell therapy costs USD 475,000. Kymriah also received approval for the treatment of refractory or relapsed large B-cell lymphoma in adults who have undergone two or more prior therapies.

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.

SEGMENTATION

By Type Analysis

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.

• In May 2022, AstraZeneca entered into a license agreement with RD Biotechnology Ltd. to develop, manufacture, and commercialize monoclonal antibodies (mAbs) against SARS-CoV-2.

The vaccines segment held the second largest share in the 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.

• According to the WHO 2022 Global Vaccine Report, the global vaccine market supplied approximately 16 million doses of 47 vaccines through 94 manufacturers in 2021. 

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.

• According to the International Diabetes Federation, in 2023, globally 537 million people are living with diabetes, which is estimated to rise to 643 million by 2030 and 783 million by 2045.

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.

By Application Analysis

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 biopharmaceuticals industry 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.

• According to the GLOBOCAN 2020 estimates, the worldwide burden of cancer is set to increase significantly by the year 2040. The estimated number of new cancer cases is expected to rise to 27.5 million by 2040, while the number of cancer-related deaths is projected to reach 16.3 million worldwide by 2040.

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.

• In June 2022, GSK plc made an R&D investment of GBP 1 billion (USD 1.22 billion) for over 10 years to accelerate research and development dedicated to infectious diseases that disproportionately impact lower-income countries.

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.

By Distribution Channel Analysis

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 biopharmaceuticals industry 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.

REGIONAL INSIGHTS

Geographically, the biopharmaceuticals market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

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.

• According to an Avalere Health article published in September 2022, hospitalizations involving CAR-T cell treatment were classified under MS-DRG 018, with USD 246,955 as the base rate of reimbursement for the fiscal year 2022.

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.

• In June 2023, Apeiron Biologics received financing of EUR 25 million (USD 26.7 million) from the European Investment Bank (EIB) to support the development of new treatments for cancer.

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.

• In June 2022, Zenyaku Kogyo Co., Ltd., and Chugai Pharmaceutical Co., Ltd. received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for an anti-CD20 monoclonal antibody Rituxan, for the prevention of recurrence of neuromyelitis optica spectrum disorder.

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.

KEY INDUSTRY PLAYERS

Pfizer Inc. Dominated the Market with a Strong Sales Performance

In terms of the competitive landscape, the biopharmaceuticals industry 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.

• According to the investor presentation of Bristol-Myers Squibb Company in 2022, the company forecasted that sales of the Breyanzi drug would reach USD 3.0 billion by 2030.

LIST OF KEY COMPANIES PROFILED IN BIOPHARMACEUTICALS MARKET:

• Pfizer Inc. (U.S.)


• AbbVie Inc. (U.S.)


• Bristol-Myers Squibb Company (U.S.)


• Johnson & Johnson Services, Inc. (U.S.)


• Bayer AG (Germany)


• Lilly (U.S.)


• Sanofi (France)


• Merck & Co., Inc. (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Novartis AG (Switzerland)


• GSK plc (U.K.)


• Takeda Pharmaceutical Company Limited. (Japan)

KEY INDUSTRY DEVELOPMENTS

• September 2023 – BieGene signed an agreement with Novartis AG for the development, manufacturing, and commercialization of the TEVIMBRA (tislelizumab) antibody.


• August 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson received conditional marketing authorization (CMA) from the European Commission (EC) for TALVEY (talquetamab) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM).


• July 2023 - Eisai Co., Ltd. and Biogen Inc. received U.S. FDA traditional approval for LEQEMBI (lecanemab-irmb) for the treatment of Alzheimer’s disease.


• June 2023 - TG Therapeutics, Inc. received European Commission approval for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).


• August 2022 - AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW)  for both prevention and treatment of symptomatic disease caused by SARS-CoV-2 infection.

REPORT COVERAGE

The biopharmaceuticals 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.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2030
Base Year	2022
Estimated Year	2023
Forecast Period	2023-2030
Historical Period	2019-2021
Growth Rate	CAGR of 7.9% from 2023-2030
Unit	Value (USD Billion)
Segmentation	By Type Immunomodulators Monoclonal Antibodies Cytokines Interferons Others Enzymes Hyrdolases Lyases Oxidoreductases Others Vaccines Recombinant/Conjugate/Subunit Inactivated Live Attenuated Toxoid Hormones Human Growth Hormones Insulin Thyroid Stimulating Hormones Others Others
By Application Cardiology Oncology Respiratory Immunology Neurology Others
By Distribution Channel Hospital Pharmacies Drug Stores & Retail Pharmacies Online Pharmacies
By Region North America (By Type, Application, Distribution Channel, and Country) U.S. (By Application) Canada (By Application) Europe (By Type, Application, Distribution Channel, Country, and Country/Sub-Region) U.K. (By Application) Germany (By Application) France (By Application) Italy (By Application) Spain (By Application) Scandinavia (By Application) Rest of Europe (By Application) Asia Pacific (By Type,  Application, Distribution Channel, and Country/Sub-Region) China (By Application) India (By Application) Japan (By Application) Australia (By Application) Southeast Asia (By Application) Rest of Asia Pacific (By Application) Latin America (By Type, Application, Distribution Channel, and Country/Sub-Region) Brazil (By Application) Mexico (By Application) Rest of Latin America (By Application) Middle East & Africa (By Type, Application, Distribution Channel, and Country/Sub-Region) GCC (By Application) South Africa (By Application) Rest of Middle East & Africa (By Application)