세계 제약용 정제 코팅 시장 규모는 2023년 10억 1,000만 달러에서 2031년 16억 2,000만 달러에 이를 것으로 예측되며, 예측기간인 2024-2031년 CAGR로 6.1% 성장이 예상됩니다. 시장의 성장은 제약 부문의 확대와 R&D 활동의 활성화에 의해 지원되고 있습니다.
제약 부문의 급성장은 세계 제약용 정제 코팅 시장 규모를 밀어 올리고 있습니다. 이 성장은 세계 여러 지역에서 다양한 질병과 장애의 유병률 증가와 인구의 급격한 증가로 인한 것입니다. 예를 들어 Invest India는 2030년까지 미국의 제약산업이 1,300억 달러에 달할 것으로 예측됩니다. 게다가, 의약품 제조의 품질이 중시되고, 제네릭 의약품의 채용이 증가하고 있기 때문에 시장에 유리한 성장 기회가 가져오고, 제약용 정제 코팅 수요가 높아지고 있습니다. 다양한 부형제 및 의약품에 대한 규제의 엄격화가 시장 확대를 더욱 강화하고 있습니다.
시장의 주요 기업이 실행 가능한 제약 정제 코팅의 비용 효율성과 적시 제공을 지원하는 장비를 생산하는 투자를 늘리고 있다는 것은 시장 성장을 더욱 촉진하고 있습니다. 게다가, 다양한 치료에 대한 접근성을 높이고 환자의 삶의 질을 향상시키는 비용 효율성이 높아 바이오시밀러의 인기가 높아지고 있는 것도 시장 확대를 뒷받침하고 있습니다. 예를 들어 Amgen Biosimilars의 2022 Biosimilar Trends Report는 지난 3년간 상시한 바이오시밀러의 치료 영역에서 평균 점유율이 75%로 추정되었습니다. 바이오시밀러는 기준이 되는 생물학적 제제의 유효성분을 모방하는 것으로, 기준이 되는 생물학적 제제와 유사한 특성의 존재를 확인하기 위해 광범위한 분석이 이루어집니다. 이와 같이 바이오시밀러 부문은 상당한 성장을 보였으며, 그 결과 제약용 정제 코팅 수요가 증가하고 시장 확대에 긍정적인 영향을 미치고 있습니다.
제네릭 의약품의 보급이 시장 수요를 끌어올립니다.
제네릭 의약품의 인기가 높아지는 것은 비용 효율성이 높고 이러한 의약품이 따라야 하는 엄격한 규제 기준에 대한 의식이 높아지기 때문일 수 있습니다. FDA로부터 인가를 받기 위해서는 제네릭 의약품은 선발 의약품과 생물학적으로 동등해야 합니다. 이것은 제네릭 의약품 제조업체가 활성 성분을 선발품으로부터 20% 변경하는 것을 인정받고 있다고 해도, 2개의 의약품이 화학적으로 동일하다는 것을 보증합니다. FDA의 허용 범위는 최대 20%이지만 일반적으로 4% 이하의 변동만 있습니다. 제네릭 의약품이 따르는 이러한 엄격한 규제 기준에 대한 일반 소비자의 의식이 높아짐에 따라 제네릭 의약품에 대한 신뢰가 높아지고 있습니다. 예를 들어, Association for Accessible Medicines는 미국에서 처방전의 약 90%가 제네릭 의약품이라고 추정합니다. 따라서 제약용 정제 코팅 수요가 높아지고 시장의 성장을 지원하고 있습니다.
제약용 정제 코팅 기술의 진보는 유리한 성장 기회를 가져옵니다.
필름 코팅 작업의 데이터 수집 및 실시간 모니터링을 위한 새로운 공정 분석 기술(PAT) 도구의 도입은 세계 제약용 정제 코팅 시장의 새로운 추세입니다. 다양한 PAT 도구에는 필름 코팅 작업을 모니터링하는 현미경 기술, 분광 기술, 이미징 기술과 같은 광범위한 기술이 포함됩니다. 최근, 다양한 첨단 기술의 개발에 성공하여 코팅 작업의 확장성이 향상되었습니다. 예를 들어, 라만 분광 기술은 사용하기 쉽고 컴팩트한 형상을 실현하고 교정 안정성을 높이기 위해 다양한 개선이 이루어졌습니다. 마찬가지로, 라트가스 대학의 연구 그룹은 고급 멀티 포인트 NIR 공간 분해 분광(SRS) 프로브를 종합적으로 평가했습니다. 이 프로브는 빠르고 정확한 측정을 가능하게 합니다. 이 기술이 제공하는 높은 효율과 정밀도로 시간당 약 20만정의 검사가 가능합니다. 이러한 개발과 진보는 예측 기간에 시장에 유리한 성장 기회를 가져올 전망입니다.
본 보고서에서는 세계의 제약용 정제 코팅 시장에 대한 조사 분석하여 시장 규모와 예측, 시장 역학, 주요 기업의 정세와 전망 등의 정보를 제공합니다.
Global pharma tablet coatings market is projected to witness a CAGR of 6.1% during the forecast period 2024-2031, growing from USD 1.01 billion in 2023 to USD 1.62 billion in 2031F. The growth of the market is supported by the expansion in the pharmaceutical sector and increasing research and development activities.
The rapid growth of the pharmaceutical sector is boosting the global pharma tablet coatings market size. The growth can be attributed to the increasing prevalence of various diseases and disorders and exponential rise in population in various regions across the globe. For instance, Invest India estimated that the pharmaceutical industry in the country is expected to reach USD 130 billion by 2030. Moreover, the increasing emphasis on the quality of pharmaceutical products manufacturing and rising adoption of generic drugs provide lucrative growth opportunities to the market, boosting the requirement for pharma tablet coatings. The increase in stringency by regulatory bodies regarding different excipients and drugs further bolstered the market expansion.
The rising investments by key players in the market to produce equipment that supports the delivery of viable pharma tablet coatings cost-efficient and timely are further propelling the global pharma tablet coatings market growth. Additionally, the rising popularity of biosimilars owing to their cost-effective nature, which increases the accessibility to various treatments and improves the quality of life of the patients, is supporting the expansion of the market for tablet coatings. For instance, 2022 Biosimilar Trends Report by Amgen Biosimilars estimates that for the biosimilars launched in the past three years, in the therapeutic areas, average share was 75%. Biosimilars mimic the active ingredient in the reference biologic and undergo extensive analysis to confirm the presence of similar characteristics to that of the reference biologics. Thus, the biosimilars sector is witnessing significant growth, which in turn is boosting the requirement for pharma tablet coatings and positively influencing the expansion of the market.
Increasing Adoption of Generics Boost Global Pharma Tablet Coatings Market Demand
The growing popularity of generics can be attributed to their cost-effective nature and the rising awareness of strict regulatory standards these drugs must follow. To receive the stamp of approval from the FDA, the generic drugs must be bioequivalent to their brand-name counterpart. It ensures that two drugs are chemically the same, though the makers of the generic medication are allowed a variation of twenty percent in the active ingredient from the original formula. Even though the wiggle room allowed by the FDA is up to 20%, variations of less than 4% are usually observed. Due to the increasing awareness among the general population about such strict regulatory standards followed by generic medications has boosted confidence in such drugs. For instance, the Association for Accessible Medicines estimates that approximately 90% of the prescriptions dispensed in the United States are of generics. Thus boosting the demand for pharma-coating tablets and supporting the market's growth.
Technological Advancements in Pharma Tablet Coatings Provide Lucrative Growth Opportunities
Introducing new process analytical technology (PAT) tools for data acquisition and real-time monitoring for filming coating operations is an emerging global pharma tablet coatings market trend. Various PAT tools include a wide range of techniques, such as microscopic techniques, spectroscopic techniques, and imaging techniques, to monitor the film coating operations. Recently, the successful development of various advanced technologies has aided in enhancing the scalability of the coating operations. For instance, the Raman spectroscopy technology underwent various improvements to make it more user-friendly, achieving a more compact form factor, and enhance the calibration stability. Similarly, a research group at Rutgers University comprehensively evaluated advanced multi-point NIR spatially resolved spectroscopy (SRS) probes. These probes provide rapid and precise measurements. The high efficiency and precision offered by this technology has allowed the inspection of approximately 200,000 tablets per hour. Such developments and advancements will provide lucrative growth opportunities to the market over the forecast period.
North America Accounts for a Significant Share of the Market
The growth of North America pharma tablet coatings market can be attributed to the rapid expansion of pharmaceutical sector in the region, strong presence of various leading market players, and increasing prevalence of several diseases and disorders. The rising investments by the market players based in the region towards the development of novel products and technologies are further aiding the growth of the market in North America.
For instance, in May 2023, Colorcon, headquartered in Pennsylvania, United States, introduced titanium dioxide-free film coating designed to mitigate the challenges associated with moisture-sensitive actives. Colorcon launched an Opadry film coating system that meets the moisture management requirements of pharmaceutical tablets without utilizing titanium dioxide. Through their portfolio of Opadry complete film coating systems, the company provides scope for reducing time-to-market and complexity by providing high-quality products to their customers. They are focused on carefully selecting ingredients that meet the local pharmaceutical regulatory requirements. Such regional developments will provide lucrative growth opportunities for the North American market.
Sustained Release Holds Significant Share of the Market
The growth of the segment can be attributed to the increasing prevalence of various diseases and disorders that require sustained and controlled release of drugs, including hypertension, diabetes, and asthma. For instance, the International Diabetes Federation estimated that, in 2021, approximately 10.5% of the adult population, i.e., individuals between the age of 20-79 years had diabetes. Also, by 2045 the number of cases of diabetes will witness an increase of 46% and 1 in 8 adults, about 783 million individuals will be living with diabetes. The increase in prevalence of diabetes will boost the requirement for sustained release pharma tablet costings, augmenting the market's growth.
Additionally, the utilization of sustained-release tablets offers various advantages, including slow drug release in the bloodstream, which allows for maintaining a constant level of medication in the bloodstream and removes the likelihood of burst drug release. Thus, it boosts demand and propels the market expansion.
Pharmaceutical Sector Accounts for Significant Market Share
The expansion of the pharmaceutical sector can be attributed to the exponential growth of the geriatric population, the increase in the prevalence of several diseases, and rising healthcare expenditure in various countries across the globe. Due to the growth, the requirement for pharma tablet coatings is increasing, augmenting the market demand. Additionally, the demand for tablet coatings by the pharmaceutical sector is augmenting as the prevalence of diseases that require tablet formulations as the primary form of treatment rises.
For instance, the rise in the number of cases of arthritis is boosting the demand for global pharma tablet coatings. According to the estimates of the Centers for Disease Control and Prevention, an estimated 53.2 million adults in the United States, approximately 21.2% of the population, have been diagnosed by a doctor to have some form of arthritis in 2023. The increase in the number of cases of arthritis is providing lucrative growth opportunities to the market as various corticosteroid medications are consumed as pills for slowing the joint damage and reducing pain and inflammation. Thus, boosting the requirement for pharma tablet coatings and supporting the expansion of the market.
Future Market Scenario (2024 - 2031F)
According to global pharma tablet coatings market analysis, the increasing emphasis on nanocoating technology will support the expansion of the market in the coming years. The growing utilization of nanotechnology will aid in enhancing the capabilities of the excipients. Nanocoating will aid in improving drug release profiles by enhancing the bioavailability of active pharmaceutical ingredient and controlling the release rate. Furthermore, the utilization of nanocoating technology will support the incorporation of different functional materials including antimicrobial agents, flavoring agents, antioxidants, and polymers, onto the surface of the tablet. The increasing utilization of nanocoating technology will provide various benefits and support the expansion of the market for pharma tablet coatings over the forecast period.
Key Players Landscape and Outlook
The increasing investments by the leading pharma tablet coatings market players towards the development of new coating manufacturing facilities will support the global pharma tablet coatings market growth. For instance, Colorcon is investing in the development of a new manufacturing facility in Johor State, Malaysia, through their subsidiary, Colorcon Malaysia. The facility will be producing advanced and high-quality film-coating products to cater to the requirements of nutraceutical and pharmaceutical manufacturers across the region of the Southeast Asia, comprising of New Zealand and Australia. With an investment of approximately USD 50 million, the strategic approach of Colorcon to be located closer to their customers will boost the ability of the company to cater to the expected growth in the region. Thus, increase in such investments over the forecast period will provide lucrative growth opportunities for the market.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work