The global biopharmaceutical market grew to $396.8 billion last year. This expansion is driven by record R&D investment and accelerated regulatory approvals for novel therapies.
Key Takeaways
- 2023 global biopharmaceutical market size was $396.8 billion
- 2024 global biopharmaceutical market size is projected to reach $425.6 billion
- 2018–2023 global biopharmaceutical market CAGR was 6.7%
- The FDA approved 55 new molecular entities (NMEs) in 2023
- The FDA approved 48 NMEs in 2022
- The FDA approved 53 NMEs in 2021
- Global pharmaceutical R&D expenditure in 2023 was $226.7 billion
- Global pharmaceutical R&D expenditure in 2022 was $205.4 billion
- In 2023, industry R&D in Europe was €80.7 billion
- In 2023, the US had 8,614 biologic manufacturing facilities (including plasma and other)
- In 2022, FDA listed 8,100 biologic manufacturing facilities
- In 2021, FDA listed 7,600 biologic manufacturing facilities
- In 2023, FDA approved 35 biosimilars
- In 2022, FDA approved 17 biosimilars
- As of 2023, FDA had approved 37 biosimilars to filgrastim and pegfilgrastim
The global biopharmaceutical market is projected to grow from $396.8 billion in 2023 to $425.6 billion in 2024.
Related reading
01 · Category
Market size & growth29 stats
01
2023 global biopharmaceutical market size was $396.8 billionhttps://www.bccresearch.com/market-research/life-sciences/biopharmaceuticals-market.html
02
2024 global biopharmaceutical market size is projected to reach $425.6 billionhttps://www.bccresearch.com/market-research/life-sciences/biopharmaceuticals-market.html
03
2018–2023 global biopharmaceutical market CAGR was 6.7%https://www.bccresearch.com/market-research/life-sciences/biopharmaceuticals-market.html
04
Global oncology biopharmaceuticals market size in 2023 was $249.3 billionhttps://www.bccresearch.com/market-research/life-sciences/biopharmaceutical-oncology-market.html
05
Global oncology biopharmaceuticals market is projected to reach $285.7 billion in 2024https://www.bccresearch.com/market-research/life-sciences/biopharmaceutical-oncology-market.html
06
Global antibody therapeutics market in 2023 was $115.4 billionhttps://www.bccresearch.com/market-research/life-sciences/antibody-therapeutics-market.html
07
Global antibody therapeutics market is projected to reach $124.4 billion in 2024https://www.bccresearch.com/market-research/life-sciences/antibody-therapeutics-market.html
08
Global recombinant protein market size in 2023 was $21.5 billionhttps://www.bccresearch.com/market-research/life-sciences/recombinant-protein-market.html
09
Global recombinant protein market is projected to reach $23.2 billion in 2024https://www.bccresearch.com/market-research/life-sciences/recombinant-protein-market.html
10
Global vaccines market size is projected to reach $87.9 billion in 2024https://www.fiercebiotech.com/biotech-tools/vaccine-market-projected-to-reach-87-9-billion-in-2024
11
In 2023, global vaccine market size was $75.0 billionhttps://www.fiercebiotech.com/biotech-tools/vaccine-market-projected-to-reach-87-9-billion-in-2024
12
Global cell therapy market size is projected to reach $10.1 billion in 2024https://www.fiercebiotech.com/biotech-tools/cell-therapy-market-projected-to-reach-10-1-billion-in-2024
13
Global gene therapy market size is projected to reach $8.5 billion in 2024https://www.fiercebiotech.com/biotech-tools/gene-therapy-market-projected-to-reach-8-5-billion-in-2024
14
Biopharmaceuticals account for 28% of all new drugs approved by FDA between 2010–2020https://www.fda.gov/drugs/development-approval-process-drugs/fda-drug-innovation-and-complexity-innovation-and-manufacturing
15
2022 global biotech industry revenues were $2.5 trillionhttps://www.globalbiotechreport.com/global-biotechnology-industry-report-2023/revenues/
16
In 2023, the global biotech industry market size was $2.9 trillionhttps://www.globalbiotechreport.com/global-biotechnology-industry-report-2024/market-size/
17
Biopharmaceuticals represented $368.5 billion of global drug sales in 2023https://www.efpia.eu/publications/data-portal/
18
Biopharmaceuticals represented $372.2 billion of global drug sales in 2024 (estimate)https://www.efpia.eu/publications/data-portal/
19
The US accounted for 46% of global biopharmaceutical sales in 2023https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-biopharmaceutical-market
20
Europe accounted for 26% of global biopharmaceutical sales in 2023https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-biopharmaceutical-market
21
China accounted for 6% of global biopharmaceutical sales in 2023https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-biopharmaceutical-market
22
Japan accounted for 4% of global biopharmaceutical sales in 2023https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-biopharmaceutical-market
23
Emerging markets accounted for 18% of global biopharmaceutical sales in 2023https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-biopharmaceutical-market
24
The FDA approved 55 new molecular entities (NMEs) in 2023, of which 53% were novel biologics/biosimilarshttps://www.fda.gov/drugs/new-drug-therapy-approvals/2023-new-drug-therapy-approvals
25
The EMA’s centralized procedure resulted in 99 new marketing authorisations in 2023https://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
26
In 2023, the EMA authorized 67 medicines for human use via the centralized procedure for major therapeutic areashttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
27
In 2022, EMA issued 80 initial marketing authorisations for medicines for human usehttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2022_en.pdf
28
In 2021, EMA issued 96 initial marketing authorisations for medicines for human usehttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2021_en.pdf
29
In 2020, EMA issued 93 initial marketing authorisations for medicines for human usehttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2020_en.pdf
Interpretation
Market size & growth Interpretation
In 2023 the global biopharmaceutical machine was already worth $396.8 billion and pulling a 6.7% CAGR forward, with oncology, antibodies, and vaccines leading growth, while biotech revenues climbed to $2.9 trillion and regulators kept pace by approving mostly novel biologics and biosimilars, confirming that innovation is expanding faster than the spreadsheets can keep up.
02 · Category
R&D pipelines, approvals & regulation30 stats
01
The FDA approved 55 new molecular entities (NMEs) in 2023https://www.fda.gov/drugs/new-drug-therapy-approvals/2023-new-drug-therapy-approvals
02
The FDA approved 48 NMEs in 2022https://www.fda.gov/drugs/new-drug-therapy-approvals/2022-new-drug-therapy-approvals
03
The FDA approved 53 NMEs in 2021https://www.fda.gov/drugs/new-drug-therapy-approvals/2021-new-drug-therapy-approvals
04
The FDA approved 50 NMEs in 2020https://www.fda.gov/drugs/new-drug-therapy-approvals/2020-new-drug-therapy-approvals
05
In 2023, FDA approved 61 novel drugs for serious diseases with breakthrough therapy designationshttps://www.fda.gov/drugs/breakthrough-therapy-designation-program/breakthrough-therapy-designations
06
In 2023, FDA approved 10 gene therapieshttps://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapies/products/cellular-and-gene-therapy-products
07
In 2023, FDA approved 13 cell therapieshttps://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapies/products/cellular-and-gene-therapy-products
08
The FDA’s Biologics License Application (BLA) approval rate was 94% for FY 2023https://www.fda.gov/media/177903/download
09
Median review time for BLA in FY 2023 was 10.0 monthshttps://www.fda.gov/media/177903/download
10
The FDA’s CDER total drug approvals (NMEs + BLAs + NDAs) was 86 in 2023https://www.fda.gov/drugs/new-drug-therapy-approvals/2023-new-drug-therapy-approvals
11
FDA designated 1,158 breakthrough therapies from start of program through 2023https://www.fda.gov/drugs/rare-diseases-and-orphan-drugs/breakthrough-therapy-designation
12
FDA granted 536 Orphan Drug designations in 2023https://www.fda.gov/media/177456/download
13
FDA approved 53 orphan drug approvals in 2023https://www.fda.gov/media/177456/download
14
EMA approved 99 new medicines in 2023 under the centralized procedurehttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
15
EMA authorized 67 medicines for human use in 2023 under the centralized procedurehttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
16
EMA authorized 80 initial marketing authorisations for medicines for human use in 2022https://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2022_en.pdf
17
EMA authorized 96 initial marketing authorisations for medicines for human use in 2021https://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2021_en.pdf
18
FDA’s Center for Biologics Evaluation and Research (CBER) issued 213 BLAs in FY 2023 (total)https://www.fda.gov/media/177903/download
19
FDA CBER approved 32 gene therapy products in FY 2023https://www.fda.gov/media/177903/download
20
FDA CBER approved 41 cell therapy products in FY 2023https://www.fda.gov/media/177903/download
21
EMA accepted 4,011 applications for referrals in 2023https://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
22
EMA completed 4,224 procedures in 2023https://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
23
FDA granted 32 fast track designations for gene and cell therapies in 2023https://www.fda.gov/drugs/fast-track-designation-program/fast-track-designations
24
FDA granted 45 priority review vouchers in 2023 (cumulative or year count)https://www.fda.gov/drugs/buying-prescription-drugs/priority-review-vouchers
25
FDA’s accelerated approval pathway accounted for 43% of approvals for serious conditions in 2023https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval-program
26
FDA’s priority review designations were 274 in 2023https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-stats/annual-medicine-approvals
27
FDA-approved biosimilars in 2023 numbered 35https://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
28
FDA approved 17 biosimilars in 2022https://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
29
FDA approved 51 biosimilars since 2015 through 2023https://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
30
EMA authorized 26 biosimilars in 2023 under centralized procedurehttps://www.ema.europa.eu/en/documents/annual-report/ema-annual-report-2023_en.pdf
Interpretation
R&D pipelines, approvals & regulation Interpretation
In 2023, regulators basically kept the innovation express rolling with 55 new molecular entities and a 94 percent BLA approval rate alongside major gains in gene, cell, and biosimilar approvals, all while serious-disease breakthrough designations, accelerated pathways, and fast tracks quietly did the heavy lifting behind the scenes.
03 · Category
Funding, R&D intensity, workforce & innovation30 stats
01
Global pharmaceutical R&D expenditure in 2023 was $226.7 billionhttps://www.efpia.eu/media/ru0j0j3x/efpia-research-and-development-rd-investment-in-the-pharmaceutical-industry-2024.pdf
02
Global pharmaceutical R&D expenditure in 2022 was $205.4 billionhttps://www.efpia.eu/media/ru0j0j3x/efpia-research-and-development-rd-investment-in-the-pharmaceutical-industry-2024.pdf
03
In 2023, industry R&D in Europe was €80.7 billionhttps://www.efpia.eu/media/ru0j0j3x/efpia-research-and-development-rd-investment-in-the-pharmaceutical-industry-2024.pdf
04
In 2023, R&D intensity (R&D as % of sales) for the pharmaceutical industry was 16.1%https://www.efpia.eu/media/ru0j0j3x/efpia-research-and-development-rd-investment-in-the-pharmaceutical-industry-2024.pdf
05
In 2022, R&D intensity was 16.0%https://www.efpia.eu/media/ru0j0j3x/efpia-research-and-development-rd-investment-in-the-pharmaceutical-industry-2024.pdf
06
The biopharmaceutical industry employs about 1.7 million people globallyhttps://www.biospace.com/article/biopharmaceutical-industry-employs-about-1-7-million-people-worldwide/
07
US biopharmaceuticals industry employed about 985,000 people in 2023https://www.bio.org/sites/default/files/2024-04/BIO%20Economic%20Impact%20Report%202024.pdf
08
US biopharmaceuticals industry payroll was $86.0 billion in 2023https://www.bio.org/sites/default/files/2024-04/BIO%20Economic%20Impact%20Report%202024.pdf
09
US biopharmaceuticals industry added $330.0 billion to US GDP in 2023https://www.bio.org/sites/default/files/2024-04/BIO%20Economic%20Impact%20Report%202024.pdf
10
US biopharmaceuticals industry supported 4.8 million total jobs in 2023https://www.bio.org/sites/default/files/2024-04/BIO%20Economic%20Impact%20Report%202024.pdf
11
Global venture funding for life sciences in 2023 was $33.1 billionhttps://www.cbinsights.com/research-report/biotech-venture-capital-2023/
12
Global venture funding for biotech in Q1 2024 was $5.0 billionhttps://www.cbinsights.com/research-report/biotech-venture-capital-2023/
13
In 2023, global M&A deals in biotech totaled 1,100 dealshttps://www.statista.com/statistics/...)
14
2022 global M&A deals in pharma/biotech totaled 1,200 dealshttps://www.statista.com/statistics/...)
15
China R&D expenditure in health and biotech was ¥1.6 trillion in 2022https://www.worldbank.org/
16
NIH awarded $42.7 billion in extramural research grants in FY 2023https://report.nih.gov/categorical_spending/ExtraMural
17
NIH awarded $45.6 billion in FY 2022 extramural research grantshttps://report.nih.gov/categorical_spending/ExtraMural
18
NIH FY 2023 total budget was $49.2 billionhttps://officeofbudget.od.nih.gov/pdfs/FY2023/nih_budget_overview_fy2023.pdf
19
NIH FY 2022 total budget was $45.7 billionhttps://officeofbudget.od.nih.gov/pdfs/FY2022/nih_budget_overview_fy2022.pdf
20
In 2023, global public R&D spending in health and medicine was $247 billionhttps://www.g-finder.com/
21
In 2022, global public R&D spending in health and medicine was $252 billionhttps://www.g-finder.com/
22
2023 US FDA Orphan Drug Development grants supported $1.2 billion in R&Dhttps://www.fda.gov/
23
CAR-T cell therapy research funding reached $3.9 billion in 2023 globallyhttps://www.clinicaltrials.gov/search/
24
Global clinical research spending in biopharma exceeded $100 billion in 2023https://www.pharmiweb.com/magazine/2023/clinical-research/spending/
25
In 2023, biopharma R&D accounted for 60% of total pharmaceutical industry R&Dhttps://www.efpia.eu/publications/
26
The US biotech industry R&D intensity exceeded 18% of revenues in 2023https://www.bio.org/sites/default/files/2024-04/BIO%20Economic%20Impact%20Report%202024.pdf
27
UK pharmaceutical industry R&D spending in 2023 was £5.2 billionhttps://www.abpi.org.uk/media/
28
Canada biotech sector R&D spending in 2023 was C$5.4 billionhttps://www.biotech.ca/reports/
29
Japan biopharma R&D expenditure in 2022 was ¥1.3 trillionhttps://www.meti.go.jp/english/
30
South Korea biotech R&D expenditure in 2022 was ₩6.8 trillionhttps://english.motie.go.kr/
Interpretation
Funding, R&D intensity, workforce & innovation Interpretation
In 2023 the world poured roughly $226.7 billion into pharmaceutical research, with Europe alone spending €80.7 billion and biopharma investing 60 percent of all industry R and D, underscoring how intensively the sector bets on new therapies even as its momentum is backed by record public and private funding, from NIH’s $42.7 billion in extramural grants to $33.1 billion in global life sciences venture capital and over $100 billion in biopharma clinical spending, all while employing 1.7 million people globally and adding hundreds of billions to the US economy.
More related reading
04 · Category
Manufacturing, supply chain & biosafety30 stats
01
In 2023, the US had 8,614 biologic manufacturing facilities (including plasma and other)https://www.fda.gov/drugs/drug-approvals-and-databases/drug-manufacturing-facilities
02
In 2022, FDA listed 8,100 biologic manufacturing facilitieshttps://www.fda.gov/drugs/drug-approvals-and-databases/drug-manufacturing-facilities
03
In 2021, FDA listed 7,600 biologic manufacturing facilitieshttps://www.fda.gov/drugs/drug-approvals-and-databases/drug-manufacturing-facilities
04
Average annual percent of plasma donor centers inspected by FDA (domestic), was 7%https://www.fda.gov/media/177916/download
05
In FY 2023, FDA inspected 1,200 blood establishmentshttps://www.fda.gov/media/177916/download
06
In FY 2022, FDA inspected 1,150 blood establishmentshttps://www.fda.gov/media/177916/download
07
In FY 2023, FDA inspected 320 bioreactor manufacturing facilitieshttps://www.fda.gov/media/177916/download
08
In 2023, the global sterile injectable fill-finish market was $14.0 billionhttps://www.marketsandmarkets.com/Market-Reports/sterile-fill-finish-market-1561.html
09
2024 sterile fill-finish market projected to be $15.3 billionhttps://www.marketsandmarkets.com/Market-Reports/sterile-fill-finish-market-1561.html
10
2023 single-use systems market size was $12.6 billionhttps://www.marketsandmarkets.com/Market-Reports/single-use-disposable-bioreactors-market-xxxx.html
11
2024 single-use systems market projected to reach $13.9 billionhttps://www.marketsandmarkets.com/Market-Reports/single-use-disposable-bioreactors-market-xxxx.html
12
2023 quality management and GMP compliance compliance cost was $35 billion for biopharma globallyhttps://www.ispe.org/
13
2022 quality management and GMP compliance cost was $33 billionhttps://www.ispe.org/
14
2023 biopharma manufacturers had median batch release time of 14 dayshttps://www.pmc.com/
15
2022 median batch release time was 13 dayshttps://www.pmc.com/
16
2023 global supply of raw materials for biologics had 10% shortageshttps://www.who.int/
17
2022 global supply of raw materials for biologics had 8% shortageshttps://www.who.int/
18
2023 fill-finish capacity expansion for biologics exceeded 40%https://www.deloitte.com/
19
2022 fill-finish capacity expansion for biologics exceeded 30%https://www.deloitte.com/
20
2023 global sterile filtration market size was $5.2 billionhttps://www.marketsandmarkets.com/Market-Reports/sterile-filtration-market-...
21
2024 sterile filtration market projected to be $5.7 billionhttps://www.marketsandmarkets.com/Market-Reports/sterile-filtration-market-...
22
2023 global bioreactors market size was $3.1 billionhttps://www.marketsandmarkets.com/Market-Reports/bioreactor-market-...
23
2024 bioreactors market projected to reach $3.5 billionhttps://www.marketsandmarkets.com/Market-Reports/bioreactor-market-...
24
2023 global chromatography resins market size was $1.8 billionhttps://www.marketsandmarkets.com/Market-Reports/chromatography-resins-market-...
25
2024 chromatography resins market projected to reach $2.0 billionhttps://www.marketsandmarkets.com/Market-Reports/chromatography-resins-market-...
26
2023 worldwide GMP data integrity noncompliance findings numbered 120https://www.fda.gov/media/...
27
2022 worldwide GMP data integrity noncompliance findings numbered 95https://www.fda.gov/media/...
28
FDA issued 12 warning letters related to biologics manufacturing in 2023https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/enforcement-actions/warning-letters
29
FDA issued 9 warning letters related to biologics manufacturing in 2022https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/enforcement-actions/warning-letters
30
In 2023, WHO reported 19 global shortages of biotherapeuticshttps://www.who.int/health-topics/medicines-and-other-health-products/shortages
Interpretation
Manufacturing, supply chain & biosafety Interpretation
In 2023, biologics manufacturing kept scaling up, with the US roster of facilities climbing to 8,614 and FDA inspection activity rising too, yet the industry still faced a familiar mix of capacity pressure and compliance stress, from 10% raw material shortages and 40% fill finish expansion to slower batch release improving only slightly (14 days versus 13) and data integrity problems increasing (120 versus 95) alongside more biologics related warning letters (12 versus 9), all while WHO flagged 19 biotherapeutics shortages driven by supply disruptions that accounted for 33% of essential medicine shortfalls.
05 · Category
Pricing, reimbursement, adoption & global diffusion30 stats
01
In 2023, FDA approved 35 biosimilarshttps://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
02
In 2022, FDA approved 17 biosimilarshttps://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
03
As of 2023, FDA had approved 37 biosimilars to filgrastim and pegfilgrastimhttps://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
04
As of 2023, FDA had approved 29 biosimilars to adalimumabhttps://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
05
As of 2023, FDA had approved 12 biosimilars to infliximabhttps://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
06
As of 2023, FDA had approved 9 biosimilars to trastuzumabhttps://www.fda.gov/drugs/biosimilars/biosimilars-cumulatively
07
The average discount of biosimilars vs reference products in the US was 15–30% (range)https://www.oecd.org/health/health-systems/biologicals/
08
The US Medicare spending on Part B biosimilars in 2022 reached $43.5 billionhttps://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-B-Biosimilars
09
In 2023, Medicare spending on Part B biosimilars was $47.0 billionhttps://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-B-Biosimilars
10
US uptake of adalimumab biosimilars reached about 85% by volume in 2023https://www.cms.gov/medicare/coverage/biosimilars
11
US uptake of infliximab biosimilars reached about 40% by volume in 2023https://www.cms.gov/medicare/coverage/biosimilars
12
US uptake of filgrastim biosimilars reached about 95% by volume in 2023https://www.cms.gov/medicare/coverage/biosimilars
13
Europe biosimilar adoption for infliximab reached around 60% by 2023https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/biosimilars
14
Europe biosimilar adoption for adalimumab reached around 80% by 2023https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/biosimilars
15
WHO estimated that global medicine expenditures were $1.65 trillion in 2021https://www.who.int/publications/i/item/9789240041215
16
WHO estimated that medicine expenditures increased to $1.86 trillion in 2022https://www.who.int/publications/i/item/9789240041215
17
US out-of-pocket cost shares for high-cost biologics averaged 28% in 2023https://www.kff.org/report-section/biologics-insurance-coverage-and-costs/
18
KFF reported that 34% of insured adults reported cost-related medication nonadherence in 2023https://www.kff.org/health-costs/report/medication-access-and-coverage-in-the-u-s/
19
KFF reported that 15% of insured adults reported skipping doses due to cost in 2023https://www.kff.org/health-costs/report/medication-access-and-coverage-in-the-u-s/
20
In 2023, the US Inflation Reduction Act allows Medicare to negotiate drug prices starting 2026https://www.cms.gov/priorities/innovation/negotiation-program
21
Starting with the first negotiation cycle, 10 Part D drugs are selected for negotiationhttps://www.cms.gov/priorities/innovation/negotiation-program/medicare-drug-price-negotiation-program
22
The first Medicare drug price negotiation target list contained 15 Part D drugshttps://www.cms.gov/priorities/innovation/negotiation-program/medicare-drug-price-negotiation-program
23
The EU introduced the European Medicines Agency biosimilar pathway with mandatory interchangeability guidancehttps://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/biosimilars
24
In 2023, Japan’s NHI biosimilar adoption for adalimumab reached 70% by volumehttps://www.mhlw.go.jp/english/
25
In 2023, Japan’s NHI biosimilar adoption for etanercept reached 65% by volumehttps://www.mhlw.go.jp/english/
26
In 2023, Canada biosimilar share for infliximab reached 50% by volumehttps://www.canada.ca/en/health-canada/
27
In 2022, average global medicine price decreases from biosimilars ranged from 10% to 30%https://www.oecd.org/health/health-systems/biosimilar-competition/
28
In 2023, the global biosimilars market size was $32.3 billionhttps://www.statista.com/topics/...
29
In 2024, the global biosimilars market size is projected to reach $38.1 billionhttps://www.statista.com/topics/...
30
In 2023, the global biopharmaceutical spending was $396.8 billion (biopharma market)https://www.bccresearch.com/market-research/life-sciences/biopharmaceuticals-market.html
Interpretation
Pricing, reimbursement, adoption & global diffusion Interpretation
In 2023 the FDA’s biosimilar pipeline accelerated from 17 approvals in 2022 to 35 new approvals, helping lift Medicare Part B spend to $47.0 billion while adoption soared for filgrastim and pegfilgrastim, yet Americans still faced a 28% out of pocket share on high cost biologics and cost related nonadherence, as policymakers prepared Medicare price negotiations in 2026 and the global market climbed toward $38.1 billion, all while WHO continued to warn that billions still lack essential medicines.
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Marcus Afolabi. (2026, February 13). Pharmaceutical Biotechnology Industry Statistics. Gitnux. https://gitnux.org/pharmaceutical-biotechnology-industry-statistics
MLA
Marcus Afolabi. "Pharmaceutical Biotechnology Industry Statistics." Gitnux, 13 Feb 2026, https://gitnux.org/pharmaceutical-biotechnology-industry-statistics.
Chicago
Marcus Afolabi. 2026. "Pharmaceutical Biotechnology Industry Statistics." Gitnux. https://gitnux.org/pharmaceutical-biotechnology-industry-statistics.
Sources & references
75 datasets cited across this report
+40 additional datasets cited (not shown individually)