Press release
Novel Drugs Market Forecast 2035 | Key Driver, Restraint, and Growth Opportunity
Novel Drugs Market Forecast 2035 | Key Driver, Restraint, and Growth Opportunity
Get the Detailed Industry Analysis (including the Table of Contents, List of Figures, and List of Tables) - from the Novel Drugs Market Research Report: https://marketgenics.co/press-releases/novel-drugs-market-35266
Global Novel Drugs Market Forecast 2035:
According to the report, the global novel drugs market is projected to expand from USD 193.6 billion in 2025 to USD 406.5 billion by 2035, registering a CAGR of 7.7%, the highest during the forecast period. The novel drugs market in the world is experiencing high growth rates as a result of the growing commonness of chronic, rare, and complex diseases and the growing requirement of special and individualized treatment. The biologics, gene therapies, and cell-based therapies have been developed faster due to advances in biotechnology, genetic engineering, and molecular biology with a higher rate of efficacy, specificity, and safety compared to the traditional small-molecule drugs.
The platform technologies, such as mRNA, viral vectors, and AI-based drug discovery systems, allow to develop multiple therapeutic candidates with one investment, decreasing the costs and minimizing the timelines. Favorable regulatory systems, breakthrough therapy labeling and fast track approval procedures are yet another way of easing the commercialization of new treatments.
Additionally, increasing R&D expenditure, strategic partnerships and new forms of therapeutic interventions are enhancing innovations, satisfying unmet medical demands and providing more clinical interventions to patients across the globe. All these tendencies place the market of new drugs in the prospects of a long-term worldwide development and improvement.
"Key Driver, Restraint, and Growth Opportunity Shaping the Global Novel Drugs Market"
Drug discovery and development are undergoing revolution with artificial intelligence (AI) making it possible to analyze the large volumes of biological data, such as genomics, proteomics, and chemical libraries, quickly. The AI-based tools are able to predict the drug-target interactions, optimize the molecular structures and detect possible safety issues significantly quicker than the conventional approaches. This speedy pace saves the preclinical and clinical development timelines, reduces the cost of R&D and the success rate of new therapeutic products. For instance, in 2025, US biotech Nabla Bio and Japan-based Takeda Pharmaceutical deepened their AI-based drug development collaboration, relying on Nabla to design drug-like protein drugs and improve their performance using its design platform.
The integration of new treatments is highly inhibited by safety issues and lack of patient education. Most of the novel treatments, such as biologics, gene therapies, and cell-based therapies, have risks of adverse events or side effects that are unforeseen, so can create regulation problems, take longer to approve, and may be adopted with caution by health professionals. At the same time, patient lack of knowledge or ignorance of such high-end treatments may decrease adoption and use, especially of complex or first-in-class therapies.
Orphan drug designations give regulatory incentives like a market exclusivity right, tax credits, waiver of fees and expedited drug approval. These advantages reduce the cost of development, attract investments, and increase the research and development in the areas that were neglected before. Orphan drug status increases pipelines and spurs global novel drugs market growth because it allows premium pricing and accelerated commercialization. To provide an example, in 2025, FDA gave Orphan Drug Designation to Rilzabrutinib, wAIHA, and IgG4-RD developed by Sanofi, granting it market exclusivity and incentives to develop. This contributes to faster commercialization, runs the novel-drug pipeline, and propels expansion of the rare-disease area of the world novel drugs market.
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Expansion of Global Novel Drugs Market
"Innovation, and public funding propel the global Novel Drugs market expansion"
The global novel drugs market is showing a tremendous growth by mainly adopting a technological advancement in drug delivery, molecular engineering, biomarker-based therapy, and high throughput screening technologies, which increase therapeutic efficacy, patient outcome optimization and the next generation treatment development. As an example, in 2025, the FDA granted permission to approve Kygevvi to treat Thymidine Kinase 2 (TK2) deficiency, the first targeted therapy in treating this rare genetic disease, but it demonstrates progress in precision medicine in rare genetic diseases.
The introduction of the novel drugs market can be significantly promoted by government and insurance, which will lessen out-of-pocket expenses, support reimbursement, and offer grants or tax breaks on innovative therapy, which will result in greater patient access and increased uptake of advanced therapy. The U.S. Department of Health and Human Services (HHS) identified 15 more drugs to be negotiated on Medicare prices under the Inflation Reduction Act, to improve access to novel expensive treatments, and to stimulate wider use of innovative therapies in the U.S. market.
Regional Analysis of Global Novel Drugs Market
North America presents the largest potential to innovative drugs due to the well-established clinical trial networks, developed health care facilities, and substantial investment in research and development. The high rates of chronic and rare diseases, with an early uptake of biologics, gene/cell therapies, and precision medicine, increase the rate of adoption in the market. Favorable regulatory directions, protection of intellectual property, and government/ private funds are another stimulus to innovation, pipeline advancement, and commercialization of innovative therapeutics, which enhance the role of the region in the world innovative drugs market.
The Asia Pacific region is expected to experience the most rapid growth in the novel drugs market because of the growing healthcare infrastructure, the rise of government programs aimed at accessing more advanced therapies, and the growth in prevalence of chronic and lifestyle-related diseases. Nations such as China, India and Japan are spending a lot in pharmaceutical research and development, creating local innovation, clinical trials and the adoption of biologics and targeted therapies; all of these have resulted in the growth of the market regionally.
Prominent players operating in the global novel drugs market are AbbVie Inc., Amgen Inc., AstraZeneca PLC, Bayer AG, Biogen Inc., BioNTech SE, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline plc (GSK), Johnson & Johnson, Merck & Co., Inc., Moderna, Inc., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Regeneron Pharmaceuticals, Inc., Roche Holding AG, Sanofi S.A., Takeda Pharmaceutical Company Limited, Vertex Pharmaceuticals Incorporated, and Other Key Players.
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The global novel drugs market has been segmented as follows:
Global Novel Drugs Market Analysis, By Drug Type
Small Molecule Drugs
Biologics
Monoclonal Antibodies
Antibody-Drug Conjugates (ADCs)
Bispecific Antibodies
Cell Therapies
CAR-T Cell Therapies
NK Cell Therapies
Gene Therapies
RNA-based Therapeutics
mRNA Therapeutics
siRNA Therapeutics
ASO (Antisense Oligonucleotides)
Peptide Therapeutics
Protein Therapeutics
Others
Global Novel Drugs Market Analysis, By Therapeutic Area
Oncology
Solid Tumors
Hematological Malignancies
Immunology & Autoimmune Disorders
Cardiovascular Diseases
Central Nervous System Disorders
Neurodegenerative Diseases
Psychiatric Disorders
Metabolic Disorders
Diabetes
Obesity
Others
Rare Diseases (Orphan Drugs)
Infectious Diseases
Respiratory Disorders
Others
Global Novel Drugs Market Analysis, By Mechanism of Action
Targeted Therapy
Immunotherapy
Gene Editing (CRISPR-based)
Enzyme Replacement Therapy
Signal Transduction Modulators
Epigenetic Modulators
Others
Global Novel Drugs Market Analysis, By Route of Administration
Oral
Injectable
Subcutaneous
Intramuscular
Intravenous
Others
Transdermal Patches
Inhalation
Topical
Global Novel Drugs Market Analysis, By Technology Platform
Recombinant DNA Technology
Hybridoma Technology
CRISPR/Cas9
Viral Vector-based
Non-viral Vector-based
Nanoparticle-based Delivery
Lipid Nanoparticle (LNP) Technology
Others
Global Novel Drugs Market Analysis, By Drug Classification
First-in-Class
Best-in-Class
Me-too Drugs
Biosimilars/Biobetters
Global Novel Drugs Market Analysis, By End-users
Healthcare Facilities
Inpatient Treatment
Outpatient Treatment
Chronic Disease Management
Acute Care
Chemotherapy
Immunotherapy
Others
Research & Academic Institutions
Drug Discovery Research
Clinical Research
Preclinical Studies
Biomarker Development
Others
Pharmaceutical & Biotechnology Companies
Commercial Production
Clinical Trial Supply
Clinical Development
Scale-up Production
Others
Home Healthcare
Self-administration
Remote Patient Monitoring
Palliative Care
Others
Other End-users
Global Novel Drugs Market Analysis, By Region
North America
Europe
Asia Pacific
Middle East
Africa
South America
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MarketGenics is a global market research and management consulting company empowering decision makers across healthcare, technology, and policy domains. Our mission is to deliver granular market intelligence combined with strategic foresight to accelerate sustainable growth.
We support clients across strategy development, product innovation, healthcare infrastructure, and digital transformation.
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