Oral Biologics & Biosimilars Market Definition
The oral biologics and biosimilars market consist of sales of oral biologics and biosimilar products and related services used to treat chronic diseases such as diabetes, arthritis, and cancer.
Biologics are drugs made from living cells using highly complex technology, while biosimilars are biological products which are being produced to be identical to a biologic already approved, known as reference drugs. Biosimilars should have similar safety and efficacy compared to the reference biologic product. The oral biologics and biosimilar market comprise of biologics and biosimilar drugs through oral delivery route, for the treatment of chronic diseases.
Oral Biologics & Biosimilars Market Size
The global oral biologics and biosimilars market reached a value of nearly $3,076.1 million in 2019, having grown at a compound annual growth rate (CAGR) of 6.5% since 2015, and is expected to grow at a CAGR of 17.1% to nearly $5,787.9 million by 2023. Also, the market is expected to growth to $8,687.7 million in 2025 at a CAGR of 22.5% and to $23,585.5 million in 2030 at a CAGR of 22.1%. Growth in the historic period resulted from increased collaboration and partnerships between market players for better insights, increased need for immunology, increased demand due for cost-effective manufacturing process, aging population, government initiatives, and the ability to command high prices. Factors that negatively affected growth in the historic period were lack of awareness on biosimilars among primary care physicians and specialists, difficulty in manufacturing biologics and pricing pressures from regulators.
Going forward, robust research and development activities for development of oral biologics, lean towards pills over injections, adoption of unhealthy lifestyles, technological advances, ease of use of oral biologics, increase in healthcare access, reimbursement of biologics, rise in biosimilars, and rising prevalence of chronic diseases are expected to drive the market. Higher supervision during clinical studies and stringent regulations related to biosimilar approvals, prolonged production and approval time, difficulties in pricing, nomenclature challenges are major factors that could hinder the growth of the oral biologics and biosimilars market in the future.
Oral Biologics & Biosimilars Market Drivers
The key drivers of the oral biologics & biosimilars market include:
Technology is expected to be a continued driver of market growth during this period. An area of particular development is likely to be physiology simulation modeling. Markets such as this one will benefit from the greater efficiencies offered by developments in this area. For example, Eli Lilly and Pfizer have adopted Amazon’s Elastic Compute Cloud (EC2) platform to conduct simulation models in early drug discovery that have been operational within hours, whereas traditional models would have taken weeks to conduct simulations. The Open Innovation Drug Discovery program is another initiative by Lilly to enhance the research and development of biologics.
Oral Biologics & Biosimilars Market Restraints
The key restraints on the oral biologics & biosimilars market include:
High Stringency And Low Turnover For Clinical Trials
For pharmaceutical drugs, clinical studies such as the pharmacokinetics - pharmacodynamics (PK-PD) studies can be carried out on healthy individuals, if it can be safely administered to the healthy population. PK studies determine the time the drug takes to get absorbed, distributed, metabolized, and excreted within the body, and PD studies determine the biochemical and physiological effect of the drug. However, for biological drugs, there are some key considerations regarding the selection of healthy individuals. This is mainly because healthy individuals may have a higher immunogenic response than the population with the disease, and sometimes the PK of the reference product is altered when administered to a healthy individual. This results in unreliable clinical data. Such hindrances may stall the progress of biological drugs.
Oral Biologics & Biosimilars Market Trends
Major trends influencing the oral biologics & biosimilars market include:
Revised FDA Regulations To Facilitate Biologics Drug Development
The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics, can now be obtained from sources other than the FDA’s Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, the FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products.
The average yearly number of new drug approvals was 25 from 2000 to 2009, and 41 from 2010 to 2018. The new biologic product approvals increased from a median of 5 from 2000 to 2013, to 12 from 2014 to 2018.
Shift From Small Molecules to Biologics
Pharmaceutical companies are shifting towards large molecules and biologics for drug development. Pharma companies had focused on small molecules for decades, but the rate of innovation in that field has slowed dramatically, leading to the shift towards biologics. The unmet needs with respect to chronic disease therapies help drive pharmaceutical companies to innovate and develop biologic molecules. For instance, in 2018, the Center for Drug Evaluation and Research (CDER) approved 29% of new molecular entity (NME) approvals for biologics compared to 26% in 2017 and 11% in 2013. This shift also increases the number of approvals for oral biologics.
Opportunities And Recommendations In The Oral Biologics & Biosimilars Market
Opportunities – The top growth potential in the oral biologics and biosimilars market by therapeutic mechanism will arise in Others (Interferons, Opioid receptors, Calcitonin receptor etc) market, which will gain $1,606.8 million of global annual sales by 2023. Vaccines and insulin products will drive the growth of these market segments. The top growth potential in the oral biologics and biosimilars market by disease will arise in the diabetes market, which will gain $1,865.5 million of global annual sales by 2030. By molecule type, Proteins & Peptides will have high market share and potential with annual sales of $15804, by 2030. The top growth potential in the oral biologics and biosimilars market by distribution channel will arise in the hospital pharmacies market, which will gain $1,770.9 million of global annual sales by 2030. The oral biologics and biosimilars market size will gain the most in USA at $1,423.2 million.
Market-trend-based strategies for the oral biologics and biosimilars market include invest in the oral biologics market to benefit from potentially strong profit margins, shift to biologics, as the innovation rate is increasing in that field, develop microneedle injectors-based drugs to increase the bioavailability and eliminate side effects of subcutaneous route. Player-adopted strategies in the oral biologics and biosimilars industry include strengthening oral biologics business with strategic collaborations, and through new launches and approvals, developing and commercializing new therapies for the treatment of patients with food allergies.
Recommendations – To take advantage of the opportunities, the business research company recommends the oral biologics and biosimilars companies to focus on strategic alliances for research & development, focus on expanding through collaborations, expand in emerging markets, consider providing biologics at a considerably lower price and manufacturers should create awareness regarding the benefits and cost effectiveness of biosimilars.
Oral Biologics & Biosimilars Market Segmentation
The oral biologics & biosimilars market is segmented by therapeutic mechanism, disease, molecule type, distribution channel and by geography.?
By Therapeutic Mechanism -
The oral biologics & biosimilars market can be segmented by therapeutic mechanism
The others (Interferons, Opioid receptors, Calcitonin receptor) was the largest segment of the oral biologics and biosimilars market by therapeutic mechanism, accounting for $676.1 million of the total market in 2019.
- a. Tumor Necrosis Factor-Alpha Inhibitors
- b. Lymphocyte Modulators
- c. Interleukin Inhibitors
- d. GPCR (insulin, growth hormone, parathyroid hormone) Modulators
- e. Immunostimulants
- f. Others
By Disease –?
The oral biologics & biosimilars market can be segmented by disease
The infectious diseases was the largest segment of the oral biologics and biosimilars market by disease, accounting for $2,305.6 million or 74.9% of the total market in 2019 and this market is expected to grow at a CAGR of 7.1% during 2019-2023. The diabetes market is expected to be the fastest-growing segment going forward at a CAGR of 82.6%.
- a. Diabetes
- b. Arthritis & Chron`s Disease
- c. Cancer
- d. Infectious Diseases
- e. Other Autoimmune Diseases
- f. Others Diseases
By Molecule Type –?
The Oral Biologics & Biosimilars market can be segmented by molecule
The vaccines was the largest segment of the oral biologics and biosimilars market by molecule type, accounting for $2,305.6 million or 74.9% of the total market in 2019 and this market is expected to grow at a CAGR of 7.1% during 2019-2023. The proteins & peptides market is expected to be the fastest-growing segment going forward at a CAGR of 38.0%.
- a. Vaccines
- b. Proteins & Peptides
- c. Monoclonal Antibodies
- d. Others
By Distribution Channel–?
The oral biologics & biosimilars market can be segmented by distribution channel
The hospital pharmacies was the largest segment of the oral biologics and biosimilars market by distribution channel, accounting for $1,891.3 million or 61.5% of the total market in 2019 and this market is expected to grow at a CAGR of 18.3% during 2019-2023. The online pharmacies distribution channel is expected to be the fastest-growing segment going forward at a CAGR of 25.0%.
- a. Hospital Pharmacies
- b. Retail Pharmacies
- c. Online Pharmacies
By Geography-?The Oral Biologics & Biosimilars market is segmented into
North America was the largest region in the oral biologics and biosimilars market, accounting for 46.2% of the global market in 2019. It was followed by Asia Pacific, Western Europe and the other regions. Going forward, the fastest growing regions in the oral biologics and biosimilars market will be Western Europe and North America, where growth will be at CAGRs of 20.3% and 18.9% respectively from 2019-2023.
- o North America
- o Western Europe
- o Asia Pacific
- South Korea
- o Eastern Europe
- o South America
- o Middle East
- o Africa
Oral Biologics & Biosimilars Competitive Landscape
Major Competitors are:
Other Competitors Include:
- • Merck & Co
- • GlaxoSmithKline
- • Novo Nordisk
- • ALK-Abello A/S
- • Aimmune Therapeutics, Inc.
- • Henlius
- • Innovent Biologics
- • Bio-Thera
- • Hisun Pharma
- • 3SBio
- • Beijing ShuangLu Pharmaceuticals
- • Qilu Pharmaceutical
- • Shanghai Fosun Pharmaceuticals
- • Biocon
- • Mylan
- • Dr Reddys
- • Kyowa Hakko Kirin
- • Takeda
- • Mitsubishi Tanabe
- • AGC Biologics
- • BiosanaPharma
- • AstraZeneca
- • Bayer
- • Boehringer Ingelheim
- • GlaxoSmithKline
- • Sanofi
- • Microgen
- • Geropharm
- • Valenta
- • NovaMedica
- • SynBio
- • Roche
- • Rani Therapeutics
- • Eli Lilly and Company
- • Emisphere Technologies, Inc
- • Enteris BioPharma
- • Allena Pharmaceuticals
- • Abbvie
- • Johnson & Johnson
- • Biogen Inc.
- • Pfizer Inc
- • Ache
- • Eurofarma
- • Novartis
- • Teva Pharmaceuticals
- • Oramed Pharmaceuticals
- • Entera Bio
- • Julphar
- • Hikma Pharmaceuticals
- • Altis Biologics
- • Cipla Medpro South Africa
- • Sanofi Genzyme