THERAPEUTIC PROTEINS AND ORAL VACCINES MARKET ANALYSIS

The global therapeutic proteins and oral vaccines market is estimated to be valued at US$ 246.7 Mn in 2023 and is expected to exhibit a CAGR of 8.1% during the forecast period (2023-2030).

Analysts’ Views on Global Therapeutic Proteins and Oral Vaccines Market:

Increasing adoption of technology by market players, growing inorganic growth strategies by market players, and increasing product launches will drive the growth of the global therapeutic proteins and oral vaccines market. For instance, in January 2022, Amgen Inc., a biotechnology company, and Generate Biomedicines, a drug generation company, announced a research collaboration agreement to discover and create protein therapeutics for five clinical targets across several therapeutic areas and multiple modalities.

Figure 1. Global Therapeutic Proteins and Oral Vaccines Market Share (%), By Drug Class, 2023

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Global Therapeutic Proteins and Oral Vaccines Market– Drivers

Rising Number of Clinical Trials by Major Companies

• The increasing number of pharmaceutical companies are focusing on research and development for the treatment of various diseases such as growth hormone deficiency (GHD) in young children and others, and this is expected to aid in growth of the market over the forecast period. For instance, in October 2019, OPKO Health Inc., a medication company,  and Pfizer Inc., a pharmaceutical company, announced that the global Phase 3 trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN (somatropin) for injection, as per measured by annual height velocity at 12 months.
• Moreover, research institutes and academic institutes are focusing on research and development for the treatment coronavirus infection affecting individuals globally.
• For instance, in March 2020, Migal Galilee Research Institute Ltd, the research and development centre of MigVax Ltd., announced that a new vaccine they developed for a deadly virus affecting poultry could be adapted for human use against the novel coronavirus known as 2019-nCoV (and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Figure 2. Global Therapeutic Proteins and Oral Vaccines Market Share (%), By Region, 2023

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Global Therapeutic Proteins and Oral Vaccines Market- Regional Analysis

Among regions, North America is estimated to hold a dominant position in the global therapeutic proteins and oral vaccines market over the forecast period. North America is estimated to hold 33.5% of the market share in 2023. The North America therapeutic proteins and oral vaccines market is expected to witness significant growth in the coming years, driven by the increasing growth strategies by market players such as signing distribution agreement in the region. For instance, in November 2021, Pfizer Inc. announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, PAXLOVID (PF-07321332; ritonavir), subject to regulatory authorization from the U.S. Food and Drug Administration (FDA). Under the terms of the agreement, the U.S. government will acquire 10 million treatment courses to be delivered by Pfizer beginning later this year and concluding in 2022.

Global Therapeutic Proteins and Oral Vaccines Market– Impact of Coronavirus (COVID-19) Pandemic

• The coronavirus disease, caused by the coronavirus 2019-nCoV that is now officially designated as severe acute respiratory syndromerelated coronavirus SARS-CoV-2, represents a pandemic threat to global public health.
• Although the epicentre of the COVID-19 outbreak in December of 2019 is Wuhan, China, this disease has now spread to more than 100 countries globally. Since the outbreak of the Coronavirus, experts across the globe are conducting research and development of possible treatment regimes, therapeutic agents and vaccines for COVID-19.
• According to the American Chemical Society’s report published in March 2020, various companies and research institutes are focused on research and development of previously approved biologicals such as therapeutic antibodies, cytokines, interfering and other therapeutic Ribonucleic acid, and vaccines for treating COVID-19, as biologics have the potential to broaden the spectrum of the treatment options for coronavirus induced diseases. 
• Moreover, key players are focusing on strategic mergers and acquisitions for research and development of novel drug candidates. For instance, in October 2020, Serum Institute of India Pvt. Ltd., a manufacturer of vaccines and biologics, announced an agreement with Merck & Co., Inc., a science and technology company, to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.

Global Therapeutic Proteins and Oral Vaccines Market Segmentation:

The therapeutic proteins and oral vaccines market report is segmented by drug class, by application, by distribution channel, and by region.

• By drug class, the market is segmented into therapeutic proteins (growth factors, fusion proteins, monoclonal antibodies, hormones, coagulation factors, and others), oral vaccines (live attenuated vaccine, inactivated vaccine, recombinant vaccine, and others). Out of which, the therapeutic proteins is expected to hold a dominant position in the global therapeutic proteins and oral vaccines market during the forecast period, and this is attributed to increasing research and development for the development of therapeutic proteins in the market.
• By application, the market is segmented into oncology, hematology, immunology, endocrinology, infectious disease, cardiovascular disease, and others. Out of which, oncology is expected to dominate the market over the forecast period, and this is attributed to a rising number of cancer patients globally.
• By Distribution Channel, the market is segmented into hospital pharmacies, retail pharmacies and online pharmacies. Out of which, hospital pharmacies is expected to dominate the market over the forecast period, and this is attributed to increasing admissions in hospitals.

Global Therapeutic Proteins and Oral Vaccines Market- Cross Sectional Analysis:

Key players operating in the market are focused on inorganic growth strategies, such as acquisition, which is expected to boost the therapeutic proteins and oral vaccines market in North America region. For instance, in November 2022, Merck & Co., Inc., and Imago BioSciences, Inc., a biotechnology company, announced that the companies had entered into a definitive agreement under which Merck, through a subsidiary, will acquire Imago Biosciences, Inc., for US$36.00 per share in cash for an approximate total equity value of US$1.35 billion. Imago Biosciences, Inc., is a clinical stage biopharmaceutical company developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases. Imago’s lead candidate bomedemstat (IMG-7289), an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, is currently being evaluated in multiple Phase 2 clinical trials for the treatment of essential thrombocythemia (ET), myelofibrosis (MF), and polycythemia vera (PV), in addition to other indications.

Global Therapeutic Proteins and Oral Vaccines Market: Key Developments

• On March 13 2023, Pfizer Inc. and Seagen Inc., a biotechnology company, announced that they had entered into a definitive merger agreement under which Pfizer will acquire Seagen for US$ 229 in cash per Seagen share for a total enterprise value of US$ 43 billion.
• In November 2022, AstraZeneca, a global, science-led biopharmaceutical company, announced an agreement to acquire Neogene Therapeutics Inc., a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts) that offer a novel cell therapy approach for targeting cancer.
• In May 2022, Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced the completion of a US$41 million Series B financing. The financing was led by new investor NexPoint and included participation from existing investors Bristol Myers Squibb, Eshelman Ventures and Kingdon Capital.
• In April 2020, AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine.

Global Therapeutic Proteins and Oral Vaccines Market: Key Trends

• Market Players are Focused on Gaining Funding from Investors for the Development of Products. Market players are focused on gaining funding from regulatory bodies, which is expected to drive the growth of the global therapeutic proteins and oral vaccines market over the forecast period.
• For instance, in July 2022, Manifold Bio, a next-generation protein therapeutics company pioneering an in vivo biologics design platform, announced the close of a US$40 million Series A financing round led by Triatomic Capital and joined by new investors Section 32, FPV Ventures, Horizons Ventures, and Tencent. Existing investors Playground Global, Fifty Years, and FAST by GETTYLAB also participated. The investment will enable Manifold Bio to advance its internal drug programs and expand its next-generation protein engineering platform to support additional programs and partnerships.
• In June 2020, C4 Therapeutics, Inc. (C4T), a biotechnology company pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation, announced the closing of a US$170 million financing, including US$ 150 million in Series B equity co-led by existing investor Cobro Ventures and new investor Perceptive Advisors and US$20 million in venture debt by Perceptive Advisors.
• In March 2020, Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to invent breakthrough protein degrader medicines for patients, announced the closing of a US$102 million Series C financing. The round was led by Biotechnology Value Fund (BVF) and Redmile Group with participation from Wellington Management Company, Bain Capital Life Sciences, funds managed by Janus Henderson Investors and BlackRock, Rock Springs Capital and a large US-based, healthcare-focused fund. Existing investors also participated in the round.

Global Therapeutic Proteins and Oral Vaccines Market: Restraint

Lower Availability and Affordability of Therapeutic Proteins in Lower Income Countries

• Middle-to-lower income countries such as India, Indonesia, Bangladesh, Mexico, Brazil, and certain European countries do not have proper availability of biologics due to high cost and lack of reimbursement for biologics. Therefore, lower availability and affordability of biologics in middle and lower income countries are expected to hamper the therapeutic proteins and oral vaccines market growth over the forecast period.
• For instance, according to an article 'Affordability Issues of Biotech Drugs in Low- and Middle Income Countries (LMICs)' published in Drug Designing and Intellectual Properties International Journal 2019, in India alone, as many as 63 million people are forced into poverty every year, owing to very high health expenses, the majority of which are out-of-pocket payments for medicines. In a country like India, most of the customers prefer low cost medications as it a price sensitive country. For instance, according to a CPhI 2016 Annual Report, in India, it is found that physicians were willing to prescribe a first-line critical therapy if it was offered at a 60% to 70% discount. Although, India lacks proper reimbursements for biologics.

Global Therapeutic Proteins and Oral Vaccines Market - Key Players

Major players operating in the global therapeutic proteins and oral vaccines market include Abbott Laboratories, Amgen, Inc., Biogen, Inc., Eli Lilly and Company, Eli Lilly and Company, Johnson and Johnson, Merck & Co.Inc., Novo Nordisk A/S, Pfizer, Inc., Sanofi S.A., Serum Institute of India Pvt. Ltd., Emergent Biosolutions Inc., TransAlgae, MigVax Ltd., and Lumen Bioscience, Inc.

Definition: Therapeutic proteins are one of the prime option of biologicals as per their clinical uses. Protein therapeutics are used extensively to treat various diseases like cancer, AIDS etc. Therapeutic proteins can be used to replace a protein that is abnormal or deficient in a particular disease. A protein is a large molecule comprised of a long chain of amino acids that is folded into a three-dimensional shape. The specific amino acid sequence and 3-D shape determines the biological function of the protein.